Pharmacy World & Science A journal dedicated to rational drug use

Supplement G

Supplement to Pharmacy World & Science, Volume 15, Number 5, 15 October 1993

Abstracts of Papers and Postezs

Safe handling of medicines 22nd European Symposium on Clinical Pharmacy

Heidelberg (Gezmany), 13-16 October i993

Organized by the European Society of Clinical Pharmacy

Organizing Committee: Sabine Konder Hannelore Kreckel Evelyn Rehring Reinhild Rohde-BShler Reinhard Schierholz Hartmut Steckner

Scientific Committee Rainer Brackertz Margarida Caramona Simone Donislawski J0rgen Hoffmann Maria A. Mangues Maria E. Rivera Bernard Usselmann Roger Walker

European

Clinical Pharmacy

m

G1

Invo lvement of P r a c t i t i o n e r s

in U n d e r g r a d u a t e Teaching

H . - J . Meyer

The presentation will briefly describe the present pharmaceutical education at German universities according to the law for education and licensure (Approbationsordnung for Apetheker, dated July 19, I989). These rules and regulations are mandatory for all schools of pharmacy in Germany.

Clinical pharmacy is not yet included in the curriculum.

Hospital pharmacists with a strong clinical pharmacy program convinced faculty members to bring practitioners back to the university to teach courses in clinical pharmacy.

The development of such a project between the school of pharmacy at the Albert-Ludwigs-University at Freiburg im Breisgau and the department of pharmacy at the Karlsruhe Klinikum will be described. The aim is, to encourage more hospital pharmacists to co-operate with faculty in teaching undergraduate students.

A strong point will be made, why it is essential that practitioners must teach courses in clinical pharmacy. Also a warning will be directed to them, only to teach, what they actually practice. The practitioner educators will be role models for faculty members and students alike.

Existing difficulties must not be overlooked between basic research and applied clinical research. The research interests of pharmaceutical sciences teachers and practitioner educators are divers.

Zentralapotheke

St~dt. Klinikum

Post fach 6280

76042 K a r l s r u h e

Germany

Knowledge, skills and attitude dcvctopmcnt in Clinical Pharmacy E. wan dcr Klcijn, PhD Michclangelodtraat 34, NL 1077 CC An~stcrdam

Despite a history as h)ng as mankind and in contrast to common belief general and specialised medicine, recognised by their distinctive subcultural organisatious and licenses, do not exist for longer than about fourty years in their current appearances. They still show all the social characteristies of the medieval Guild-structure with its master-student relationships and tribal rituals. Pharmacy, the art ofcompoundins and disoeusin~, for quality reasons was divorced from medicine, its art of prescribing in the twelve's century with inherent professional and cultural consequences. The current fragmented heslthcare and - maintenance system has grown weary in terms of managerial, emotional as well as economic outcome and satisfaction.

Redesigning healthcare from human needs, and demands-perspectives, provided the desired and available skills, knowledge and means at affordable or accepted expenditure requires new social and professional structures with a emphasis on collaboration among the various practitioners. These needs may require redasigniag pharmacies, locations, jobdascriprions and reimbursement policies for drugs and services.

Pharmacy in the past two decades by adopting the clinical adjection, has attempted to offer and merge its services to patients via the medical stuctures. The success has been limited partly due to opposition from both the medical as well the pharmaceutical community. Despite obviously being better trained, experienced and equiped for assisting in pharmaco-tberapeuties than their medical and surgical colleagues, pbarmasists have not yet been able lo convince the public at large of their prime position.

Without sacrificing their chemical, physical and technological knowledge and skills that prepares the pharmacist as an expert for individualised cx)mpounding and dispensing of patient's drugase, pharmacists require to adopt a n u m b e r of competencias that allows them to act harmoniously, professionally in the medical environment with patients. These competencies are categodsed as: - pefformanco in daily practice: * patient consultation on medication history, current reasons for encounter and medical decision

making in confident consensus with the physician, * intraspective prescrlption-surveillance, �9 individualising and dispensing medication, " monitoring drug-utilisation, - e d u c a t i o a a n d training: * support of prospective therapeutic decision making, �9 retrospective auditing and evaluation, * prescription formulary development, - r ~ c h and development: " phar maco-cpidemiology, * technology assessment and costs containment, * diagnostic and therapeutic protocol development, �9 pharmacokinetic monitoring services, * mini-technology in medical supplies and pharmaccuties.

A description of tho various accomplishments in clinical pharmacy of the last three decades will be given with assistance of contem[x)rary decision making logic and technology.

SPECIALIZATION IN COMMUNITY PHARMACY

Th(Dick) F J Tromp

Professionalism of community pharmacists is increasing.

In many countries we see an increase of the fact that, in practice, pharmac=sts give pharmaceutical care to patients. Pharmaceutical care is the supervising of a patient by the pharmacist in such a way, that during the whole period of his or her therapy the pharmacist is offering the optimal supervision. This is done by way of delivery and refill, and at present by means of e.g. Therapeutic Output Monitoring.

In the various countries the pharmacies differ in respect to size. In some countries the pharmacist is supported by one or two (non-qualified) assistants, in other countries large teams of pharmacists and assistants are working together. So besides giving care to patients, a community pharmacist must be capable of managing a substantial organization. Thus the community pharmacist should be able to manage responsibil- ities, reliabilities, quality etc. etc.

Students in the Schools of Pharmacy or in the Faculties of Pharmacy don't encoun- ter the appropriate circumstances during their studies to be able to bear final responsi- bility of a pharmacy, as soon as they have graduated. They need post-graduate training. But in many countries the law permits graduates to take over finat responsibility immediately. From a professional point of view this can lead to non-optimal situations. That is why the european group of commumty pharmacists is putting emphasis on the introduction of a legany accepted speziatisation.

In this lecture an actual overview will be presented.

University Centre for Pharmacy, University of Groningen, Antomus Deusinglaan 2, 9713 AW Groningen, The Netherlands.

S A I ~ 1 Y F O R H E A L T H C A R E S T A F F

Suzanne M. Fields

Concern exists regarding the safety of handling cytotoxic a g e n t s in t he w o r k p l a c e d u e to t h e c a r c i n o g e n i c , t e r a t o g e n i c , a n d m u t a g e n i c p o t e n t i a l o f t he se a ge n t s . E m p l o y e e s m a y be e x p o s e d to cy to tox ic a g e n t s a t a n y t i m e d u r i n g d r u g p r e p a r a t i o n , a d m i n i s t r a t i o n , o r d i s p o s a l . T h i s e x p o s u r e occu r s v i a i n h a l a t i o n or d i rec t s k i n c on t a c t w i t h the d r u g . H e a l t h r i s k s for p e r s o n s h a n d l i n g cy to toxic d r u g s h a v e b e e n a d d r e s s e d in seve ra l s t u d i e s , b u t the l o n g - t e r m effects o f c o n t i n u e d e x p o s u r e r e m a i n u n k n o w n . V a r i o u s m e t h o d s for d e t e r m i n i n g the a m o u n t of po t en t i a l e x p o s u r e to h a z a r d o u s d r u g s h a v e b e e n p r o p o s e d for p h a r m a c i s t s , t echn ic i ans , a n d n u r s e s w h o h a n d l e these p r o d u c t s in the w o r k e n v i r o n m e n t , all o f w h i c h h a v e p r o v e n to be i n s u f f i c i e n t l y s e n s i t i v e or p o o r l y va l i da t ed . F u r t h e r m o r e , m a x i m u m s a f e e x p o s u r e l eve l s h a v e n o t b e e n e s t a b l i s h e d for c y t o t o x i c agen t s . The re fo re , all h e a l t h care s t a f f h a n d l i n g cyto toxics s h o u l d t ake the n e c e s s a r y p r e c a u t i o n s to p r e v e n t o r m i n i m i z e e x p o s u r e to t he se h a z a r d o u s d r u g s in all a spe c t s o f the w o r k e n v i r o n m e n t . T h e s e s t eps c ons i s t o f e s t a b l i s h i n g s t a n d a r d p r o c e d u r e s fo r d r u g h a n d l i n g , h a n d l i n g the c y t o t o x i c s i n a s u i t a b l e e n v i r o n m e n t , p r a c t i c i n g a p p r o p r i a t e h a n d l i n g p r e c a u t i o n s , t r a i n i n g e m p l o y e e s e x t e n s i v e l y w i t h f r e q u e n t r e a s s e s s m e n t , u n d e r s t a n d i n g p r o c e d u r e s fo r a c c i d e n t a l s p i l l a g e , a n d e s t a b l i s h i n g g u i d e l i n e s for h a n d l i n g w a s t e f r o m p a t i e n t s t r ea ted w i t h cy to tox ic d r u g s . T h e t r a n s p o r t a n d d i s p o s a l of cy to toxic d r u g s a n d m a t e r i a l s c o n t a m i n a t e d w i t h t h e m s h o u l d also be a d d r e s s e d in the p o l i c i e s a n d p r o c e d u r e s of the ins t i tu t ion .

Investigatinnal Drug Section, Cancer Therapy & Research Center and the Department of Pharmacology, The University of Texas Health Science Center at San Antonio, 8122 Datapoint Drive, Suite 700, San Antonio, Texas, 78229, U.S.A.

I~hamaM , Ilbrld ~'~ ?; .c . ,c

HANDLING MEDICINES - SAFETY FOR ENVIRONMENT

J.P.P. Moors

The long term protection of the environment is now seen to be an important factor in the plans and actions of both Govern- ment and Pharmaceutical Industry. Safeguards in respect of the construction and operation of facilities and in product design itself are emerging as one of the most pressing issues facing business today. 'Cradle to grave' is a fundamental concept in environmental management and requires the consideration of the whole life cycle of a product, the production processes and use and final disposal by the user of the pharmaceutical. In Pharmaehemie, the responsibility for the environmental challenge is reflected in the new state of the art facility using closed production systems and contained areas for manufacturing. The traditional approach of environmental protection has evaluated to full integration of environmental aspects in design of products and waste management.

Pharmachemie B.V., Postbox 552, 2003 RN Haarlem, The Nether- lands

SAFE H A N D L I N G OF MEDICINES - S A F E T Y FOR C O M M U N I T Y

H. Enlund

The amount o f medicines in the community is increasing every year. Drugs arc becoming more potent and recent trends in many countries of switching prescription drugs to nonprescription (OTC) status increase the risk for unwanted effects and accidents. Also the g rowing number of new ethnic minorities in many European countries represent a chal lenge in the safe handling of medicines.

Children is the primary risk group for accidents, but also the elderly as hoarders of drugs are exposed to these risks, Small children l iving together with old people in the same household or vis i t ing them pose an extra risk situation. The drugs used by the elderly are often readily avai lable and they belong to those most potential for accidents. The number of these accidental poisonings among children has diminished after the introduction o f chi ld-res is tant closures.

The safe handling of drugs in the community can be seen as a chain, starting front the drug manufacturer, continuing with the prescriber who should carefully consider the need for drug treatment and the amounts prescribed. Unnecessary prescribing linked with patient noncompliance increases the number of leftover drugs in the homes. To reduce the risks with these leftover drugs, specially designed "Dump campaigns" have been introduced both locally and nationally. In addition to these campaigns there is also a need to establish a permanent disposal channel through pharmacies.

In addition to a more widespread use of technical solutions like packaging, information and education on the comrnunity level are the most intportant means to reduce the hazards with medicines and other chemicals. Some countries have introduced so called Poison Prevention Weeks to highlight ihe importanca of these preventive measures.

The appropriate handling of drags on the community level is both a matter of health ulld appropriate use of community resources. Phamlaey call make a contribution to

society in minimizing unnecessary hospitalization and death through the education of the public. The public needs a better understanding of the risks with medicines and chemicals, motivation to act, knowledge and skills to handle the drugs, This is a cnnlinuing process that ~hould start already in childhood and continue thnmgh aduhhood,

Dcpurtnlcnt of Social Pharmacy. University of Kunpio, POB 1627, SF-7I)211 Kuopio, Finland

SAFETY FOR INDIVIDUAL PATIENTS

D.K. Luscombe

With the advent of potent modem medicines and the realisation that absolute safety is impossible to achieve, a central role of the clinical pharmacist is to ensure that medicines are only administered when necessary and then only when the intended beneficial effects of drug therapy have been balanced against the risks.

Despite an appropriate medicine being initially selected based on a knowledge of the patient gained when taking a drug history, there remains the possibility that the patient will experience an unwanted drug-indoced effect, At best this may be a minor side-effect whilst at worse a serious adverse drug reaction or interaction may result, Many of the unwanted effects are readily predictable from a knowledge of the mode of action of the drug (or dregs) involved whilst others are unrelated to the drug's pharmacological profile. Generally, unwanted effects due to the principal pharmacological action are reversible and the problem can be resolved by reducing the dose lie, bleeding with anticoagulants) or changing to a different drug. However, they are not always reversible, for example, tardive dyskinesia induced by neuroleptic drugs, Adverse reactions which are unrelated to the drug's pharmacological activity are frequently serious such as hepatotoxicity with paracetamol and nephrotoxieity with cyclosporin. The considerable problems associated with adverse reactions earmot be over-emphasized: 10-20% of hospital in-patients suffer an adverse reaction; 0.24-2.9% of deaths in hospital are drug related; 0.3-5.0% of hospital admissions result from adverse drug reactions. Whilst the harmful effects of drugs cannot be eliminated, a rapid alerting system such as that described by Booth I will limit the harm caused to the patient by ~ ad,m:'se drug .,'eactlm1.,

Drug-induced side-effects are generally a less serious problem and may in some instances be avoided by direct measurement of a pharmacological or clinical effect of the drag or by measuring the parent drug and metabolite concentrations in body fluids. A new approach to assessing drug safety has resulted from the development of health-related quality of life instruments. Such instruments have proved useful in quantii3'ing the side-effect profile of individual patients to drug therapy t. Safety is also a major factor to consider when patients are discharged from hospital. The pharmacist has a special duty to ensure that prescribed medication continues to be taken Correctly once the patient leaves hospital. Structured self-medication programmes and discharge counselling are particularly helpful especially in the elderly. The accuracy of discharge prescription should always be monitored since they frequently contain errors which could lead to patient morbidity ~. Furthermore, home visits should be carried out by the pharmacist to monitor compliance of prescribed therapy. Non-compliance can be a safety hazard and in fact, is a leading cause of organ rejection and death after kidney transplantation, Checks on storage can also be carried out during home visits and out-of-date or unwanted medicines removed to reduce risk factors.

Clearly, the safety of the patient is of uppermost importance when taking medicines, however, there remains a need to increase the awareness of pharmacists to the many facets of the drug administration process which can affect patient safety.

I. NC Booth, DK Luscombe et at. Pharm J 1988; 241 : R3. 2. MS Snick. DK Luscombe. ] Drug Dev I992: 5: 137-153. 3. S Gammie, DK l_uscombe. Proc 3rd Eur Conf Adv in Clin Pharm 1992; 4-5.

Medicines Research Unit, Welsh School of Pharmacy, University of Wales, Cardiff, CFI 3XF, United Kingdom,

G 4 i,h,m.,, l, II~b,ld r

AN ALGORITHM FOR THE STUDY OF THE PATIENT'S MEDICAL RECORD : A PREREQUISITE FOR AN EFFICIENT PARTICIPATION OF THE CLINICAL

Pt tARMACIST IN HEALTH-CARE TEAM ROUNDS.

J.-Ph Re,mend* and S Martx

All important aspect of pharmaceatmal services in institutions Is to mlL'~imlze the safct 3, appropriateness and cost-cffectwc use of drugs This rcqmres the followmg resources" an up- to-date formulaD, of drug products approved for use m the mstltutlon, a reliable manufacmrmg equipment and staff, an optimal drug distribution system, as wcg as an cffiemnt drug information center Such resources can fulfill the needs of the msumtlon only ff staff phamaacists are present in the patient care areas on a regular basts m order to provide the pharmacy with the necessary feed-back from the front. A major aspect of this presence at the front is the particlpanon of the pharmacist to health-care team rounds. Study of the patients' records files ts therefore necessary"

a) to identify Inadequacies of the medlcatmn profile to be discussed wlth the health-care team during the patmnts' rounds b) for an efficient mvolvement in the case discussion c) to ansger questions of the health-care team.

In our environement, personal and geographical constramts - 6 district-hospitals of I ltl - 280 beds located up to 60 km from the central pharmacy - allow the presence of a pharmacist a maximum of half a day per week m each restitution This requests a methodical organization of the nme available on site. especmlly m the stud 3 of the patients' records

An algorithm has been developed to allow a s_vsttnnatlc rewev~ of the patients' records The followmg steps and cntcnons are considered:

I ) Basic for the analysis of the drug regimen: Demographic data. diagnostic, general condition of the patient, lab parameters affecting the Absorptmn. Dtstnbutlon Metabolism and Excretion of drugs as well as other environmenLa] data.

2) Analysis and momtormg of the drug regimen. Appropriateness of use. dose. dosage regimen, route of admmlstratlon, rcgunen compliance, therapeutic dupheatc, drug mteracnons and adverse drug reacoons.

Each problem identified is consigned on a special x~orkshcet. ~hmh allows further search and a structured mterveotion dunng the patients' round. Qualitative (by type of problem) and quantztatlvc (number of patients studied) classifieattons allow a documentation of the mvolvcmeot of the climeal pharmacist.

An algonthm for the study of the panents' medical records is an essential tool for an efficient integration of the clinical pharmacist in the health-care team. baste m instituttonal pharmaceutical se~lecs of patient-oriented resources

lnsntut Central des H6paaux Valalsans. Dw de Phannaoe. CP 5 Ill. 1051 Stun. Sx~ltzcrland

DEVELOPMENT OF A NEW MODULAR DIPLOMA/MSc IN PtlARMACY PRACTICE

S. I)IIII,LON t D. TAYLOR, A. KOSTRZEWSKI_

A p o s t g r a d u a t e Diploma Course in Cl inical P h a r m a c y o r g a n i s e d by the School of Pha rmacy in a s soc ia t ion wi th Four Thames and Eas t Angl ian Regional I teal th A u t h o r i t i e s has been o f f e r e d s i n c e J u n e 1989. A s u r v e y o v e r t h e l a s t 3 y e a r s r e v e a l s o v e r 500 s t u d e n t s h a v e comple ted t h e [ ' a r t 1 c o u r s e and 95 pharmax:is ts h a v e been a w a r d e d t h e ful l Diploma.

In r e s l • to t he NIIS Community Care Act 1990 and the i d e n t i f i c a t i o n of "stzxff t r a i n i n g needs" the c o u r s e has been deve loped f u r t h e r to p r o v i d e a p a r t - t i m e modula r based educa t i on a n d t r a i n i n g p rog ramme in p h a r m a c y p r a c t i c e , S t u d e n t s ga in q u a l i f i c a t i o n s from Cer t i f i c a t e , Diploma o r MSc in P h a r m a c y Pr:~ctice a p p r o v e d by the U n i v e r s i t y of London.

The c o u r s e is o f f e r e d a t t h r e e l eve l s : Leve l A ( lOOhrs) - e q u i v a l e n t to the c u r r e n t P a r t 1 Diploma s t u d e n t s comple te c o u r s e r e q u i r e m e n t s t h r o u g h an a c c r e d i t e d in - s e r v i c e e d u c a t i o n a n d t r a i n i n g scheme - a n d c o v e r s bas i c c l in ica l p h a r m a c y sk i l l s , p r e s c r i p t i o n mon i to r ing , i n t e r p r e t a t i o n of l a b o r a t o r y d a t a ant i a p p l i e d p h a r m a c o k i n e t i c s . S u c c e s s f u l s t u d e n t s a r e a w a r d e d a C e r t i f i c a t e in Clinical Pharmacy .

Level n - Diploma 12 months p a r t - t i m e s t u d y - S t u d e n t s u n d e r t a k e a compul so ry co re module (180h r s ) c o v e r i n g Cour se i n t r o d u c t i o n , T a r g e t i n g s e r v i c e s and NIIS r e fo rms , Clinical and Appl ied T h e r a p e u t i c s and P h a r m a c y P rac t i ce . In add i t i on s t u d e n t s comple te t h r e e opt ion modules ( l S 0 h r s ) front a cho ice of: Pub l i c l i ea l th , l l ea l th Economics and P u r c h a s i n g ; Qual i ty A s s u r a n c e ; P r ima ry and Community Care; T e a c h i n g and L e a r n i n g ; I n f o r m a t i o n T e c h n o l o g y ; I m m u n o l o g y / A I D S ; Oncology/llaematology; Psychiatry/Neurology; Clinical Nutrition. The Diploma in Pharmacy Practice award is based on students completing Level A and D, and comprises a to ta l 460hrs learning.

Level C - MSc an a d d i t i o n a l 12 months p a r t - t i m e s t u d y - s t u d e n t s un(lert~ke a compulsory research module (300hrs) plus two Level B options (]20hrs) and two self development assignments (120hrs). The MSc in Pharmacy Practice award is based on students completing Levels A, B, :ind C, and comprises a total lO00hrs learning.

Option modules can be taken irrespective of whether students are registered for a formal postgraduate qualification. Credits will he awarded rot successful conlpletion of modules and can be carried towards future l)iploma/MSc registration.

The new cours<~ design offers students a part-time practice based training progranlme. Flexibility of entry to the course and its modular design ~dlows students to set their learning programme at their own pace and meet i n d i v i d u a l arid m a n a g e r i a l needs .

Ce n t r e for Pha rmacy P rac t i c e t, The School of Pha rmacy , U n i v e r s i t y of t .undon, 29 /39 D r u n s w i c k S q u a r e , London WC1N lAX Engl;xnd

IMPROVING MEDICATION USE THROUGH THE DOCUMENTATION OF CLINICAL PHARMACIST ACTIVITIES WITH HAND HELD ELECTRONIC ORGANIZERS

B.M. 81uml, M.L. Enlow, S.E. Metzler

The Department of Pharmacy Services at Saint Joseph Health Center, Kansas City, USA, is pursuing the concept of providing drug therapy that meets the needs of the whole patient and improves their quality of life. Accurate documentation of clinical pharmacist activities provides a foundation for outcome and trend analysis which is reported to the medical staff (through the Pharmacy and Therapeutics Committee) and to the hospital staff (through the Quality Management Council).

