FORMULARY DECISIONS FROM JANUARY 2012 ONWARDS

FM

G M

inut

e r

ef

Decision

MedicineRestrictions

/IndicationsPrescribers

TLL

Licens

ed? (Y/N

)

Guideline / place in therapy /rationale behind

proposed change/comments(Amber shading = amendment to netFormulary required once

further action completed)

Restriction as it appears in Formulary

entries only May 2013 onwards

(Green = netFormulary updated)

(Unshaded = netFormulary not yet updated)

(Amber = clarification required) BNF c

ate

gory

Decision

date

De

c 1

6.1

Add Degarelix 80mg,

160mg (Firmagon®)

(injection)

For treatment of advanced

hormone-dependent

prostate cancer in

accordance with NICE TA

404. Degarelix will be

reserved for patients with

spinal metastases with / or

impending spinal cord

compression

• Prescribing initiation

by or consultant

Oncologists,

continuation by GPs

once an amber

guideline is in place

Re

d

Y

• Prescribing initiation by consultant Oncologists, continuation

by GPs once an amber guideline is in place

• For treatment of advanced hormone-dependent prostate

cancer in accordance with NICE TA 404. Degarelix will be

reserved for patients with spinal metastases with / or

impending spinal cord compression.

• Degarelix will be used for the first three months of treatment,

after which it will routinely be switched to an LHRA agonist

(currently triptorelin three monthly).

The first injection will be administered by the hospital followed

by two monthly injections administered by the GP. Switch to

LHRA agonist will take place after a review by the Specialist at

three months.

Restricted- prescribing initiation by consultant

Oncologists only. For continuation by GPs once amber

guideline is in place (guideline awaiting).

For treatment of advanced hormone-dependent prostate

cancer in accordance with NICE TA 404. Degarelix will

be reserved for patients with spinal metastases with / or

impending spinal cord compression.

8.3

.4.2

(G

on

ad

otr

op

hin

-re

lea

sin

g

ho

rmo

ne

an

tag

on

ists

)D

ec-1

6

De

c 1

6.3

Add

indication

Nivolumab 10mg/ml

(solution for infusion)

4ml, 10ml

Treatment of previously

treated advanced renal cell

carcinoma, NICE TA 417

and NHSE SSC 1663, Oct

16

• Prescribing by

Consultant

Oncologists (Renal)

only

Re

d

Y

• Prescribing by Consultant Oncologists (Renal) only

• For treatment of previously treated advanced renal cell

carcinoma, NICE TA 417 and NHSE SSC 1663, Oct 16

FOR ALL PRESCRIBING - a completed and approved

HIGH COST DRUG compliance form, via BLUETEQ, is

required.

1. Restricted - prescribing by Consultant Oncologists

(Melanoma) at OUH only in accordance with:

i. NICE TA 384 for treating advanced (unresectable or

metastatic) melanoma and in accordance with NHS

England Specialised Services Circular (SSC 1617)

ii. In combination with ipilimumab for treating advanced

melanoma in accordance with NICE TA 400, Jul 16 and

NHSE Letter ref 1640 from end Oct 2016.

2. Restricted- prescribing initiation by consultant

Oncologists (Renal) only. For treatment of previously

treated advanced renal cell carcinoma in line with NICE

TA 417 and NHSE SSC 1663, Oct 16

8.1

.5

De

c-1

6

De

c 1

6.4

Add Osimertinib 40mg,

80mg (Tagrisso®) (film-

coated tablets)

• For treatment of locally

advanced or metastatic

EGFR T790M mutation-

positive non-small-cell lung

cancer in accordance with

NICE TA 416 and NHSE

SSC 1660

consultant

Oncologists (Lung)

Re

d

Y

• Prescribing by consultant Oncologists (Lung)

• For treatment of locally advanced or metastatic EGFR T790M

mutation-positive non-small-cell lung cancer in accordance with

NICE TA 416 and NHSE SSC 1660



required.

Restricted - prescribing by Consultant Oncologists

(Lung) in accordance with NICE TA 416 and NHSE SSC

1660 for treatment of locally advanced or metastatic

EGFR T790M mutation-positive non-small-cell lung

cancer. 8.1

.5 (

pro

tein

kin

ase

inh

ibito

rs)

De

c-1

6

FORMULARY DECISIONS FROM JANUARY 2012 ONWARDS - most recent decisions listed first

FMG DECISIONS DECEMBER 2016

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

De

c 1

6.5

Add Certolizumab Pegol

200mg (Cimzia®)

(injection, prefilled

syringe

• Treatment rheumatoid

arthritis in adult patients

(monotherapy or in

combination with

methotrexate) in


415 and the Bucks

Biologics in Rheumatoid

arthritis algorithm

Consultant

Rheumatologists

Re

d

Y

• Prescribing by Consultant Rheumatologists

• Treatment rheumatoid arthritis in adult patients (monotherapy

or in combination with methotrexate) in accordance with NICE

TA 415 and the Bucks Biologics in Rheumatoid arthritis

algorithm

FOR ALL PRESCRIBING - NICE compliance form

required - see link from Formulary homepage. NICE

compliance to be verified if form not yet available.

NOTE: use restricted in BHT to patients with a low

number of co-morbidities and low risk of infection and is

subject to further audit.

Restricted - prescribing by Consultant Rheumatologists

only,

1. in accordance with Biologics for Rheumatoid Arthritis

guideline (BHTCG 749FM), NICE TA 375 and NICE TA

415.

2. as an alternative first line biologic treatment for

Psoriatic Arthritis in accordance with Biologics for

Psoriatic Arthritis guideline (BHTCG 740FM) and to be

used as described for other anti TNF treatments in

Etanercept, Infliximab and Adalimumab for the treatment

of Psoriatic Arthritis (NICE TA199)or Golimumab for

Psoriatic Arthritis (NICE TA220)

10

.1.3

(C

yto

kin

e m

od

ula

tors

)

De

c-1

6

Add Tocilizumab 162mg

(sub-cutaneous

injection, pre-filled

syringe)

Add Tocilizumab

80mg/4mL,

200mg/10mL,

400mg/20mL

(RoActemra®)

(concentrate for

intravenous infusion)

De

c-1

6

De

c 1

6.7

• Treatment for Takayasu

Arteritis (TAK) in adult in

accordance to criteria

defined in NHS England

Clinical Commissioning

Policy 16056/P

• Prescribing by

consultant

Rheumatologists

following approval by

Thames Valley

Specialised

Rheumatology

Network MDT

Re

d

Y

• Treatment for Takayasu Arteritis (TAK) in adult in accordance

to criteria defined in NHS England Clinical Commissioning

Policy 16056/P

• Prescribing by consultant Rheumatologists following approval

by Thames Valley Specialised Rheumatology Network MDT.

BHT Rheumatology consultants will prescribe as outreach to

the Specialist Centre delivered as part of a provider network.

Name of Specialist centre and clinician involved in MDT to be

communicated to Formulary Team prior to initiating treatment

at BHT


required - see link from Formulary homepage. (NICE

compliance to be verified if NICE compliance form not

yet available)

1. Restricted - to Rheumatology consultant prescribing

only for treatment of rheumatoid arthritis, as an

alternative to tocilizumab IV recommendations in NICE

TA 247 and in accordance with Biologics for Rheumatoid

Arthritis guideline (BHTCG 749FM)

2. Restricted - consultant Rheumatologists following

approval by Thames Valley Specialised Rheumatology

Network MDT. For treatment for Takayasu Arteritis (TAK)

in adult in accordance to criteria defined in NHS England

Clinical Commissioning Policy 16056/P. BHT

Rheumatology consultants will prescribe as outreach to

the Specialist Centre delivered as part of a provider

network. Name of Specialist centre and clinician

involved in MDT to be communicated to Formulary Team

prior to initiating treatment at BHT

NOTE: Patients should use either IV or SC tocilizumab.

If they fail on either of the routes, they may not use the

alternative route.

10

.1.3

(C

yto

kin

e m

od

ula

tors

)

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

De

c 1

6.8

Add Rituximab

100mg/10mL,

500mg/50mL

(MabThera®)

(intravenous infusion)

• Treatment of ANCA-

associated vasculitis in

adults, NHSE Clinical

Commissioning policy

A13/P, Jan 15

• Prescribing by

consultant

Rheumatologists


Thames Valley

Specialised

Rheumatology

Network MDT.

Re

d S

pe

c C

en

tre

Y

• Treatment of ANCA-associated vasculitis in adults, NHSE

Clinical Commissioning policy A13/P, Jan 15







at BHT

De

c-1

6

De

c 1

6.9

Add Rituximab

100mg/10mL,

500mg/50mL

(MabThera®)


• Treatment of

dermatomyositis and

polymyositis (adults),

NHSE SSC Policy 1636/P

,July 2016

• Prescribing by

consultant

Rheumatologists


Thames Valley

Specialised

Rheumatology

Network MDT. R

ed

Y

• Treatment of dermatomyositis and polymyositis (adults),

NHSE SSC Policy 1636/P ,July 2016







at BHT

Add Carbocisteine

750mg/10ml oral

sachets

Gre

en

Y

As second line to carbocisteine capsules where

carbocisteine capsules cannot be swallowed

In secondary care restricted - Respiratory Team

In primary care review effectiveness after 2-4 weeks

3.7

(M

uco

lytics)

De

c-1

6

Delete Carbocisteine

250mg/5ml liquid

Bla

ck

Y

3.7

(M

uco

lytics)

De

c-1

6


required - see link from Formulary homepage.


only, in accordance with Biologics for Rheumatoid

Arthritis guideline (BHTCG 749FM) and NICE TA 195.

2. Restricted - to consultant consultant Rheumatologists

prescribing following approval by Thames Valley

Specialised Rheumatology Network MDT for:

a. treatment of ANCA-associated vasculitis in adults,

NHSE Clinical Commissioning policy A13/P, Jan 15.

b. treatment of dermatomyositis and polymyositis

(adults), NHSE SSC Policy 1636/P ,July 2016.

BHT Rheumatology consultants will prescribe as

outreach to the Specialist Centre delivered as part of a

provider network. Name of Specialist centre and clinician

involved in MDT to be communicated to Formulary Team

prior to initiating treatment at BHT

see Section 8.2.3 (for Haematology)

10

.1.3

(C

yto

kin

e m

od

ula

tors

)

De

c 1

6.1

6

• Carbocisteine sachets are cheaper in hospital and primary

care than carbocisteine 150mg in 5mL solution,

• Carbocisteine sachets are much more expensive than

capsules in hospital and primary care.

• Delete carbocisteine 250mg in 5mL solution from the

formulary

• Add carbocisteine sachets as a second line to carbocisteine

capsules when carbocisteine capsules cannot be swallowed

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

De

c 1

6.2

2

Add Elsbavir 50mg/

grazopevir 100mg

(Zepatier®) (film-

coated tablets)

• Treatment of chronic

Hepatitis C in accordance

with NICE TA 413

• Prescribing by

Consultant

Gastroenterologists/H

epatologists and

Associate Specialist

(Gastroenterology),

as part of Thames

Valley ODN

Re

d

Y

• Treatment of chronic Hepatitis C in accordance with NICE TA

413

• Prescribing by Consultant Gastroenterologists/Hepatologists

and Associate Specialist (Gastroenterology), as part of Thames

Valley ODN

• Future new hepatitis C NICE TAs and NHSE policies and

circulars need to be noted at FMG but the consultant does not

need to be present



required.

Restricted- prescribing by Consultant

Gastroenterologists/Hepatologists and Associate

Specialist (Gastroenterology), as part of Thames Valley

ODN in accordance with NICE TA 413.

05

.03

.03

.02

De

c-1

6

De

c 1

6.2

3

Add Ivacaftor 150mg

(Kalydeco®) (film-

coated tablets)

Cystic Fibrosis in

accordance with NHSE

Clinical Commissioning

Policy A01/P/c and SSC

1541,Oct 2015

• Prescribing by

Respiratory and

Paediatric

consultants only after

initiation in a

Specialist Centre and

delivered as outreach

as part of a provider

network

Re

d S

pe

c C

en

tre

Y

• For Cystic Fibrosis in accordance with NHSE Clinical

Commissioning Policy A01/P/c and SSC 1541,Oct 2015

• Prescribing by Respiratory and Paediatric consultants only

after initiation in a Specialist Centre and delivered as outreach

as part of a provider network

• The name of the Specialist centre and consultant initiating

ivacaftor to be communicated to Pharmacy Formulary Team

prior to prescribing

Restricted- prescribing by Respiratory and Paediatric

consultants only after initiation in a Specialist Centre and

delivered as outreach as part of a provider network.

For Cystic Fibrosis in accordance with NHSE Clinical

Commissioning Policy A01/P/c and SSC 1541,Oct 2015.

The name of the Specialist centre and consultant

initiating ivacaftor to be communicated to Pharmacy

Formulary Team prior to prescribing 3.7

(M

uco

lytics)

De

c-1

6

Add Sildenafil 20mg, 25mg

tablet

Add Taladafil 20mg tablet

Add Bosentan 62.5mg,

125mg

(tablet)

Restricted- prescribing by Respiratory consultants only

after initiation in a Specialist Centre. May be continued in

BHT via shared care between Specialist centre and BHT

via a network model

For pulmonary arterial hypertension in accordance with

NHSE Specialised Commissioning Policy A11/P/b, June

2014: National policy for targeted therapies for the

treatment of pulmonary hypertension in adults


initiating drug to be communicated to Pharmacy

Formulary Team prior to prescribing

See also 7.4.5 for use in erectile dysfunction

2.5

.1

De

c-1

6




via a network model







Formulary Team prior to prescribingDe

c 1

6.2

3

Prescribing by

Respiratory


initiation by a

Specialist Centre.

May be continued in

BHT via shared care

between Specialist

centre and BHT via a

network model

Re

d S

pe

c C

en

tre

Y

For pulmonary arterial hypertension in accordance with NHSE

Specialised Commissioning Policy A11/P/b, June 2014:

National policy for targeted therapies for the treatment of

pulmonary hypertension in adults

• Prescribing by Respiratory consultants only after initiation by a

Specialist Centre. May be continued in BHT via shared care

between Specialist centre and BHT via a network model


drug to be communicated to Pharmacy Formulary Team prior to

prescribing

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Ambrisentan 5mg

(tablet)

Add Macitentan 10mg (film-

coated tablets)

Add Iloprost

50micrograms/0.5mL

(injection)

Unlicensed - High Risk

1. Restricted - prescribing by Consultant vascular

surgeons, rheumatologists and dermatologists only.

See Iloprost Infusion Protocol (BHTCG 684)

2. Restricted- prescribing by Respiratory consultants

only after initiation in a Specialist Centre. May be

continued in BHT via shared care between Specialist

centre and BHT via a network model.








Add Iloprost 10

micrograms/mL

(Ventavis®) (nebuliser

solution)




via a network model








2.5

.1

De

c-1

6




via a network model







Formulary Team prior to prescribingDe

c 1

6.2

3

Prescribing by

Respiratory


initiation by a

Specialist Centre.

May be continued in

BHT via shared care

between Specialist


network model

Re

d S

pe

c C

en

tre

Y










prescribing

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Epoprostenol

500micrograms

(infusion)

1. Restricted - for use on NICU, ITU and SCBU only

2. Restricted- prescribing by Respiratory consultants

only after initiation in a Specialist Centre. May be

continued in BHT via shared care between Specialist

centre and BHT via a network model.








2.8

.1 (

Ep

op

roste

no

l)

Remove Lumacaftor/ivacaftor

200mg/125mg

(Orkambi®)

(Tablets)

Bla

ck

Y

Negative recommendation in NICE TA398 for treating cystic

fibrosis homozygous for the F508del mutation

Blacklist

3.7

De

c-1

6

Oct

16

.10

Add Belimumab 100mg,

400mg powder for

concentrate for

solution for infusion

Active autoantibody-

positive systematic lupus

erythematosus

• Initiation by

consultant

Rheumatologists

under shared care

with a Specialist

Centre. In BHT this is

generally OUH

Re

d S

pe

c C

en

tre

Y

• For treating active autoantibody-positive systemic lupus

erythematosus in accordance with NICE TA397

• Steroids, DMARDs doesn’t increase infections; maybe

regional guidelines re rel place in therapy, Centres

• Initiation by consultant Rheumatologists under shared care

with a Specialist Centre. In BHT this is generally OUH



required.

Restricted- prescribing by Consultant Rheumatologists,

under a shared care with a Specialist Centre. In BHT this

is generally OUH. Prescribing is in accordance with

NICE TA 397 and NHSE SSC 1705.

10

.1.3

De

c-1

6

Ju

n 1

6.3

Add Capsaicin 0.025%

(Zacin®)

(cream)

Gre

en

Y

• For the symptomatic treatment of osteoarthritis of the hand as

an adjunct to core treatments in line with a Bucks Osteoarthritis

treatment algorithm which needs to be developed

The algorithm should describe the following place in therapy for

capsaicin 0.025% cream::

• Step 1: Regular oral paracetamol

• Step 2: Regular oral paracetamol + topical NSAID*.

*First choice ibuprofen gel, 2nd choice diclofenac gel, 3rd

choice piroxicam gel.

After a trial of all THREE topical NSAIDs has failed due to

inefficacy, intolerance or CI

• Step 3: Regular paracetamol and oral NSAIDs

• Step 4: Regular paracetamol and codeine

• Step 5: Topical capsaicin only.when all of the above

treatments are unsuitable if

Capsaicin 0.025% cream should be prescribed for three months

maximum after which it should be stopped. It should not be

added as a repeat prescription on GP computer systems.

For the symptomatic treatment of knee and hand

osteoarthritis as an adjunct to core treatments in line

with Bucks Osteoarthritis treatment algorithm (BHTCG

819FM).

Capsaicin 0.025% cream should be prescribed for three

months maximum after which it should be stopped. It

should not be added as a repeat prescription on GP

computer systems.

10

.3.2

De

c-1

6D

ec-1

6

Prescribing by

Respiratory


initiation by a

Specialist Centre.

May be continued in

BHT via shared care

between Specialist


network model

Re

d S

pe

c C

en

tre

Y










prescribing

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Fe

b 1

5.5

Add Adapalene/Benzoyl

Peroxide 0.1%/ 2.5%

(Epiduo®) gel

Gre

en

Y

Epiduo® was approved for formulary inclusion as follows:

• Prescribing by all prescribers in hospital and primary care

(Green on the traffic light list)

• For the treatment of acne in line with BAD/ CKS guideline on

acne vulgaris and the Bucks acne treatments algorithm as a

second line topical fixed dose combined agent when first line

topical fixed dose combinations (Duac® or Isotrexin®) are

either ineffective or unsuitable

For use in accordance with the Bucks Acne Treatment

Algorithm.

13

.6.1

De

c-1

6

Fe

b 1

5.5

Add Benzoyl

Peroxide/Clindamycin

5%/ 1% (Duac® Once

Daily) gel

Gre

en

Y


Algorithm.

13

.6.1

De

c-1

6

Fe

b 1

5.5

Add Erythromycin/Isotretin

oin 2%/0.05%

(Isotrexin®) gel

Gre

en

Y


Algorithm.

13

.6.1

De

c-1

6

Fe

b 1

5.5

Reject Erythromycin/Tretinoi

n 0.025%/ 4%

(Aknemycin®) solution

Bla

ck

Y

Reviewed as part of acne treatment algorithm

13

.6.1

De

c-1

6

Fe

b 1

5.5

Reject Clindamycin/ Tretinoin

1%/0.025% (Treclin®)

gel

Bla

ck

Y

Reviewed as part of acne treatment algorithm

13

.6,1

De

c-1

6

De

c 1

6.2

5 Add Metolazone tablet

2.5mg Re

d

N

5mg tablet is formulary and 2.5mg is also in use. Both are

unlicensed and 2.5mg added to formulary already as result of

first unlicensed meeting.

2

De

c-1

6

Delete Streptokinase 250,000

iu Bla

ck

N

No longer available and not ordered for more than 2 years

De

c-1

6

Add Streptokinase 1.5MU

Re

d

N

In small but regular use. Movianto is supplier

De

c-1

6

DeletePhosphate buffered

0.83mmol/ml

bla

ck

N

No use in community

Not on JAC. Eastbourne DGH may manufacture but not

ordered in years.

9

De

c-1

6

• For the treatment of moderate acne at risk of scarring when

use of monotherapy (benzoyl peroxide or a retinoid) is

ineffective, in line with BAD/CKS guidance.

• Green on the traffic light list

• Joint second line options (after monotherapy with benzoyl

peroxide or a retinoid has been unsuccessful)

FORMULARY MEDICINES TRAFFIC LIGHT CLASSIFICATION DECEMBER 2016

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

TLL

Phosphate buffered

solution saline pH 7.4

inj

Re

d

N

All use in by Burns Unit and manufactured by Tayside

P'ceuticals.

20 issued per year

Special and needs risk assessment and updating of JAC

9

De

c-1

6

TLL

Phosphate Mixture (JR

formula) 527mmol/litre -

Unlicensed - low risk

Re

d

N

No use in community

70-90 per yr. £20.65 per 100mL. Virtually all use is by

Paediatrics/NICU 9

De

c-1

6

TLLCalcium acetate tablets

1g

AI

NRestricted - initiation in secondary care with continuation by

GPs. Unlicensed - low risk9

De

c-1

6

TLL

Cefuroxime 125/5

AR

an

d B

lack

N

£23.75 / 180 3 issued 15/16 and 10 to date 16/17 5

De

c-1

6

TLL

Cefuroxime 125mg,

250mg tabs AR

an

d

N

Agreed AR with CCG 5

De

c-1

6

TLL

Fusidic acid 250mg/5mL

AR

N


De

c-1

6

TLL

Fusidic acid tablets

250mg

AR

N


De

c-1

6

Revise

restriction

Clindamycin capsules

75mg, 150mg

Gre

en

N

Expand note on formulary for all regarding opening of capsules

and mixing with food/liquid in place of suspension. Primary

care already have this note and Micro suggested this when

Chapter 5 Traffic light classification was discussed.

In secondary care restricted - Microbiology approval

required for use in patients over 85 years of age, but

caution in prescribing for any patient over 65 years due

to increased risk of Clostridium difficile associated

diarrhoea

In primary care 2nd/3rd line choice in cellulitis and 2nd

line in dental abcesses. No other indications for use

identified in primary care antibiotic guidelines.

NOTE: If patient cannot swallow capsules they can be

opened, dispersed in water and administered.

5

De

c-1

6

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Revise

restriction

Clindamycin suspension

75mg/5mL Re

d

N

NOTE: If patient cannot swallow capsules they can be opened

and dispersed in water and administered. Only prescribe

suspension if patient cannot swallow capsules or manage to

open and disperse contents of capsule.

Savings may be possible for BHT if stop using suspension

Unlicensed - Medium risk

In secondary care restricted - Microbiology approval

required for use in patients over 85 years of age, but

caution in prescribing for any patient over 65 years due

to increased risk of Clostridium difficile associated

diarrhoea. Use in accordance with Recommended

Empirical Antibiotic Regimens for Common Hospital

Infectious Conditions (BHTCG 279)

NOTE: If patient cannot swallow capsules they can be

opened and dispersed in water and administered. Only

prescribe suspension if patient cannot swallow capsules

or manage to open and disperse contents of capsule.

5

De

c-1

6

DELETEAlpha Tocoppheryl

Acetate tablets 50mg,

200mg

Bla

ck

N50mg not listed on JAC and not use of 200mg for several

years. Using licensed suspension in place

9

De

c-1

6

ADD Amylmetacresol/Dichlor

obenzyl lozenges

(Strepsils)

Re

d

Y

Missed being added to netFormulary at upload.

Formulary states: In community patients to purchase OTC

12

De

c-1

6

ADD Benzocaine/Cetylpyridin

ium chloride

10mg/1.4mg

(Merocaine) lozenge

Gre

en

Y

Added note to formular: yIn community encourage patient to

purchase OTC.

12

De

c-1

6

Revise Haloperidol

500micrograms

Gre

en

Y

Sometimes tablets are cheaper and other times capsules are

cheaper. Added option of tab or cap for the 500microgram.

4

De

c-1

6

Revise

restriction

Sotalol tablets 40mg,

80mg

AR

an

d B

lack Y Amber Recommendation - restricted to recommendation

by secondary care with continuation by GPs for anti-

arrhythmic treatment only.

Black - Not to be prescribed to treat hypertension

2

De

c-1

6

Agreed TLL

and

restriction

Naftidrofuryl capsules AI

Y Restricted - to be initiated in secondary care with

continuation by GPs in accordance with NICE TA223 for

the treatment of intermittent claudication in people with

peripheral arterial disease.

Agree with CCG as part of TLL/Unlic work

2

De

c-1

6

Delete Doxepin tablets

Bla

ck Y Not been used since 2012. Only appear in Ox Health formulary

under a Dermatology entry (Xepin), 5% cream.

4

De

c-1

6

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Delete Gabapentin suspension

250mg/5mL Bla

ck N Removed from formulary as licensed solution now available

from Rosemont p'ceuticals

4

De

c-1

6

Add Gabapentin solution

50mg/1mL

Gre

en Y Replaced unlicensed product with same restriction: May be prescribed generically (see link to MHRA

Epilepsy alert above)

Before prescribing, consider opening gabapentin

capsules (this is preferable and is more cost effective)

Restricted - only for use in patients who, cannot swallow

capsules and are unable to manage opening the

capsules.

4

De

c-1

6

Revise

restriction

Zuclopenthixol acetate

50mg/1mL, 100mg/2ml

Clopixol Acuphase

Re

d Y Restricted - initiation by Consultant Psychiatrist (Mental

Health Trust) only.

IMPORTANT NOTE:- when prescribing, dispensing or

administering, check that this is the correct preparation -

this preparation is usually used in hospital for an acute

episode and should not be confused with depot

preparations which are usually used in the community or

clinics for maintenance treatment.

4

De

c-1

6

Revise

restriction

Tuberculin 2u/0.1ml

Gre

en CCG requested addition of note to formulary stating:

"Public Health responsible for testing in Primary Care"

14

Revise

restriction

Tuberculin 10u/0.1mlG

reen CCG requested addition of note to formulary stating:

"Public Health responsible for testing in Primary Care"

14

TLL Lidocaine

HCl/adrenaline 2%/

1:80000 2.2mL cartridge

Re

d Y Injection - red

No use in community

15

TLL Lidocaine 0.5%, 10mL

amps Re

d Y Injection - red

No use in community

15

TLL Lidocaine HCl

2%/adrenaline

1:200,000 10ml vial

Re

d N Injection - red

No use in community

15

TLL Ethyl Chloride

Re

d Make red as not likely to be prescribed 15

Add Paraldehyde 50% in

olive oil

red N replacing paraldehyde in sunflower oil. Medium Risk Unlicensed- medium risk 4

Delete Paraldehyde 50% in

sunflower oil Bla

c N Not ordered for years by BHT 4

Delete Paraldehyde injection

Bla

ck N Only enema referred to in BHT CG 383 Epilepsy in Children.

No use at BHT in several years

4

Add Triclosan 1% surgical

scrub Re

d In regular use by theatres in Trust 13

De

c-1

6

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Hydrogen Peroxide

Sterile 10 volume 3%, Re

d N In regular use by theatres in Trust . Unlicensed - Low Risk Unlicensed- low risk 13

Add Lidocaine HCl

2%/adrenaline

1:200,000 20ml

multidose vial

Gre

en Y 10mL vial is unlicensed and used across BHT. Multidose

widely used by CCG. Add to formulary

15

Delete Povidone iodine 10%

alcoholic paint 8mL Bla

ck No longer available 13

Delete Furosemide solution

1mg/1mL Bla

ck N Removed when paediatric liquids reviewed by BHT. Unlicensed 2

DELETE Neostigmine tablets

15mg

Bla

ck? Y No longer unlicensed. Amend formulary to remove unlicensed

symbol and primary care comment regarding availability.

Check with ITU lead as to whether these should remain on

formulary as not ordered in many years (OCt12).

2

Delete Chloral hydrate

suppositories 60mg Bla

ck N No use in years. Retain 50mg as red and delete the 60mg 4

TLL Chloral hydrate

suppositories 50mg Re

d N 4

revise

restriction

Clonazepam

500micrograms, 2mg

tablets

gre

en Y Add note saying tablets disperse easily in water as a more cost

effective option if patients cannot swallow tablets. Info from MI

25Nov16 Clonazepam tablets disperse quite easily in water. If

giving down an NG tube, should be dispersed in about 30mL of

water before administration (the large volume of water is

necessary to stop the clonazepam from sticking to the feeding

tube)

Prescribing generically or by brand is discretionary

NOTE: tablets disperse quite easily in water and are a

more cost effective option for patients who cannot

swallow tablets. If giving down an NG tube, disperse in

30mL water before administration. The large volume of

water is to stop the clonazepam sticking to the NG tubing

4

revise

restriction

Clonazepam oral

solution

500micrograms/5mL

AI

Y Add note saying tablets disperse easily in water as a more cost

effective option if patients cannot swallow tablets.


Restricted - initiation by Psychiatric team only for use

when patient cannot swallow tablets.

NOTE: Clonazepam tablets disperse easily in water and

are a more cost effective option for patients who cannot

swallow the tablets.

4

TLL Lidocaine 0.5%

/Adrenaline 1:200,000

10mL amps

Re

d N Injection - red

No use in community

15

De

c-1

6

TLL LidocaineHCl

1%/adrenaline

1:200,000 10ml

Re

d N Injection - red

No use in community

15

De

c-1

6

ADD Lidocaine HCl

2%/adrenaline

1:200,000 20ml

multidose vial

Gre

en Y Not currently on formulary but in regular use in community.

CCG agree green. Not currently in use at BHT.

15

De

c-1

6D

ec-1

6D

ec-1

6

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Delete Amobarbital sodium

200mg cap

Amobarbital

sodium/secobarbital

sodium caps

50mg/50mg

Butobarbital tablet

Bla

ck No longer in use 4

De

c-1

6

DELETE Lidocaine 0.5%

/Adrenaline 1:200,00

pre-filled syringe

Bla

ck Y No longer available. 15

De

c-1

6

Revise

restriction

Theophylline 60mg,

125mg, 250mg (Slo-

Phyllin) MR capsule Gre

en Y Add note to formulary: for patients who experience difficulty in

swallowing capsules, the contents of a capsule may be

sprinkled on to a spoonful of soft food, e.g. yoghurt.

NOTE: For patients who cannot swallow the capsules,

the contents of the capsule can be opened and sprinkled

onto a spoonful of soft food eg yoghurt.

3

De

c-1

6

Revise

restriction

Theophylline 200mg,

300mg, 400mg

(Uniphyllin Continus®)

(MR tablet)

Gre

en N Add note to formulary: Tablets should be swallowed whole and

not crushed or chewed.

3

De

c-1

6

Revise

restriction

Theophylline oral

solution 60mg/5mL

?? N 15 (15/16), 7 issued yr to date

Agree addition of note saying the capsules can be opened and

sprinkled on food.

Traffic light position still not agreed. Ideally if all patients were

on Slophyllin the capsules could be opened and sprinkled if

patient unable to swallow capsules. Further discussion/work

required on switching all patients to Slophyllin as more cost

effective and consistent levels.

Restricted - Phone Pharmacy to Order.

unlicensed - LOW risk

Named patient

NOTE: For patients who cannot swallow capsules, the

contents of the capsules (Slo-Phyllin®) can be opened

and sprinkled onto a spoonful of soft food eg yoghurt.

3

De

c-1

6

Revise

restriction

Indometacin 25mg/5ml

suspension Re

d N Propose addition of note to formulary suggesting Ibuprofen as a

liquid alternative if treatment with a liquid is to be continued in

the community. The unlicensed indometacin and naproxen are

very costly.

Need agreement from Rheumatology? Paeds?

10

De

c-1

6

Revise

restriction

Naproxen 125mg/5ml

suspension Re

d Y Propose addition of note to formulary suggesting Ibuprofen as a

liquid alternative if treatment with a liquid is to be continued in

the community. The unlicensed indometacin and naproxen are

very costly.

Need agreement from Rheumatology? Paeds?

When first discussed at FMG it was agree to hold at Red until

such time as it was needed or removed.

11Feb15 Sally Edmonds, Cons Rheu agreed that first

prescription to be written in secondary care. She would also be

happy with AR if GPs agree. Usage is virtually nil so AR not

really appropriate. No use in community at all. Keep as red for

now but consider removal from formulary once discussed with

Rheumatology and Paeds.

10

De

c-1

6

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Change from

Unlic to

Licensed

Cocaine 10% sterile

solution Re

d N 24Nov16 Change status on Formulary from unlicensed to

licensed. MI noted a licensed product is now available from

Martindale. Cease buying unlicensed from Huddersfield.

15

De

c-1

6

Revise

restriction

Spironolactone

suspension - all

strengths Gre

en N CCG have agreed all green but current formulary wording

states initiation in secondary care with continuation by GPs

which suggests amber initiation, therefore remove this wording

if green.

Note that it is more cost effective to crush the tablets is already

on the formulary.

2

De

c-1

6

ADD Spironolactone

suspension 10mg in

5mL Gre

en N In use in community and not at BHT. Paed Liq review for BHT

recently removed all strengths except the 25/5.

DT prices for 125mL are:

5/5 £51.86, (£2.07 per dose) 10/5 £58.58 ( £1.17 per 5mg

dose)

25/5 £39.24 (£0.31 per 5mg dose) 50/5 £62.51 (£0.25 per

5mg dose)

The 25/5 is significantly more cost effective than the 10/5

Note to crush tablets is already on formulary.

Note added to formulary: not in use in secondary care, primary

care use only.

2

De

c-1

6

Revise

restriction

Spironolactone

suspension 5mg in 5mL Bla

ck N Note to be added to formulary: not in use in secondary care,

primary care use only.

2

De

c-1

6

Revise

restriction

Spironolactone

suspensions

Gre

en Add a note to this entry saying that only the 25mg in 5mL is to

be used in secondary care.

Add second note labelling this as the most cost effective

formulation.

In primary care 44 issued in last year £3344

2

De

c-1

6

De

c 1

6.2

4 Add

restriction

Alpha Tocopheryl

Acetate 500mg/5mL

(Vitamin E)

Gre

en

Y

Super high doses are for metabolic disorders and require

specialist input

Dose according to specialist recommendation in Cystic

Fibrosis and RDA in other conditions (green on TLL)

9.6

.5

De

c-1

6

Add Alpha Tocopheryl

Acetate 500mg/5mL

(Vitamin E)

(suspension)

Re

d

N

As above Restricted- for treatment continuation in metabolic

disorders, only after initiation by tertiary specialist

centres (e.g. Oxford - John Radcliffe) .

9.6

.5

De

c-1

6

Change TLL Naltrexone

Hydrochloride 50mg

(tablet) Re

d

Y

Oxford Health have discussed and red-listed this (this is how it

appears on Oxford Health formulary)

Restricted - Initiation by Mental Health Trust physicians

only

4.1

0.3

De

c-1

6

unlicensed - Low risk

NOTE 1: before prescribing a suspension consider the

more cost effective option to crush the tablets.

NOTE 2: only 25mg/5mL in use in secondary care.

NOTE 3: 25mg/5mL liquid is the most cost effective of

the available liquid formulations.

BHT FORMULARY CHANGE TO NOTE Dec 2016

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Kerramax Care 20 cm

x 50 cm

Gre

en

Y

Available from ONPOS

19

.1.3

De

c-1

6

Add Nomegestrol acetate

2.5mg/ estradiol 1.5mg

tablets (Zoely®) Bla

ck

Y

New drug never discussed

7.3

.1

De

c-1

6

Add Ivermectin 10mg/g

cream

Bla

ck

Y


13

.6

De

c-1

6

Add Avanafil 50mg, 100mg,

200mg tablets

Bla

ck

Y


7.4

.5

De

c-1

6

Add Triamcinolone

acetonide 0.1%

oramucousal paste Bla

ck

Y

Discontinued

12

.3.1

De

c-1

6

Add Calipostriol

50micrograms/g /

Betametasone 0.5mg/g

cutaneous foam

(Enstilar®) Bla

ck

Y


13

.5.2

De

c-1

6

Add Chlorhexidine 2% in

70% IPA wipes (Sani-

Cloth®) Re

d

Y

New product following disinfectant products review in BHT.

Confirmed with Claire Brandish, anti-infectives pharmacist

Available via Supplies.

For peripheral line insertion, venepuncture and hub and

connection port cleaning.

13

.11

.3

De

c-1

6

Remove

brand name

Fludroxycortide

4micrograms/cm2

(Haelan®)

(tape)

Gre

en

Y

Note Branded haelan tape has been discontinued as of

Nov 2016. This is now available as generic

13

.4

De

c-1

6

Change TLL Hydrocortisone

2mg/mL

(suspension)

Bla

ck

Y

Current formulary states In primary care not recommended as a

pharmaceutical special, consider lozenges or a soluble steroid

tablet. In secondary care we never use this as mouthwash. Also

confirmed with paeds not used. 12

.3.1

De

c-1

6

Add note Hydrocortisone 2.5mg

(mucoadhesive buccal

tablet)

Gre

en

Y

In primary care hydrocortisone suspension is not

recommended as unlicensed, consider licensed

alternatives (e.g. lozenges or soluble steroid tablets)

12

.3.1

De

c-1

6

Add Hydrocortisone

1mg/mL

(suspension)

Gre

en

Y

Paeds pharmacists requested in the past.

Wanted the 5mg/5mL as that is what they use in Oxford and

often we get patients transferred across to us so it makes

sense from a continuity of care point of view. Hydrocortisone

tablets are very difficult to crush.

Risk assessed as LOW.

Restricted- for use in paediatrics.

6.3

.2

De

c-1

6

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add ACD-A Anticoagulant

Citrate Dextrose

Solution

Re

d

Y

This is already stocklist in Wycombe theatres but not on

formulary. It is used for the cell saver machines which allow

theatres to give patients their own blood back. Theatres are

worried it would be a risk to use a bag of saline that you would

need to add heparin to rather than having a pre-made bag of

ACD which is easier to differentiate.

Restricted- for use in theatres for cell salvage

2.8

.1

De

c-1

6

Add

indication

Fibrin Sealant

(Tisseel®)

(Ready to use syringe)

Re

d

Y

Expected use is average of 2 packs per month. Cost agreed

with SDU

• Restrictions:

o Prescribing by Cardiology Consultant only

o For use in patients at increased risk of bleeds during device

implant or box change procedures

Restricted - for use by:

1. Spinal surgeons

2. Anterior segment procedures in Ophthalmology

3. Cardiology Consultant for use in patients at increased

risk of bleeds during device implant or box change

procedures

16

.1

De

c-1

6

Add note Moxifloxacin 400mg

tablets

AR Y

For use in accordance with BHT CG 133 Management and

antibiotic therapy for respiratory tract conditions in adults for

patients who are penicillin-allergic and with a CURB-65 score of

2.

In secondary care restricted:

1. for use in accordance with BHT CG 133 Management

and antibiotic therapy for respiratory tract conditions in

adults for patients who are penicillin-allergic and with a

CURB-65 score of 2

2. Ophthalmology patients.

For all other uses Microbiology approval required.

May be recommended by specialist in secondary care

with continuation by GPs

5.1

.12

De

c-1

6

Add note +

restriction

Moxifloxacin

400mg/250mL

(intravenous infusion)R

ed

Y

As above and IV is 3 x more expensive than oral. Oral

bioavailability is 92%

Restricted- only to be used if nil by mouth or nausea and

vomiting. Oral bioavailability is good.

For use in accordance with BHT CG 133 Management

and antibiotic therapy for respiratory tract conditions in

adults for patients who are penicillin-allergic and with a

CURB-65 score of 2.

For all other uses Microbiology approval required.

5.1

.12

De

c-1

6

Amend link Liraglutide 6mg/mL

(injection, 3mL

prefilled pen Am

be

r

Y

NICE TA 203 has been superseded by NICE NG28

6.1

.2.3

De

c-1

6

Amend link Exenatide 2mg

(Bydureon®)

(MR injection, vial and

pre-filled pen) Am

be

r

Y

NICE TA 203 has been superseded by NICE NG28

6.1

.2.3

De

c-1

6

Amend

licensed

status

Cocaine

Hydrochloride 10%

(topical sterile

solution)

Re

d

Y

There is now a licensed cocaine solution 10% which is made by

Martindale. Originally buying unlicensed preparation

15

.2

De

c-1

6

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Amend

restriction

Tacrolimus

500micrograms, 1mg,

5mg (Prograf®,

Adoport®)

(capsule)

Re

d

Y

Currently bullet point 2- formulary states for transplant patients

but not quite clear. Also it still states that patients under shared

care by GP would be transferred back to secondary care

prescribing by April 2016- which is passed the deadline.

1. Restricted - to prescribing by Consultant

Dermatologists (see Section 13.05.03)

2. Restricted - to prescribing by Consultant Renal

physicians and other consultants for transplant patients

after initiation by a Specialist Centre.

3. Restricted - to prescribing by Consultant

Gastroenterologists for autoimmune hepatitis following

initiation by a Specialist Centre

Oral Tacrolimus products should be prescribed and

dispensed by brand name only (MHRA drug safety

update, June 2012). Adaport® brand is the first choice.

8.2

.2

De

c-1

6

Amend

restriction

Tacrolimus

500micrograms, 1mg

(Progaf®, Adoport®)

(capsule)

Re

d

Y

Restricted - to prescribing by Consultant Dermatologists

Adaport® brand is the first choice. If changing brands,

monitoring is required.



update, June 2012)

see also Section 08.02.02

13

.5.3

De

c-1

6

Add link Prednisolone 1mg,

5mg, 25mg

(tablet)G

reen

Y

Add link to leaflet as prednisolone 5mg tablets can be

crushed

http://www.medicinesforchildren.org.uk/prednisolone-

asthma 6.3

.2

De

c-1

6

Add Riluzole 25mg/5ml

(liquid)

Re

d

Y

Confirmed with the neurologists that they are not stopping

riluzole when patients are NBM. They have requested to be

used for patients who are on PEG- which is not easy for

patients to manage in their own homes

Restricted to patients who cannot swallow riluzole tablets

4.9

.3

De

c-1

6

Add size Sodium Hyaluronate

10mg in 1ml pre-filled

syringe

Re

d

Y

Cheaper alternative brand available

11

.99

.99

.99

De

c-1

6

Oct

16

.3

Add

indication

Radium-223 dichloride

1000 kBq/ml (Xofigo®)

(solution for injection)

For treating hormone-

relapsed prostate cancer

with bone metastases in


412

OUH Oncologists

only

Re

d

Y

NICE TA 376 replaced with NICE TA 412 published September

2016.

Approved for:

• Prescribing by OUH Oncologists only

• For treating hormone-relapsed prostate cancer with bone

metastases in accordance with NICE TA 412

Restricted - prescribing by consultant oncologists at

OUH only for the treatment of hormone-relapsed

prostate cancer with bone metastases in accordance

with NICE TA 412

8.3

.4.2

Oct-

16

FMG DECISIONS OCTOBER 2016

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Oct

16

.4

Add

indication

Pemetrexed 500mg

(injection)

For maintenance treatment

for non-squamous non-

small-cell lung cancer after

pemetrexed and cisplatin in


402 and NHSE SSC 16 47

Consultant

Oncologist (Lung)

Re

d

Y

• For maintenance treatment for non-squamous non-small-cell

lung cancer after pemetrexed and cisplatin in accordance with

NICE TA 402 (Aug 2016) and NHSE SSC 16 47.

• Prescribing by consultant Oncologist (Lung)

FOR ALL PRESCRIBING: NICE compliance form

required - see link from Formulary homepage or via

Blueteq. NICE compliance to be verified if form not

available.

1. Restricted - Consultant Oncologist prescribing only in

accordance with NICE TA 181.

2. Restricted - prescribing by Oncologists only, in


3. Restricted - prescribing by Oncologists only, in


4. Restricted - prescribing by consultant Oncologists

(Lung) only. For maintenance treatment for non-

squamous non-small-cell lung cancer after pemetrexed

and cisplatin in accordance with NICE TA 402 and NHSE

SSC 16 47

8.1

.3

Oct-

16

Oct

16

.5

Add Crizotinib 250mg

capsules (Xalkori®)

For untreated anaplastic

lymphoma kinase-positive

advanced non-small-cell

lung cancer in accordance

with NICE TA 406

Consultant

Oncologist (Lung)

Re

d

Y

• for untreated anaplastic lymphoma kinase-positive advanced

non-small-cell lung cancer in accordance with NICE TA 406

• Prescribing by consultant Oncologist (Lung)


required - see link from Formulary homepage or via

Blueteq. NICE compliance to be verified if form not

available.

Restricted - prescribing by consultant Oncologists (Lung)

only. For untreated anaplastic lymphoma kinase-positive

advanced non-small-cell lung cancer in accordance with

NICE TA 406

8.1

.5

Oct-

16

Oct

16

.6

Add Trifluridine-tipiracil

15mg/6.14mg,

20mg/8.19mg film-

coated tablets

(Lonsurf®)

For previously treated

metastatic colorectal

cancer in accordance with

NICE TA 405 and NHSE

SCC 1662

Consultant

Oncologists

Re

d

Y

• For previously treated metastatic colorectal cancer in

accordance with NICE TA 405 and NHSE SCC 1662

• Prescribing by consultant Oncologists

FOR ALL PRESCRIBING: NICE compliance form via

Blueteq required.

Restricted - prescribing by consultant Oncologists. For

previously treated metastatic colorectal cancer in


8.1

Oct-

16

Oct

16

.7

Add Talimogene

laherparepvec

solution for injection

(Imlygic®)

Treatiment of unresectable

metastatic melanoma.

NICE TA 410

OUH Consultant

Oncologists (Skin)

Re

d

Y

• Prescribing by OUH Consultant Oncologists (Skin)

• Treatiment of unresectable metastatic melanoma. NICE TA

410

Restricted - prescribing by OUH consultant Oncologists

(skin). For treatment of unresectable metastatic

melanoma in accordance with NICE TA 410. 8.2

.4

Oct-

16

Oct

16

.8

Add Bosutinib 100mg,

500mg film-coated

tablets (Bosulif®)

previously treated chronic

myeloid leukaemia in


401 and NHSE SCC 1661

Consultant

Haematologists

Re

d

Y

• for previously treated chronic myeloid leukaemia in


• prescribing by consultant Haematologists only


Blueteq required.

Restricted - prescribing by consultant Haematologists.

For previously treated chronic myeloid leukaemia in

accordance with NICE TA 401 and NHSE SSC 1661.

8.1

.5 (

Pro

tein

kin

ase

inh

ibito

rs)

Oct-

16

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Revise

restriction

Palivizumab 50mg,

100mg

(injection)

Use in accordance with

SSC 1646 Palivizumab (To

reduce the risk of RSV in

High Risk Infants) for the

2016 Vaccination Season

Consultant

Paediatricians

Re

d

Y

Amend entry to state Blueteq form required and in line with

SSC 1646


Blueteq required.

Restricted - prescribing by consultant Paediatricians. To

reduce risk of RSV in high risk infants, in accordance

with JCVI criteria and SSC 1646 palivizumab for the

2016 vaccination season.

5.3

.5

Oct-

16

Add Atarulen 125mg,

250mg, 1000mg

granules for oral

suspension

Use in accordance with

SSC 16 33 NICE HST3

Ataluren for treating

Duchenne muscular

dystrophy with a nonsense

mutation in the dystrophin

OUH Specialist

centre

Re

d

Y

• use in accordance with SSC 16 33 NICE HST3 Ataluren for

treating Duchenne muscular dystrophy with a nonsense

mutation in the dystrophin gene July 16 and NHSE Aug 16.

• Prescribable by OUH Specialist Centre only; not prescribable

by BHT

Restricted- prescribing by OUH specialist centre only,

not prescribable by BHT. For treatment of Ducehenne

muscular dystrophy with a nonsense mutation in the

dystrophin gene in accordance with SSC 16 33 NICE

HST3 and NHSE Aug 16.

10

.2.1

Oct-

16

Add Bedaquiline 100mg

tablets

Add Delamanid 50mg

tablets

Revise

restriction

Sofosbuvir/Ledipasvir

400mg/90mg

(Harvoni® )

(tablet)



required.

Restricted - prescribing by Consultant



ODN in accordance with NICE TA 363 or NHSE

Commissioning Policy statement 1524, June 2015 -

Hepatitis C with cirrhosis and NHSE SSC 1615. All

patients will be discussed in the ODN MDT.

Revise

restriction

Daclatasvir 30mg,

60mg (Daklinza®)

(tablet)



required.








use in accordance with SSC 1645: Bedaquiline and Delamanid

for defined patients with Multidrug-Resistant/Extensively Drug-

resistant Tuberculosis (MDR/XDR-TB)

Prescribing by OUH Specialists in multiple resistant TB only -

not BHT, blueteq approval form required


Blueteq required.

Restricted- prescribing by OUH specialists only, not

prescribable by BHT. Use in multidrug-resistant TB in

accordance with NHSE SSC 1645.

5.1

.9

Oct-

16

Restricted -

prescribing by

Consultant


epatologists and


(Gastroenterology),

as part of Thames

Valley ODN

Re

d

Y

Amend entry to include SSC 1615 implementation of NICE Tas

363, 364, 365

5.3

.3.2

Oct-

16

Oct

16

.12

use in accordance with

SSC 1645: Bedaquiline

and Delamanid for defined

patients with Multidrug-

Resistant/Extensively Drug-

resistant Tuberculosis

(MDR/XDR-TB)

Prescribing by OUH

Specialists in multiple

resistant TB only - not

BHT

Re

d

Y

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Revise

restriction

Viekirax

12.5mg/75mg/50mg

(tablet)

Contains: Ombitasvir/Paritaprevir/Ritonavir



required.








Add note Chapter 5.3.1

Re

d

Y

New NHSE Clinical Commissioning Policy F03/P/c • HIV

treatment as prevention in infection adults

Prescribing of all HIV medicines restricted to

Genitourinary (GUM) consultants only. Traffic light list:

Red

• HIV treatment as prevention in infection adults in

accordance to NHSE Clinical Commisioning Policy

F03/P/c 5.3

.1

Oct-

16

Remove

note

Fluphenazine

Decanoate 25mg/1mL

(injection (oily))

Remove

note

Fluphenazine

Decanoate

50mg/0.5mL,

100mg/1mL

(injection (oily))

Change TLL Mianserin

Hydrochloride 10mg,

30mg

(tablet)

Bla

ck

Y

Black on Oxford Health formulary no use in primary or

secondary care

4.3

.1

Oct-

16

Add

restriction

Tisseel Ready to use

(Baxter)

Spinal surgeons,

opthamologists

Re

d

Y

Currently on formulary for spinal use only. Opthamologists

proposed to use for gluing the conjunctival autograft after

pterygium excision. It has amazing results, both in terms of

postoperative inflammation (the lack of it with the use of glue as

opposed to sutures) and surgical time (shorter by about

20minutes).

Restricted- for use by:

1. Spinal surgeons

2. Anterior segment procedures in Ophthalmology

16

.1

Oct-

16

Restricted -

prescribing by

Consultant


epatologists and


(Gastroenterology),

as part of Thames

Valley ODN

Re

d

Y

Amend entry to include SSC 1615 implementation of NICE Tas

363, 364, 365

5.3

.3.2

Oct-

16

Oct

16

.12

Oct-

16

Oct

16

.15

Am

be

r

Y

Stock now available from Sanofi Sep 16. Remove previous

notes stating that this was not available and then available

again

Protocol in development

4.2

.2

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add note Dexamethasone

500micrograms, 2mg

(tablet)

Gre

en

Y

Add for 2mg: "use soluble tablets as they are currently cheaper

than plain tablets Oct 16"

Note for 2mg tablets: Use soluble 2mg tablets as they

are currently cheaper than plain 2mg tablets Oct 16

6.3

.2

Oct-

16

Add Dexamethasone 2mg

soluble tablets

Gre

en

Y

"soluble tablets are currently cheaper than plain tablets and are

therefore recommended for all uses Oct 16"

Note soluble tablets are currently cheaper than plain

2mg tablets and are therefore recommended for all uses

Oct 16

6.3

.2

Oct-

16

Ju

n 1

6.6

Add Medroxyprogesterone

acetate 104 mg in 0.65

mL subcutaneous

prefilled injector

device (Sayana

Press®) Gre

en

Y

• As an alternative to IM medroxyprogesterone acetate injection

for patients who wish to self administer (following training)

• Prescribable in primary or secondary care.

• As an alternative to IM medroxyprogesterone acetate

injection for patients who wish to self administer

(following training)

See video training links below for further information:

For Health Care Professionals:

https://www.youtube.com/watch?v=H_BH7RWfPWI

For patients:

https://www.youtube.com/watch?v=hi2o-mlQJjc

07

.03

.02

.02

Oct-

16

Ju

n 1

6.1

1a

Add Sacubitril/Valsartan

24mg/26mg

49mg/51mg

97mg/103mg

(tablet

For treating symptomatic

chronic heart failure with

reduced ejection fraction in


388

Initiation by

consultant

Cardiologists, dose

titration and

monitoring by the

heart failure team for

the first three months

prior to transfer to the

G

Am

be

rY

For treating symptomatic chronic heart failure with reduced

ejection fraction in accordance with NICE TA 388 in people

with:

• with New York Heart Association (NYHA) class II to IV

symptoms and

• with a left ventricular ejection fraction of 35% or less and

• who are already taking a stable dose of ACE inhibitors or

ARB.

