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The challenge for the designer in pharmaceutical packaging – Designing for an improved level of patient compliance. Ashley Wiltshire Royal College of Art Innovation Design Engineering 04 October 2013 Word Count 9931

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Contents List of Illustrations 1.0 The Industry 1.1 Patient Compliance - Introduction 1.2 The pharmaceutical industry and the cost of non-compliance 1.3 NHS Effect 1.4 Regulation 2.0 The stakeholders 2.1 The person/patient 2.1.1 The Engaged Patient 2.1.2 The power of patient empowerment 2.2 The Doctor/GP 2.3 The Nurse 2.4 The Friendly pharmacist 2.5 Hierarchal Decisions 3.0 Design philosophy 3.1 Assumptions 3.2 Foundations 3.3 Implications 4.0 Design Process 4.1 Current process approach 4.2 What is missing? 4.3 Marketing power 5.0 Design delivery 5.1 Typo – Point Size & Language 5.2 Similar Name Different Effect 5.3 The Information Problem 6.0 Recommendations 6.1 Relevant to the industry 6.2 Relevant to the stakeholders 6.3 Co-creation - change the game 6.4 How the process can change 6.5 Interactive ways designers can improve adherence 7.0 Conclusion Bibliography Appendix

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List of Illustrations

Figure 1: Pharmaceutical Packaging Rack Photograph by Martin Lewin (2012) http://www.projectfreerange.com/wp-content/uploads/2012/10/Processed-9220.jpeg (28 February 2013) Figure 2: Reasons for Medication Non-Adherence Graph part of the study by P. Micheal Ho (2009) http://circ.ahajournals.org/content/119/23/3028/T1.expansion.html (8 April 2013) Figure 3: Self-Managed Patient Image provided by Ernst & Young (2012) Beyond Borders 2012 Ernst & Young (2 June 2013) Figure 4: Plastic Pill Box Photograph by Julia Losa (2013) Figure 5: ALMUS medication packaging Photograph by Maria Florio (2013) Figure 6: Multiple Medication Image Photograph by Maria Florio (2013) Figure 7: Daily intake print on foil packaging Photograph by Maria Florio (2013) Figure 8: Modern Prescribed Medication Packaging Photograph by Ashley Wiltshire (2013) Figure 9: Printed label Photograph by Ashley Wiltshire (2013) Figure 10: MWV’s Avive multiple medication dispenser Image provided by MWV (2013) http://www.meadwestvaco.com/mwv/groups/content/documents/image/mwv040456.gif (25 May 2013) Figure 11: Self-Expiring Packaging Image by Kanupriya Goel, Gautam Goel (2013) Self-Expiring http://www.red-dot.sg/en/online-exhibition/concept/?code=688&y=2012&c=14&a=0 Figure 12: Nike iD website customisation page Image by Brian Betschart (26 July 2007) http://www.sneakerfiles.com/wp-content/uploads/2007/07/nike-zoom-kobe-ii-hit-nike-id-1.gif (20 September 2013) Figure 13: Medication Instruction Icons Image by Haejin Song (June 4 2013) http://dribbble.s3.amazonaws.com/users/72948/screenshots/1099510/d.png (20 September 2013) Figure 14: Screenshot of Experientia Concept Video Image by Ashley Wiltshire (2013) Experientia, ‘Experientia - The Pharmacy of the Future - 03 Alison’ http://www.youtube.com/watch?v=jHuQazVO4AQ

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1.0 The Industry

1.1 Patient Compliance - Intro

Patient compliance (also known as adherence) is the degree to which patients take their medication

‘as prescribed’. Globally, compliance is below 50%, meaning half of all pharmaceutical medications are

never taken or taken incorrectly. This problem contributes to a loss of £250 billion for the industry

and 200,000 deaths each year.1 This dissertation aims to demonstrate how a shift in design philosophy

and execution can help improve this massive problem for both the patient and pharmaceutical

companies.

Over the course of the last year I have become heavily involved in a start-up company focussed on

improving health and wellness of people in the United Kingdom. The aim is to bridge the gap between

the healthcare industry and the patient by making healthcare a more human experience. The research

and work conducted over the last year has led me to question the philosophies behind how

healthcare and pharmaceutical products (specifically pharmaceutical packaging of prescription drugs)

fail to appeal to and understand the consumer, the patient. (fig1).

Arriving at the Royal College of Art last October allowed me to step back from the zoomed in view I

had on healthcare and take a more balanced approach to what is a big problem for not only the NHS

but medication users as well. I see this dissertation as an opportunity to consider to what extent does

the graphic design of pharma (pharmaceutical) packaging impact on the users interpretation of

medication use.

Through interviews I aim to uncover:

• What are the challenges designers of packaging face on improving patient compliance?

• How do patients feel about the current state of medication packaging in the UK and what

are there concerns?