One of the pdmary reasons for establishing a system to document clinical pharmacist activity is to provide the information and insight required to identify trends in drug therapy and to continuously facilitate improvement in medication use.

Consistent documentation of clinical pharmacist activities had been an elusive goal for several years. Clinical activity logs were maintained but were often incomplete. The data that was obtained with the logs subsequently required additional resources for entry into a clinical database. The logs alone were not an effective way to provide the volume of data required for determining trends in drug therapy so another system was sought.

In December ]99t, ~he QARx chn,cal database system Ires the American Soctety ot Hospital Pharmacists was identified as having the capability to meet the documentation requirements which had been previously identified. The QARx software offered an option to enter data directly into the database from Sharp IQ's or Wizards. These hand held electronic organizers were purchased for the clinical staff and the telephone directories (Tel files) were configured as described in the associated appendices of the QARx documentation manual. Categories were established to facilitate data collection and analysis for clinical interventions, therapeutic consults, reference searches, information encounters, adverse drug reaction reviews, and drug use evaluations.

The clinical staff began using the Sharp Wizards to document clinical pharmacist interventions in January 1992. There were a total of 1834 clinical interventions and therapeutic consults documented in 1992 which resulted in 1309 changes that effected a standard of practice, 120 changes that prevented a potential medication error, 200 changes that prevented potential adverse drug reactions, and 3 changes that were potentially life saving. Medical staff acceptance for the same period was 94.6% and estimated cost avoidance exceeded 365 thousand dollars. Emphasis on reporting of clinical pharmacist activity improved individual pharmacist reporting, and the technology provided by the hand held electronic organizers provided the mechanism for resource efficient data input into the computerized database. Reportmg and evaluation that was not previously possible has provided valuable insight into trends in improved patient outcomes, medical staff acceptance, and cosFavoidance data that was only anecdotally available before.

Department of Pharmacy Services. Saint Joseph Health Center, Kansas City, Missouri, USA

N E W D U T C H G U I D E L I N E S O N C Y T O S T A T I C S

i m p l e m e n t a t i o n p r o b l e m s in a un ive r s i ty hosp i t a l

Ph i l ip A. de V r i e s

In o c t o b e r 1992 a n e w se t o f g u i d e l i n e s o n the p r e v e n t i o n o f cytostat ics

expos u r e was p u b l i s h e d by t h e D u t c h N a t i o n a l B o a r d o f C a n c e r Cen t res .

T h e s e g u i d e l i n e s w e r e f o r m u l a t e d in c o o p e r a t i o n wi th exper t s f r o m

d i f f e r e n t f ie lds .

Cy tos t a t i c d rugs w e r e c lass i f i ed as geno tox ic a n d t h e r e f o r e the p r inc ip l e o f

z e r o e x p o s u r e was a d h e r e d to . T h e s t r a t egy tha t shou ld l e a d to less

expos ed h e a l t h c a r e w o r k e r s a n d less e x p o s u r e p e r w o r k e r is d e s c r i b e d in

d e t a i l in t h e gu ide l ines . T h e g u i d e l i n e s h a v e ins t ruc t ions on: p resc r ip t ion ,

p r e p a r a t i o n / d i s p e n s i n g , t r a n s p o r t a t i o n , a d m i n i s t r a t i o n , , c a l a m i t i e s and a

c h a p t e r w i t h d r u g m o n o g r a p h s .

I m p l e m e n t a t i o n o f t h e b a s i c p r inc ip l e ( z e r o exposure ) in the hosp i ta l

posed m a n y p r o b l e m s :

I. R e d u c t i o n o f e x p o s u r e does not only m e a n c e n t r a l i z a t i o n o f p r e p a r a -

t i on bu t a lso c e n t r a l i z a t i o n o f ca re . T h e l a t t e r conf l ic ts w i th p r e s e n t ideas

on nu r s ing .

2. A l t h o u g h t h e l eve l o f p e r s o n n e l p r o t e c t i o n was d e s c r i b e d , t h e necessa ry

qua l i ty o f t h e d e s i r e d p r o d u c t s was not . T h i s l e a d to a s e a r c h o f g o o d

qua l i ty p r o d u c t s e.g. g loves , masks , g a r m e n t s etc . by e a c h hosp i t a l invol-

ved .

3. T h e p r o t e c t i o n d e s c r i b e d was so t i m e c o n s u m i n g tha t o u t p a t i e n t c ance r

c l in ic shou ld h a v e to be r e s c h e d u l e d !

4. T h e p r o t e c t i o n d e s c r i b e d was very e x p e n s i v e . ( f X 0 0 . 0 0 0 , - / p e r a n n u m )

B e c a u s e o f t he imposs ib i l i ty to s t a t e t he l eve l o f p r o t e c t i o n tha t is ga ined

by al l t h e s e m e a s u r e s a p r a c t i c a l a p p r o a c h was a d o p t e d tha t was affor-

d a b l e a n d t h a t w o u l d b e k e p t by hosp i t a l staff .

T h i s a p p r o a c h a n d i ts o u t c o m e wil l be p r e s e n t e d .

Center of Pharmacy, University Hospital Utrecht, P.O.Box 85500, 3508 GA Utrecht, The Netherlands

Plmmm, y If'odd ~5 Nacmc

volume IS Nr 5 199t ~ 5

PHARMACEUTICAL NEEDS ASSESSMENT OF ASTHMA PATIENTS

C. J. Duty', H. Y. Lee s, S. Dhillon ~

It is currently recommended that asthma patients should play a part in their managemend. To be capable of self management patients need a basic understanding of asthma, its management and medication. A survey of 101 Asthma patients was conducted in Basildon and Thurrock District. U K. The study design consisted of semi- structured interview which were carried out with Hospital Outpatients (n=24), GP patients from two surgeries with (n=22 and n=33), and one without (n=22) asthma clinics. The data was collected using open and closed questions during, a taped semi- structured interview. The results were analysed using an Excel spreadsheet.

The study revealed a large proportion of all patients did not know what asthma was (40%), or what happened in their lungs during an attack (58%). 80% of patients were not aware of any Over The Counter medications to be avoided. Many patients (38%) did not use a peak flow meter to monitor their asthma, and only 20% of all patients had definite ideas on when they would call their GP for an attack. The main reason why 80% of patients would be reluctant to call their GP was that they did not wish to bother him. Patients' recognition of the 'preventer" and 'reliever' medication was poor and this has significant implications for their ability to self-manage.

lnspite of this knowledge gap in all groups, the majority of patients were satisfied with their care and did not recognise any tack of knowledge and the implications of this on thek ability to self-manage,

Asthma is a major killer in the United Kingdom with one asthma patient dying from an attack every four hours, with most of these deaths occurring in young adults and being preventable. There is a need for this perception of asthma attacks not being important enough to bother the GP to be alleviated, by patient counselling. This would probably be most effective coming from the GP, with reinforcement from other health care professionals including nurse specialists and pharmacists. This problem needs to be addressed as it would appear that the present set up of care for asthma patients is not having the desired impact. This study showed that a majority of these patients do not posses a level of knowledge and understanding sufficient for adequate self-management

1. Guidelines for the management off Asthma 1990 British Medical Journal 301 p651 -653 and p797 - 800

Departments of Pharmacy" and Respiratory Medicine s, Basildon and Thurrock General Hospitals Trust and Centre for Pharmacy Practice*, The School of Pharmacy, University of London, 29/39 Brunswick Square, London WCIN IAX England + Address for correspondance

PHARMACY-BASED CLINICAL PSYCHOPHARMACOLOGY CONSULTATION: A MODEL FOR CLINICAL SERVICE, TEACHING, AND RESEARCH

A_A_ Cardoni

Since 1987, a clinical psychopharmacology consultation service has been provided to the 40-bed inpatient psychiatry service of Hartford (Conn) Hospital. The goal of this service is to optimize pharmacotherapy of psychiatric inpatients through clinical service, education, and research.

Clinical service activities include: (i) provision of formal written consults on request to private attending psychiatrists and "house" staff. Since February 1987, 243 consults have been provided. The yearly ar for the years (1988-92) is 42 (range 24-55). Consults include (a) patient interview, (b) assessment of past and current medication response, need for pharmacokinetic intervention and presence of adverse effects and (o) recommendations for changes, if warranted. No follow-up studies have been done, but estimated physician compliance with recommendations is about 95~; (2) leading weekly medication groups, and (8) obtaining formal medication history using standardized forms.

Education activities include: (i) precepting clinical pharmacy clerkship in psychiatry (2) leading weekly psychopharmacology conferences for first-year psychiatry residents and medical students on psychiatry clerkship; (8) coordinating and participating in monthly "Clinical Psychopharmacology Rounds", a lunchtime conference(4) participation in biweekly Psychiatry Grand Rounds.

Research activities include (I) pharmaookinetics of fluphenazine decanoate dosage forms, (2) frequency of drug-drug interactions in psychiatric inpatients, and (3) correlates of positive and negative outcomes in chronic schizophrenic outpatients.

A pharmacy-based clinical psychopharmacology consult service can optimize response to pharmacotherapy, provide ongoing education to students and practitioners, and be a focus for psychopharmaoology research.

Section of Pharmacy Practice, School of Pharmacy, University of Connecticut, Box U-92, Storre, CTUSA 06268.

THE PHARMACIST AS A SOURCE OF INFORMATION IN IMPROVING PATIENT COMPLIANCE, EFFECTIVENESS OF INTERFERON THERAPY

Dr. Tibor ~brah~m

Interferons are relatively new entities, now becoming more and more widely used in oncology, hapatology in Hungary. Though side effects (ADRs) are regularly detailed to the physicians by the pharmacists (be in the ist group a senior doctor or a GP, in 2nd a hospital pharmacist or a retailer) introduction of interferons (e.g. Intron A) raised some rather special Issues that are discussed here: Which are these side effects? Early side effects: "flu-like" syndrome: fever, chilis, nausea, vomiting, headache. These are the most frequently experienced side effects of interferon therapy. They generally occur within an hour or two of each injection and last for a few hours. Long-term side effects These are: fatlgue, diarrhoea, anorexia, dnpression, alopeeia. In the lack of information patients should discountinue treatment for any of these reasons. (Reduction in dose may help reduce these symptoms). Rare severe side effects - bacterial infection or septieaemia, - acute psychosis, - autoimmune disease, - acute renal failure, - congestive heart failure, - hepatic influence

Which are the problems? The early "flu-like" side effects may discourage the patient, who is sometimes even symptomless, to cooperate and the therapy is interrupted. Late side effects e.g. depression requlre close monitoring. Our experience in Hungary shows that patients compliance can be improved by: - patient-physician interaction - information about expectable early side-effects help the patient to overcome these. - evening administration, use of an analgesic prior to administratlon, - tendency of the early ADBs to diminish in some weeks - awareness of the patient's environment about his/her possible psychic instability - possibillty in self-administration to improve quality of life - then - storage informatlon of interfercns

Until certain traditions in use of interferons become establlshed the pharmacist seems to pay - in our opinion - a special role in the pharmacist-physlclan and pharmacist-patient interactions.

Bajcsy-Zsilinszky District Hospital, Hospital Pharmacy Budapest, H-J108 Hungary

POSTGRADUATE EDUCATION IN CLINICAL PH/d%MACY IN SLOVAK REPUBLIC

J.S�kora*, S.Sz~csov6

Postgraduate education in clinical pharmacy in Slovakia was institutionalised in the year 1981. The Department of Pharmacy of the Postgraduate Medical and Pharmaceu- tical School was in charge of the organisation and co- ordination of postgraduate clinical pharmacy education. In 1991 the Subdepartment of Clinical Pharmacy was es- tablished as a separate part of the Dept. of Pharmacy.

There are two basic specializations in clinical pharma- cy (Ist and 2nd degree clinical pharmacy) and five sub- specializations. These specializations and subspeciali- zations were specified for those pharmacists working mainly in clinically oriented departments, such as de- partment of clinical pharmacology, internal medicine, pediatrics, oncology, biochemistry, microbiology, toxi- cology and for the pharmaceutical representatives of pharmaceutical industry. From these specializations, pharmacists working in the community and hospital phar- macies were excluded.

The curriculum in clinical pharmacy consists of two parts. The first part takes place at the working place of the clinical pharmacists under the supervision of the head of this department according a detailed prog- ramme. The second part is held at the accredited cent- res of clinical pharmacy. The accretited centres train pharmacists in those clinical pharmacy activities which are usually not performed by the trainee s department. The durations for specializations in clini- cal pharmacy are 30-60 months.

During the years 1985-1992 45 specialists completed preparation in clinical pharmacy. 18 st them were phar- macists working at the Depts. of Clinical Pharmacology,

Currently there is a discussion about a new system of specializations for pharmacists. Specializations in clinical pharmacy should be more oriented towards phar- macists working in hospital pharmacies.

Dept. of Pharmacy, Postgraduate Medical and Pharmaceu- tical School, Limbova 12, 833 03 Bratislava, Slovak re- public.

G6 /'h,,.,.,,). I Ibdd ~. S~..n,c

TIlE POST-GRADUATE TRAINING IN CLINICAL PHAIL%IACY OF THE INSTITUT CENTRAL DES HOPITAUX VALAISANS :

A PREPAIL%.TION OF THE PHARMACIST TO ITS PIVOTAL ROLE OF PROMOTING THE SAFEST USE OF DRUGS

J -Ph. Reymond* and S Many

The Instuut Central des H6puaux Valmsans provides regional hospitals and other health care facdmes of the canton of Valms v, lth laboratory and pharmaceatmal services. In order to eonmbute to a safe handling of drugs m the hospitals, the pharmacists. ;',hdc optimizing the management and distribution of drug-products, have to focus their attention to the effects of drug therapy in paoents

Such an approach is yen_ tmportant in institutions but also nceessar3' in community pharmacy. Therefore, in parallel to a regular participation of staff pharmacists to health-care-team rounds in the medical department of the hospitals of the canton, a post-graduate training in clinical phammcy of one }'ear is proposed to t~o phasmaclsts. This adds a clmieal education to the cumculum of swiss pharmacists prcpanng thcm to help patients make the safest, most rational use of drugs

Aficr an introduction to the v, orking environment (lnstltut Central, Division of Pharmacy. working Bases in Climeal Pharmacy). the resident pharmacist pamcipates m a one month medical labomtorx tramthg (hematology, microbiology, serology, clinical chemistry and immunology). Durmg the climeat part of the program (I 1 months), each resident ~s mvotved every morning in the department of adult internal medicine. The systt,nnatic daily reviev, of the patients' medical records to analyze and monitor the drug regimens is followed by the patient rounds wtth the health-case-team. The resident pharmacist has thus the opportunity to intervene about the problem noticed through his study of the patients' records. He also consults with prescrthers to recommend drug therapy selection or drug thcrap3 changes as well as answers questtons of the health-care-team On request, the pharmacist wdl provide patient edueanon and counseling regasdmg drug therapy The a~ernoon is devoted to handle delayed ansv, ers to questtons of the team wlth the help of the drug information center resources. Each resident has also to complete a elimeal research project over the 3"ear. Evaluation related to the resident's progress in achLevang the preset goals and learning objectives ~s provided both through personal evatuatlons of :he clinical activi b" (threc times a ",'car) and d~ffcrent weekly meetings.

Tlns post-graduate training allov, s the pharmacist to develop knovdedge, attitudes and skills to provide, as partner of the health-care-team, the patient with a rational and safe drug therapy.

Instltut Central des H6pttaux Valaisans, Div de Pharmaclc. CP 510, 1951 Sion. Sx~ttzerland

A STUDY OF THE ANTIBACTERIAL ACTIVITY OF TAXOL ALONE AND IN COMBINATION WITH OTHER CYTOTOXIC DRUGS ON SALMONELLA MINNESOTA R595 DEEP ROUGH MUTANT STRAIN.

"Tabachnlk A.,Cass Y.,Jacobs J.,-vexler A., R. "Gorodetsky.

Introduction. Medical personnel handling cytotoxic drugs used in cllnlcal treatment of neoplasms and in immunosupression may be at r~sk of chronic low dose exposure to a wlde range of genotoxic agents, even when following stringent safety precautions. Evaluation of the rlsk of exposure to cytotoxic drugs necessltates the development of blologzcal test systems uniquely sensitive to these agents (I). Amongst different short-term biological assays, those that utilzse bacterial (prokaryotic) test systems have good potential. It has been previously demonstrated that a growth inhibition system based on a deep rough mutant strain of S.mlnnesota R595 grown in alkaline culture medium was relatively sensitive to bleomycin (bleo) alone and in combination with anthracycline antibiotics (2). The present study evaluated this system wlth the new antineoplastic drug, Taxol (Ta). Results. Complete bacterial growth inhibition was observed both on solid agar and zn liquid culture ~edza, although this was dependant on the addition of Tris-bsse at optimal concentration 0.05M (pH 8.4). The mlnlmal inhibitory concentration (MIC) of Ta was 0.1 mg/ml, The growth kinetics of the test organism showed that Ta's Inhlbltory activity was bacteriostatlc, Addition of a sub- inhlbltory concentration of Ta to the culture medium produced an increase in the test strain's sensitlvlty to bleo, MIC of bleo was reduced from 2 ~g/ml to 0.5~g/ml. Conclusions. This system was able to detect the biological activity of Ta even though prokaryotic organlsms do not contain microtubules, the maln target for Ta in eukaryotic cells. Further development of thls system is 3ustifled as a possible method for detectlng the blologlcal hazard of a single cytotoxic drug or a combinatlon of them. References. t.Allwood MC, Y Cass, IJ Coss, MG Lee, and RJS Shaw. Health and Safety Aspects of Cytotoxlc Services in "The Cytotox~c Handbook" 2 ~d Ed. MC Allwood, P.Wrzght.Radcllffe Press Oxford. 1993 pp.47-67. 2.Cass Y,Tabachnzk A,Ganelln B, Jacobs J and Vexler A. Detection of the biologlcal activity of bleomycln and other antlneoplastic drugs using a deep rough mutant of Salmonella

minnesota R595. 3 ~d Int. Symposium on 0ncology Pharmacy Practice. Abstr.Toronto

1993

Pharmacy Divlslon and "0ncology Dept. Hadassah Universlty Hospital, Jerusalem Ii-91120 Israel.

A QUANTITATIVE APPRAISAL OF PHARMACY PRACTICE TEACHING BASED ON MEASURES OF COMPETENCE.

D. Enqova r, J. Sheridan, J. Vl~ek t, DG. Webb, *I.P. Bates.

We have previously described a problem-based approach to the teaching of pharmacy practice (patient orientated pharmacy) in the UK ~. This communication describes a quantitative measure of this method of teaching, based on tutor appraised competencies, and formulates a comparison with student self-appraisal of the same variables.

Problem-based learning methodology relies on the setting and achievement of objectives, with the specificity of the objectives defining the level (or competence) of the knowledge or ';kill concerned. Students are appraised on how and when they achieve the stated objectives using a criterion referenced system. Competence is assessed by student and tutor "for each learning experience over the two year pharmacy practice course. These appraisals have been collated for a cohort of 103 students; this sample population represents the first cohort of learners to progress through the new course design. The total number of variables measured for each student over this period is approximately 1500. These have been coded and grouped, and assigned an a pr ior i score in the first instance. The communication will report on a comparison of student and tutor appraisal of competencies, with the hypothesis that there is no difference between learner and tutor appraisal for each of the course objectives. The analysis will attempt to present a general learning profile for this cohort over the two year period. The data will define the degree of success associated with the teaching methodology.

The communication will enable other teachers and course designers to deduce the value of a competency based learning model in the context of pharmacy practice, and is a collaborative effort between The School of Pharmacy, University of London (UK) and The Faculty of Pharmacy, Charles University (Czech Republic).

The Centre 1or Pharmacy Practice, The School ol Pharmacy, University of London, 29139 Brunswpck Square, London WC1 N 1AX, United Kingdom and rFaculty of Pharmacy, Charles University, Heyrovsk4~ho 1203, 501 65 Hradec Kr&lov~, Czech Republic. {'Correspondence)

I. Teaching and learning m plumnacy practice: Rclx)rl of a novel approach. I, Bates, J. Shcrid;m, D. Wehb. Ptocs European Sot'leO' o]Clinictd Plmrmarv. Edurauon ill P, lll(*ltl ()llenltlted Pharmacy Hradcc Kmhwe. Czech Repuhltc. 1993: [,49.

I'h,.,.a,}, [tbrld (~ S,~,',l,r G 7 Vulun)e t~ Nr 5 199~

AN ADVERSE DRUG REACTION REPORTING SCHEME FOR C O M M U N I T Y P H A R M A C I S T S

*C.M.C. Whittlesea., R. Walker, F. Khan. J. Houghton. I. Phillips.

There is no formal mechanism by which a community pharmacist can report an ADR in the UK. Moreover, there is little evidence to show that community pharmacists are motivated to participate in such a monitoring programme, or that they have access to sufficient, appropriate and relevant information to satisfactorily complete an ADR report. The present study was therefore undertaken to pilot, over a 12 month period an ADR reporting scheme for community pharmacists.

All community pharmacists in Wales holding patient medication records were invited to participate in the study. Those that a=m'eed to participate received a file with details of the study and ADR report forms/The ADR report form used was designed specifically for the project, The form had an attached carbon copy so that on completion one copy could be forwarded to the project centre with the other going to the patient's GP. Eight months into the study a covering letter and questionnaire was sent to all pharmacists participating in the study. The questionnaire was designed to determine overall satisfaction with the ADR scheme.

Of the 196 community pharmacies approached, 100 agreed to participate in the study. Thirty one ADR reports were submitted from seventeen pharmacies during the first eight months of the study. Eight of the ADR reports related to the 'black triangle drugs' Lamical, Lustral, Oxivent, Dovonex, Cystrin, Klaricid, Paroxetine and Adifax. Six ADR reports involved Nicotinell TTS, three reports related to generic atenolol and there were single reports for Fru-Co, Zantac, Losec, ibuprufen, Deteclo, Voltarol, Buspar, Seroxat, nifedipine, Estracombi, lstin, Utinor, Nicorette patch and Paramax.

After a follow up letter 69 (70%) of the questionnaires were returned. Forty pharmacists (70%) considered that ADR reporting was made easier by placing small reminder cards in the prescription bag which encouraged patients to report ADRs. However 29 (42%) pharmacists found it difficult to remember to supply such cards with dispensed medication. Sixty seven pharmacists reported that participation in the scheme had not adversely affected the relationship with their GP.