Initiation by consultant Cardiologists, dose titration and

monitoring by the heart failure team for the first three months

prior to transfer to the GP in accordance with an amber

initiation guideline.

Restricted - initiation by Consultant cardiologists for

treating symptomatic chronic heart failure with reduced

ejection fraction in accordance with NICE TA388. Dose

titration and monitoring by the heart failure team for the

first three months prior to transfer to the GP in

accordance with Sacubitiril Valsartan for Symptomatic

Chronic Heart Failure - Secondary/ Primary Care

Guideline (BHTCG 817FM) 2.5

.5.2

Oct-

16

Oct

16

.15

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Ju

n 1

6.1

5

Add Insulin Glargine

300units/mL

(injection)

For treatment of type 1 or

type 2 diabetes in patients

who are already receiving

an optimised insulin

regimen AND:

• receiving basal analogue

insulin at a high dose

(more than 80 Units in a

single dose) in order to

reduce injection volume

OR

• receiving insulin glargine

100 Units/mL and

experiencing nocturnal

hypoglycaemia OR

requiring more flexibility in

injection timing

Prescribing initiation

by Consultant

Diabetologists or

Diabetes Specialist

Nurses only, dose

titration on the advice

of Diabetes Specialist

Nurses, continuation

by GPs

Am

be

r

Y

For treatment of type 1 or type 2 diabetes in patients who are

already receiving an optimised insulin regimen AND:

• receiving basal analogue insulin at a high dose (more than 80

Units in a single dose) in order to reduce injection volume OR

• receiving insulin glargine 100 Units/mL and experiencing

nocturnal hypoglycaemia OR

requiring more flexibility in injection timing

Prescribing initiation by Consultant Diabetologists or Diabetes

Specialist Nurses only, dose titration on the advice of Diabetes

Specialist Nurses, continuation by GPs

Initiation will also include GP practices’ who sign up to this

service (in due course once the “Direct Award” is developed

and agreed). This action should not prevent this drug

becoming available on the formulary.

Prescribing by brand name in accordance with MHRA advice

All discharge letters recommending a change to a high strength

insulin should highlight clearly the unusual strength in an effort

to reduce the risk of errors.

NOTE: Prescribe all insulins by brand

Toujeo (3mL prefilled disposable injection device)

Restricted- initiation by Consultant Diabetologists or

Diabetes Specialist Nurses only, dose titration on the

advice of Diabetes Specialist Nurses, continuation by

GPs. Initiation will also include GP practices’ who sign

up to this service (in due course once the “Direct Award”

is developed and agreed

For treatment of type 1 or type 2 diabetes in patients

who are already receiving an optimised insulin regimen

AND:

• receiving basal analogue insulin at a high dose (more

than 80 Units in a single dose) in order to reduce

injection volume OR

• receiving insulin glargine 100 Units/mL and

experiencing nocturnal hypoglycaemia OR

requiring more flexibility in injection timing

All discharge letters recommending a change to a high

6.1

.1.2

Oct-

16

Ju

n 1

6.1

6

Add Insulin Degludec

200units/mL

(injection)

For treatment of type 1 or


already receiving an

optimised insulin regimen

AND

• receiving basal analogue

insulin at a high dose

(more than 80 units in a

single dose) such that an

increase in dose would

require administration of an

extra injection OR

• receiving insulin glargine

100 Units/mL and

experiencing nocturnal

hypoglycaemia. In this

situation, insulin degludec

200 Units/mL Tresiba®

would be second line to

insulin glargine 300

Units/mL Toujeo®


by Consultant

Diabetologists or

Diabetes Specialist

Nurses only, dose




by GPs

Am

be

r

Y

Insulin degludec 200 Units/mL Tresiba® was approved for

formulary inclusion as follows:

For treatment of type 1 or type 2 diabetes in patients already

receiving an optimised insulin regimen AND

• receiving basal analogue insulin at a high dose (more than 80

units in a single dose) such that an increase in dose would

require administration of an extra injection OR

• receiving insulin glargine 100 Units/mL and experiencing

nocturnal hypoglycaemia. In this situation, insulin degludec 200

Units/mL Tresiba® would be second line to insulin glargine 300

Units/mL Toujeo®

Where more flexibility in injection timing is required

Prescribing initiation by Consultant Diabetologists or Diabetes



Initiation will also include GP practices’ who sign up to this

service (in due course once the “Direct award” is developed


becoming available on the formulary.

Prescribing by brand name in accordance with MHRA advice

• All discharge letters recommending a change to a

high strength insulin should highlight clearly the unusual

strength in an effort to reduce the risk of errors.


Tresiba (FlexTouch 3mL prefilled disposable injection

device)




GPs. Initiation will also include GP practices’ who sign

up to this service (in due course once the “Direct award”

is developed and agreed).


already receiving an optimised insulin regimen AND

• receiving basal analogue insulin at a high dose (more

than 80 units in a single dose) such that an increase in

dose would require administration of an extra injection

OR

• receiving insulin glargine 100 Units/mL and

experiencing nocturnal hypoglycaemia. In this situation,

insulin degludec 200 Units/mL Tresiba® would be

second line to insulin glargine 300 Units/mL Toujeo®

where more flexibility in injection timing is required


strength insulin should highlight clearly the unusual


See also above Guideline for Using High Strength

Insulins - Primary/Secondary Care Guideline (BHTCG

818FM)

6.1

.1.2

Oct-

16

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Ju

n 1

6.1

7

Add Insulin lispro 200

units/ml (injection)

• For treatment of type 1 or


receiving more than 60

units of prandial insulin as

a single dose in order to

reduce injection volume

• Prescribing initiation

by Consultant

Diabetologists or

Diabetes Specialist

Nurses only, dose




by GPs

• For treatment of type 1 or type 2 diabetes in patients receiving

more than 60 units of prandial insulin as a single dose in order

to reduce injection volume

• Prescribing initiation by Consultant Diabetologists or Diabetes



• Initiation will also include GPs practices’ who sign up to this

service (in due course once the “Direct award” is developed


becoming available on the formulary. Prescribing by brand

name in accordance with MHRA advice

• All discharge letters recommending a change to a high

strength insulin should highlight clearly the unusual strength in

an effort to reduce the risk of errors.


Humalog® (Kwikpen 3mL prefilled disposable injection

device)




GPs. Initiation will also include GPs practices’ who sign

up to this service (in due course once the “Direct award”

is developed and agreed).


receiving more than 60 units of prandial insulin as a

single dose in order to reduce injection volume


strength insulin should highlight clearly the unusual


See also above Guideline for Using High Strength

Insulins - Primary/Secondary Care Guideline (BHTCG

818FM)

6.1

.1.2

Oct-

16

Ap

r 1

6.6

Add Fidaxomicin 200mg

film-coated tablets

(Dificlir®)

• Treatment of recurrent

Closridium difficile infection

(CDI) or for use in patients

at high risk (elderly

patients or those with

severe CDI) of recurrent

CDI.

• Prescribing on

Consultant

Microbiologist

recommendation onlyR

ed

Y

• Treatment of recurrent Closridium difficile infection (CDI) or for

use in patients at high risk (elderly patients or those with severe

CDI) of recurrent CDI.

• Prescribing on Consultant Microbiologist recommendation

only

Restricted- on Consultant Microbiologist

recommendation only

Treatment of recurrent Closridium difficile infection (CDI)

or for use in patients at high risk (elderly patients or

those with severe CDI) of recurrent CDI.

5.1

.7

Oct-

16

Abatacept 125mg

(Orencia®)

(sub-cutaneous

injection)




Restricted - to prescribing by Consultant

Rheumatologists only for the treatment of rheumatoid

arthritis, as the preferred choice when abatacept IV is

recommended in accordance with Biologics for

Rheumatoid Arthritis guideline (BHTCG 749FM) and

NICE TA 375

NOTE If patients fail to respond to one route they may

NOT try the alternative route.

Ap

r 1

6.3

a

Amend

restriction

• For the treatment of

rheumatoid arthritis not

previously treated with

DMARDs or after

conventional DMARDs only

have failed, in accordance

with NICE TA 375

Consultant

Rheumatologists

Re

d

Y

• For the treatment of rheumatoid arthritis not previously treated

with DMARDs or after conventional DMARDs only have failed,

in accordance with NICE TA 375,

• NICE TA 375 supersedes and replaces the following NICE

TAs on the formulary:

o adalimumab, etanercept and infliximab for the treatment of

rheumatoid arthritis (TA130)

o certolizumab pegol for the treatment of rheumatoid arthritis

(TA186)

o golimumab for the treatment of methotrexate-naive

rheumatoid arthritis (TA224) and

o abatacept for treating rheumatoid arthritis after the failure of

conventional disease-modifying anti-rheumatic drugs (TA280).

• NICE TA 375 partially updates golimumab for the treatment of

rheumatoid arthritis after the failure of previous disease-

modifying anti-rheumatic drugs (TA225) and tocilizumab for the

treatment of rheumatoid arthritis (TA247).

10

.1.3

Oct-

16

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Abatacept 250mg

(Orencia®)



required - see link from Formulary homepage

Restricted - to Rheumatology consultant prescribing


Arthritis guideline (BHTCG 749FM) and NICE TA 195

and NICE TA 375

Certolizumab Pegol

200mg (Cimzia®)


syringe)



compliance to be very verified if form not yet available.

NOTE: use restricted in BHT to patients with a low

number of co-morbidities and low risk of infection and is

subject to further audit.

Adalimumab 40mg

(Humira®)


pen or syringe)






and TA 195.


only, in accordance with Biologics for Ankylosing

Spondylitis guideline (BHTCG 737FM) and NICE TA 143.

3. Restricted - to prescribing by Rheumatology or

Dermatology consultants only, in accordance Biologics

for Psoriatic arthritis guideline (BHTCG 740FM) and

NICE TA 199

See section 01.05.03 (Gastroenterology) and 13.05.03 Etanercept 25mg

(Enbrel®)

(injection)



NOTE:

ALL prescribing of etanercept must include generic and

brand name.

Benepali® is first choice etanercept preparation for the

treatment of patients greater than 18 years with

Ap

r 1

6.3

a

Amend

restriction




DMARDs or after



with NICE TA 375

Consultant

Rheumatologists

Re

d

Y









(TA186)









10

.1.3

Oct-

16

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Etanercept 50mg

(Benepali®, Enbrel®)

(injection)



NOTE:

ALL prescribing of etanercept must include generic and

brand name.

Benepali® is first choice etanercept preparation for the

treatment of patients greater than 18 years with

rheumatoid arthritis (NICE TA375), psoriatic arthritis

(NICE TA199) and ankylosing spondylitis (NICE TA383)

- as the first choice for new patients

- as an option in patients already established on

Enbrel®if the clinician decides that it is appropriate and

the patient consents to switching

Enbrel® brand is the treatment of choice for initiation in

patients who are less than 18 years of age, those with

juvenile idiopathic arthritis (JIA) and those requiring a

dose of 25mg


only in accordance with NICE TA 35.


only in accordance with Biologics for Ankylosing





NICE TA 199.




and NICE TA 195.Golimumab 50mg

(Simponi®)


pen or syringe)







NICE TA 220.



Arthritis guideline (BHTCG 749FM) and NICE TA 375.


only in accordance with Biologics for Ankylosing


Ap

r 1

6.3

a

Amend

restriction




DMARDs or after



with NICE TA 375

Consultant

Rheumatologists

Re

d

Y









(TA186)









10

.1.3

Oct-

16

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Infliximab 100mg

(Inflectra, Remsima,

Remicade®)




NOTE:

ALL prescribing of infliximab must include generic and

brand name.

Inflectra® is first choice infliximab biosimilar for all new

patients, with Remsima® second choice only when first

choice is more expensive or not available.

Infliximab biosimilars may be prescribed for patients

currently receiving Remicade® brand when considered

clinically appropriate by the relevant consultant and with

consent of the patient.




and 195.



for Psoriatic arthritis guideline (BHTCG 740) and NICE

TA 199.

see Section 1.5.3 (for Gastroenterology) and 13.5.3 (for

Dermatology)

De

c 1

5.1

8

Add brand Magnesium

Glycerophosphate

(Mg2+ 4mmol)

(tablet)

Initiation in secondary

care with continuation

by GPs

Am

be

r

N

• A less expensive unlicensed brand (YourMag®) has been

approved for use instead and this will lead to a saving of £1,000

in BHT and £20,000 in the community

- Maglyphos® tablets will continue to be the formulary oral

magnesium brand of choice for patients requiring less than

4mmol Magnesium and those for whom PEG and NG tube

administration is required. YourMag® tablets to be used for all

other patients.

Unlicensed - Low Risk

Restricted - to initiation in secondary care with

continuation by GPs.

Maglyphos® brand for patients requiring < 4mmol

magnesium and PEG/NG tube administration

YourMag® brand preferred for all other patients

In primary care these are a pharmaceutical special

Contains: Mg2+ 4mmol per tablet

9.5

.1.3

Oct-

16

Oct

16

.9

Add Secukinumab 150mg


pen)

Treatment of active

ankylosing spondylitis in

adults in accordance with

NICE TA 407 as described

in Bucks Biologics in AS

algorithm. It will be used as

a first line biologic if there

are contraindications to an

antiTNF and as a second

line biologic after failure of

two anti TNFs.

Consultant

Rheumatologists

Re

d

Y

• Treatment of active ankylosing spondylitis in adults in

accordance with NICE TA 407 as described in Bucks Biologics

in AS algorithm. It will be used as a first line biologic if there are

contraindications to an antiTNF and as a second line biologic

after failure of two anti TNFs.

• Prescribing by consultant Rheumatologists only



Restricted - to Rheumatology consultant prescribing

only, in accordance with Biologics in Ankylosing

Spondylitis algorithm and NICE TA 407.

See section 13.5.3 (for Dermatology)

10

.1.3

Oct-

16

Amend

restriction




DMARDs or after



with NICE TA 375

Consultant

Rheumatologists

Re

d

Y









(TA186)









FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Urgoclean 10cm x

10cm dressing

Gre

en

Restricted - only to be used in accordance with the Leg

Ulcer Treatment Pathway (Primary Care).

Available on ONPOS

In Secondary Care restricted to prescribing by Tissue

Viability only. Phone Pharmacy to Order

A5

.2

Add Urgostart 10cm x

10cm dressing

Gre

en

Restricted - only to be used in accordance with the Leg

Ulcer Treatment Pathway (Primary Care).

Available on ONPOS

In Secondary Care restricted to prescribing by Tissue

Viability only. Phone Pharmacy to Order

A5

.4.1

Delete Tegaderm Foam -

6.9cm x 6.9cm soft

cloth border

Bla

ck

Formulary states: Biatain Silicone is an appropriate alternative

A5

.2.5

Oct-

16

Delete Tegaderm Foam oval -

10cm x 11cm

Bla

ck


A5

.2.5

Oct-

16

Delete Mepilex Border Lite -

4cm x 5cm, 6cm x

8.5cm

Bla

ck

Formulary states: Biatain Silicone/Lite is an appropriate

alternative

A5

.2.3

Oct-

16

Delete Aquacel Foam Non

Adh - 10cm x 10cm,

15cm x 15cm

Bla

ck

Formulary states: Biatain Non-Adhesive is an appropriate

alternative

A5

.2.4

Oct-

16

revise

restriction

Aquacel Foam

Adhesive - 19.8cm x

14cm (Heel)

Gre

en

Formulary states: 2nd Choice if Tegaderm Heel not

working or contraindicated.

In Primary Care available on prescription only A5

.2.4

Oct-

16

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

revise

restriction

Aquacel Foam

Adhesive - 8cm x 8cm,

10cm x 10cm, 12.5cm

x 12.5cm, 17.5cm x

17.5cm, 10cm x 20cm

Gre

en

. 16.9cm x 20cm (sacral)(420626)

Sizes below are 2nd Choice if Biatain Silicone® not

appropriate or contraindicated.

8cm x 8cm (420804)(ONPOS)

10cm x 10cm (420680)(ONPOS)

19.8cm x 14cm (heel)(420625) 2nd Choice if

Tegaderm® Heel not working or contraindicated. (In

primary care available on prescription only)

12.5cm x 12.5cm (420619)(ONPOS)

17.5cm x 17.5cm (420621)(ONPOS)(in secondary care

may only be stocked in Spinal Outpatients)

In primary care available as stock through the On-line

Non-Prescription Ordering System (ONPOS) except

19.8cm x 14cm (heel) which is presciption only.

In secondary care all above, restricted to prescribing

only by TV Nurse, Dermatology, Burns and Plastics and

Spinal teams

A5

.2.4

Oct-

16

Add Aquacel Foam 10cm x

20cm

Gre

en

Included in above entry. New size approved for surgical

wounds.

A5

.2.4

Oct-

16

Delete Biatain Adhesive -

12.5cm x 12.5cm,

18cm x 18cmB

lack


A5

.2.5

Oct-

16

revise

restriction

Biatain Adhesive -

7.5cmx 7.5cm,

10cmx10cm, 18cm x

28cm

Gre

en

Fomulary states:

7.5cm 7.5cm (3462)

10cm x 10cm (3430)(this size not available in secondary

care)

18cm x 28cm (3426)

In primary care available as stock through the On-line

Non-Prescription Ordering System (ONPOS)

BNF A5.2.5

In secondary care obtain from Pharmacy

A5

.2.5

Oct-

16

Add Biatain Silicone -,

12.5cm x 12.5cm,

15cm x 15cm, 17.5cm

x 17.5cm

Gre

en

Formulary states:

12.5cm x 12.5cm (3436)

15cm x 15cm (3437)

17.5cm x 17.5cm (3438)

Available in primary care as stock through the On-line


BNF A5.2.5

In secondary care to be ordered through Pharmacy

A5

.2.5

Oct-

16

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Biatain Silicon Lite -

5cm x 5cm.

Gre

en

Formulary states:

5cm x 5cm (3452)

In secondary care - restricted for use by Dermatology

only or on Tissue Viability recommendation.



BNF A5.2.5

In secondary care to be ordered through Pharmacy

A5

.2.5

Oct-

16

revise

restriction

Mepilex Border - 7 x

7.5cm, 10cm x 12.5cm,

15cm X 17.5cm, 17cm

x 20cm Re

d

Biatain Silicone is an appropriate alternative.

Restricted - to prescribing only on the Burns/Plastics or

Spinal wards/units. A5

.2.3

Oct-

16

Delete Aquacel Ag Burn

Bla

ck

This product was originally added to the formulary to be

evaluated. The evaluation was never completed and no

feedback was received from Burns to justify continued

inclusion in the formulary. There has been little use of

this product and Burns are using up the stock albeit

slowly. Pharmacy will not order more. Any further

request for use will need to be applied for through the

proper process for a new wound dressing.

?

Oct-

16

Delete Steripaste

Bla

ck

No longer available

A5

.8.9

Oct-

16

Add Viscopaste

Gre

en

Restricted - for use in eczema. NOT recommended for

leg ulcers as long term use may lead to the development

of sensitivity.

Available on ONPOS

BNF A5.8.9

In secondary care obtain from Pharmacy

A5

.8.9

Oct-

16

1st Choice Tegaderm Foal Heel

(13.9cmx 13.9cm)

Gre

en

Made 1st choice as Aquacel Foam heel is agreed 2nd Choice.

A5

.2.5

Oct-

16

FMG DECISIONS SEPTEMBER 2016

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Se

p 1

6.1

Add Cabazitaxel 60mg in

1.5ml concentrate for

infusion

In accordance with NICE

TA 391 and NHSE SSC 16

37

Consultant

Oncologists

(Prostate)

Re

d

Y

Treatment of hormone-relapsed metastatic prostate cancer

treated with Docetaxel in accordance with NICE TA 391 and

NHSE SSC 16 37



required.


(prostate) only

Treatment of hormone-relapsed metastatic prostate

cancer treated with Docetaxel in accordance with NICE

TA 391 and NHSE SSC 16 37.

8.1

.5

Sep-1

6

Se

p 1

6.2

Add Ceritinib 150mg

capsules

in accordance with NICE

TA 395 and NHSE SSC 15

38

Consultant

Oncologists (Lung)

Re

d

Y

As an option for treating advanced anaplastic lymphoma kinase

positive non small cell lung cancer in adults who have

previously had crizotinib in accordance with NICE TA 395 and

NHSE SSC 15 38



required.

Restricted - prescribing by Consultant Oncologists (lung)

only

As an option for treating advanced anaplastic lymphoma

kinase positive non small cell lung cancer in adults who

have previously had crizotinib in accordance with NICE

TA 395 and NHSE SSC 15 38 8.1

.5 (

pro

tein

kin

ase

inh

ibito

rs)

Sep-1

6

Add

indication

Nivolumab 10mg/1ml

(Injection)

In combination with

ipilimumab in accordance

with NICE TA 400, Jul 16

and NHSE Letter ref 1640

from end Oct 2016.

Consultant

Oncologists

(Melanoma) at OUH

only

Re

d

Y

Nivolumab in combination with ipilimumab was approved for

formulary inclusion as follows

• for treating advanced melanoma in accordance with NICE TA

400, Jul 16 and NHSE Letter ref 1640 from end Oct 2016.



required.



1. NICE TA 384 for treating advanced (unresectable or



2. In combination with ipilimumab for treating advanced


NHSE Letter ref 1640 from end Oct 2016. 8.1

.5 (

an

tin

eo

pla

stic d

rug

s)

Sep-1

6

Add

indication

Ipilimumab

50mg/10mL,

200mg/40mL

(concentrate for


As above Consultant

Oncologists

(Melanoma) at OUH

only

Re

d

Y

Add note to Ipilimumab entry as above Restricted:

1. Prescribing by ORH Oncology consultants in

accordance with TVCN protocol and NICE TA 268

2. Prescribing by Oxford University Hospitals (OUH)

only, in accordance with NICE TA 319.

3. Prescribing by consultant oncologists (Melanoma) at

OUH only. To be used In combination with nivolumab for

treating advanced melanoma in accordance with NICE

TA 400, Jul 16 and NHSE Letter ref 1640 from end Oct

2016.

8.1

.5 (

Ipili

mu

ma

b)

Sep-1

6

Se

p 1

6.4

Add Trametinib 0.5mg,

2mg film-coated

tablets

in combination with

dabrafenib for treating

unresectable or metastatic

melanoma in accordance

with NICE TA 396, June 16

and NHSE Letter 1639

funded by NHSE from 20th

Sept 2016

Consultant

Oncologists

(Melanoma) at OUH

only

Re

d

Y

NICE TA 396, June 16 and NHSE letter 1639 published FOR ALL PRESCRIBING - a completed and approved


required.


(Melanoma) at OUH only

Use in combination with dabrafenib for treating

unresectable or metastatic melanoma in accordance with

NICE TA 396, June 16 and NHSE Letter 1639

8.1

.5 (

pro

tein

kin

ase

inh

ibito

rs)

Sep-1

6

Se

p 1

6.3

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Se

p 1

6.5

Amend

indication

Ezetimibe 10mg

tablets

Monotherapy or co-

administration with a statin

in accordance with NICA

TA 385 and CG 71

Initiation and

continuation in

secondary or primary

care

Gre

en

Y

• The Bucks Lipid modification guideline 104FM.2 recommends

ezetimibe monotherapy in secondary prevention of CVD as an

option when all statins are unsuitable due to intolerance or

contraindications, in line with NICE TA 132.

• NICE TA 132 has been replaced by NICE TA 385 Ezetimibe

for treating primary heterozygous-familial and non-familial

hypercholesterolaemia; NICE CG 71 Familial

hypercholesterolaemia has been updated to reflect TA 385.

Approved for treatment of primary heterozygous-familial (FH)

and non-familial (NF) hypercholesterolaemia in accordance

with NICE TA 385 and in the updated 104FM.3 Bucks Lipid

modification for secondary and primary prevention of CVD in

adult patients guideline. The amendments re. ezetimibe in the

guideline were approved. The revised place of ezetimibe is as

follows:

plus a maximum potency tolerated statin (usually atorvastatin

80mg) is fourth line. Ezetimibe monotherapy would be fifth line.

or ezetimibe plus a maximum potency tolerate statin are also

used for primary prevention of CVD

familial and familial hypercholesterolaemia : prescribing

initiation and continuation in secondary or primary care (Green

on TLL)

Restricted for treatment of primary heterozygous-familial

(FH) and non-familial (NF) hypercholesterolaemia in

accordance with NICE TA 385 and in the updated

104FM.3 Bucks Lipid modification for secondary and

primary prevention of CVD in adult patients guideline

(guideline awaited). See link above for Bucks lipid

modification for secondary and primary prevention of

CVD in adult patients guideline (BHTCG 104FM).

2.1

2

Sep-1

6

Add drug Alirocumab 75mg/ml,

150mg/ml injection

(pre-filled pen or

syringe)

Treatment of primary

hypercholesterolaemia

(heterozygous familial and

non-familial) and mixed

dyslipidaemia in


393 (alirocumab) and NICE

TA 394 (evolocumab) and

Bucks guideline 104FM.3

Lipid Modification for

secondary and primary

prevention of

cardiovascular disease

(CVD) in adult patients


and continuation by

Consultant Chemical

Pathologists

(Lipidologists) only

Re

d

Y

New NICE TA 393 and NICE TA 394 published.

Approved for treatment of primary hypercholesterolaemia

(heterozygous familial and non-familial) and mixed

dyslipidaemia in accordance with NICE TA 393 (alirocumab)

and NICE TA 394 (evolocumab) and Bucks guideline 104FM.3

Lipid Modification for secondary and primary prevention of

cardiovascular disease (CVD) in adult patients


HIGH COST DRUG compliance form is required.

Prescribing initiation and continuation by Consultant

Chemical Pathologists (Lipidologists) only.

For treatment of primary hypercholesterolaemia


dyslipidaemia in accordance with NICE TA 393

(alirocumab) and Bucks guideline 104FM.3 Lipid

Modification for secondary and primary prevention of

cardiovascular disease (CVD) in adult patients (guideline

awaited)

2.1

2

Sep-1

6

Se

p 1

6.6

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add drug Evolocumab 140mg/ml

injection (pre-filled

pen or syringe)


hypercholesterolaemia

(heterozygous familial and

non-familial) and mixed

dyslipidaemia in


393 (alirocumab) and NICE

TA 394 (evolocumab) and

Bucks guideline 104FM.3

Lipid Modification for


prevention of




and continuation by

Consultant Chemical

Pathologists

(Lipidologists) only

Re

d

Y

New NICE TA 393 and NICE TA 394 published.

Approved for treatment of primary hypercholesterolaemia


dyslipidaemia in accordance with NICE TA 393 (alirocumab)

and NICE TA 394 (evolocumab) and Bucks guideline 104FM.3

Lipid Modification for secondary and primary prevention of

cardiovascular disease (CVD) in adult patients



Prescribing initiation and continuation by Consultant

Chemical Pathologists (Lipidologists) only.

For treatment of primary hypercholesterolaemia


dyslipidaemia in accordance with NICE TA 394

(evolocumab) and Bucks guideline 104FM.3 Lipid

Modification for secondary and primary prevention of

cardiovascular disease (CVD) in adult patients (guideline

awaited)

2.1

2

Sep-1

6

Se

p 1

6.8

Add

indication

Adalimumab 40mg

(Humira®)


pen or syringe)

Treatment of moderate to

severe hidradenitis

suppurativa in accordance

with NICE TA 392 and

NHSE circular 1643

September 2016


by Specialist Centre

Consultant

Dermatologists e.g;

OUH and continued

by BHT Consultant

Dermatologists

Re

d

Y

• Approved for treatment of moderate to severe hidradenitis

suppurativa in accordance with NICE TA 392 and NHSE

circular 1643 September 2016

• Prescribing initiation by Specialist Centre Consultant

Dermatologists e.g; OUH and continued by BHT Consultant

Dermatologists after NICE compliance and funding approval

has been confirmed



1. Restricted - to prescribing by Dermatology consultants

only, in accordance with Biologics for Psoriasis guideline

(BHTCG 738FM) and NICE TA 146.


Dermatology consultants only, in accordance with

Biologics for Psoriatic arthritis guideline (BHTCG 740FM)

and NICE TA 199.

3. Restricted - prescribing initiation by Specialist Centre

Consultant Dermatologists e.g; OUH and continued by

BHT Consultant Dermatologists in accordance with

NICE TA 392 and NHSE circular 1643 September 2016

13

.5.3

Sep-1

6

Se

p 1

6.6

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Se

p 1

6.9

Add Flucloxacillin 12g, 18g

24 hour infusers

• Patients with the following

infections who are unable

to receive suitable oral

antibiotic(s) and who are

suitable to receive out-

patient antimicrobial

therapy (OPAT)

penicillinase producing

staphylococci and other

gram-positive organisms

susceptible to this anti-

infective including MSSA

bacteriaemias associated

with cellulitis, osteomyelitis,

endocarditis and of

unknown source.

OPAT team on the

advice of

Microbiologists and

in conjunction with

the team responsible

for the patient

Re

d

N

• Flucloxacillin is first line for treating cellulitis and has the best

efficacy and safety profile. It is administered in hospital as

intermittent doses but on discharge is switched to IV ceftriaxone

or teicoplanin to facilitate administration in the outpatient

setting.

• Flucloxacillin administered via a 24 hour infuser has

demonstrated equivalent efficacy to flucloxacillin administered

intermittently.

Flucloxacillin 12g and 18g 24 hour controlled infusion devices

were approved for formulary inclusion as follows

• Patients with the following infections who are unable to

receive suitable oral antibiotic(s) and who are suitable to

receive out-patient antimicrobial therapy (OPAT)

other gram-positive organisms susceptible to this anti-infective

including MSSA bacteriaemias associated with cellulitis,

osteomyelitis, endocarditis and of unknown source.

• Prescribing by the OPAT team on the advice of

Microbiologists and in conjunction with the team responsible

for the patient

Restricted - to prescribing by OPAT team on the advice

of microbiologists and in conjunction with the team

responsible for the patient.

For patients with the following infections who are unable

to receive suitable oral antibiotic(s) and who are suitable

to receive out-patient antimicrobial therapy (OPAT):

- infections due to penicillinase producing staphylococci

and other gram-positive organisms susceptible to this

anti-infective including MSSA bacteriaemias associated

with cellulitis, osteomyelitis, endocarditis and of unknown

source

5.1

.1.2

Sep-1

6

Se

p 1

6.1

0

Add Piperacillin /

tazobactam 13.5g, 18g

controlled infusion

devices

Patients with the following

infections who are unable

to receive suitable oral

antibiotic(s) and who are

suitable to receive out-

patient antimicrobial

therapy (OPAT)

including hospital-acquired

pneumonia

infections (including

pyelonephritis)

infections

soft tissue infections

(including diabetic foot

infections)

in association with, or is

suspected to be associated

with, any of the infections

listed above.

OPAT team on the

advice of

Microbiologists and

in conjunction with

the team responsible

for the patient

Re

d

N

• Two systematic reviews with meta-analyses have

demonstrated a lower mortality rate with continuous extended

infusions of Pip/Taz compared to intermittent dosing,.

The incidence of adverse effects was found to be similar

between the two regimens

• In hospital, current practice for bronchiectasis patients

infected with Ps.aeruginosa is to administer Pip/Taz three times

daily for two weeks. Transfer to OPAT will reduce duration of

admission for medically stable patients.

Approved for:

• Patients with the following infections who are unable to



foot infections)

to be associated with, any of the infections listed above.

• Prescribing by the OPAT team on the advice of

Microbiologists in conjunction with the team responsible for the

patient

Restricted - to prescribing by OPAT team on the advice

of microbiologists and in conjunction with the team

responsible for the patient.

Patients with the following infections who are unable to



pneumonia

pyelonephritis)

diabetic foot infections)

suspected to be associated with, any of the infections

listed above.

5.1

.1.4

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Se

p 1

6.1

1

Add

indication

Metformin 500mg,

850mg (tablet)

For treatment of women

with polycystic ovary

syndrome (PCOS) as

second line to hormonal

contraceptive

Any prescriber in

hospital or primary

care

Gre

en

N

• PCOS is an unlicensed indication for use of metformin. This

use has been standard treatment for many years but is not

currently on the Bucks formulary

Approved for:

• Treatment of women with polycystic ovary syndrome (PCOS)

as second line to hormonal contraceptives. Hormonal

See separate entry and restrictions when using to control

weight gain in Oxfordshire Health paediatric patients

receiving antipsychotic therapy.

1. For use in accordance with Type 2 Diabetes; blood-

glucose-lowering therapy - Primary/Secondary Care

6.1

.2.2

Sep-1

6

Add Canagliflozin 100mg,

300mg

(tablet)

As monotherapy for

treating type 2 diabetes in


NICE TA 390 May 16

No restrictions

Gre

en

Y

NICE TA 390 published in May 2016

Approved for:

• As monotherapy for treating type 2 diabetes in adults in

accordance with NICE TA 390, i.e. when metformin is

unsuitable due to contraindications or intolerance when diet and

exercise alone do not provide adequate glycaemic control,

when a DPP-4 inhibitor would otherwise be prescribed and a

sulfonylurea or pioglitazone are inappropriate

• Prescribing by primary and secondary care

3rd Choice SGLT2 Inhibitor after Dapagliflozin and

Empagliflozin

Restricted - for use in accordance with The Management

of Type 2 Diabetes: Blood-Glucose Lowering therapy -

Primary/Secondary Care guideline (BHTCG 667FM)

(updated guideline awaited- see link above) :

1.For the treatment of adults with Type 2 diabetes in

accordance with NICE TA315 in the following

circumstances, when dapagliflozin cannot be used:

- in dual therapy with metformin for patients over 75

years of age when sitagliptin is not suitable or,

- in triple therapy with metformin and a sulphonylurea

when sitagliptin is not suitable.

2. As monotherapy for treating type 2 diabetes in adults

in accordance with NICE TA 390, i.e. when metformin is

unsuitable due to contraindications or intolerance when

diet and exercise alone do not provide adequate

glycaemic control, when a DPP-4 inhibitor would

otherwise be prescribed and a sulfonylurea or

pioglitazone are inappropriate

6.1

.2.3

Sep-1

6

Add Dapagliflozin 5mg,

10mg

(tablet)

As monotherapy for



NICE TA 390 May 16

No restrictions

Gre

en

Y


Approved for:








1st Choice SGLT2 Inhibitor





1. In combination with other blood-glucose-lowering

therapies








6.1

.2.3

Sep-1

6

Se

p 1

6.1

3

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Empagliflozin 10mg,

25mg

(tablet)

As monotherapy for



NICE TA 390 May 16

No restrictions

Gre

en

Y


Approved for:








2nd Choice SGLT2 Inhibitor after dapagliflozin





1. In combination with other blood-glucose-lowering

therapies in accordance with NICE TA 336.








6.1

.2.3

Sep-1

6

Amend

traffic light

restriction

and

formulary

wording

Exenatide

5micrograms/dose,

10micrograms/dose

(Byetta®)

(injection)

Initiation by hospital

Diabetes consultants

or Hospital Diabetes

specialist nurses or

by GPs who have

received training

Gre

en

Y

Traffic light re-classification AI to green

Approved for:

Initiation by hospital Diabetes consultants or Hospital Diabetes

specialist nurses or by GPs who have received training

NOTE: 5microgram pre-filled pen only, to be used when

initiating treatment in secondary care. 10microgram pre-

filled pen to be used in primary care, and in secondary

care only for continuation of in-patient treatment.

Restricted -Initiation by hospital Diabetes consultants or

Hospital Diabetes specialist nurses or by GPs who have

received training in accordance with NICE CG 87 Type 2

Diabetes with the exception of the last criteria which is

changed to: BMI 30-35kg/m2 and insulin is unacceptable

because of occupational implication or weight loss would

benefit other co-morbidities in accordance with Glucagon-

like peptide-1 (GLP-1) Agonist Injectable Therapy -

Primary/ Secondary Care guideline (BHT CG109FM).

Also see Type 2 Diabetes: blood-glucose-lowering

therapy guideline (BHTCG 667FM)(see link above)

EXENATIDE and INSULIN

Exenatide in combination with insulin may only be

initiated by Consultant Diabetologists with continuation

by GPs, in accordance with the criteria defined in the

High Cost Drug compliance form - see link from

Formulary home page. The decision to continue or stop

therapy to be made by Consultant Diabetologist at 6

months.

6.1

.2.3

Sep-1

6

Se

p 1

6.1

3A

pr

16

.8

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Amend

traffic light

restriction

and

formulary

wording

Exenatide 2mg

(Bydureon®)

(MR injection, vial and

pre-filled pen)





by GPs who have

received training

Gre

en

Y


Approved for:



Restricted - initiation by hospital Diabetes consultants or

Hospital Diabetes specialist nurses or by primary care

health professionals who have received training in

accordance with Glucagon-like peptide-1 (GLP-1)

Agonist Injectable Therapy - Primary/ Secondary Care

guideline (BHT CG109FM) and NICE TA 248. Also see

Type 2 Diabetes blood glucose-lowering therapy

(BHTCG 667FM) (see link above)








months.

6.1

.2.3

Sep-1

6

Amend

traffic light

restriction

and

formulary

wording

Liraglutide 6mg/mL

(injection, 3mL

prefilled pen)





by GPs who have

received training Gre

en

Y


Approved for:



Restricted - to prescribing by hospital Diabetes

consultants or Hospital Diabetes specialist nurses or by

primary care health professionals who have received

training, in accordance with Glucagon-like peptide-1

(GLP-1) Agonist Injectable Therapy - Primary/

Secondary Care guideline (BHT CG109FM)and NICE TA

203, and in line with Type 2 Diabetes blood glucose-

lowering therapy guideline (BHTCG 667FM)(see above)

6.1

.2.3

Sep-1

6

Se

p 1

6.1

9

Amend

traffic light

restriction

Minoxidil (Regaine®)

Bla

ck

Y

Minoxidil, all topical forms are Nationally blacklisted Non-formulary black listed

13

.9

Sep-1

6

Se

p 1

6.1

9

formatting -

combine

entries

Octreotide

50micrograms/1mL,

100micrograms/1mL,

500micrograms/1mL,

1g/5mL Various

Y

Currently 3 entries with different TLL positions on the formulary.

To be combined into one entry. TLL positions to remain the

same

RED

1. Restricted - prescribing by Oncology team.

2. Restricted - prescribing by Paediatric consultants for

insulin resistance (Congenital Hyperinsulinism (CHI)) in

paediatric patients (as shared care with tertiary referral

centres)(Unlicensed Use)

8.3

.4.3

Sep-1

6

Se

p 1

6.1

9 Add link Formulary Chapter 25:

A2 - Borderline

substances

Add link to link to chapter A2 - 'Healthcare professional

guidance: Cows' milk protein allergy in infants' (CCG guideline)

http://www.bucksformulary.nhs.uk/docs/avc/CMPAguidance121

214.pdf

A2

Sep-1

6

Ap

r 1

6.8

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Se

p 1

6.1

9

Add note All Insulins Add a note to prescribe insulin by brand - guidance on the safe

use of high strength insulins has been written, going to next

CGS (see jun16.8 FMG minutes) so how we enter these on

formulary will be addressed once the guidance is approved.

Add note for all insulins:

NOTE to be prescribed by brand

6.1

.1.2

Sep-1

6

Sep

16

.19 Add note Dexamethasone

2mg/5mL

(oral solution, sugar-

free)

Gre

en

Y

add: "use dexamethasone tablets which are less expensive."

Our current contract brand is soluble

NOTE: Before prescribing dexamethasone solution

consider prescribing dexamethasone tablets which are

soluble and less expensive. 6.3

.2

Sep-1

6

Se

p 1

6.1

9

Add

presciber

Mycophenolate Mofetil

250mg,500mg

(tablet/capsule)

Re

d

Y

Mycophenolate tabs/caps ALL strengths expand the restriction

to include consultant Respiratory physicians when

recommended by a tertiary centre for interstitial lung disease

Red

Restricted to prescribing by

1. Consultant Dermatologists and Rheumatologists

2. Consultant Repiratory physicians when recommended

by a tertiary centre for interstitial lung disease.

Amber Traffic Light Amber Protocol - Restricted - Renal

transplant patients

8.2

.1

Sep-1

6

Se

p 1

6.1

9

add

restriction

Nivolumab 10mg/1ml

(Injection)

Re

dY

Nivolumab for advanced (unresectable or metastatic)

melanoma NICE TA 384 funded Mar 16 prescribing by

consultant Oncologists (Melanoma) currently at OUH only ADD

‘and in accordance with NHSE Specialised Services Circular

16 17’



required.



1. NICE TA 384 for treating advanced (unresectable or



2. In combination with ipilimumab for treating advanced


NHSE Letter ref 1640 from end Oct 2016.

08

.05

.01

Sep-1

6

Se

p 1

6.1

9

add

restriction

Pembrolizumab 50mg

(powder for

concentrate for

solution for infusion)

Re

d

Y

Pembrolizumab for melanoma in accordance with NICE TA 357

ADD ‘and NHSE Specialised Services Circular 16

Restricted - prescribing by Oxford University Hospitals

(OUH) melanoma oncologists only in accordance with

NHS England Specialised Services Circular (SSC 1617):

1. for advanced melanoma after disease progression

with Ipilimumab in accordance with NICE TA357.

2. for advanced melanoma not previously treated with

Ipilimumab in accordance with NICE TA366

08

.02

.03

Sep-1

6

Se

p 1

6.1

9

Blacklist Lumacaftor/ivacaftor

200mg/125mg

tablets

Bla

ck

Y

NICE TA 398 Lumacaftor–ivacaftor for treating cystic fibrosis

homozygous for the F508del mutation with negative

recommendation July 16

Blacklist

Sep-1

6

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Se

p 1

6.1

9

Blacklist Azacitidine 100mg

(injection)

Bla

ck

Y

NICE TA 399 Azacitidine for treating AML in more than 30%

bone marrow blasts has negative recommendation July 16

Blacklist

8.1

.3

Sep-1

6

Apr

16

.1

Add Zolmitriptan

5mg/0.1mL

(nasal spray)

in accordance with Bucks

Headache management for

adults guideline gre

en

yFor the acute treatment of migraine attacks with or without aura

for patients unsuitable for two oral triptans (sumatriptan and

almotriptan) due to prominent vomiting or treatment failure at

For the acute treatment of migraine attacks for patients

unsuitable for two oral triptans due to prominent vomiting

or treatment failure at maximum tolerated dose and in 04

.07

.

04

.01

Apr-

16

Apr

16

.4

Add Etanercept biosimilar

50mg injection

(Benepali®)

As Enbrel Consultant

Rheumatologists,

Dermatologists

Re

d

Y

As for Etanercept previously except Benepali® is not licensed

for use in Juvenile Idiopathic Arthritis or in paediatric plaque

psoriasis as it is only currently available as a 50mg dose

NOTE: ALL prescribing of etanercept must include

generic and brand name.

Benepali® is first choice etanercept preparation for the 10

.01

.

03

A

pr-

16

Ap

r 1

6.7 Amend Gluten-free and Sip

Feed formulary

chapter revision

The amendments to the Gluten-free and SIP feed formulary

chapter, as listed below under CCG FORMULARY CHANGE

TRACKING DOCUMENT - PROPOSED CHANGES FOR

APRIL 2016 FMG, were approved

A2

.06

.0

1A

pr-

16

Apr

16

.8

Add new section to Bucks

Formulary Policy

Bucks Formulary Policy: NEW section re. Process for NHSE

Clinical commissioning policies and circulars

the process was approved Apr-

16

Apr

16

.10 Add link to Rx guidelines

app

Inclusion of new link to Rx guidelines app (mainly hospital

antibiotic guidelines) on Formulary home page

Dapagliflozin 5mg,

10mg

MHRA Drug Saftey Update - April 2016 - SGLT2 inhibitors:

updated advice on the risk of diabetic ketoacidosisNatalizumab

300mg/15mL

(concentrate for


MHRA Drug Saftey Update - April 2016 - Natalizumab

(Tysabri▼): progressive multifocal

leukoencephalopathy—updated advice to support early

detection

FMG DECISIONS APRIL 2016

Ap

r 1

6.1

0

Add links to

MHRA drug

safety

updates

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Dimethyl Fumarate

120mg, 240mg

(capsule)

MHRA Drug Saftey Update - April 2016 - Dimethyl fumarate

(Tecfidera): updated advice on risk of progressive multifocal

leukoencephalopathy

Fingolimod

500micrograms

(capsule)

MHRA Drug Saftey Update - April 2016 - Fingolimod

(Gilenya▼): risks of progressive multifocal

leukoencephalopathy, basal-cell carcinoma, and opportunistic

infections

Chapter 14:

Immunological

products and vaccines

MHRA drug safety update - April 2016 - Live attenuated

vaccines: avoid in those who are clinically immunosuppressed

Oct

15

.6

Add Perampanel 2mg,

4mg, 6mg, 8mg, 10mg,

12mg (Fycompa®)

(Tablet)

Consultant

Neurologists at BHT

and the national

centre of epilepsy

AI

y

For the adjunctive treatment of partial-onset seizures with or

without secondarily generalised seizures in people aged 12

years and older with epilepsy for whom first line and ‘standard

adjunct therapy are ineffective or unsuitable and for whom

lacosamide, phenobarbital, phenytoin, vigabatrin, zonisamide

and retigabine are ineffective or unsuitable

Restricted - prescribing initiation by consultant

neurologists at BHT and the National Society for

Epilepsy for the first 6 months with continuation by GPs

when patient is stabilised

04

.08

.01

r

Ap

r 1

6.1

0

Add links to

MHRA drug

safety

updates

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Ju

n 1

5.5

Add Capsaicin 0.075%

(Axsain®)

(cream)

in accordance with

Pharmacological treatment

of chronic pain following

spinal cord injury in adults

guideline(BHTCG 375FM)

Spinal consultants or

pain team

Re

d

n

Treatment of localized neuropathic pain for Spinal Cord Injury

(SCI) patients who cannot tolerate, or have failed to respond to,

or are contraindicated to maximum doses of oral treatment with

Tricyclic antidepressants (TCAs), Gabapentinoids, and

Duloxetine

Restricted - prescribing by spinal consultants or pain

team for the treatment of localized neuropathic pain for

spinal cord injury (SCI) patients who cannot tolerate, or

who have failed to respond to, or are contra-indicated to

maximum doses of oral treatment with tricyclic

antidepressants, gabapentinoids and duloxetine and in

accordance with Pharmacological treatment of chronic

pain following spinal cord injury in adults


10

.03

.02

Ju

n 1

5.6

Add

IndicationLidocaine 5%

(700mg/medicated

plaster)

and in accordance with

Pharmacological treatment

of chronic pain following

spinal cord injury in adults


Spinal consultants or

pain team

Re

d

xlvii. Treatment of localized neuropathic pain for Spinal Cord

Injury (SCI) patients who cannot tolerate, or have failed to

respond to, or are contraindicated to oral treatment with TCA’s,

Gabapentinoids, Duloxetine, and topical Capsaicin 0.075%

Cream

Restricted - prescribing by spinal consultants or pain

team for the treatment of localized neuropathic pain for

spinal cord injury (SCI) patients who cannot tolerate, or

who have failed to respond to, or are contra-indicated to

maximum doses of oral treatment with tricyclic

antidepressants, gabapentinoids, duloxetine and topical

capsaicin 0.075% cream and in accordance with

Pharmacological treatment of chronic pain following

spinal cord injury in adults guideline(BHTCG 375FM)

15

.02

De

c 1

5.3

Add Midodrine 2.5mg, 5mg

(tablet)

in accordance with amber

initiation guideline

Initiation by

consultant

neurologists and

spinal also

appropriate

consultant e.g.

cardiologists

continuation by GPs

AI

y

Midodrine has recently received a licence for use in orthostatic

hypotension due to autonomic dysfunction

Restricted - Initiation by hospital consultants with

continuation by GPs in accordance with amber initiation

guideline (awaiting upload) for use when all other

corrective factors have failed and other treatment is

ineffective or not tolerated

1. Initiation by consultant neurologists and spinal for the

treatment of orthostatic hypotension due to autonomic

dysfunction

2. Initiation by appropriate consultant e.g. cardiologists

for unprovoked vasovagal syncope (where no reversible

cause can be found)

02

.07

.02

Apr-

16

De

c 1

5.1

2

Add Brinzolamide/Brimoni

dine 10mg/2mg in 1mL

(ophthalmic

suspension, preserved

consultant

ophthalmologists

AI

y

second line to the individual components prescribed

concomitantly - For use in adults with open angle glaucoma /

intra-ocular hypertension for whom beta blockers and

prostaglandin analogues are unsuitable and the use of the two

components (brimonidine/brinzolamide) as separate entities is

inappropriate

Restricted - to initiation by Consultant Ophthalmologists

with continuation by GPs for use in adults with open

angle glaucoma/intra-ocular hypertension for whom beta

blockers and prostaglandin analogues are unsuitable

and the use of the two components

(brinzolamide/brimonidine) as separate entities in

inappropriate

11

.06

Apr-

16

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

De

c 1

5.1

3 Add Tafluprost/Timolol

15micrograms/5mg in

1mL

(eye drops, unit dose,

preservative-free

consultant

ophthalmologists

AI

y

As a third line preservative free Prostaglandin analogue

inhibitor/Beta Blocker combination eye drop for patients who

have not responded to or are unsuitable for other PF formulary

choices

Restricted - to initiation by Consultant Ophthalmologists

with continuaton by GPs as a third line preservative free

prostaglandin analogue (PGA)/beta blocker combination

eye drop in patients who are using both a PGA and beta

blocker in preservative free forms but a combination may

11

.06

Apr-

16

Fe

b 1

4.9

Add TLL

amend

restriction

Sevelamer

Hydrochloride 800mg

(Renagel®)

(tablet)

Renal team

Re

d

y

previous proposed AI traffic light position changed to red for all

patients (new and established)

Restricted - prescribing by the Renal team only.

Red traffic light position applies to new and established

patients

09

.05

.02

.02

Apr-

16

Ap

r 1

6.9 Add

restrictionTemozolomide 5mg,

20mg, 100mg, 250mg

(capsules)


TA23, updated March 2016

consultant

oncologists - OUH

only Re

d

y


OUH in accordance with NICE TA 23, updated March

2016 for the treatment of recurrent malignant glioma

(brain cancer) 08

.01

.05

Apr-

16

Ap

r 1

6.9

Add Nivolumab 10mg/1ml

(Injection)


TA384

Consultant

Oncologists

(melanoma) at OUH

only

Re

d

y


(melanoma) at OUH only in accordance with NICE TA

384 for treating advanced (unresectable or metastatic)

melanoma Apr-

16

Ap

r 1

6.9 Add Elosulfase alfa

5mg/5ml

(concentrate for

solution for infusion)


HST2 and the Managed

Access Scheme

consultant

paediatricians on

initiation by a Highly

Specialised Service

Re

d

Initiation by a Highly Specialised Centre Restricted - prescribing by consultant paediatricians in

accordance with NICE HST2 and the Managed Access

Scheme on initiation by a Highly Specialised Service for

treating mucopolysaccharidosis type IVa

16

.01

Apr-

16

Add Irinotecan, oxaliplatin

and raletrexed

PbR excluded, NHSE

NICE TA 93 published Aug

2005

NICE CG 131

Consultant

Oncologists only

red y

NICE TA 93 published Aug 2005 Colorectal cancer (advanced)

- irinotecan, oxaliplatin and raletrexed. It was noticed this is not

reflected in the formulary. Irinotecan, oxaliplatin are on

formulary for other indications, ralitrexed not on formulary at all

NICE TA93 has now been replaced with NICE CG131

Colorectal cancer: diagnosis and management

Restricted - prescribing by consultant oncologists only in

accordance with NICE clinical guideline 131

8.0

1

Apr-

16

Add Vortioxetine

5mg, 10mg, 20mg

Tablets


TA 367

Prescribing by Oxford

Health Consultant

Psychiatrists only red y

for major depressive disorder in accordance with NICE TA 367.

Red on TLL; Prescribing by Oxford Health Consultant

Psychiatrists only

Restricted - prescribing by Oxford Health Consultant

Psychiatrists only in accordance with NICE TA367 -

Vortioxetine for treating major depressive episodes 04

.03

.04

01

-ma

r-1

6A

pr-

16

Add Darunavir 800mg

tablet

PbR excluded, NHSE

in accordance with BHIVA

2013 HIV

HIV and Specialist

Sexual Health

consultants (GUM

and Contraception)

teams red

y

150mg, 400mg and 600mg already on formulary. 800mg is

used via Homecare a lot. 800mg same price as 400mg tablets

tablets and offer improved compliance for patients requiring this

medicine.

Restricted – to be prescribed by HIV and Specialist

Sexual Health consultants (GUM and Contraception)

teams in accordance with BHIVA 2013 HIV treatment

guidelines.

05

.03

.01

Apr-

16

BHT FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED FORMULARY CHANGES FOR NOTE APRIL 2016 FMG

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Meningococcal group

B Vaccine (injection)

in accordance with the

recommendations in the

immunisation schedule. gre

en

y

To be used in accordance with the recommendations in

the immunisation schedule.

14

.04

Apr-

16

remove

unlicensed Glycopyrronium

Bromide 1mg, 2mg these are now licensed

Re

d

y consultant Paediatricians only Restricted - prescribing by consultant Paediatricians

only. Supply on a named patient basis

15.