• How do people deal with handling multiple medications with multiple designs at one time?

                                                                                                               1  Glen  Giovannetti,  Gautam  Jaggi,  Siegfried  Bialojan,  et  al.  “Beyond  borders:  Global  Biotechnology  Report  2012.”    

Ernst  &  Young.  2012.  

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• Why has pharma failed thus far when other areas of design that deal with millions of people

have excelled?

Clarity on the above questions will help this research paper explore and understand the possibility of

enabling and empowering patients to take direct action when feeling confused or unsure with the

medication information provided by erroneous packaging design. This paper will encompass thoughts

and prospective views on the handling of graphic design of medical packaging in the future, whilst

taking into account the bigger picture of the pharmaceutical industry and looming changes to the

National Health Service in the United Kingdom.

Figure 1: Martin Lewin, Pharmaceutical packaging rack 2012

It is estimated that a third of medication errors in the NHS are caused by confusion over packaging

and labelling instructions2. This section will analyse how and why some modern medication packaging

fails to clearly communicate the use of its contents.

                                                                                                               2  “Design  for  patient  safety:  A  guide  to  the  graphic  design  of  medication  packaging.”  NHS.      

http://www.nrls.npsa.nhs.uk/resources/?EntryId45=63053  (accessed  10  February  2013)  

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The Helen Hamlyn Centre has released two editions of a study titled ‘a guide to the graphic design of

medication packaging’. These studies are used as a guideline to gain an understanding of the

background material and subject matter surrounding pharmaceutical packaging. There are on average

900,000 recorded adverse events in the NHS every year.3 This is a substantial amount that could be

reduced through an increase in patient compliance of medication.

1.2 The Pharmaceutical Industry – cost of non-compliance

Looking across the Atlantic at the individual patient who does not take their medication or finds it

difficult to understand the directions, then we can see that patient non-adherence in the United States

is costing their healthcare system between $100-289 billion annually4. In the UK, primary studies have

been conducted by The Aston Medication Adherence study and initial reports claim that £300 million

is lost to medication misuse and non-use in the United Kingdom5 annually.

This is a remarkable statistic and raises questions as to why the problem exists, a graph6 created by P.

Micheal Ho as part of a study into the effects of non-adherence of medication and its importance in

cardiovascular outcome proposes reasons why. Low-literacy/language problems, vision problems, and

most integral to my study is the poor quality of provider-patient relations, something that Tomlinson

stated as well, as these can be directly related to the importance of packaging clarity and patient-

specific design, something I cover later in the paper.

                                                                                                               3  “About  patient  safety.”  NHS.  http://www.nrls.npsa.nhs.uk/about-­‐us  (accessed  10  February  2013)  4  “Interventions  to  Improve  Adherence  to  Self-­‐administered  Medications  for  Chronic  Diseases  in  the  United  States:  A    

Systematic  Review.”  Meera  Viswanathan.  http://annals.org/article.aspx?articleid=1357338#r3-­‐6  (Accessed  April  10,  2013)  

5  “Action  on  medicine  wastage  and  improving  medicine  use.”  Lord  Howe.  https://www.gov.uk/government/news/action-­‐on-­‐medicine-­‐wastage-­‐and-­‐improving-­‐medicine-­‐use  (Accessed  18  April  2013)  

6  Ho,  P.  Michael,  Bryson,  Chris  L.  and  Rumsfeld,  John  S.  .  “Key  Issues  in  Outcomes  Research:  Medication  Adherence:    Its  Importance  in  Cardiovascular  Outcomes”  Circulation,  2009  Jun  16;  119(23):  3028-­‐35.  Accessed  April  10,  2013  http://circ.ahajournals.org/content/119/23/3028.full#cited-­‐by  

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Figure 2: P. Micheal Ho, Reasons for medication non-adherence, 2009

To further rise this cost, patients have been oversubscribed medication, which just ends up as waste

and the BBC reported that around £300 million is wasted due to this every year7.

In response, doctors have been urged to stop over-prescribing with the article stating that

‘Pharmacists say this would be easy to do - if doctors offered more tailored, personal advice to

patients and stopped prescribing large amounts of drugs to cover long periods of time.’ Clearly, there

is a breakdown in communication and understanding across the channels from pharma company

down to the pharmacist.

1.3 NHS effect

The NHS is on its way to no longer being a free health service to the population of the UK. Changes

to the way services are conducted, funded and situated will come into effect as early as April 20148.

NHS Trusts will apply to become Foundation trusts, effectively privately run, privately funded

institutions which in turn affects the costing and opportunity for patients to receive care and

consistent care shall they need it.