The results of the present study demonstrate that the relationship between patients and community pharmacists is appropriate to allow ADRs to be identified and reported. The questionnaire distributed showed that some improvements could be made to the present scheme.

The project is scheduled for completion in August i993, At that time all ADR reports will be evaluated by an independent review panel for completeness according to international guidelines.

The Welsh School of Pharmacy, University of Wales, Cardiff. PO Box 13, Cardiff CF 1 3XF UK.

ADVERSE DRUG REACTIONS REPORTS WITH POSITIVE RECHALLENGE IN THE BASQUE COUNTRY (SPAIN)

I AvaniLMF Errecalde 2, Jlyl Rodriouez- Sasiain 1. C Aouirre 1.

The spanish national drug surveillance system uses a modified version of the Karch and Lasagna algorithm to assess the relationship between a drug and an adverse reaction (ADR). One of its five items considers "relapse on rechallenge", We reviewed all notifications recorded at the regional drug surveillance center of Basque Country (CFPV) with relapse on rechallenge, in order to estimate the type of rechallenge, the drug and the ADR.

In March 1993, the CFPV had 1880 notifications recorded; of these. 59 (3.13%) were documented as relapse on rechallenge. The data were analyzed by using the statistical package SAS.

Ninety percent of ADR were produced by accidental reexposure, and the rest by rechallenge (deliberate readministration). Most commonly involved drugs were: NSAIDs 14 (23,8%), antimicrobials 13 (22,1%) and gastrointestinal drugs 10 (16%). The distribution of organ systems involved were: skin 45 (37.8%), general complaint 14 (11.8%) and psychiatric disorders 13 (11%).

Drugs involved in relapse do not differ of those found in all reports included in our database; however, there are differences in the organ affected and in the type of adverse drug reaction notified. We find a low percentage of reexposure in our serie, this could be improved by encouraging health professionals to notify all the ADR with positive rechallenge.

1Basque Country Pharmacosurveillance Center. Galdakao Hospital. 48960 GALDAKAO, Spain. 2Service of Pharmacy. Galdakao Hospital. 48960 GALDAKAO, Spain.

ADVERSE DRUG REACTIONS AND SAFE TREATMENT

OF ENDOGENOUS DEPRESSION~

J.$zymura-Oleksiak, A.Wasieczko, E.Wyska

In this paper data from 71 patients with a diagnosis of

major depression (DSM III R criteria) suffering from uni-

polar or bipolar affective disorders are discussed.

Trieyelic antidepressants (TAD) in conventional doses

(2-3 mg/kg) were administered to the patients and steady-

state serum concentrations were measured by FPIA method .

In 55 (77 %) patients the most common adverse drug rea-

ctions (ADR) which include: dry mouth, disturbance of acco-

mmodation, sweating and slightly decreased blood pressure

Were observed. Since the reactions were mild TAD dosage

adjustments were :lot made.

In 40 (72 %) patients with mild ADR, serum concentra-

tions were within therapeutic range, in 8 (15 %) and 7

(13 %) patients the concentrations were subtherapeutie or

potentially toxic, respectively.

In 6 out 71 patients (8 %) serious ADR such as: delu-

sions (2 patients), severe disturbance of accommodation,

dizziness, tachyeardia (3) and orthostatie hypotension (q)

occurred, despite the fact that TAD serum concentrations

in these patients were therapeutic or slightly above the-

rapeutic range. ADR intensity in these patients required

TAD dosage adjustment or even withdrawal from TAD.

It is concluded that ADR occurring in discussed patient

group influenced to some extent the conventional dosage of

TAD and their occurrence was not closely related to TDM.

Dept. of Physical Chemistry, Dept. of Psychiatry, Medical

Academy, Lubiez 34 Str., 31-512 Cracow, Poland.

AMIODARONE POPULATION pHARMACOKIIqETIC

Bellts Medall MD, Casab6 Aloe VG, Hcrv,~s Botella MA', Cabrera P6rez A', Jim6nez Torres NV, Casterfi Melchor DE, Abad Gimeno FJ.

AIM. Ratio plasma elearance/bioavallabilky (CIp/F), as a pharmacokinetic population parameter, was estimated from amiodarone plasma levels in steady state, The interindividual variations of the parameter and intraindlvldual variability of the plasma levels error were calculated too. The coefficients of regression that related to demographic and clinical patient characteristics and ClpfF, and theirs variabilities were defined. Finally accuracy, and precision of the model, applied to individual drug dosage regimens by Bayesian method, were evaluated.

METHOD. Adults patients (36-76 years old) with ventrieular fibrillation, receiving 200 nag of amlodaroneJday, five days a week, were analized. Three plasma levels/patient hi steady state, were determinated by HPLC. Patients were divided into two groups aleatory, group A (n = 14) to define population model and group B (n = 14) to predict the second and third Cp"m~ hi each patient. Pharrnaeokinetir model D/r

Cp . = CIp / F

CIp/F = A 4" B*PP + C*Obeslty + D~ + E*Dgx + F'CH A,B,C,D,E,F = coefficients of variables, PP = plasma proteins, Obesity = weight (Kg)/height= (era), Dgx ~ concomitant ,~dmi,lqration with dlgoxin (1/0) and CH ~ congestive heart failure(L/0). The model has been considered without predictors and with differants combinations of them. Error model: additive error for parameters and additive and proportional errors for Cp, were tested. Software: MULTI(ELS) Choice of model: F-Snedecor test and Akaike's information criterion (AIC). Assessment ofpreddctive method: the mean, mean absolute and mean root squared prediction errors and residual representation were used.

RESULTS: Selected model: D/'r ~a2A ~ 5.691 10 "~ Cp~ ~ ~2 a = 7.648 :tO "2

6.313 - 7.81410 ~ " PP o2c~ = 0.146

All predictions of plasma levels, in patient group B, were accurate (mean error not significantly different from zero) but the most precise predictions were the third Cp,. The model predicts values less scattered than experimental values because of these data provide variability not taken into account in the model.

CONCLUSIONS: The selected model only takes into account clearance predictors and not bioavallability predictors. Amiodarone shows a great variability in its bloavailability, which can not be estimated in tiffs work, so the chosen model becomes restrictive,

Department of Pharmacy and pharmaceutlcs. University of V',dencia. 46100-Valencia.Spain. (*)Department of Cardiology. Secundary care. Camlno de Benlferri,s/n.46100.Vulencia.Spaln

Vo;ume 15 NI S 199)

~ 8 Iqmr.h.y Ilbrhl ~ S~.'mc

AN ANALYSIS OF CLINICAL PHARMACIST DRUG THERAPY INTERVENTIONS IN CRITICAL CARE SETTINGS

J,E. Clark,* E.C. Gomez, A.C. Cruz, R.L. Wilbur I. Alfonso

Patient care activities of clinical pharmacists assigned to intensive care units were evaluated to determine the impact of drug therapy interventions on medication order transcribing, physician prescribing, and drug therapy cost. Patients in the medical intensive care unit, surgical intensive care unit, and the trauma intensive care unit were monitored during the period of September 1992 to February 1993 for an approximate total of 122 days. A drug therapy intervention form was used to collect clinical information. A total of ii0 documented drug therapy interventions were used in the data analysis. The majority of the pharmacists' recommendations was to change (increase) the dosing interval of drugs (37.6%) followed by recommendations to discontinue a drug (16.6%). Most interventions took between 1-5 minutes to complete. Ninety-seven percent of pharmacists' recommendations were accepted by the physicians. The pharmacists identified 64 physician prescribing errors and 2 nursing transcribing errors. The pharmacists' interventions had the impact of increasing drug therapy effectiveness, decreasing toxicity and decreasing cost. The projected drug cost avoidance for accepted interventions totaled $ 8,994.98. Projected over a 12 month period (I000 interventions), the cost avoidance from pharmacists' drug therapy interventions could total over $ 81,000.00 annually. Clinical pharmacists assigned to critical care areas can have an impact on the costs associated with drug therapy as defined in this study. Since a large number of costly drugs are used in the critical care units as well as drugs requiring pharmacokinetic monitoring, the presence of a critical care pharmacist can aid in providing high quality and cost effective services.

Department of Pharmacy, Jackson Memorial/University of Miami Medical Center, 1611 N.W. 12th Avenue, Miami, FL 33136 USA

THE APPLICATION OF PERSONAL CONSTRUCTS IN THE EVALUATION OF WARD-BASED CLINICAL PHARMACY TEACHING

C.It,Grout

Self-audit is at the heart of good practice l i t . Chnical pharnmcy tutors should evaluate their own performance in order to improve the standard of their teaching. Personal constructs, in which the individual identifies his own strengths and weaknesses on criteria he sees as important, have been incorporated into a model for teacher self-appraisal (2). The present study was undertaken to define the attributes that clinical pharmacy tutors associate with good teaching so that a self-evaluation model for these tutors may be established.

Five tutors at Llandough Hospital. who had taught for between one and five years on a postgraduate clinical pharmacy course, were asked to list all the criteria they felt constituted good ward-based teaching. One week was allowed for completion of this task.

Twenty-three different personal attributes were identified. Only one criterion, communication skills, was stated by all five respondents. KnOwledge of the subject area bemg taught, allowing the student independence for learning and the importance of giving feedback were also mentioned several times but other responses varied.

It would therefore appear from this study that there ts 11o ideal list of attributes for a clinical tutor. However. by incorporating all the criteria of good teaching listed by the tutors, it is intended to design a self-evaluation tool

t 1) Audit m Pharmacy. Working Party Report. Phamt ./ 1992; 248:505-509

(2) Keen T Appraisal of Teacher Performance. In: Todd E lEd.) Planning Connnumg Professional Development London. Cruom Helm. 1987

Pharmacy Department. Llandough Hospital. Penarth, South Glantorgan, CF64 2XX. l IK

ARE ELDERLY PEOPLE MANAGING THEIR MEDICATION CORRECTLY'? A SURVEY TO IDENTIFY THE NEEDS OF ELDERLY PEOPLE AND THEIR CARERS

R. Goldstein*, P. Rivers

There is g rowing evidence to suggest that elderly people rely heavily upon support from caters to enable them to cope with increasing physical and mental frailty t. The purpose o f this study was to identify medication related problems experienced by elderly people and their eaters and to make recommendations for development o f pharmaceutical services. The object ives were to: describe methods o f acquiring, handling and using medication; identify any problems experienced with medication management; and to quantify and qualify the type and extent o f assistance with medication that carets provide.

From a random sample o f 400 people aged 75 and over, 201 interviews were conducted. Data collected included: physical and cognit ive ability; number and type o f medication taken; knowledge o f purpose and dose o f medication; method o f acquiring prescriptions; problems encountered with handling and taking medication; and the type and extent o f carer support.

The mean age o f the interviewees was 80 (range 75 - 965, 120 (60%) were female and 71 (41%) lived alone. One hundred and seventy three (86%) were taking prescribed medication (median number o f medications 3, interquartile range 3). People taking medication experienced several problems, 49 (28%) had difficulty removing container closures and 32 (18%) could not read directions on labels. Thirty one ( t 8%) received support handling their medication and 33 (19%) were helped to actually use them. Informal carers visi ted 153 (90%) people and supported 31 (20%) with their medication. District nurses and home Parers visited 21 (12%) and 73 (42%) people respectively and, in total, provided assistance with medication to 14. F ive (3%) did not receive any visi ts from formal or informal caters.

Many elderly people manage their own medicat ion but some have to place considerable reliance on support from caters. People who do not receive visits from carcrs cannot receive assistance with their medication. The implication o f caret involvement in the medication process is discussed in light o f recent Communi ty Care legislation-*. It is concluded that current pharmaceutical services do not take account o f the involvement and needs o f carers and clients. Future pharmaceutical care should be developed for both groups o f service-users.

1 Green H. Informal c, zte~s. General Household Survey 1985. Series GHS no. 15 Supplement A. London. HMSO, I989.

2. Caring for people. Community care in the next decade and beyond. London: }IMSO. 1989

Medicine~ Research Unil. Institute of Health am:[ Community Sludles. Univermty of Derby, Western Road, MJcldeover, Derby DF-~ 5GX. England

CHEMICAL STABILITY OF RECONSTITUTED AND DILUTED DOXORUBICIN IN POLYPROPYLENE CONTAINERS:

INFLUENCE OF LIGHT EXPOSURE AND STORAGE TEMPERATURE

*K Stutz, S. Muhlcbach

Doxorabmm represents a potent anticanccr drug acttv against a x~ide range o f tumors. It belongs to the anthracycline compounds, a group of tctracyelic aminosugar-linked antlblotms. The e}totoxm effect results from intercalation between DNA pairs, To minimize toxicity indtviduahzed dose regimens are given preferenttalty over prolonged penods of time by carefull} inspecting t.v. administration to prevent extravasatton, For the hospital pharmacist invol~ed in prcparauon and disposal of eytotoxic drugs an essential point o f interest is to reduce ~aste from admixing, leading to cost savings ~itbout reduction in the clinical efficacy Therefore, reformation about the stability of ready to use eytotoxics is very important Because of conflicting or esen lacking rcpo~s on doxorubicin stablhty and shelf-live admitted after aseptic rcconstltution (13ophihzed drug) or ready to use dilution dccompos*tion o f doxorubtcm 0.05 m~ml (in normal saline) was invesugated at different storage conditions over 8 to 10 ~eeks in polypropylene contamers The influence of bght exposure, temperature (-20 ~ C, 2 - 8 ~ C. room temperature), and frcczing-thax'.mg e}elcs x',erc studied. Anal}sis ~as performed using an isocratlc reverse-phased hlgh-perfom*ancc hquid chromatograph3 (HPLC) method x~Jth diode-array detection (mobile phase: acetonitril and diethylammonium phosphate buffer pH 2,5 (35% + 65 %), flow rate 1,2 ml/min.; column: Grum-Sil 80- ODS 2. 5 ~tm, 4 x 250 ram. column-temperature: 40 ~ C). 20 samples of diluted soluuons ~ere determined. Lmeantiy in the concentration range of 0.5 - 2.5 p. ,g/ml (k = 233 nm) shm~od a correlation coefficient of r 2 = 0.994 (n = 15). The coefficient of variation (CV) for multiple determinations and day-to-day variation over I(I x~ccks x~as _< 10 % for all calibration values. The nominal content of commercial products used for the investlgation correlated ~ith a doxorubiein standard. Degradation products did not interfere v, lth the doxorubicin peak in the HPLC method applied Light exposure was most deleterious to doxorubmm solution A 10 % decomposition occured ~ithin 5 days. increasing to about 80 % after 10 ~ceks if stored at room tcnlperaturc. Light protection nmmtamcd a concentration of doxorublcin of > 00% during about 40 da.',s at room temperature. Ooxon.lbleln contunt did not decline over 10 ~ccks tf stored hgbt protected at 2 - g~ C Rcconstltutod and ddutcd doxorubicm sohmons sho~cd no mesurublc degradation upon multiple freezing and thanking cycles The rcstdts of this investigation indicate that dokorublein in a read', to use concentration of'0,05 mg/ml nt normal sahne and poll prop'.lone containers ma 3 be used ~ithout hght protection for 24 hours It ma 3 he stored protected from light at 2 - 8 ~ C over at least 2 iltonths, tf ascpUc prcparauon is gnurantccd For a longer period of tlnlc freezing of the solution ma 3 bc the storage condition of choice Thcreb 3 CCOllOnne preparation of tlldl ~, iduahzed doses ~.% lilt nnninlal \,.aste of reconstituted do\orublclll ",~. d l he achieved

Dcpt of Pharmuc.-,. Kantonssp~tal ,\znatt, I ' l l -5001 .karau. S~tzcrlaud

I~h,..m,) , I Ibdd ~- >,,~tl. '

Vulume 15 ~4r S 1~9~ G 9

C L I N I C A L A N O E C O N O M I C I M P A C T OF O U T P A T I E N T G-CSF T H E R A P Y

IN N E U T R O P E N I C CANCER P A T I E N T S

Georqe Udeani Pharm.O., Irene Zervopoulous Pharm.O., Krishna Patel Pharm.D., Micheel Mullane, M.O.

G-CSF is an agent indicated in the treatment of neutr0penia secondary to chemotherapy. In order to assess the clinical and economic impact of outpatient G-CSF therapy, we followed 21 cases of patients discharged on G-CSF from our institution over a one year period. There were 13 male and 8 female cases, ranging in age from 21.71 years (mean 44.4 __* 19.2). Chemotherapy protocols administered were: EAP (6), CF (2), VAD (3), HDMTX (1), T-IO(A)-BCD (2), T.IO(AI-AC (4) 6EP (2), and MVAC (1). The potential for developing neutropenia was observed either from previous or current chemotherapy. Discharge G-CSF dosage ranged from 3.0-16.5 mcg/kgld (mean 7.2 * 3.9). Therapy was initiated in six cases for 1-3 days while still hospitalized. Length of G-CSF therapy ranged from 1-14 days (mean 5.2 * 3.0). Mean admission, discharge, and clinic visit WBCs were 8.4 * 8.0, 5.5 * 3.9, and 13.15 _~ 11.9, respectively. Mean admission, discharge, and clinic visit neutrophils were 65.7 +_ 17.1, 64.86 +_.. 19, and 62.2 +_. 32.9, respectively. Mean admission, discharge, and clinic visit platelets were 282.4 _+ 131.9, 217 _.* 111.5, and 124 __* 64.9, respectively. Only 4 of the 21 cases resulted in readmissions for

neutropenic fever. Two patients received additional G.CSF doses during clinic visits. Mean length of stay in cancer patients (those without leukemia) treated for chemotherapy induced neutropenia with G-CSF in our institution is 7.0 + 3.6 days. Mean length of stay for those patients managed without G.CSF is 10.6 .,- 2.7 days. In conclusion, outpatient G-CSF therapy appears to he safe and efficacious. Hospital costs for neutropenic fever could potentially be avoided if patients are discharged on G.CSF therapy and monitored closely.

Colleges of Pharmacy & Medicine, The Univers,ty of Illinois at Chicago, 833 South Wood Street, Chicago, Illinois 60612, U.S.A.

T H E C O M M E N T A R Y O F P R E S C R I P T I O N

P R I O R T O H O S P I T A L D I S C H A R G E : A CONTRIBUTION TO A SAFE MANAGEMENT OF TI lE OUTPATIENT

MEDICATION REGllVl EN

J Beach, P Mu if, S. Mare *. J -Pb. Rc~ m o&d.d

Older people often endure muhlple pathologies and. therefore, take a large number of medicines at the discharge of the hospital. The concept of" Commentar3. of Prcscrtptinn " has boon developed in order to reduce the risk of readmission due to comphancc related problems

On request from the health-care team. the pharmacist provides verbal medication counselling and memory device intervention during 15 to 20 rmnutes. According to the case. the use era seven-day reminder package ts proposed

Before the talk. the resident rewinds the patient's medical records, anal)zes the prescripuon. prepares a ~ritten medication card. selects practical information and counsel to give for each drug. and then takes medicines and their packages as visual support for the talk. Dunng the talk. the pharmacist provides information and counsel, and presents a sevcn-da3 reminder package. If the patient decides to use the devine, a letter to the community pharmacist ts joined to the prescription: this letter explains the approach and asks him to ensure the right handling of the device.

From August to December 1992. 16 reports of commentary of prescription have been realized, mean age was 69 years (48 to 86). mean number of medicines v, as 6 (4 to 9) After the talk. 12 persons decided to use a seven-de', reminder package. 3 persons didn't v,~ant the system, and one person already had one

During this five month activity. It has been noticed that the regular presence of the pharmacist in the pattent care area is important to make the health care team sensitive to his approach. The follo~-up of the patient during the hospital sta3 by the pharmacist allm~s him to target the commcntaly,: moreover, the confidence relationship ~hich grows during the daily patients' round enhances the quality of the talk. After the first commentaries, it ~as noticed that the understanding of the medication regimen is somettmes insufficient. "Ibis underlines the fact that an overall effort has to be made to inform the patient about his medication during the whofe hospital stay.

The commentary of prescription prior to hospital thschargc Is a contribution to the safe management of the outpatient medication regimen. Long-term follo~-up m the cortmaunit3 is required to assess benefit and cost of such a service ~hich is an occasion of collaboration with community pharmacists and ph3 sictans.

lnstltut CcntraI des Hfpltaux Valatsans. Di',. de Pharmaclc. CP 510. 1951 Sion. Switzerland

CLINICAL PHARMACY AT THE UNIVERSITY OF MARBURG

R. Radziwill 1 *T J- Dudek2r U. Herbst 3

Within the next few years the role of pharmacy will change from an only drug- centred to a more patient- oriented profession. But the curriculum in Germany, even today, emphasizes the sciences - especially chemistry, biochemistry, pharmaceutical biology - without connecting theory and practice in the hospital and in community pharmacy in an adequate manner, i.e. clinical pharmacy and pharmaceutical cam. In 1992 the Landesapothekerkammer Hessen and the University of Marburg have established a seminar dealing with some aspects of clinical pharmacy. The students are teached how they can practise their skills and knowledge they have learnt at the university. At the end of the seminar the participants have the chance to stay for a short residency in a hospital.

One aim of the course is to show the different demands for pharmaceutical services connected with drug therapy. The main subjects of the seminar are: - drug information - clinical studies - bioequivalence of drugs - patient compliance - changes in pharmacokinetic parameters during life - therapeutic drug monitoring - antihypertensive therapy - treatment of cancer patients

Although the course has about sixty to seventy participants, it is tried to change the lessons from the traditional lecture based teaching to a more problem based learning. After a short introduction by the lecturer, the students have to present seminar papers covering different aspects of the subject. After the presentation the speaker discusses the paper with the audience, only supervised by the tutor. After the experience of two semesters at the University of Marburg it is evident, that the seminar is accepted by the students, since this course is nearly the only possibility for the students, during the pharmaceutical curriculum, to learn how to use their theoretical knowledge and skills in their profession.

1 r Dep. of Pha macy, S~dtisches Klinikum, D-36013 Fulda 2Dep. of Pharmacy, Krankenhaus Nordwest, D-60488 Frankfurt 3Landesapothekerkammer Hessen, D-60446 Frankfurt, Germany

COMPARISON OF SPECIFIC RADIOIMMUNOASSAY AND FLUORESCENCE POLARIZATION IMMUNOASSAY FOR CYCLOSPORINE MONITORING IN RENAL, LIVER, AND HEART TRANSPLANTATION

Aumente MD', Panadero MD, Latre JM' , Torres M ' , Ville~as MJ, Atvarez J.