01.

Add note to

verify

funding has

been

approved

Pirfenidone 267mg

(hard capsule)

PbR excluded, NHSE

Initiation by consultant

Respiratory physicians in

named Specialist Services

only but prescribing may

be continued in BHT by

red

Re

d

It must be verified, via blueteq, that funding approval has been

obtained.

Restricted - prescribing in accordance with NICE TA 282

with initiation by consultant Respiratory physicians in

named Specialist Services only (Oxford University

Hospitals NHS Trust, Interstitial Lung Disease Service

(ILD Service), University Hospital Southampton NHS

03

.11

Azithromycin 250mg

capsules

gre

en

y

Ceftazidime 250mg,

500mg, 1g, 2g

injection red

y

Ceftriaxone 250mg,

1g, 2g injection

red y

Add

restrictionCabergoline

500micrograms, 1mg,

2mg Tablets

AI

y

included in O+G guidelines as a single dose for suppression of

lactation

Guideline 437 Induction of Labour (IOL) for fetal death from 20

weeks gestation

Guideline 662 Termination of pregnancy (TOP) for fetal

abnormality)

Restricted - initiation by consultant endocrinologists and


In secondary care - also for use in lactation supression

as a SINGLE dose in accordance with Guideline 437

Induction of Labour (IOL) for fetal death from 20 weeks

gestation or Guideline 662 Termination of pregnancy

(TOP) for fetal abnormality

06

.07

.01

Add

restriction

included in secondary care

guideline 133 Management

and antibiotic therapy for

respiratory tract conditions

in adults

In secondary care restricted - in accordance with

Guideline 133 - Management and antibiotic therapy for

respiratory tract conditions in adults 05

.01

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Uploaded The routine

immunisation

schedule from Spring

2016

to replace previous version

Add Desmopressin

120 microgram,

240 microgram

Oral lyophilisates,

green; 2nd line

Gre

en

Required as a 2nd line choice for children with primary

nocturnal enuresis who cannot swallow tablets. More

expensive than tablets but in use (CCG spend over £40K a

year on this and it is regularly recommended by BHT clinicians).

Mentioned in the existing NICE clinical guideline 111 -

nocturnal enuresis

Restricted - as a 2nd line choice for children with primary

nocturnal enuresis who cannot swallow tablets

06

.05

.02

Delete

Vitasavoury 200

(sip feed) Discontinued Jan 2016

A2

.02

Add Slo Milkshake In primary care initiation on

the recommendation of a

Dietitian only AR

In Primary Care - Initiation on the recommendation of a

dietitian only.

In Secondary Care, not stocked. Requires dietitian input

regarding appropriate alternative A2

.02

change

switch

recommend

ation

Barkat®

(500 G Multigrain

bread (sliced))

AR

In Primary Care - Less cost effective choice for people with

coeliac disease or dermatitis herpetiformis. Consider switching

to - currently Dietary Specials Loaf Sliced Multigrain to be

changed to Glutafin Select Sliced seeded loaf

In Primary Care - Less cost effective choice for people

with coeliac disease or dermatitis herpetiformis.

Consider switching to Glutafin Select Sliced seeded loaf A2

.06

.01

Apr-

16

change

switch

recommend

ation

Ener-G

(474g Brown or white

rice bread (sliced))

AR


coeliac disease or dermatitis herpetiformis. Switch to -

currently EnerG Rice Loaf (sliced) Proceli Brown Rice Bread.

To delete Proceli Brown Rice Bread


with coeliac disease or dermatitis herpetiformis. Switch

to EnerG Rice Loaf (sliced) A2

.06

.01

Apr-

16

change

switch

recommend

ation

Proceli®

(8 x 34g White lunch

rolls)

AR



to - currently Livwell White rolls, to be changed to Lifestyle

Bread rolls (white)



Consider switching to Lifestyle Bread rolls (white) A2

.06

.01

Apr-

16

change

switch

recommend

ation

Livwell® (4 x 50g

Toasting Bread Buns)

AR



to -currently Livwell White rolls, to be changed to Lifestyle

Bread rolls (white)



Consider switching to Lifestyle Bread rolls (white) A2

.06

.01

Apr-

16

CCG FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED CHANGES FOR APRIL 2016 FMG

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

change

switch

recommend

ation

Ener-G® (4 x 55g White

rolls (long or round)) AR



to - currently EnerG Seattle Brown Rolls (hot dog) or Livwell

White rolls. to be changed toEnerG Seattle Brown Rolls (hot

dog) or Lifestyle Bread Rolls (white)



Consider switching to EnerG Seattle Brown Rolls (hot

dog) or Lifestyle Bread Rolls (white) A2

.06

.01

Apr-

16

change

switch

recommend

ation

Glutafin® Select (4 x

50g Part baked rolls

(white))

Bla

ck

In Primary Care - Non cost effective choice for people with

coeliac disease or dermatitis herpetiformis.

Current recommendation Switch to Livwell White rolls . To be

changed to Lifestyle Bread Rolls (white)

In Primary Care - Non cost effective choice for people

with coeliac disease or dermatitis herpetiformis.Switch

to Lifestyle Bread Rolls (white) A2

.06

.01

Apr-

16

change

switch

Glutafin® WF (4 x 50g

Rolls (fibre or white)) Bla




with coeliac disease or dermatitis herpetiformis.Unless A2

.

##

change

switch

recommend

ation

Proceli®

(3 x 35g Hot dog rolls)

Bla

ck

Delete 'Delivery charge may apply to Pharmacies.' and switch

recommendation of Livwell White rolls


with coeliac disease or dermatitis herpetiformis.Switch

to Seattle Brown Rolls (hot dog) A2

.06

.01

Apr-

16

change

switch

recommend

ation

Barkat®

(750g Flour Mix)

AR


coeliac disease or dermatitis herpetiformis. Current

recommendation Consider switching to Ultra Flour mix. To be

changed to Innovative Solutions Blended Flour



Consider switching to Innovative Solutions Blended Flour A2

.06

.01

Apr-

16

Finax®

(3 x 900g Flour mix

(regular or coarse)) G

reen

no switching recommendation currently on formulary as it is a

cost effective choice



Consider switching to Tobia Flour (brown) or Innovative

Solutions Blended Flour A2

.06

.01

Apr-

16

Finax® (Fibre Bread

Mix)

(3 x 1 kg )

Gre

en

no switching recommendation currently on formulary as it is a

cost effective choice



Consider switching to Tritamyl Brown Bread mix Mrs

Crimbles Bread Mix A2

.06

.01

Apr-

16

change

switch

recommend

ation

Glutafin® WF

(500g Multipupose mix

(white or fibre) )

AR


coeliac disease or dermatitis herpetiformis. Unless also allergic

to wheat consider switching to current recommendation Ultra

Flour mixto change to Innovative Solutions Blended Flour


with coeliac disease or dermatitis herpetiformis. Unless

also allergic to wheat consider switching to Innovative

Solutions Blended Flour A2

.06

.01

Apr-

16

change

switch

recommend

ation

Glutafin® WF

(500g Fibre bread mix)

AR


coeliac disease or dermatitis herpetiformis. Unless also allergic

to wheat, consider switching to current recommendation

Tritamyl Brown Bread Mix to change to Mrs Crimbles Bread

mix


with coeliac disease or dermatitis herpetiformis. Unless

also allergic to wheat, consider switching to Mrs

Crimbles Bread mix A2

.06

.01

Apr-

16

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

change

switch

recommend

ation

Glutafin® Select

(500g Fibre Bread mix)

AR



to current recommentdation Tritamyl Brown Bread mix to

change to Mrs Crimbles Bread Mix



Consider switching to Mrs Crimbles Bread Mix A2

.06

.01

Apr-

16

change

switch

recommend

ation

Glutafin® Select

(500g Multipupose mix

(white or fibre) )

AR



to current recommendation Ultra Flour mix To change to

Innovative Solutions Blended Flour or Tobia Flour (brown)



Consider switching to Innovative Solutions Blended Flour

or Tobia Flour (brown) A2

.06

.01

Apr-

16

change

switch

recommend

ation

Heron Foods® (500g Hi

fibre bread mix)

Bla

ck


coeliac disease or dermatitis herpetiformis. Switch to current

recommendation Tritamyl Brown Bread mix to change to Mrs

Crimbles Bread mix


with coeliac disease or dermatitis herpetiformis. Switch

to Mrs Crimbles Bread mix A2

.06

.01

Apr-

16

Add switch

recommend

ation

change TLL

Orgran® (250g Pasta

spirals (buckwheat

corn, rice & millet, rice,

rice & maize))

AR

current: green TLL

In primary care - a cost effective choice for patients with coeliac

disease or dermatitis herpetiformis. No longer cost effective so

add consider switch to Rizopia fusilli



Consider switching to Rizopia fusilli A2

.06

.01

Apr-

16

change

switch

recommend

ation

Barkat® (500G pasta

(spaghetti, spirals,

tagliatelle, animal

shapes, macaroni))

AR



Currently - Consider switching to Rizopia spaghetti, fusilli or

penne or Orgran Rice and Corn Macaroni or EnerG macaroni

(white rice) . nolonger recommend switch to EnerG macaroni



Consider switching to Rizopia spaghetti, fusilli or penne

or Orgran Rice and Corn Macaroni(white rice) A2

.06

.01

Apr-

16

change

switch

recommend

ation

Proceli® (250g Pasta

macaroni, penne)

AR



Consider switching to currently Rizopia penne or EnerG

macaroni (white rice)to be tanged to Rizopia penne or Orgran

Rice and Corn Macaroni



Consider switching to Rizopia penne or Orgran Rice and

Corn Macaroni A2

.06

.01

Apr-

16

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

change

switch

recommend

ation

BiAlimenta® (6 x 500g

pasta (spiral, grains,

sagnette, penne,

mixed))

AR


coeliac disease or dermatitis herpetiformis.Consider switching

to current - Rizopia spaghetti, fusilli or penne or EnerG

macaroni (white rice) or EnerG pasta (small shells) To remove

EnerG macaroni (white rice) or EnerG pasta (small shells)



Consider switching to Rizopia spaghetti, fusilli or penne A2

.06

.01

Apr-

16

change

switch

recommend

ation

Juvela® GF (6 x 500g

Penne (fibre))

AR


coeliac disease or dermatitis herpetiformis.Consider switching

to current recommendation Glutafin Fibre pasta Spirals. to

change to Glutafin Fibre pasta Fusilli


with coeliac disease or dermatitis herpetiformis.Consider

switching to Glutafin Fibre pasta Fusilli A2

.06

.01

Apr-

16

change

switch

recommend

ation


Tagliatelle)

current formulary wording - In primary care - a LESS cost

effective choice for patients with coeliac disease or dermatitis

herpetiformis Consider switching to Rizopia spaghetti or Juvela

GF fibre linguine


with coeliac disease or dermatitis herpetiformis.Consider

switching to Rizopia spaghetti or Juvela GF fibre linguine.

Not Barkat Pasta Tagliatelle Apr-

16

Glutafin®

(250g Pasta (lasagne,

tagliatelle))

In primary care - a LESS cost effective choice for patients with

coeliac disease or dermatitis herpetiformis. Current

recommendatiion - Consider switching to Rizopia

lasagne/spaghetti



Consider switching to Rizopia Lasagne or Juvela Fibre

linguine. Apr-

16

change

switch

recommend

ation


Spaghetti, macaroni,

fusilli)

AR



to current recommendations Rizopia spaghetti, fusilli or penne

or Dietary specials pasta fusilli, spaghetti or EnerG macaroni

(white rice) . To change to to Rizopia spaghetti, fusilli or penne

or Orgran Rice and corn macaroni



Consider switching to Rizopia spaghetti, fusilli or penne

or Orgran Rice and corn macaroni A2

.06

.01

Apr-

16

change

switch

recommend

ation

Orgran® (150g Lasagne

(rice & maize))

Bla

ck



Switch to current recommendation is EnerG Lasagne (white

rice) to change to Rizopia Lasagne



Switch to Rizopia Lasagne A2

.06

.01

Apr-

16

change

switch

recommend

ation

Ener-G (300G

Vermicelli)

Bla

ck



Switch to current recommendation Rizopia Spaghetti or EnerG

pasta (small shells). To delete recommmendation for EnerG

pasta (small shells).



Switch to Rizopia Spaghetti. A2

.06

.01

Apr-

16

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Proceli® (4 x 50G

Bread buns) Bla

ck

A2

.06

Proceli® (4 x 35G Part

Baked white dinner

rolls) Bla

ck

A2

.06

.0

Fe

b 1

6.4

Add

indication

Docetaxel

20mg/0.5ml/80mg/2ml

(infusion)

in accordance with NHS

England Clinical

Commissioning Policy

B15/PS/a

Prescribing by

consultant

Oncologists

(Prostate)

red

n

For the treatment of hormone naïve metastatic prostate cancer

In combination with androgen deprivation therapy in

accordance with NHS England Clinical Commissioning Policy

B15/PS/a


(Prostate) for the treatment of hormone naïve metastatic

prostate cancer in combination with androgen

deprivation therapy in accordance with NHS England

Clinical Commissioning Policy B15/PS/a

08

.01

.05

Fe

b-1

6

Fe

b 1

6.6

Add Radium-223 dichloride

1000 kBq/ml (Xofigo®)

(solution for injection)

PbR excl, NHS

England


TA 376

Prescribing by

consultant

Oncologists at OUH

only

For the treatment of hormone-relapsed prostate cancer with

bone metastases in accordance with NICE TA 376, Prescribing

by consultant Oncologists at OUH only.


OUH only for the treatment of hormone-relapsed

prostate cancer with bone metastases in accordance

with NICE TA 376

08

.03

.04

.02

Fe

b-1

6

Fe

b 1

6.7

Add Ciclosprin

1mg/ml (Ikervis®)

(eye drops, emulsion)


TA 369and the Ocular

Lubricants guideline

371FM (to be updated)

Consultant

Ophthalmologists in

the Corneal Clinic

red

y

For the treatment of severe keratitis in adult patients with dry

eye disease that has not improved despite treatment with tear

substitutes in accordance with NICE TA 369 and the Ocular

Lubricants guideline 371FM (to be updated). In this cohort,

ciclosporin eye drops 0.1% would be used after all formulary

ocular lubricant choices had been found to be unsuitable due to

Restricted - prescribing by consultant ophthalmologists

in the corneal clinic

1. for the treatment of severe keratitis in adult patients

with dry eye disease that has not improved despite

treatment with tear substitutes in accordance with NICE

TA369 and the Ocular Lubricants Guideline (BHTCG

11

.04

.02

Fe

b-1

6

Fe

b 1

6.7

Delete Ciclosporin 0.2%

(Eye ointment)

(unlicensed) n

Replaced by licensed Ciclosprin 1mg/ml (Ikervis®) (eye drops,

emulsion). See above

11

.99

.99

Fe

b-1

6

the following no longer have delivery charges

FMG DECISIONS FEBRUARY 2016

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Fe

b 1

6.1

2

Add Tolvaptan 15mg,

30mg, 45mg, 60mg,

90mg (Jinarc®)

PbR excl, CCG

(Tablets)


TA358 and the OUH

Tolvaptan guideline

Oxford renal

consultants

Re

d

Y

The NICE TA is being implemented by the OUH Renal Service

for treatment of autosomal dominant polycystic kidney disease

in accordance with NICE TA258. Prescribing by OUH Renal

consultants

Restricted - prescribing by Oxford renal consultants for

treatment of autosomal dominant polycystic kidney

disease in accordance with NICE TA258 and the Oxford

University Hospitals Tolvaptan guideline.

Fe

b-1

6

Add

prescribing

restriction

Add MHRA

warning

Change TLL

Intra-uterine

Progestogen Only

System (Mirena®)

(intrauterine system)

Jaydess® 13.5mg

(intrauterine delivery

system)

Fe

b 1

6.1

7

Add Nintedanib

100mg, 150mg (Ofev®)

(capsule)

PbR excl, NHS

England

restricted to prescribing by

a Tertiary Centre

NICE TA

Re

d

y

Restricted - to prescribing by a tertiary centre (e.g

Brompton) for idiopathic pulmonary fibrosis - NICE TA

379

03

.11

Fe

b-1

6

Fe

b 1

6.1

3

Sodium valproate

MR tablet, crushable

tablet, ec tablet, oral

solution


by a consultant

Neurologist,

Psychiatrist,

Paediatrician or Pain

consultant only,

continuation by GPs

AI

y

MHRA Drug Safety Update - February 2016: Valproate and risk

of abnormal pregnancy outcomes

Sodium valproate oral preparations for use in all patients are to

receive the following amended formulary restriction: Prescribing

initiation by a consultant Neurologist, Psychiatrist, Paediatrician

or Pain consultant only, continuation by GPs

https://www.gov.uk/drug-safety-update/valproate-and-of-risk-of-

abnormal-pregnancy-outcomes-new-communication-materials


Restricted - prescribing initiation by a consultant

Neurologist, Psychiatrist, Paediatrician or Pain

consultant only, continuation by GPs

07

.03

.02

.03

Fe

b-1

6

BHT FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED FORMULARY CHANGES FOR NOTE FEBRUARY 2016 FMG

04

.08

.01

Fe

b-1

6

Fe

b 1

6.1

6

Add MHRA

warning

Gre

en

y

MHRA Drug Safety Alert - Levonorgestrel-releasing IUDs

should be prescribed by brand

Levonogestrol-releasing IUDs should be prescribed by

brand (see MHRA drug safety update, link below)

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add

Esmolol 100mg/10ml

Injection

red

y

currently 2.5g in 10ml (injection concentrate) is on the

formulary, to remain on for time being. 02

.04

.0 0F

eb

-16

Add

indication

Tacrolimus

500micrograms, 1mg

Capsules

Consultant

Gastroenterologists

red

y

For autoimmune hepatitis

No policy / guideline to refer to

Two patients per year


Gastroenterologists for autoimmune hepatitis 13

.05

.0 3F

eb

-16

Add

Bupivacaine 0.125%

epidural inj 250ml bagpain team

red

y to align with epidural guideline 15

.02

#####

Add

Tacrolimus

500micrograms, 1mg,

5mg Capsules Adoport®

brand

red

y

Adoport is used by the Renal and Transplant Units at OUH so

standardise brand at BHT .

patients should be switched from PROGRAF brand where

possible. PROGRAF to remain on formulary until patients have

been switched.

08

.02

.02

13

.05

.03

Fe

b-1

6

Add MHRA

warning

Tacrolimus

500micrograms, 1mg,

5mg Capsules

red

y

MHRA Drug Saftey Update june 2012 says potential for

inadvertent switching between products, which has been

associated with reports of toxicity and graft rejection. Therefore,

to ensure maintenance of therapeutic response when a patient

is stabilised on a particular brand, oral tacrolimus products

should be prescribed and dispensed by brand name only.



update, June 2012)

08

.02

.02

13

.05

.03

Fe

b-1

6

Add MHRA

warning

Vemurafenib 240mg

Tablets

red

y

MHRA Drug Saftey Update - Vemurafenib : risk of potentiation

of radiation toxicity

Nov 2015 08

.01

.0 5F

eb

-16

Add

Clotrimazole 10%

vaginal cream gre

en

y

Included in Management of Infection Guidance for Primary

Care which was approvedat CGS Feb16

Use in accordance with Management of Infection

Guidance for Primary Care 07

.02

.0 2F

eb

-16

Add

Tisseel Ready To Use

Solutions for Sealant

(fibrin sealant)

Spinal surgeons

red

y restricted to hosp only, red, use for Spinal surgeons only Restricted - for use by spinal surgeons only 16

.01

.0 0F

eb

-16

Delete

Amitryptiline

hydrochloride 50mg in

5ml oral solution gre

en

y

rationalise to keep only 25mg in 5ml

04

.03

.0 1F

eb

-16

Delete

Furosemide 1mg in 1ml

red

n

keep only 40mg in 5ml

02

.02

.0 2F

eb

-16

Delete

Haloperidol 5mg in 5ml

red

Y

keep only 10mg in 5ml

04

.02

.0 1F

eb

-16


FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

de

c1

5.1

Add indications Lidocaine Hydrochloride

1%

(100mg/10mL,

200mg/20mL)

(injection) when used as

Lidocaine infusion

In accordance with

Administration of

Intravenous Lidocaine for

Neuropathic Paine

Guideline (BHTCG 673FM)

Prescribing by the

Pain Service on the

advice of a consultant

anaesthetist (Pain

specialist)

Re

d

n

• As a diagnostic tool for neuropathic pain. Where a positive

response will guide subsequent management e.g. the use of

membrane stabilizing drugs

• For the treatment of neuropathic pain where all other agents

are ineffective or not tolerated at maximum doses

• To put a ceiling on high levels of neuropathic pain in patients

taking very high doses of neuropathic pain agents

When used as an intravenous infusion (unlicensed use),

restricted to prescribing by the pain service on the

advice of a consultant anaesthetist (pain specialist) in

accordance with The Administration of Intravenous

Lidocaine for Neuropathic Pain Management (BHTCG

673FM) Guideline

1.As a diagnostic tool for neuropathic pain. Where a

positive response will guide subsequent management

e.g. the use of membrane stabilising drugs

2.For the treatment of neuropathic pain where all other

agents are ineffective or not tolerated at maximum

doses.

3.To put a ceiling on high levels of neuropathic pain in

patients taking very high doses of neuropathic pain

agents

15

.02

De

c-1

5

de

c 1

5.4

Add Naloxegol 12.5mg,

25mg Tablets

For treatment of opioid

induced constipation in

adults whose constipation

has not adequately

responded to laxatives in


345

on the

recommendation of a

hospital consultant,

continuation by GPs

AR y

Prescribing on the recommendation of a hospital consultant e.g.

Palliative care, Spinal, Pain, MfOP consultant), continuation by

GPs For treatment of opioid induced constipation in adults

whose constipation has not adequately responded to laxatives

in accordance with NICE TA 345.

Consider use when there has been an inadequate response to

at least two oral and one rectal laxative at maximum tolerated

doses for at least two weeks. E.gs are macrogol (Laxido®),

docusate, senna, bisacodyl

Patients to be reviewed for efficacy at one month. If this is

positive, it may be appropriate to stop the naloxegol and return

to earlier treatment options

Restricted - prescribing on the recommendation of a

hospital consultant with continuation by GPs for

treatment of opioid induced constipation in adults whose

constipation has not adequately responded to laxatives

in accordance with NICE TA345, when there has been

an inadequate response to at least two oral and one

rectal laxative at maximum tolerated doses for a least

two weeks.

Patients to be reviewed for efficacy at 1 month and if

positive it may be appropriate to stop

01

.06

De

c-1

5

de

c 1

5.5

Amend

restrictionViekirax 12.5 mg/75

mg/50 mg tablet

Ombitasvir/Paritaprevi

r/Ritonavir

PbR excl, NHSE, PAS

with or without dasabuvir

for treating adults with

chronic hepatitis C in

accordance with NICE

TA365 and NHSE

commissioning policy 1524

Consultant

Gastroenterologists/

Hepatologists and


Gastroenterology

Re

d

y

Already on formulary for use in cirrhotic hepatitis C patients in

accordance with NHSE Commissioning policy 1524 June 2015

NICE TA365 subsequently published in November 2015



required.






Hepatitis C with cirrhosis. All patients will be discussed in

the ODN MDT. De

c-1

5

de

c 1

5.5

Amend

restrictionSofosbuvir/Ledipasvir

400mg/90mg tablets

PbR excl, NHSE, PAS

For treating chronic

hepatitis C in accordance


NHSE commissioning

policy 1524

Consultant


Hepatologists and


Gastroenterology

Re

d

y






required.







the ODN MDT. De

c-1

5

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

de

c 1

5.5

Amend

restrictionDaclatasvir 30mg,

60mg tablets

PbR excl, NHSE, PAS

for treating chronic

hepatitis C in accordance


NHSE commissioning

policy 1524

Consultant


Hepatologists and


Gastroenterology

Re

d

y






required.







the ODN MDT. De

c-1

5

de

c 1

5.6

Add Idelalisib 100mg,

125mg Tablets

PbR excl, NHSE, PAS

NICE TA359 Idelalisib for

treating chronic

lymphoblastic leukaemia

Consultant

Haematologists

red y

1. untreated chronic lymphocytic leukaemia in adults with a 17p

deletion or TP53 mutation or

2. chronic lymphocytic leukaemia in adults when the disease

has been treated but has relapsed within 24 months.

For patients in category 1, prior to NICE TA359, alemtuzumab

would have been used (if fit enough) or dexamethasone (if unfit

for alemtuzumab).

For patients in category 2, prior to and following NICE TA359,

Ibrutinib (Cancer Drugs Fund) is the first choice agent.

However, if patients relapse within 24 months of ibrutinib,

idelalisib will be used



compliance to be verified if form not yet available

Restricted - prescribing by Consultant Haematologists in

accordance with NICE TA359

08

.01

.05

De

c-1

5

de

c

15. Add Indications Rotigotine patch 1mg,

2mg,3mg, 4mg, 6mg,

Neurology team or

PD nurses red

y Indications added -

1b patients unable to swallow and discharged to palliative care

Restricted - to prescribing by Neurology team or PD

nurses for Parkinson's disease

##

de

c 1

5.8

Remove Co-

careldopa/Entacapone

7 strengths

Stalevo® brand

recommendation by

Clinical Nurse

Specialist

(Parkinson's) or

Neurology team

AR y

see entry ref Jun15.9

Sastravi® has been use in six Stalevo® naïve patients. No

clinical issues have arisen and the use of Sastravi® instead of

Stalevo® as a Bucks wide formulary decision was felt

appropriate

Restricted - recommendation by Clinical Nurse Specialist

(Parkinson's) or Neurology team

Where suitable the separate component parts may be

used at the discretion of the Parkinson's nurses

New patient suitable for the combined product will be

initiated on Sastravi®. Existing patients on Stalevo® will

be switched to Sastravi®.

Switching of existing patients from Stalevo® to Sastravi®

may be undertaken by the GP

04

.09

.01

De

c-1

5

de

c 1

5.1

Revise TLL Fosfomycin Trometamol

3g sachet

recommendation by

microbiology

AR y

Oral fosfomycin trometamol (Monuril®) is now newly available

as a licensed product in the UK. To improve accessibility and

timely administration the formulary status changed from Red to

Amber Recommended so that GPs may prescribe it based

upon sensitivity results released by Microbiology.

Restricted - to be prescribed on the recommendation of

microbiology sensitivity results.

When results are given in response to a secondary care

initiated sample, clear communication between the

secondary care clinician and GP should take place.

05

.01

.05

De

c-1

5

de

c 1

5.1

1

Add indication Chlorhexidine

Gluconate 2% in

Isopropyl Alcohol 70%

(ChloraPrep®)

(cutaneous solution,

3mL)

red y

Extend use of chlorhexidine 2% in 70% IPA (Chloraprep®) to

include use to prepare skin pre-operatively for breast surgery

Chlorhexidine products review

In secondary care restricted -

1. to areas where central venous catheters, mid and

PICC lines are inserted

2. to prepare skin pre-operatively for breast surgery

13

.11

.02

De

c-1

5

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

de

c 1

5.1

1

Amend

restrictionsChlorhexidine

Gluconate 2% (Clinell®)

(wash cloth (4 per

pack)) red

n

Indication for “pre-op cleansing regimen” removed in

accordance with MHRA /RCS statement on use of topical

chlorhexidine for skin preparation prior to surgery. This is

supported by correspondence from MHRA and does not

represent a change to practice as the wash cloths are not used

for pre-op cleansing.


unlicensed - low risk

Restricted - for skin cleansing in patients receiving

inpatient care in ICU.

13

.11

.02

De

c-1

5

de

c 1

5.1

1 Add indication Chlorhexidine

Gluconate 2% in

Isopropyl Alcohol 70%

(200mL)

red

n

Add for disinfection prior to trauma surgery.previously only prior

to orthopaedic surgery


unlicensed - low risk

In secondary care restricted - only for disinfection prior to

trauma and orthopaedic surgery 13

.11

.02

De

c-1

5

de

c 1

5.1

1 Delete Chlorhexidine/Cetrimide

0.015%/0.15%

(Tisept®)

sachets 25ml

To be replace by Chlorhexidine gluconate 0.05% (Unisept®)

pink single use 25mL, 100mL sachets


13

.11

.02

De

c-1

5

de

c 1

5.1

1

Add Chlorhexidine

Gluconate 0.05%

(Unisept®)

(sterile solution, 100mL

sachet)

gre

en

y

see above (Tisept® entry)

new size added, 100ml 25ml size already on fromulary

13

.11

.02

De

c-1

5

de

c

15

.11

TLL change Chlorhexidine Acetate

0.05%

(sterile solution, 1L) red y

TLL changed from AR to red - Chlorhexidine products review

13

.11

.02

De

c-1

5

de

c 1

5.1

1

Additional

presentation

and restriction

Chlorhexidine

Gluconate 0.5% in

Denatured Ethanol 70%

(solution, 600mL, 500ml

spray bottle)

500ml spray bottle presentation added for use by podiatry only 500ml spray bottle restricted to podiatry for pre and post

intervention skin disinfection

13

.11

.02

De

c-1

5

de

c 1

5.6

Delete Ethinylestradiol

10 microgram,

50 microgram and 1mg

tablets

Due to the high cost of the branded generic decision made to

delete. Agreed with SDU Lead Obs/Gynaecology:

06

.04

.01

De

c-1

5

De

c 1

5.2

0

Add Pembrolizumab

50 mg powder for

concentrate for solution

for infusion

NICE TA357 and NICE

TA366

prescribing by OUH

Melanoma

Oncologists

Re

d

y

Restricted - prescribing by Oxford University Hospitals

(OUH) melanoma oncologists only

Restricted - prescribing by OUH Oncologists only

1. for advanced melanoma after disease progression

with Ipilimumab in accordance with NICE TA357.

2. for advanced melanoma not previously treated with

Ipilimumab in accordance with NICE TA366.

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Se

p 1

5.1

Add Indication Omalizumab 150mg

prefilled syringe

PBr excl CCG

NICE TA 339 Consultant

dermatologists

Re

d

y

Desicion at Dec15 FMG was

in accordance with formal shared care arrangements between

BHT and a Highly Specialised Service (in line with NHS

England commissioning guidance) as add-on therapy for the

treatment of chronic spontaneous urticaria in adult and

adolescent (12 years and above) patients with inadequate

response to H1 antihistamine treatment in accordance with

NICE TA 339

Post Dec FMG, A circular from NHSE to Acute Trusts has

confirmed that NHSE have re-classified omalizumab for

urticaria as a non- Highly Specialised Centre use. This is based

on NICE confirming the wording of their TA. It is now expected



Restricted - prescribing by Consultant Dermatologists in

accordance with NICE TA339 for previously treated

chronic spontaneous urticaria

change wording Cefotaxime inj (all

strengths)

gre

en y In primary care stat dose is green on Traffic lights list when

used for meningitis infections in penicillin allergic patients. ARG

agreed, this use has always been in primary care antibiotic

guidance

In primary care for use as a stat dose in suspected

meningitis when penicillin allergic

05

.01

.02

.01

05

.01

.02

.01

change wording metronidazole 0.75%

vaginal gel

gre

en y In primary care recommended when other choices not suitable.

ARG agreed, this use has always been in primary care

antibiotic guidance

In primary care only recommended when other choices

not suitable

07

.02

.02

07

.02

.02

BHT FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED FORMULARY CHANGES FOR NOTE DECEMBER 2015 FMG

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

change wording Clindamycin 2% vaginal

cream

gre

en y In primary care recommended when other choices not suitable.

ARG agreed, this use has always been in primary care

antibiotic guidance

In primary care only recommended when other choices

not suitable

07

.02

.02

07

.02

.02

change wording Add wording to all

ketone monitoring sticks

on the formulary as per

published low priority

statement (Policy No.

TVPC 13 issued

Aug15)

AR y There is insufficient evidence to recommend routine

measurement of ketones in patients with type 1 or type 2

diabetes. The proposed policy recommends that the following

high risk patients should receive ketone testing strips to self-

monitor when required:

- Insulin pump users

- Patients with a history of admissions with ketoacidosis within

last 5 years

- HbA1c >11% (97 mmol/mol) or blood glucose often > 20

mmol/l

- Pregnant patients with type 1 diabetes

- Newly diagnosed type 1 diabetes

6.1

.6

6.1

.6

WC

F N

ov1

5

add for

evaluationKliniderm Foam Silicone

Border adhesive foam

dressing

7.5cm x 7.5cm

10cm x 10cm

12.5cm x 12.5cm

15cm x 15cm

17.5cm x17.5cm

Added to formulary for evaluation by Spinal, Paediatrics and

Burns/Plastics. Evaluation comparing Mepilex Border against

Kliniderm and Biatain Silicon will run from December 2015 to

end of February 2016.

During January 2016, as part of a controlled evaluation

only, available on formulary for use by Spinal (St

Patrick's Ward), Burns and Plastics and Paediatric

Ward. Evaluation forms to be completed for each use in

these areas. A5

,2,5

WOUNDCARE FORMULARY COMMITTEE DECISIONS NOVEMBER 2015

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

WC

F N

ov1

5

add for

evaluationBiatain Silicon adhesive

foam dressing

7.5cm x 7.5cm

10cm x 10cm

12.5cm x 12.5cm

15cm x 15cm

17.5cm x17.5cm

Added to formulary for evaluation by Spinal, Paediatrics and

Burns/Plastics. Evaluation comparing Mepilex Border against

Kliniderm and Biatain Silicon will run from December 2015 to

end of February 2016.

During February 2016, as part of a controlled evaluation

only, available on formulary for use by Spinal (St

Patrick's Ward), Burns and Plastics and Paediatric

Ward. Evaluation forms to be completed for each use in

these areas.

A5

,2,5

Delete Steripaste No longer available 7.5cm x 7.5cm

A5

.8.9

WC

F

No

v1 Delete Drymax super

absorbent dressing

Spend on super absorbers increased since introduction.

Change to Kerramax now cheaper. xxx

WC

F N

ov1

5

revise

restriction, add

size

Kerramax super

absorbent dressing

20 x 30cm

gre

en

No longer only restricted to nursing home use

xxx

WC

F

No

v1 Add Biatain Ag Silicone

7.5cm x7.5cm

10cm x 10cm

gre

en Savings with switcfh to Biatain Ag Silicone from existing Biatain

Ag adhesive and non-adhesive.

Three smallest sizes available in primary care as stock

through the On-line Non-Prescription Ordering System

(ONPOS), Largest two sizes available on prescription

A5

.3.

3

Delete Biatain Ag adhesive and

non-adhesive - all sizes

Replaced by Biatain Ag

Silicon

NOTE: to be replaced with Biatain Ag Silicone low

adherence dressing, see entry below

A5

.3.3

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

WC

F N

ov1

5

ADD Medi Derma-S barrier

cream

2g sachet, 28g, 90g

tube

Replacing Cavilon barrier

products

gre

en

2g sachet barrier cream

28g, 90g tube barrier cream

All above, except 90g tube, available in primary care as

stock through On-line Non-Prescription Ordering System

(ONPOS)

Apply sparingly For each buttock only a pea-sized

quantity required.

WC

F N

ov 1

5

WC

F N

ov1

5

ADD Medi Derma-S barrier

film

1mL, 3mL foam

applicator (sterile),

30mL non-sting pump

spray

Replacing Cavilon barrier

products

gre

en

1mL, 3mL foam applicator (sterile)

30mL non-sting pump spray



In secondary care obtain from Supplies

WC

F N

ov 1

5

WC

F

No

v1

5

Delete Cavilon No Sting Barrier

film

1ml, 3mL applicator

Replaced by Medi Derma-

S barrier products

bla

ck

NOTE: will become non-formulary from 2016

WC

F N

ov

WC

F

No

v1

5

Delete Cavilon Durable barrier

cream 2g sachet, 28g,

98g tube.

Replaced by Medi Derma-

S barrier products

bla

ck

NOTE: will become non-formulary from 2016

WC

F N

ov

Oc

t 1

5.4 Add Edoxaban 15mg, 30mg,

60mg Tablets


TA 354 and the Bucks

NOACs for use in DVT/PE

amber initiation guideline.

Consultant

Haematologists or

NOAC pharmacists.

In hospital, any

consultant physician

may refer DVT / PE

cases to the NOAC

service for decision

about choice of

treatment after

dalteparin has

already been initiated

red

un

til g

uid

elin

e a

pp

rove

d

y

Place in therapy has been shown in the Table of Considerations

in the NOACs for DVT/PE guideline (FMG 15.9)

An alternative to Rivaroxaban, Dabigatran and Apixaban

for the treatment of DVT and PE, and prevention of

recurrent DVT and PE in adult patients unsuitable for

warfarin for whom dalteparin would otherwise be

considered in accordance with NICE TA 354 and the

Bucks NOACs for use in DVT/PE guideline (not yet

uploaded)

The choice of NOAC will be based upon the table of

considerations for choosing a NOAC described in the

NOACs for DVT/PE guideline

Restricted to initiation by

1. Consultant haematologists or NOAC pharmacists with

continuation by GPs

2. In hospital any consultant physician may refer DVT/PE

cases to the NOAC service for decision about treatment

after dalteparin has already been initiated

Traffic light red until guideline approved

02

.08

.02

Oct-

15


FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Oc

t 1

5.5 Add Edoxaban 15mg, 30mg,

60mg Tablets


TA 355 and the NOACs for

stroke prevention in AF


1. Consultant Stroke

physicians .

2. NOAC Pharmacy

service.

3. Consultant

Cardiologists for

urgent AF patients

Prescribing for

emergency cover

only

All patients initiated

by consultants to be

referred to the NOAC

service for next

working day follow-

up.

red

un

til g

uid

elin

e a

pp

rove

d

y

Place in therapy has been shown in the Table of Considerations

in the NOACs for AF guideline (FMG Sep 15.10)

This updated NOACs for AF guideline

- has revised the definition of an urgent patient 'without a

previous stroke or TIA but with a CHADSVASC2 of 5 or more

should be referred to the NOAC clinic for an urgent initial

appointment. ' (previously CHA2DS2VASc of 6 or more)

- includes a table of considerations for choosing a NOAC upon

which the choice of treatment should be made

- Includes emergency prescribing by consultant Cardiologists

when NOAC service not available at weekends

NOTE 1. Any urgent patient without a previous stroke or

TIA but with a CHA2DS2VASc of 5 or more should be

referred to the NOAC Service for an urgent initial

appointment.

Red Traffic Light For preventing stroke and systemic

embolism in adults with non-valvular atrial fibrillation in

accordance with the NICE TA355 and the NOACs for

stroke prevention in AF amber initiation guideline. The

choice of NOAC will be based upon the Table of

considerations for choosing a NOAC described in the

NOACs for stroke prevention AF guideline (not yet

uploaded)

Restricted to prescribing by

1. Consultant stroke physicians for urgent patients who

have had a previous stroke or TIA. All patients initiated

by consultants to be subsequently referred to the NOAC

service for follow-up.

2. NOAC Pharmacy service

3. Consultant cardiologists for urgent AF patients with a

CHA2DSVASc of 5 or more when the consultant has

confirmed with the NOAC service that the patient cannot

be seen the next working day due to the weekend.

Prescribing for emergency cover only (normally 3 days'

supply) All patients initiated by consultants to be referred

to the NOAC service for next working day follow up.

02

.08

.02

Oct-

15

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Se

p 1

5.1

0 Amend

restrictionApixaban 2.5mg, 5mg

tablet

1. Consultant Stroke

physicians .

2. NOAC Pharmacy

service.

3. Consultant

Cardiologists for

urgent AF patients

Prescribing for

emergency cover

only

All patients initiated

by consultants to be

referred to the NOAC

service for next

working day follow-

up.

Continuation by GPs AI

y

Updated NOACs for AF guideline




appointment.' (previously CHA2DS2VASc of 6 or more)





NOTE 1. Any urgent patient without a previous stroke or



appointment.

NOTE 2. In secondary care tablets can be

dissolved/crushed and administered via

nasogastric/PEG tubes.

Amber Traffic Light for preventing stroke and systemic

embolism in adults with non-valvular atrial fibrillation in

accordance with NICE TA 275 and Dabigatran,

Rivaroxaban and Apixaban for Atrial Fibrillation - Amber

Initiation guideline (BHTCG 313FM) (to be replaced by

the NOACs for stroke prevention in AF amber initiation

guideline)

The choice of NOAC will be based upon the Table of

Considerations for choosing a NOAC described in the

NOACs for stroke prevention AF guideline (awaited)

Restricted to initiation by (with continuation by GPs)

1. Stroke physicians for urgent patients who have had a

previous stroke or TIA. All patients initiated by

consultants to be subsequently referred to the NOAC

service for follow-up.

2. NOAC pharmacy service

3. Consultant Cardiologists for urgent AF patients with a

CHA2DS2VASc of 5 or more when the consultant has

confirmed with the NOAC service that the patient cannot

be seen the next working day due to the weekend.

Prescribing for emergency cover only (normally 3 days'

supply) All patients initiated by consultants to be referred

to the NOAC service for next working day follow-up.

02

.08

.02

Oct-

15

Se

p 1

5.1

0 Amend

restrictionDabigatran etexilate

110mg, 150mg

capsules


TA249 and the NOACs for



as for Edoxaban

tablets in AF above

with continuation by

GPs

AI

y










as for Edoxaban tablets in AF above

02

.08

.02

Oct-

15

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Se

p 1

5.1

0 Amend

restrictionRivaroxaban 15mg,

20mg Tablets


TA256 and the NOACs for



as for Edoxaban

tablets in AF above


GPs

AI

y










as for Edoxaban tablets in AF above

02

.08

.02

Oct-

15

Fe

b 1

5.2

an

d S

ep

15

.9 Amend wording Dabigatran 110mg,

150mg capsules


TA327 and the Bucks



(awaited)

as for Edoxaban

tablets in DVT/PE

above with

continuation by GPs

AI

Updated NOACs for DVT/PE guideline (FMG 15.9) includes a

table of considerations for choosing a NOAC upon which the

choice of NOAC should be made

as for Edoxaban tablets in DVT/PE above

02

.08

.02

Oct-

15

Se

p 1

5.8 Amend wording Apixaban 2.5mg, 5mg

Tablets


TA341 and the Bucks



(awaited)

as for Edoxaban

tablets in DVT/PE

above with

continuation by GPs

red

un

til g

uid

elin

e

y





02

.08

.02

Oct-

15

Se

p 1

5.8 Amend wording Rivaroxaban 15mg,

20mg Tablets


TA 261 and TA 287, and

the Bucks NOACs for use

in DVT/PE amber initiation

guideline. (awaited)

as for Edoxaban

tablets in DVT/PE

above with

continuation by GPs AI





02

.08

.02

Oct-

15

Oc

t 1

5.7 Add Glatiramer acetate

40mg/ml pre-filled

syringe

PbR excl - NHS

England

In accordance with NHS

England circular SSC1534

Consultant

Neurologists and

Clinical Nurse

Specialists (MS)

red

y

NHS England commissioning circular SSC1534 confirms

commissioning of two new products for RRMS both of which

have demonstrated similar efficacy and tolerability to their

current formulary alternatives and have price parity


required - see link from Formulary home page. NICE

compliance to be verified if form not yet available

Restricted - prescribing by Consultant Neurologists and

clinical nurse specialists (MS) as a first line treatment

option for adults with relapsing-remitting multiple

sclerosis in accordance with: NHS England circular

SSC1534.

08

.02

.04

Oct-

15

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Oc

t 1

5.7 Add Peginterferon beta-1a

125 micrograms/0.5ml

pre-filled pen

63micrograms in 0.5ml

and 94micrograms in

0.5ml pre-filled pens

(treatment initiation

pack)

PbR excl - NHS

England

In accordance with NHS

England circular SSC1535

Consultant

Neurologists and

Clinical Nurse

Specialists (MS)

red y

NHS England commissioning circular SSC1534 confirms

commissioning of two new products for RRMS both of which

have demonstrated similar efficacy and tolerability to their

current formulary alternatives and have price parity

FOR ALL PRESCRIBING - Compliance form required -

see link from Formulary home page. Compliance to be

verified if form not yet available


clinical nurse specialists (MS) as a first line treatment

option for adults with relapsing-remitting multiple

sclerosis in accordance with NHS England circular

SSC1534 08

.02

.04

Oct-

15

Oc

t 1

5.9 Add Dexamethasone

700microgram

intravitreal implant

PbR excluded CCG

For diabetic macular

oedema (DMO) in


TA349

Consultant

Ophthalmologists

red

y

Dexamethasone implant is a second line option in

pseudophakic lensed DMO patients for whom antiVEGF

treatment fails or is unsuitable due to intolerance or

contraindications


required - see link form Formulary home page.

Restricted - prescribing by consultant ophthalmologists

as a 2nd line option in pseudophakic diabetic macular

oedema patients for whom anti VEGF treatment fails or

is unsuitable due to intolerance or contraindications in


11

.04

.01

Oct-

15

Oc

t 1

5.1

0 Add Aflibercept 40mg/ml

solution for

intravitreal injection

PbR excluded CCG

For diabetic macular

oedema (DMO) in


TA346

Consultant

Ophthalmologists

red

y

Aflibercept would be an alternative first and second line

antiVEGF to first choice ranibizumab for treatment of DMO as

described in the draft Intravitreal injections algorithm and based

upon the principle that ’When all clinical considerations are

equal, priority will be given to the product with the greatest

experience and lowest short and long term treatment costs’



Restricted - prescribing by consultant Ophthalmologists:

As an alternative 1st and 2nd line anti VEGF to 1st

choice ranibizumab for treating visual impairment caused

by diabetic macular oedema in accordance with NICE TA

346 and as described in the draft intravitreal injections

algorithm and based upon the principle that 'when all

clinical considerations are equal, priority will be given to

the product with greatest experience and lowest short

and long term treatment costs'

11

.08

.02

Oct-

15

Oc

t 1

5.1

1 Add Vedolizumab 300mg

intravenous infusion

PbR excluded CCG

PAS

in accordance with

Biologics Crohn's disease

guideline (in development)

and NICE TA 352

Consultant

Gastroenterologists

red

y

NICE TA 352. Biologics in Crohn's Disease algorithm being

developed



compliance to be confirmed if form not yet available.

Restricted - For treatment of moderate to severe active

Crohn’s disease in adult patients in accordance with

biologics Crohn's disease algorithm (in development)

and NICE TA 352 Vedolizumab for treating moderately to

severely active Crohn's disease after prior therapy

01

.05

.03

Oct-

15

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Oc

t 1

5.3 Add Gluten free foods - new

section added to

netFormulary

8 Units of Gluten free food

per patient on prescription

per month in the form of

gluten free bread, flour and

pasta.

The Nutrition committee has approved the following:

Gluten free foods (new formulary section)

Gluten free restrictions are similar to those approved in

Oxfordshire and East Berkshire i.e.

• 8 Units of Gluten free food per patient on prescription per

month in the form of gluten free bread, flour and pasta.

• The previous limit was less restrictive quantities as per

Coeliac Society Guidelines which varied for age and sex

From December 2015 we will be recommending a

maximum of 8 units of G/F food per patient per month.

We have consulted widely on this recommendation and

it is supported by the majority of the pubic and the

majority of healthcare professionals in 2 separate

surveys.

A2

.06

.01

Oct-

15

Oct

15

.13Add SIP feeds added to Sip feeds section Approved by Nutrition committee

A2

.02

Oct-

15

Oc

t 1

5.1

5 Link added PPI's

MHRA warning to be

linked to the formulary

website

y

MHRA Drug Safety Update - September 2015: PPIs and very

low risk of subacute cutaneous lupus erythematosus

01

.03

.05

Oct-

15

Oc

t 1

5.1

6 Link added Mirabegron

risk of severe

hypertension, cerebro

and cardiovascular

events MHRA

AR y

MHRA Drug Safety Update - October 2015: Mirabegron - risk of

severe hypertension and associated cerebrovascular and

cardiac events

MHRA have warned Mirabegron is now contraindicated

in patients with severe uncontrolled hypertension; advice

about regular monitoring is being introduced because of

cases of severe hypertension. 07

.04

.02

Oct-

15

Se

p 1

5.1

4 guideline

approvedEmpagliflozin 10mg

20mg Tablets

In accordance with BHTCG

667FM and NICE TA 336

Empagliflozin in

combination therapy for

treating Type 2 diabetes

(March 2015) Gre

en

y

The management of Type 2 Diabetes: Blood-Glucose lowering

therapy Primary/Secondary Care guideline (BHTCG 667FM)

approved at CGS nov15

2nd Choice SGLT2 Inhibitor after dapagliflozin

Restricted - prescribing initiation and continuation by any

prescriber in secondary or primary care for the treatment

of adults with Type 2 diabetes in accordance with NICE

TA336 and The management of Type 2 Diabetes: Blood-

Glucose lowering therapy Primary/Secondary Care

guideline (BHTCG 667FM) (see link above)

CG

S n

ov1

5

Ju

n 1

5.2 high cost drug

form approvedPosaconazole

Voriconazole

Liposomal Amphotericin

Caspofungin

In accordance with Fungal

Infections in Haematology

patients - Treatment &

Prophylaxis - Secondary

Care guideline (BHTCG

203FM)

Haematology Team

Re

d

y

Antifungals (Voriconazole, Liposomal Amphotericin

(Ambisome®), Caspofungin and Posaconazole) for the

Treatment or Prophylaxis of Fungal Infections in Haematology

Patients Issued August 2015 - compliance form approved at

CGS nov15

FOR ALL HAEMATOLOGY PRESCRIBING: HIGH

COST DRUG compliance form required - see link from

Formulary homepage

CG

S n

ov1

5

Ap

r 1

5.1

0

revise TLL Amiodarone 100mg,

200mg Tablets

In accordance with

Amiodarone for use in

Cardiology - Shared Care

(Amber) Protocol (BHTCG

632FM)

Initiation by

Consultant

Cardiologist with

continuation by GPs

AP y

change in traffic light status from AI to AP. This will support

more reliable monitoring by GPs

Restricted - initiation in secondary care with continuation

by GPs in accordance with Amiodarone for use in

Cardiology - Shared Care (Amber) Protocol (BHTCG

632FM) 02

.03

.02

Oct-

15

Add Avance SOLO -

negative pressure

wound therapy

only available in secondary

care for use by Podiatry

only, for treatment for 7

days

Podiatry

red

Replaces VIA

BHT have a contract with Avance and SOLO is the VIA

equivalent

Restricted - only available in secondary care for use by

Podiatry only, for treatment for 7 days.

xxx

Oct-

15

Delete VIA - negative pressure

wound therapy red

replaced by Avance Solo

xxx

#####

BHT FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED FORMULARY CHANGES FOR NOTE OCTOBER 2015 FMG

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Note on

FormularyMelatonin 3mg tablets

(Bio-Melatonin brand)

Paediatrics team

red n

To encourage use of less expensive tablets rather than the

more costly liquid, add note to say tablets can be dissolved in a

small amount of water if broken and stirred, or can be crushed

to a fine powder and mixed with water, or given with cold soft

food such as a teaspoon of Yoghurt or jam.

Brand name added to formulary entry

6Jul15

NOTE: Tablets can be dissolved in a small amount of

water if broken and stirred, or can be crushed to a fine

powder and mixed with water, or given with cold soft food

such as a teaspoon of yoghurt or jam.

4.1

.1

Oct-

15

Add Amoxicillin 1g IV MHRA drug alert (July

2014)

red y

Currentlycontracted to Wockhardt but Due to MHRA drug alert

(July 2014) advising not to use any Wockhardt Amoxicillin

Sodium Powder for Solution for Injection (all batches) in

patients <1 year of age. BHT have switched to using Bowmed

(off contract) for all patients to avoid Wockhardt products being

used in this patient group inadvertantly. Currently issues

obtaining the 500mg vial amoxicillin and as a result, the Trust is

using a high volume of the 250mg vials.

The 1g injection is also useful to keep on the formulary for

patients on doses of 1g TDS (CAP) and 2g every 4 hours

(Listerial meningitis/ Native valve endocarditis)

05

.01

.01

.03

Oct-

15

revise restriction

for BHT useRifampicin

tablets, syrup, injection

red and green entries

red

an

d g

ree

n

y

approval from Microbiology no longer needed for legionnarires

disease

In secondary care restricted - for use in mycobacterial

infections, Legionnaire's disease and for meningococcal

contacts. Microbiology approval required for all other

uses.

05

.01

.09

Oct-

15

remove brand Hydrocortisone sodium

phosphate 100ml/1ml

injection

glass ampoules

gre

en

y

Used to be Efcortesol brand but no longer called this, therefore

remove brand name

06

.03

.02

Oct-

15

Combining

entriesEpoetin Alfa,

Darbepoetin, Epoetin

Beta, Aripiprazole tabs,

orodisp tabs, oral

solution,

Chlorpromazine tablet

and oral solution,

Promazine tablets and

oral solution,

Pivmecillinam

Drugs in this list were listed as separate entries each with a

different traffic light status. These have now been combined

into one entry and each entry contains two or more traffic light

sections.

Oct-

15

Add Haloperidol oral

solution 5mg/5mL

red y In wide use across the Trust but not on the formulary.

10mg/5mL sugar-free is on formulary, green on TLL. Both

strengths similar cost although one is half the strength.

To be added as TLL red for now. The trust may want to

consider removing 5mg in 5ml from the formulary

4.2

.1

Oct-

15

Add Clonidine tablets

25microgram

In secondary care

restricted - for use in

Spinal patients only

for spinal patients

only

gre

en y omitted to be added to formulary when merge took place. Is in

use by Spinal patients using 25-50mcg qds for BP control

In secondary care restricted - for use in Spinal patients

only. 2.5

.2

Oct-

15

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Clonidine intrathecal

injection 2mg/mL

Unlicensed - Moderate

risk

for spacticity in spinal

patients only

Spinal Consultants

red N Spasticity, unlicensed use. Currently 2 patients on NSIC . Restricted - prescribing by Spinal Consultants only.

Unlicensed use - moderate risk 2.5

.2

Oct-

15

Add Povidone Iodine 5%

minims®

Restricted - in secondary

to be used by out-patient

ophthalmology glaucoma

team only, prior to 5-

fluorouracil injections.

ophthalmology

glaucoma team

red y Currently povidone iodine 5% is used pre-intravitreal injection

and in theatre. aqueous 10% povidone-iodine is diluted with

WFI but this is not always available. Now minims are now

available can be used for pre 5fu injection only. If usage was to

spread across trust it would generate large cost impact.

Restricted - for use by glaucoma team in out patient

setting only as single use prior to 5-fluorouracil

administration.

11

.04

.01

Oct-

15

Revise

restrictionDemeclocycline

capsules 150mg

Note: capsules are

currently unavailable

and in the interim BHT

will be importing

unlicensed tablets via

Durbin Plc while there

are supply problems

with the capsules (Aug-

Dec 15)

Tablets: Restricted - only

for use if the licensed

capsules are unavailable.

AI n licensed product unavailable at the moment, expected back in

stock dec2015

unlicensed tablets are available. A risk assessment has been

done on Durbibn brand (low risk)

NOTE: capsules are currently unavailable and in the

interim BHT will be importing unlicensed tablets via

Durbin Plc. (capsules expected back in late 2015)

Demeclocylcine 150mg tablets - unlicensed- Low Risk

ONLY for use if licensed capsules unavailable.

05

.01

.03

Oct-

15

revise restriction Alteplase 10mg

injection unlicensed

use

For use in treating retinal

bleed (intravitreal) -

Unlicensed use

Ophthalmic

consultants only

red n have been using on a non-formulary basis to treat retinal bleeds

with good results

Restricted - prescribing by Ophthalmology consultants

for intraocular use after retinal bleeding.

2.1

0.2

Oct-

15

Add Xailin Night eye

ointment

Medical Device

gre

en M

D

Lacri-Lube® on formulary but currently there are problems with

production. Xailin night® to be added to formulary until Lacri-

Lube is available again. Ophthalmic lubricant guideline will be

updated when new ophthalmic consultant (corneal) is appointed

early in the new year.

For use whilst Lacri-Lube is unavailable

11

.8.1

Oct-

15

Revise

restrictionLacri-Lube

gre

en Y Currently there are supply problems with this product, due to

product recall due to black particles around cap. Xailin night to

be added to formulary until supply issue is resolved 11

.8.1

Oct-

15

Delete Steripaste

gre

en see entry above under WOUNDCARE FORMULARY

COMMITTEE DECISIONS NOVEMBER 2015

#####

Add Triumeq® tablets

abacavir (as sulfate)

600 mg, dolutegravir

(as sodium) 50 mg,

lamivudine 300 mg

PbR excuded SCG

In accordance with NHSE

policy

HIV consultants

red y To be used in accordance with NHSE policy Restricted - prescribing by HIV Consultants only in

accordance with BHIVA guidelines and NHSE Clinical

Commissioning policy.

5.3

.1

Oct-

15

Add Dolutegravir 50mg

tablets

PbR excluded SCG

In accordance with NHSE

policy

HIV consultants

red y http://www.england.nhs.uk/wp-

content/uploads/2014/06/Dolutegravir.pdf

Restricted - prescribing by HIV Consultants only in



5.3

.1

Oct-

15

revise TLL Adapalene 0.1% gel

gre

en y Change from AR to Green to bring into line with Acne guideline

13

.6.1

#####

http://www.england.nhs.uk/wp-content/uploads/2014/06/Dolutegravir.pdf

http://www.england.nhs.uk/wp-content/uploads/2014/06/Dolutegravir.pdf

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

revise TLL Tretinoin 0.025% lotion

gre

en y Change from AR to Green to bring into line with Acne guideline

13

.6.1

#####

revise restriction

until stock

depleted, then

delete

Diclofenac dispersible

tablets 50mg

gre

en y Advised by Pharmacy Procurement that now discontinued and

no replacement available. To be left on formulary with a note to

say discontinued for a period of time to allow stock to be used

up.

NOTE: diclofenac 50mg dispersible tablets now

discontinued

10

.1.1

Oct-

15

Revise

restrictionCaspofungin 50mg,

70mg IV infusion

In secondary care

restricted for Haematology

in accordance with Fungal

Infections in Haematology

Patients - Treatment and

Prophylaxis Secondary

Care guideline (BHTCG

203FM) or on Microbiology

approval

Consultant

Haematologists

red y Caspofungin to be used in accordance with the guideline

203FM where it is first line in some conditions and 3rd line in

others.

In secondary care Restricted - for Haematology in

accordance with Fungal Infections in Haematology

Patients - Treatment and Prophylaxis Secondary Care

guideline (BHTCG 203FM) or on Microbiology approval

5.2

.4

Oct-

15

Add Triomel Supplemented

N4-700E (FKCN

12001)

NOTE: the first 14 days

is in tariff and after 14

days, funded by NHS

England.

red N First of possibly several different TPN products used in BHT.

This section of the formulary has never been populated so

spoken with Aseptics to see what they use. Baxter Triomel N4-

700E 2.5L supplemented is the only standard formulary choice.

All other requirements are bespoke and outsourced to ITH

pharma.

SS

9.3

Oct-

15

revise restriction Oxybutynin tablets

2.5mg, 5mg

NOTE: tablets may be

crushed/dispersed in

10mL water and

administered orally or

via NG/PEG tubes.

gre

en y Change in restriction to oxybutynin liquid (see below) so add

note to Formulary as per info from MI regarding crushing of

tablets and mixing with water and administering. Suitable for

admin via nasogastric and PEG tubes. (info from Medicines

Information)

NOTE: immediate release (ordinary) tablets can be

dispersed/crushed in 10mL water and administered

orally or via NG/PEG tubes

7.4

.2

Oct-

15

Add Pilocarpine

hydrochloride tablets

5mg

Requests have come form

specialist centres in

London and Swindon.

Currently being approved

on NF basis in CCG. No

use in BHT

gre

en y Restricted - for use to increase secretions in sjogren's

syndrome

12

.3.5

Oct-

15

revise restriction Oxybutynin oral solution

2.5mg/5mL

to be prescribed for

paediatric patients only

red y Current liq is now discontinued, 2.5mgin 5ml unlicensed. A new

licensed liquid is now being made at greatly increaed cost. MI

have confirmed it is possible to crush tablets.

Restrict use to Paediatrics.

Restricted - to be prescribed for paediatric patients only.

NOTE: immediate release (ordinary) tablets can be

dispersed/crushed in 10mL water and administered

orally or via NG/PEG tub es. .

7.4

.2

Oct-

15

TLL change Fludroxycortide

0.0125% cream

(Haelan)

Was agreed Red at Dec 14

FMG subject to

Dermatology agreeing but

at Dermatology meeting

recently agreed to change

to green

gre

en y Agreed at dermatology SDU Meeting 6th Oct 2015 Potency: Moderate

13

.4

Oct-

15

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Diflucortolone valerate

0.1% oily cream

gre

en y Agreed at dermatology SDU Meeting 6th Oct 2015

Green on Traffic Light List, Post meeting proposal: 3rd choice

Potency: potent

13

.4

Oct-

15

Add Diflucortolone valerate

0.3% oily cream

Potency - Very Potent

gre

en y Agreed at dermatology SDU Meeting 6th Oct 2015

Add as an alternative to Dermovate when there are Dermovate

supply problems.

Green on Traffic Light List, 2nd choice

Potency: Very Potent

2nd line to Dermovate when there are Dermovate supply

problems.

In primary care try to avoid using very potent topical

steroids


steroids

13

.4

Oct-

15

Add Epimax

emollient cream

gre

en y Agreed at dermatology SDU Meeting 6th Oct 2015 In primary care - first choice basic emollient.

Note - patients may be prescribed an alternative if it is

not found suitable

13

.02

.01

Oct-

15

Add Clobetasol propionate

0.05% shampoo

(Etrivex®) (Levon®)

2nd line for use when

dermovate scalp

application not available

gre

en Agreed at dermatology SDU Meeting 6th Oct 2015 Potency: Very Potent

Second choice after Dermovate® scalp application when

this is not available


steroids

Choice Immunoglobulin

Privigen 1st Choice

consultants only

red y Privigen is stored at room temp and everything else being equal

to Octagam including use in Paeds

First choice Immunoglobulin is Privigen®

14

.05

.0 1O

ct-

15

Add Cheapest

brand Colecalciferol/Calcium

Carbonate

10micrograms

(400units)/1.5g

Accrete D3

greeny Accrete® is the cheapest Ca/vit D product on the market.

Currently Primary care recommend Calceos which will

gradually be phased out over 6 months.

Review Calceos in 6 months

In primary care Accrete D3® preferred brand

previous prefered brand Calceos® to be phased out over

6 months

9.6

.4

Oct-

15

new restriction Glibenclamide 2.5mg,

5mg tablet

gr

ee

n

y glibenclamide is no longer recommended because the long half

life means a greater risk of hypos

Restricted - New patients not to be started on

glibenclamide because long half life increases the risk of

hypoglycaemia 6.1

.2.1

Oct-

15

new restriction Tolbutamide 500mg tabletNot a 1st choice treatment

because of the interactions

in use.

greeny F Restricted - not to be used as a first choice treatment

because of the interactions in use

6.1

.2.1

Oct-

15

Swap Macrogol Oral Powder,

Compound.

gr

ee

n

y Cosmocol is a cheaper brand (compared to Movicol). In

Primary care savings can be achieved by actively switching.

Formulary states Macrogol Oral Powder Compound with no

brand names stated so no changes made.

CCG will actively switch to this brand and BHT will remain with

contract product.

1.6

.4

Oct-

15

CCG FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED CHANGES FOR SEPTEMBER -NOVEMBER 2015 FMG

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Methylphenidate

Hydrochloride MR tablet

54mg (Concerta XL)

Restricted - initiation by

Consultant Paediatricians

specialising in childhood

behavioural disorders or

Child or Adult Mental

Health Specialist

initiation by

Consultant

Paediatricians

specialising in

childhood behavioural

disorders or Child or

Adult Mental Health

Specialist

A

P

y New strentgth MR tablet, in use in primary care Restricted - initiation by Consultant Paediatricians

specialising in childhood behavioural disorders or Child

or Adult Mental Health Specialist with continuation by

GPs for the treatment of ADHD in children over 6 years

and in accordance with ADHD amber protocol (BHTCG

796FM)

4.4

Oct-

15

Se

p 1

5.2

Add Secukinumab 150mg

pre-filled pen

PbR excl- CCG

funded. PAS

NICE TA350 Secukinumab

for treating moderate to

severe plaque psoriasis

(July 2015)

Consultant

Dermatologists

red y

Add although NICE form awaited. FOR ALL PRESCRIBING - NICE compliance form



Restricted - prescribing by Consulant Dermatologists for

moderate to severe plaque psoriasis in adults, in

accordance with Psoriasis Biologics treatment guidline


13

.5.3

Sep-1

5

Sep

15

.3

Update Biologics in Psoriasis

algorithm (BHTCG

738FM)

Updated guideline approved (awaiting upload)

Sep-1

5

Sep

15

.4

Update Biologics in Psoriatic

arthritis algorithm

(BHTCG 740FM)

Updated guideline approved (awaiting upload)

Sep-1

5

Se

p 1

5.5

Revise

restrictionCertolizumab pegol

200mg pre-filled

syringe

Consultant

Rheumatologistsre

d

y

Add note regarding restricted use in BHT. FOR ALL PRESCRIBING - NICE compliance form


1. Restricted - prescribing by Consultant

Rheumatologists only, in accordance Biologics for

Rheumatoid Arthritis guideline (BHTCG 749FM) and

NICE TA 186.

NOTE: use restricted in BHT to rheumatoid arthritis

patients with a low number of co-morbidities and low risk

of infection and is subject to further audit.

10

.1.3

Sep-1

5

Se

p 1

5.7

Add Ofatumumab 100mg,

1000mg concentrate

for infusion

PbR excl - SCG. PAS

NICE TA 344 Ofatumumab

in combination with

chlorambucil or

bendamustine for

untreated lymphocytic

leukaemia

Consultant

Haematologists

red

y

• To replace rituximab and chlorambucil as the standard of care

for less fit newly diagnosed CLL patients.

• The choice between ofatumumab and obinutuzumab will be

made by the lymphoma MDT





accordance with NICE TA 344. To replace rituximab and

chlorambucil as the standard of care for less fit newly

diagnosed CLL patients. The choice between

ofatumumab and obinutuzumab will be made by the

Lymphoma MDT.

8.2

.3

Sep-1

5

FMG DECISIONS SEPTEMBER 2015

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Se

p 1

5.7

Add Obinutuzumab

1000mg concentrate

for infusion

PbR excl - SCG. PAS

NICE TA 343

Obinutuzumab in

combination with

chlorambucil for untreated

lymphocytic leukaemia.

Consultant

Haematologists

red

y

• To replace rituximab and chlorambucil as the standard of care

for less fit newly diagnosed CLL patients.

• The choice between ofatumumab and obinutuzumab will be

made by the lymphoma MDT





accordance with NICE TA 343. To replace rituximab and

chlorambucil as the standard of care for less fit newly

diagnosed CLL patients. The choice between

ofatumumab and obinutuzumab will be made by the

Lymphoma MDT.

8.2

.3

Sep-1

5

Se

p 1

5.8

?

Add Apixaban 2.5mg, 5mg

tablet

NICE TA 341 Apixaban for

treatment and secondary

prevention of DVT and PE.

Initiation by

Consultant

Haematologists in the

DVT clinic, or NOAC

service, with


In hospital, any

consultant physician

(POD) may refer DVT

cases to the

Haemostasis or

NOAC clinic for

decision about choice

of treatment after

dalteparin has been

initiated

AI

y

As an alternative to rivaroxaban and dabigatran for the

treatment of DVT and PE, and prevention of recurrent DVT and

PE in adult patients unsuitable for warfarin for whom dalteparin

would otherwise be considered in accordance with NICE TA

341 and the Bucks NOACs for use in DVT/PE amber initiation

guideline.

Red traffic light symbol in place initially becoming AI for the

entire entry after guideline approved (AI guideline awaited)

2. Restricted - to initiation by Consultant

Haematologists in the DVT clinic, or NOAC service, with

continuation by GPs. In hospital, any consultant

physician (POD) may refer DVT cases to the

Haemostasis or NOAC clinic for decision about choice of

treatment after dalteparin has been initiated.

To be used as an alternative to rivaroxaban and

dabigatran for the treatment of DVT and PE, and

prevention of recurrent DVT and PE in adult patients

unsuitable for warfarin, for whom dalteparin would

otherwise be considered, in accordance with NICE TA

341 and the Bucks NOACs for use in DVT/PE Amber

Initiation guideline. (guideline awaited and traffic light

status is RED until guideline uploaded and available)

2.8

.2

Sep-1

5

Se

p1

5.1

3

Add Daclatasvir tablet

30mg, 60mg (Daklinza)

PbR excl - NHSE PAS

NHSE Commissioning

policy 1524 June 2015 -

Hepatitis C with cirrhosis.

Consultant


epatologists and


Gastroenterology red

y

Link to NHSE Commissioning policy statement June 2015 FOR ALL PRESCRIBING - a completed and approved

HIGH COST DRUG compliance form via BLUETEQ is

required


Gastroenterologists/Hepatologists and Assoicate

Specialist (Gastroenterology), as part of ODN in

accordance with NHSE Commissioning Policy statement

June 2015 - Hepatitis C with Cirrhosis

5.3

.3.2

Sep-1

5

Add Viekirax 12.5 mg/75

mg/50 mg tablet

Ombitasvir/Paritaprevi

r/Ritonavir

NHSE Commissioning



Consultant


epatologists and



y



required






5.3

.3.2

Sep-1

5

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Dasabuvir 250mg

tablet

PbR excl - NHSE PAS

NHSE Commissioning



Consultant


epatologists and



y



required






5.3

.3.2

Sep-1

5

Add Sofosbuvir/Ledipasvir

400mg/90mg tablet

(Harvoni)

PbR excl - NHSE PAS

NHSE Commissioning



Consultant


epatologists and



y



required






5.3

.3.2

Sep-1

5

Add Sofosbuvir 400mg

tablet

PbR excl - NHSE PAS

NHSE Commissioning



Consultant


epatologists and



y



required

2...Restricted - prescribing by Consultant





5.3

.3.2

Sep-1

5

Se

p1

5.1

4

Add Empagliflozin 10mg,

25mg tablet

NICE TA 336 Empagliflozin

in combination therapy for

treating Type 2 diabetes

(March 2015) gre

en

y

Guideline (update awaited) 2nd Choice SGLT2 Inhibitor afater Dapagliflozin

Restricted - for the treatment of adults with Type 2

diabetes in accordance with NICE TA336 and Type 2

Diabetes guideline (BHTCG 667FM) (guideline being

updated)(see link above)

6.1

.2.3

Sep-1

5

Oct1

4.2

Add Rifaximin 550mg tablet

(Targaxan)

NICE TA 337 Rifaximin for

preventing epiosdes of

overt hepatic

encephalopathy

Consultants

Gastroenterologists

and Hepatologists

red

Y

Confirm funding SCG/CCG? FOR ALL PRESCRIBING - NICE compliance form



Prescribing by Consultant Gastroenterologists and

Hepatologists for reduction in recurrence of episodes of

overt hepatic encephalopathy in patients over 18 years

of age in accordance with NICE TA 337. When following

up at 1 and 6 months NICE form to be completed each

time.

5.1

.7

Sep-1

5

Se

p 1

5.1

1

Add Vedolizumab 300mg

powder for

concentrate for


PbR Excl CCG PAS

NICE TA 342 Vedolizumab

for treating moderately to

severely active ulcerative

colitis

Consultant

Gastroenterologists

red

y




Prescribing by Consultant Gastroenterologists in

accordance with NICE TA 342 and Biologics in

Ulcerative Colitis guideline (awaited)

1.5

.3

Sep-1

5


FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Se

p 1

5. Revise

restriction Rifampicin 150mg,

300mg capsules and

syrup 100mg/5mL

Respiratory physicians

able to prescribe for

Legionnaire's disease

without Micro approval

gre

en

y


infections, Legionnaire's disease and for meningococcal

contacts. Microbiology approval required for all other

uses

5.1

.9

FM

G

Add Adalimumab 40mg

prefilled pen or

syringe

Infliximab 100mg

infusion

Golimumab 50mg

prefilled pen or

syringe

PbR excl CCG funded


TA329 Infliximab,

adalimumab and

golimumab for treating

moderately to severely

active ulcerative colitis

after the failure of

conventional therapy

(including review of TA140

and TA262)

Prescribing by

Consultant

Gastroenterologists

red y

NOTE (added in full to adalimumab and infliximab entry and in

part to golimumab entry)

In NICE TA 329, adalimumab is the first choice biologic for

adult use and infliximab for paediatric use; in NICE TA 163

infliximab is approved for acute exacerbations. If a patient on

infliximab for NICE TA 163 continues treatment long term in

accordance with NICE TA 329, infliximab should be the drug of

choice and switching to adalimumab should not take place

It should be noted that NICE TA 329 recommends titrating up to

weekly dosing for adalimumab. This is in contrast to current

Thames Valley Priorities Committee recommendations and

supersedes them.





Gastroenterologists in accordance with NICE TA329

Infliximab, adalimumab and golimumab for treating

moderately to severely active ulcerative colitis after the

failure of conventional therapy and in accordance with

BHT Ulcerative Colitis treatment algorithm (in

development)

NOTE (see adjacent column) added to adalimumaband

infliximab and in part to golimumab

1.5

.3

Ju

ne

15

FM

G

Add Eculizumab 300mg

concentrate for


PbR excl NHSE

NICE Highly Specialised

Technology guidance 1:

Eculizumab for treating

atypical haemolytic

uraemic syndrome

Restricted - to

prescribing by

consultant

paediatricians in

shared care with

tertiary centres

red

y




Restricted - prescribing by Consultant Paediatricians in

shared care with tertiary centres only.

un

kn

ow

n

Ju

ne

15

FM

G

Add Axitinib 1mg, 3mg,

5mg, 7mg tablet

PbR excl NHSE

Treatment of advanced

renal cell cancer after

failure of prior systemic

treatments in accordance

with NICE TA 333


by consultant

oncologist (renal) or

consultant oncologist

SDU Lead,

continuation by

consultant

oncologists (all)

red y

Cost impact to be circulated electronically and NICE form

upload awaited. Coming to CGS Aug15




Restricted - prescribing to be initiated by Consultant

Oncologist (renal) or their SDU Lead, with continuation

by all Consultant Oncologists in accordance with NICE

TA 333 Axitinib for the treatment of advanced renal cell

carcinoma after failure of prior systemic treatment.

8.1

.5

Ju

ne

15

FM

G

Add Use of Exenatide with

Insulin

Use of exenatide and

insulin in combination in

accordance with criteria

defined in HCD compliance

form

Diabetes consultant

only

AI

HCD form completed and awaiting upload. Wording added to

exenatide entries.








months.

6.1

.2.3

Ju

ne

15

FM

G

FMG DECISIONS JUNE 2015

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Updated Lipid Modification for


prevention of



guideline

Updated, approved and uploaded to website.

Ju

ne

15

FM

G

Ju

ne

15

.1

Add Infliximab biosimilars

Inflectra® and

Remsima® 100mg


PbR excluded - CCG

funded

Consultant

Gastroenterologists,

Rheumatologists,

Dermatologists

Re

d

y

As for infliximab previously. HCD updates still awaited. FOR ALL PRESCRIBING - NICE compliance form



NOTE:

ALL prescribing of infliximab must include generic and

brand name.

Inflectra® is first choice infliximab biosimilar for all new

patients, with Remsima® second choice only when first

choice is more expensive or not available.

Infliximab biosimilars may be prescribed for patients

currently receiving Remicade® brand when considered

clinically appropriate by the relevant consultant and with

consent of the patient.

1.5

.3,

10

.1.3

, 1

3.5

.3

Ju

ne

15

FM

G

Ju

ne

15

.2

Add Ustekinemab 45mg

pre-filled syringe

PbR excl - CCG

funded

NICE TA 340 Ustekinumab

for treating active psoriatic

arthritis (rapid review of TA

313) June 2015

Consultant

Rheumatologists and

Dermatologists

Re

d

y

Added to formulary with note informing: not funded until end of

August 2015. Updated Biologics guideline for Psoriatic arthritis

in process.

Wording removed as now funded.



Restricted to:

1. Prescribing by Consultant Dermatologists only, in

accordance with Biologics for Psoriasis guideline


2. From September 2015 - Prescribing by Consultant

Dermatologists and Rheumatologists, in accordance with

Biologics for Psoriatic Arthritis guideline (BHTCG

740FM)(updating in process) and NICE TA 340. (NOTE:

not funded for NICE TA 340 until after August 2015)

10

.1.3

, 1

3.5

.3

Ju

ne

15

FM

G

Add Rituximab 1400mg sub-

cutaneous injection

PbR excl - NHS

England

NICE TA 226 Rituximab for

first line maintenance

therapy of folllicular non-

Hodgkin's lymphoma (June

2011)

Consultant

Haematologists only

Re

d

y

Link active to England Specialised services circular (PDF

uploaded to website)

HCD form needs updating - awaited




1. Restricted - prescribing by Haematologists only, in

accordance with NICE TA 226 and in accordance with

NHS England Specialised Services Circular (see link

below).

1. Restricted - prescribing by Haematologists only, in


8.2

.3

Ju

ne

15

FM

G

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Ju

n 1

5.7

Add Rivaroxaban 2.5mg NICE TA 335 Riva for

preventing adverse

outcomes after acute

management of acute

coronary syndromes

Consultant

Cardiologists and

continuation by GPs

AI

y

add but AI guideline in development. Restricted - prescribing by Consultant Cardiologists with

continuation by GPs, in accordance with NICE TA 335.

To be stopped by the GP at 12 months, at the same time

as clopidogrel unless consultant clearly specifies at

discharge that treatmetn is lifelong (for a small cohort of

patients each year)

02

.8.2

Ju

ne

15

FM

G

Ju

n 1

5.8

Add Aromatherapy in Labour FMG acknowledged and accepted the use of aromatherapy for

patients' wellbeing in the Midwife led Unit in BHT.

16sep15 add in accordance with guideline BHT CG500 to be

added to formulary

The aromatherapy oils do not need to be prescribed nor be

included on the formulary.

For use in accordance with Aromatherapy in Labour

guidleline (BHTCG 500) (awaited)(BHT users only)

Ju

ne

15

FM

G

Ju

n 1

5.9

Add Co-

careldopa/Entacapone

7 strengths

Sastravi® (generic

Stalevo® equivalent)

Advice Clinical Nurse

Specialist

(Parkinson's) or

Neurology team with

continuation by GPS AR y

Sastravi® is product of choice.

The choice between prescribing separate component parts or

the combined product is made on the recommendation of the

PArkinson's Nurse/Neurology team, with continuation by GPs.

Restricted - the choice between prescribing the separate

component parts or the combined product is made on

the recommendation of the Clinical Nurse Specialist

(Parkinson's)/Neurology team with continuation by GPs.

If the combined product is recommended then Sastravi®

is first choice for Stalevo® naive patients.

Ju

ne

15

FM

G

Ju

n 1

5.1

0

revise

restrictionMultiple sclerosis

therapy - beta-

interferon, glatiramer,

natalizumab and

fingolimod

PbR excl - NHS

England

NHSE Clinical

Commissioning Policy -

Disease Modifying

Therapies for Patients with

Multiple Sclerosis

as for individual drug

red

y

Link to NHSE Clinical Commissioning Policy - Disease

Modifying Therapies for Patients with MS added to website,

section 8.2.4 and reference to policy added to the named

drugs.

Copy link to formulary.

Restricted - prescribing by Neurologists only in

accordance with NHSE Clinical Commissioning Policy -

Disease Modifying Therapies for Patients with MS (see

link above)

8.2

.4

Ju

ne

15

FM

G

Ap

ril 1

5.1

4

Add Sofosbuvir 400mg

tablet

PbR excl - NHS

England

NICE TA 330 Sofosbuvir

for treating chronic

hepatitis C

Consultant

Gastroenterologists

and Associate

Specialist (Gastro)

Re

d

y

Prescribing in accordance with NICE TA 331 and with

Operational Delivery network as defined by NHS England. Not

funded until August 2015 - noted on formulary entry on website.

16sep remove funding note need to add using blueteq




NOTE: Only funded from August 2015 onwards as per

NICE and NHS England and as defined in NICE TA 331


Gastroenterologists and Associate Specialist

Gastroenterology in accordance with NICE TA330 and

within the framework of an Operational Delivery Network

in accordance with NHSE Specialized Commissioning.

1.5

.3.

Ju

ne

15

FM

G

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Fe

b 1

5.4

Add Brimonidine (Mirvaso)

3mg/g (0.33%) gel

(brimonidine tartrate

5mg/g

Treatment of moderate to

severe persistent facial

erythema assoicated with

rosacea

Consultant

Dermatologists only

Re

d

y

Restricted - prescribing by Consultant Dermatologists

only for the treatment of moderate to severe persistent

facial erythema associated with rosacea. Patient to be

reviewed by consultant one month after commencing

treatment.

Efficacy and safety to be audited with review of results

after 6 months (March 2016)

13

.6.3

Ju

ne

15

FM

G

Add Botulinum toxin type

A (Dysport) 300units

red

y PROPOSAL: add Dysport 300 Units to the formulary for all

restrictions / indications/ specialties currently applied to Dysport

500 units.

Not to be used for the treatment of hyperhidrosis.

NOTE: When writing prescriptions for botulinum toxin

Type A or B, both the GENERIC and BRAND name

MUST be included.

1. Restricted - prescribing by Opthalmology, consultant

Neurologists and Spinal Unit Specialist Clinic.

2. Restricted - prescribing by colorectal surgeons. For

use (unlicensed)when glyceryl trinitrate and diltiazem

ointments have failed, in line with the poisiton statement

on the management of anal fissures produced by the

Association of Coloproctology in 2008.

3. Restricted - prescribing by Paediatric consultant (Jo

Hicks) only, for cerebral palsy spasticity.

11

.99

4.9

.3Ju

ne

15

FM

G

Revise

restrictionAll botulinum injections

add this note:

red

y and add a note for all botulinum injections: “All prescribing of

botulinum toxin type A or B to be written by generic AND brand

name”

NOTE: When writing prescriptions for botulinum toxin

Type A or B, both the GENERIC and BRAND name

MUST be included.

11

.99

4.9

.3Ju

ne

15

Classification Biologic Drugs

red

Not classified as cytotoxics. Agreed at DTC. Also reflected in

National Injectables Guide and also verified in BS

Rhematology. Therefore biologics not listed as cytotoxic.

8.2

.3

Ju

ne

15

Add link Stribild tablets HIV Consultants only

red

Clinical Commissioning policy updated. Linked to formulary

now

Contains: cobicistat 150mg/elvitegravir

150mg/emtricitabine 200mg/tenofovir disoproxil 245mg




5.3

.1

Ju

ne

15

FM

G

Revise

restrictionOxybutynin MR 5mg,

10mg tablets

gre

en

y Clarify prescribing in primary care with addition of primary care

statement.

In secondary care restricted - for use on the Spinal Unit

or for prescribing by consultants only, when the ordinary

tablets are not suitable or there are problems with

compliance

In primary care may be used where ordinary tablets have

caused side effects or where concordance is an issue.

7.4

.2

Ju

ne

15

FM

G

BHT FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED FORMULARY CHANGES FOR NOTE JUNE 2015 FMG

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Revise

restrictionTetanus

Immunoglobulin

250units red

Addition of link to guidance and reworded restriction. Restricted - to be prescribed in accordance with Public

Health England - HPA expert working group interim

guidance on the use of tetanus immunoglobulin for the

treatment of Tetanus.

14

.5

Ju

ne

15

Add Co-trimoxazole tablets

960mg

red

y The shortage of IV CTX is resolving slowly. 960mg tablets to

be added to the formulary and restricted to use in patients

suffering from pneumocystis pneumonia (PCP) to aid

compliance given the large tablet load.

Restricted - only to be prescribed for patients with

pneumocystis pneumonia (PCP) to aid compliance. 5.1

.8

Ju

ne

15

Revise

restrictionNitrofurantoin 100mg

MR tablet

gre

en

y Green (current status)- Removed restriction to patients unable

to tolerate capsules/ suspension and can now be used as joint

first line formulation (with non-MR)

For use in uncomplicated urinary tract infections as 1st line

therapy for lower UTI with eGFR >45mL/min. Female patients 3-

5 day course and male patients 7-10day course.

Evidence - Public Health England: Management of Infection

Guidance for primary care for consultation and local adaptation.

October 2014. Guidance written in accordance with PHE Urine,

SIGN, CKS women, CKS men, RCGP UTI clinical module and

SAPG UTI. Modified-release preparations can be used to

reduce dosing frequency. Reduced dosing frequency (e.g. from

four times a day to twice a day) improves compliance.

In primary care = a first choice for UTI

5.1

.13

Ju

ne

15

FM

G

Add Nifedipine oral drops

20mg/mL 30mL

Autonomic dysflexia Initiation by

Consultant

Paediatricians and

Spinal ConsultantsA

I

N Used for autonomic dysreflexia and patients require urgently. Unlicensed - Medium Risk

Restricted - initiation by Consultant Paediatricians and

Spinal Consultants for treatment of autonomic

dysreflexia in paediatric patients only.

2.6

.2

Ju

ne

15

Nifedipine oral drops

20mg/mL 30mL

(£85.11 excl VAT)

Alcura red

n Used on the advice of a tertiary referral centre only (GOS or

Oxford) and not expected that patient would be discharged into

community requiring this.

Unlicensed - Medium Risk

Restricted - to paediatric patient prescribing in secondary

care only.

NOTE: for treatment of autonomic dysreflexia see

separate amber initiationa entry

2.6

.2

Ju

ne

15

FM

G

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

TLL from

Autumn 2015

and revise

restriction

Pivmecillinam

hydrochloride 200mg

tablet

AR

y Following specialist advice from PHE based on National data of

culture and sensitivity results. Is it possible to make this clear

on the formulary so that the Microbiology department are not

inundated with unnecessarily calls?

The advantages of pivmecillinam are that it is a narrower

spectrum drug which will provide excellent cover for gram

negative organisms (including some resistant ones) and it is not

as broad-spectrum as co-amoxiclav and so is less likely to

cause C.difficile infections.

The urinary tract infection is an important section in the Adult

Flashcard which we need to review ready for the new doctors in

August so if possible, could we ask that this is reviewed

urgently?

NOTE: from Autumn 2015 Microbiology will provide urine

sensitivity results for mecillinam (pivmecillinam is the pro-

drug). When treating UTIs, until such sensitivities are

provided, follow the GREEN entry for pivmecillinam (see

below)

Restricted - to be recommended by Microbiology with

continuation by GPs except when prescribing for urinary

tract infections where pivmecillinam is the 3rd line

choice. If Microbiology release mecillinam on urine

reports this constitutes 'recommendation by

Microbiology' and GPs to prescribe pivmecillinam

accordingly. Microbiology may also recommend in the

absence of results.

In secondary care nitrofurantoin MR is 1st line and

trimethoprim is 2nd line, in accordance with urinary tract

infection guidance and in primary care nitrofurantoin and

trimethoprim are 1st line.

5.1

.1.5

Ju

ne

15

FM

G

TLL change &

revise restrictionPivmecillinam

hydrochloride 200mg

tablet

gre

en

Y Add additional note to formulary until Autumn 2015. Green until

Micro begin providing sensitivities, then go back to AR

Restricted - to be recommended by Microbiology with

continuation by GPs except when prescribing for urinary

tract infections where, until pivmecillinam sensitivities

are provided by Microbiology (expected Autumn 2015),

pivmecillinam to be prescribed 3rd line for urinary tract

infections. In secondary care nitrofurantoin MR is 1st line

and trimethoprim is 2nd line, in accordance with urinary

tract infection guidance. In primary care nitrofurantoin

and trimethoprim are 1st line.

5.1

.1.5

Ju

ne

15

FM

G

Revise

restrictionTrimethoprim tablets

100mg, 200mg and

Trimethoprim

suspension 50mg/5mL

gre

en

y Updated BHT UTI guideline, recommend as 2nd line treatment

after nitrofurantoin.

Add note to formulary stating 2nd line for UTI

In secondary care - 2nd line treatment for urinary tract

infections after nitrofurantoin. 5.1

.8

Ju

ne

15

Add NeoNatal TPN

NeoStart and NeoMain

aqueous parenteral

nutrition bags.

SMOFlipid

PbR excl - CCG

NeoStart and NeoMain

aqueous standard 500 ml

PN bags, SMOF 120 lipid

standard PN 120ml bag as

per Oxford tertiary centre.

Manufacturered by Baxter. red

N Only recently approved TPN products are currently listed on the

formulary.

Restricted - for use as per Oxforde Tertiary centre

9.3

Ju

ne

15

FM

G

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Acenocoumarol 1mg

tablets

AP

y Add further info to formulary when Haematologists advise re

place in therapy and who may initiate prescribing.

Restricted - for use in accordance with Oral

Anticoagulants - Warfarin, Phenindione, Acenocoumarol

(Nicoumalone) when doses are adjusted by the

anticoagulation clinic and prescribed by the GP Amber

Protocol (BHTCG 797FM)

2.8

.2

Ju

ne

15

revise restriction Warfarin 1mg, 3mg,

5mg, 500microgram

tablets and

Phenindione 10mg

tablet

Restriction requires

updating in relation to the

revised Amber Protocol

and also as use extends

beyond Outpatient and

Discharge clinics.

AP

y Currently restriction states: for use in Outpatient prescribing

and Discharge clinics only and in accordance with Oral

Anticoagulant guideline. Add further info to formulary when

Haematologists advise re place in therapy and who may initiate

prescribing.

Restricted - for use in Outpatient prescribing and

Discharge clinics only and in accordance with Oral

Anticoagulants - Warfarin, Phenindione, Acenocoumarol

(Nicoumalone) when doses are adjusted by the

anticoagulation clinic and prescribed by the GP Amber

Protocol (BHTCG 797FM)

2.8

.2

Ju

ne

15

FM

G

Add Colesevelam

hydrochloride 625mg

tablets

Restricted: For bile acid

diarrhoea.

Initiation by

Consultant

Gastroenterologists

or tertiary centre for

BAM with

continuation by GPs

AI

y Should be started by a specialist and established on a stable

and effective dose before transfer to GP for prescribing. Not for

use to lower lipids for which it remains blacklisted and non-

formulary.

Restricted - initiation by Consultant Gastroenterologists

or a tertiary centre for Bile Acid Malabsorption (BAM),

with continuation by GPs for BAM in patients for whom

colestyramine is ineffective or not tolerated. Patients to

receive first 3 months supply from hospital and following

a review in secondary care, treatment is then either

stopped or continued by GPs.

2.1

2

Ju

ne

15

FM

G

CCG FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED CHANGES FOR JUNE 2015 FMGNote Tripotassium

dicitratobismuthate

120mg (De-Noltab)

gre

en

y Being discontinued 31Dec15. Add note to formulary stating

discontinuation date. Confirmed with Astellas 6 Jul 15

Restricted - to prescribing in Primary Care only and in

accordance with the Primary Care antibiotics guideline.

NOTE: to be discontinued 31 December 2015 1.3

.3

Ju

ne

15

Add Clonidine hydrochloride

100micrograms

Use in ADHD for difficult to

manage cases.

Prescribing by

Consultant

Paediatricians/Consul

tants treating ADHD red

n Occasionally prescribed by consultants for difficult to manage

cases. It is not part of any shared care agreement for ADHD.

Similar monitoring required as for other ADHD drugs. Is usually

used in combination with methylphenidate. Oxfordfordshire

Health agree red listing for this use.

Agreement from Paediatric consultant treating ADHD within

BHT received 12Sep15


Paediatricians/Consultants treating ADHD only.

2.5

.2

Ju

ne

15

FM

G

revise restriction Clonidine hydrochloride

100micrograms

gre

en y Add note to to formulary indicating red indication for ADHD use. NOTE: restricted when used for ADHD treatment - see

below.

2.5

.2

Ju

ne

Clomifene citrate 50mg

tablet

Consultant in

Reproductive Health

red

y Traffic light classification agreed as Red. For assisted

conception all patients go to OUH where status is also red.

Most prescribing will be by Oxford or London.

In primary care patients who cannot access hospital

treatment on the NHS may need a private prescription

6.5

.1

Ju

ne

15

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Prednisolone solution

1mg/mL, 10x5mL

gre

en

Y New, licensed and less costly alternative to prednisolone

soluble tablets. Soluble tablets will remain on formulary for a

transition period. Review January 2016

From SPC: Single-dose polyethylene containers containing 5 ml

of oral solution, grouped in strips of five containers. All opened

units should be discarded once the required dose is removed.

Each unit carton contains two over-pouches (ten single-doses),

a patient leaflet and a measuring spoon (dosing 3.75 ml, 2.5 ml

and 1.25 ml, corresponding to partial doses).

In secondary care restricted - only for use in paediatric

patients, who cannot manage the crushed and dispersed

tablets or where the dose required is less than 5mg.

NOTE: it is most cost effective to use ordinary 5mg

tablets which can be crushed, dispersed in water and

administered orally or via PEG/NG tubes

NOTE: All opened units should be discarded once the

required dose is removed

6.3

.2

Ju

ne

15

FM

G

revise restriction Prednisolone soluble

tablets 5mg x 30

Could replace solution

completely. Until this

happens revise restriction

slightly to encourage use

of the oral solution over the

soluble tablets. Also

strengthen the note

regarding cost

effectiveness.

Review for possible

deletion Dec 2015

gre

en

y To remain on formulary for a period of time to allow transition to

1mg/mL licensed solution. Review usage in January

In secondary care restricted - only for use in paediatric

patients and only when prednisolone oral solution

1mg/mL is not available or suitable and patients cannot

manage the crushed and dispersed tablets.

NOTE: it is most cost effective to use ordinary 5mg

tablets which can be crushed, dispersed in water and

administered orally or via PEG/NG tubes.

6.3

.2

Ju

ne

15

FM

G

Ap

r 1

5.1

a

Revise

restrictionSugammadex

200mg/2mL,

500mg/5mL injection

Reversal of neuromuscular

blockade caused by

vecuronium bromide or

recuronium bromide.

Anaesthetics Team

red

y

Removed requirement for replacement of stock only on receipt

of completed audit form for a previous patient.

Revised audit form and guideline approved CGS June 15.

Restricted - prescribing by Anaesthetics team for

reversal of neuromuscular blockade caused by

vecuronium bromide or rocuronium bromide in

accordance with Sugammadex for reversal of

Neuromuscular blockade in Theatres (BHTCG 151) 15

.1.6

FM

G A

pr1

5


FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Ap

r 1

5.2

Add Posaconazole 100mg

tablet, 200mg/5mL

suspension and

300mg concentrate for


PbR excl - NHS

England funded

Fungal infection -

treatment and prophylaxis

in accordance with BHT

guideline 203 The

treatment and prophylaxis

of fungal infections in

Haematology patients

Haematology team

and Microbiology

consultants .

red

y

(E

U)

Indications as per FMG April 2015 Decision

Added from application: where possible use tablets instead of

oral suspension as tablets have higher bioavailability. The

suspension is NOT interchangeable with the tablets on a mg-for-

mg basis.

Restricted - to prescribing by Haematology Team and

Microbiology consultants in accordance with the

treatment and prophylaxis of fungal infections in

Haematology patients (BHTCG 203) for:

Treatment of invasive fungal infections (IFI)

- Fourth line antifungal for the empirical treatment of

presumed invasive fungal infection or confirmed invasive

aspergillosis. Alternative oral agent if voriconazole

toxicity or intolerance occurs and triazole antifungal

required. (1st line voriconazole; 2nd line liposomal

amphotericin; 3rd line caspofungin)

- Second line antifungal for the treatment of other

moulds or proven sinus infections or deep seated

mycoses (1st line liposomal amphotericin).

Prophylaxis of IFI

- Empirical prophylaxis for patients receiving remission-

induction chemotherapy for AML or myelodysplastic

syndromes (MDS) expected to result in prolonged

neutropenia who are at high risk of developing invasive

fungal infections.

High Cost Drug form awaited

5.2

1.

FM

G A

pr1

5

Ap

r 1

5.4

Add Imatinib 100mg,

400mg tablet

PbR excl - funded NHS

England

For adjuvant treatment of

gastrointestinal stromal

tumours (GIST) in


326

Consultant

Oncologist (Gastro)re

d y

GIST in accordance with NICE TA 326

NICE TA 326 replaces NICE TA 196.

NICE TA 86 moved to NICE static list




Restricted - to prescribing by Consultant Oncologist

(Gastro) for adjuvant treatment of gastrointestinal

stromal tumours (GIST) in accordance with NICE TA

326 (review NICE TA 196).

8.1

.5

Add NexoBrid 2g, 5g powder Consultant Burns and

Plastic

red

y (

EU

)

• Prescribing by consultant Burns and Plastics

• For adults with deep partial and full thickness thermal burns

up to a maximum of 15% TBSA who would normally be

considered for surgical debridement

Audit form awaited

Set up on netFormulary but not live yet

Restricted - to prescribing by Consultant Burns and

Plastic for adults with deep partial and full thickness

thermal burns up to a maximum of 15% total body

surface area (TBSA) who would normally be considered

for surgical debridement. 99

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Fe

b 1

5.9

Simeprevir 150mg

capsules

PbR excl - funded NHS

England

Chronic Hepatitis C in


331

Consultant

Gastroenterologists

and Associate

Specialist (Gastro)

red y

see sofosbuvir FOR ALL PRESCRIBING - NICE compliance form




Gastroenterologists and Associate Specialist (Gastro) in

accordance with NICE TA 331 Simeprevir in combination

with peginterferon alfa and ribavirin for treating

genotypes 1 and 4 chronic hepatitis C and within the

framework of an Operational Delivery Network in

accordance with NHSE Specialized Commissioning.

Add Bimatoprost

100micrograms/mL

eyedrops

Consultant

Ophthalmologists with

continuation by GPs

AI

y To replace the discontinued 0.03%. If a generic 0.01%

becomes available to be reconsidered

2nd Choice of prostaglandin analogue eyedrops if

300microgram/mL product no longer available.

Restricted - to initiation by Consultant Ophthalmologist


Branded Lumigan®, bimatoprost 300micrograms/mL

eyedrops are being discontinued by the manufacturer. A

generic equivalent is planned but not yet available. If

the 300micrograms/mL (0.03%) strength cannot be

obtained the GP may transfer prescribing to the

100microgram/mL (0.01%) strength, which has a similar

effect. This has been agreed with BHT

Ophthalmologists. A small number of patients may need

300microgram/mL preservative-free unit dose eyedrops.

Such patients will be identified by BHT Ophthalmologists

and a request for a repeat prescription will be made in

the discharge letter to the GP.

11

.6

FM

G A

pr1

5

revise restriction Bimatoprost

300micrograms/mL

eyedrops

Consultant

Ophthalmologists with

continuation by GPs

AI

y To be discontinued from 1 May 2015. Bring in the 0.01% for

use once stock of 0.03% runs out.

Generic product may be available from Sandoz in the near

future.

2nd Choice of prostaglandin analogue eyedrops if

300microgram/mL product no longer available.



Branded Lumigan®, bimatoprost 300micrograms/mL

eyedrops are being discontinued by the manufacturer. A

generic equivalent is planned but not yet available. If

the 300micrograms/mL (0.03%) strength cannot be

obtained the GP may transfer prescribing to the

100microgram/mL (0.01%) strength, which has a similar

effect. This has been agreed with BHT

Ophthalmologists. A small number of patients may need

300microgram/mL preservative-free unit dose eyedrops.

Such patients will be identified by BHT Ophthalmologists

and a request for a repeat prescription will be made in

the discharge letter to the GP.

11

.6

FM

G A

pr1

5

Add Calcium chloride

10mmol in 10mL

ampoules

Only for use with CRRT

red y Required for use with CRRT solutions (Prismacitrate, Prismocal

and Phoxilium) now available on ITU. Calcium chloride

ampoules required rather than pre-filled syringes.

Restricted - only for use within clinical areas using CRRT

(Continuous Renal Replacement Therapy)

9.5

.1.1

FM

G


Fo

rmu

lary

Ch

an

ge

s f

or

No

tin

g A

pril 2

01

5

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

revise restriction Rifampicin injection

600mg IV infusion

red y Restriction currently states, "in secondary care restricted - for

use in mycobacterial infections and for meningococcal

contacts. Microbiology approval required for all others uses".

Add , "and for the treatment of endocarditis in accordance with

Investigation and Antimicrobial treatment of Infective

Endocarditis in Adults (BHTCG 236)"


infections, for meningococcal contacts and for the

treatment of endocarditis in accordance with


Endocarditis in Adults (BHTCG 236). Microbiology

approval required for all other uses.

5.1

.9

FM

G A

pr1

5

Add Lenograstim

13.4million units

(105mg), 33.6million

units (263mg) vial

injection

PbR excl NHS

England funded

Consultant Paediatric

Oncologists

red y For use in paediatrics in accordance with Oxford protocol

(shared care from tertiary referral centre). We are treating the

patients here under a shared care agreement with Oxford and

so should stay on the treatment they are started on by Oxford -

Lenograstim. Oxford would not want the patient to be changed

onto a different GSCF. Patients who are on protocols are

usually supplied their lenograstim from Oxford which is

administered by the community nurses but very occasionally we

may need to supply doses if they don’t have enough, this is

very rare. GSCF is not used routinely for neutropenia unless

the counts do not improve, in which case Lenograstim is

recommended by Oxford.

Restricted - to prescribing by Consultant Paediatric

Oncologists in accordance with Oxford protocol (Shared

care from tertiary referral centre)

9.1

.6

FM

G A

pr1

5

Add Sodium nitroprusside

50mg/5mL infusion

red no Now unlicensed and imported from Spain via UL Medicines.

Risk Assessed as Moderate

Agreed

Note: Powder for dilution and use as an infusion


2.5

.1

FM

G

Add link Chapter 14 Vaccines Add link to The Green Book - Immunisation Against Infection

Disease. Public Health England

https://www.gov.uk/government/collections/immunisation-

against-infectious-disease-the-green-book

FM

G

Add Naloxone injection

400micrograms/1mL

PFS

red y Injection listed on formulary but pre-filled syringes also need to

be listed.

Restricted for use in Emergency Treatment of opiate

Overdosage.

15

.1.7

FM

G

Add Vitamins A

5000unit/Vitamin D

400unit capsule

gre

en no The product which is available and is being supplied to

community pharmacies and hospital pharmacies is the

5000unit/400unit capsules made by Alissa Healthcare.

Restricted - for use in accordance with Vitamin

Supplementation for Paediatric Cystic Fibrosis (CF)

Patients - Primary/Secondary Care guideline (BHTCG

378FM)

NOTE: Product containing Vitamin A 4000units and

Vitamin D 400units no longer available.

09

.06

.01

FM

G A

pr1

5

revised

restriction Mupirocin 2% in WSP

Nasal cream (Bactroban

Nasal)

gre

en y Mupirocin is 1st Choice for MRSA decolonisation but

Dermatology may use Naseptin first line for other staphy aureus

infections. Request that we provide link to guidelines 14 B and

C

1st Choice - when used for MRSA decolonisation in

accordance with, Suppression of MRSA Colonisation -

patients only (BHTCG 14B) and Eradication of MRSA

Colonisation - patients only (BHTCG 14C)

12

.2.3

FM

G A

pr1

5

revised

restrictionChlorhexidine

Hydrochloride 0.1% with

Neomycin Sulphate

0.5% Nasal cream

(Naseptin)

gre

en y Naseptin is 2nd Choice for MRSA decolonisation. Request also

that we provide link to guidelines 14 B and C

2nd Choice - when used for MRSA decolonisation in

accordance with, Suppression of MRSA Colonisation -

patients only (BHTCG 14B) and Eradication of MRSA

Colonisation - patients only (BHTCG 14C)

12

.2.3

FM

G A

pr1

5

Fo

rmu

lary

Ch

an

ge

s f

or

No

tin

g A

pril 2

01

5

https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

revise restriction Prontoderm Nasal Gel

Light

gre

en y Revised wording: Restricted - for use only as 3rd line for MRSA

decolonisation when 1st and 2nd line agents cannot be used

i.e. MRSA is resistant to mupirocin, MRSA is resistant to

neomycin (Naspetin®), product unavailability, patient allergic to

the ingredients/excipients contained in mupirocin or Naseptin®

The guidelines for which Prontoderm may be used do not

include use in neonates. A separate guideline exists for

neonatal MRSA decolonisation.

Restricted - for use only as 3rd line for MRSA

decolonisation when 1st and 2nd line agents cannot be

used ie. MRSA is resistant to mupirocin, MRSA is

resistant to chlorhexidine hydrochloride 0.1%/neomycin

sulphate 0.5% (Naseptin®), product unavailability,

patient allergic to the ingredients/excipients contained in

mupirocin or Naseptin®. To be used in accordance with,

Suppression of MRSA Colonisation - patients only

(BHTCG 14B) and Eradication of MRSA Colonisation -

patients only (BHTCG 14C)

12

.2.3

FM

G A

pr1

5

Now licensed Magnaspartate

(magnesium aspartate

oral granules) 243mg

(10mmol magnesium)

powder for oral solution

(sachet)

red y Now available as a licensed product was previously Unlicensed

- Low Risk.

Restricted - for treatment of post chemotherapy induced

Mg loss in children. Named Patient. An alternative to

Magnesium glycerophosphate tablets in young children

who cannot swallow large tablets.

Contains Mg2+

10mmol per sachet

9.5

.1.3

FM

G A

pr1

5

revise restriction Ferric Carboxymaltose

(Ferinject) 100mg/2mL,

500mg/10mL and

1g/20mL injection

Haematology team

and Oxford Renal

Service

red y in accordance with Oxford renal formulary. BHT reimbursed for

all renal drugs

Restricted - prescribing by Haematology team in

accordance with Parenteral Iron for Iron Deficiency

Anaemia (BHTCG 58) and for renal patients in

accordance with Oxford Renal formulary

9.1

.1.2

FM

G

Revise TLL Montelukast Granules

4mg x 28 gre

e y Part of Step 2 in asthma guidelines (BTS) Restricted - only for use in children who cannot manage

chewable tablets 3.3

.2

FM

G

CCG FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED CHANGES FOR APRIL 2015 FMGadd note Pipothiazine depot

injection

bl

ac

k

has been discontinued, please add a note which says

discontinued April 15 patients on this depot will need a

specialist review to determine the most appropriate choice of

therapy. Mental Health Trust advocating change to

paliperidone which is a redlisted choice.