AIM: To study the relationship between whole-blood specific measurement of the cyclosporine (CyA) parent compound obtained by RIA and FPIA with a view to changing the analytic method used in our hospital. METHOD: A total of 319 blood samples were collected from 57 Renal transplants (131 samples), 39 liver transplants (90 samples), and 34 heart transplants (98 samples). Each CyA level in whole-blood was determined by RIA (Cyclo-Trae-SP) and FPIA (Abbott TDx). Both methods use a monoelonal antibody specific for the parent drug. The non-parametric method of Passing and Bablok (I) was used to estimate de regression parameters (Both variables with error terms). Precision study was performed by repetitive analyses of control material. RESULTS: Cusum tests for deviation from linearity were not significative in all types of transplant.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Transplant CONFIDENCE REGION CONFIDENCE REGION r types FOR "a" FOR "b" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Renal from -3.4 to 24.6 from 0.86 to 1.02 0.969 Heart from 4.7 to 33 from 0.94 to 1.06 0.954 Liver from -3.5 to 29.4 from 0.88 to 1.05 0.928

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

lnterassay CVs for FPIA were 6.27% at CyA values of 150ng/ml (n=29), 4.95% at CyA values of 400 ng/ml (n=26), 5.03% at CyA values of 800 ng/mI (n=27). DISCUSSION AND CONCLUSIONS: Because the confidence region for "a" includes "0", there is no systematic constant error between the two variables, with the exception of heart transplant, where the region is close to "0". Since the confidence region tot "b" includes "1", there is no systematic proportional error between e,ther variable. No significant differences (p < 0.05) were observed between these methods. Changing the method of CyA measurement has not altered the physician's CyA dosing decisions.

References: (I) Bablok W, Passing H. Application of statistical procedures in analytical instrument testing. Qu �9 imica clinica 1986; 5( I):61-65.

Pharmacy and Nuclear Medicine*' Departments, Hospital Universit;Jrio Reina Sofia. CIAvda. Menrndez Pidal s/n, 14004-Crrdoba. Spain.

G I O l'lh*..,i,)" It',.hl ~" .W,..,*

C O N T I N U O U S QUALITY I M P R O V E M E N T OF D R U G DISTRIBUTION

PROCEDURES IN A G E N E R A L HOSPITAL

E.A. van Dijk, E.M. Logman, B. Ploeger,

T.G. van der Schors", D.J. Steensma.

From 1991 to 1992 the Hospital Pharmacy of the Deventer Ziekenhuizen imple-

mented new drug distribution procedures in the hospital by means of a new computerized prescription management system. As the whole route from prescrip- tion to administration of drugs to a patient is quite complex, it seemed necessary

to assure the quality of the system. For this purpose basic principles of Continu-

ous Quality Improvement were applied. The principles are: 1. Defining the custo-

mers 2. Building the team that monitors the process 3. Def in ing the requirements

4. Defining a plan and setting up a schedule 5. Execut ing the plan 6. Evaluat ing the results 7. Adjusting the plan 8. Periodically repeat ing steps 3 to 7. In order to define the requirements we set up a process analysis and a problem

analysis. We conducted, among other things, questionnaires for doctors, nurses,

pharmacists and pharmacy technicians. We also conducted investigations into

quality aspects in the pharmacy and in the wards. Major findings were that the

new system was very effect ive as to the requirement of the correct drug admi-

nistration to the patient, but its efficiency could be improved upon. The time

available to process the prescriptions (about 2 hours per ward) in the pharmacy

was insuff icient in 50% of the cases. The quality of the prescriptions was insuf-

f icient in 5% of the cases and therefore contact with prescribers was necessary

before processing the data. The customers were satisfied with the system during

the week, but it proved insufficient in weekends owing to di f ferent procedures.

As a result of the investigations in step 4 targets for improvement were set. The

main targets are: 1. Improvement of the processing of prescriptions in order to reduce overtime from 50% to 25%. 2. Improvement of the procedures during the

weekend. 3. Investigation into the cause of the shortcomings in the prescriptions.

4. Investigation into the (in)correct use of the d i f ferent forms.

The action plan has been accomplished (step 5). The results will be evaluated. Af ter finishing the first cycle the drug distribution procedures will be monitored

in accordance with the principles of Continuous Quality Improvement. We conclude that the general principles of Continuous Quality Improvement are

very well applicable to drug distribution procedures in a general hospital.

Hospital Pharmacy, Deventer Ziekenhuizen, Ceintuurbaan 4-A, 7415 AL

Deventer, The Netherlands

CYCLOSPORINE-A MONITORING IN PATIENTS WAITING FOR RENAL TRANSPLANT

M E . Arafijo P e r e i r a * ! ~ 2 ~ a ~ 2 " . I. M e ~ a ! 1 A.._Gomes Costa-2; J.A. Morai~3; M M . Prata 2

Immunosuppression with cyctosporine-A (CsA) is a widely used therapy to pre,,~nt rejection of kidney transplant. CsA has a narrow therapeutic window subject to high intraindividual variability. Therefore close monitoring of bhiod concentrauons is mandatory.

According to some authors (see Transplantation 1989; 47.806-810) the AUC measurements obtained from single dose intravenous and oral tests, performed before the transplant, can be predictwe of the AUC obtained after the transplant and the steady-state average concentration, obtained by dividing the AUC into the dosing interval, shows a better correlation with the dose than the trough blood concentration.

The main objective of this prospective study is to establish individual intravenous and oral pesology of CsA in renal transplant recipients and confirm the predictive value and the usefulness of tnis pre-tmnsplant strategy for calculating pharmacokinetic parameters. We studied 16 adult pat, ents to be submitted to renal transplant in Santa Maria Hospital.

Blood concentrations were assayed by Polarized ImtmofluoresCence (TDX-AbboR) using a monoclonal antibody. The table shows the main pharmacoldneue parameters (average and standard deviation) estimated using PKS-Utility-Noncompertmental Analysis (Abboa) and the CsA posohigy to be used aBer the transplant to attain an tdeal average concentration of 400 ng/ml.

P-'aramcters i.v. (3 mg/kg) p.o. (15 mg/kg)

AUC (h-rig/m1) 6680 (2343) 7430 (3378) CI (L/h) 32.5 (14,9) - - Vdss (I/kg) 2.37 (1.23) - - Ke (h-l) 0.24 (0.09) - - 1112 (h) 3.00 (0.95) - - F (%) -- 25.0 (10.5)

On the basis of these findings i.v. and oral doses of ca. 5 mg/kg/d and 20 mg/kg/d respecevely are suggested. Whereas the i.v. dose ts identical to. the oral dose is higher than the empmcally recommended one (15 mg/kg/d) Perhaps this fact is related to irregular absorption, as most of our patients are diabetics.

(1) pharmacy and (2) Ncphrology Unit, Hospital de St' Maria; (3) Faculdadc de Farm:~cia. Umversidnde de Lisboa

Hospital de St" Maria - Farmficia - Av. Prof. Egas Moniz 1699 Lisbea - Portugal

COST-EFFECTIVE EVALUATION OF SELECTIVE DIGESTIVE TRACT DECONTAMINATION IN MULTIPLE TRAUMA PATIENTS

A. LANGLOIS-KARAGA A. DAVICaNON. M. 8UES-CHARBIT ~ V. SOMME. J. ALBANESE. O. DURBEC. C. MARTIN. N. MORATI. G. BALANSARD

Mechanically ventilated patients may acquire nosocomial pneumonia particularly in debilited patients because of facilitated colonisation by pathogenic bacteria in the oropharyngeal and digestive tract. For a few years Selective Digestive tract Decontamination (SDD) has been used to avoid these respiratory infections. In fact, up to now, the benefit of SDD was not really proved in spite of many studies.

[ntensivists decided to test SDD in collaboration with pharmacists, to determine the interest of this method in a defined group of people : multiple trauma patients. Pharmacists had to prepare decontamination products, and to watch the therapy. This double blind randomized trial was performed over two years in multiple trauma patients who were mechanically ventilated during at least two days, and who stayed five days or more in the I.C.U. The protocole was accepted by the Ethics Commitee. The antibiotics used to decontaminate were gentamicin and colimycin, and amphotericin B as an antifungal drug. Two preparations were made in the pharmacy : an oral gel and a naso-digestive suspension. They were applied in topical administration four times a day. Sterility was tested after fabrication. Blood gentamicin levels were determined in order to verify its non-absorption.

This protocole included 105 patients, 51 received treatment (group A) and 54 placebo (group B). Nosocomial infections were significantly more important in the placebo group (p = .0072) : 87% patients had at least one nosocomial infection, and 53,7% had pneumonia. In the treated group, there were only 64,7% nosocomial infections and 35,3% pneumonia. The average hospitalization duration was almost the same in both groups (21,9 days in the group A and 21,5 in the group B). An antibiotic therapy had to be dispensed in 60,8% to traited patients and 7g,6% in the other group (p = .0344). Antibiotic cost was lower in the group A. If we take into account drugs cost of SDD (15 640 FF), this regimen was less expansive (201 593 FF versus 293 102 FF). The average cost of antibiotic therapy per day was higher in the group B.

This method is efficacy in multiple trauma patients, because there is a significant difference between the number of nosocomial infections in both groups, particularly with pneumonia. The antibiotherapy expenditure is a little lower when SDD is used. Moreover, SDD does not select particular ge rms : the responsible bacteria for infections are the same in both groups, with predominance for Staphylococcus aureus. This one was found more often in the placebo group (17 pneumonia and 6 in the treated group).

Pharmacy, Intensive Care Uml, Medical Information Unit, H6pital Nord, Chemm des Bourrelly, 13326 Marsedle, Cedex 15, France

CYTOTOXIC DRUG COST REDUCTION IN A CENTRALIZED RECONSTITUTION SERVICE

G. cajaraville, M.J. Tam~s*~ B. Garcla.

Introduction: A centralized cytotoxic drug reconstitution system generates a saving in drugs due to a reduction in drug wastage by reusing partly used vials or by promoting an accommodation of prescribed doses to the commercially available preparation packs. Few previous reports (i) have evaluated this economical impact and they are based on retrospective data.

Aim: A prospective quantitative cytotoxic drug cos~ reduction study due to a centralized system was carried out over a nine month period (October 1991-June 1992).

Method: The study hospital is a 108 bed cancer center with an outpatient clinic, The pharmacy department prepares over 600 doses of antineoplastic drugs monthly. Data was obtained by using a computer programme which provides a work sheet indicating the number of drug preparabion packs necessary to prepare a prescription. Differences between the number given by the computer and the number that was really used were logged out daily. The data was analized over the 9 month period and quaterly to evaluate variability over time.

Results and discussion: The average saving of the drug cost was 7,7% over the 9 month period and 7,5%, 7,7% and 7,9% for each of the 3 quarters. The expenditure for each individual drug with reference to the total amount spent on cytotoxic drugs wast Epirrubicin 29,95%, carboplatin 14,91%, Cisplatin 12,56%, Doxorrubicin 9,51%, Etoposide 5,01%, Vindesine 4,53%, 81eomicyn 4,03% and other drugs 19,5%. Cytotoxic drugs which caused greater impact on the total saving were: Epirrubicin 14,51%, Carhoplatin 10,82%, Mitoxantrone 10,55%, Vindesine 9,12%, Cyclophosphamide 8,95%, Etoposide 8,95%, Vincristine 7.74%, Doxorrubicin 7,52%, Methotrexate 6,61% and others drugs 15,12% .

Conclusions: A 7,7% cytotoxic cost reduction was obtained, remaining constant throughout the period under study. Data obtained is consistent with that reported in previous studies (1). Antineoplastic agents may represent one of the highest drug costs per therapeutic category in the pharmacy budget and any potential saving should be donsidered when setting up a centralized reconstitution unit. Each institution must examine its costs individually based on the number of doses prepared, utilization rate for each specific drug and- the different .preparation packs available in the country. Savings may increase as the workload of the unit does.

(i) J. Pharm. Olin. 1987; 6:225-236.

Pharmacy service. Instituto Oncologico. Aldako-enea, 44. 20012 San Sebastian, Spain.

/'h,m.,~,y Hbrld :: ";,w..' . . . . . . . . . . . . . . . . . . . . G l 1

DEVELOPMENT OF A PROTOCOL FOR A COMMUNITY PHARMACY-BASED PROGRAM TO MONITOR DIABETIC PATIENTS

Batel Marques F.I, Ph;=rm.D.~ Capela IIS~ ph;=rrn.D.~ D.mingucs~Pharm.D.~ Feio JA~Pharm.D. an(_l Siha C, Pharm.D.

This study ~as undertaken to find Out the reasnblhty oFs progrmn to monitor diabcUc patients zn a conlnlunlt% pharmacy

A nhcct to idcnt=f.~ diabetic patzcnts ~us dexclopad, compnsmg demographic dma, *dentificauon of patzcnts famil.', pit)sicmns and spceialised diabetic climes, ant=diabetic trcatmcnt as v, cil a~ details of coocurrcm drug thorax. A qucstionnairc to ~dcnti% paticm$ kno~ Icdge and nceds on areas of patient education ~tas also dcxcloped.

O~er s thrcc months pcrtod patiente attending a commum|) pharmacy ~]di a prescription of an oral antkfiabetlc drag or insulin ~crc idcnnficd and asked to ans~cr the questionnaire. Of the 24 patients identified, 4 (2 malcs) ~erc insulin-<tcpandcnt and 20 (12 malce) wcrc taking oral anudiabctic drugs (2 patients ~clc taking a biguanidc. 14 a sulfonylurca and 4 u higuanidc plus u sulfonylurea). All patmnts v, crc assisted by thc=r farad) physician, but o,ly 7 (4 msulin<lcpandent and 3 i~on-insulin dcpondentl attended a spacmlissd diabeuc clinic. Concurrent medication included antihypori.cnsvc (5 pahcms), anuh~perlipidacmic (2 poucntsL antiduprcssam I I patient) and anticoagulant (t patient) drugs. Qucstionnmrc results rc,.calcd a poor kno~lcdgc of diabutcs (t~thogcncsis and complications associated x~idi th=s condition) as x~ell as of the mcamng of h}po and h~,porglicacmm and thctr signs and ~mptoms (30% of correct ane~crs) All tile patients reported their avmtablhty to port~c~patc m a pharmacy-based program far diabetes

and diabctcs complications monitoring, mcluding gl.',cacm*c control, d~ugs adinimstrauon, education on dict. cxcreiss, foot carc and prexcntion of cardio'~ascular risk factors.

Thc stud3, rc%ca~ud the need to educate and monitor ~habctic patients. Pharmacy imer~cntione x~crc ~cll accepctcd by patients, supporting and jusufying tile development of u protocol for a community pharnmcyq~asad program to motntor dialoohc pahents. Such protocol ie no~ subject of di~useion w,h the local family ph}s~cmns, m the I~ght of the questionnaire rcsuhe.

COIMBR.% PUARM %( '(}TIm ERAPV STI "DY (:RO{'P .~,P.%RTAIX) H#~3nlR) (X)IMnlt%. IP~RTI'(;AI.

DRUG ALLERGY ON HOSpiTAL ADMISSION.

A.Stuur~an

When a patlent ~s admlr to a hospital, a lot of information a~ou~ he~/his person is colleo~ed : aDorn-economic data, pr%vious admissions and disea=es, and, about ell, ~rug usage, and who did prescribe it. According to a study by schiphorst (Z) in a large community hQspital, ~he most reliable information about t~e drug usage is given by r/%e patient her/him-self and the family-pharma- cist, but not by t~e family-doctor, who o~he~Wise 18 supposed to be t/le central person in ~he treatment of patients.

There is another, mostly, drag-related q~estion ~/%at will be asked to every patient who is a~itted to a hospital : " Is ~here any allergy to food, drugs eke.". it is in ~he experience from every hospital-doctor and - phar- macist tha~ the information ~he patient gives is not always co~ec~ and consequent : most doctors do agree that e.g. the allergy ~o penicillin is frequently mentioned, but seldom really the case.

In our, prospective, study 15 patients, who did mention One or more drug allergies on admission, were asked to answer a q~estionaire about this allergy, which was reviewed hy their specialist and V-he hospital pharmacist. Apar~ from this information, consent was asked to inquire at ~-~e f~mily-do~oE and - pha~-macist about their knowledge about d~ug-alle~y in this patient, without mentioning the nat%ire of the information the patient had given.

According to ~he patients 16 out of 22 allergies were known to their doctor, in reality the doctors did mention this only in 10 out of Z6 cases. Wi~ the pharmacists the results were even worse ; according tQ r/~e patients el allergies s~ould be known hy their pharma- cist, in reality only 3 allergies were known to them. F~r~bermore : in i0 cases rARe d~ag in question, or a related d2~g, had been prescribed to ~atients.

Conclusion :

I~ contrast to the drug usage, the pa=ien= her/hlmseif is not a reliable source abOUt drug-allergy. From the questionaire it bec~me clear that patients d~ give a different meaning to "drug allergy,' than doctors and pharma- cists do : in most cases the "allergy" presented itself as an, innocent, ~a=h or gasr-Tm-intestinal intolermnce- M~re effor~ should he given to instruct patients about the meaning of drug allergy.

(I) schiphorst PP,Benraed ~B, Muller NF. pha~m Weekbl.1992; 127:1~8

Can~al ~ospi~al pharmacy Breda, Molengracnt 21, 4818 C~ Breda, The Netherlands

DEVELOPMENT OF ROUTINE THERAPEUTIC DRUG MONITORING (TDM) FOR TEICOPLANIN iT) WITH BAYESIAN APPROACH AND THE USE IN PATIENTS WITH RENAL DYSFUNCTION

~. N01te~ I*, E. Fritscbka 2 , H, Schnesmann 1

TO reduce toxicity and increase phe~aoologic efficacy, ~4 for drugs with IlU~OU therapeutic range is nell established. To perforn individual serum level predictions and dose adjustments, the computer prograe kbbotthese Pbarescokinetic Systems (l~, version 1.0; kbbott lab.), which is based on Bayesian principles, can be used. Hewer drugs for which routine T~ is advisable can be added to the systen by defining their kinetic ~raneters. Therefore, the specific kinetic parameters of T, a glycopaptidn antibiotic, wure evaluated by a literature research and entered into the program. T exhibits an open thres-cum[artment linear pherescokinetic model (3-4~).

parameter Value (gnitsi Coefficlent parameter limits o[ variation lower upper

volume of the central compartment V c 0,O86 (I/kq) 0.27 0.05 0.2 nes-ranal clearance CLur 5.75 (nl/h~/kq) OA 2.0 10.0 renal clearance (slo~) 0.t2~,5 0.3 0.07 0.15 iutero0npartmenfal traanfer rate constants k12 i~33 il/hr) 0.37 0.686 2.19 k21 0.856 (i/h~) 0.&4 0.6 2.014 k13 0.544 (i/hr) 0.35 0.11 0.845 k3t 0.058 {tl~) 0.27" o.o4 0.io

Because T is eliminated primarily by the kidneys, pharmacokinetics are altered in patients with renal dysfusction. To validate the PKS program uith the above mentioned kinetic paraneters frum the literature far meniberiog T, 7 chronic haemedialysis {ao% patients and 5 patients with acute renal failure treated by continuous uanovenoes haumodialysis (CVV~) were studied. Blood samples were drawn before ever 7 dose and 0.25, 0.5, 1, 2, 4, 8 and 24 hr after the first dose and then in 24 hr s up tn the next dose. T seI~ concentrations (C) uere dotemined by fluorescence polarization immune assay (TDX, ~bott Lab.; seanitivity: 1.2 eg/l). The dose wan adjusted according to the target trough C of 5-15 zg/l. kll measured C values of T were correlated vith the predicted C. kddltioeally, 1iterat=e values (i] of C frne 6 healthy volunteers after 440 lq T were cnrrelated with the corresponding C predicted by the PKS proqrae. The correlation of the 3&3 me~ured C values with the predicted ones uus good and statistically significant (r=0.938, p<O.W5). The 84 C values from the literature ill also showed a good correlation with the predi~ed C (r=0.942, p<o.w5). The [~4Z progrum nalool~ted the following iedividsalhed kinetic parameters fnean -+S0): volume of distribution at steady-stats (Vdss) 0.94 .'0.12 i/kq in l~ potiants and 0.% f0A2 I/kq in CW~D patients; V c 0.082 .+O.O12 ~nd 0.073 t0.O1 i/kq, respectively; disposition half-lives O.20 f0.024 and 3.34 .+0.46 hr in lid add 0.27 f0.03 and 2.08 t0.6 hr in CVV~; terminal half-lives 179.4 129.6 and i~i .+41 hr, respectively, The defined 3-~ of T seees to he adequate to calculate individual kinetic parameters a,d to perform routine TON for T and to provide 8 sate and effective therapy.

(i) HCNulty C~/4, Garden GHF, Wise R, kncb:ess Jl4. The pbarsaookinetics and tissue penetration of teicoplanio. J kntinicrob Cbeeother 1985; ( 161:743-749.

1 Dept. of Pharmacy, 2 Dept. of Hephrology and Hypertensive Diseases, University clinic Essee, Hufelasdotr. 55, 4300 s Gernasy.

DRUG ASSAYS IN DENMARK

A.GudionsdottL r1*, H R Anue 02 M Rasmussen 1, S N Rasmussen~

Background: During the last 15-;>0 years therapeutic drug monitoring has bean used to individualize dosage regimens for a number of drugs. In the US, the pharmacokinetic services have been established to take care of the therapeutic drug monitoring. Literature shows that only 14-40% of the performed assays are appropriately indicated, sampled and used to make correct dosage adjustments, whereas with clinical pharmacokinetic services these figures are 41-95%. Many investigations show that savings by only performing the appropriate drug assays is equal or bieger than the costs of establishing pharmacokinetic services. Some pharmacokinetic services have showed additional savings based on patient outcome parameters as length of hospital stay, length of treatment, incidence of adverse reactions and rate of mortality.

Aim: The aim of this study is to register which drugs are assayed in Denmark, and to quantify the numbers of assays performed during a year in order to evaluate the need for establishing pharmacokinetic services in Denmark.