No longer available.

Patients on this depot will need a specialist review to

determine the most appropriate choice of therapy.

4.2

.2

FM

G A

pr1

5

Add Paliperidone pre-filled

syringe 50mg, 75mg,

100mg, 150mg

re

d

Mental Health Trust only and recommended by Mental Health

Trust for patients discontinued from pipothiazine

Restricted - prescribing by Mental Health Trust only and

recommended for patinets discontinued from

pipothiazine depot injection.

4.2

.2

FM

G

Revise

restrictionSildenafil 25mg, 50mg,

100mg tablet

gr

ee

n

y

South Central Priorities Committee, April 2015 states: Funding

for the treatment of generic sildenafil in the minimum effective

dose is recommended for any man with erectile dysfunction,

with a frequency of dosing of two times per month.

Discussed with Spinal Pharmacist. Restriction is correct for

secondary care but remove reference to DoH as prescribing

restrictions removed for Sildenafil.

In secondary care restricted - to Spinal patients only.

Doses are provided for the initial dose calibration and

then for Spinal in-patients on weekend leave (2 doses

per weekend)

In primary care for erectile dysfunction restricted to

2/month

7.4

.5

FM

G A

pr1

5

change TLL

status

Nitrazepam tablets and

liquid

AI

Change from green to amber initiation to reduce initiation Restricted - initiation in secondary care with continuation

by GPs

4.1

.1

FM

G

change TLL

status

Zolpidem tartrate 5mg,

10mg tabletsre

d

Changed from black to red with prescribing by Mental Health

Trust team only

Restricted - prescribing by Mental Health Trust team only

4.1

.1

FM

G

Fo

rmu

lary

Ch

an

ge

s f

or

No

tin

g A

pril 2

01

5

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

change TLL

status

Cloral betaine 707mg

tablet and 143.3mg/5mL

elixirbl

ac

k

Large increase in cost, no use across Trust. Agreed to black

list

4.1

.1

FM

G

change TLL

status

Clomethiazole 192mg

capsule bl

ac

k

Green to Black-listed. No longer recommended in BNF for

indication used for.

4.1

.1

FM

G

change TLL

status

Oxazepam 10mg tablet

AI

Restriction was Mental Health Trust initiation only, now

requested change to black. Small use by BHT therefore agreed

to restrict and not recommended for initiation.

Restricted - to continuation only and not recommended

for initiation.

4.1

.2

FM

G

change TLL

status

Benperidol

250microgram tablet bl

ac

k

Mental Health Trust requesting change from AI & Mental Health

Trust only to black

4.1

.2

FM

G

change TLL

status

Chlorpromazine


25mg, 50mg, 100mg

and oral solution

25mg/5mL, 100mg/5mL

AI

for all traditional antipsychotic use Restricted - to initiation in secondary care with

continuation by GPs, when used for traditional

antipsychotic treatment.

4.2

.1

FM

G A

pr1

5

revise restriction

Chlorpromazine


25mg, 50mg, 100mg

and oral solution

25mg/5mL, 100mg/5mL

gr

ee

n

for treatment of nausea or for prescribing in Palliative Care Restricted - for treatment of nausea or for prescribing in

Palliatve Care (for traditional antipsychotic use see

separate amber initiation entry)

4.2

.1

FM

G A

pr1

5

change TLL

status

Pericyazine 10mg tablet

bl

ac

k

Mental Health Trust requested red to black

4.2

.1

FM

G

change TLL

status

Flupentixol

500micrograms, 1mg,

3mg tablets AI

Licensed for schizophrenia and other psychoses Restricted - to initiation in secondary care with


4.2

.1

FM

G

change TLL

status

Pimozide 4mg tablet

bl

ac

k

7 scripts in last 3 months in primary care. No use across Trust

since 2008.

4.2

.1

FM

G

change TLL

status

Promazine 25mg,

50mg tabs and

25mg/5mL, 50mg/5mL

oral solution AI

for all traditional antipsychotic use . Licensed as adjunct to

short-term treatment of moderate to severe psychomotor

agitation and agitation and restlessness in the elderly

Restricted - to initiation in secondary care with

continuation by GPs, when used for traditional

antipsychotic treatment.

4.2

.1

FM

G

change TLL

status

Promazine 25mg,

50mg tabs and

25mg/5mL, 50mg/5mL

oral solution

gr

ee

n

for treatment of nausea or for prescribing in Palliative Care Restricted - for treatment of nausea or for prescribing in

Palliatve Care (for traditional antipsychotic use see

separate amber initiation entry)

4.2

.1

FM

G

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

change TLL

status

Sulpiride 200mg, 400mg

tablets and oral solution

200mg/5mL

AI

Licensed for acute and chronic schizophrenia Restricted - to initiation in secondary care with


4.2

.1

FM

G

change TLL

status

Zuclopenthixol

Decanoate 200mg/1mL,

500mg/1mL depot

injection A

P

Amber protocol in development Protocol in development

4.2

.2

FM

G A

pr1

5

change TLL

status

Zuclopenthixol tabs

2mg, 10mg, 25mgAI

Licensed for psychoses and schizophrenia Restricted - to initiation in secondary care with


4.2

.1

FM

G

typo

Amisulpiride 100mg/mL

solution and 50mg,

200mg tablets

AI

typo change neurologist to psychiatrists; 2 entries Restricted - initiation by Consultant Psychiatrists with

continuation by GPs

4.2

.1

FM

G

change TLL

status

Aripiprazole solution,

tablets & orodispersible

tablets AI

Licensed for schizophrenia in adults and in adolescents aged

15years and older, for moderate to severe manic episodes. Ar

to AI

Restricted - initiation by Psychiatric (Mental Health Trust)

team.

4.2

.1

FM

G

change TLL

status

Olanzapine tablets and

orodispersible tablets,

all strengths.

AI

green to AI Restricted - initiation by Consultant Psychiatrist (Mental

Health Trust) only, with continuation by GPs.

4.2

.1

FM

G

change TLL

status

Sertindole

bl

ac

k

Mental Health trust agreed to red list but not available or listed

in Mims, BNF etc, therefore remove

4.2

.1

FM

G

change TLL

status

Risperidone all oral

formulationsAI

Green to Amber Initiation Restricted - to initiation in secondary care and

continuation by GPs

4.2

.1

FM

G

change TLL

status

Olanzapine embonate

injection 210mg,

300mg, 405mg

Prescribing only by

Mental Health Trustre

d

Restricted - prescribing by Mental Health Trust only

4.2

.2

FM

G

change TLL

status

Asenapine tablet 5mg,

10mgPrescribing only by

Mental Health Trust

re

d

Restricted - prescribing by Mental Health Trust only

4.2

3.

FM

G

change TLL

status

Amitriptyline

hydrochloride/Perphena

zine 25mg/2mg tabletbl

ac

k

Not in use in primary or secondary care

4.3

.1

FM

G

change TLL

status

Clomipramine

Hydrochloride 10mg,

25mg, 50mg tabletgr

ee

n

green on TLL

4.3

.1

FM

G

change TLL

status

Mianserin 10mg 30mg

tablets

AI

Agreed to leave on formulary with recommendation that it not

be initiated. (MHTrust requested black but some use in BHT)

Restricted - recommended not to be initiated

4.3

.1

FM

G

change TLL

status

Phenelzine 15mg tablet

AI

1st choice traditional MAOI with tranylcypromine and

isocarboxid 2nd line.

Restricted - initiation by Consultant Psychiatrist (Mental

Health Trust) only.

4.3

.2

FM

G

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

change TLL

status

Isocarboxazid tablet

10mg Initiation by Mental

Health Trust only

AI

Non-formulary to Amber initiation. Restricted - to initiation by Mental Health Trust only

4.3

.2

FM

G

Fe

b1

5.7

Revised

wordingNalmefene 18mg tablet For reducing alcohol

consumption in people with

alcohol dependence in


325

Prescribing on advice

of Drug and Alcohol

Advisory Team

(DAAT) red y

• For reducing alcohol consumption in people with alcohol

dependence in accordance with NICE TA 325

• Prescribing on the advice of the Drug and Alcohol Advisory

Team (DAAT)

Restricted - prescribing on the advice of the Drug and

Alchohol Advisory Team (DAAT) in accordance with

NICE TA 325 Nalmefene for reducing alcohol

consumption in people with alcohol dependence

4.1

0.1

Fe

b-1

5

De

c 1

4.6

Revise TLL Naproxen suspension

125mg/5mL

Secondary care

Re

d

n

Since naproxen suspension has not been used in the past 5

years and it is an unlicensed product which is particularly

expensive to primary care, it should be red on the traffic light

list for the time being

Restricted - prescribing in secondary care only.

In primary care this is a pharmaceutical special

Use in accordance with NSAIDs in Adults -

Primary/Secondary Care guideline (BHTCG 299FM) Fe

b-1

5

De

c 1

4.4

Add Colecalciferol capsules

20,000units

gre

en

yThere are two licensed brands available: Aviticol and Fultium

D3. Neither contain peanut oil or lactose, but do contain

gelatine.

Restricted - 1st Choice product for the treatment of

Vitamin D deficiency in accordance with Vitamin D

Testing and Treatment in Adults (BHTCG 785FM) - see

above

9.6

.4

Fe

b-1

5

Fe

b

15

.8

Add link Hydroxyzine - all dose

forms

Awareness of EMA PRAC

advice

lenol

gre

en

y

Ensure prescribers are made aware of report and its

recommendations so that they can be considered.

Medicines Information to send email alert to all BHT doctors to

make them aware of risk.

Dermatology have reviewed at SDU Governance meeting (Feb

2015)

Link to EMA PRAC - Hydroxyzine review

3.4

.1

Fe

b-1

5

Fe

b

15

.6

Review Gliptins review Sitagliptin will remain the only DPP-4 inhibitor on the Bucks

formulary. Although alogliptin is currently 20% cheaper than all

other DPP-4 inhibitors, a review of its evidence led the FMG to

decide to avoid its formulary inclusion at this time.

6.1

.2.3

Fe

b-1

5

Fe

b

15

.6

Black list Alopgliptin

Saxagliptin

Vildagliptin

Sitagliptin - only gliptin to

be on formulary

bla

ck

y

6.1

.2.3

Fe

b-1

5

Fe

b 1

5.3

Add Epoetin (Eprex®)

PbR excluded Funded

NHS England)

For use in accordance with

NICE TA 323

Oncology and

Haematology teams

red

y

Formulary not yet updated - awaiting NICE compliance form

approval/upload



1st Choice

Restricted - prescribing by Oncology and Haematology

teams for use in accordance with NICE TA 323

Erythropoiesis stimulating agents (Epoetin and

Darbepoetin) for treating anaemia in people with cancer

having chemotherapy (supersedes NICE TA142)

9.1

.3

Fe

b-1

5

NOTE - drugs above shaded peach (Flupentixol, Sulpiride, Aripiprazole and Zuclopentixol) were to be split into 2 entries: AI for traditional anti-psychotic use and Green for use in

palliative care and treatment of nausea. Palliative Care Team do not use these drugs for palliative care treatment and they are not licensed for nausea treatment. Therefore CCG

and BHT have agreed to leave as one entry for antipsychotic use as amber initiation. 12June15


FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Fe

b 1

5.3

Add Darbepoetin alfa

PbR excluded Funded

NHS England

For use in accordance with

NICE TA 323

Oncology and

Haematology teams

red

y

Formulary not yet updated - awaiting NICE compliance form

approval/upload



2nd Choice , if patients cannot have Epoetin alfa

(Eprex®)

Restricted - prescribing by Oncology and Haematology

teams for use in accordance with NICE TA 323

Erythropoiesis stimulating agents (Epoetin and

Darbepoetin) for treating anaemia in people with cancer

having chemotherapy (supersedes NICE TA142)

9.1

.3

Fe

b-1

5

Fe

b 1

5.2

Add Dabigatran for DVT/PE as an alternative to

rivaroxaban for treatment

DVT/PE and prevention

recurrent DVT/PE in

accordance NICE TA 327

Initiation by

Consultant

Haematologists in the

DVT clinic, or NOAC

Pharmacy service


GPs.

AI

y

Formulary not yet updated - await Rivaroxaban for DVT/PE

Amber Initiation guideline(BHTCG 295FM) approval/upload



Restricted - to initiation by Consultant Haematologists in

the DVT clinic, or NOAC Pharmacy service with

continuation by GPs, as an alternative to rivaroxaban for

the treatment of DVT and PE and prevention of recurrent

DVT and PE in accordance with NICE TA 327 and Bucks

criteria for use of NOACs in DVT/PE (described in

Rivaroxaban for DVT/PE Amber Initiation

guideline(BHTCG 295FM)). Rivaroxaban is 1st choice

NOAC for DVT and PE. Dabigatran to be reserved for

patients on medicines which interact with rivaroxaban,

intolerance to rivaroxaban or other clinical situations

deemed appropriate. In hospital, any consultant

physician (POD) may refer DVT cases to the

Haemostasis or NOAC clinic for a decision regarding

choice of treatment after dalteparin has been initiated.

2.8

.2

Fe

b-1

5

Fe

b1

5.1

a

Audit 2014 Audit Data for

Rivaroxaban DVT/PE

Showed more than 95% patients were prescribed in accordance

with BHTCG 295FM. It was felt that formulary approved criteria

for use are reasonable and do not require changing

2015 data to be reviewed February 2016

Fe

b-1

5

Oct

14

.6

Add Prismocitrate 18/0

solution

For critically ill patients who

require continuous renal

replacement therapy

(CRRT) and are not

contraindicated for RCA.

These include but are not

restricted to, metabolic

disturbance, renal

impairment, poisoning

cases cleared by dialysis

and septic multi-organ

failure

Consultant

Anaesthetists

Re

d

y

guideline approved at CGS Feb 2015 and storage

arrangements confirmed to be in place.

Add reference to guideline once uploaded

Restricted - to prescribing by Consultant Anaesthetists

only, for critically ill patients who require continuous

renal replacement therapy (CRRT) and are not

contraindicated for RCA, in accordance with Continuous

Renal Replacement Therapy (CRRT) using Citrate

(BHTCG 404FM)

no

t in

BN

F-

99

Fe

b-1

5

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Oct

14

.6

Add Prism0cal B22

Bicarbonate-buffered

dialysis solution



replacement therapy

(CRRT) and are not




disturbance, renal




failure

Consultant

Anaesthetists

Re

d

y









(BHTCG 404FM)

no

t in

BN

F-

99

Fe

b-1

5

Oct

14

.6

Add Phoxilium 1.2mmol/L

phosphate solution



replacement therapy

(CRRT) and are not




disturbance, renal




failure

Consultant

Anaesthetists

Re

d

y









(BHTCG 404FM)

no

t in

BN

F-

99

Fe

b-1

5

Ma

y1

3.3

Add AquADEKs liquid, 60mL Approved for CF patients

who cannot swallow tablets

and who require Vitamin K

supplementation

Initiation by

Consultant

Paediatricians and


n

Aquadeks® liquid was approved for formulary inclusion for CF

patients who cannot swallow tablets and has been on the

formulary but now there is a guideline available..

Restricted - initiation by Consultant Paediatricians with

continuation by GPs for cystic fibrosis patients who cannot

swallow tablets.


continuation by GPs for cystic fibrosis patients requiring

Vitamin K supplementation, who cannot swallow tablets

and to be used in accordance with Vitamin

Supplementation for Paediatric Cystic Fibrosis Patients -

Primary/Secondary care guideline (BHTCG 378FM)

Ma

y-1

3

Se

p1

4.8

Add Hepatitis A and B

Vaccine - Primary Care

Travel Guidance

Guideline approved at CGS

Link to be added to Chapter 14 when guideline uploaded to

netFormulary 14

Fe

b-1

5

CCG FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED CHANGES FOR FEB 2015 FMGadd ibuprofen 5% gel, 30g,

50g, 100g

NICE CG on osteoarthritis

suggests topical NSAID

with paracetamol is 1st

choice

gre

en y In primary care consider patient purchasing - often

cheaper than paying a prescription charge.

10

.3.

2

Fe

b-1

5

add ibuprofen 10% gel, 30g,

50g, 100g

NICE CG on osteoarthritis



choice

gre



10

.3.

2

Fe

b-1

5

add diclofenac gel 1.16% NICE CG on osteoarthritis



choice

gre



10

.3.

2

Fe

b-1

5

In primary care consider patient purchasing -often cheaper than

a prescription charge.

Consultant Rheumatologist, Malgosia Magliano commonly

recommends diclofenac and ibuprofen gel in patients with hand

OA

MI Response April 15: NICE do not specify which topical NSAID

to use for osteoarthritis of the knee in their guidelines. A

Cochrane review in 2010 found insufficient data to reliably

compare individual topical NSAIDs with each other. Another

Cochrane review in 2012 which looked at the use of topical

NSAIDs for chronic musculoskeletal pain in adults found that

the best data were for topical diclofenac in osteoarthritis where

the NNT for at least 50% pain relief over 8 to 12 weeks

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

new wording Helicobacter Test

INFAI®

un

sp

eciif

ied ? In primary care the CCGs commission a service from

GPs to test for helicobacter status. Within this service

the kit to test for helicobacter can be ordered (free) from

Stoke Mandevilla Hospital Pharmacy using the specific

form.

2

Fe

b-1

5

Choice of

therapy 1st 2nd

3rd line

Mupiricin 2% in WSP

Nasal cream (Bactroban

Nasal)

1st Choice - recommended

by ARG and in MRSA

guideline

gre

en y NOTE: if unavailable, Chlorhexidine hydrochloride 0.1%

with Neomycin sulphate 0.5% (Naspetin) nasal cream

recommended as there is no direct equivalent.

y

Fe

b-1

5

Choice of

therapy 1st 2nd

3rd line

Chlorhexidine


Neomycin Sulphate

0.5% Nasal cream

(Naseptin)

nd Choice - recommended

by ARG and in MRSA

guideline

gre

en y y

Fe

b-1

5

Choice of

therapy 1st 2nd

3rd line

Prontoderm Nasal Gel

Light 3rd

Choice

3rd Choice - recommended

by ARG

gre

en BHT agree 3rd choice. (not for neonates due to a lack of

experience) Neonate comment not confirmed by BHT and

Prontoderm not included in MRSA guideline but was only

approved at December 14 FMG


decolonisation if mupirocin is unavailable and Naseptin

nasal cream is unsuitable due to resistance or if patients

are allergic to the ingredients/excipients contained in

mupirocin or Naseptin..

y

Fe

b-1

5

Add Montelukast Granules

4mg x 28

Prophylaxis of asthma in

children who cannot

manage the chewable

tablets.

Initiation by

Consultant

Paediatricians and

continuation by GPs

AI y Montelukast sits in Step 2 of BTS guidelines for paediatric

patients. Amber initiation agreed but will apply for green

status at April FMG


continuation by GPs for use in children who cannot

manage chewable tablets.

3.3

.2

Fe

b-1

5

Revise

restrictionMontelukast 4mg, 5mg

tablet

Existing restriction

states: In secondary

care - restricted to

prescribing by

respiratory, ENT and

Dermatology teams only

Consider removing all

restrictions so it can

prescribed throughout the

hospital. emove restrictions

in secondary care

Gre

en y

3.3

.2

Fe

b-1

5

Revise

restrictionMontelukast 10mg

tablet

Existing restriction

states: In secondary

care - restricted to

prescribing by

respiratory, ENT and

Dermatology teams only

Consider removing all

restrictions so it can

prescribed throughout the

hospital.

Gre

en y

3.3

.2

Fe

b-1

5

BHT FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED FORMULARY CHANGES FOR NOTE FEBRUARY 2015 FMG

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Carbex for radiology Each 2.8g sachet contains

sodium bicarbonate and

simethicone. Each 10mL

bottle of Carbex contains

citric acid.. Gas producing

agend for double contract

radiography of the

gastrointestinal tract.

Carbex is given orally.

Radiology use only

red PGD written for this product. Restricted - prescribing by Radiology team only

Mis

ce

llan

ou

e

Fe

b-1

5

Add Barium sulphate 100%

(Baritop 100)

X-ray contract medium for

use in the radiological

examination fo GI tract.

Radiology use only

red Restricted - prescribing by Radiology team only

Mis

ce

llan

ou e

Fe

b-1

5

Add E-Z-HD 98% barium

sulphate

Barium sulphate 98.45%

powder for oral suspension

for use as a radiopaque

agent during X-ray

visualisation of the upper

gastrointestinal tract.

Radiology use only

red PGD written for this product. Radiology order directly from

Bracco UK .

Restricted - prescribing by Radiology team only

Mis

ce

llan

ou

e

Fe

b-1

5

Revise

restrictionFondaparinux

2.5mg/0.5mL

Acute Medical Team

or Consultant

Haematologists

Re

d y Haematologists have requested add to formulary for prescribing

by Consultant Haematologists for patients intolerant of

dalteparin eg. due to heparin-induced thrombocytopenia (HITT),

skin rash.

Restricted to:

1. Prescribing by acute medical team for suspected

ACS. Refer to ICP for ACS

2. Prescribing by Consultant Haematologists for patients

intolerant of dalteparin (eg. Due to heparin-induced

thrombocytopenia (HITT), skin rash)

2.8

.1

Fe

b-1

5

Revise TLL Pivmecillinam

hydrochloride 200mg

tablet

Pivmecillinam is part of the

penicillins group, however,

it is in a class of its own

(5.1.1.5 mecillinams) as it

has additional activity

against gram negative

organisms that are

ESBL/AMPC producers. It

should never be used if

amoxicillin can be, from a

cost and preservation

perspective, but offers a

valuable oral agent for the

treatment of resistant

organisms that otherwise

require IV antibiotics.

Microbiology to

recommend.

AR y Change from Red to AR. Restrict to recommendation by

Microbiology with GPs to prescribe.

Restricted - in secondary care, to be recommended by

Microbiology and,

- in primary care, Microbiology to recommend and GPs

prescribe.

5.1

.1.5

Fe

b-1

5

Revise

restrictionPrednisolone tablets

5mg soluble

gre

en y Add a restriction in secondary care to restrict use to paediatrics

only. Also add note: Normal tablets are suitable to be crushed

and administered down PEG/NG tubes.

5mgx28 tabs £1.33 compared to £47 for soluble tablets.

In secondary care restricted - for use in paediatric

patients only.

NOTE: ordinary 5mg tablets are able to be crushed,

dispersed in water and administered orally or via

PEG/NG tube.

6.3

.2

Fe

b-1

5

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

revise restriction Haloperidol injection

5mg/mL

red No longer licensed for IV use. Some IV use may occur but

restricted to Critical Care areas. Also sub-cutaneous use

ongoing. Formulary worded to say IV use now unlicensed and

restricted to Critical Care areas only

NOTE: Intravenous use is now an unlicensed use. All IV

use restricted to Critical Care areas only. 4.2

.1

Fe

b-1

5

revise restriction Rifampicin injection

300mg

red Restriction currently states, "in secondary care restricted - for

use in mycobacterial infections and for meningococcal

contacts. Microbiology approval required for all others uses".

Add , "and for the treatment of endocarditis in accordance with


Endocarditis in Adults (BHTCG 236)"


infection, for meningococcal contacts and for the

treatment of endocarditis in accordance with


Endocarditis in Adults (BHTCG 236). Microbiology

approval required for all other uses.

5.1

.9

Fe

b-1

5

Unlic Clonazepam injection

1mg/mL

Used in epilepsy but not

first line.

Some use in ITU to control

dystonic reactions. Often

other alternatives have

been tried (eg midazolam,

lorazepam)

red no No longer manufactured in the UK. Unlicensed - Medium Risk

Cloazepam 1mg/mL in solvent, for dilution with 1mL

water for injections immediately before injection.

4.8

.2

Fe

b-1

5

DELETE Diprobath additive

(contained isopropyl

myristate and liquid

paraffin)

gre

en y No longer available therefore removed from formulary.

Dermatology agree remaining emollient bath and shower

preparations are sufficient for formulary purposes. 13

.2.1

.1

Fe

b-1

5

Add Urea 10% cream

(Hydromol Intensive)

30g, 100g

gre

en y Dermatology and CCG agree cheapest as 1st Choice ie

Hydromol Intensive. Dermatology also requested both products

remain on formulary. 13

.2.1

Fe

b-1

5

Add Betamethasone

dipropionate

0.05%/salicylic acid 2%

in alcoholic basis.

(Diprosalic Scalp

Application) 100mL

(Potent)

Diprosalic ointment is on

the formulary and the scalp

application has been

requested by Dermatology.

gre

en y Potency: Potent

13

.4

Fe

b-1

5

Add Dermol Cream 100g,

500g pump

Dermol 500 lotion is on

formulary and cream also

requested by Dermatology

gre

en y

13

.2.1

Fe

b-1

5

Add Stribild (cobicistat

150mg/elvitegravir

150mg/emtricitabine

200mg/tenofovir

disoproxil 245mg)

tablets

£1034.72 (excl

VAT)/30tabs

Restricted - to prescribing

by HIV Consultants only in

accordance with BHIVA

guidelines.

red y Contains: cobicistat 150mg/ elvitegravir 150mg/

emtricitabine 200mg/ tenofovir disoproxil 245mg


accordance with BHIVA guidelines.

5.3

.1

Fe

b-1

5

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Change

(Remove and

Add)

REMOVE

Calcium Sandoz liquid

108mg or 2.7mmol

Ca/5mL licensed but

no longer manufactured

ADD

Calcium syrup

102mg/5mL

(2.55mmol/5mL) to be

added to formulary

(unlicensed)(food

supplement)

for use in paediatric

patients only

gre

en n Calcium-Sandoz liquid no longer manufactured by Alliance due

to inability to source one of ingredients. Therefore remove from

formulary. Small amount of use at BHT .

Alliance now making Alliance Calcium syrup 102mg calcium in

5mL (2.55mmol/5mL) £8.71/250mL for children over 4 yrs.

Calcium-Sandoz was £3.74/300mL (£4.49 incl VAT)

Calcium Sandoz tablets 1000 (25mmol) disperse in 200mL

water and this equates to 20mL QDS for a one year old

compared to 5mL of the liquid. Also need to consider the

sodium content of some of the effervescent products especially

if renal patient.

16Mar15 Emailed Alexa to query frequency of monitoring in

secondary care, if patient requires long-term treatment. May

put note on formulary.

Restricted - for use in paediatric patients only. Adults

requiring a soluble form of calcium should use

soluble/dispersible calcium tablets 9.5

.1.1

Fe

b-1

5

Add Vitamins A and D

(Vitamin A 4000 units,

Vitamin D 400 units) 84

capsules pack

required as in guideline for

children with CF

gre

en BNF states may be difficult to obtain. Product available and

sold via wholesalers contains 5000units Vitamin A. 4000 unit

product not available. Formulary amended to include 5000unit

product

Restricted - for use in accordance with Vitamin

Supplementation for Paediatric Cystic Fibrosis (CF)

Patients (BHTCG 378FM)

9.6

.4

Fe

b-1

5

Delete De Kristol 20,000

tablets (unlicensed)

remove as licensed

capsules now available

gre

en no Now non-formulary as licensed capsules are now

available.

CAUTION: this product is NOT peanut-free, NOT

suitable for patients with peanut allergy

Unlicensed - Medium risk (IDIS)

9.6

.4

Fe

b-1

5

Choice change InVita D3 ampoule Licensed capsules now

available as 1 st Choice

product for Vitamin D

replacement with InVita D3

now 2nd Choice for

patients who cannot

manage the capsules

gre

en y NOTE: dose NOT contain peanut, gelatine or lactose

Restricted - 2nd Choice product for use in patients who

cannot manage capsules, in accordance with Vitamin D

Testing and Treatment in Adults guideline (BHTCG

785FM)

9.6

.4

Fe

b-1

5

revise restriction Nicotine Invisi Patch

10mg.

gre

en y All patches listed in formulary are available in primary care.

Only the 25mg Invisi patch was recommended for hospital use

however Smoking Cessation team agree a lower strength patch

would be useful for stepping down in secondary care.

NRT guideline updated by Smoking Cessation Team and

awaiting approval.

releasing approx. 10mg, 15mg or 25mg over 16 hours

Restricted - in secondary care use in accordance with

Guidelines for Nicotine Replacement Therapy (NRT) for

Inpatients (BHTCG 369). The '25mg' patch should be

used initially, with the '10mg' patch only for use for

"stepping down" from the '25mg' patch if required, or for

very light smokers (0-5 cigarettes/day)

4.1

0.2

Fe

b-1

5

revise

restriction for

BHT use

Apixaban 2.5mg, 5mg

tablet

as listed in formulary Consultant Stroke

Physicians/NOAC

service to initiate,

continuation by GPs

AI

y Manufacturer has advised it is possible to crush/dissolve

tablets and administer via nasogastric/PEG tube - add note to

formulary to reflect this for use in secondary care.

Added :

NOTE 2. In secondary care tablets can be

dissolved/crushed and administered via nasgastric/PEG

tubes.

2.8

.2

Fe

b-1

5

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

new dose form Exenatide 2mg PFS pen

(Bydureon Pen) - new

presentation to replace

the Bydureon vial.

Initiation by Diabetes

Team with

continuation by GPS

AI

y Patent expiry on Bydureon confirm with Astra Zeneca 2023. No

price difference. New product launched Jan 15, withdrawal of

vial in 2015, date as yet unknown

Listed on the formulary as modified release injection (vial and

pre-filled pen)

Restricted - initiation by Diabetes team in accordance

with NICE TA 248 Exenatide pro-longed release

suspension for injection in combination with oral

antidiabetic therapy for the treatment of type 2 diabetes,

and Exenatide (Twice Daily or Once Weekly) for use in

Type 2 Diabetes amber initiation guideline (BHTCG

83FM). Also see Type 2 Diabetes blood-glucose

lowering therapy (BHTCG 667FM) (see link above)

6.1

.2.3

Fe

b-1

5

Revise

restrictionEpoprostenol

500microgram infusion

Prescribing in

secondary care only

red y Previous restriction referred to use for ischaemic limbs. MI has

requested this be removed as it is not used for ischaemic limbs.

Restricted - for use on NICU, ITU and SCBU only

2.8

.1

Fe

b-1

5

De

c 1

4.1 Add Abatacept

subcutaneous 125mg

pre-filled syringe

PbR excluded CCg

funded

For Rheumatoid Arthritis as

an alternative to abatacept

IV and in accordance with

NICE TA 280 and TA 195

Consultant

Rheumatologists Re

d y Abatacept should remain on formulary

Preferred choice for treatment of Rheumatoid Arthritis when

abatacept IV is recommended NICE TA280 and TA195 and in

accordance with Biologics for Rheumatoid Arthritis (BHTCG

749)




yet available)



arthritis, as the preferred choice when abatacept IV is

recommended in NICE TA280 and in accordance with

Biologics for Rheumatoid Arthritis (BHTCG 749)

NOTE If patients fail to respond to one route they may

not try the alternative route.

10

.1.3

FM

G D

ec1

4

De

c 1

4.1 Revise

restrictionAbatacept 250mg


PbR excluded, CCG

funded

For Rheumatoid Arthritis in


280 and TA 195

Consultant

Rheumatologists

red y To remain on formulary for use when Abatacept SC is

inappropriate eg. Inability to self-administer, intolerance etc.

Restricted - ro Rheumatology consultant prescribing

only, in accordance with NICE TA195, NICE TA280 and

Biologics for Rheumatoid Arthritis (BHTCG 749)

NOTE 1: to remain on formulary for use when abatacept

sub-cutaneous is inappropriate eg. Inability to self-

administer, intolerance etc.

NOTE 2: If patients fail to respond to one route they may

not use the alternative route.

10

.1.3

FM

G D

ec1

4

De

c 1

4.4 revise

restrictionCholecalciferol oral

solution (InVita D3)

25,000 IU in 1mL

gre

en Jan CGS

Note - does not contain peanut, gelatine or lactose.

NOTE: does NOT contain peanut, gelatine or lactose

Restricted - for use in accordance with Vitamin D Testing

and Treatment in Adults guidleline (BHTCG 785FM)

9.6

.4

FM

G

De

c 1

4.4 revise

restrictionCholecalciferol

(Dekristol) 20,000 IU

gre

en JanCGS - remove reference in guideline CAUTION: this product is NOT peanut-free. Not suitable

for use in patients with peanut allergy.

Unlicensed - Medium risk (imported from IDIS)

Restricted - to be used as second choice product for the

treatment of Vitamin D deficiency in adults only if InVita

D3 is unavailable and in accordance with Vitamin D

Testing and Treatment in Adults (BHTCG 785FM) - see

link below

9.6

.4

FM

G D

ec1

4


FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Oct

14

.1 Add Tocilizumab 162mg

pre-filled syringe,

subcutaneous

injection

PBR excluded

CCG funded

For Rheumatoid Arthritis as

an alternative to

tocilizumab IV and in


247

Consultant

Rheumatologists Re

d y FOR ALL PRESCRIBING - NICE compliance form



yet available)



arthritis, as an alternative to tocilizumab IV

recommendations in NICE TA247 and in accordance

with Biologics for Rheumatoid Arthritis (BHTCG 749)

Patients should use either IV or SC tocilizumab. If they

fail on either of the routes, they may not use the

alternative route.

10

.1.3

FM

G D

ec1

4

Oct

14

.5 revised TLL

positionOctreotide/Lanreotide For use in palliative care Palliative Care Team

AR y Restricted - recommendation by Palliative Care Team

8.3

.4.3

FM

G

Se

p 1

4.1

1 Add Canagliflozin 100mg,

300mg tablet

gre

en y add as per decision and say Await update of Diabetes guideline Restricted - for the treatment of adults with Type 2

diabetes in accordance with NICE TA315 and Type 2

Diabetes guidelin (BHTCG 667FM) (guideline being

updated) in the following circumstances, when

dapagliflozin cannot be used:

- in dual therapy with metformin for patients over 75

years of age when sitagliptin is not suitable or,

- in triple therapy with metformin and a sulphonylurea

when sitagliptin is not suitable.

6.1

.2.3

FM

G D

ec1

4

Se

p1

4.5 Revised

guidelineContraceptive Guideline links all active

xxx

FM

G

Se

p 1

4.2 Revised

guidelinePsoriasis Bioligcs

guideline

Links to guideline in place from drugs included in guideline eg

adalimumab, etanercept, infliximab and ustekinumab

xxx

FM

G

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

revise restriction Avance Negative

Pressure Wound

Therapy

NPWT is approved for

formulary inclusion for the

healing of a wound which

has excessive exudate

levels and is not

progressing towards

healing.

to included Tissue

Viability nurses

red

me

dic

al d

evic

e Formulary restriction is widened to include initiation in primary

care by Tissue Viability ONLY with supply via ONPOS for

patients who have been or need to be discharged on NPWT

from an out-of-area acute Trust and require continued NPWT or

patients who need NPWT to help prevent admission or re-

admission to hospital.

NOt to be prescribed on FP10s

Restricted -

1. In secondary care to be initiated by Tissue Viability,

Spinal, Burns & Plastics, Orthopaedics and General

Surgery.

2. In primary care, intiation by Tissue Viability ONLY

with supply via ONPOS for patient who:

- have been, or need to be, discharged on NPWT from

an out-of-area acute Trust and require continued NPWT

or,

- need NPWT to help prevent admission or readmission

to hospital

NOTE: NOT to be prescribed on FP10

After initiation of treatment, patients should be reviewed

weekly under the direction/supervision of the Tissue

Viability Team. If no significant improvement is seen in 2

weeks therapy will be stopped. If improvement is

confirmed then the usual length of treatment is 4 weeks

although occasionally patients may require longer

treatment (generally a maximum of 8 weeks)

[Audit results to FMG after 20 patients have received

treatment initiated in primary care using either Avance or

PICO NPWT]

xxx

FM

G D

ec1

4

De

c 1

4.9 Add PICO Negative

Pressure Wound care

dressing 15cm x 15cm,

10cm x 20cm

small, highly exuding

wounds for a maximum of

4 weeks.

recommendation by

Tissue Viability only

in Primary Care.

red

me

dic

al d

evic

e Use on 20 patients per year approved. Audit results, once the

first 20 patients have been treated, to come to FMG.

NOT TO BE USED IN SECONDARY CARE - ONLY FOR

USE IN PRIMARY CARE

In primary care restricted to recommendation by TV only

for short term use (not exceeding 4 weeks), on small,

highly exuding wounds.

- Patients require regular TV specialist review. In

community must be supplied through TV nurse who will

organise supplies to go to the patient's nurse.

- Not to be prescribed on FP10.

- In primary care restricted to TV recommendation

ONLY.

xxx

FM

G D

ec1

4

De

c 1

4.8 Add Lenalidomide 5mg,

10mg, 15mg, 25mg

capsule

PbR excluded, NHSE

funded

For myelodysplastic

syndromes associated with

an isolated deletion 5q

cytogenetic abnormality

NICE TA322

Cons Haematologists

red y Check whether need to add note as per BNF: NOTE: patient,

prescriber and supplying pharmacy must comply with a

pregnancy prevention programme. Every prescription must be

accompanied by a completed Prescription Authorisation Form




yet available)

Restricted - to prescribing by Consultant Haematologists

for myelodysplastic syndromes in accordance with NICE

TA 322 Lenalidomide for treating myelodysplastic

syndromes associated with an isolated deletion 5q

cytogenetic abnormality.

8.2

.4

FM

G D

ec1

4

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

De

c 1

4.6 revise restriction Celecoxib 100mg,

200mg capsule

When used in

secondary care,

restricted to

prescribing by

Consultant

Rheumatologists

gre

en y in accordance with NSAIDs guideline In secondary care - restricted to prescribing by

Consultant Rheumatologists only.

Use in accordance with NSAIDs in Adult -

Primary/Secondary Care guideline (BHTCG 299FM) -

see link above.

10

.1.1

FM

G D

ec1

4

CCG FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED CHANGES FOR DECEMBER 2014 FMGRevise

restrictionsLiothyronine

5micrograms and 20

micrograms

AI

y In secondary care liothyronine has the advantage of a shorter

halflife and faster onset of action. Apart from this acute use,

which is usually short term, liothyronine should not be used as a

1st line treatment choice when prescribed on the NHS. Use in

primary care should only be in patients who have had a

therapeutic trial of levothyroxine and failed to derive adequate

benefits from this treatment.

2nd line to levothyroxine

Problem in primary care of privately initiated treatments being

requested for ongoing prescribing on NHS. Restriction should

help restrict use on NHS after private initiation.

Restricted - initiation in secondary care with continuation

by GPs. 2nd line to levothyroxine.

6.2

FM

G D

ec1

4

BHT FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED FORMULARY CHANGES FOR NOTE DECEMBER 2014 FMGRevise

restrictionsOseltamivir 30mg,

45mg, 75mg (Tamiflu)

caps

Influenza post-exposure

prophylaxis and treatment

gre

en

y

Restrictions revised to reflect latest PHE guidance. Restricted - for seasonal influenza post-exposure

prophylaxis and treatment (see Public Health England

(PHE) advice/local guidance above), or when there is a

high level of seasonal influenza circulating as

determined by PHE.

NICE guidance should be considered by all clinicians

(primary and secondary).

In secondary care - clinicians should use their clinical

judgement to prescribe antivirals, particularly for patients

with proven or suspected influenza whose overal clinical

condition required admission.

In primary care - prescribe when directed by PHE and

GPs may, at their discretion, prescribe antiviral

medicines for people who may not be in the specified at-

risk groups but who they believe would suffer serious

complications if not treated with an antiviral medicine eg

those whoare clinically very unwell or at risk of hospital

admission.

5.3

.4

FM

G D

ec1

4

Revise

restrictionsOseltamivir 6mg/ml

(30mg/5mL) Tamiflu

oral suspension

Restricted - only for use

in children less than 1

year of age

Restricted - as above

for oseltamivir tablets



gre

en

y

and restriction also includes "only for use in children less than

1 year of age."

5.3

.4

FM

G D

ec1

4

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Revise

restrictionsZanamivir 5mg blister

for inhalation (Relenza)

dry powder for

inhalation disks

Restriction - as for

oseltamivir tablets

above



gre

en

y

Restrictions revised to reflect latest PHE guidance.

5.3

.4

FM

G D

ec1

4

Revise

restrictionsZanamivir 200mg/20mL

(Relenza) aqueous

solution



red

N

Restriction revised to include manufacturer and phone number Unlicensed - Medium risk

Available on a named patient basis from

GlaxoSmithKline (0800 036 1060) for patients who fit the

Public Health England criteria (BHTCG 302)

5.3

.4

FM

G

Supply

problemsAlprostadil

10micrograms,

20micrograms

(Caverject Dual

Chamber)

Ai a

nd

Re

d y Availability problems. Add comment to both Red and AI entries

on formulary

If problems with supply, please use Viridal® Duo

7.4

.5

Add Alprostadil

10micrograms,

20micrograms (Viridal

Duo)

Re

d a

nd

AI

-

y Add to formulary whilst supply problems For use while supply problems exist with Caverject® Dual

Chamber 7.4

.5

Add Raltegravir 400mg

tablet Re

d y NHSE have produced new post exposure prophylaxis guidance.

1st line PEP (post exposure prophylaxis for occupational and

non-occupational use)

For PEP (post-exposure prophylaxis), to be used in

combination with tenofovir disoproxil/emtricitabine

(Truvada) and in accordance with November 2014

guidance from EAGA (Expert Advisory Group on AIDS)

5.3

.1

Revise

restrictionZidovudine/Lamivudine

300mg/150mg tablet

(Combivir)

Re

d y Restricted - prescribing for the prevention of maternal to foetal

HIV transmission. See protocol by Obs & Gynae Depts

Restricted - prescribing for patients treated for PEP (post

exposure prophylaxis), in combination with lopinavir/ritonavir.

Initial 5 day treatment followed by a further 25 days if

appropriate.

The latter restriction should be removed.

1. Restricted - prescribing for the prevention of maternal

to foetal HIV transmission. See protocol by Obs &

Gynae Depts.

2. Restricted - prescribing for patients treated for PEP

(post-exposure prophylaxis), in combination with

lopinavir/ritonavir. Initial 5 day treatment followed by a

further 25 days if appropriate.

NOTE: New guidance from EAGA (Expert advisory

Group on AIDS) states PEP prophylaxis to change to

Raltegravir and Truvada from November 2014 (see

entries for Raltegravir and Truvada)

5.3

.1

Revise

restrictionTenofovir

Disoproxil/Emtricitabine

245mg/200mg

(Truvada) tablet

Re

d y For PEP (post exposure prophylaxis)

5.3

.1

Delete Fluenz nasal spray

influenza vaccine Re

d y Discontinued 14

Add Fluenz Tetra nasal

spray influenza vaccine Re

d y replaced Fluenz 14

replacement Urokinase 10,000units

red We removed 5000U as no longer available but didn’t add in the

10,000units which is what the nurses have been using for ages

to give the dose of 5000units now. Done already as I didn't

want to cause issues with something that has been this way for

a long time.

Available on a named patient basis for central line

blockages - see hospital protocol

2.1

0.2

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Revise

restrictionCalcium folinate 15mg

tablet

red Presently on formulary for Methotrexate rescue only. It is

included in the Uveitis guideline and therefore propose adding

as separate entry, as Red on TLL, for use in accordance with

Uveitis Guideline for the treatment of toxoplasmosis.

Restricted - for use in accordance with Uveitis guideline

(BHTCG 374FM)

8.1

Remove Pyrimethamine/sulfadox

ine tablet 25mg/500mg

bla

ck? No longer in Uveitis guideline. Remove as long as no other use

across Trust.


blockages - see hospital protocol 5.4

.1

Add Nicotine inhalator

15mg/cartridge x 4 pack

gre

en y For use in accordance with NRT guideline

Additional pack size. More cost effective for use in hospital

rather than the 36 cartridge pack presently in use.

Community are discussing their needs regarding this size.

Clare Hodsdon and Nicky Blyth

Restricted - in secondary care use in accordance with

NRT guideline

4.1

0.2

revise

restriction Omeprazole injection

40mg

Omeprazole infusion to be used across Trust (and not

omeprazole IV) To avoid potential for error and confusion.

Don't want to delete from formulary as if in future there were to

be supply issues the IV product may be required. Therefore

tightly restrict and word formulary accordingly. Agreed with

Tracy Percival

NOTE: Omeprazole intravenous infusion to be used.

Omeprazole injection is not to be used unless the

infusion is unavailable due to supply problems. (If using

the injection, restrictions apply as for the infusion above)

Revise

restrictionMirabegron 25mg,

50mg

AR y Add Consultant neurologists as prescribers for recommendation Restricted - recommendation by Consultant

Urogynaeacologists, Consultant Urologists, Neurologists

and Spinal Consultants with continuation by GPs, as an

option when patients fail on, or are intolerant of,

solifenacin or for whom anticholinergics are

contraindicated. To be used in accordance with, Over-

Active Bladder - Medical Management -

Primary/Secondary Care guideline (BHTCG 110FM) (see

link above) and NICE TA 290 Overactive bladder -

Mirabegron.

7.4

.2

ADD Ametop cream

gre

e y requested by CCG during Chapter 15 netformulary review Restricted - for use in primary care.

REVISE Captopril suspension

5mg/5mL

AI

y Now a licensed preparation therefore remove unlicensed

wording from formulary.

Restricted - to initiation by Paediatric consultants with


2.5

.5.1

Add Formoterol

12micrograms/metered

inhalation, dry powder

for inhalation

(Easyhaler)

gre

en y Listed in COPD guideline but missed Restricted - may be used as an alternative to salmeterol

for treatment of COPD. See COPD Inhaled Treatment

algorithm (BHTCG 726FM) 3.1

.1.1

Add Formoterol


inhalation, aerosol

inhalation (Atimos

Modulite)

gre

en y Listed in COPD guideline but missed Restricted - may be used as an alternative to salmeterol

for treatment of COPD. See COPD Inhaled Treatment

algorithm (BHTCG 726FM) 3.1

.1.1

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Prontoderm Nasal Gel

Light 30mL

gre

en y as 3rd line agent for MRSA decolonisation as there continues to

be supply issues with Mupirocin Nasal and an alternative is

required in case of Naseptin resistance or if patients are allergic

to the ingredients/excipients (chlorhexidine, arachis oil)

30mL £4.45 (Mupirocin £4.25 and Naseptin £1.67)

Estimated use - one patient per month.

Sodium fusidate is an alternative but resistance is an issue.

Polyfax eye ointment (£3.26 excl VAT) was also a possibility.


decolonisation if mupirocin is unavailable and Naseptin

nasal cream is unsuitable due to resistance or if patients

are allergic to the ingredients/excipients contained in

mupirocin or Naseptin..

no

t in

BN

F

Add Dabrafenib 50mg, 75mg

capsule

red y NICE TA 321 Dabrafenib for treating unresectable or metastatic

BRAF V600 mutation positive melanoma.

No use at BHT

This Specialty is entirely based at OUH and all patients with this

condition needing dabrafenib are treated there.

Restricted - prescribing byt Oxfdord University Hospitals

(OUH) only, in accordance with NICE TA 321 Dabrafenib

for treating unresectable or metastatic BRAF V600

mutation positive melanoma.

8.1

.5

Add Omeprazole MUPS

20mg

gre

en y In secondary care restricted - for use in patients who cannot

swallow because they are in ITU or have a NG/PEG tube and

paediatric patients

In primary care only for use in patients unable to swallow the

capsules

NOTE: Before prescribing omeprazole MUPS consider

lansoprazole Fastab as they are the most cost effective

dispersible tablet

In secondary care restricted - for use in patients who

cannot swallow because they are in ITU or have a

NG/PEG tube and paediatric patients

In primary care only for use in patients unable to swallow

the capsules



dispersible tablet

1.3

.5

Revise

restrictionOmeprazole MUPS

10mg, 20mg dispersible

tablet

gre

en y Added paed patients and Note regarding use of Lansoprazole

FasTabs

In secondary care restricted - for use in patients who




the capsules



dispersible tablet

1.3

.5

Revise

restrictionLansoprazole 15mg,

30mg (FasTab

(orodispersible))

gre

en y Added use for paediatrics and cost effective NOTE In secondary care restricted - for use in patients who




the capsules

NOTE: Lansoprazole Fastab are the most cost effective

dispersible tablet

1.3

.5


FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Oct

14

.3 Add Lubiprostone

24micrograms capsule

Chronic idiopathic

constipation in accordance

with NICE TA 318

Consultant

Gastroenterologists

and Spinal

Consultants with

continuation by GP

AI

y For adults in whom treatment with at least two laxatives from

different classes at the highest tolerated recommended doses

for at least 6 months has failed to provide adequate relief and

for whom invasive treatment for constipation is being

considered.

The first course will be initiated by the consultants and reviewed

at the end of the course (two weeks) to consider the benefit of

treatment; second and subsequent courses will be initiated by

GPs on the advice of the consultant.

At first initiation consultants to provide GPs with clear guidance

regarding expected duration of ongoing treatment.

Restricted - initiation by Gastroenterologists and Spinal

Consultants, with continuation by GPs in accordance

with NICE TA318, for adults in whom treatment with at

least two laxatives from different classes at the highest

tolerated recommended doses for at least 6 months has

failed to provide adequate relief and for whom invasive

treatment for constipation is being considered.

When first course initiated, consultant to:

- provide GPs with clear guidance regarding the

expected duration of ongoing treatment and,

- review patient at the end of the initial 2 week course to

consider the benefit of treatment.

Second and subsequent courses to be initiated by GPs

on the advice of the consultant.

1.6

.7

FM

G O

ct1

4

Oct

14

.3 Revise

restrictionPrucalopride 1mg, 2mg

tablet

Spinal Consultant

may also prescribe

AI

y see formulary restriction Restricted - initiation by Gastroenterologists and Spinal

Consultants, with continuation by GPs after first hospital

review at 4 weeks, in accordance with NICE TA 211

Prucalopride for the treatment of chronic constipation in

women. A supply of 2 weeks to be provided by the

hospital after the first review at four weeks ie. total of 6

weeks supply from hospital

1.6

.7

FM

G O

ct1

4

OC

t14

.5 revised TLL

positionOctreotide/Lanreotide For use in cancer Oncology team

red y Restricted - prescribing by Oncology team

8.3

.4.3

FM

G

Oct

14

.5 revised TLL

positionOctreotide/Lanreotide For use in insulin

resistance (CHI -

Congenital

Hyperinsulinism) in

paediatric patients. (As

shared care with tertiary

referral centres)

Paediatriciansre

d y Unlicensed Use

Restricted - prescribing by Consultant Paediatricians for

use in insulin resistance (Congenital Hyperinsulinism

(CHI)) in paediatric patients (as shared care with tertiary

referral centres)

8.3

.4.3

FM

G O

ct1

4

Oct

14

.5 revised TLL

positionOctreotide/Lanreotide Acromegaly Consultant

Paediatricians and

Endocrinologists

AP y Restricted - prescribing by Consultant Paediatricians and

Endocrinologists for the treatment of acromegaly.

(shared care protocol awaited) 8.3

.4.3

FM

G

Oct

14

.7 Add Trastuzumab s.c

injection 600mg

PBr excluded funded

NHS England

same as entry on formulary

but not for GIST. In


34 and NICE TA107 for

adjuvant for HER2 positive

breast cancer

Breast oncologists

red y FOR ALL PRESCRIBING - NICE compliance form



yet available)

Restricted - prescribing by Breast Oncologists for:

1. use in accordance with NICE TA34 for advanced

breast cancer

2. use in accordance with NICE TA107 for the adjuvant

treatment of early-stage HER2-positive breast cancer

8.1

.5

FM

G O

ct1

4

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Se

pt

14

.4 Add Levonorgestrel IUD

(Jaydess)

use in Women's health in

primary and secondary

care in accordance with the

Contraceptives guideline

BHTCG updated NOv2014

gre

en M

D

Not on formulary until mid-November (after APC and CGS) To be used in accordance with Contraception (Summary

of Key Messages) (BHTCG 783FM)

In secondary care restricted - to Family Planning and

Obs & Gynae Consultants/SPRs only

In primary care GP must have undergone training on

insertion

7.3

.2.3

FM

G O

ct1

4

Se

p 1

4.5 Add Alemtuzumab 12mg

concentrate for


PBr excl. Funded NHS

England

treatment of adults with

relapsing remitting multiple

sclerosis with active

disease in accordance with

NICE TA 312

Consultant

Neurologists and

Clinical Nurse

Specialist for

Neurology

red y HCD Form approved Dec 2014 - NICE wording to be removed FOR ALL PRESCRIBING - NICE compliance form


compliance to be verified if form not yet available)


Clinical Nurse Specialist for Neurology for the treatment

of adults with relapsing remitting multiple sclerosis with

active disease in accordance with NICE TA312.

8.2

.3

FM

G O

ct1

4

Se

p 1

4.6 Add Dimethyl fumarate

120mg, 240mg

capsules

PBR excl Funded NHS

England

treatment of adults with

relapsing remitting multiple

sclerosis with active

disease in accordance with

NICE TA 320

Consultant

Neurologists and

Clinical Nurse

Specialist for

Neurology





Clinical Nurse Specialist for Neurology for the treatment

of adults with relapsing remitting multiple sclerosis with

active disease in accordance with NICE TA320.

8.2

.4

FM

G O

ct1

4

Se

p 1

4.7 Add Enzalutamide 40mg

capsules

PBR excl Funded NHS

England

for treatment of metastatic

hromone-relapse prostate

cancer in adults whose

disease has progressed

during or after docetaxel-

containing chemotherapy


TA 316

Consultant

Oncologists

(Prostate)





(Prostate) for the treatment of metastatic hormone-

relapsed prostate cancer in adults whose disease has

progressed during or after docetaxel-containing

chemotherapy in accordance with NICE TA316

8.3

.4.2

FM

G O

ct1

4

Fe

b1

4.6 Add Ranolazine MR 375mg,

500mg, 750mg tablets

treatment of stable angina

only in patients who

symptoms are not

adequately controlled or

there is intolerance or

contraindications to four

anti-anginal medicines

(beta-blockers, calcium

channel blockers, long-

acting nitrates and

nicorandil) and where

revascularisation is not

appropriate.

Initiation by

Consultant

Cardiologist with

continuation by GPs

AI

y Not added to formulary until mid-November. (CGS and APC

Nov 6th and 12th)

Restricted - initiation by Consultant Cardiologists with

continuation by GPs, in accordance with Ranolazine

Amber Initiation guideline (BHTCG ), for the

treatment of stable angina only in patients whose

symptoms are not adequately controlled or there is

intolerance or contraindications to four anti-anginal

medicines (beta-blockers, calcium channel blockers,

long-acting nitrates and nicorandil) and where

revascularisation is not appropriate.

2.6

.3

FM

G O

ct1

4

CCG FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED CHANGES FOR OCTOBER 2014 FMGChange TLL

positionHydrocortisone (as

sodium phosphate)

100mg/1mL (Efcortesol)

injection Gre

en

y

Reclassified from red to green so available as ready made

preparation for Doctors bag in primary care

Glass ampoules in case of latex allergy.

Comes as a ready diluted form, so may be more suitable

for GP emergency bags than Solu-Cortef

6.3

.2

FM

G O

CT

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Blacklist/NF Lactase 50,000units/g

(Colief)

Bla

ck

y

DROP list recomends listing as NF. In primary care may be

purchased OTC, should be listed as NF

If required may be purchase OTC

A2

.5.1

FM

G O

CT

Blacklist/NF Fentanyl lozenge

(Buccal) all strengths

(Actiq) Bla

ck

y

Black list and NF as per DROP list

4.7

.2

FM

G

Blacklist/NF Fentanyl tablets

(buccal), all strengths

(Effentora)

Bla

ck

y


4.7

.2

FM

G O

CT

Blacklist/NF Fentanyl tablets

(sublingual) all strengths

(Abstral) Bla

ck

y


4.7

.2

FM

G

Blacklist/NF Fentanyl nasal spray, all

strengths (Instanyl)

Bla

ck

y


4.7

.2

FM

G

Blacklist/NF Fentanyl nasal spray, all

strengths (PecFent)

Bla

ck

y


4.7

.2

FM

G O

CT

Choice added Resource Thicken-Up

Clear

AR

List as 1st choice thickener Initiation on recommendation of SALT only

A2

.5.2

FM

G O

CT

Choice added Thick and Easy

AR

List as 2nd choice thickener Initiation on recommendation of SALT only

A2

.5.2

FM

G O

CT

Add Lurasidone

Hydrochloride tablet

18.5mg, 37mg, 74mg

Restriction - only for

patients with schizophrenia

who cannot tolerate or who

have contraindications to

usual 1st or 2nd choices or

aripiprazole

Consultant

Psychiatrist

Re

d y

E

U

Queried with SC whether any further detail re 1st and 2nd

Choices required?

Restricted - prescribing by Consultant Psychiatrist only

for patients with schizophrenia who cannot tolerate, or

have contraindications to, commonly presribed

antipsychotics or aripirazole.

4.7

.2

FM

G O

CT

14

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Remove Multivitamins BPC

y

Traffic light position not yet agreed.

Do not contain RDA of vitamins. If a multivitamin is needed use

alternative such as Forceval or Multivitamins with minerals.

Agreed to add note to say not recommended for initiation as

does not contain RDA of vitamins and note to say in primary

care it is recommended that all patients are stopped or

switched to a suitable alternative and should be purchased over

the counter.

Not recommended for initiation as does not contain RDA

of vitamins. In primary care it is recommended that all

patients are stopped or switched to a suitable alternative

and should be purchased over the counter.

9.6

.7

FM

G O

CT

14

Add Cholecalciferol oral

solution (InVita D3)

25,000 IU in 1mL

Licensed Vitamin D in a

liquid form. This could

replace unlicensed high

dose (DeKristol). Restrict

use in accordance with

Adult Vitamin D guideline

In last year 56 issues

Colecalciferol 20,000U

(DeKristol) caps £11.52

(excl VAT) £650

3 ampoules per pack £3.89

(excl VAT). SPC states for

Vit D deficiency

50,000U/week for 6-8

weeks. Ie 2amps weekly

for 6 weeks = 300,000U 4x

£3.89 = £15.56 (£18.67 incl

VAT) (similar to Vit D

guideline DeKristol

2x20,000 caps for 7 days,

14caps=£3.22)

Gre

en

y

Agree to add, pending confirmation from Vit D subgroup and

subsequent amending of Vit D guidelines. Green list and place

note restricting use in patients for whom DeKristol is not

suitable, for eg peanut allergy.

Also added warning regarding peanut allergy to DeKristol entry

Restricted - only for use in patients recommneded by

Heatherwood and Wexham Park Trust or in patients for

whom colecalciferol 20,000unit capsules (DeKristol) is

not suitable, for eg. in peanut allergy

(Restriction to be revised following discussion/approval

by Bucks Vitamin D subgroup and amendment of

Vitamin D guideline)

9.6

.4

FM

G O

CT

14

Add Oxybutynin patches

3.9mg/24hours

Dose: 1 patch twice

weekly

gre

en y Cost effective alternative to the more costly unlicensed

solutions. Restrict use on formulary for patients unable to

swallow the tablets and for whom the solution might otherwise

be considered

£23.80 (£28.56 incl VAT) / 8 patches

Licensed 2.5mg/5mL (£7.22 incl VAT /150mL) 5mg tds for 1

month = £43.32 (6 bottles)[Approx £700 last yr approx 104

issues]

Unlicensed 5mg/5mL (£52.20 incl VAT/125mL) 5mg tds for 1

month = £187.92 [87 issues £4541.40]

Restricted - for use only in patients unable to swallow

tablets and for whom the oral liquid, which is more

costly, might otherwise be considered.

7.4

.2

FM

G O

CT

14

Reinstate Metolazone tablet 5mg

Re

d no Licensed product was discontinued and metolazone was

removed from formulary.On reflection this was hasty as stocks

have been used up in Pharmacy and problems have occurred

due to its absence from the formulary. It is available as a

special now and has been requested several times recently for

heart failure.

MSt/SS agreed to restore metolazone to the formulary (Red

TLL) until cardiology are able to reach a decision given latest

information from MI

Unlicensed

Restricted - prescribing by secondary care only. 2.2

.1

FM

G O

CT

14

BHT FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED FORMULARY CHANGES FOR NOTE OCTOBER 2014 FMG

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Missed during

Netformulary

population

Diclofenac 12.5mg,

25mg, 50mg, 100mg

suppositories

gre

en y Diclofenac suppositories were inadvertently missed during

establishment of netFormulary

10

.1.1

FM

G

Add Fluarix Tetra

vaccination Re

d y For use in Influenza Vaccination in Special Schools where

Fluenz is not appropriate.

Restricted - only for use in Influenza Vaccination in

Special Schools where Fluenz is not appropriate.

14

.04

FM

G O

CT

Delete Urokinase 5000units

Re

d no Not available therefore remove, but added 10,000u as nurses

use this to give 5000u dose.


blockages - see hospital protocol

2.1

0.2

FM

G O

CT

Change Fentanyl & Bupivacaine

Re

d

y Licensed preparation is now available - so remove "unlicensed "

wording from formulary 15

.2

FM

G O

CT

Delete Dexamethasone

4mg/mL injection

Gre

en y There were supply problems with this product which has now

been remarketed as 3.8mg/mL. To avoid confusion remove

from formulary leaving only the 3.3mg/mL product.

MHRA Alert Oct 14

Added to formulary a note stating:

(Dexamethasone injection 4mg/mL is no longer available

and is non-formulary)

6.3

.2

FM

G O

CT

Se

p1

4.1 Add Prilocaine Hydrochloride

20mg/Ml (2%), glucose

60mg/mL, 5ml Ampoule

Adults for spinal

anaesthesia in short term

surgical procedures.

Consultant

Anaestthetistsre

d y

Restricted - prescribing by Consultant Anaesthetists for

Day Case procedures where surgical anaesthesia is

required for approximately 60-90 minutes.

15

.2

Sep-1

4

Se

p1

4.3 Add Cefuroxime 50mg

powder for solution for

intracameral injection

As a replacement for sub-

conjunctival cefuroxime to

be used routinely for all

cataract procedures

performed at SMH and

WYC.

Ophthalmology team

red y

Uptake should be aimed to be achieved by all consultants

within three months . Confirmation of this (or explanation of

cause of delay) via SDU Governance meeting minutes is

requested.

Audit of rate of endophthalmitis for cataract surgery patients to

be reported to FMG twelve months after uptake (December

2015)

Restricted - prescribing by Ophthalmology team as a stat

dose immediately after cataract surgery.

11

.08

.02

Sep-1

4

CCG FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED CHANGES FOR SEPTEMBER 2014 FMG

Add Glucose Rx Nexus

meter

gre

en

yJoint 1st Choice in primary care for all type 2 diabetics

6.1

.6

#####

Add Glucose Rx Nexus

blood glucose strips

gre

en


6.1

.6

#####

Add Supecheck 2 meter

gre

en


6.1

.6

#####

Add Supercheck 2 strips

gre

en


6.1

.6

#####

FMG DECISIONS SEPT 2014

FORMULARY TRACKING DOCUMENT- CHANGES FOR NOTE (including Woundcare Formulary)- AGREED SEPTEMBER 2014 FMG

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add GlucoRx FinePoint

insulin pen needles, all

sizes gre

en

y

1st Choice in primary care for all type 2 diabetics

6.1

.6

Sep-1

4

Add Apollo twist lancets

gre

en

y1st Choice in primary care for all type 2 diabetics

6.1

.6

#####

Add Diphtheria, tetanus,

pertussis (acellular,

component) and

poliomyelitis

(inactivated) Vaccine

(Boostrix-IPV)

gre

en

y

This is in the national immunisation list for use from 28 weeks

gestation onwards in pregnancy to protect against pertussis.

Clarify exact name of vaccine

For use from 28 weeks gestation onwards in pregnancy

(National Immunisation programme)

14

.1

Sep-1

4

Note on

FormularyBenzoyl peroxide 2.5%,

5% (PanOxyl aquagel)

gre

en

y

Currently unavailable due to manufacturing delays Currently unavailable due to manufacturing delays

13

.6.1

FM

G

Note on

FormularyBenzoyl peroxide 5%

(PanOxyl cream)

gre

en

y

Currently unavailable due to manufacturing delays Currently unavailable due to manufacturing delays

13

.6.1

FM

G

Note on

FormularyMupirocin (Bactroban)

NOTE: if unavailable

Chlorhexidine


Neomycin Sulphate

0.5% (Naseptin) nasal

cream recommended as

there is no direct

equivalent.

y

Mupirocin nasal ointment unavailable at present.

Recommend Naspetin instead as there is no direct equivalent

Mupirocin nasal ointment unavailable at present.

Recommend Naspetin instead as there is no direct

equivalent 12

.2.3

FM

G S

ep

14

Add Iopamidol 61.24%w/v

(Gastromiro) 20ml, 50ml

and 100ml, oral/rectal

solution

Prescribing by

Radiology team only

red y

Contrast media in use. Restricted to prescribing by Radiology team only

Mis

c

FM

G S

ep

14

Change dose

formMethotrexate 50mg/mL

(7.5mg, 10mg, 12.5mg,

15mg, 17.5mg, 20mg,

22.5mg, 25mg)

(Metoject PEN) injection

pen device

AP y

Metoject (methotrexate) syringe (could be given via IM, IV or

SC injection) was discontinued on 1 July 2014 and has been

replaced with Metoject PEN, a pre-filled, single use injection

device


and Dermatologists only, in accordance with

Methotrexate for use in Rheumatology, Dermatology,

Gastroenterology and Respiratory Medicine amber

protocol (BHTCG 794FM) for patients on oral

methotrexate, with severe GI side effects despite regular

folic acid (5m, 6 days a week) or non-responders to oral

therapy after an 8-12 week trial, in order to improve

bioavailability.

10

.1.3

FM

G S

ep

14

ADD Acetylcysteine

concentrate for

intravenous infusion,

2g/10mL

Re

d

no

IV use for paracetamol overdose: use via nebulisation as a

mucolytic for ventilated patients at risk of chest sepsis.

(Restricted for use on ITU, Spinal and Respiratory)

Restricted for use:

1. In paracetamol overdose and,

2. On ITU, Spinal and Respiratory wards, via

nebulisation as a mucolytic, for ventilated patients at risk

of chest sepsis

Po

iso

nin

g

FM

G S

ep

14

BHT FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED FORMULARY CHANGES FOR NOTE SEPTEMBER 2014 FMG

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add

temporarilyKetamine 50mg/5mL

(injection) - unlicensed

red no

Ketamine is already on the formulary and always has been.

The licensed product is not available at present and we are

buying in an Unlicensed injection from Germany. Risk

assessment to be noted on formulary - Low Risk


NOTE: The licensed product is currently unavailable

Restricted - treated as a CD inthis Trust. Order, store

and record all issues as per a controlled drug.

15

.1.1

FM

G

ADD Sodium Tetradecyl

Sulphate 3% (Fibro-

Vein) 3% STD

Local sclerosant Prescribing by

vascular team only red

In accordance with NICE CG Varicose veins in the legs CG168.

To be prescribed by vascular team

Restricted - prescribing by vascular team only in

accordance with NICE CG168 Varicose veins in the legs. 2.1

3

FM

G

ADD Ferric carboxymaltose

injection (Ferinject) 1g

vial

Iron Deficiency anaemai Haematology team

only

red y

Additional size now available. More cost effective Resticted - prescribing by Haematology team only in

accordance with Parenteral Iron for Iron Deficiency

Anaemia (BHTCG 58) 9.1

.1.2

FM

G

Add Chlorhexidine gluconate

2% in isopropyl alcohol

70% (ChloraPrep with

tint cutaneous solution,

3mL)

red y

Already on formulary without tint. Price difference minimal.

Current restriction to remain (in secondary care restricted to

areas where central venous catheters, mid and PIC lines are

inserted)

In secondary care restricted - to areas where central

venous catheters, mid and PIC lines are inserted

13

.11

.2

FM

G S

ep

14

Add Biotin 5mg tablet Consultant

Paediatricians on

recommendation of

tertiary Paediatric

specialist.

red no

Mitochondrial metabolic disorder in paeds patient on

recommendation of tertiary Paediatrics Specialist. To be

prescribed by consultant Paediatricians; one patient per year

(COST PRESSURE from Nicky T/F)


Restricted - to prescribing by Consultant Paediatricians

on the recommendation of tertiary Paediatric specialists

only

9.8

.1

FM

G S

ep

14

Add Ipilimumab

50mg/10mL,

200mg/40mL

(concentrate for


PbR excl - SCG funded

ORH Oncology

consultants only

red

y

NICE TA 319 Previously untreated advanced (unresectable or

metastatic) melanoma.

No use at BHT

This Specialty is entirely based at OUH and all patients with this

condition needing ipilimumab are treated there. 2 patients per

year estimate.

Restricted:

2. Prescribing by Oxford University Hospitals (OUH)

only, in accordance with NICE TA 319 Ipilimumab for

previously UNtreated advanced (unresctable or metstatic

) melanoma.

8.1

.5

FM

G S

ep

14

Add Hydroxycarbamide

100mg tablets

Chemotherapy funded

by SCG

red y

500mg capsules already on formulary. Additional strengths

required.

Restriction wording? Discussed with Maire and decided to leave

without restriction.

8.1

.5

FM

G S

ep

14

Add new dose

formRanibizumab 1.65mg

in 0.165mL PFS

PbR excl - CCG

red y

reduced risk of infection. Vials to remain on formulary. If price

of vials is less than the PFS then the use of the PFS/formulary

inclusion to be re-considered

Restriction as it appears in Formulary for Ranibizumab

2.3mg in 0.23mL intravitreal injection

11

.8.2

FM

G

Add Methylprednisolone

acetate 40mg with

lidocaine hydrochloride

10mg in 1mL

red

y

Has been in use across Trust by physiotherapists for a long

time. Breda discovered not on formulary whilst checking a

PGD. 10

.1.2

FM

G

Added use Midazolam

2.5mg/0.5mL

oromucosal solution,

prefilled syringe.

red Y

Already on formulary for several other clinical situations.

Included in guidelines for use in MRI sedation

Restricted - prescribing only in accordance with

Guidelines for the sedation of children undergoing MRI

or CT scan (BHTCG 343) 15

.1.4

.1

FM

G

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Added use Midazolam 5mg/mL

injection

red y

On formulary but use restricted to anaesthesia and intensive

care sedation and in clinical areas where its use has been

formally risk assessed.

Restricted - use of all 5mg/mL and 2mg/mL strengths is

restricted to anaesthesia and intensive care sedation

and in clinical areas where its use has been formally risk

assessed.

15

.1.4

.1

FM

G

Added use Alimemazine 30mg/5ml

Re

d

y

Included in a guideline for sedation in children.

Paediatrics usage is usually the 30mg/5mL therefore some

concerns re both strengths being used in the Paed

environment. May need further investigation into which is the

best strength to use in this group of patients.

Restricted - prescribing only in accordance with

Guidelines for the sedation of children undergoing MRI

or CT scan (BHTCG 343)

3.4

.1

FM

G S

ep

14

Revise

restrictionCo-trimoxazole oral

suspension

240mg/5mL,

480mg/5mL and tablet

480mg

AR y

Included in Rheumatology guidelines for PCP prophylaxis for

patients who have oral/iv cyclophosphamide.

No chewable/soluble tablets available.

In secondary care restricted - for use in Rheumatology

for PCP prophylaxis for patients receiving oral/iv

cyclophosphamide or for use in Genitourinary Medicine.

Microbiology approval required for all other uses. May

be recommended by secondary care for prescribing by

GPs.

5.1

.8

FM

G S

ep

14

place in

therapyCarvedilol tablets

3.125mg, 6.25mg.

12.5mg, 25mg

gre

en

y

Carvedilol green on formulary but strength of tablets not

included. Also make 2nd line after bisprolol

2nd Choice after bisoprolol

2.4

FM

G

revise License

statusProflavine cream BPC

Re

d

no

Add unlicensed product status

CCG do not want unlicensed version to be used in community.

Is there an alternative?


Licensed product is presently unavailable. Unlicensed

product not to be prescribed in secondary care. 13

.10

.5

FM

G

Amend entry Proflavine cream BPCgre

en

y

Put note on formulary re manufacturing problems Currently unavailable due to manufacturing delays

13

.10

. 5F

MG

Add Sitagliptin tablets 25mg,

50mg

gre

en

yAdditional strengths to be added to formulary for use in renal

impairment

Restriction - as per formulary entry - no change with the

addition of alternate strength tablets

6.1

.2.3

FM

G

ADD New Poisoning section added to netFormulary. All drugs

mentioned based on College of Emergency Medicine guidelines

which state which drugs should be immediately available in

areas where treatment of poisoning might occur and other

drugs which should be available within an hour (in the hospital

setting) and some rare drugs which are seldom required.

Po

iso

nin

g S

ectio

n

FM

G S

ep

14

Oct

12

.7 Add Erlotinib 25mg,

100mg, 150mg tablet

PBr - SCG

NICE TA 258 Erlotinib first

line treatment of locally

advanced or metastatic

EGFR-TK mutation positive

non-SCLC

Consultant

Oncologists (Lung)

red y

NICE Form approved FOR ALL PRESCRIBING: NICE compliance form

required - see link from Formulary homepage. .....

2. Restricted - prescribing by Consultant Oncologist

(Lung) as 1st line treatment of locally advanced or

metastatic EGFR-TK mutation positive non-SCLC, in


8.1

.5

Ju

n-1

4

Poisoning Section - was originally part of the formulary prior to population of

netformulary. The following drugs to be included: acetylcysteine 2g,

activated charcoal suspension 50g/250mL, atropine injection, calcium

folinate injection, calcium chloride injection, calcium gluconate gel 2.5%,

dantrolene injection, desferrioxamine injection, diazepam injection, dicobalt

edetate injection, absolute alcohol injection, flumazenil injection, glucagon

injection, haloperidol injection, isoprenaline injection, lorazepam injection,

FMG DECISIONS JUNE 2014

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

De

c 1

3.8 Add Ciclesonide

80micrograms,

160micrograms per

metered inhalation, 60

and 120 dose units

For treatment of astma for

patients who required an

inhaled steroid, with

unacceptable side effects

(dyphonia, oropharyngeal

candidiasis, cough, throat

irritation and reflex

bronchospasm) caused by

standard and high dose

inhaled corticosteroids

despite thorough post-dose

mouth rinsing, use of

spacer and treatment of

candidiasis.

Initiated by consultant

respiratory physicians


GPs

AI

y

Approved at CGS Restricted - to initiation by Consultant Respiratory

Physicians with continuation by GPs, for patients who

require an inhaled corticosteroid who have unacceptable

side effects (dysphonia, oropharyngeal candidiasis,

cough, throat irritation and reflex bronchospasm) caused

by standard and high dose corticosteroid inhalers

(budesonide, fluticasone or beclometasone) despite

thorough post-dose mouth rinsing, use of a spacer and

treatment of candidiasis, and in accordance with

Ciclesonide Amber Initiation guideline (BHTCG 744FM)

3.2

Ju

n-1

4

Ju

n1

4..

4 revise

restrictionDomperidone

gre

en

y

Add link to MHRA Drug Safety Update May 2014 Restricted - MHRA have advised should only to be

used for nausea and vomiting. It's use is contraindicated

in patients with underlying cardiovascular conditions and

risk factors. Dose and duration have been revised to a

maximum of 10mg three times daily for one week in

adults. For more details see MHRA link below

4.6

Ju

n-1

4

Fe

b 1

4.1

0 Updated TLL

and place in

therapy

Strontium ranelate 6th Choice for secondary

prevention of osteoporosis.

Initiation by

Endocrinologists,

Rheumatologists

AR y

IN accordance with Strontium for Secondary Fracture

Prevention in Osteoporosis (BHTCG 802FM) and Osteoporosis

Secondary Fracture Prevention over 50years (BHTCG 403FM)

6th Choice for Osteoporosis: Secondary fracture

prevention (not recommended for primary prevention)

Restricted - to be prescribed by GPs on the

recommendation of Pheumatology or Endocrinology

teams, in accordance with Osteoporosis: Secondary

fracture prevention over 50 yrs (BHTCG 403FM)(see link

above) and with Strontium for Secondary Fracture

Prevention in OSteoporosis (BHTCG 802FM)

6.6

.2

Ju

n-1

4

Ju

ne

14

.5 Add Sodium benzoate

100mg/mL

50mg, 250mg, 400mg,

500mg capsules,

500mg tablets,

2g/10mL injection

PbR excl - SCG

Treatment of metabolic

disorders after initiation by

tertiary centres in

accordance with NHS

England commissioning of

highly specialised

metabolic disorders

services

Continuaton by

Consultant Paeds

red

N

All unlicensed Unlicensed

Restricted - to initiation by Consultant Paediatricians for

the treatment of metabolic disorders, on the advice of

the teritiary care centre in accordance with NHS

England commissioning of highly specialised metabolic

disorder services.

9.8

.1

Ju

n-1

4

Ju

ne

14

.5 Add Sodium

phenylbutyrate 500mg

tablet, syrup

250mg/mL, Injection

2g/10mL

PbR excl - SCG



tertiary centres in

accordance with NHS


highly specialised

metabolic disorders

services

Continuaton by

Consultant Paeds

red

N

&

Y

Tablets are licensed, the rest unlicensed and formulary

annotated accordingly

Unlicensed





disorder services.

9.8

.1

Ju

n-1

4

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Ju

ne

14

.5 Add L-arginine 100mg/mL

syrup, 5g/10mL

injection, 500mg tabs

PbR - SCG



tertiary centres in

accordance with NHS


highly specialised

metabolic disorders

services

Continuaton by

Consultant Paeds

red N

All unlicensed Unlicensed





disorder services.

9.8

.1

Ju

n-1

4

Ju

ne

14

.12 Revise

restriction Colistimethate Sodium

injection 1million units

(Colomycin and generic

brands)

Initiation in secondary

care with continuation

by GPs

AI

Y

For treatment of conditions other than cycstic bibrosis (eg

bronchiectasis). This is an interim decision until the exact place

in therapy is fully established

For uses, other than cystic fibrosis (see separate entry

above), to be initiated in secondary care, with approval

from Microbiology, and continuation by GPs. (Guideline

under development)

5.1

.7

Ju

n-1

4

Ju

ne

14

.2 Add Bortezomib injection

3.5mg

PbR Excl - SCG

In combination with

dexamethasone or

dexamethasone and

thalidomide for induction

treatment of patients with

previously untreated

multiple myeloma in line

with NICE TA 311

Consulant

Haematologists

red y

NICE prescribing statement and compliance form approved FOR ALL PRESCRIBING - NICE compliance form



combination with dexamethasone or dexamethasone

and thalidomide for induction treatment of patients with

previously untreated multiple myeloma in accordance

with NICE TA311.

8.1

.5

Ju

l-1

4

Ap

ril 1

4.2 Add Probenecid 500mg

tablet

Treatment chronic gout in

patients with normal renal

function who are intolerant

or have contraindications

to, allopurinol , febuxostat

and benzbromarone. To

be prescribed in in

accordance with Bucks

Management of Gout

guideline

Initiation by

Consultant

Rheumatologists with

continuation by GPs

AI

n

Unlicensed - needs risk assessment Restricted - to initiation by Consultant Rheumatologists

with continuation by GPs for treatment of gout ibn

patients with normal renal function who are intolerant of,

or have contraindications to, allopurinol, febuxostat and

benzbromarone. To be prescribed in accordance with

Management of Gout guideline (upload awaited)

10

.1.4

Ju

l-1

4

Ap

ril 1

4.2 Add Sulphinpyrazone

100mg, 200mg


patients with normal renal

function who are intolerant

or have contraindications

to, allopurinol , febuxostat

and benbromarone. To be

prescribed in in


Management of Gout

guideline

Initiation by

Consultant


continuation by GPs

AI

y

Restricted - to initiation by Consultant Rheumatologists

with continuation by GPs for treatment of gout ibn

patients with normal renal function who are intolerant of,

or have contraindications to, allopurinol, febuxostat and

benzbromarone. To be prescribed in accordance with

Management of Gout guideline (upload awaited)

10

.1.4

Ju

l-1

4

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Ap

ril 1

4.1 Add Benzbromarone 50mg,

100mg tablets


patients with mild to

moderate renal impairment

who are intolerant or have

contraindications to,

allopurinol and febuxostat.

To be prescribed in in


Management of Gout

guideline.

Consultant

Rheumatologists

red n

Unlicensed Risk Assessment - HIGH risk Unlicensed - High Risk


for treatment of chronic gout in patients with mild to

moderate renal impairment who are intolerant or have

contraindications to, allopurinol and febuxostat. To be

prescribed in accordance with Management of Gout

guideline (upload awaited)

10

.1.4

Ju

l-1

4

Ju

ne

14

.9 Add Rituximab

100mg/10mL

concentrate for


PbR excl - SCG

Treatment of ANCA-

associated vasculitis in


308

Consultant physicians

with an interest in

vasculitis

red y

Need another NICE link on formulary



Restricted - prescribing by Consultant Physicians with an

interest in vasculitis for the treatment of ANCA-

associated vasculitis in accordance with NICE TA 308

8.2

.3

Ju

l-1

4

Ju

ne

14

.8 Add Beclometasone

dipropionate/Formoterol

100micrograms/6microg

rams aerosol inhalation

(Fostair)

For the treatment of

COPD. 1st Choice ICS

LABA when an MDI is

appropriate, in accordance

with COPD guideline

gre

en

y

in COPD guideline for sizes Restricted - for the treatment of COPD. 1st Choice

LABA when an MDI is appropriate, in accordance with

COPD Inhaled Treatment algorithm (BHTCG 726FM)

3.2

Ju

l-1

4

Ju

n e

14

.7 Rejected Fluticasone

furoate/Vilatnerol

(Relvar)

For the treatment of

COPD.

bla

ck

y

Rejected for inclusion on formulary due to concerns about the

potential for patient perception of the product as a "reliever"

rather than a "preventer" which could lead to ICS overdose.

Also there is a lack of wider experience with use of both active

ingredients of the product. Increasing concern about links

between fluticasone compared to less potent ICS with

pneumonia. Ju

n-1

4

Ju

ne

14

.3 Add Pixantrone injection

29mg

PbR exclu - SCG

Treatment with multiple

relapsed or refractory

aggressive non-Hodgkins

lymphoma in accordance

with NICE TA 306

Consultant

Haematologists

red y


required - see link from Formulary homepage. 8.1

.2

Ju

l-1

4

Ju

n1

4.1 Add Afatinib 20mg, 30mg,

40mg, 50mg tablet

PbR excluded - SCG

Treatment of adults with

locally advanced or

metastatic non- SCLC if

tests positive for EGFR-TK

mutation. Patient has not

previously had a EGFR-TK

inhibitor in line with NICE

TA 310

Consultant

oncologists (Lung)

red y




(Lung) only for treatment of adults with locally advanced

or metastatic non-SCLC if tests positive for EGFR-TK

mutation. PAtient has not previously had a EGRF-TK

inhibitor, in line iwth NICE TA310

8.1

.5

Ju

l-1

4

Fe

b

14

.11Add Dapagliflozin tablet

5mg, 10mg

Diabetes treatment in

accordance with Diabetes

Type 2 guideline gre

en

y

For use in accordance with The Management of Type 2

Diabetes: Blood Glucose -lowering therapy -


6.1

.2

Fe

b-1

4

CCG FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED CHANGES FOR JUNE 2014 FMG

FORMULARY CHANGES FOR NOTE - AGREED June 2014 FMG

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

add Peptac suspension Cheaper alternative to

Gaviscon Advance. GPs

use widely and we have a

switch on their software to

encourage this. It is a 1st

line antacid

gre

en

y

Restricted - only for use in Primary Care - it is a 1st

Choice antacid, for use as a cheaper alternative to

Gaviscon Advance. Patients coming from secondary

care who may have been prescribed Gaviscon Advance

to be switched to Peptac suspension.

1.1

.2

Ju

n-1

4

Add Colistimethate

nebuliser powder

(Promixin®) 1million-

unit vial

Consultant

Paediatricians

red y

Expected patient numbers = 5

Note: Promixin 1MU is therapeuticlaly equivalent to 2MU

standard vials - to be clearly stated on formulary

Cost pressure if 5 patients use Promixin instead of 2megaunits

of Colomycin twice daily: £17,388 - 12,247 = £5141 (( £4.83-

£3.40 ) x2 x30 x12 x5 )

Benefits - improved compliance. Shared device (I-neb) can

also be used for tobramycin.

In use by local specialist centres and paid for by NHS England,

who name it as a funded line in their CF commissioning

statement 2013 (SC)

Restricted - prescribing by Consultant Paediatricians for

the treatment of cystic fibrosis in children in accordance

with "Clinical Commissioning Policy Statement: Inhaled

Therapy for Adults and Children with Cystic Fibrosis April

2013 (see link below)

NOTE: Promixin 1million units is therapeutically

equivalent to 2million units standard colistimethate

sodium (eg Colomycin) ONLY if Promixin is nebulised

via the I-Neb device.

5.1

Ju

n-1

4

Revise

restrictionCiprofloxacin - tablet

(250mg, 500mg),

suspension

(250mg/5mL), iv

infusion 400mg in

glucose 5%,

100mg/50mL,

200mg/100mL,

400mg/200mLg

ree

n (

tab

s&

su

sp

), r

ed

(IV

)

5.

1.

12

Secondary care Gastroenteritis guideline (2011) recommends

using ciprofloxacin first line without consulting micro. The

formulary needs to be altered to reflect this. It was picked up

during recent review of the gastroenteritis guideline (new

guideline yet to be uploaded BHTCG 204) and has been agreed

with David Waghorn, Consultant Microbiologist.

Need to ensure formulary makes clear that use for enteric fever

is within secondary care only.

In secondary care restricted to:-

1. TTO and Outpatient prescriptions,

2. Inpatient urology and respiratory patients where no

other suitable alternative,

3. Use by Ophthalomology and Obstetrics and

Gynaecology,

4. Treatment of enteric fever as described in the hospital

guideline for Antimicrobial Therapy for Infectious

Gastroenteritis (BHTCG 204)

5.1

.12

Ju

n-1

4

Replacement Trichloracetic acid 90% Prescribing by

Specialist Sexual

Health consultants

(GUM and

Contraception)

red N

80% no longer available. GUM staff prefer 90%

Risk assessment to be completed by Rachel

Restricted - use by Specialist Sexual Health consultants

(GUM and Contraception) for the treatment of anogenital

warts only.

13

.7

Ju

n-1

4

Add Taurolidine/Citrate 4%

with Heparin

500units/mL

(Taurolock® Hep 500)

Renal Physicians

Only

red xx

x

FR CAUTION - always double check you have selected the

correct Taurolock® product.

Restricted - prescribing by Renal Physicians Only for

locking haemodialysis and haemofiltration lines

Ju

n-1

4

Add Taurolidine/Citrate 4%

with Urokinase

25,000units/mL

(Taurolock®Urokinase

25,000)

Renal Physicians

Only

red xx

x

FR CAUTION - always double check you have selected the

correct Taurolock® product.

Restricted - prescribing by Renal Physicians Only for

locking haemodialysis and haemofiltration lines

Ju

n-1

4

BHT FORMULARY CHANGE TRACKING DOCUMENT - PROPOSED FORMULARY CHANGES FOR NOTE JUNE 2014 FMG

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Creon Micro Gastro

resistant granules 20g

Consultant

Paediatricians

AR

1.

9.

4

For pancreatic enzyme deficiency in infants with cystic fibrosis.

When infants are diagnosed this product needs to be

immediately available. Time is lost following the non-formulary

process for these babies.

Expected numbers = 2

£27.56 (£33.07 incl VAT) every months, x12 = £396.84 per yr

per patients, x2 = £794 for 2 patients per year.

Restricted - to be recommended by Consultant

Paediatricians for the treatment of cystic fibrosis in

infants.

1.9

.4

Ju

n-1

4

Delete Metformin 500mg

sachets

discontinued

bla

ck

6.

1.

2.

2

Discontinued product

Agre

ed

Ju

n-1

4

Delete Metformin 1000mg

sachets

to be discontinued. To

remain on formulary until

no longer available. Added

syrup as replacement

6.

1.

2.

2

To be discontinued but to remain on formulary until no

longer available

Agre

ed

Ju

n-1

4

Add Metformin Oral solution

500mg/5mL, sugar free

sachets discontinued

gre

en

y

Restricted - to patients who cannot swallow metformin

hydrochloride tablets.

Agre

ed

Ju

n-1

4

Delete Chlorhexidine

acetate1% dusting

powder Bla

ck

long term supply problems. Dr Waghorn has advised

colleagues to stop requesting on prescription and is not

concerned about sourcing an alternative. They will stick with

standard MRSA suppression kits.

Non-formulary - due to ongoing supply problems

13

.11

.2

Ju

n-1

4

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Fomepizole injection

red

y

The College of Emergency Medicine and Toxbase recommend

this over absolute alcohol (updated recommendation Dec 13).

Four patients treated for this type of poisoning in last FY with

absolute alcohol. Absolute alcohol unavailable indefinitely.

Predict four patients to be treated with fomepizole in 14-15 at a

cost of £5013 per patient. This is PbR excluded funded by

CCGs. Included in horizon scanning / budget setting for 14-15

with Bucks CCGs.

HCD compliance form will be needed

For emergency treatment of ethylene glycol and

methanol poisoning in accordance with National

Poisoning Information Centre (Toxbase)

recommendations.

FOR ALL PRESCRIBING - completion of Compliance

form required. If Compliance form not yet available

confimation that National Poisoning Information Centre

recommendations are met, is required.

Ag

ree

d t

o a

dd

to

fo

rmu

lary

su

bje

ct

to t

he

de

ve

lop

me

nt

an

d a

pp

rova

l o

f a

Co

mp

lian

ce

Fo

rm o

r so

me

oth

er

ag

ree

d m

ea

ns o

f ca

ptu

rin

g a

nd

en

su

rin

g c

om

plia

nce

with

Na

tio

na

l

Ju

n-1

4

Clarify

guidance for

use

Digoxin specific

antibody fragments

40mg

red

y

CCG now responsible for payments, urgently need a NICE

compliance form, or some agreed way of ensuring appropriate

usage.

If used in accordance with National Poisoning

Information Centre (Toxbase) recommendations. FOR

ALL PRESCRIBING - completion of Compliance form

required. If Compliance form not yet available

confimation that National Poisoning Information Centre

recommendations are met, is required.

2.1

.1

Ju

n-1

4

Revise

restrictionMiragbegron and

Solifenacin for OAB

Spinal Consultants

may initiate for OAB

AI

y

Spinal consultants also initiate treatment of OAB and need to

be included in the restriction for initiation of miragbegron and

solifenacin. Use of solifenacin and mirabegron by Spinal

consultants currently being agreed via NF approval process in

BHT

Both presently have restriction which says: "Restricted -

initiation by Consultant Urogynaecologists and Consultant

Urologists…."

The new restriction would also include Spinal Consultants.

LInk to new guideline

Restricted - to initiation by Urologists, Uro-

gynaecologists and Spinal Consultants only, with

continuation by GPs…….

7.4

.2

Ju

n-1

4

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Gelatin - Gelaspan change brand from

Gelofusin to Gelaspan red y 9.3

#####

Delete Dexamethasone 4mg/ml

injection

Supply problems ongoing

bla

ck

y

Not available at present due to ongoing supply problems.

See Dexamethasone injection 3.3mg/mL entry above

and note important dosing information

6.3

.2

Ju

n-1

4

Add Dexamethasone

3.3mg/ml injection

ON contract. Savings to be

made and 4mg/ml very

difficult to assure

regularsupply

£3.75/10 (excl VAT)

£9.90/5 (excl VAT) PASA

contract

gre

en

y

There are several preparations of intravenous

dexamethasone available in different concentrations.

Check carefully that the preparation administered

provides the prescribed dose.

Dexamethasone injection 4mg/mL is currently

unavailable.

Dexamethasone injection 3.3mg/mL is available

Most prescriptions for dexamthasone injection will be

4mg (or a multiple of). So please follow one of the

options below:

1. The patient can be converted to 3.3mg (of multiples

of, as appropriate) - doctors will need to rewrite the

prescription so that this dose can be given OR

2. Use 1.2mL of dexamethasone injection 3.3mg/mL

(approximately equal to 4mg dexamethasone injection)

6.3

.2

Ju

n-1

4

Delete Domperidone suppositories 30mgNo longer available

bla

ck y no longer available

4.6

#####

Ap

r 1

4.4 Add Aflibercept 4mg/0.1mL

solution for


PBT excl CCG

For Central Retinal Vein

Occlusion NICE TA 305

Consultant

Ophthalmologists

Re

d

Y

2nd line option to Ranibizumab

HCD drug form approved




Ophthalmologists, as a 2nd line option after ranibizumab,

for Central Retinal Vein Occlusion in accordance with

NICE TA 305.

11

.8.2

Ju

n-1

4

Ap

r 1

4.9 Additional

adviceJext and Epipen, adult

and junior strengths

gre

en

y

Additional advice: ensure that training is given to all patients,

for all prescriptions for Jext and Epipen, irrespective of whether

patients have received or used the product previously - added

to all 4 entries on formulary

NOTE: Ensure that training is given to all patients, for all

prescriptions, irrespective of whether patients have

received or used the product previously.

3.4

.3

Apr-

14

Ap

r 1

4.7 Add Aclidinium inhaler


inhalation

Treatment of COPD in

adults

In secondary care to

be initiated by

Respiratory team only

gre

en

y

2nd line to tiotropium in patients for whom tiotropium is

unsuitable due to intolerance or contraindications

1st line LAMA in renal impairment.

IN secondary care to be initiated by Respiratory team in

accordance with COPD Inhaled Treatment algorithmin BHTCG

726FM - updated version approved CGS May14 awaiting APC

July 16th

Restricted - to be prescribed in accordance with COPD

Inhaled Treatment algorithm (BHTCG 726FM)(see link

above) as:

1. To be prescribed 2nd line to tiotropium in patients for

whom tiotropium is unsuitable due to intolerance or

contraindications or,

2. 1st line LAMA in renal impairment.

In secondary care to be initiated by the Respiratory team

only.

3.1

2.

Apr-

14


FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Fe

b 1

4.2 TLL Revision

and Restriction

revisions

Rivaroxaban Treatment of DVT and PE Initiation by

Consultant

Haematologistsand

NOAC (not cardiology

or stroke team)

AI

Y

NICE HCD approved

Await upload. Approved at CGS (JUNE 14) but waiting for APC

(July 16th)



1. Restricted - initiation by Consultant Haematologists or

NOAC Pharmacy service for patients unsuitable for

warfarin for whom dalteparin would otherwise be

considered and only in accordance with;

NICE TA 261 Rivaroxaban for the treatment of deep vein

thrombosis and prevention of recurrent DVT and PE and

NICE TA 287 Pulmonary embolism and recurrent venous

thromboembolism - rivaroxaban,

and in accordance with Rivaroxaban for DVT and PE -

Amber initiation guideline (BHTCG 295FM)

2.8

.2

Ju

l-1

4

Fe

b 1

4.3 Revised TLL Apixaban Prevention stroke in AF same as dabi and

riva

AI

Y

NICE HCD approved - same wording as for dabi and riva

guideline for dabi and riva, sep guidelines for AF need to be

replace with combined guideline which lists 3 drugs and this

was approved at CGS

Dabi for AF and Riva for AF guidelines to be removed and

replaced by Riva, Dabi and Apixa for AF once approved at

APC. CGS approved.

NOTE: Any urgent patient without a previous stroke or



appointment.

Restricted - to initiation by:

1. Consultant Stroke physicians for urgent patients who

have had a previous stroke or TIA. All patients initiated

by consultants to be subsequently referred to NOAC

clinic for follow-up

2. NOAC Service

for the prevention of stroke and systemic embolism in

patients with AF when a NOAC is indicated, in

accordance with Dabigatran, Rivaroxaban and Apixaban

for Atrial Fibrillation - Amber Initiation guideline (BHTCG

313FM) and the patient has had a GI disturbance or

bleeding with dabigatran and rivaroxaban OR the patient

is unable to take either dabigatran or rivaroxaban due to

a history of GI bleeding or ulceration and in accordance

with NICE TA275 Apixaban for preventing stroke and

systemic embolism in people with nonvalvular atrial

fibrillation.

2.8

.2

Ju

l-1

4

Rejected Domperidone For increased milk supply Breastfeeding

Service only

AI

In light of the MHRA Drug Safety Update, the use of

domperidone should be restricted to one week due to potential

adverse effects and therefore Obs & Gynae have requested it

be removed from the formulary for enhanced breast milk

production. Ju

n-1

4

Fe

b 1

4.8 Add Chapter 25 Borderline

substances (Sip Feeds

and Fluid Thickeners)

• Chapter 25 Borderline substances (sip feeds and fluid

thickeners) as described in the draft Bucks formulary (date of

access April 9th 2014) was approved.

,

Ch

ap

ter

25

FM

G A

pril

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Fe

b 1

4.8 Add Ames Shake • Ames Shake® was approved for inclusion on the formulary

for use in primary care. It replaces Complan Shake as first

choice prescribed sip feed when evidence of malnutrition has

been established and the ‘food first’ approach alone has proven

to be inadequate

CCG to manage formulary entries in Chapter 25

Ch

ap

ter

25

FM

G A

pril 1

4

De

c 1

3.3 Add Ranibizumab

2.3mg/0.23mL


PbR - CCG

For treatment of visual

impairment due to

choroidal

neovascularisation (CNV)

secondary to pathologic

myopia, NICE TA 298

Consultant

Ophthalmologists

red

y

NICE HCD approved FOR ALL PRESCRIBING: NICE compliance form


Restricted - prescribing by Consultant Ophthalmologists

only for the treatment of visual impairment due to

choroidal neovascularisation (CNV) secondary to

pathologic myopia in accordance with NICE TA298.

11

.8.2

Ma

y-1

4

Add Teriflunomide 40mg

tablet

PBR excl SCG

NICE TA 303

Teriflunomide for treating

Relapsing-remitting

Multiple Sclerosis.

Consultant

Neurologist and

Clinical Nurse

Specialist

Re

d

Y

NICE HCD form approved at CGS May14 FOR ALL PRESCRIBING - NICE compliance form



Clinical Nurse Specialists for Relapsing-remitting

Multiple Sclerosis in accordance with NICE TA 303

Teriflunomide for treating Relapsing-remitting Multiple

Sclerosis in accordance with NICE TA 303 Teriflunomide

for treating Relapsing-remitting Multiple Sclerosis

8.2

.4

CG

S M

Ay1

4

Ap

r 1

4.8 Revise Choice Sodium cromoglicate

2% eye drops

gre

en

y

Agreed 1st Choice 1st Choice

In primary care consider if more suitable for patients to

purchase over the counter. 11

.4.2

FM

G A

pril

Ap

r 1

4.8 Revise Choice Olopatadine 1mg/mL

eye drops

gre

en

y

Historic "choice" related only to use within secondary care and

did not accurately reflect across joint formulary

11

.4.2

FM

G A

pril

Ap

r 1

4.8 Revise Choice Lodoxamide 0.1% eye

drops

gre

en

y



11

.4.2

FM

G A

pril

Ap

r 1

4.8 Revise Choice Emedastine 0.05% eye

drops

gre

en

y



11

.4.2

FM

G A

pril

Apr

14

.8Add Fenofibrate 200mg

capsule

gre

en

y

Addition of cheaper product in this class of medicines.

Agreed as 1st Choice with Bezafibrate now 2nd Choice.

Lipid guideline to be reviewed and updated Oct 14 approx.

1st Choice

2.1

2

FM

G

Ap

r 1

4.8 Add Resource Thicken-Up

Clear

Restricted Use. Only for patients who have diagnosed

dysphagia and have been advised by SALT to thicken fluids (to

reduce risk of aspiration). More cost effective that Thick and

Easy. Already in use and recommended by SALT and hospital

and community dieticians.

CCG to manage formulary entries in Chapter 26 25

FM

G A

pril

FORMULARY TRACKING DOCUMENT- CHANGES FOR NOTE (including Woundcare Formulary)- AGREED APRIL 2014 FMG

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Ap

r 1

4.8 Add Alendronic acid oral

solution 70mg/100mL,

sugar-free

gre

en

y

Restricted - only for use in patients who cannot swallow

alendronic acid tablets. 6.6

.2

FM

G A

pril

Ap

r 1

4.8 revise

restrictionAlimemazine

suspension 30mg/5mL

Recommendation by

Paediatric or

Haematology teams

and continuation by

GPs

AR y

Restricted - recommendation by Paediatric or

Haematology teams with continuation by GPs 3.4

.1

FM

G A

pril

Apr

14

.8revise

restrictionAlimemazine

suspension 7.5mg/5mL

Recommendation by

Spinal team and

continuation by GPs

AR y

Restricted - recommendation by Spinal team with

continuation by GPs 3.4

.1

FM

G

Ap

r 1

4.8 revise

restrictionPeg-asparaginase

3750units injection

PbR excl - SCG

Haematology

Consultants

red

N

The UKALL 2003 trial is still ongoing, for one patient in the

Trust. The trial is for children and young adults. It is closed to

new patients and expected to conclude June 2014.

Although patients have their chemotherapy treatment in

Oxford, some of the follow-up treatment, such as peg-

asparaginase, may be given at BHT. The UKALL 2011 trial (2

year trial)is ongoing and were patients to receive treatment at

BHT it would be under the supervision of Consultant

Haematologists.


Restricted - use by Haematology Consultants for

Treatment of Childhood ALL in MRC UK ALL 2003 and

2001 trials (inpatients only). Named patient basis.

8.1

.5

FM

G A

pril 1

4

Ap

r 1

4.8 Add Botulinum toxin type

A (Dysport) 500units

vial

PbR excl - CCG

10 patients per year

PBr excluded, CCG funded

Paediatric consultant

red Y

Previously patients were seen at Oxford but are now seen at

SMH every 3 months. It is used for relieving spasticity in

cerebral palsy patients.

3. Restricted - prescribing by Paediatric consultant (Jo

Hicks) only. For cerebral palsy spacticity. 4.9

.3

FM

G A

pril

Ap

r 1

4.8 Rename GUM Ulipristal Acetate 30mg

tablet (EllaOne)

Prevention of pregnancy

after unprotected

intercourse when patients

present at more than 72

hours and less than 120

hours and an IUD is not a

suitable option.

A&E, Specialist

Sexual Health

consultants (GUM

and Contraception),

GPs gre

en

y

GUM consultans and Family Planning Clinics to be replaced by

Specialist Sexual Health consultants (GUM and Contraception)

Restricted - prescribing in secondary care by A&E and

Specialist Sexual Health consultants (GUM and

Contraception) and by GPs and Family Planning Clinics,

for the prevention of pregnancy after unprotected

intercourse when patients present at more than 72 hours

and less than 120 hours and an IUD is not a suitable

option.

7.3

.5

FM

G A

pril 1

4

Ap

r 1

4.8 Add Calcium carbonate 1.5g

and colecalciferol

10micrograms (Adcal-

D3 Dissolve)

effervescent tablet

For use in hospital in

patients who required

calcium and vitamin D

administration via a PEG. red Y

Additional NOTE: For patients discharged from secondary care

on Adcal-D3 effervescent tablets, a switch to Calfovit powder is

recommended.

Restricted - only for use in secondary care for patients

who require calcium and colecalciferol administration via

a PEG

NOTE: For patients discharged from secondary care on

Adcal-D3 Dissolve effervescent tablets a switch to

Calfovit powder is recommended.

9.6

.4

FM

G A

pril 1

4

Ap

r 1

4.8 Add Calcium phosphate

3.1g and colecalciferol

20micrograms (Calfovit

D3) Powder gre

en

Y

Calfovit is in use in primary care Restricted - for use in primary care only.

NOTE: if patients are discharged from secondary care

on Adcal-D3 Dissolve effervescent tablets a switch to

Calfovit D3 powder is recommended

9.6

.4

FM

G A

pril

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Ap

r 1

4.8 Revise

restrictionFludroxycortide 4

micrograms/cm2

(Haelan tape)

Restriction revised and

agreed by Woundcare

Formulary subgroup

gre

en

Y

NOT TO BE USED FOR COSMETIC ONLY USE

Restricted - only for use in the following:

1. Wound care - only to be used for over granulation

tissued on wounds/ulcers for 5 days and then review.

2. Eczema - for skin cracks/fissures in areas difficult to

treat with conventional methods eg. hands and feet

3. Painful keloid scars

13

.4

FM

G A

pril 1

4

Ap

r 1

4.8 Delete Olanzepine injection

10mg/2mL

red Y

No longer available no longer available

FM

G A

pril

Ap

r 1

4.8 Add Sodium amidotrizoate /

Meglumine

amidotrizoate

100mg/660mg in 1mL

(Gastrografin),

gastroenteral solution

Radiology use only

red Y

In use in radiology. Restricted - to use by Radiology team only

16

.01

FM

G A

pril 1

4

Apr

14

.8Add Pyrimethamine 25mg

tablet

Treatment of

toxoplasmosis in uveitis

guideline BHTCG 374

Consultant

Ophthalmologists

red Y


for the treatment of tocoplasmosis in accordance with

Uveitis guidelines (BHTCG 374)

5.4

.7

Ap

r 1

4.8 New Entry Colistimethate injection

1,000,000units

Consultant

Paediatricians,

Respiratory

Physicians and

Consultant

MicrobiologistsR

ed

y

Colistimethate is available on the formulary. The existing

restriction is under revision. For cystic fibrosis patients only

agree the inclusion of Colomycin brand injection, licensed for

nebulisation.

Antimicrobial pharmacists recommend Colomycin brand be

stocked and named on formulary as it is licensed for

nebulisation. The generic injection is not licensed for this use.

Promixin injection is not licensed for nebulisation because

Promixin powder for nebulisation is available

Restricted - prescribing by Respiratory Physicians,

Consultant Paediatricians and Consultant Microbiologists

for use in cystic fibrosis only.

NOTE: Colomycin® injection is licensed for nebulisation

and may be given by inhalation as a nebulised solution

as an adjunct to standard antibacterial therapy in cystic

fibrosis patients with severe pseudomonal chest

infections.

5.1

.7

Ap

r 1

4.8 Add Actifast bandage

10.75cm, 7.5cm and

5cm - all 10metre

lengths

red

In use across Trust. All 10m lengths restricted and only

available in secondary care.