Medial: A questionnaire was sent to all laboratories in Denmark that perform serum drug assays.

Results: The results of our study show that approximately 250.000 assays are performed during a year in Denmark at 50 laboratories. Drugs most often analyzed are: Aminoglycosides, Carbamazeplne, Cyclosporine, Digoxin. Lithium, Phenytoin, Theophylline, Tricyclic antidepressants and Valproic acid. All these drugs are candidates for therapeutic drug monitoring,

Discussion: At an average cost of 100 DDK per analysis, the total spending can be estimated to 25 million DKK. Providing a percentage of inappropriate assays similar to the ones reported for the US, the cost of establishing pharmacokinetic services in Denmark can be contained within the existing budget of the Danish heath care system.

Condusion: Further investigations are needed to evaluate the use of serum drug assays in Denmark. A prospective trial is planned where the overall use of serum drug assays is evaluated with and without pharmacokinetic services.

Acknowledgement: We want to thank all the persons who have helped filling in the questionnaires.

Department of Pharmaceuticsl, Department of Biological Sciences 2, The Royal Danish School of Pharmacy, 2 Universitetsparken. 2100 Copenhagen ~,Denmark. Department of Clinical Chemistry 3, Bispebjerg Hospital, 23 Bispebjerg gakke. 2400 Copenhagen NV, Denmark.

G 1 2 Pl~,l..ar y I I'odd U .'~t wu, c

DRUGS USE REVIEW: SOMATOSTATIN-OCTREOTIDE

J. Carrera, A. Ideate, A. Modreqo, I. Tejedor, J. Gir~Idez.

Somatostatin (SST) and its analogous synthetic Octreotide (SMS) are two drugs widely used in our hospital with a high economic repercussion over drug cost. In order to being able to control their ut i l izat ion a whole standard of using were elaborated and introduced by the Pharmacy and Therapeutic Commission. The objetives of this investigation are to verify the fulfi lment degree of the approved 8ST & SMS Protocol and to value the economic repercussion of i ts setting-up. A retrospective research has been made about the uti l ization of both drugs in our hospital (450 beds) and eight months before (over 38 patients) and eight months after (over 33 patients) protocol setting-up. In order that i t has been used a consumption l i s t which details for each patient the number of consumed units, the duration of the treatment and his total cost.' The in i t ia l information has been completed with another one, obtained through the review of the evaluated patient's clinical histories. Among the 38 patient treated before the protocol, 36 recived SST and 3 SMS. It was evaluated the total cost of both drugs, being greater the cost corresponding to SST which amounted to 99.5%. Global adjustment to the approved terapeutics indications reached 11.8%. After the protocol setting-up 33 patients were evaluated, 17 with SST and 21 with SMS. Total cost decreased in a 78.7%, concerning a 68.8% to the SST and 31.2% to the SMS. Among all the patients treated in this period a 66.7% were treated according to the indications. Drugs were used in this way: oesophagicg varicnses (20.9%), high digestive haemorrhages (33.3%) and fistules (45.8%). The protocol fulfi lment degree reached 100% in the case of oesophagics varicoses, 75% in the high digestive haemorrhages and 45.5% in fistules. SST and SMS were employed in duodenumpancreatecthomlas as a prophylactic measure of fistules appearance, a data to be rated in the future. Setting-up a protocol of using those drugs means a more rational use of them, besides a significant economic saving to the patient and the hospital. An increase in the SMS uti l ization, as opposed to the SST, has been checked on since the protocol setting-up, because of a better knowledge about his therapeutics possibilit ies by our physician staff.

Pharmacy Service, University Clinic of Navarra. Avenida Pin XII s/n. 31008 Pamplona, SPAIN

E V A L U A T I O N OF A NEW GENTAMICIN DOSAGE SCHEDULE IN NEONATES WITH G E S T A T I O N A L ' A G E LOWER T H A N 32 WEEKS

MA Maneues*. R Farr6.X Demest reLG Ginovart+.J Orozco.G Julio. MA Moral.

Gentamicin, a drug with a narrow therapeutic range, is the most prescribed antibiotic in the neonatal period. In 1989 our group designed a specific gentamicin dosage schedule for neonates (NN) with gestational age (GA) lower than 32 weeks t.

The aim of this study was to evaluate a gentamicin dosage schedule of 2.5 mg/Kg every day in NN with GA lower than 32 weeks.

Twenty four NN were included in the study. Mean GA was 28 (25 - 31) weeks, and mean weight was 1067 (690 - 1870) g. The initial dose (2.5 mg/Kg) was infused over 30 min. Dose interval was 24 h. Two gestamicin serum steady-state concentrations, 1 h post-infusion (Cmax) and immediately before the dose (Cmin), were used to identify individual pharmacokinetic parameters and to correct the dosage when necessary, applying Sawchuk and Zaske method. The therapeutic range was: Cmax: 4-9 ag/ml and Cmin < 2 #g/ml. (Analytical method: FPIA)

The mean values ( + SD) of the elimination constant (Ke, h "t) and volume of distribution (Vd, mllKg) were 0.0615 (4- 0 .0227) and 0.5091 (4- 0.1483), respectively. Levels inside the therapeutic range were achieved in 71% of the NN. That means a dramatic improvement versus the doses previously used in this group of NN (26 .7%)k In 25% ( n = 6 ) of the NN gentamicin levels were in the toxic range. The patophysiological factors that have contributed to the achievement of these high plasma levels were: very short GA (26-27 weeks, n = 3 ) ; abnormal renal function (elevated serum urea and creatinine, reflecting prerrenal failure, n = 6); and gentamicin-indomethacin interaction (n=2 ) . Only one patient had levels under the therapeutic range.

An initial gentamicin dosage of 2,5 mg/Kg every 24 h may be considered an appropriate schedule for NN with GA lower than 32 weeks. However, individual GA, renal function and potential drug interactions should be taken into account and adapt gentamicin doses requeriments to the individual clinical situation.

I. Gallastegui C, Farr~ R, Jim~nez MA, et at. Proceedings of the lSth European Symposium on Clinical Pharmacy, 1989: 344-345.

Pharmacy Dept and "Neonatal Unit. Hospital de la Sta Creu i St Pau. Avda. Antoni M. Claret, 167. 08025 - BARCELONA. SPAIN.

E V A L U A T I O N O F G A N C I C L O V I R D R U G M O N I T O R I N G

C. Busin I. C. Bardin *1. C. Seroux I. H. Sauva~eon-Marlre I. J.-D. Sraer 2-. F. Chast I

The hlgh frequency of either toxicity or unefficiency of ganciclovir (DHPG) in lhe treatment of CMV infections may lead clinicians to investigate the phannacokinetic profile of the drug. The renal route being the main ganciclovir excretion pathway, the drug dosage is usually calculated as a function of file serum creatinine.

The aim of the sludy is the validation of the ganciclovir drug monitoring in various clinical situanons and the investigation of the serum tevel-tO-loxicny and serum level-to-efftcacy ratios.

A group of 91 pallents was investigated including mainly Jmmunocompromised patients (transplantions, AIDS. cancer). The drug monitoring consisled in the determination of 2 plasma levels : peak (Cmax) and valley (Cmin) after drug administration. Plasma samples were analyzed through an HPLC method (sensitivity S 25 ~g/L).

Our results show that pharmacokinetic data are closely correlated to the re.at function ~:sumed by the creaunme serum concentration (Scr). In spue of dosage adjustments according to the serum creatinine value in patients with impaired renal function, plasma ganciclovir levels remains significantly higher than in patients with normal renal function:

Scr-< 120 ~tmol/L n Dosage(m~Jkq/dav) Cmin (~t2/ml/ Cmax fft~ml) ] 8.2 +- 0.7 0.8 -+ 0.2 6.9 -+ 0.9

Scr I > 20 47 btmol / L 5. _+0.4 3.6_+0.9 2.6_+4.

The drug concentration was explored in 23 pauents showing a toxicity and in 7 patients with unefficacious annviral activity :

[ t J ~ e (m~dav~ I cmi" r cmax ("~/m*~l Toxicity n3 5.6 -+ 1.4 2.8 -+ 0.6 8.7 -+ i.2 I

Unefficiencv 7 6.8 + .2 1.5 _+ 0.6 6.4 + .7

If toxicity is well correlated weh high plasma ganeiclovir levels, demonstrating a higher risk of neurological but mostly haematological disorders, the unefficiency of the antiviral drug is poorly related Io plasma levels. More than ganciclovir plasma concentration, the virus resislanee or a Ix:or inlracellular penetration may explain the lack of antiviral activity.

Ipharrnacy and Pharmacology Department, H6teI-Dieu Hospital, 1 place du Parvis Notre-Dame. 75004 Paris - 2Nephrology Department, Tenon Hospital, paris - FRANCE

EVALUATION OF INTRAVENOUS FLUID THERAPY BY THE USE OF A GLUCOELECTROLYTE 2-LITER CONTAINER

J.V. Real, M. Climente, I. Fo~t, C.P~rez. J.P. Ordov~s. M.Hermeneaildo. J.L. Catal~n. J. Juan. N.V. Jim~nez.

The interannual hospital use of large volume intravenous fluids (LVIVF) is increasing nowadays between 5 and i0 %. The efforts directed towards its rational use may improve the quality of intravenous fluid therapy and contain its cost.

The influence of 2-1iter PVC bags on the global hospital profile of intravenous fluid therapy and the restriction of direct costs was analyzed.

Since 1977 until 1992 the utilization profile of LVIVF in our hospital was analyzed both quantitatively and qualitatively, according to the composition and volumen of LVIVF. Thus, a proposal of criteria to define standars for rational evaluation of intravenous fluid therapy, was carried out.

The parameter volume (liters/100 hospital stay) was: 1977 1982 1987 1992 P

Carbohydrates 12.61 23.39 24.48 17.37 ns Electrolytes 9.35 6.64 12.01 27.35 0.05 Glucoelectrolytes 3.35 2.54 9.48 19.01 0.05 Total 25.31 32.57 45.97 63.73 0.05

The distribution (percentage of liters/100 hospital stay) of the several size containers found in 1987 against 1992 was: 3.8 vs 6.4; 53 vs 40.4; 25.9 vs 33.5 and 17.2 vs 19.2 for 250, 500, i000 and 2000 ml containers, respectively . The cost/liter, refered to 500 ml size, was 186%, 58,9% and 54.3% for the 250, i000 and 2000 ml containers, respectively.

The availability of a glucoelectrolyte fluid in a 2-1iter container has allowed an improvement of the global profile of intravenous fluid utilization in our hospital. This situation improves the rational individualized intravenous fluid therapy and decreases its direct cost.

Pharmacy Service, Hospital Pharmacy and Pharmaceutics. Spain.

*Gaspar Aguilar, 90 46017- VALENCIA SPAIN

Dr. Peset* and Dept. of University of Valencia,

IJh ,m. ,~c F I l i , r h l U. ,'4, h ' . :

vo, ...... ~., ~.,~ G13

EVALUATION OF USER'S SATISFACTION IN A FRENCH DRUG INFORMATION CENTER

F Amiot*, S Cla'(e, B Sarrut, C Doreau

The objective of our work was to evaluate the quality of the service and to compare it with the last study, presented in 1991 It).

A retrospective survey of user's satisfaction of our phone question-answer service was conducted from mid-june to mid-july 1993. A 24 items questionnaire was sent to 100 users selected using a random table from all the caIls received during a six month period (December 1992- May 1993)

The 24 items were grouped in 4 categories : - user's identification and circumstances of the call - phone service organization - answering service evaluation - suggestions.

A follow-up letter was sent after a month to non responders

Data were analyzed and the results of the survey were presented in tables and histograms, giving the global percentages, with the list of the comments and suggestions for each item.

The assessment of user's satisfaction permitted us to complete the quality assurance program of the Drug Information Center, initiated in 1991

(1) PHILIPPE C . . M6moire pour le Concours de la Medaille de rlnternat 199t.

Service d'Intbrmation Medico-Pharmaceutique, Pharmacie Centrale, AP-HP, 7 rue du Per/t Moulin, BP 09, 75221 Paris, France.

EvaLuatio~ on handlth~ end methotoov of s t e r i l e prepare[ions bY ~he FINGERPRINT --~ethod. Pt~m. Vamdenbroucke J.

In t rpduct ion: Since many of the s t e r i l e preparations made by the hosp i ta l pharmacy are for irradiate use, s t e r i l i t y test are not su i tab le for qua l i t y cont ro l . The q u a l i t y assurance for the extempo- raneous preparat io, cat* he achieved by process ~imutaticm tes t ing (I} and by cont inu ing t ra in ing and hygiene Instructions. ~

Qual i ty i rovement arKI management is bui lded upon the need for ob jec t i ve data wi th can be analysed, p~O With the fingerprint-m~thod we estlm~te to have an additional tool to improve the quality of o~r star1 le p~eparatio~s.

Method : The ~narmacy technic ian ~ork i n a [~mlnaiP a i r f low hood w i th respect of the normal hygien ic measurements as described i n the GMP guide l ines, ALL products are desinfected by passing through an alcohol bath before enter ing i n the f low hood. The technic ian s ta r t the prepara- t io~ by pu t t ing on s t e r i l e gloves in the f lo~ hood. Af ter the preparat ion, when a l l I .V. admixtures and manipulat ions are done, the technic ian takes a f i nge rp r i n t of the gloves ( a l t 10 f ingers ) using a blood agar plate. TipPing order as well as the code for identiflcati~ Of manipulator , type and batchnumber are described i n Droce0bres. The plates are incubated by 37 o C for 7 days and the resu l t s are inputted ~n a database for fu r the r analysis . Every semester the resu l ts are discussed with the i nd i v idua l ass is tant and the mean resu l t with the whole group of t~nLr

Res41~sT * The number of f i ngerp r in ts s t rongly depends on the i nd i v i dua l technic ian. * he percentage o f pos i t i ve plates var ies a Lot ~nong the i nd i v idua l technicians.

The average number of cont~ain~ted f i ngerp r in ts over one year is about 20 percent. A highee contaminatio~ rate is observed for some types of preparations, al though he same number of manipulat ion is required. The ind iv idua l analysis and hearing shows to in f luence the score of the next observatL- on period pos i t i ve l y .

Discussion : = The d i f ference in pos i t i ve cu l tures between the pharmacy technic ians could be explained

by the thd iv idua l s k i l l s and motivatlc<1 tO improve them.Older technicians undergo more d i f f i c u l t i e s or ape less motivated to adapt and correct t h e i r preparation techniques. These di f ferences proves that a cont lnous education program is necessary, We accept a maxir~Jm variation of t 3 percent o f the average pos i t i ve plates. A Dos l t i ve f l nge rp r th t does NOT automat ical ly imply that the proration is contamtha- ted. because d i f f e r e n t barr iers ex i s t independently, the oDportunity however for con tamin~ t l~ is s t rong ly correlated w i th the number of p u s i t i v e gloves. Because some types of prep~ratic~s ~re m~-a l i k e l y to pro@dee positive fln~erprlnt - cu l tures , the need for revieathg and adapting proouct ion methods is raised,

Conclusion : we bel ieve that the f i nge rp r i n t method is a usefuLt tool to improve qua l i t y assurance, espec ia l ly to observe the manipulat ion and preparat ion techniques of the ind iv idua l technic ian. By reducing the numbe~ of pos i t i ve f i n g e r p r i n t - c u l t i u r e the Improvement can be abject ivated.

References : (1) Draf t ~luidel I nes on qua l i t y assurance for pharmacy-prepared s t e r i l e pro- ducts ,AJHP1992; 69:407-~ 17. (2) GHP-directive ?l/356/EEG, obapler Z:personnel

Corresoondence: Apr. vandenbroucke J., Central Pharmacy DDt. Univers i ty Hospital of Gent

Pintelaan la5 9000 Gent, Belgium

EDUCATION OF PATIENT COUNSELZNS AT THE SEMMELWEIS P45 MEDICAL UNIVERSITY IN BUDAPEST

F~ Is . Hi~s~ Sy. Smde~ r PetS-NaZI ; Z. Vlncze

The cc~c~pt o f Pat ient Counsel~n~ Even~ IPCE) ~as f i r s t r e a l i s ~ in the US~ in the ear ly 1980"5, because the Ame~iuan ~harmacy s~u~en~s and graauat= p~armar had fo~ a long ~ime ~ecognised the need fo r an event tha~ w~ Id a~ford the students p~act ical sM i l l s in t h i s important a c t i v i t y of p h a r m a c y mractice. The In te rna t i ona l Pharma~eutlcal Students" Federation i den t i f i ed a s lmi la~ need, ~ d 1989 p~ov~d to be a s t a r t i n g yeae fo r IPSF as the f i r s t ev=~ In te rna t i ona l Patlmnt Coun~ellng E v e n t (IPCE} was held a t ~ e 34th IPSF anual c~ng~ess in Phi ladelph ia , USA. The second IPCE wa~ help ~xact ly one year late~ in Vienna. (At t h i s Event was par t i c ipa ted one o~ the authors, too.) In Hungary the authors s tQ =rganisI lu~h ~ e v ~ t a l the same l l k e held in Vienna.

H . a l t h i a r e i s a l l about ~elat ing to patlmnt as people and c~mmunicating ~ i t h them. In t h . past few yea~s, the i n t e ~ a t i o n a l ro le of the pharmacist has changed from t r a d i t i o n a l compounder 09 medicines to a medical i g n f u l t a n t and pa t ien t edu=atur. Therefor i t i s neciessary to be adequately equipped Nit~ good communication s k i l l s . This very important work s k i l l can anly be learned trough Practicm~

In the year 1992 c l i n i c a l pharmacy has been introduced as an ob l igatory sub~ect fo r the f i f t h year pharmacy =tud~nt a t the Semmel~ii= Madical Lk~iv=r t i ty . The pract ice program comprize Pat ien t Coun~l ing among the main f i e l d s of pharmacOtheeapy (~idespred Slseases, i n t e r n a l medicine, psyc , l a t r y , dermatology, TDM and IV addi t ives therapy) .

The goal of thw pract ices are to give an ove~wiev about the pa t ien t counseling end increase the communication s k i l l s of the student.

The p o s t e r conteln Qui~elinel and kea~hlng method~ of Pat ien t Counseling a t the Semmel~eis Medical University.

The aim of the study to increase t~e i n t e r e s t of students and change the teaching methode and to givm a general overview about Pat ient Counseling.

References are the f o l l o~ ing : US. Phapm d July [990 32. IPSF USP Evaluators Handbook

Dept. o f ~ha~ma~y Administ rat ion, Dept. of Dermatology, Un ivers i ty of S~mmelwes HSgyes E.u, 9. H-iO?Z ~udap~t , Hungary.

HOW TO MANAGE PROBLEMS OF IV-MEDICATION ON INTENSIVE CARE UNITS

A, Freidank', A. Fischer, R. Radziwill

Nearly every patient in an intensive care unit needs besides parenteral nutrition many different drugs. In- sufficient knowledge about stability, half-life period, compatibility and interactions often leads to an in- effective therapy.

The aim of the present study is to develop guidelines of iv-medication for a more effective therapy.

To get a survey about the iv-medication on our hospital three intensive care units are visited. According to a questionnaire the technique, the used equipment and usual admixtures are checked. To obtain further information the individual medication of about fifty patients is recorded.

The most frequent problems are: - there exist no general guidelines hew to combine dif-

ferent drugs and which route of administration should be used.

- bacterial 96-h-filters will be blocked within fourty hours, because of particles (incompatibilities, in- fusion system)

- drugs are given parenteral, even if oral administration is possible.

The compatibility of normal admixtures is checked with the help of literature and own studies. With these results the staff is informed of stable admixtures. As far as possible drugs are given peroral and the amount of drugs is reduced. Together with the medical staff infusion regimes are developed to promote the use of bacterial 96-h-filters. The preparation of TPN-solutions is offered by the Pharmacy Department.

Department of Pharmacy, st~dtisches Klinikum Fulda, 36013 Fulda, Germany

G14 I'h,lo..l~y I I ~ . / d t: S, i< . , r

THE HUMAN FACTOR, rh G-CSF: FOLLOWING ON CLINICAL USE

M. Cordovilla, B. Font, A. Orteqa, A.Idoate, J Gir~Idez.

The human granulocyte colony-stimulating factor (rh G-CSF), can accelerate granulocyte recovery, during febrile neutropenia, after cytotoxic chemoterapy for solid tumors or leukemias. For this reason,it's important a good clinical use of i t .

The purpose of this study is to evaluate the clinical use in our hospital; for this, our Pharmacy Service confronted with an own feature model drug-use, in 30 oncology patients, (18 Oncology Service (O.S.), 8 Pediatric Oncology Service (P.O.S) and 13 Haematology Service (H.S.) .

The f i r s t indicator was the adequate clinical use, the result obtained was 100 % in all patients; the prophylactic therapia occuped a 75 % in haematologic patients, I0 % in pediatric oncology and 32 Z in oncolgy patients.

The complete blood count, with differential and platelet count done before cancer chemotherapy, and twice weekly during rh G-CSF treatment, was the second indicator, the result was a 100 % over acomplishment. In spite of the secundary effects monitored were complimented in 28,32 % (H.S.), 89,78 % (O.S.), and 15,14 % (P.O.S.).

The rh G-CSF dosage was acomplishment in i00 %, except in autologous bone marrow, 52,70 % , in due the high-dose chemotherapy treatment of these patients. Concerning the duration of rh G-CSF therapy until patient achieved ANC of > IO,O00 cells/cumm, was 51,95 % H.S., 37,50 % P.O.S., and 42,40 % O.S.

The clinical use of G-CSF was the adequated with regard to dosage,haematologic analysis and indication use. But, i t would be necessary to increase the following analytical of possibles complications, during rh G-CSF therapy. At once, our deparment advised an enlargement in the duration of treatment at least until ANC achieved was the recommended.

I M P R O V E D C O M M U N I C A T I O N WITH T H E C U S T O M E R - A S I M P L E A N D C H E A P W A Y T O I M P R O V E H O W T H E P A T I E N T S H A N D L E THEIR DRUGS.