10.75cm, 7.5cm and 5cm x 10m lengths only available in

secondary care.

In primary care 1m and 5m lengths available as stock

through the On-line Non-Prescription Orderin System

(ONPOS)

A5

.8.3

Apr

14

.8Delete Chlorhexidine aqueous

solution 0.5% (blue)

No longer available therefore removed from formulary

13

.11

.2

Ap

r 1

4.8 Revise

Restriction Sudocrem Restrict for use on intact

skin only.

Not for use on incontinent

patients - consider Cavilon

Durable Barrier cream and

Honey as an alternative

gre

en

y

Woundcare formulary committee have considered and revised

restriction

Restricted for use on intact skin only

NOTE: Not for use on incontinent patients - consider

Cavilon Durable Barrier cream + Honey as an alternative

for incontinent patients.

13

.2.2


FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Fe

b 1

4.1 Add Eltrombopag tablet

25mg, 50mg

PbR excl - CCG

Chronic IPT in accordance

with NICE TA 293

Consultant

Haematologists only

red Y

NICE compliance form is complete FOR ALL PRESCRIBING - NICE compliance form


Restricted - to prescribing by Consultant Haematologists

only for Chronic Idiopathic Thrombocytopenic purpura

(ITP) in accordance with NICE TA 293

Thrombocytopenic purpura - Eltrombopag.

9.1

.4

FM

G F

eb

14

Fe

b 1

4.5 Delete Omacor Post MI no longer

recommended by NICE CG

172 MI Secondary

prevention published 2013 bla

ck

To be removed from Formulary as no longer recommended by

NICE.

This was restricted to adjuvant treatment in secondary

prevention after myocardial infarction in addition to other

standard therapy in accordance with NICE clinical guideline NO.

48

2.1

2

FM

G F

eb

14

Fe

b 1

4.7 Add Oxycodone

Hydrochloride MR tablet

5mg, 10mg, 20mg

Oxycodone

Hydrochloride Oral

Solution 5mg/5mL

For pain management in

enhanced recovery for hip

and knee arthroplasty and

colorectal surgical patients

Initiation by

Anesthetics team and

continuation by Pain

team and Ward

Surgical and

Orthopaedia doctors

red Y

Unless patients are admitted on oxycodone, the TTOS should

not include it unless countersigned by a Consultant

Anaethetist.

Oxycodone liquid and tabs use as second line when morphine

is unsuitable (green)

Red as first line analgesia in enhanced recovery for stated

conditions.

Restricted - to initiation by Anaesthetics team and

continuation by the Pain team and ward surgical and

othopaedic doctors for pain management in enhanced

recovery for hip and knee arthroplasty and colorectal

surgical patients.

NOTE: unless patients are admitted on oxycodone, the

TTOs should not include it unless countersigned by a

Consultant Anaesthetist.

4.7

.2

FM

G F

eb

14

De

c1

3.1 Add Fluocinolone

Acetonide intravitreal

implant

190micrograms

PbR excl - CCG

chronic diabetic macular

oedema

Consultant

Ophthalmologists

red Y

in accordance with NICE TA 301

Plus NICE statement for approved form

http://guidance.nice.org.uk/TA301




in accordance with NICE TA 301 Fluocinolone acetonide

intravitreal implant for treating chronic diabetic macular

oedema after an inadequate response to prior therapy.

11

.4.1

FM

G F

eb

14

De

c 1

3.2 Add Ocriplasmin intravitreal

injection 0.5mg in

0.2mL

treatment of vitromacular

traction (VMT)

Consultant

Ophthalmologists

red Y

in accordance with NICE TA 297

plus NICE statement for approved form

http://guidance.nice.org.uk/TA297




in accordance with NICE TA 297 Vitreomacular traction -

ocriplasmin

11

.99

FM

G F

eb

14

De

c 1

3.6 Add Fluticasone

Propionate/Formoterol

Fumarate (Flutiform)

50micrograms/5microgr

ams,

125micrograms/5microg

rams,

250micrograms/10micro

grams

for treatment of asthma.

gre

en

Y

For patients who required ICS /LABA combination MDI in

accordance with Joint Asthma in Adults guideline awaited

upload

To be used in accordance with Joint Asthma in Adults

guideline (upload awaited) for patients who require

ICS/LABA combination MDI.

3.2

FM

G F

eb

14

De

c

13

.6reject Fostair for treatment of asthma.

bla

ck

Y

The lack of three strengths does not allow clear monitoring that

doses have been stepped down.

FM

G

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

De

c 1

3.7

Add Asthma guideline Note to "see link above: Asthma - Inhaled Treatment Algorithm -

Adults (BHTCG 803FM)" added to all drugs mentioned in

guideline

FM

G

De

c 1

3.1

1 Add Glaucoma prescribing

guideline

Glaucoma prescribing guideline added to netformulary by

CCGs

FM

G

Dec

13.

12

Add Insulin Degludec 100units/mL

Tresiba, 3ml cartridge, 3mL

FlexTouch prefilled

disposable injection device.

Type I Diabetes when nocturnal

hypoglycaemia is a problem in

spite of treatment with isophane

insulin

Consultant Diabetologists

and continuation by GPs

AI

Y

Restricted - initiation by Consultant Diabetologists with continuation by

GPs for the treatment of Type I diabetes in patients with problematic

nocturnal hypoglycaemia who are unable to achieve adequate blood

glucose control. This is inspite of treatment with basal insulin

analogue therapy, with insulin glargine, which has been optimised in

terms of insulin delivery, dosage and timing.

FM

G F

eb

14

Oct

13

.3

revised

guidelineDrug Treatment for

Urinary Incontinence

Revised guideline uploaded

FM

G

Ma

y 1

3.4

Add Aprepitant capsule

80mg, 125mg

PbR excl - SCG

Chemotherapy induced

nausea and vomiting for

patients on highly

emetogenic regimens (FEC

100 or Cisplatin

>70mg/m2) only in

accordance with the TVCN

CINV guidelines

Consultant

Oncologists

red Y

Restricted - prescribing by Consultant Oncologists for

chemotherapy induced nausea and vomiting to patients

on highly emetogenic regimens (FEC 100 or Cisplatin

>70mg/m2) only, in accordance with TVCN CINV guidelines

4.6

FM

G F

eb

14

Ma

r 1

1.2 Revise

restrictionMelatonin 3mg

immediate release

tablet

Paediatric team

red

N


1. Restricted - prescribing by Paediatrics team only for

Pre-EEG sedation.

2. Restricted - prescribing by Consultant Paediatricians

only, for induction of normal sleep pattern in ADHD and

neuro-developmental paediatric patients.

4.1

.1

FM

G F

eb

14

Au

g 1

0.2 Add Lidocaine plaster 5%

(700mg/medicated

plaster)

Neuropathic pain in the

palliative care setting only

Initiation by Palliative

Care Team only and

continuation by GPS AI

Y

in accordance with Neuropathic Pain in Palliative Care guideline

BHTCG

Restricted - to initiation by Palliative Care team only with

continuation by GPs, in accordance with the Neuropathic

Pain in Palliative Care in Adults (BHTCG 275FM)

15

.2

FM

G

Fe

b-1

4 Delete Otosporin ear drops

Y

product discontinued -remove

Alternatives include Betnesol N, Otomize and Otocomb Otic

(unlicensed). MI have contacted Mr Bottrill and he is happy

with the alternatives. So MI have not investigated the

availability of any unlicensed versions of Otosporin.

Add comment to formulary in the non-formulary part

giving alternatives: Betnesol N and Otomize or Otocomb

Otic 12

.1.2

FM

G F

eb

14

##### Delete Clinitest

Yproduct discontinued -remove

6.1

.6

FM

G

FORMULARY CHANGES FOR NOTE - AGREED FEBRUARY 2014 FMG

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Fe

b-1

4 Delete Multistixs SG

Y

remove - Multistixs 8SG replaces this & is already formulary.

Not deleted as 8SG and GP contain the same tests. SG and

10SG are different from each other and offer different tests

from 8SG or GP. All contain restriction advice on formulary

6.1

.6

FM

G F

eb

14

Fe

b-1

4 Delete Distigmine 5 mg discontinued remove from formulary

Previously this was on the formulary and restricted to Spinal

use only.

7.4

.1

FM

G

Fe

b-1

4 Add Peginterferon alfa 2a

and ribavirin and

Peginterferon alfa2b

and ribavirin

PbR excl - SCG

Treatment Chronic

Hepatitis C in children and

yound people in


200

red Y

NICE Costing template estimate Incidence in England to be

150 patients per year so for Bucks population one patient per

year. NHSE funded. Patients are not treated at BHT. They are

treated at Specialist Centres eg. Oxford.



2. Restricted - prescribing by Consultant Paediatric

Gastroenterologists in accordance with NICE TA 200

Hepatitis C - Peginterferon alfo and ribavirin. FM

G F

eb

14

De

c 1

3.8

TLL revised Glycerin BP 100mL,

Glycerin eye drops

50%,

Mannitol infusion 20%,

Apraclonidine 1%, 0.5%

eyedrops,

Acetazolamide injection

500mg

Re

d

All medicines listed have been reviewed and traffic light

classification is Red

11

.6

FM

G D

ec1

3 -

De

c 1

3.8 TLL revised Betaxolol suspension

eyedrops 0.25%

AR

Glaucoma review: Restricted - only to be prescribed if recommended by

Consultant Ophthalmologist.

If cardio-selectivity required this is 1st Choice, otherwise

2nd choice beta-blocker eye drop

De

c

13

.8

Delete Carteolol hydrochloride

1% eye drops

Bla

ck

Glaucoma review: not used and more expensive than betaxolol FMG Dec13 Glaucoma review - non formulary

De

c 1

3.8

Revise

restrictionTimolol 0.25% eye

drops (preserved)

gre

en

Glaucoma review 1st Choice beta-blocker (If cardio-selectivity required

select betaxolol 0.25% eye drops)

May be prescribed once daily in stable patients

Glaucoma review (FMG Dec13) 0.5% to become non-

formulary

De

c 1

3.8

Delete Timolol 0.5% eye drops

bla

ck

Glaucoma review - shaded amber as entry will need to be

deleted from formulary after implementation of review

2nd Choice beta-blocker (If cardio-selectivity required

select betaxolol 0.25% eye drops)

May be prescribed once daily in stable patients


formulary

De

c

13

.8

Revise

restrictionTimolol 0.25% single

use eye drops

(preservative-free) gre

en

Glaucoma review Restricted - only for use if patient has an established

allergy to preservatives or is using more than 6 drops

daily in the affected eye(s)

De

c

13

.8

Delete Timolol 0.5% single use

eye drops

bla

ck




formulary

De

c

13

.8

Delete Timolol ophthalmic gel-

forming solution 0.5%

bla

ck




formulary


FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

De

c

13

.8

Add Timolol 0.1% unit dose

eye gel (preservative-

free) gre

en

Glaucoma review Restricted - only for use if patient has an established



De

c 1

3.8

Delete Bimatoprost eye drops

100micrograms/mL

bla

ck

Glaucoma review: this strength contains a higher concentration

of benzalkonium chloride than the 300micrograms/mL .

Consultant ophthalmologists have requested this

shaded amber as entry will need to be deleted from formulary

after implementation of review

Glaucoma review (FMG Dec13) 100micrograms/mL to

become non-formulary

De

c

13

.8

TLL revised Bimatoprost eye drops

300micrograms/mL

(preserved)

AI

Glaucoma review 2nd Choice prostaglandin analogue


with continuation by GPs.

De

c

13

.8

TLL and

restriction

revised

Bimatoprost/Timolol eye

drops 0.3mg/5mg in

1mL (preserved)

AI

Glaucoma review: remove restriction relating to 6 month trial

and add Amber Initiation restriction



De

c

13

.8

Revise

restrictionLatanoprost eye drops

50micrograms/mL

(preserved) gre

en

Glaucoma review: Agree as 1st choice prostaglandin analogue.

Remove brand name from formulary as should be prescribed

generically

1st Choice prostaglandin analogue eye drop

De

c 1

3.8 Revise

restrictionLatanoprost/Timolol eye

drops

50micrograms/5mg in

1mL (preserved)

AI

Glaucoma review: Remove brand name as generic available. Restricted - to initiation by Consultant Ophthalmologist


De

c

13

.8

Delete Tafluprost unit dose eye

drops 15micrograms.mL

bla

ck

Glaucoma review: - make non-formulary and switch patients to

other preservative free prostaglandins

Glaucoma review (FMG Dec13) - non-formulary

De

c 1

3.8

Add Latanoprost

preservative free eye

drops

50micrograms/mL,

30x0.2mL

gre

en

Glaucoma review: added as new product Restricted - only for use if patient has an established



De

c 1

3.8

Add Bimatoprost

preservative-free eye

drops

300micrograms/mL, 30

x 0.4mL

gre

en

Glaucoma review: added as new product Restricted - only for use if patient has an established



De

c 1

3.8 Add Travoprost eye drops

40micrograms/mL

(preserved with

POLYQUAD)

gre

en?

Glaucoma review: added as new product 3rd Choice Prostaglandin analogue eye drops,

containing Polyquad, an alternative preservative to

benzalkonium chloride, if latanoprost and bimatoprost

have not proved suitable.

De

c

13

.8

Add Bimatoprost/timolol eye

drops 0.3mg/5mg in

1mL (preserved)

AI

Glaucoma review: added as new product Restricted - initiation by Consultant Ophthalmologists


De

c 1

3.8 Revise

restrictionTravoprost/Timolol eye

drops

40micrograms/5mg in

1mL (preserved)

AI

Glaucoma review: - removed restriction relating to 6 month trial

and make Amber Initiation

Restricted - initiation by Consultant Ophthalmologists


FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

De

c

13

.8

Revise TLL Brimonidine tartrate eye

drops 0.2% (preserved)

AI

Glaucoma review: - add TLL classification Alphagan®



De

c

13

.8

Revise

restrictionBrimonidine

tartrate/Timolol eye

drops 0.2%/0,5%

AI

Glaucoma review: - removed restriction relating tocompliance

issues and make Amber Initiation

Combigan®



De

c

13

.8

Delete Dipivefrin hydrochloride

eye drops 0.1%

bla

ck

Glaucoma review: - discontinued. If unlicensed product is

being used TLL is Red.

De

c

13

.8

TLL revised Acetazolamide 250mg

tablet, 250mg MR

capsule

AI

Glaucoma review - add TLL classification Restricted - initiation by Consultant Ophthalmologists


De

c 1

3.8 TLL revised Dorzolamide eye drops

2% (preserved)

AI

Glaucoma review - add TLL classification Trusopt®

1st Choice topical carbonic anhydrase inhibitors



De

c 1

3.8 TLL revised Brinzolamide eye drops

10mg/1mL (preserved)

AI

Glaucoma review - add TLL classification Azopt®

2nd Choice topical carbonic anhydrase inhibitors



De

c

13

.8

TLL revised Dorzolamide/Timolol

eye drops 2%/0.5%,

0.2mL (preserved)

AI

Glaucoma review - add TLL classification

15Jan14 Added as inadvertently omitted from initial list



De

c 1

3.8 TLL revised Dorzolamide/Timolol

preservative-free unit

dose eye drops

2%/0.5%, 0.2mL

AI


with continuation by GPs for patients who have an

established allergy to preservatives or who are using

more than 6 drops daily in the affected eye(s)

De

c 1

3.8 TLL revised Brinzolamide / Timolol

ophthalmic suspension

10mg/5mg per mL

(preserved)

AI

Glaucoma review - add TLL classification Azarga®



De

c 1

3.8 TLL revised Pilocarpine

hydrochloride eye drops

1%, 2% (preserved) AI



De

c 1

3.8

TLL revised Pilocarpine


2% single use eye

drops (preservative-

free)

AI


with continuation by GPs for patients who have an

established allergy to preservatives or who are using

more than 6 drops daily in the affected eye(s)

De

c 1

3.8

Delete Pilocarpine


4%, single use 4% and

ophthalmic gel 4% bla

ck

Glaucoma review - delete from formulary Glaucoma review (FMG Dec13) - non-formulary

FORMULARY CHANGES FOR NOTE - AGREED DECEMBER 2013 FMG

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

add Nalmefene 18mg tablet

red y

Oxfordshire Health decision Restricted - to be prescribed only by Oxford Health

NOTE: Not to be prescribed or dispensed by

Buckinghamshire Hospitals NHS Trust 4.1

0.1

DE

CE

MB

E

revise

restrictionPhenytoin

Carbamazepine

Phenobarbital

Primidone

NO

Label to prescribe by brand and state brand used in hospital as

"in secondary care the usual brand used is….."

Prescribe by brand to ensure patient is maintained on

specific manufacturer's product. In secondary care the

usual brand stocked is……..

4.8

.1

revise

restrictionSodium valproate

Lamotrigine

Retigabine

Clobazam

Clonazepam

Oxcarbazepine

Zonisamide

Topiramate

add usual brand stocked by hospital, prescribing generically or

by brand is discretionary and this decision should be taken in

consultation with the patient


4.8

.1

Add wording to

NF entryPermanel

Rufinamide

Eslicarbazepine

Tiagabine

Pregabalin (epilepsy NF

entry only)

add usual brand stocked by hospital, prescribing generically or

by brand is discretionary and this decision should be taken in

consultation with the patient

List medicines as non-formulary and refer to MHRA warning

See link to MHRA warning above

4.8

.1

Revise

restrictionLevetiracetam

Lacosamide

Gabapentin

Ethosuximide

Vigabatrin

Prescibe generically May be prescribed generically

4.8

.1

add drug as a

2nd line

treatment

choice

varenicline

green

(this drug has been available in the community for years but is

not listed in the formulary currently).

Usually started on the advice of the smoking cessation team,

along with psychological support. In secondary care not to be

started for in patients - but available for continuation in

established patients.

Restricted - to be used in accordance with NICE TA123

Varenicline for smoking cessation and Public Health

guidance Volumne 10, 200, as second line therapy when

NRT has failed.

4.1

0.3

Revise

restrictionFluticasone

Propionate/Salmeterol

250micrograms/50micro

grams per blister

(Seretide 250

accuhaler) dry powder

for inhalation

gre

en

y

Using the Seretide 500 accuhaler is more cost effective than

the Seretide 250

Add note to state that for COPD the Seretide 500 accuhaler

should be used (see COPD guideline)

Using the Seretide 500 Accuhaler for COPD treatment

is more cost effective than the Seretide 250 Accuhaler.

(See link to Bucks COPD guideline above)

3.2

FM

GD

EC

13

Add Thiopental 500mg in

2mL prefilled syringes

red N

Maternity theatres requesting

Less work for aseptic unit who are presently making.

Several risk assessments have been done for various

manufacturers the most recent being Medium Risk from UDG.

All risk assessments have come out as medium and all were

completed Dec12, Feb13 and Mar13.


Restricted - for use in Maternity Theatres only

15

.1.1

FM

GD

EC

13

All epilepsy medication listed below - revised restriction as a result of CHM warning regarding brand dispensing

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Revise

restrictionCeftriaxone 250mg, 1g,

2g injection

red ye

s

Antibiotic guideline for gastroenteritis states ceftriaxone can be

used for enteric fever. Need to add this as a restriction. (Added

to formulary by SS

In secondary care restricted - Paediatrics, suspected

meningitis or meningococcal septicasemia, serious

Orthopaedic infections; cellulitis; pelvic inflammatory

disease; enteric fever and sexually transmitted

infections. Also for use in accordance with Guidelines

for antibiotic treatment of infections within Obstetrics and

Gynaecology (BHTCG 207) May also be used in

accordance with OPAT guideline 103 (Empirical short

course home antibiotic regimens)

Microbiology approval required for all other uses.

In primary care not listed in local antibiotic guide.

5.1

.2.1

FM

GD

EC

13

Add Bupropion hydrochloride

150mg MR tablet

gre

en ye

s

The position of bupropion needs clarification with respect to the

NRT guideline and factsheet.

Bupropion is on the formulary for the community LES services

and it is in the Service Spec that it is offered through GP

prescription. In community varenicline is low priority drug and

should be prescribed 2nd line after therapy has failed, with

bupropion available as 3rd line. (confirmed with Val Mills

11Dec13)

In primary care - only to be prescribed as a 3rd line

treatment if 1st line treatment with nicotine replacement

therapy (NRT) has not been successful and second line

treatment with varenicline is not appropriate. To be used

in accordance with NRT guideline

In secondary care - only to be supplied to inpatients for

continuation of existing treatment in accordance with

NRT guideline.

4.1

0.2

FM

GD

EC

13

Add Miconazole ovule 1.2g

available to replace

100mg pessary gre

en ye

s

Miconazole pessary 100mg was 2nd choice after clotrimazole.

The ovule is now second choice 7.2

.2

FM

GD

E

Delete Miconazole pessary

100mggre

en

no longer available.

7.2

.2

FM

GD

EC

1

Add Adrenaline /

Epinephrine

150micrograms (child)

(Epipen Jr Auto-injector

0.15mg

gre

en ye

s

Jext® have recently recalled many batches due to a potential

problem with the delivery of adrenaline, which has led to

insufficient stocks in primary care. The availability of Epipen®

on formulary as a back up for such situations is proposed

Restricted - 2nd Choice adrenaline auto-injector pen only

to be used when there are supply issues with the Jext

brand

03

.04

.03

FM

GD

EC

13

Add Adrenaline /

Epinephrine

300micrograms (adult)

(Epipen Auto-injector

0.3mg

gre

en ye

s

Restricted - 2nd Choice adrenaline auto-injector pen only

to be used when there are supply issues with the Jext

brand

03

.04

.03

FM

GD

EC

13

Add Nystatin 100,000 units

vaginal cream

For vaginal candidiasis

resistant to clotrimazole

GUM team only

red no

The licensed product is no longer manufactured.

If to be prescribed more widely will be discussed at subsequent

meeting and traffic light position to be reviewed.

Unlicensed - Medium Rsk

Restricted - prescribing by GUM team only for vaginal

candidiasis resistant to clotrimazole.

13

.10

.02

FM

GD

EC

1

Add Iobitridol (Xenetix)

300mg iodine/mL and

350mg iodine/mL

Consultant

Radiologists only

red

In regular use in radiology Restricted - prescribing by Consultant Radiologists only

no

t in

BN

F

FM

GD

EC

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Diloxanide furoate

500mg tablets.

Treatment of amoebiasis On the advice of

Consultant

Microbiologist

Re

d

Y

This drug is used very rarely, however, it is the only effective

treatment for amoebiasis eradication, which requires urgent

treatment. . I would recommend that the item has a restriction,

that it should be prescribed following microbiology advice.

PHone Pharmacy to order if required.

Restricted - to be prescribed only on advice from

Consultant Microbiologists, for the treatment of

amoebiasis.

Phone Pharmacy to order

5.4

.2

FM

GD

EC

13

Add Azithromycin 500mg

powder for solution for

infusion (Zedbac).

patients presenting with

CAP or enteric fever who

are NBM

On the advice of

Consultant

Microbiologist

red Y

Oral preparations of azithromycin currently on formulary,

however, it is felt by the microbiology consultants that an IV

option would be useful for patients presenting with CAP or

enteric fever who are NBM.

Not currently in the BNF but SPC is available. Phone

Pharmacy to order if required

Restricted - to be prescribed only on advice from

Consultant Microbiologists, for the treatment of CAP or

enteric fever in patients who are nil by mouth.

Phone Pharmacy to order

5.1

.5

FM

GD

EC

13

Dec

FM

G

revise

RestrictionDabigatran for AF guideline Guideline revised to include

NOTE regarding urgent patients

Restricted to prescribing for stroke prevention in AF in accordance

with NICE TA 294 Dabigatran for Stroke Prevention in AF and

Dabigatran for AF Amber Initiation guideline (BHTCG 313) with

initiation by:

1. Consultant Stroke physicians for urgent patients who have had a

previous stroke or TIA. All patients initiated by consultants to be

subsequently referred to NOAC clinic for follow-up

2. NOAC Pharmacists

NOTE: Any urgent patient without a previous stroke or TIA but with a

CHA2DS2VASc of 6 or more should be referred to the NOAC clinic for

an urgent initial appointment.

Dec

FM

G

revise

RestrictionRivaroxaban for AF guideline Guideline revised to include

NOTE regarding urgent patients

Restricted to prescribing for stroke prevention in AF in accordance

with NICE TA 294 Dabigatran for Stroke Prevention in AF and

Dabigatran for AF Amber Initiation guideline (BHTCG 313) with

initiation by:

1. Consultant Stroke physicians for urgent patients who have had a

previous stroke or TIA. All patients initiated by consultants to be

subsequently referred to NOAC clinic for follow-up

2. NOAC Pharmacists

NOTE: Any urgent patient without a previous stroke or TIA but with a

CHA2DS2VASc of 6 or more should be referred to the NOAC clinic for

an urgent initial appointment.

Oct

13.3

Add Mirabegron 25mg, 50mg

tablet

Over active bladder Consultant

Urogynaecologists and

Consultant Urologists

AI

Y

Restricted - initiation by Consultant Urogynaecologists and Consultant

Urologists in accordance with NICE TA290

as an option when patients fail on, or are intolerant of solifenacin or

for whom anticholinergics are contraindicated.

Urinary Incontinence (BHTCG 110) being updated

7.4.

2

Oct

13 F

MG

FMG Decisions October 2013

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Oct

13.

5

Add Rivaroxaban 15mg, 20mg Treatment PE and prevention PE

and DVT

Consultant Haematologists

Red Y

NICE compliance form required.

In accordance with NICE TA 297 and in accordance with awaited guideline.

FOR ALL PRESCRIBING - NICE compliance form required - see link

from Formulary homepage. Named patient approval only as

NICE/HCD compliance form awaited.

2. Restricted - prescribing by Consultant Haematologists for patients

unsuitable for warfarin in accordance with NICE TA287 Pulmonary

embolism and recurrent venous thromboembolism - rivaroxaban and

in accordance with BHT guideline (awaited).

Audit results to be brought to FMG February 2014

2.8.

2

Oct

13 F

MG

Oct

13.7

Reject Linaclotide Symptomatic treatment of

patients with moderate to severe

constipation predominant irritable

bowel syndrome which hasn't

responded to laxatives and anti-

spasmodics

Bla

ck

Y

Rejected because evidence of efficacy could not confirm that linaclotide would

provide at least equivalent levels of efficacy to standard treatment

1.6.

7

Oct

13 F

MG

Oct

Reject Esomeprazole All licensed indications

Bla

ck

Y

Rejected because no evidence to support its superior efficacy or safety

compared to other PPIs at equivalent acid suppression doses.

1.3.

5

Oct

13

May

13.5

Add Ibandronic acid 50mg tablets Prevention of skeletal events in

patients with breast cancer and

bone metastases. For patients

not receiving IV therapy for their

breast cancer

Initiation by Consultant

Breast Oncologists and


Y

Restricted - initiation by Consultant Breast Oncologists with

continuation by GPs.for metastatic bone disease in cancer patients

not receiving iv therapy, in accordance with Ibandronic Acid for

treatment of metastatic bone disease in breast cancer (BHTCG

307FM)

06.0

6.02

Oct

13

FM

G

Revise

restrictionSeretide evohaler,

Symbicort and Flixotide

inhalers - all strengths

Initiation by

respiratory teamgre

en

Y

Seretide 50 Evohaler already restricted for treatment of asthma

in accordance with British Guideline on the Management of

Asthma revised 2009

Seretide 125 Evohaler - restricted. May ony be used for

continuation of therapy. Not to be initiated as not cost effective

compared to other strengths.

In secondary care - restricted to initiation by respiratory

team only

3.2

FM

G O

ct1

3

Add FreeStyle Optium

glucose test strips

gre

en

YRecently agreed for Trust. Not aligned with primary care Restricted - only for use by patients using FreeStyle

Optium beta-ketone test strips.

6.1

.6

FM

G

Add FreeStyle Optium beta-

ketone test strips

gre

en

Y

Recently agreed for Trust. Not aligned with primary care Restricted for Type 1 Diabetics and patients on insulin

6.1

.6

FM

G

Delete Ascensia glucose and

ketone blood testing

products

?? Y

Still in use in the community along with ketone test strips.

Added ketone test strips to formulary

6.1

.6

FM

G

Revise TLL

classificationLanreotide 60mg

(Somatuline Autogel®)


syringe)

PbR excluded SCG

funded

Paediatric

consultants

Re

d

U

nli

c

U

se

SCP with GOS; Bucks GPs do not wish to 'share care' with

GOS for this drug because it is a very rare condition,

Unlicensed indication, not a routinely used medication for a GP

(even in adults), commissioned by specialist commissioning

according to their manual.

GOS guideline states Somatuline Autogel 60mg syringes (Nicky

Greenberg 8Nov13)

Unlicensed use.

Restricted - prescribing by Paediatric consultants for

Congenital Hyperinsulinism (CHI) in accordance with

Great Ormond Street hospital guidelines

8.3

.4.3

.

FM

G O

ct1

3

Formulary Changes for Note FMG October 2013

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Revise TLL

classificationOctreotide

50micrograms/1mL,

100micrograms/1mL,

500micrograms/1mL,

1g/5mL

(injection)

PbR excluded SCG

funded

Re

d

U

nli

c

U

se

SCP with GOS; Bucks GPs do not wish to 'share care' with

GOS for this drug because it is a very rare condition,

Unlicensed indication, not a routinely used medication for a GP

(even in adults), commissioned by specialist commissioning

according to their manual.

Clarify strengths required according to GOS guideline

Unlicensed use.

Restricted - prescribing by Paediatric consultants for

Congenital Hyperinsulinism (CHI) in accordance with

Great Ormond Street hospital guidelines

8.3

.4.3

.

FM

G O

ct1

4

Add Colistimethate sodium

1,662,500IU inhalation

powder, hard capsules

for use with

Turbospin® powder

inhaler Colobreathe®

DPI (dry powder

inhaler)

PbR excluded SCG

funded

Consultants Paed

specialising in Cystic

Fibrosis management

red

Y

NICE TA 276 (March 2013) Colistimethate sodium dry powder

inhaler is recommended for use in patients unsuitable or unable

to use colistimethate sodium nebulisers. Colistimethate sodium

nebuliser remains the first line agent for the management of

chronic pulmonary infections due to Pseudomonas aeruginosa

in patients with Cystic Fibrosis,. Colistin inhaler is similar in

price to Tobramycin POD haler. Both have the same place in

therapy and NICE TA. Colistin inhaler was not included in the

Tobi Podhaler application in May 13 as it was not marketed at

the time. Approx 2 patients per year

Restricted - prescribing by consultant Paediatricians

specialising in Cystic Fibrosis for the management of

chronic pulmonary infection due to Pseudomonas

aeruginosa in patients with cystic fibrosis aged 6 years

and older if nebulised colistin is not tolerated or if clinical

progress is unsatisfactory. To be used in accordance

with NICE TA276 Colistimethat sodium and tobramycin

dry powders for inhalation for treating pseudomonas lung

infection in cystic fibrosis.

5.1

.4

FM

G O

ct1

3

Revise Cetraben emollient

cream 50g, 500g, 150g,

1.05kg pump packs

gre

en

Y

Clarification of sizes on formulary. Secondary care require 50g

and 500g. 50g, 150g, 500g and 1.05kg requested for use in

primary care. Cetraben already on formulary. Address sizes

required as result of Woundcare Formulary merge action and in

line with moisturizing and cleansing advice from Dermatology.

In Primary care all sizes available.

In Secondary care 50g and 500g available

13

.02

.01

.01

FM

G O

ct1

3

Add Diprobase cream 50g

tube

gre

en

Y

Diprobase already on formulary. This convenient 50g size to be

added as a result of Woundcare Formulary merge action and in

line with moisturizine and cleansing advice from Dermatology.

13

.02

.01

.0

1F

MG

Revise

restrictionDenosumab 60mg/1mL

(Prolia)

Osteoporosis Consultant

Endocrinologists and

Consultant


continuation by GPs

AP Y

NOTE: Denosumab 120mg (Xgeva®) is administered monthly.

Denosumab 60mg (Prolia®) is administered every six months.

Apply notes to both entries on Formulary to alert users to the

potential for confusion between the two drugs and highlight

need for care when prescribing and administering

Add: "WARNING: There are TWO brands of denosumab, each

a different strength - take extra care and attention when

prescribing and administering.

Combined entry from CCG adding in 4th Choice

4th Choice for secondary prevention of osteoporosis (not

recommended for primary prevention)

WARNING: - There are TWO brands of denosumab,

each a different strength - take extra care when

prescibing and administering.

NOTE: Prolia® is administered every six months

Restricted - to prescribing by Rheumatologists and

Endocrinologists only, with continuation by GPs, in

accordance with: Denosumab for primary and secondary

fracture prevention in men and women over 50 years

(BHTCG 401) and BHTCG 402 and 403 (see above link

to osteoporosis guidelines) for patients with confirmed

intolerance or contraindications to oral bishosphonates

and strontium ranelate and in accordance with NICE TA

204 Osteoporotic fractures - Denosumab.

6.6

.2

FM

G O

ct1

3

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Revise

restrictionDenosumab vial

120mg/1.7mL (XGEVA)

Bone Metastases in Solid

Tumours

Consultant Breast

Oncologists

Re

d

Y

NOTE: Denosumab 120mg (Xgeva®) is administered monthly.

Denosumab 60mg (Prolia®) is administered every six months.

Apply notes to both entries on Formulary to alert users to the

potential for confusion between the two drugs and highlight

need for care when prescribing and administering

Add: "WARNING: There are TWO brands of denosumab, each

a different strength - take extra care and attention when

prescribing and administering.

WARNING: - There are TWO brands of denosumab,

each a different strength - take extra care when

prescibing and administering.

NOTE: XGEVA® is administered monthly



Restricted - prescribing by Consultant Breast

Oncologists in accordance with Denosumab for Bone

Metastases in Solid Tumours (BHTCG 305FM) and in


6.6

.2

FM

G O

ct1

3

Revise

restrictionBendroflumethiazide

2.5mg, 5mg

gre

en

Y

NOTE: in accordance with Clinical Management of

Hypertension in Adults BHTCG 227 bendroflumethiazide is

ONLY for continuation in stable patients and is NOT to be

initiated for treatment of hypertension

Restricted - when used for hypertension to be prescribed

in accordance with Clinical Management of Hypertension

in Adults (BHTCG 227) and only for continuation in

stable patients and NOT to be initiated for the treatment

of hypertension.

02

.02

.01

FM

G O

ct1

3

Revise

restrictionBendroflumethiazide

5mg

gre

en

Y

Split into 2 entries with 5mg only for use with loop diuretics for

treating oedema.

Restricted - only for use with loop diuretics for controlling

oedema.

NOTE: Use 2.5mg only when treating hypertension (see

entry below) 02

.02

.01

FM

G O

ct1

3

Revise

restrictionTenofovir Disoproxil

245mg/Emtricitabine

200mg tablet (Truvada)

HIV/GUM team

red Y

Advice to Phone Pharmacy was added originally to ensure that

the prescriber knew where to obtain stocks from IF the patient

could not have a standard PEP pack but Truvada is also used

for treatment as well as PEP so to avoid confusion restriction is

removed... Normal restriction to HIV and GUM consultant

prescribing still stands across the whole group.

05

.03

.01

FM

G O

ct1

3

Add Darunavir 150mg,

400mg, 600mg tablet

PbR excluded SCG

funded

HIV/GUM team

Re

d

Y

treatment of HIV in accordance with BHIVA 2012 HIV

treatment guidelines

Restricted - to be prescribed by HIV and GUM teams in

accordance with BHIVA 2012 HIV treatment guidelines

05

.03

.01

FM

G O

ct1

3

Add Rilpivirine 25mg tablet

PbR excluded SCG

funded

HIV/GUM team

Re

d

Y

Treatment of HIV in accordance with BHIVA 2012 HIV

treatment guidelines. For patients who are unable to take first

line anti-retrovirals due to resistance or as a alternative to

- efavirenz where tolerability is/has potential (e.g. due to

working patterns)to be a problem due to adverse effects

- nevirapine - due to adverse effects or high CD4 levels

- protease inhibitors - to spare these and in view of possible

long term metabolic side effects. Max 10 patients per year.

Funded by SCG as included in BHIVA guidelines

Restricted - prescribing by HIV and GUM teams in


and restricted to patients who are unable to take first line

anti-retrovirals due to resistance or as an alternative to:

- efavirenz - where tolerability is/has potential (eg. due to

working patterns) to be a problem due to adverse effects

- nevirapine - due to adverse effects or high CD4 levels,

or

- protease inhibitors - to spare these and in view of

possible long term metabolic side effects.

05

.03

.01

FM

G O

ct1

3

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Emtricitabine 200mg,

rilpivirine 25mg and

tenofovir disoproxil

245mg tablet

(Eviplera®)

PbR excluded, SCG

funded

HIV/GUM team

Re

d

Y

treatment of HIV in accordance with BHIVA 2012 HIV

treatment guidelines. To be used in patients who experience

side effects from efavirenz. Max 10 patients per year. Funded

by SCG as included in BHIVA guidelines

Restricted - to be prescribed by HIV and GUM teams in


forpatients who experience side effects from efavirenz.

05

.03

.01

FM

G O

ct1

3

Add Nevirapine 400mg MR

tablet

PbR excluded, SCG

funded

HIV/GUM team

Re

d

Y

treatment of HIV in accordance with BHIVA 2012 HIV treatment

guidelines

Treatment of HIV in accordance with BHIVA 2012 HIV

treatment guidelines

05

.03

.01

FM

G O

ct1

3

expand

restrictionRibavirin oral solution

200mg/5mL

PBr excl SCG

Unexplained acute

encephalopathy

Paediatric team

red

Y

Short course of treatment (3 days)

Prescribing by Paed team.in accordance with BHTCG 771

which recommends use for children with measles who have not

been vaccinated against it.

Restricted - to prescribing by Paediatric team in

accordance with Investigation of unexplained acute

encephalopathy in paediatrics (BHTCG 771)

05

.03

.05

FM

G

expand

restrictionRibavirin 200mg tablet

PBr excl SCG

Unexplained acute

encephalopathy

Paediatric team

red

Y

Short course of treatment (3 days)

Prescribing by Paed team.in accordance with BHTCG 771

which recommends use for children with measles who have not

been vaccinated against it.

Restricted - to prescribing by Paediatric team in

accordance with Investigation of unexplained acute

encephalopathy in paediatrics (BHTCG 771)

05

.03

.05

FM

G

Delete Metaraminol 10mg in

1ml injection

red

N

Unlicensed - Medium Risk. To be deleted and replaced by a

lower strength for reasons of safety.

NOTE: This strength will be deleted from the formulary once

there is an assured supply of the lower strength.

Unlicensed - Medium risk

WARNING: Take extra care when prescribing and

administering as there are TWO different strengths of

this drug.

NOTE: This strength will be deleted from the formulary

once there is an assured supply of the lower strength

02

.07

.02

FM

G O

ct1

3

Add Metaraminol 2.5mg in

5ml injection (all sizes)

red N

Unlicensed LOW risk. Unlicensed - Low risk

WARNING: Take extra care when prescribing and

administering as there are TWO different strengths of

this drug.

02

.07

.02

FM

G O

ct1

3

Add Paracetamol

suppositories 60mg,

125mg, 250mg, 500mg,

1g

gre

en

Y

All available as licensed products 60mg suppository: Unlicensed - Low Risk

In primary care the licensed 60mg, 125mg, 250mg,

500mg, 1g preferred

In secondary care the unlicensed 60mg, 120mg and

240mg to be deleted and the licensed 60mg, 125mg,

250mg, 500mg and 1g suppositories to be introduced.

04

.07

.01

FM

G O

ct1

3

delete Paracetamol

suppositories 60mg

(unlicensed), 120mg,

240mg and 500mg

gre

en

N

These strengths are on formulary. Licensed strengths now

available to replace 60mg and the other two strengths no

licensed product available.

To be deleted once new licensed strengths are introduced and

implemented

60mg suppository: Unlicensed - Low Risk

In primary care the licensed 60mg, 125mg, 250mg,

500mg, 1g preferred

In secondary care the unlicensed 60mg, 120mg and

240mg to be deleted and the licensed 60mg, 125mg,

250mg, 500mg and 1g suppositories to be introduced.

04

.07

.01

FM

G O

ct1

3

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

revise

restrictionBevacizumab

2.5mg/0.1mL

red

N

Update restriction which was out of date and include direction to

complete NICE form (MSt, 18Sep13)




Restricted - prescribing by consultant Ophthalmologists

for treatment of non-AMD choroidal neovascular

membranes, rubeotic glaucoma and as an adjunct to

vitrectomy for proliferative diabetic retinopathy

11

.08

.02

FM

G O

ct1

3

add Sildenafil

800micrograms in

1mL injection, 20mL

vial

PBr excluded drug

SCG

Primary pulmonary arterial

hypertension

red

Y

primary pulmonary arterial hypertension in patients who cannot

swallow tablets

For treatment of pulmonary arterial hypertension.

FIRST DOSE MUST BE GIVEN IN HOSPITAL - risk of

first-dose hypotension.

Restricted - only for patients who are unable to swallow

the tablets with initiation by Respiratory consultants in

secondary or tertiary care. See European Society of

Cardiology guideline on diagnosis and treatment of

pulmonary arterial hypertension, European Heart Journal

2004.

02

.05

.01

FM

G O

ct1

3

Add Peginterferon alfa 2b

pens

Hepatitis C,Christine

Helmer

red

Y

prefilled syringes are already on formulary and the cost is the

same.

Left entry unaltered as only changing from prefilled pen to a

click device prefilled pen



Restricted - prescribing by Gastroenterologists and

Associate Specialist Gastroenterology in accordance

with NICE TA 75 Interferon alfa and ribavirin for the

treatment of chronic hepatitis, NICE TA 106

Peginterferon alfa and ribavirin for the treatment of mild

hepatitis C and NICE TA 200 Hepatitis C - peginterferon

alfa and ribavirin.

FM

G O

ct1

3

Add Palivizumab 50mg,

100mg vial

PbR excluded funded

by SCG

Prevention of RSV

(Respiratory Syncytial

Virus) infection

Consultant

Paediatricians

Re

d

Y

Used to be approved via IFR at PCT. This is now funded by

SCG and they do not want to use IFRs for this product unless

the JCVI criteria are not met. BHT internal approval process

with NICE / HCD compliance form will be used instead



compliance to be confirmed if form not available.

Restricted - prescribing by Consultant Paediatricians

only in accordance with JCVI criteria. Approval required

prior to initiation.

05

.03

.05

FM

G O

ct1

3

Add choice Indapamide 2.5 mg

gre

en

Y

1st choice thiazide for hypertension 1st Choice thiazide for treatment of hypertension

For use in accordance with Clinical management of

hypertension in adults (BHTCG 227)(see link above)

2.2

.1

FM

G

Add choice Alendronic acid 70mg

gre

en

Y1st choice for osteoporosis 1st Choice for osteoporosis

6.6

.2

FM

G

Add choice Risedronate 35 mg

gre

en

Y

2nd choice for osteoporosis 2nd line treatment when intolerant to Alendronate

6.6

.2

FM

G

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add choice Strontium

gre

en

Y

3rd choice for osteoporosis treatment (but not recommended

for primary prevention)

3rd Choice for Osteoporosis treatment (but not


Restricted to Consultant Rheumatologists and Care of

the Elderly for treatment of post menopausal

osteoporosis to reduce the risk of vertebral and hip

fractures.

6.6

.2

FM

G O

ct1

3

Add choice Denosumab s/c 60mg

AP Y

4th choice for secondary prevention of osteoporosis (not


see entry above

6.6

.2

FM

G

Add Varicella-Zoster vaccine

(Zostavax®)

gre

en

YAdd as part of 1ary care national immunisation programme for

adults aged 70 and 79 14

.4

FM

G

Add Pneumococcal vaccine

(Prevenar 13®)

gre

en

YAdd as part of 1ary care national immunisation programme

14

.4

FM

G

Add Rotavirus vaccine

(Rotarix®) oral

suspension 1.5mL

prefilled oral syringe

gre

en

Y

Add as part of 1ary care national immunisation programme

14

.4

FM

G

Add Influenza vaccine

(Fluenz®) nasal spray,

0.2mL nasal applicator

gre

en

Y

Add as part of 1ary care national immunisation programme for

childrens aged 2 and 3

14

.4

FM

G

Add new

indicationAripipazole - all

strengths and dose

forms

Moderate to severe manic

episodes in adolescents

aged 13-18 with bipolar

disorder within its

marketing authorisation (ie

up to 12 weeks of

treatment for moderate to

severe manic episodes in

bipolar disorder)

Oxford Health

initiation onlyre

d

Y

TA292 Aripiprazole is recommended as an option for treating

moderate to severe manic episodes in adolescents aged 13-18

with bipolar I disorder, within its marketing authorisation (that is,

up to 12 weeks of treatment for moderate to severe manic

episodes in bipolar disorder)

Restricted - prescribing by Psychiatric (Mental Health

Trust) team only.

NICE TA292 - Aripiprazole is recommended as an option

for treating moderate to severe manic episodes in

adolescents aged 13-18 years, with bipolar 1 disorder,

within its marketing authorisation (ie. up to 12 weeks of

treatment for moderate to severe manic episodes in

bipolar disorder)(see link above)

4.2

.1

FM

G O

ct1

3

Add Eurax HC®

gre

en

Y

As recommended in Dermatolog referral guidelines; it does not

pose a cost pressure

This is still manufactured even though not mentioned in BNF 13

.3

FM

G

Add Emulsiderm liquid

emulsion

gre

en

Y



13

.2.1

.

1F

MG

Add Alphosyl 2 in 1®

shampoo

gre

en

Y



13

.9

FM

G

Add Lisdexamphetamine

Mesilate capsule 30mg,

50mg, 70mg

Oxfordshire Health

red Y

3rd line for ASHD instaed of dexampheatamine - reviewed by

Oxford Health DTC

not listed in BNF

Restricted - to be prescribed only by Oxford Health

NOTE: Not to be prescribed or dispensed by

Buckinghamshire Hospitals NHS Trust FM

G

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

revise

restrictionMetformin 500mg,

850mg tablet

gre

en

Y

See separate entry and restrictions when using to

control weight gain in Oxfordshire Health

paediatric patients receiving antipsychotic

therapy.

6.1

.2.2

FM

G

Add new

indicationMetformin 850mg tab Oxfordshire Health

red N

OH protocol approved by their DTC to control weight gain in

Oxfordshire Health paediatric patients

Unlicensed Use

Restricted - prescribing and management by Oxfordshire

Health only when used to control weight gain in

paediatrics caused by antipsychotic therapy.

6.1

.2.2

FM

G O

ct1

3

Au

g 1

3.1 Add Ranibizumab

2.3mg/0.23mL

(Lucentis) intravitreal

injection

PBR excl CCG

Macular Oedema caused

by retinal vein occlusion

(NICE TA 283)

Consultant

Ophthalmologosts

red y

Dexamethasone implant is the first line treatment for macular

oedema caused by CRVO or BRVO. Ranibizumab may be used

as a second line treatment instead of dexamethasone implant

when dexamethasone is deemed unsuitable in the following

circumstances:

Audit results for one year, for the relative use of ranibizumab

and dexamethasone to come back to FMG Sept 14



1. Restricted - Prescribing by Ophthalmologists only for

the treatment of Age Related Macular Degeneration.

Intravitreal use only.

See Guideline: Ranibizumab for the treatment of age-

related macular degeneration (based upon NICE TA

155).

2. Restricted - Prescribing by Ophthalmologists only in

accordance with NICE TA 274 Ranibizumab for the

treatment of Diabetic Macular Oedema (DMO).

3. Restricted - Prescribing by Ophthalmologists only as

second line treatment, instead of dexamethasone

implant, when dexamethasone is deemed unsuitable in

the following circumstances: raised intraocular pressure

or a strong family history of raised intraocular pressure

and in accordance with NICE TA 283 Macular oedema

(retinal vein occlusion) ranibizumab.

Audit results confirming the relative use of ranibizumab

and dexamethasone in one year to be brought back to

FMG September 2014

11

.08

.02

Sep-1

3

Au

g1

3.2 Add Aflibercept 4mg in

0.1mL solution for


PBR excl CCG

Wet Age Related Macular

degeneration

Consultant

Ophthalmologists

red

y

NOT AVAILABLE UNTIL LATE OCTOBER WHEN FUNDING

AGREED - NOT ENTERED ON NET FORMULARY

Approved as alternative to ranibizumab as a first line treatment

for wet AMD in accordance with NICE TA 294

Audit results for one year, for the relative use of ranibizumab

and dexamethasone to come back to FMG Sept 14

NICE Compliance form approved CGS Sept 13



1. Restricted - Prescribing by Ophthalmologists as an

alternative to ranibizumab as a first line treatment for wet

Age Related Macular Degeneration (AMD) in accordance

with NICE TA 294 Macular degeneration (wet age-

related) aflibercept (1st line)

Audit results confirming the relative use of ranibizumab

and aflibercept in one year to be brought back to FMG

September 2014

11

.08

.02

Sep-1

3

FMG Decisions August 2013

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Au

g 1

3.5 Add Omalizumab 150mg

prefilled syringe

PBr excl SCG

Severe Persistent allergic

asthma

Respiratory

physicians and

Consultant

Paediatricians

red y

Approved for treatment of severe persistent allergic asthma in

accordance with NICE TA 278 and BHTCG 271 Omalizumab for

severe persistent allergic asthma



1 .Restricted - prescribing by Consultant Respiratory

Physicians and Consulant Paediatricians only in

accordance with Omalizumab for severe persistent

allergic asthma (BHTCG 271) and in accordance with

NICE TA 278 Omalizumab for treating severe persistent

allergic asthma

3.4

.2

Sep-1

3

Au

g 1

3.3 Rejected Preservision tablets Age related macular

degeneration

Recommended by

Consultant

Ophthalmologist

bla

ck

Listed as Non-Formulary - see note on Formulary This product, containing the AREDS formula, may be

recommended for purchase by consultant

Ophthalmologists for AMD patients whom they consider

have an insufficient dietary intake of the necessary

vitamins. The only group of patients who may potentially

benefit are defined by the Royal College of

Ophthalmologists - patients with extensive intermediate

size drusen, one or more large drusen, noncentral

geographic atrophy in one or both eyes, or advanced

AMD or vision loss due to AMD in one eye.

Au

g 1

3.3 Rejected Viteyes Original tablets Age related macular

degeneration

Recommended by

Consultant

Ophthalmologist

bla

ck

Listed as Non-Formulary - see note on Formulary This product, containing the AREDS formula, may be

recommended for purchase by consultant

Ophthalmologists for AMD patients whom they consider

have an insufficient dietary intake of the necessary

vitamins. The only group of patients who may potentially

benefit are defined by the Royal College of

Ophthalmologists - patients with extensive intermediate

size drusen, one or more large drusen, noncentral

geographic atrophy in one or both eyes, or advanced

AMD or vision loss due to AMD in one eye.

Au

g 1

3.4 Add Pirfenidone 267mg

capsule

PBr excl SCG

Idiopathic pulmonary

fibrosis TA 282

Initiation only by

Consultant

Respiratory

physicians in named

Specialist Centres


BHT Respiratory

physicians red

In accordance with NICE TA 282 Pirfenidone for treating

idiopathic pulmonary fibrosis

Initiation by Consultant Respiratory physician in named

Specialist Services (Oxford University Hospitals NHS Trust,

Interstial Lung Disease Service (ILD Service), University

Hospital Southampton NHS Trust, Royal Brompton & Harefield

NHS Foundation Trust, Imperial College Heathcare NHS Trust

and Guys and St Thomas' NHS Foundation Trust).

Prescribing may be continued in BHT by Consultant Respiratory

physicians. BHT will not stock pirfenidone. The formulary

should advise doctors and pharmacists to obtain supplies of

pirfenidone from either the patient or the Specialist Service if a

patient is admitted to BHT with IPF exacerbations.

Restricted - prescribing in accordance with NICE TA 282

Pirfenidone for treating idiopathic pulmonary fibrosis

)IPF) with initiation by consultant Respiratory physicians

in named Specialist Services only (Oxford University

Hospitals NHS Trust, Interstial Lung Disease Service

(ILD Service), University Hospital Southampton NHS

Trust, Royal Brompton & Harefield NHS Foundation

Trust, Imperial College Heathcare NHS Trust and Guys

and St Thomas' NHS Foundation Trust) and prescribing

may be continued in BHT by Consultant Respiratory

physicians.

BHT will not stock pirfenidone. If a patient is admitted to

BHT with IPF exacerbations supplies to be obtained from

either the patient or the Specialist Service.

Au

g 1

3.7 Add Chlorhexidine Wash

Cloths (Clinell)

Part of ICU and

Trauma and

Orthopaedics

package of care.

red

• All patients receiving inpatient care in ICU

• Trauma and Orthopaedics, to be prescribed in pre-operative

clinics prior to elective joint replacement surgery

Restricted - for patients receiving inpatient care in ICU

and for patients attending pre-operative clinics prior to

elective joint replacement surgery.

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Au

g 1

3.6 Rejected Glycopyrronium

inhalation powder

50micrograms

Treatment of COPD

bla

ck

• Aclidinium inhaler and glycopyrronium inhaler were not

approved for formulary inclusion as an alternative to Tiotropium

in moderate to severe COPD. The duration of trial evidence

was short in the treatment of COPD which is a chronic

condition. Aclidinium was studied for 12 and 24 weeks.