A Ekedahl ~ in Sweden, the pressurized aerosol metered dose inhalers have been superseded by

powder inhalers - Diskhaler and Turbuhaler - which are used by the majority of patients with inhalation medication of bela-2-agonists and/or steroids. The powder inhalers have several advantages - there is no need of a propellant and there is a higher degree of deposition of the inhaled dose In the lung tissue (al least for the Turbuhaler). In clinical trials it has also been evident that, in contrast to pressurized aerosols, almost even/patient �9 even the very young children - can use the device in a correct manner after a short instruction. However in every-day clinical practice, a large proportion of the patients were found to do one or several mistakes that may jeopardize the effects of the treatment. One of the reasons seems to be that the device has been regarded so simple to use that it have been overlooked to give the proper tnstructiona to the patient/customer and it has seldom been checked how he or she have handled the inhaler. In the Pharmacy-group in Lund in the southernmost of Sweden with 19 pharmacies and in total 265 employees serving a papulatior, of 215.000 people, an educahnn program to improve the communicating skills and the information was inihated two years ago. From the beginning of 1992, emphasis was put on the use of open-ended questions

and to let the customer "show- and tell" how they used their prescribed drugs lo be able to adjust the information to the notions of the individual customer. To evaluate the outcome of this technique, users of Turbuhaler were selected. During two one- month periods - april 1992 and april 1993 - it was documented on a simple protocol, how the Turbuhaler was handled by the customers.

Results: In april 1992, only 53 % of the users handled their Turbuhaler in a correct way. 40% of all users made the same kind of mistake when the dose was revolved. However one year later a significantly higher proportion of the patients could use their device in a correct way. A significantly decreased proportion of users held the Turbuhalar in a wrong fashion when the dose was revolved, however this was still the most common mistake. Conclusions: If the customedpahant ~s asked to "show and tell" how he uses his drugs and how they have interpreted the information given, the adjustment of the information to the individual patient/customer gives a significant improvement of the handling of devices like asthma-inhalers, and without any increase in information time or costs. However, as the handling of different devices in many instances is practiced for several years and is a"apinal cord behaviour", there is a high probability of relapses to "the old behavioor".The objective is that all patients know how to use their device in a correct way. To reach this the instruction must be repeated and re-checked.

H]orten Pharmacy, Box 2001, S-220 02 Lund, Sweden.

Pharmacy Service. University Clinic of Navarra. Avenida Pin XII s/n. 31008. Pamplona. Spain.

THE IMPACT OF MEMORY CLINIC ASSESSMENT ON THE QUALITY OF LIFE OF PATIENTS WITH COGNITIVE DECLINE:

SENSITIVITY OF THE UK SICKNESS IMPACT PROFILE M.S. Salek*, S Thomas, D.K. Luscombe, A.J. Baverw

Assessment of the impact of medical inmrvention on a patient's quality of life is increasingly recognised as an important outcome measure, particularly in areas for which there is no effective drug treatment, such as dementia. Thus. quality of life considerations should form part of the overall assessment of these patients. The aim of this study was therefore to assess the impact of Memory Clinic assessment on the quality of life of patients with dementia.

Sixteen patients with dementia (13 female, 3 male; median age 72.5 years, range 62-86 years) newly referred to Memory Clinic of the Department of Geriatric Medicine, Cardiff Royal Infirmary, were recruited sequentially. Following thezr referral to the Memory Clinic, 12 were diagnosed as having mild to moderate Alzheimer's Disease and 4 as having Multi Infarct Dementia. Each patient's carer completed a general quality of life instrument (the United Kingdom Sickness Impact Profile - UKSIP) and a global 5-point rating scale of overall health (very good to very poor) as a proxy at week 0 (in, baseline - before Memory Clinic intervention) and at week 7. In addition, assessment of cognitive status was performed by using the Mini-Mental Status Examination (MMSE).

The results indicated a substantial impairment in the quality of life of these patients in all areas of daily activity, both physical and psychosocial. The patient's quality of life measured 7 weeks after the Memory Clinic intervention showed further impairment in most areas of daily living. In particular, overall UKSIP score (mean baseline=23.8, mean week 7=25.3 - p<0.05), alertness behaviour component of psychosocial activity (mean baseline=76.2, mean week 7=84.5 - p=0.0t), home management (mean baseline=41.8, mean week 7=53.6 - p=0,0i), The changes in the scores for other categories of the UKSIP did not reach statistical significance. Slight improvement was seen in areas such as communication, sleep and rest, recreational activity and eating. The correlation coefficients between UKSIP and MMSE scores were generally in the right direction but did not reach statistical significance, In general, there was no correlation between the quality of life scores and patients age and gender.

These findings clearly indicate that the UKSIP is sensitive in detecting changes in the quality of life of patients with dementia as a result of Memory Clinic intervention. Furthermore, the findings generate a greater awareness and new understanding of the overall assessment of patients with dementia and emphasise the importance of the need for a more comprehensive multi disciplinary approach in creating a better understanding and perception for the patient's carer.

Division of Clinical Pharmacy. and w of Geriatric Medicine, Universi~ of ~les. Cardiff, UK.

INITIATIVES FOR IMPROVING MEDICATION SAFETY THROUGH CLINICAL PHARMACY ON THE WARD

Tuovinen K. Wallenius K*. Enlund H

In Finnish hospitals patient medication is based on physician's verbal or written order, which is transcribed onto several documents by nurse. Because administration is generally not recorded in any documents, it is difficult to obtain a complete picture of the medication. Pharmacy's role in patient medication is generally quite modest�9

The aim of this study was to introduce written medication prescribing and documentation procedures and pharmacist's active participation in patient medication dispensing. Also doctor's and nurse's attitudes towards clinical pharmacy services were assessed.

The trial was carried OUt in the oncology ward (40 beds) of Kuopio University Hospital during November Iggl - February 1992. During the first study period patient- specific drug doses were prepared in the pharmacy and during the second period pharmacist dispensed them on the ward. Through the whole study a written medication order form with a two-week monitoring sheet for documentation of the administration were used�9

Ward personnel preferred decentralized pharmacy services and were satisfied with pharmacist's working on the ward�9 AS the administration of drugs was documented, it was possible to monitor the fulfillment of patient medication. Drugs dispensed deviated more often from that prescribed during the centralized dispensing system. Minimized manual transfer of information and a more accurate control of drug administration were the most important advantages of the modified drug order system and the monitoring form. On the other hand, updating and recording of drug changes appeared to be troublesome.

This trial showed that medication safety can be improved through the co-operation of pharmacy and ward personnel. However, the drug prescribing and documentation procedures used in this study still need to be developed further since the forms were not practical enough�9 The attitudes of the waYd personnel were positive, but the introduction of new working routines may easily face resistance because of "increased supervision alld hureaue[acy".

Dept. of pharmacy, University Ito~pttdi of Kuopio, P.O.B. 1777, SF-70211 Kuopio and Dept. of social pharmacy, University of Kuopio, Finland

l}h,m.,i(}, rlbrhl ~ S~w.,c

INTEGRAL QUALITY CONTROL IN HOSPITAL DRUG DISTRIBUTION

A.W. Boeke, E.J. Veenstra. M.A.P.C, van de Poll. K, Nonkes

In many places in the Netherlands the nursing organiza- tion in hospitals is in a state of transition from a functional to a patient oriented one. The resulting nursing organization, also called team nursing, turns the nursing orientation back to their core activities.

However this proces complicates the cooperation with supporting services, e.g. the hospital pharmacy, providing the ward with an unit dose drug distribution system. The risen troubles can't be solved by further protocolizing mutual arrangements. We investigated alternative solutions to restore effective and safe cooperation in the new situation, incorporating principles of integral quality control.

For this purpose Galbraith's contingency theory I was applied. As a result a pharmacy technician was incorporated at the ward adopting the main part of the protocolled nursing tasks concerning drug management. This impli- cated an employee formation transfer of 4 full time units from nursing to hospital pharmacy (373 beds hospital).

We emphasize the meaning of a well-founded application of organization system theory for the quality of the drug distribution proces and for the safety of the hospitalized patient.

Our main conclusion is that the specific, professional knowledge of the (supporting) hospital pharmacy was better operationalized in favour of the safe drug treatment of the patient.

Hospital Pharmacy, Scheperziekenhuis, P.O. Box 30002, NL-7800 RA Emmen, Netherlands

1 Galbraith, JR, "Organization Design", Addison- Wesley, Menlo Park, California, 1977

I N T R O I ) U C T I O N O F D C I - P R E S C R I B I N G A N D G E N E R I C S I N H O S P I T A L M E D I C I N E :

D E F I C I E N C Y O F S E C U R I T Y ?

A P I L O T P R O J E C T IN A SWISS R E G I O N A L HOSPITAL

I. Carlen ~*, M. Tanner:, C. Rcinkc'~ J. Escher~ J. Fischer).,(;;. Marly'

The costs of health care. especially in hospital medicine, are increasing continuously. Measures to lower the costs must be found. We have stndied one possibility in lowering drug expenses: replacement of expensive branded drugs with similar low- priced generic drugs.

In a prospective pilot study the introduction of DCl(Dcnominatio communis internationalis)-prescribing and generics in hospital medicine was investigated for its acceptance and security.

A first period of 6 month before the introduction of DCl-prescribing was compared with a second period after the introduction. 70 patients and all physicians In=10). nurses (n=32). pharmacy employees In=2) replied on lbur occasions: before (t,,). week 3 (L), 12 It:), 24 (tO alter the introduction, to a standardized questionnaire concerning drug compliance, security and acceptance of DCl-prescHbing.

The overall participation in this study was 95% (n=108/114). The first preliminary data (t,, t,) show that DCl-prescibing was estimated as significantly more difficult at h, (70%) than at t, (32%) (p<0.01). Subjectively scored security of drug prescribing didn't change in brand name drug prescribing and DCI-prescribing and was judged as very good by 34% vs 22%. as good by 57% vs 61% and as bad by 0% vs I t%. Time spent for prescription and preparation of drugs increased subjectively in this first period by administrating DCl-prescibing (very much: 8%. much: 76%, clidn't change: 8%). Adverse drug effects didn't increase and patients were not unsecured by generics.

'The conclusions in this phase of the study are: I. The introduction of DCl-prescribing in hospital modicine is practicable and is accepted by most of the concerned persons. 2. While providing good information such an introduction has no additional security risk. 3. The introduction of generics did neither increase drug-induced adverse side effects nor changed drug compliance in our pilot study.

The study is supported by the scientific foundation of the Zentralinstltut der Walliscr Spit:)let. 1950 Sitten and the health department of the state of Valais.

Zcnlrahn,tlmt dcr Walh~cr Spltalcr. IL).'~) Smcn 1, Sch%~cltcnschc~ Tropcnln,mul 4051 B~,cl 2, Phdrln~u'cUll~:hc, l l l~nlu l der Ijnp. orbital ~)51 Bv-~el 3, Obvr~alh~er Krcl~,pl lal. hmere Mcdl/Hl-.~txlo [3ll~ ~=~. ~%% IL/Cr[~LIld.

AN INVESTIGATION INTO HISTANiD4E2-ANTAGONIST PRESCRIBING IN ACUTE MEDICAL WARDS AT WATFORD GENERAL HOSPITAL AND

A LOCAL GENERAL PRACTITIONER'S sURGERY

G.K. Ooi*, A~ Cottle~ A. Savage

The extensive use of histamine 2-antagonist has led to concern for doctmaenting ways in which these drugs are prescribed. This is due to the increasing numbers of agents available, diversity of indications and associated expenditure (Caden et al 1989).

The aim of this study was to investigate whether H2-aaingonists are used appropriately in Watford General Hospital (WGtD and a local general practitioner (GP) surgery.

Over a four week period, all prescriptions for H2 -antagonists in 5 medical wards at WGH and a local GP surgery were reviewed. This study confmmed that there is a high proportion of inappropriate prescribing ie 61% and 51.9% at WGH and the local group practice, respectively. 67.2% of medical in-patients and 76.9% of the GP patients could be converted from ranitidine to cimetidine, in uncomplicated cases. As a result of ward pharmacists' interventions at WGH, we have saved the hospital a total of s per month (28 days) and s (excludes VAT) to the GPs when patients are discharged into the community.

The areas of concern highlighted for this study are: the need for education and training of pharmacists and doctors improving communications between hospital and general practitioners tighter control of repeat prescribing at GP surgeries, and reviewing patients medications on admission to hospital

When analysing the surgary's PACT (Prescribing Analysis & Cost Information) data, GPs blame WGH for initiating ranitidine therapy. However, this study quite positively showed that this is an incorrect assumption.

As a result of this study, it is important that guidelines are devised (in conjunction with District Drugs & Therapeutics Committee), promoting cimetidine as the first-llne H 2- antagonist. Ranitidine should be reserved for patients receiving interacting drugs or for prophyla.xls of NSAID-induced duedenal.ulcer. Such guidellnes should incorporate tbe dosages appropriate to the indications and should be widely available to the local GPs in the community.

Caden B, Littleweed A.M. (1989) "A Drug Usage Review of Ranitidine" Pharm. J. 243, pR52.

This dissertation is submitted in part falftlmant of the requirements for the Diploma in Clinical Pharmacy, School of Pharmacy (University of London).

Dept. nf Clinical Pharmacy, Watfard General Hospital, Vicarage Road, Watford, WD1 8HB.

INVESTIGATION OF CLINICAL ADVERSE REACTION

- SEOATION - OF NEWER HI-BLOCKERS

Gy. So6s, E. Temesv~ri

The classical Hi-blockers -called earlier antihistam-

ines - induce major side effects, mainly sedation at

lower doses then needed for a therapeutic effect. The

question is, can be obtained Hi-blocker without CNS

side effects? It was told, the second generation of

these drugs - T e l d a n e R, H i s m a n a l R, C l a r i t i n e R, Z y r t e c R-

a r e free of sedation, therefore they called non-sedative

antihistamines.

We tried to assess during the clinical practice whether

the fact mentioned above is actually exist or not. We

applied three different methods= patient's diary analys-

is; special psychological questionary, instrumental

determination of reflex times. In every investigational

course were used two of the methods comparatively.

We concluded that the incidence of sedation is 5-10%

during the use of newer antihistamines in contrast to

the classical ones, which cause at least in 30-40%,

and does not exist a solely method to achieve with

an objective evaluation.

Semmelweis Medical University Department of Dermatology

MGria str. &l. Budapest H-1085 Hungary

G ] 6 Ph,.m,.y H',,dd ~. S, , , ' . , ;

INTRAVITREAL GANCICLOVIR IN THE TREATMENT OF CYTOMEGALOVIRUS RETINITIS IN ACQUIRED IMMUNE

DEFICIENCY SYNDROME.

M.C. Montero, M. Pastor*, M.L. Valdivia, C. Buenestado, A. Lluch, M. Atienza, B. Santos.

Cytomegalovirus (CMV) retinitis is the most frequent infection ocular complication of the acquired immune deficiency syndrome (AIDS) and it is responsible for blindness (i).

Since June 1990 (first case) to April 1993, twelve patients (16 eyes) with AIDS-CMV retinitis were diagnosed in the Department of Ophthalmology.

The induction therapy consisted of either intravenous foscarnet or ganciclovir, both intravenous and intravitreal therapy or intravitreal injections alone. After a 2-3 week course of induction therapy, all patients were each treated with one 200-~g intravitreal ganciclovir injection a week until relapse during maintenance therapy.

Vision improved or remained stable in ii eyes and worsened in 5 eyes. Two eyes developed optic neuritis. The retinitis only progressed to the other eye in one of the eight patients who had unilateral involvement. The rate of relapse on maintenance therapy was 8% (1/12) within the first 9 weeks. Treatment was very well tolerated. There was no evidence of toxicity from repeated intravitreal ganciclovir injections: no cataract, retinal detachment or endophtalmitis was observed with a total of 226 injections.

All the patients were able to received AZT or DDI concomitantly.

Intravitreal ganciclovir appears to be an effective ~!ternative to systemic gancic!ovir in those patients with severe neutropenia and in those patients who desire to remain on systemic AZT or DDI. Early treatment and long term maintenance therapy is essential for preserving sight.

1.- Jabs D.A., Enger C., Bartlett J.G. Cytomegalovirus retinitis and acquired immune deficency syndrome. Arch. Ophthalmol. 1989;107:75-80.

Department of Pharmacy. *Department of Ophthalmology. University Hospital "Virgen del Rocio". Avenida Manuel Siurot S/N, 31012-Sevilla. Spain.

MANAGEMENT OF EMERGENCY DRUGS

*Echeverria Roca M., Fernandez Gallastegui S., Alonso Rizaldos C., Arce Trueba M.D.

The Medical Emergency Department in the Cruces Hospital (1300 beds) asked the Pharmacy Department to review the guidelines of drugs used for cardiopulmonary arrest.

Once the new guidelines of cardiopulmonary resuscitation were achieved the clinical pharmacists carried out a review of all the Emergency-drug~ kits placed in the different wards of the Hospital, with the purpose of evaluating their current situation.

The reviewed kits were not found to be homogeneous ~ith regards to the type, quantity and control of the drugs.

As a means of avoiding this diversity, using as its basis the guidelines for cardiopulmonary arrest, a new simplified stock of drugs was established. Index cards, aimed at the nursery staff, were produced providing information about how to prepare and administer these drugs. A control-based system for the re-evaluation of expiry dates was set up operating from the PharmacyDepartment.

With this new system in operation, a greater degree of efficiency in Emergency-drugs kits was achieved, while at the same time overall costs were disminished.

Dept. of Pharmacy, Cruces Hospital, Postbox 48903, Plaza de Cruces s/n, Baracaldo, Vizcaya, Spain.

PHA1LMACEUTICAL CARE: COUNSELLING PATIENTS W I T H DIABETES r Booth & R. Walker*

Diabetes medication counselling is usually undertaken by clinicians or nurse specialists. It is unclear whether there is a role for the pharmacist in counselling these patients. A recent survey undertaken in the diabetic clinic at Airedale General Hospital showed 76% of patients with non-insulin dependent diabetes (NIDDM) considered that it would be useful to discuss their medication with a pharmacisd. As a result of the survey, a medication counselling service was established in the hospital outpatient diabetic clinic for patients with NIDDM. This paper outlines the nature of the service and presents a preliminary assessment of its operation.

The pharmacist responsible for the clinic (CDB) reviews the medical notes of each patient during the week before they attend and identifies those who may benefit from counselling. Patients aged over 70, those receiving more than one oral bypoglycaemic agent, and those receiving concurrent therapies are identified as high priority patients for counselling. On arrival at the clinic, such patients are counselled before they see the clinician. An assessment of the patient's knowledge is made, followed by a counselling session covering topics such as name and dose of diabetic medication, the mechanism of action, possible side effects and what to do about missed doses. The pharmacist also discusses the patient's other medication, and related subjects such as diet, smoking and alcohol. Each counselling session normally takes 10 to 15 minutes.

Two weeks after the clinic, each patient is normally contacted by phone. A repeat assessment of the patient's knowledge is carried out. This follow-up interview allows the patient another opportunity to ask questions regarding their diabetes or drug therapy. Two to three weeks after the follow-up interview a questionnaire is mailed to each patient to assess their reaction to the counselling session.

Four months into the study 40 patients have been counselled and 25 follow-up questionnaires returned. The results of the preliminary evaluation have been encouraging. Twenty-two patients (84%) considered that they knew more about their medication since speaking to the pharmacist, and 11 (44%) stated that they had changed the way they take their tablets. Twenty-three patients (92%) felt that others with diabetes would benefit from discussing their medication with a pharmacist.

This preliminary assessment shows that the counselling service has been well received. By improving the knowledge of patients with NIDDM the safety and efficacy of their treatment should be improved. A counselling service could prove to be cost effective by reducing admissions to hospital.

I. Booth C.D. Do diabetic patients feel that it would be useful to talk to a pharmacist? Poster Abstract. Residential Spring Symposium, UKCPA 1993: 7-8.

Department of Pharmacy, Airedale General Hospital, Keigbley, West Yorkshire, U.K+ and *Welsh School of Pharmacy, University of Wales, Cardiff, U.K.

PHARMACOKINETIC PARAMETERS OF GENTAMICIN IN A POPULATION OF NEWBORNS

I A. Ortega, A. Aldaz, 0. Lacasa, M. Cordovilla, V. Alzina.

High var iab i l i ty of the pharmacokinetic parameters of gentamicin in neonates and the high risk of tox ic i ty using standard gentamicin dosage regimen guidelines have induced during the last years some publications typifying gentamicin pharmacokinetic behaviour of diFFerent newborn populations.

Our purpose in this study was to define the gentamicin pharmacokinetic parameters in our population in order to establish an empiric gentamicin dosing schedule to achieve therapeutic concentrations.

Forty one newborns requiring gentamicin treatment were enrolled after being admitted to the Newborn Intensive Care Unit at the University Clinic of Navarra. Serum concentrations (peak and trough at the steady state) were mesured using the polarized fluorescence immunoassay (TDx). Pharmacokinetic parameters (Vd, Cl, t1/2, Ke) were calculated according to the method of Sawchuck and Zaske.

Patients characteristics including gestational age(GA), postconceptional age (PCA), postnatal age (PNA) and weight (WT) were documented.

Basic stadistic was applied to the results obtained. Means • SD of GA, PNA and WT were respectively 32,04 • 4,31 weeks, 6,34 • 6,6 days and 1765,09 • 865,12 g. And means • SD of Vd, CI, t I/2, were respectively 0,40 • 0,18 I/kg, 0,03 • O,OI I/h/kg and 9,42 • 3,4 h. A coefficient of variation (CV) above 25 ~ was Found in all studied parameters+

In i t ia l dosing schedule according to physician discretion was 2,78 • 1,16 mg/kg/day each 20,07 • 6,07 h. Recommended dose was 2,26 • I , l mg/kg/day each 25,13 • 8,35 hours wich was better correlated with GA (r= 0,7071g) or PCA (r= 0,70475) than with WT (r= 0,6333). But homogeneous groups (CV<25%) based in GA were not possible to be established.

In conclusion, therapeutic drug monitoring is necessary in this population, better at the f i r s t dose. Safe standard dosage regfmens can not be determinated, only i t is possible to establish, based in our population parameters, an in i t i a l dosing guideline in order to minimize toxic i ty incidence.

Pharmacy Service.(1) Ped+atric Department, Neonatal Unit. University Clinic of Navarra. Avenlda Pie XII s/n 31008. Pamplona. Spain.

IV+,+rmdt y [ | ~,rld G ~ Stw.,c . . . . . . . . . . . . . . . . . . . G17

PHARMACY EDUCATION IN HIV/AIDS AND DRUG MISUSE: THE EFFECT ON THE KNOWLED(;E AND A'ITITUDES 01" PHARMACY UNDERGRADUATES.