Glycopyrronium was only studied for 26 and 52 weeks.

Au

g 1

3.6 Rejected Aclidinium inhaler


inhalation

Treatment of COPD

bla

ck

• Aclidinium inhaler and glycopyrronium inhaler were not

approved for formulary inclusion as an alternative to Tiotropium

in moderate to severe COPD. The duration of trial evidence

was short in the treatment of COPD which is a chronic

condition. Aclidinium was studied for 12 and 24 weeks.

Glycopyrronium was only studied for 26 and 52 weeks.

Au

g 1

3.8 Add Sucrose 24% oral

solution

Re

d

Y

• Sucrose 24% is approved as a first line agent in addition to

the use of current non-pharmacological strategies for the

treatment of procedural pain in neonates, to be used in

accordance with the draft guideline

Restricted - prescribing by paediatrics team for

procedural pain in neonates, in accordance with Sucrose

Solution for Pain Relief Guidelines (BHTCG 326).

Au

g 1

3.1

0 Add Caffeine citrate solution

for infusion and oral

solution 20mg/mL

(Peyona)


apnoea of premature

newborns

Paediatrics team in

NICU only

red y

Each ml contains 20mg caffeine citrate (equivalent to

10mg caffeine).

Restricted - prescribing by paediatrics team in NICU only

in accordance with Neonatal Dosage Guidelines

(BHTCG 69).

Aug

13

.13 New All traffic light related

guidelines agreed

review date of 3 years.

Ma

y1

3.9 Add

Audit: April 14Dexmedetomidine

200micrograms/2mL,

400micrograms/4mL,

1mg/10mL

For sedation in ICU Consultant

Anaesthetists on ITU

red y

In accordance with Dexmedetomidine (Dexdor) Use in ICU

(BHTCG 50)

Guideline approved CGS June 13, Audit protocol approved

FMG Aug 13. Addition of protocol to guideline due for approval

CGS Sept 13 Therefore formulary inclusion after CGS Sept 13


on ICU in accordance with Dexmedetomidine (Dexdor)

Use in ICU (BHTCG 50)

Audit results to be reviewed at FMG April 2014

Ma

r13

.4 NF process

notedTolvaptan 15mg, 30mg

tablets

PBr excl SCG

Hyponatraemia Endocrinologists

red

y

Tolvaptan for hyponatraemia secondary to SIADH and

hyponatraemia guideline

Ja

n 1

3.3 Guideline

AddedRetigabine for use as

adjunctive treatment for

partial seizures clinical

guideline

AI

BHT CG 801

Ja

n 1

3.3 Add Retigabine tablet, 50mg,

100mg, 200mg, 300mg,

400mg

Adjunct treatment epilepsy Initiation Consultant

Neurologist and


y

Restricted - initiation by Consultant Neurologists with

continuation by GPs, in accordance with NICE TA 232

Retigabine for the adjunctive treatment of partial onset

seizures in epilepsy and Retigabine for use as adjunctive

treatment for partial seizures (BHTCG 801)

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Oct

12

.10 NF process

notedCinacalcet 30mg,

60mg, 90mg tablets

PBr exlc SCG

Hyperparathyroidism Endocrinologists

red

y

Cinacalcet funding is subject to a business case for review by

SCG for patients who do not fulfill NICE TA 117 criteria.

Ja

n1

2.6

Guideline

AddedAntiplatelets for the

secondary prevention of

occlusive vascular

events guideline

Aspirin, clopidogrel, prasugrel, ticagrelor to be used in

accordance with Antiplatelets for the Secondary Prevention of

Occlusive Vascular event (BHTCG 708)

Add Chloral hydrate

500mg/5mL, 300mL

AI

n


Rationalisation of chloral hydrate products and standardising on

500mg/5ml x 300ml bottle.

Rationale: 500mg/5ml chloral hydrate essential for sedation

prior to MRI. Problems with getting volume into children using

the 200mg/5ml due large doses for this procedure and dose

given as chloral hydrate (BNFC) Tertiary centres use

500mg/5ml. For neuro patients doses and changes are often

recommended by the tertiary centres Oxford, GOS or Evelina -

all use 500mg/5ml. I believe dose normally prescribed as

chloral hydrate. Children who take chloral hydrate often have

complex needs and getting them to take 4 times the amount of

liquid is not possible. Another risk is that the licensed product

is chloral betaine so a dose conversion is required from the

chloral hydrate -level of risk. Chloral hydrate 500mg/5ml is in

the drug tariff in the specials section with a minimum volume of

200ml and a cost of £26.95 .

Chloral Mixture BP


Restricted - for initiation in secondary care and

continuation by GPs, for neurology patients with complex

needs and for sedation prior to MRI scans

4.1

.1

Delete Chloral hydrate

200mg/5ml liquid

Rationalisation of chloral hydrate products and standardising on

500mg/5ml x 300ml bottle. 4.1

.1

Delete Chloral hydrate 1g/5ml

liquid

Rationalisation of chloral hydrate products

4.1

.1

Add Multivitamins with

minerals tablets

ValuPak®

In accordance with BHT

Gdeline 276.1 Refeeding

Syndrome Guidelines

Gastoenterology,

Dietetics teams

red N


BHT 276.1 Refeeding syndrome Unlicensed - Medium Risk

Restricted - prescribing by Gastroenterology and

Dietetics teams in accordance with Refeeding Syndrome

guidelines (BHTCG 276)

9.6

.7

Amend

restrictionNitrofurantoin

capsule/tablet 50mg,

100mg gre

en

Tablets may be crushed and mixed with water for administration

to patients unable to take solid dosage forms. (recognised off-

license use)

Tablets may be crushed, or capsules opened, and mixed

with water for administration to patients unable to take

solid dosage forms. (recognised off-license use)

5.1

.13

Amend

restrictionNitrofurantoin

suspension 25mg/5mL

gre

en

Restricted - Phone Pharmacy to Order.

Restricted - only for use in Paediatrics or when discharging

patients who are unable to swallow tablets or capsules.

In secondary care - restricted for use in Paediatric

outpatients or paediatric TTOs.

For inpatients unable to take solid dosage forms the

preferred option is to crush the tablet(s)or open the

capsule(s)and mix with water (recognised off-license

use). On discharge, these patients should continue to

crush the tablets or open the capsules, if competent to

do so, otherwise the suspension should be dispensed.

5.1

.13

Formulary Changes for Note FMG August 2013

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Simeticone 40mg/ml

(Infacol®)

Use in Endoscopy Unit for

removal of bubbles before

procedures

Gastroenterology

team red y

Costs £2.45 per 50mL bottle; need 10 per year. This is diluted

to 1:50 pre Endoscopy list with sterile water

In secondary care restricted to use in the Endoscopy

Unit for removal of bubbles before procedures.

Remove Tetrastarch

(hydroxyethyl starch)

6% in sodium chloride


0.9%, 500mL bag

(Voluven)

Delete

red

MHRA withdrawal

Changed to non-formulary and Black TLL.

9.2

.2.2

Remove Tetrastarch

(hydroxyethyl starch)

6% in sodium chloride


0.6% 500mL bag

(Volulyte)

Delete

red

MHRA withdrawal

Changed to non-formulary and Black TLL.

9.2

.2.2

Remove Hyoscine patch 1.5mg

y

This product has not changed. The information on the label as

been updated to state the amount of hyoscine released over 72

hours, rather than the quantity of hyoscine contained in the

patch.

4.6

Add Hyoscine patch

releasing hyoscine

approx. 1.0mg/ 72 hours

gre

en

y

The average amount of hyoscine absorbed from each system in

72 hours is 1mg. (SPC 04/09/12)

Have added info to formulary from the SPC to further clarify.

In secondary care restricted - for patients with nausea

and vomiting - not controlled by other post-operative

nausea and vomiting drugs

Each system has a contact surface area measuring

2.5cm2 and hyoscine content of 1.5mg The average

amount of hyoscine absorbed from each system in 72

hours is 1mg

4.6

Add Proguanil Hydrochloride

with Atovaquone

100mg/250mg

For treatment of malariare

d

y

Malarone

NOTE for Formulary - If required for malaria prophylaxis for

holiday travel GP to prescribe on private prescription basis only.

If required for malaria prophylaxis for holiday travel GP

to prescribe on private prescription basis only.

5.4

.1

Add Proguanil Hydrochloride

with Atovaquone

25mg/62.5mg

paediatric tablet

For treatment of malaria

red y

Malarone

NOTE for Formulary - If required for malaria prophylaxis for

holiday travel GP to prescribe on private prescription basis only.

If required for malaria prophylaxis for holiday travel GP

to prescribe on private prescription basis only.

5.4

.1

Revise product Dimeticone lotion 4%

(Hedrin)

Primary Care advocate

combing only– if treatment

is to be given this should

be purchased OTC

red

y

For use in secondary care only For use in secondary care only

13

.10

.4

Ma

y1

3.1 Add Tobramycin nebuliser

solution 300mg

(Bramitob)

PBr -SCG

Cystic fibrosis Initiation by

Consultant

Paediatricians


fibrosis red y

Approved for the management of chronic pulmonary infection

due to Pseudomonas aeruginosa in patients with cystic fibrosis

aged 6 years and older if nebulised colistin is not tolerated or if

clinical progress is unsatisfactory

Restricted - initiation by consultant Paediatricians




and older if nebulised colistin is not tolerated or if clinical

progress is unsatisfactory.

Traffic light status to be agreed

5.1

.4

Ma

y-1

3

FMG Decisions May 2013

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Ma

y 1

3.1 Add Tobramycin dry

powder for inhalation

Tobi Podhaler

28mg/capsule

Cystic fibrosis Initiation by

Consultant

Paediatricians


fibrosis

red

y

Approved for the management of chronic pulmonary infection

due to Pseudomonas aeruginosa in patients with cystic fibrosis

aged 6 years and older in accordance with NICE TA 276. To be

used as a second line to tobramycin nebuliser solution

Bramitob)

30Oct13 removed comment re TLL to be agreed. Agreed red

Restricted - initiation by consultant Paediatricians




and older in accordance with NICE TA 276

To be used second line to tobramycin nebuliser solution

(Bramitob®)

5.1

.4

Ma

y-1

3

Ma

y 1

3.3 Add AquADEKs liquid Initiation by

Consultant

Paediatricians and

continuation by GPs

AI

n

Aquadeks® liquid is approved for formulary inclusion for CF

patients who cannot swallow tablets.


continuation by GPs for cystic fibrosis patients who

cannot swallow tablets.

Ma

y-1

3

Ma

y1

3.3 Rejected Aquadeks soft gel

capsules and chewable

tablets bla

ck

n

Children over 6 who are able to swallow tablets/capsules to be

prescribed the 3 separate products of vitamin A and D

capsules, vitamin E capsules and menadiol tablets, the latter if

required. Ma

y-1

3

MA

y1

3.8 Add Apixaban tablet 2.5mg,

5mg

Prevention of stroke and

systemic embolism in

patients with AF when a

NOAC is indicated

according to the Bucks

local criteria and the

patient has had GI

disturbance or bleeding

with dabigatran and

rivaroxaban OR the

patient is unable to take

either dabigatran or

rivaroxaban due to a

history of GI bleeding or

ulceration

Initiated and

continued by NOAC

clinic only

Re

d

y

review TLL position once protocol available. Traffic light

position to change to AI once protocol approved

Restricted - initiation and continuation by NOAC clinic

only for the prevention of stroke and systemic embolism

in patients with AF when a NOAC is indicated according

to the Bucks local criteria and the patient has had a GI

disturbance or bleeding with dabigatran and rivaroxaban

OR the patient is unable to take either dabigatran or

rivaroxaban due to a history of GI bleeding or ulceration.

2.8

.2

Ma

y-1

3

Ma

r 1

3.3 Add Ranibizumab solution

for intravitreal injection,

2.3mg/0.23mL

Diabetic Macular Oedema Consultant

Ophthalmologists

red y

NICE compliance in accordance with NICE TA 274 FOR ALL PRESCRIBING - NICE compliance form


1. Restricted - Prescribing by Ophthalmologists only for

the treatment of Age Related Macular Degeneration

(AMD). Intravitreal use only. Traffic light list: Red

See Guideline: Ranibizumab for the treatment of age-

related macular degeneration (based upon NICE TA

155).

2. Restricted - Prescribing by Ophthalmologists only in

accordance with NICE TA 274 Ranibizumab for the

treatment of Diabetic Macular Oedema (DMO).

Intravitreal use only. Traffic light list: Red

11

.8.2

Ju

n-1

3

Revise

restricionMinocycline 50mg,

100mg capsules and

Minocycline MR 100mg

For treatment of

dermatological conditions

other than acne AI

y

In accordance with Dermatology Referral guidelines Restricted - for treatment of dermatological conditions

OTHER than acne in accordance with Dermatology

Referral guidelines.

For all other uses - Microbiology approval required 5.1

.3

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Revise

restricionMinocycline 50mg,

100mg capsules and

Minocycline MR 100mg

for treatment of acne

gre

en

y

In accordance with Dermatology Referral guidelines - only

100mg m/r strength used in acne

for the treatment of acne.

5.1

.3

Change Betamethasone

0.05%/calcipotriol

50micrograms/g

ointment, 60g

(Dovobet)

Prescribing by

Dermatology team

red y

Dovobet® may be therapeutically substituted with

betamethasone dipropionate ointment 0.05% (Diprosone®) and

calcipotriol ointment 50micrograms/g in accordance with

primary care current practice

Dovobet®

In secondary care restricted - to prescribing by

Dermatology team.

Dovobet® ointment may be therapeutically substituted

with betamethasone dipropionate ointment 0.05%

(Diprosone®) and calcipotriol ointment 50micrograms/g,

in accordance with primary care current practice

13

.5.1

Add Betamethasone

dipropionate 0.05%

ointment (Diprosone) gre

en

y

Added as per above statement regarding substitution of

Dovobet.

Diprosone

13

.4

Add or amend Nicotine"10mg",

"15mg","25mg" patch

NRT for primary care use,

except for 25mg patch

gre

en

y

Nicorette Invisi patches releasing approx. 10mg, 15mg

or 25mg over 16 hours.

Restricted - use in accordance with NRT guideline. All

strengths available for use in Primary Care. In

Secondary Care only the "25mg" patch may be used.

4.1

0.2

Add Nicotine "7mg", "14mg",

"21mg" patch

NRT for primary care use

gre

en

y

NiQuitin patch

Releasing approx. 7mg, 14mg or 21mg over 24 hours

Restricted - for use in Primary Care only 4.1

0.2

De

c

12

.3 Revise Nicotine lozenge, sugar-

free 1.5mg, 4mg

gre

en

y

NiQuitin Mini lozenge

4.1

0.2

De

c

12

.3 Add Nicotine inhalator

15mg/cartridge, 36

cartridges gre

en

y

Nicorette

Restricted - use in accordance with NRT guideline

4.1

0.2

Add Nicotine 1mg, 2mg,

4mg lozenge, sugar-free


gre

en

y

Restricted - for use in Primary Care only.

NiQuitin® Minis lozenge 1.5mg and 4mg available for

use in Secondary Care (see entry above) 4.1

0.2

Add Nicotine 2mg sublingual

tablet


gre

en

yNicorette Microtab

Restricted - for use in Primary Care only

4.1

0.2

Add Nicotine chewing gum,

2mg, 4mg


gre

en

yRestricted - for use in Primary Care only

4.1

0.2

Add Nicotine


spray


gre

en

y

Restricted - for use in Primary Care only

4.1

0.2

Add Sodium hypochlorite

320mg tablet (Milton®)

Disinfection of diagnostic

contact lenses

Ophthalmology team

red

yRCog guidelines; ‘Managing CJD/vCJD risk in opthalmology’ Restricted - for use by Ophthalmology team only for

disinfection of diagnostic contact lenses xx

#####

Reinstate Carmustine 100mg

injection red

?

Was deleted as thought no longer available but is required

occasionally and now obtainable through IDIS. (ask MTS)

8.1

.1

#####

Formulary Changes for Note FMG May 2013

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add isosorbide mononitrate

M/R 40mg and 60mg

tablet

gre

en

y

For use when there is a shortage of isosorbide mononitrate

immediate release 10mg, 20mg and 40mg tablets, change to

the modified release tablets on a mg - mg basis. For example,

isosorbide mononitrate 20mg twice daily should be changed to

isosorbide mononitrate MR 40mg once daily.

Restricted - only for use if there is a shortage of

immediate release 10mg, 20mg and 40mg tablets.

Change to SR tablets on a mg to mg basis. Eg.

Isosorbide 20mg twice daily should be changed to

isosorbide SR 40mg daily.

2.6

.1

Ma

y-1

3

Revise

restrictionBotulinum toxin type B

Neurobloc® brand

Consultant

Neurologists

red y

Cervical dystonia (Spasmodic torticollis) in accordance with the

SPC and MHRA advice Feb 2013

Restricted - prescribing by Consultant Neurologists

1. When resistance to Botulinum toxin type A has been

confirmed

2. For cervical dystonia (spasmodic torticollis) in

accordance with the SPC and MHRA advice Feb 2013

4.9

.3

Ma

y-1

3

Specify brand Carmellose 0.5%

Celluvisc® eye drops

Hospital diagnostic contact

lenses. For all other

indications the generic

product may be used

Hospital

Ophthalmology team

red y

Celluvisc® brand restricted - for use by hospital

ophthalmology team only for contact lens diagnostics.

For all other indications generic product to be used.

Traffic light list: Red 11

.8.1

Ma

y-1

3

Add C1 esterase inhibitor

injection 500units

Treatment of acute attacks

of potentially life

threatening hereditary

angioedema in accordance

with MOBBB Policy

statement 87 dated

September 2012

On the advice of A&E

consultants only

red

To be used in accordance with criteria defined in I MOBBB

Policy statement for acute life threatening attacks of HO only

when symptoms described in the policy statement are

confirmed to be present,

Restricted - prescribed only on advice of A&E

consultants in accordance with criteria defined in

MOBBB Policy statement 27 for acute life threatening

attacks of hereditary angioedema only when symptoms

described in policy statement are confirmed to be

present Traffic light list: Red

3.4

.3

Ma

y-1

3

Revise

restricitonRemifentanil injection all

strengths

PCA in labour where

epidural or pethidine is not

an option

consultant

anaesthetists

red

n

23. Guideline for remifentanil PCA in labour Restricted to prescribing by Consultant Anaesthetists

only.

1. Use in accordance with Guidelines for the use of

Intravenous (IV) infusion of remifentanil for sedation in

the general ICU (BHTCG 735) Use to be recorded and

reviewed on the Remifentanil Sedation in Adult Patients

on ITU - Compliance Form

2. Use in accordance with Guideline for Remifentanil

PCA in Labour (BHTCG 23)

15

.1.4

.3

Ma

y-1

3

Add Bivalirudin 250mg

injection

STENI ACS in accordance

with NICE TA 230

Consultant

Cardiologists

red y

For patients intolerant to first line treatment options Restricted - prescribing by Cardiologists only for patients

intolerant to first line treatment options for ACS STEMI

and in accordance with NICE TA 230 Bivalirudin for the

treatment of ST-segment-elevation myocardial infarction.

Traffic light list: Red

2.8

.1

Ma

y-1

3

Add Precision Xceed Pro

blood test strips

For use within secondary

care for blood glucose and

ketone testing red

Ongoing discussion between trust and CCGs for product

choice.

From Abbott Diabetes Care. Entered on netFormulary

23Feb15. Unsure of outcome of discussion between CCG and

BHT but these products are in regular use in BHT.

For use within secondary care for blood glucose and

ketone testing

6.1

.6

Ma

y-1

3

Add Precision Xceed Pro

ketone test strips red


ketone testing

6.1

.6

#####

Add Medisense Control

solution (High/low) red


ketone testing

6.1

.6

#####

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Medisense QC solution

(high/low)

For use within primary care

for blood glucose and

ketone testing gre

en 23 Feb15 Check if actually in use in primary care before

entering on netFormulary.

For use within primary care for blood glucose and ketone

testing

6.1

.6

#####

Delete Halothane No longer available

15

.1.2

#####

Revise

restrictionBone Cement with

gentamicin and

vancomycin

(Copal G+V)

red

Microbiology do not need to give approval for use therefore

remove restriction

Medical Device

xx

Ma

y-1

3

De

c1

2.2 Revise

restrictionBotulinum type A for migraine

red

NICE compliance form not yet available. Going to CGS June13 1. Restricted - prescribing by Ian Currie, Consultant

Urogynaecologist and Mr Greenland, Consultant

Urologist, for treatment of detrusor overactivity. Named

patient. Unlicensed use.

2. Restricted - prescribing by Matthew Koshy,

Consultant Neuro-rehabilitation medicine for Spasticity.

3. Restricted - prescribing by Consultant Neurologists

and Chronic Pain consultants only in accordance with

NICE TA 260 Botulinum toxin type A for the prevention

of headaches in adults with chronic migraine. ALL

PRESCRIBING in accordance with NICE TAs - NICE

compliance form required - see link from Formulary

homepage.

4.9

.3

Add Crotamiton cream

gre

en

#####

not added Eurax HC No longer available

#####

Add Methylphenidate MR

(Concerta XL) 27mg

for treatment of ADHD in

children over 6 years

Initiation by Cons

Paediatricians who

specialise in

behavioural disorders

and continued by

GPs

AP y

Added as included in updated SCP for ADHD Restricted - initiation by Consultant Paediatricians





796)

4.4

Ma

y-1

3

Add Methylphenidate MR

(Equasym XL) 20mg



Initiation by Cons

Paediatricians who

specialise in


and continued by

GPs

AP y






796)

4.4

Ma

y-1

3

Add Atomoxetine capsules

80mg



Initiation by Cons

Paediatricians who

specialise in


and continued by

GPs

AP y



or Adult Mental Health Specialists with continuation by



796)

4.4

Ma

y-1

3

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Add Nevirapine 400mg

prolonged release cap

HIV Treatment GUM consultants

red

y

Alternative to the standard 200mg immediate release

formulation. It reduces the pill burden once patients are

established & tolerate the treatment Used in Oxford where

patients are treated under shared arrangements

All HIV drugs are on the formulary as being restricted to

prescribing by GUM consultants only and TLL is Red

5.3

.1

Ma

y-1

3

Revis UMP risk

ratingVinblastine injection Haematology indications Haematology and

Oncology teams

red

N

Unlicensed medicine - Medium Risk - risk increased because

licensed manufacturer supply difficulties. Expected to be

resolved by September 2013

Should risk be high as CYTO?


8.1

.4

Ma

y-1

3

Reinstate Gadofosveset

(Ablavar®)

Contrast agent Consultant

Radiologists

red

N


Identical to the UK licensed Vasovist® brand which was on

formulary but discontinued. Ablavar® is a US licensed

equivalent product


Restricted - prescribing by Consultant Radiologists only

Mis

c

Ma

y-1

3

Add Healthy Start Children's

vitamin drops

Paediatrics team,

Health visitors,

Womens and

Childrens team

red

n

Daily dose of 5 drops contains: 233micrograms Vitamin A,

20mg Vitamins C and 7.5micrograms Vitamin D3

In accordance with DOH guidance and the Bucks Vitamin D

guidelines

Service commissioned via BHT via District Nurses

Daily dose of 5 drops contains approx. 233micrograms

Vitamin A 700units (233micrograms), Vitamin C 20mg

and Vitamin D 300units (7.5microgams)

Restricted to prescribing by Paediatric team, Health

Visitors, Women's and Children's team in accordance

with DOH guidance and the Bucks Vitamin D guidelines.

Service commissioned via BHT via District Nurses.

9.6

.1

Ma

y-1

3

Add Healthy Start vitamins

for women

Paediatrics team,

Health visitors,

Womens and

Childrens team

red

n

One tablet daily contains: 70mg Vitamin C, 10micrograms

Vitamin D and 400micrograms Folic Acid

in accordance with DOH guidance and the Bucks Vitamin D

guidelines

Service commissioned via BHT via District Nurses

Each tablet contains approx. Vitamin C 70mg, Vitamin D

10micrograms and Folic Acid 400micrograms.

Restricted to prescribing by Paediatric team, Health

Visitors, Women's and Children's team in accordance

with DOH guidance and the Bucks Vitamin D guidelines.

Service commissioned via BHT via District Nurses.

9.6

.1

Ma

y-1

3

Ma

y 1

3.2 Add Mannitol 40mg powder

for inhalation

Cystic fibrosis in adults Respiratory

consultants

red

In accordance with NICE TA 266 Mannitol dry powder for

inhalation recommended as an option for treating cystic fibrosis

in adults: who cannot use rhDNase because of neligibility,

intolerance or inadequate response to rhDNase and whose

lung function is rapidly declining (forced expiratory volume in 1

second [FEV1] decline greater than % annually) and for whom

other osmotic agents are not considered appropriate. Not used

in BHT as all adult CF patients are treated at Oxford or in

London.

FOR ALL PRESCRIBING - NICE compliance to be

verified.

Restricted - to prescribing by Respiratory consultants in

accordance with NICE TA 266 Mannitol as an option for

treating cystic fibrosis in adults.

NOTE: Unlikely to be used in BHT as all adult CF

patients are treated in Oxford or London.

3.7

Ma

y-1

3

Ma

r 1

3.2 Add Methylphenidate MR

(Medikinet XL) 5mg,

10mg, 20mg, 30mg,

40mg



Initiation by Cons

Paediatricians and

Child/Adult Mental

Health specialists and

continued by GPs

AP y

In accordance with shared care protocol

4.4

Ma

r-1

3

Ja

n1

3. 2 Revise

restrictionTicagrelor tablet 90mg see BHT CG Antiplatelet

guideline

Cardiology team only


GPs

AI

y

In accordance with BHT CG Antiplatelet guideline

2.9

Ma

r-1

3

FMG Decision March 2013

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Ja

n

13

.5 Revise TLL

classificationVoriconazole

red y

Restricted – Haematology and Oncology consultants, GUM and

solid organ transplant patients. Microbiology approval required

for all other uses. Traffic light list: Red.

Ma

r-1

3

Oct

12

.1 Revise

restrictionMinocycline

y

Uses see guideline

Ma

r-1

3

Oct1

2.1 2 Guideline

approved CGSSomatropin Paediatric

red y

Ma

r-1

3

De

c

12

.3 Add Nicotine inhalator

15mg/cartridge

Additional NRT product for

hospital to use

gre

en

y

Nicorette SEE BELOW

4.1

0.2

Ma

r-1

3

Ma

y1

1.4 Add Colecalcifierol capsules

20,000units

Vitamin D deficiency

gre

en

n

Unlicensed Medium risk

Dekristol® Imported via IDIS

Restricted - for use in accordance with BHT CG 785.1 Vitamin

D Testing and Treatment in Adults. Ma

r-1

3

Add Ergocalciferol i.m.

injection 7.5mg

(300,000units/mL)

Vitamin D deficiency

gre

en

y

Restricted - for use in accordance with BHT CG 785.1 Vitamin

D Testing and Treatment in Adults.

9.6

.4

Ma

r-1

3

Ja

n1

3.1 Add Ivabradine tablet 5mg,

7.5mg

For Chronic Heart Failure


TA 267

Initiated by

Consultant

Cardiologists on

name patient

approval until NICE

compliance form

approved and GP

continuation

AI

y

Named patient approval only until AI guideline in place

2.6

.3

Ja

n-1

3

Ja

n1

3.3 Add Retigabine tablet, 50mg,

100mg, 200mg, 300mg,

400mg

For adjuvant treatment of

epilepsy in accordance

with NICE TA 232

Initiated by

Consultant

Neurologists with GP

continuation

AI

y

Named patient approval only until AI guideline in place

4.8

.1

Ja

n-1

3

De

c1

2.2 Add Botulinum toxin type A

(Botox brand)

For prevention of

headache in patients with

migraine in accordance

NICE TA260

Prescibing by

Consultant

Neurologist and

Consultant Chronic

Pain only

Re

d

y

4.9

.3

Ja

n-1

3

Oct

12

.9 Guideline

approved CGSTriptorelin for use in

Obs & Gynae AR

guideline

AR

Ja

n-1

3

Ma

y1

2.5 Guideline

approved CGSBHT CG315 Protease

Inhibitors Telaprevir and

Boceprevir for the

treatment of Genotype 1

Chronic Hepatitus C


TA 252 and TA253

Ja

n-1

3

Ma

r12

. 4 Guideline

approved CGSActinic keratoses

guideline

Ja

n-1

3

FMG Decisions January 2013

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

OC

t11

. 1 Guideline

approved CGSIntranasal Steroid

Guideline

Ja

n-1

3

Add Bone Cement with

gentamicin and

vancomycin

(Copal G+V)

Revision total hip

replacemen t surgery

Orthopaedics

consultants only, on

the advice of

Microbiology and

named patient

advanced formulary

approval

red y

Palacos R is being used at present and this does not contain

vancomycin. Vancomycin is currently being added to Palacos R

by mixing it manually in theatres. Microbiology recommend the

use of Copal G+V for specific patients undergoing orthopaedic

surgery where risk of non-union due to infection is high .

Named patient approval by Microbiologist required.

£270 per 40g powder. Palacos R 2x40g £54

xx

Ja

n-1

3

Add Ipilimumab

concentrate for IV

infusion vial

50mg/10mL,

200mg/40mL

previously treated

advanced (unresectable or

metastatic) melanoma in


268

ORH Oncology

consultants

red Y

Horizon scanning identified zero patients for treatment at BHT.

Any patients will be referred to ORH and use with be in

accordance with TVCN Protocol. NICE TA costing template

estimates very little cost pressure 8.1

.5

Ja

n-1

3

Add Vemurafenib tablet

240mg

treating locally advanced

or metastatic BRAF V600

mutation-positive

malignant melanoma

ORH Oncology

consultants

red y

Horizon scanning identified zero patients for treatment at BHT.

Any patients will be referred to ORH and use with be in

accordance with TVCN Protocol. NICE TA costing template

estimates 4 patients for Bucks population with a cost pressure

of 205,372.

8.1

.5

Ja

n-1

3

Add Vitamin A and D

capsules

4000units/400units

(10micrograms)

Prophylaxis of vitamin A

and D deficiency in

paediatric cystic fibrosis

patients

Paediatrics team

initiation, continuation

by GPs gre

en

y

BNF price is 3.44 per pack. 20 CF patients under BHT

Paediatrics team care each year. Mainly prescribed by GPs for

these patients 9.6

.1

Ja

n-1

3

Ja

n

13

.4 Add Calcitriol (Silkis®)

ointment

3micrograms/g, 100g gre

en

13

.5.2

Ja

n-1

3

Ja

n 1

3.4 Add Hydrocortisone ointment

0.5%, 15g, 30g

gre

en

Potency: Mild

13

.4

Ja

n-1

3

Ja

n

13

.4 Add Hydrocortisone/Urea

cream 1%/10%, 30g,

100g (Alphaderm®) gre

en Potency: Moderate

13

.4

Ja

n-1

3

Ja

n

13

.4 Add Azelaic acid cream

20%, 30g

Skinoren® gre

en

13

.6.1

Ja

n-1

3

Ja

n

13

.4 Add Azelaic acid gel 15%,

30g

Finacea® gre

en

13

.6.1

Ja

n-1

3

Ja

n 1

3.4 Add Benzoyl

peroxide/potassium

hydroxyquinoline sulfate

cream 5%/0.5%, 50g

and 10%/0.5%, 25g,

50g (Quinoderm®)

gre

en

13

.6.1

Ja

n-1

3

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Ja

n

13

.4 Add Benzoyl peroxide cream

4%, 40g (Brevoxyl®)

gre

en

13

.6.1

Ja

n-1

3

Ja

n

13

.4 Add Coal tar extract

shampoo 2%, 125mL,

250mL (T/Ggel®) gre

en

13

.9

Ja

n-1

3

Ja

n 1

3.4 Add Isopropyl myristate/

Liquid paraffin gel

15%/15%, 100g, 500g

(Doublebase®)

gre

en

13

.2.1

Ja

n-1

3

Ma

r

12

.4 Guideline

approved CGSActinic Keratoses

guideline

Ja

n-1

3

Ma

r

12

.3 Add Fluorouracil/salicyclic

acid 0.5%/10% solution,

25mL

For actinic keratoses

gre

en

y

Actikerall®

To be used in accordance with CG365 Treatment of Actinic

Keratoses 13

.8.1

De

c-1

2

Ma

r 1

2.3 Add Diclofenac sodium 3%

in a sodium hyaluronate

gel basis, 50g

For actinic keratoses

gre

en

y

Solaraze

In accordance with AK guideline

13

.8.1

De

c-1

2

Oct

12

.9 Add Triptorelin MR i.m.

injection 3mg

Recommendation of

Obs and Gynae team


GPsA

R y

On recommendation of Obs and Gynae team for treatment of

endometriosis and reducing the size of uterine fibroids

6.7

.2

De

c-1

2

Oct1

2.9 Add Triptorelin MR i.m.

injection 11.25mg

AR y

Decapeptyl SR® (11.25mg i.m. injection every 3 months)

Restricted to prescribing in Primary care only (not to be

prescribed in Secondary care)

May be used for treatment of endometriosis and reducing the

size of uterine fibroids on the recomendation of Obs & Gynae

team with continuation by GPs. Traffic light list: Amber

recommendation

6.7

.2

De

c-1

2

Oct

12

.8 Add

NICE

compliance

form awaited

Abiraterone NICE TA 259 Abiraterone

acetate for castration-

resistant metastatic

prostate cancer previously

treated with a docetaxel-

containing regime

Consultant

Oncologists for

patients with prostate

cancer red y

8.3

.4

De

c-1

2

Oct

12

.6 Add

NICE

compliance

form awaited

Imatinib (standard

dose)

PBR excl funded NHS

England

For CML in accordance

NICE TA 251 Dasatanib,

standard dose imatinib and

nilotinib for CML (dasatanib

not recommended)

Consultant

Haematologists

red y

De

c-1

2

Oct

12

.6 Add

NICE

compliance

form awaited

Nilotinib

PBR Excl funded NHS

England



standard dose imatinib and


not recommended)

Consultant

Haematologists

red y

De

c-1

2

FMG Decision December 2012

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Oct

12

.4 Add

NICE

compliance

form awaited

Nilotinib

PBR Excl funded NHS

England



high dose imatinib and


and high dose imatinib not

recommended)

Consultant

Haematologists

red

y

De

c-1

2

Oct

12

.3 Add

NICE/HCD form

awaited

Hospital

guideline

awaited

Rivaroxaban Treatment of DVT and

prevention of recurrent

DVT and PE.

NICE TA 261

Consultant

Haematologists

red y

Named patient approval only as NICE/HCD compliance form

awaited.

De

c-1

2

Aug

12

.6 Guideline

approved CGSHypertension gudieline Hypertension NICE CG

127

De

c-1

2

Oct1

2.5 Add

HCD form

awaited

Rituximab Follicular lymphoma NICE

TA 243

Haematologists

red

y

In accordance with NICE TA 243

NICE compliance form required

De

c-1

2

Aug

12

.5 Add Indapamide 2.5mg Hypertension NICE CG

127

gre

en

y

In accordance with NICE CG 127 Hypertension and BHT CG

227 Clinical Management of Hypertension is Adults

2.5

.5.1

De

c-1

2

Aug

12

.6 Guideline

approved CGSHypertension guideline Hypertension NICE CG

127

De

c-1

2

Aug

12

.9 HCD form

approvedGolimumab psoriatic arthritis NICE TA

220

consultant

rheumatologistsre

d y

Psoriatic arthritis in accordance with NICE TA 220. NICE

compliance form required

In accordance with BHT CG Biologics in Psoriatic Arthritis. 10

.1.3

De

c-1

2

Add Nicotine (NiQuitin)

lozenge 1.5mg, 4mg

additional NRT product for

immediate use, the

NiQuitin lozenge (NiQuitin

Minis) 1.5mg and 4mg

were approved as an

interim measure.

gre

en

y

4.1

0.2

De

c-1

2

Remove Oseltamivir 15mg/ml

liquid unlicensed

Treatment of influenza in

infants less than one year

of age; Prophylaxis of

influenza in children aged

one year or more

n

Not required as licensed 6mg/ml product available

5.3

.4

De

c-1

2

Delete Carmustine injection

100mg

No longer available

8.1

.1

#####

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Change Mesalazine MR 400mg

tablets

1st Choice - Mesren MR®.

(bioequivalent to Asacol

MR®)

Mesren MR® to be

prescribed 1st line instead

of Asacol MR®. Patients

stabilised on Asacol MR®

should not to be switched

unless prescribed

generically.

gre

en

y

1st Choice - Octasa MR®. (bioequivalent to Asacol MR®)

Octasa MR® to be prescribed 1st line instead of Asacol MR®.

Patients stabilised on Asacol MR® should not to be switched

unless prescribed generically.

1.5

.1

De

c-1

2

Add Adenosine infusion

130mg in 130mL red N

MPSA Safety Alert 20 recommend using ready prepared

solutions where available.

2.3

.2

#####

Add Atropine injection

1mg/mL red

New strength due to lack of availability of other strength.

15

.1.3

#####

Update

restrictionAlteplase infusion 50mg Ischaemic stroke Stroke team and A&E

senior physicians

red

y

In accordance with NICE TA 264. NOTE: BHT Clinical

Guideline 146.4 Management of Acute Stroke and 12.1 Stroke

Thombolysis Protocol will need to be amended in line with NICE

TA 264. De

c-1

2

Add Seretide® 50 inhaler Paediatric respiratory

disorders

gre

en

y

For treatment of asthma in accordance with British Thoracic

Society BTS Guideline on the Management of Asthma revised

2009

3.2

De

c-1

2

Add Triptorelin 22.5mg vial For locally advanced non-

metastatic prostate cancer

Consultant Urologists

or Oncologists, and

continuation by GPs AP y

Restricted - for use in Primary Care only for patients who are

receiving triptorelin 3 monthly as Shared Care and are deemed

suitable for the 6 monthly injections.

No cost difference 3/12 £207 and 6/12 £414

8.3

.4

De

c-1

2

Oct

12

.3 Add Rivaroxaban Treatment of DVT and

prevention of recurrent

DVT and PE.

Consultant

Haematologists

Re

d

y

Use NICE compliance form

NICE TA 261 Rivaroxaban for the treatment of deep vein

thrombosis and

prevention of recurrent DVT and PE. To be used for patients

unsuitable for warfarin for whom dalteparin would otherwise be

considered,

2.8

.2

Oct-

12

Au

g 1

2.8 Add Tocilizumab Rheumatoid Arthritis Consultant

Rheumatologists

Re

d

y


NICE TA 247 Tocilizumab in Rheumatoid Arthritis and in

accordance with BHT CG 749 Biologics Rheumatoid Arthritis

guideline

10

.1.3

Oct-

12

Ma

y 1

2.5 Add Telaprevir Hepatitis C Consultant

Gastroenterologist

and Associate

Specialist

Gastroenterology Re

d

y


NICE TA 252 Telaprevir for the treatment of genotype 1 chronic

hepatitis C and TA253 Boceprevir for the treatment of genotype

1 chronic hepatitis C and in accordance with BHT CG Protease

Inhibitors Telaprevir and Boceprevir for the treatment of

Genotype 1

Chronic Hepatitis C

5.3

.3.2

Oct-

12

FMG Decision October 2012

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Ma

y 1

2.5 Add Boceprevir Hepatitis C Consultant

Gastroenterologist

and Associate

Specialist

Gastroenterology Re

d

y


NICE TA 252 Telaprevir for the treatment of genotype 1 chronic

hepatitis C and TA253 Boceprevir for the treatment of genotype

1 chronic hepatitis C and in accordance with BHT CG Protease

Inhibitors Telaprevir and Boceprevir for the treatment of

Genotype 1

Chronic Hepatitis C

5.3

.3.2

Oct-

12

De

c 1

1.4 Add Adrenaline (Jext) auto-

injector 150micrograms

and 300micrograms

Emergency treatment of

acute anaphylaxis

In secondary care

restricted to

prescribing by middle

grade doctors and

above.

Gre

en

y

All prescribing to ensure patient has 2 devices. Prescriptions

may be written for up to 2 devices per patient at one time for

adults and children.

3.4

.3

Oct-

12

De

c1

1.4 Delete Adrenaline (Epipen)

auto-injector

150micrograms and

300micrograms

Emergency treatment of

acute anaphylaxis

Gre

en

y

3.4

.3

Oct-

12

Fo

r n

otin

g Revised

restrictionClindamycin capsules,

injection and

suspension

Microbiology

y/

n

Restricted - Microbiology approval required for use in patients

over 85 years of age, but caution in prescribing for any patient

over 65 years due to increased risk of Clostridium difficile

associated diarrhoea

5.1

.6

Oct-

12

Fo

r

no

tin

g Revised

formulary

entry

MS treatment algorithm All DMTs to be used in

accordance with BHT CG

MS treatment algorithm

Oct-

12

Au

g 1

2.1 Revise TLL

classificationSomatropin Growth deficiency Consultant

Paediatricians and

Consultant

Endocrinologists

(adults)

AI/

Re

dAI for adults. Hospital only for new paediatrics. Existing

paediatrics to become Hospital Only from April 2013.

Guidelines awaited

6.5

.1

Oct-

12

Aug

12

.3 Add Fingolimod Multiple Sclerosis Consultant

Neurologists

Re

d

y

NICE compliance form required

To be used in accordance with NICE TA 254 MS (Relapsing-

remitting) and BHT CG MS Algorithm 8.2

.4

Oct-

12

Aug

12

.4 Revised TLL

classificationRiluzole Motor Neurone disease Consultant

Neurologists

Re

d

y

To be used in accordance with Hospital Only Riluzole guideline

4.9

.3

Oct-

12

Ma

y 1

2.1 Add Dabigatran Stoke prevention in AF in


249

INITIATION

Consultant

Cardiologists, Stroke

and Haematologists

(urgent cases only,

NOAC Pharmacist

(all other patients)

CONTINUATION

GPs

AI

y

All patients initiated by consultants to be referred to NOAC

clinic for followup in accordance with Dabigatran for Stroke and

AF AI guideline.

2.8

.2

Oct-

12

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Oct

10

.1 Add Almotriptan Treatment of migraine

gre

en

y

In accordance with BHT CG First and Second line treatments

for migraine

4.7

.4.1

Oct-

12

Add Rotigotine patch 1mg,

2mg,3mg, 4mg, 6mg,

8mg per 24 hours.

Parkinson's disease PD nurse or

Neurology team only

red y

Restricted - to prescribing by Neurology team or PD Nurses for

Parkinson's Disease when there is no other route of

administration possible. Patients are NOT to be discharged on

this product. Strengths other than 2mg and 4mg, are Phone

Pharmacy to Order.

4.9

.1

Oct-

12

Add Estradiol vaginal tablet

10micrograms

Vaginal atrophy

gre

en

y25microgram tablet already on formulary and 10microgram

required for initial use.

7.2

.1

#####

Ma

r12

.1 revised

restrictionDalteparin

subcutaneous injection

all strengths

For treatment and

prevention DVT and PE

AI

y

Treatment doses (exceeding 5000 units daily) and all

indications for use within obstetrics and gynaecology are

hospital only and Red on the TLL

For amber initiation indications see Amber Initiation guideline.

Note:for amber initiation the first 6 weeks supply to be provided

by hospital.

2.8

.1

Aug-1

2

Oct

11

.23 NICE form

approvedBortezomib and

thalidomide

1st line treatment of

multiple myeloma

Consultant

Haematologists

Re

d

Y


NICE 228 for multiple myeloma

8.1

.5

8.1

.3A

ug-1

2

Aug

11

.2 NICE form

approvedRituximab Follicular non-Hodgkin's

lymphoma

Haematologists

red


NICE TA 226 for first-line maintenance of follicular non-

Hodgkins' lymphoma 8.2

.3

Aug-1

2

Ma

y 1

1.3 NICE form

approvedPeginterferon alfa 2a

or 2b and ribavirin for

Hepatitis C

Hepatitis C Consultant and

Assoc. Spec in

Gastroenterology Re

d

y


In accordance with NICE TA 200

8.2

.4,5

.3.

5A

ug-1

2

ADD additional

strengthRibavirin 400mg tablet hepatitis C Consultant

Gastroenterologist,


Gastroenteroly and

Consultant

Paediatrician

red

y

Use in accordance with NICE TA 75 Interferon alfa and ribavirin

for the treatment of chronic hepatitis, NICE TA 106

Peginterferon alfa and ribavirin for the treatment of mild

hepatitis C and NICE TA 200 Hepatitis C - peginterferon alfa

and ribavirin. FOR ALL PRESCRIBING: NICE compliance form



5.3

.5

Aug-1

2

REVISE

restriction to

align with TLL

Rosuvastatin tablets (all

strengths)

Hyperlipidaemia Lipid clinic initiation;

continuation by GP AI

Ytreatment of hyperlipidaemia in patients who are intolerant of all

high intensity statins.

2.1

2

#####

FMG Decision August 2012

Formulary changes noted at FMG August 2012

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

REVISE

restrictionPatent blue injection sentinel node biopsy Plastic surgeons

red

n

m

ed

ris

k

sentinel node biopsy in malignant melanoma patients (already

on formulary for use in breast surgery)

Aug-1

2

ADD Klean-Prep® paediatric patients with

bowel obstruction

Paeds team

red y

1.6

.5

#####

REVISE

restrictionBevacizumab PFS

1.25mg in 0.5ml

Sight threatening

disorders: pre vitrectomy

for proliferative diabetic

retinopathy, rubeotic

glaucoma, non AMD

choroidal neo-vascular

membranes,

Consultant

ophthalmologists

red

n

REMOVE retinal venous occlusions (MOBBB 57), diabetic

macular oedema (MOBBB 56)

Aug-1

2

ADD Pentamidine isetionate

Injection 300mg

Prophylaxis of

Pneumocystis jirovecii

(Pneumocystis carinii)

pneumonia, by inhalation

of nebulised solution (using

suitable

equipment—consult

product literature

on recommendation

of Microbiology team

red y

Caution in handling Pentamidine isetionate is toxic and

personnel should be adequately protected during handling and

administration—consult product literature

5.4

.8

Aug-1

2

Revise

restrictionDapsone 50mg tablets Prophylaxis of

Pneumocystis jirovecii

(Pneumocystis carinii)

pneumonia,

on recommendation

of Microbiology teamre

dy

5.1

.10

Aug-1

2

ADD Indocyanine green dye

25mg in 5ml

Ophthalmology diagnostic

use

ophthalmology team

red

n

hi

gh

ris

k

Aug-1

2

ADD Insuman brands of

insulin 6.1

#####

REVISE

RESTRICTIONAdalimumab sc inj severe Crohn's disease in

adults (18YRS AND

OLDER)

consultant

Gastroenterologists

red y

in accordance with MOBBB Policy recommendation 61 'Dose

escalation therapy with infliximab and adalimumab in patients

with severe Crohn's disease Dec 2011 NOTE Dose Escalation

for severe Crohn's in 6-17 years age group (MOBBB

recommendation 62). and for active fistulising Crohn's (MOBBB

policy 600 are Nonformulary

1.5

.3

Aug-1

2

REVISE

RESTRICTIONInfliximab inj severe Crohn's disease in

adults (18YRS AND

OLDER)

consultant

Gastroenterologists

red y

in accordance with MOBBB Policy recommendation 61 'Dose

escalation therapy with infliximab and adalimumab in patients

with severe Crohn's disease Dec 2011 NOTE Dose Escalation

for severe Crohn's in 6-17 years age group (MOBBB

recommendation 62). and for active fistulising Crohn's (MOBBB

policy 600 are Nonformulary

1.5

.3

Aug-1

2

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

ADD Buprenorphine 400mcg

S/L tab

adjunct in the treatment of

opioid dependence

initiation by the

CAMS team

gre

en

Y

In accordance with NICE TA 114 - Methadone and

Buprenorphine for management of opioid dependence (Jan07)

4.1

0.3

Aug-1

2

Ma

y 1

2.3 Revised TLL

classificationMercaptopurine - use in

Gastroenterology –

traffic light review and

draft Shared Care

Protocol

AP

1.5

.3

Ju

n-1

2

Ja

n 1

2.2 ADD Febuxostat for gout (NICE TA 164) Restricted - to

prescribing by GPs

on the

recommendation of

the rheumatology

team.

AR

In accordance with amber recommendation guidance

10

.1.4

Apr-

12

De

c 1

1.5 APROVED Traffic light system

process version 2.1 (for

incorporation into the

Policy for Managed

Entry of New Medicines

Ma

y-1

2

Ma

r12

.6 Guideline

approvedMidazolam oromucosal

solution 5mg/mL

0.5mL (2.5mg),

1mL (5mg),

1.5mL (7.5mg),

2mL (10mg) prefilled

syringe

Epilepsy Adults: restricted to

initiation by

consultant

neurologists only.

Children: Restricted

to initiation by

Consultant

Paediatricians and

Neurologists, teams

from National Society

for Epilepsy Centre

and Ridgeway

Partnership (for

learning disabiltiy)

AI

for

ad

ults a

nd

pa

ed

s

Y

Buccolam®

in accordance with Status epilepticus algorithm and CG384.1

Buccal midazolam treatment algorithm. Traffic light list: Amber

Initiation.

4.8

.2

Ma

y-1

2

Ja

n1

2.8 Add Exenatide modified

release injection 2mg

vial, once weekly

Type 2 Diabetes Diabetes team

AI

Y

Restricted - initiation by Diabetes team in accordance with

NICE TA 248 Exenatide prolonged-release suspension for

injection in combination with oral antidiabetic therapy for the

treatment of type 2 diabetes and BHT CG83.1 Exenatide (Twice

Daily or Once Weekly) for use in Type 2 Diabetes amber

initiation guideline. Traffic light list: Amber initiation

6.1

.2.3

Ju

n-1

2

De

c1

1.1 add for primary

preventionDenosumab injection

pre-filled syringe

60mg/mL

Osteoporosis Cons Rheumatologist

and Endocrinologists

Re

d

y

To be prescribed in accordance with BHT CG 402 Osteoporosis

– Primary fracture prevention guidelines in men and women

over the age of 50 with risk factors and BHT CG 403

Osteoporosis – Secondary fracture prevention guidelines in

men and women over the age of 50 who sustain fragility

fracture and NICE TA 204 Osteoporotic fractures - Denosumab

6.6

.2

Ju

n-1

2

FMG May 12 decisions

FM

G M

inut

e r

ef

Decision



TLL

Licens

ed? (Y/N

)









ate

gory

Decision

date

Oct1

1.7 APPROVED Osteoporosis guidelines

for primary and

secondary fracture

prevention Ju

n-1

2

Oct1

1.2 2 Add Golimumab Ankylosing spondylitis Consultant

Rheumatologist

Re

d

y

In accordance with NICE TA 233 Golimumab for Ank Spond

10

.1.3

Ju

l-1

2

Au

g 1

1.3 Add Golimumab for Rheu Arthritis after

failure of previous disease

modifying anti-rheumatic

drugs

Consultant

Rheumatologist

Re

d

y

In accordance with NICE TA 225 Golimumab for Rheu Arthritis

after failure of previous disease modifying anti-rheumatic drugs

10

.1.3

Ju

l-1

2

Ma

y1

1.5 Add Ferric carboxymaltose Iron Deficiency anaemia Restricted -

prescribing by

Haematology team

only in accordance

with BHT CG

Re

d

Y

In accordance with BHT CG 58 Parenteral Iron for Iron

Deficiency Anaemia.

9.1

.1

Ma

y-1

2

Au

g 1

0.1 ADD Sugammadex for reversal of

neuromuscular block

produced by vecuronium or

rocuronium

restricted to

prescribing by

Anaesthetics team. red

In accordance with BHT CG151 Sugammadex for Reversal of

Neuromuscular blockade in Theatres.

15

.1.6

Ja

n-1

2

Ma

r

12

.2 Revised TLL

classificationFluorouracil cream

(Efudix®)

for use in Dermatology:

traffic light classification

review

Initiation by

Dermatology team AI

to be used in accordance with AK algorithm

13

.8.1

Ma

r-1

2

Ma

r

12

.5 REJECTED Linagliptin for Type 2 Diabetes

6.1

.2.3

Ma

r-1

2

Ja

n

12

.1 Revised TLL

classificationMycophenolate mofetil

(MMF)

in rheumatology traffic light

classification review

Consultant

Rheumatologists and

Dermatologists

red

8.2

.1

Apr-

12

Ja

n

12

.5 Add new

indicationClopidogrel for secondary prevention of

TIA

GR

EE

N

y 2.9

Ma

r-1

2

Ja

n

12

.7

Rationalised Contraceptives –

formulary review

In accordance with guideline BHT CG 783

7.3

Apr-

12

Ja

n

12

.9 ADD Ticagrelor for ACS – NICE TA 236

October 2011

Restricted to

prescribing by

Cardiology team

red

for in-patients with ACS (unstable angina, nSTEMI) who have

had an angiogram, are not suitable for PCI and are awaiting a

CABG

2.9

Ja

n-1

2

FMG March 12 decisions

FMG January 12 decisions

FORMULARY DECISIONS FROM JANUARY 2012 ONWARDS

Documents

Transcript of FORMULARY DECISIONS FROM JANUARY 2012 ONWARDS