J.L. Sheredan, l.P. Bates~ D.C. Webb,

Community pharmacists in the UK may become involved in preventing the spread of HIV via the intravenous (IV) route, by providing injecting equipment to drug misusers. However, this is not cumpulsory. In 1989. Glad. identified that only 28% of community pharmacies in England and W',des were involved. ~ Over 6(1% of pharmacy graduates from the School of Pharmacy enter community pharmacy, and as part of their undergraduate course, undertake a course of lectures and seminars on HIV/AIDS and IV drug misusc~ The aim of this research was to: (il investigate student attitudes to these subjects ( i f ) assess fire students' knowledge tff HIV/AIDS till) evMuate any change in level of knowledge or of attitude after aucnding the course. (iv) investigate students attitudes towards the teaching of these subjects.

Final year students were required to complete a qaesdt.nmaire before the course and to complete the same questionnaire two weeks after the last seminar. Only students completing both questionnaires and attending all teaching sessions were included in the an',dysis of results.

Of tOt students, 55 were used in the analysis. The level of knowledge, as assessed by a "Knowledge of AIDS" questionnaire=, increased significantly after attending the course (p<0,005 paired t-test). Students were asked sf they felt confident counselling patients on (al drug misuse, and (b) H/V/AIDS. After the course significantly more responded "Yes", ira) 1:)<0.091, (b) p<0.001 chi"]. There was a significant increase in the number of respondents who felt that "supplying injecting equipmem....cncouraged drug misuse" (I)<0.05 chi") and in the number of students who felt that "IV drug misasers had only themselves to blame if the became HIV positive" (p<0.05 chi-'). Students were asked their opinion on the teaching of HIV/AIDS and drug misuse at fire school. Alter ate course significantly more responded "Good" or Very good" with regard to roaching on (a) g~ci',d issues in drug misuse (p<t')O01), (b) rehabilitation and treatment of tlntg misuscrs (p<0.05 chi-'), tel health education on HIV/AIDS (p<0.0001 chi2).

Thera was no sig/fificam dlange in attitude ~.owards HIV/AIDS and students became more negative in their attitudes towards some aspects of drug misuse. Results from the study indicate that attending the course had the effect of increasing knowledge of HIV/AIDS and increasing confidence in counselling clients. Tire perception of ate teaching of these subjects was alan seen to be more po~itive. As a consequence of these results aspects of the course will be reasscssed.

I. Glanz A, Byme C, Jackson J, Rule of community pharmacies in the prevention of AIDS among injecting drug misuscrs. Findings of a survey in England and Wales. Br Med J 1989; 299: 465-469.

2. Wilt A L, Authoritarianism, km)wledge of AIDS and 'affect n)wards persons with AIDS: implications for Health Education. J. AppL Soc. Psych. 1989; 19:599-607,

The Centre for Pharmacy Practice Research, The School of Pharmacy, Londou University, 29-39 Brunswick Square. Lond~m WCIN lAX, England.

POPULATION PHARMACOKINETICS OF CAFFEINE IN PREMATURE NEONATES

AC. Falcao ~ MM. Fem~ndez de Gatta. F. Nieto Cobo A.C. Alonso Gonz~lez=

J.M Lanao A Dominnuez-Gil

The population pharmacokinetic analysis of caffeine in preform neonates assumes the selection

of a model that explain the interindividuat vadability in the pharmacokinetic parameters as a

function Of physiopathological conditions w=ch can affect their kinetic profile.

The aim of the present work was the selection of this model using clearance (CI) and volume of

distribution (Vd) as dependenl variables, and body weight (BW) and postconceptional age

(PCA) as predictor variables. The clearance and volume of distribution were estimated by using

a single-compartment model with i.v. or oral administration (Srst-order absorption).

The model selection was made using the intt.-mation obtained from 12 patients subpopuiation,

concerning a 25 preterm neonates population, with 27-35 weeks of postconcepbona[ age and

720-1760 gr et actual body weight. Two or more serum levels from each of this 12 patients were

available by routine clinical care. The data fitting to the different models suggested (n=10) was

carried out by the Muiti(ELS) program. The discrimination between models was made by

appropriately statistical cdtenons (Akaike's cdtedon, residual analysis and F-test).

The obtained results suggest the following model as the more accurate one:

CI = P1.BW V d = P2.PCA + P3.BW

This model could be used as a starting-point for the establishment of caffeine population

kinetics, when applied in a target number ol patients. A more complex mode! could be

developed, nevertheless taking in account the scarce available serum levels per patient, in this

kind of population, the number of parameters of the model should be obviously limited.

Department of Pharmacy and Pharmaceutical Technology. Faculty of Pharmacy. University of

Salamanca. Salamanca. Spain.

" Supported by Junta Nacionat de tnvestiga(;ao Cienfiflca e Tecnol6gica (JNtCT) - Portugal

PERMEABILITY OF PROTECTIVE GLOVES TO CARMUSTINE SOLUTION

B. Usselmann G. Carstens

The use of protective gloves is a substantial safety measurement for personnel handling cytotoxic medicines. For enjoying a complete protection it is essential to ensure constant quality on high level.

International quality standards are stated being more or less insufficient as far as special requirements on protective gloves for handling eytotoxic medicines are concerned [1], With the intention to find data more meaningful several investigators examined protective gloves with regard to the permeability to cytotoxin medicines [2, 3, 4]. The permeability of three protective gloves for the preparation of eytotoxic medicines available on the market, one protective glove intending to enter the market, and two nol specialised protective gloves which are used together dudng the preparation of cytotoxic medicines was studied. A test receptacle was filled wdh earmustine solution 3 3 rog/mL The fingertip of a glove was fixed inside out over the test receptacle without dilation in such a way that the outside of the glove was in contact with the carmustine solution and the inside with pudfied water as acceptor medium. Samples of 0.2 ml were taken from the acceptor medium and analysed by high pressure liquid chromatography. After 30 minutes cormustine could be detected in the acceptor medium with only one exception. After 15 minutes carmustine could be detected for the not established glove in 3/10, for the gtove combination in 5/10, for two specialised cytotoxic gloves in 6/10, anci for one specialised r glove in 8/10 cases.

All gloves included in this study have been obtained from colleagues out of general commodity weth exception of the not established glove provided by the producer. We recommend further investigations on the quality of the not established glove as soon as it is available. If the use of only one pair of gloves is preferred protective gloves of proven quality should be chosen.

Acknowledgement We gratefully acknowledge the suppori given by S. Becket, Apotheke des St. Madenhospitals, Gelsenkirehen S. Donislawski. Apotheke des AIIgemeinen Krankenhauses. Hart~urg H. Paul, Zentralapotheke der Mediainisehen Hochschule. Hannover H. Sternkopf, Dep. Arbeitssicherheit, Univecsit~'tskrankenhaus Eppendorf, Hamburg Semperit GmbH, WLen

References 1 Dinter-Heidom H, Carstens G. Comparative study on protective gloves for handling

cytotoxic medicines: a model study with carmustine. Pharm WeekkN [SCI] 1992;14(4):180-4

2 Laidlaw JL, Connor TH, Theiss JC, Anderson RW, Matney TS. Peremeability of latex and polyvinyt chloride gloves to 29 antineoplastic drugs. AM J Hosp Pharm 1984,41.2618-23.

3 Thomas PH. Fenton-May V. Protection offered by various gloves to canT~usfine exposure. Pharm J 1987"238;775-7.

Apotheke der Hennettenstlfiung, MarienstraEe 80 - 90, 30171 Hannover, Deutschland

POST TRIAZOLAM IIYPNOTIC PRESCRIBING

A Burr, "R Walker, G Wilson

Triazolam was marketed in the UK in 1979 as a short acting benzodiazepine. In October 1991 it was withdrawn from the market on advice from the Committee on Safety of Medicines (CSM) following receipt of 402 adverse drug reaction reports. In Wales there was over 44,000 prescriptions written for triazolam in the six months preceding its withdrawal. This accounted for 15% of all hypnotic agents prescribed. Consequently, when triazolam was withdrawn many patients required a review of their medication. The present study was undertaken to identify which agents were prescribed after triazolam was withdrawn and to determine if the agents prescribed were consistent with guidelines circulated at the time.

Data for central nervous system agents prescribed by general practitioners (GPs) in Wales was obtained for the two quarters preceding triazolam's withdrawal (April to September 1991; Quarters 1 & 2), the quarter of its withdrawal (October to December 199 I) and the following two quarters (January to June 1992; Quarters 4 & 5). The defined daily dose (DDD) prescribed per 10130 population/day was calculated for oral preparations in each quarter under study.

The DDDs prescribed per 1000 population/day for hypnotic agents are shown in the following table:

Drug Quarter I Quarter 2 Quarter 4 Quarter 5

Chloral 0.32 0.33 0.41 0.49 Chlormethiazole 0.15 0.13 O. 13 0.12 Loprazolam 0.38 0.60 0.91 0.89 Lormr 0.50 0.51 0.82 0.79 Nitrazepam 12.95 12.87 12.98 12.69 Temazepam 15,59 15,69 1"/,60 17,17 Tr/azofam 5.74 3.47 0.00 0.00 TrlcloEm 0.01 0.01 0.01 0.01 Zoptclone 0.79 0.81 1.10 1.05

There was an increase in the prescribing of loprazolam, lormetazepam, zopiclone and temazepam after triazolam was withdrawn. In the quarter ending June 1992 temazepam had 51.9% of the market compared to nitrazepam (38.3%), zopiclone (3.2%), Ioprazolam (2.7%) and Iormetazepam (2.4%).

It is concluded that intermediate acting benzodiazepines were the main hypnotics prescribed in Wales after triazolam was withdrawn. Moreover, the hypnotic agents prescribed were consistent with the gtudelines circulated to GPs.

Medicines Research Unit, Welsh School of Pharmacy, University of Wales, PO Box 13, Cardiff CFI 3XF, Wales, UK.

PRESCRIPTION OF ANTIBIOTICS IN SURGERY

M P. Ferrelra, M.O Rodfigues, M.E Pereira, M.F. Marques, M.C. Vicente A.P. Carrondo, M.A. Pires, M.A. Granja

Inappropriate use of antdimtlcs is a major factor leading to bactenal resistance, side effects and increasing costs. Therefore our terclary hospital implemented an "Antibiotic Policy": antibiotics were supplied according to an individualized prescription for prophylaxis, suspectod or proven infection. In addition antibiotics were divided in: non-jastified, jasttfied and "in reserve". The objective of this study was to evaluate how surgical departments complied with the established rules. During the first three months of 1993, all antibiotic prescripeorm concerning 1298 patients (age 18-96 years) were analysed, 751 in general and 547 in specialized surgical wards.

Data included: therapeutic objectives, evidence of infection as well as microbiological sensitivity testing, prescribed antibiotics, posology and lenght of administration. Seventy five per cent of all panents had proven infection and 25% had suspected infection. Only 7* mentioned isolataoa of bacteria and tested sensibility to antibiotics. Monotherapy was used in 53% of all patients. Antibiotic assocmtions, mostly ampicilin + gentamicin and clindamycin + gentsmicfu with o r

without amplcthn, were used in 47% of all patients. Antibiotics "in reserve", namely imipanera, were used m only 5%, mainly in severe abdormnal infections and patients with vascular prosthesis.

In conclusion, the basic pobcy rules, such as the use of 1st line antibiotics, are adopted. However the widespread prescription of antibiotics wath higher risk of side effects e.g. clindamycin and gentamicm wnhout supporting microbiolo~ testing and proper control are of great concern and demand further audit intervention.

Pharmacy, Hospital de Santa Maria Lisboa - Portugal

Hospaal de Santa Maria - Farm~cia Av. Prof. Egas Moniz, 1699 Lisbon Codex - Portugal

PREVALENCE STUDY O F UNDERNOURISHED PATIENTS IN A SPAN1Stl UNIVERSITY HOSPITAL.

Authors: Tuneu L*. Serna J,. Said E.. Cerutti P,, (~prOooa D.. Bona1,1,

Introduction: Nutritional status plays a vital role in the morbitity and mortality of inpatients. A malnourished patient is at increased risk for complications and death so it is important to identify these "high risk" patients.

Aim: To establish what proportion of inpatients is undernourished, which main pathologies cause malnutrition and what type of undernourishment is the most frequent.

Materials and Methods: A prevalence study was carried out in order to evaluate the nutritional assessment of 108 patients (56 men, 52 women) ranged in age from 19 to 87 years old. These patients were selected at random from 158 patients who were in the gastroenterology, surgery, traumatology, respiratory and oncologic wards. These wards were selected in order to be the most representative of our hospitalized populations. 108 patients were evaluated because this was the number that let us assess a population of 158 patients, with an estimated error of 5% and an estimated malnutrition frequency of 35 %'. All the patients placed on artificial nutrition (parenteral nutrition and/or onteral nutrition) and the patients who suffered radiotherapy were excluded. The nutritional assessment methods include: serum albumin, triceps skinfold thickness and the arm muscle circumference b. The prevalence of undernourishment was determined in 95% of confidence interval using student's T-test.

Results: In our hospital, the prevalence of undernourished inpatients was from 30.49% to 49.15%. The Kwashiorkor -like was the most frequent type of undernourishment and the wards with the higher prevalence of undernourished patients were the ontology and the respiratory ones.

Conclusion: Despite of the development of new technologies on artificial nutrition a very high proportion of inpatients remain undernourished.

a.- Guarnieri G. Nutritional assessment in hospital malnutritions. JPEN 1 l(suppl) 34- 35, 1981. b.- Gassull MA, Cabrfi E., Vilar A. Protein-energy malnutrition: An integral approach and a simple new classification. Human nutrition. Clinical nutrition 386:419-431, 1984

Pharmacy Dept. Hospital de la Santa Creu i Sant Pau. Avda. Antoni M. Claret. 167.08025 BARCELONA. SPAIN.

A QUALITY ASSURANCE PROGRAMME FOR CLINICAL PHARMACY SERVICES tN AN AUSTRALIAN TEACHING HOSPITAL

D.G.Cosh. F.Abbott, C.P Alderman, F.W.Mav. P G.Peters. S.D.Seott

Repatriation General Hospital Daw Park is a 270 bed acute care geriatric teaching hospital serving Adelaide's veteran community. The hospital's pharmacy department employs five specialist clinical pharmacists.

In November 1992 the department began a quality assurance audit of its clinical pharmacy service with the aim of objectively quantifying the quality of service. Once a week two patients from two different wards are randomly selected. The pharmacists responsible for each patient are required to demonstrate to their peers an adequate knowledge of the reason for admission to hospital, relevant past medical history, the nature of any major biochemical or haematological abnormalities, the admission date and discharge plans. Medication charts are reviewed to ensure that the patient is clearly identified, medication orders are legible, pharmacist annotations are present when needed and are appropriate, and that allergy documentation is accurate.

There are four critical performance indicators (CPI) against which performance is judged:

1. Has the patient been charted for a drug where there is a known major history of allergy, hypersensitivity or definitive contraindication?

2. Has there been a major adverse drug reaction which has not been adequately documented?

3. Is there a dosage rate for a drug of low therapeutic index which is inappropriate?

4. Are the chart annotations incorrect, incomplete, inappropriate or illegible?

In the first six months of operation, 44 patient's records have been reviewed. Failure to meet a critical performance indicator occurred on 9 occasions in 8 patients. Cha~ annotations (CPI 4) were at fault on 7 occasions and one patient failed on both CPI I and 2.

The results have provided some objective measure of the standard of our clinical pharmacy service while participation in the survey on a weekly basis has enabled staff to define in more detail the elements of appropriate clinical practice, and has allowed identification of areas of practice where improvement is required.

Dept. of Pharmacy. Repatriation General Hospital. Daw Park, South Australia 5041

THE QUALrTY OF WRITTEN INPATIENT PRESCRIPTIONS

D Jenkins C Catrns ~ and N D Barbe~r'

In Britain preseripttons are written onto charts which are kept at the foot of the patient's bed and are a unique record of the drugs prescribed and administered. The way in which doctors should write on these charts Ls laid down in the British National Formulary and in local procedures. In this study the qualify of prescription writing was measured against the criteria set in these documents.

The study was conducted at a Distoct General hospital and at a Teaching hospital. A sample of prescription charts of recently discharged patients was drawn from the two hospitals, strahfied by specialty according to the hoepitars discharges in the previous year. One assessor measured each against the standards.

434 charts were examined and contained 4536 prescriptions. Of the regularly prescribed drugs (n=1567) 14% failed to use the approved name and 4% were judged to have illegible or ambiguous names. The dose units were not specified in t% of cases and the units not wntten correctly m 5%; the dose was written incorrectly (for example by using Roman numera{s) m 11% of cases and had been altered, rather than being rewritten, in 4% of cases. The duration of therapy was rarely entered, although the chart has a space for this; 71% of antibiohc prescnpttons had no fixed duration and no analgesic prescriptions had one.

Use of the approved name was more of a problem for the "as required" and "once only" prescriptions. Intravenous fluid additives were illegible or ambiguous 10% of the time and did not use the approved name in 12% of cases. Only 8% of intravenous drug prescrlptrons gave the times at which they should be admmtstered.

Overall there was a reasonable standard of prescription writing by the doctors, however there was room for improvement. The use of approved names is important in Britain where hosptta) pharmacists have the right of generic substitution and label all drugs by the approved name; ward pharmaeists have to correct trade names. However, it is understandable that a prescriber will rather wnte frumil than oo-amilofruse. Unclear writing is a problem that can lead to death and can not be condoned. The use of Roman numerals can lead to , being read as 11, and meg can be read as rag. The practice of defining the duration of therapy ts encouraged, yet there seems to be little response to it, even though it might reduce costs.

The assessment of the quahty of wntten prescriptions should become a routine part of medical audit, This will not only gwe tt a higher profile and support of the medical hierarchy, but will highlight areas where standards are felt to be unreasonabte and allow the development of locally owned standards. In the future computerlsation of prescription wrthng would presumably improve the standard of prescnptton wntmg

The Centre for Pharmacy Practice, The Schoot of Pharmacy, University of London, London WC1N l A X UK (1) Clintcal Pharmacy Unit, St George's Hospital, London

lqmrma O, f ibd,l E~ ~(w.."

vo,,..,e ~ ~, ~. ,~9~ G 1 9

REPEAT PRESCRIPTION REVIEW

S.M. Gammie ". A.J: Burr, R. Walker, D.K. Luscombe

The practice of repeat prescribing by medical practitioners (GPs) may place patients at risk from drug-related problems as a result of inappropriate prescribing. This study aimed to investigate whether a pharmacist could identify drug-related problems from the medical records of patients prescribed six or more items on repeat prescription.

The computerised repeat prescription records of 30 patients (age range 50-92 years, mean 73.9 years) prescribed six or more items on repeat prescription in a general medical practice were accessed by a pharmacist to determine potential drug-related problems.

A total number of 281 repeat prescription items were identified for the 30 patients. The range of items prescribed per patient was 6 to 19 (median 8.5, mean 9.4). Some li3 items (40.2%) had not been issued in the two months prior to the analysis, indicating that they were not being issued regularly and 42 items (14.9%) had only beau issued once. Twenty-seven instances of therapeutic duplication were also noted. The pharmacist identified 123 potential drug-related problems which included problems of inaccurate records (38% of problems), therapeutic duplication (11%), duration of therapy (15%), drug choice (9%), dosage (9%), potential interactions with other diseases (8%), efficacy (7%) and drug interactions (2%). Details of the drug-related problems identified were circulated to the GPs and positive feedback received. As a result, a protooal for repeat prescription review sessions facilitated by pharmacists has been developed and is eurrendy under investigation.

The results indicate that a pharmacist can identify drug-related problems from the medical records of patients prescribed six or more items on repeat prescription. The results obtained have been used to initiate repeat prescription review by pharmacists within general medical practice.

Medicines Research Unit, Welsh School of Pharmacy, University of Wales, Cardiff, UK. CFI 3XF and Mid Glamorgan Family Health Services Authority, Cardiff, UK. CFI 4TW.

REVIEW ~ ITE TREAIi~TS FOR C(]MPASSIONATE USE

CARRIED OUT IN OUR HOSPITAL SINCE 1989

P. Giner Boya, C. Parref~ Ahaga, M.M. Negrado Gcoz~lez, L. Lorente Mansilla

We have carried out a revisico of the trealm~Its for "Ccmpassionate Use" (CU) re(~ested in our hospital sidce 1989 to M~y 1993. The authorization to admi- nister these treatments in our country is granted by the "Ministerio de Sani- dad y CCOSUTO" (Health and Drug #dmintstratien Authority).

procedure followad by the Hospital's Pharmacy for the petition of the treat- r~ t , and the c0ta~ion or adquisition of the drug is hebery described. We have designed a format-sheet for the collection of data. Since 1989 and up ~fcil now 154 treatments have been requested by CU, with 13 drug, in the followin 3 services: Endocrinology, Pediatrics, Balatolocjy, Oncology, AIDS Unit. Fro~ those, 84 patients had mdergone a prior treatment, 70 patie~rLs had not. In 60 cases there were protocols for the treatment and in 38 cases the treat- mmlt was effective or mildly effective. lhe revision of the data gathered yield the following findings: Ith Tne diagnosis for wfiich CU has been most fFe~ently called for are: AIDS,

GR~LL~ENIMLELKCPENIA and AI~]~IA IN PRB~ll/RE NEONAIES. 2th ~ most frequently requested drugs belong to the following therapeutic

groups: ANTIVIRAL (analogous nucleosides), I M ~ T O R S (sti~lators of granulcoytes and macrefagms colonies).

3th Out of the tested tF~atments, a 25% of effectiv~ess has been fo~d in patients. ~ effectiveness of 98 patients not be evaluated due to pre- mature death, AIDS cases...

4th The Medical Services that most frequently requested this type of treat- merit aye: AIDS UNIT, PEDIATRICS and O~OLOGY being 78,13 and 6% of pa- tiB%s treated with regard to the total nLmber of patients treated with CO ~n our hospital.

Phan~cy, Hospital Universitari Germans Trias i Pujol, Badalona,Barcelona,Spaln. Crta de Canyet s/n. Badalma (Y3916

RESPONSIBILITY IN DRUG HANDLING ON THE WARDS FOR TUTORS

AND NURSING STUDENTS.

I Brannstrom

Quality assurance in drug handling on the wards is important An often neglected field is the responsibility in drug handling for tutors and nursing students.

In order to clarify the responsibilites, the pharmacy - in cooperation with the College of Health and Care Sciences and the wards - has made a description containing

�9 what does the law say ? �9 two cases judged by the Responsibility Board for Health and Medical

Care clarifying the limits of responsibihty for the tutors and the nursing students

�9 how to behave as a tutor and a nursing student �9 signature by the tutor and the nursing student confirming that they

have studied the above instructions.

As a complement, the wards have a system for reporting incidents.

The description has been approved by the Regional unit of the National Board of Health and Welfare and the Drug Committee. The contents of the description have been introduced and discussed on the wards in seminars.

Hospital pharmacy, Box 806 S-971 25, Lule~, Sweden

S A F E T Y O F T R E A T M E N T W I T H A M I O D A R O N E - I N T R O D U C T I O N I N T O P R O S P E C T I V E S T U D Y

J . V l~ek l ) , V. P i d r m a n 2 ) , Z. F e n d r i c h 1)

A m i o d a r o n e ha s been p r o g r e s s i v e l y r e c o g n i s e d as a m a r k e d l y effect ive an t i a r ry , t hmic agen t . I t a p p e a r s to be use fu l in the m a n a g e m e n t o f p r e v i o u s l y d r u g - r e s i s t a n t v e n t r i c u l a r a r r y t m i a s a s well a s p a r o x y s m a l s u p r a v e n t r i c u l a r t a c h y c a r d i a a n d a t r i a l fibrilation. T h e c h r o n i c use o f a m i o d a r o n e has been associated with a d v e r s e r eac t ions , i nc lud ing p u l m o n a r y compl ica t ions , n e u r o l o g i c s ide effects, p r o x i m a l musc le w e a k n e s s , v a r i o u s c u t a n e o u s man i f e s t a t i ons , o c u l a r d i s t u r b a n c e s a n d t hy ro id dysfunc t ion . These s ide effects d e c r e a s e t he safety, o f this t h e r a p y . Some types o f u n w a n t e d r eac t i ons o f a m i o d a r o n e a r e dose dependent and t h e r e f o r e the r i g h t choose o f a dose is v e r y i m p o r t a n t for sa fe ty o f pa t i en t s . In the U n i v e r s i t y H o s p i t a l in H e a d e c Krf i inv~ as in o t h e r p a r t o f E u r o p e the l o w e r doses o f a m i o d a r o n e ( l o a d i n g doses - about 600 - 800rag dai ly a n d m a i n t e n a n c e doses - 1000 - 1400rag weak ly ) a r e used c o m p a r e d wi th t he U n i t e d States . T h e r e f o r e we c o m p a r e r e su l t s o f o u r database with those f r o m o t h e r p a p e r s . O u r d a t a b a s e con t a in s all p r o s p e c t i v e e x p e r i e n c e w i th the drug from 37 outpatients during t h e i r r e g u l a r l y v is i t in t he D e p a r t m e n t o f I n t e r n a l Med ic ine o f the U n i v e r s i t y Hosp i t a l . I t c o n t a i n s se t o f ob j ec t ive examina t i ons , w h e r e eff icacy and all known side effects of amiodarone are tested. Results of a questionnaire o f subjective evaluation o f patients concerning drug treatment as wel l as values o f plasma levels o f amiodarone and its a c t i v e m e t a b o l i t e - d e s e t y l a m i o d a r o n e w e r e a lso p u t in the d a t a b a s e . The e n t i r e e v a l u a t i o n s o f the resu l t s s h o w good compl i ance , good ef f icacy a n d low f r e q u e n c y o f s ide effects. T h e c o m p a r i s o n o f o u r p r e l i m i n a r y r e su l t s w i t h l i t e r a t u r e s o u r c e s shows a d e q u a t e sa fe ty for t he use o f l ower doses o f a m i o d a r o n e .

Vrobel R. at al: A general overview of amlodaron~ to.dry: [Is prevention and management. prog. Cardlvasr DI~ 1989, 31:393 - 425

l)Faculty of Pharmacy, Charles University, 2)University Hospital, Charles University., Hradec Knilov~, Czech Republic

STABILITY OF ORNIDAZOLE IN 5% DEXTROSE INJECTION AND 0,9%

SODIUM CHLORIDE INJECTION

*C.Alberola, B. Cast i l lo , C. Gir6n, A. Morell

The s t a b i l i t y of ornidazole at a concentration of 10 mg/ml in 5%

dextrose inject ion and 0,9% sodium chloride inject ion in po lyv in i l

chloride infusion bags stored at room, re f r igerat ion and freezing

temperatures for up to t h i r t y days, was studied.

Ornidazole was diluted to a concentration of 10 mg/ml. Ten admixtu-

res were prepared with each diluent; six were stored at room tempe-

rature (25~ I~C), two were refr igerated (4~ IgC) and two were f ree-

zed (-40~ lgC).

At 0 hours and 2, 7, 15 and 30 days, 2 ml aliquots were removed.

1 ml of each aliquot was diluted to a ornidazole concnetration of

approximately 100 ~g/ml and assayed i n duplicate by a s t a b i l i t y -

indicating high-performance l iquid chromatographic method.

Sample pH and visual inspection was performed at each sampling t i -

me for precip i tat ion, tu rb id i ty , color change and gas formation.

In a l l admixtures, more than 97% of the i n i t i a l ornidazole concen-

t ra t ion remained throughout the study period. No visual or pH chan-

ges were observed. Ornidazole 10 mg/ml in admixtures with 5% dex-

trose inject ion or 0,9% sodium chloride injection stored in poly-

v i n i l chloride infusion bags was stable for up to t h i r t y days at

room temperature, under refr igerat ion and freezing conditions.

Deph. of Pharmacy, Getafe University Hospital. Ctra. loledo, km

12,500. 28905 Getafe-Madrtd, Spain.

A STRATEGY TO I M P R O V E T H E PRACTICE OF ANTIBIOTIC SURGICAl . PROPHYLAXIS

Authors: Castro l*, Farr6 R, Saura R +, P~rez JM. Bonal I.

Introduction : The use o f antibiotics in surgical prophylaxis accounts for 40-60% of inappropriate use o f antibiotics in hospitals. A study performed in gastrointestinal surgery in our hospital showed that about 40 % of antibiotic surgical prophylaxis was incorrect. The main reasons for incorrect prophylaxis were preoperative antibiotic administration time and duration o f prophylaxis. In view of these results, a strategy for the improvement o f surgical prophylaxis was established.

Aim : to establish and assess a strategy to improve antibiotic surgical prophylaxis practice in our hospital.

Method : Strategy carried out was : - review of antibiotic surgical prophylaxis protocols with the consensus of surgeons and Infectious diseases, Pharmacy and Quality Assurance departments, thereby trying to establish a single antibiotic dose whenever possible and fixing antibiotic administration time at the induction o f anaesthesia. The review of protocols has been done in a progressive manner. - establishment of "prophylaxis sets" containing the exact number o f antibiotic doses needed for each type of surgery. "Prophylaxis se ts ' , identified for each patient undergoing surgery (when prophylaxis is prescribed), are sent by the Pharmacy to the operating room, every day. - establishment o f a circuit to be followed for the prescription, delivery, administration and control of antibiotic prophylaxzs. A special form to be filled in by nurses m the operating room in order to control antibiotic administration has been designed. These forms are returned to the Pharmacy, every day. - a preliminary evaluation of prophylaxis practice was made reviewing all the steps of the circuit, calculating also effectiveness, efficacy and efficiency .

Results : The preliminary evaluation gave the following results :

Pre-strategy Post-strategy Prophylaxis administered 62 .2 % 95.7 % Correct prophylaxis 8.7 % 66.7 % Incorrect prophylaxis 91.3 % 33.3 % Effectiveness 1.g % 63.8 % Efficacy 2 .9 % 66.7 % Efficiency 22 .8 % 56.6 %

Conclusions : Based on these results, antibiotic prophylaxis practice, in our hospital, has been improved in those surgeries where strategy was implemented. Consequently the strategy is currently being implemented m the rest of surgeries.

Pharmacy and +Quality Assurance Depts. Hospital de la Sta Creu i St Pau. Avda. Antoni M.Claret , 167. 08025- B A R C E L O N A . SPAIN.

STABILITY OF A RANITIDINE SOLUTION FOR PEDIATRIC USE.

Authors : L.6pez-Calun C. Gart:ia-Caodevda L. Sanz M. Cardona I), Boaal J.

Introduction : Solutions containing ranitidinr in concentrations for pediatric us* am not available from Drug Companies. A solution containing ranitidme 5 mglml was prepared in the hospttal pharmacy and the chemical stability of ranitidine was investigated.

Aim : The purpo~ of this study was to determine the time needgd for ranitidine solution to 1o~ I0 % of the initial concentratmon, using an accelerated preliminary stability study.

Methods : The composition of ranitidine solution is as follows: ranitidme clorhidrat~ 5.6 rag, sodium dihydrogeaphosphate dthydrate 4.2 rag, "sodium monohydrogenphosphate dihydrate 7.11 rag, sodium clofide 4 g, sodium methyl hydroxyhanzoatr 0.7 g, sodium propyl hydroxybenzoate 0. l g, hydroxyethyl cellulos~ 10 g, sorbito170 % 250 ml and distilled water ad 1(100 ml. Thr pH of the solution was 7.0. The sotution glass reservoirs were protected from light and stored at 40oc or 60 =C, The ~mples were tested for both storage rendition at 0,1,3,5 and 8 days. Arrbenius equation at two temperatures, 40 "C and 60 ~ was used to establish the relationship between temperature and speed of reaction. The stability at 25 "C was determined. Ranitidinr coner were determined in triphcate by a validated high perfornmace liquid chromatography method. Standard solutions of ranitidine in blank .solution were made. Curve standards were prepared on different days. Linearity , mtraday and interday precision , accuracy and extraction efficency where studied at different concentrations before the study was carried out. Specificity and degradation products were also tested. Drug recovery at time 0 was considered to be 100 %; all other values were determined from this point. A change of potency of more than 10 % was considered to be significant; less than 90% recovery was considered to indicate instability,

Resu!!s : Assay validation gave linearity (r a > 0.990), mtraday precismn ( < 5 %), interday precision ( < 10%), accuracy ( 95 %) and extracnon efficeney ( > 95%). Tbe first order constants (k) were as follows: k= 4.62.10 "3/day (40 oC), k= 7,88.10":/day (60 ~ and k= 4.24"104/day (25 ~ The preliminary results showed that ranitidine 5 mg/ml .solution stored at 25 ~ loses I0 % of its initial concentration after 248.5 days.

Conclusions : Ranitidine 5 mg/ml solution was chemically stable lbr 248.5 days stored at 25 ~ in glass reservoirs and protected from light. More temperatures should be studied for more complete results.

Pharmacy Department. Hospital de la Santa Creu i Sant Pau. Avgda. Sant Antoni M' Claret 167. 08025 Barcelona. Spain.

TEST OF HOSPITAL PHARMACY PERSONNEL WORKING WITH PRE- PARATION OF ANTINEOPLASTIC DRUGS

Eva Johnsen', Ole Krogsg~rd

The aim of the test was to measure the contamination during preparation of fictive doses of antineoplastic drugs, using a radioactive isotop. The test was carried out at the end of a training periode of new personnel, and repeated after 3 years af continous experience.

Preparation of a fictive dose of antineoplastic drug was carried out with a vial containing 200 mg dry powder Sodium Chloride added 30 - 50 ~i "'~Tc-eluat equivalent to i00 MBq. The contamination of gloves and surgical masks worn during preparation was measured.

The results of the test showed that by the end of the training periode the personnel was able to prepare doses, where the measured contamination was less than i0 ng. After 3 years of routine experience the test results also showed contamination less than i0 ng.

Department of Pharmacy, National University Hospital of Denmark (Rigshospitalet), Blegdamsvej 9, 2100 Copen- hagen ~, Denmark.

Ph,m,,iQ, ll'odd ~ ,%J*mc Volume 1S Nr. 5 1993 G21

THERAPEUTIC DRUG MONITORING IN A GENERAL HOSPITAL

M.O. Rndrigues 1, A. P. Carrondo l, M.C. Vicente I , I. Mesa I , M.E. Perelra 1 , ILL. Pinheim 1, J.A. Mornis 2

In the last few years an increase in the number of patients in intensive care ants, including organ transplantation has b ~ n observed in our hospital. The number of elderly patients has also increased significantly. These patient populations raise special therapeutic drug monitoting problems.

A retrospective evaluation of the volume and =mpact of our TDM service during a thres month period is presented.

Steady-state serum levels were meesuted by FPlA (TDX, Abbott) and EMIT (Cobes Mira, Syva). Posology was individualised in adults by Bayesian software (PKS, Abbott) and in pediatric patients by phannacokinetic calculations based on s~mdard methods, at the pharmacy departulent.

From Janua~ to April 93, we monitored a total of 314 adults and 25 pediatric patients, with age range (23-90 years) and (8 months-3 years) respecUvely, mainly from intensive care ants.

serum total levels/ pesology posology levels patients patient medificafion modification

(n o) (u o) (n*) (n*) %

Cyclosporin A 667 71 9.39* ~ -- Ge, ntanticin 236 102 2.31 45 44.1 Amicacin 96 36 2.07 8 22.2 Netilmicin 50 26 1.92 7 26.9 Vancomyciu 175 53 3.30 18 34.0 Theephylline 87 43 2.02 15 34.9 Methotmxate 34 g 4.25 - -

The table shows the number of serum level determinations, and of patients with posology modification based on pharmaeakanetic parameters. Antiepileptic drugs are not included.

The average number of determinations per patient was 2.65 (excluding CsA (*) due to the fact that a pre-transplant test with AUC determination was performed in 14% of these patients).

The average percentage of posology modification was 32.4% with respect to the total number of patients, w~th a minimum for amieacin (22.2*/0) and a mammum for gentamicin (44.1"/,).

These values show the need for ranintaining and improving the work in this unit.

(1) Pharmacy, Hospital de SP Maria (2) Faealdade de Farmlicia, Universidade de Lisbea

Hospital de St= Mann - Farmficia - Av. Prof. Egas Moniz 1699 Lisbea Cndex - Portugal

TOTAL Ct lOLESTEROL LEVELS IN IIYPERTENSIVE PA'FIENTS TREATED WITt l DIURETICS AND ACE INnlBITORS: A COMMUNITY PllARMACY-BASED STUDY

Bia_tql Marques FJ "~ Pharm.D., Cupola HS~ Pharm.D., l~mlngues P, Pharm.D.~Feio .IA~ Pharm.D. and Siha ('~ Pharm. D.

Chnical studies suggest that thm/Ide diuretics ma?. increase coronary heart deaths, passibl.', through their influence on blood liptds Thin/ides hax e been sllmsn to mcrease total cholesterol of about In'V,,. Deleterious influences of ACE mlubttors on hpid profiles ha~e not h.-en described. Tile present stud)' ~as undertaken to c~alUalC adxcrse changes m total cholesterol reduced I~. flnazldes compared to ACE mh=baors

A controflcd prospacnve cross-sectional stud), xsas carried out based on a conmltlnit) phannac). H?.pencnsive patients attending the pharlna~ ~lth a prescription of a thmzlda or an ACE inhibitor xscre reviled to participate m the study. Patients mccting the following cmcria xscrc cxcludcd: lasting of antihspertensisc therapy less than thc 6 previous months, diabetes mclhtus, rcnal end/or hepatic lmpatrmcnt, h)poth.~roidism, secondau, r h)perhpidacmia and an.,,' of thc foflos~mg drugs, anti- h.', perhpldacmies, glucoconicoids, oral contraceptives and Ocstrogcns. Patients x~erc e',aluated according to a stud) protocol, comprising demographic data. blond pressure

(BP) Imm HgL body. mass index (BMI) IQuetelet's indcxl and total blood cholestcrdi (TC) (mmal/ll collection. TC xsas measured using the Lipotrend C kfl. Txsenty patterns xsith a median age of 65 (range 4o-84 xcars) x~ere recruited oxer a tx~o monflls pane4. 12 ~sere on thia/adas and ~ on ACE inhthitors. Results arc presented as mean (SEY

number males females ~ stolic BP diastohc BP BMI TC Total 20 9 II 165(6.6) 89(3.4) 28.6(0.8) 5.2 Th iaz.ides t2 3 9 157(69) 86(4.3) 28.7(I.II 5.0 ACE inhib S 6 2 164(12.4) 93(5.4) 2S.3(I.4) 5.3

Differences in TC le,,cls bct~ccn groups were not found and TC Icxcls x~erc not mcreased in tile thlazldes group. Diastolic BP ~alues ~erc posstively assocmtcd wlth TC. Also a positive association bct~ccn TC and BMI ~as found for patients on ACE inhlbitors, x~hde the same association ~as negative for patients on thtazidcs. Tile results lead us to extend the stud?. ~ ' increasmg the somplc stze and mcluding a health) control

group to investigate the present trends. Focus also should be inade in the stad) of hpld profiles in patients taking ACE inhthaors The rctanonship betx~een BMI and TC m both groups ~sarrants further invcsttgation. This study also proves the feasibdit 3 of porforming climeat research ~. comnlunit?, pharmaclsts, since it has been dcsigocd, conducted and anal)sed m a communit?, pharnmc).

('OlSl BR. t. PIIA U ~,IA('O'I 11ER.~, p~l s.r 11 oy (;rOl'p .~t PART.Sl}O 11178 - 3(RN ('(11~,IIIRA, PORT('GA1.

THE USE OF 'DECISION SUPPORT WINDOWS" IN SAFE HANDLING OF DRUG INTERACTIONS

C. I .Las td rage r *. T .Scha l ekamp *. I.J. de Gier ", G .W.H. R u t t e n **

Decision Support Windows (DSW's) have been designed to provide a 'one screen overview' on risk factors and relevant risk management options in computerized medication surveillance. The purpose of this study was to determine the use of DSW's by General Practitioners (GP's) and Community Pharmacists (CP's) in handling drug interactions. During a period of 3 months 27 GP's and 27 CP's, all users of the Pharma- com/Medicom system for medication surveillance, were involved in using the DSW's developed for 13 drug interactions. All participants were instructed to use DSW's whenever one of the 13 drug interactions was detected and to indicate risk factors (if present) and selected management options. Results revealed that only 22.5% of GP's and CP's did use the DSW accordingly. This rather low score was partly due to the high incidence of repeat medications (80-90%) in drug interactions (generating alerts for the second or third time in the same patients during the study-period), and the significant proportion (39%) of prescriptions (once) ordered by medical specialists. In these situations DSW's are not considered to support an action or a change in strategy. These results will be discussed with respect to better communication tools needed to provide feedback on earlier communication with prescribers and decisions taken before pertaining to the same situations. Finally, the possible use of DSW's in quality assuran- ce programs will be discussed. It is concluded that DSW's are expected to provide management options in handling drug interactions, primarily when the drugs are prescribed and dispensed for the first time to patients.

* C o m m i t t e e f o r M e d i c a t i o n S u r v e i l l a n c e , H e a l t h B a s e F o u n d a t i o n ,

V a n E e d e n s t r a a t 7, 2012 EL H a a r l e m , T h e N e t h e r l a n d s

** P h a r m a P a r t n e r s R & D , S l o t l a a n 15, 4 9 0 2 A D O o s t e r h o u t , T h e

N e t h e r l a n d s

V A N C O M Y C I N R E Q U I R E M E N T S D U R I N G RENAL R E P L A C E M E N T T H E R A P I E S : H E M O D I A L Y S I S vs C A V H D

MA Moral ' . MA Maniacs . MC Rivers, M Vilan0va, I Mattei. A Roalan*. J Serna. J Bonal.

Vaneomycin is widely used for the treatment of infections by gram-positive bacteria in patients with acute renal failure (ARF).Two commonly used renal replacement therapies are: intermittent hemodialysis (IHD) and continuous artariovenous hemodialysis (CAVHD). These techniques have different ability to remove endogenous solutes, so drug clearances are also expected to be different.

The aim of this study was to compare the dispOsition and dose requirements for vancomyoin in intensive care tIC) patients with ARF, undergoing either IHD (Group A, n = 5 ) or C A V H D (Group B, n=41 and documented infection requiring vancomycin therapy.

Nine adult patients were included. Patients in group A (2 females, 3 males) had a mean age of 62 years and a mean weight o fT0 ks. Patients in group B (4 males) had a mean age of 58 years and a mean weight of 77 kg.lnitial Vancomycin doses ranged from 500 mg to 1250 mg (infusion time 1-2 hours). Serum levels were determined frequently by Fluorescence Polarization lmmunoassay (TDx',Abbott) . Individual vanenmycin pharmacokinetic parameters were estimated by nonqinear regression applying ADAPT PC Program (USC Laboratory of Applied Pharmacokineties, L .A. California) using a one-compartment open model. A dosage schedule was established in order to achieve vancomycin levels within the therapeutic range.

Pharmaeokinctlr Vd (L/kg) CI (L/h) TI/2 th) Paramet~

IlID Mean 1.0126 0.5681 103.17 (n=5) Group A Range 0.9068-1.1936 0.3306-0.8484 53.1-168.8

CAVnD Mean 0.6729 I. t 100 32.57 (n=4) Group B Range 0.5229-0.9069 0.7682-1.3040 27.1-40.11

As vancomycin clearance in CAVHD patients was twice as much as that of IHD patients, dose requirements were lower in the latest group. The biggest difference between the two groups was found in the elimination half-life. The mean value of the volume of distribution (Vd) was higher for group A. However, all patients in both groups had Vd values within those reported for vanenmycin in patients with ARF (0.5- 1.4 L/ks). These results suggests that patients undergoing 1HD or CAVHD require the same initial vancomicyn doses, but the recommended dose interval has to be longer in IHD. Close therapeutic drug monitoring is mandatory in patients receiving renal support. Periodic determinations of vancomycin revels should be performed taking into account that dose intervals can vary from 4 days to a fortnight in IHD patients and from 2 to 4 days in C A V H D patients.

Pharmacy Dept. and *Intensive Cam Unit. Hospital de la Set Crcu i St Pau. Avda. Antoni M. Claret, t6"L 08025 - BARCELONA. SPAIN.

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