                                                                                                               7  Chittenden,  Stephen.  “Doctors  urged  to  cut  medicine  prescription  waste.”  BBC.  July  22,  2013.    

http://www.bbc.co.uk/news/health-­‐23374000  (Accessed  September  21,  2013)  8  “Supporting  all  NHS  Trusts  to  achieve  NHS  Foundation  Trust  status  by  April  2014.”  DoH,  NHS.          

http://www.wsh.nhs.uk/AboutUs/TrustBoardMeetingsandPapers/2011/July29th2011/Item13bWestSuffolkTFAFinal.pdf  (Accessed  September  20,  2013)  

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The challenge for the designer here becomes additional layers of complexity and decision-making.

There is no longer one governing body to approach to make changes made to existing packaging

design. Before this break and redistribution of services in the NHS, uniform change may have been

harder to convince the MHRA of but it would have taken affect throughout the service with greater

fluency. With for-profit care institutions such as Virgin Care and CARE UK already operating many

general practices9 it will add further distance from the end user; patient and the drug producer, GSK

for example.

1.4 Regulation

It is known that advertising pharma goods in the public domain is banned, as it cannot be seen to

entice the patient. In contrast to this point, there is a difference between advertising and empowering

a patient to want to get better by taking their medication. Though the strict regulations regarding

usability are also a reason why there haven’t been radical changes to the way packaging has become

more personable.

I enquired about the process that a pharmaceutical company has to go through when they want to

change an aspect of their packaging. It all depends on whether it was in the licence initially granted by

the governing body, in the UK it is the Medicines and Healthcare Products Regulatory Agency

(MHRA). Wilson gives a clear, extensive example of the process required to make changes to existing

packaging design.

“As a global company the design of the packaging has been rolled out on a global level and follows

strict branding guidelines, which is then adapted to suite the individual countries regulations.

In the UK, if you want to make a change on a National level, UK only, then a variation must be

submitted to the MHRA. Depending on the extent of the change and which category it falls under,

this can take anywhere from a few weeks to years to be assessed and approved by the MHRA.

Also, depending on the category of variation, a fee is paid for each product licence that the change

affects.

                                                                                                               9  Davis,  Jacky,  and  Raymond  Tallis.  NHS  SOS:  How  the  NHS  was  betrayed  –  and  how  we  can  save  it.  London,  One  World,    

2013,  p.191-­‐192  

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So, the Regulatory Affairs team within in the company will prepare the submission package and submit

the change to the MHRA. During the time the MHRA asses the change they may have questions or

request further changes that Regulatory Affairs team will need to respond to.

Once the MHRA approve the change they will notify us of the approval and the date it was approved.

We, the pharmaceutical company will then have 6 months to implement that change. The 6 months is

deemed as the date the first batch is released following approval. So, if the implementation date was

30/09/2013. Any batches released after this date must include new artwork.

To implement the new artwork we have a change procedure we must follow. This requires

generating a change document and tracking the change with the suppliers who are located throughout

the EU. We liaise with them to communicate when the new artwork must be used depending on our

orders and demand.

Finally when the product is release onto the market with the new artwork we can close out the

change to make sure the artwork has been implemented within the six month timeframe.”10

This extremely, extensive process is clear to see that any change made would be very time consuming

and I imagine cost consuming as well. With this knowledge in mind I will move on to discuss and

explore the stakeholders I believe are integral to the designing taking new routes and methods in this

field.

                                                                                                               10  Wiltshire,  A;  “Questions  on  the  challenges  designers  face  in  improving  patient  compliance  through  pharmaceutical    

packaging.”  Interview.  September  2013    

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2.0 The stakeholders

The company that I work for place patients and people at the centre of all we do, this shift in how

healthcare is delivered is part of a growing paradigm described in Ernst & Youngs – Beyond Borders

study. The ultimate goal of this, is the self-managed patient who is part of a community of caregivers,

pharmacists, doctors and other medical care workers to ensure that feedback and input comes from

all levels of interaction. These kind of networks are described as “collective intent care networks”

and if the designer is truly interested in involving themselves in improving patient compliance, the use

of the model (Fig. 3) would go a long way to understanding the prospective changes in care delivery.

Figure 3: Ernst & Young, Self-Managed Patient, 2012

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2.1 The person/patient

2.1.1 Engaged patients

The Kings Fund UK ran a project into inquiring the quality of general practices and on the subject of

patient engagement and states that:

‘It is used to describe patients’ engagement in primary care consultations regarding their own health,

care and treatment.’11

Through working for the healthcare start-up I can comment on my experience in meeting engaged

patients that they have the self-efficacy to maintain their treatments, as well as have the confidence to

share their experience with others, help friends and family in understanding their own ailments and

problems as well as feel empowered about their lives in a way that has rarely been seen before.

2.1.2 Power of patient empowerment

The potential for patients to gain control over their compliance of medication has never been more

exciting. The range of products that aim to give the user an understanding of their health, their sleep

patterns, their dietary needs have all been welcomed with open arms, yet there is nothing to really

combat the chance of human error, forgetting to take your medication, or not having the knowledge

at hand or the confidence to gain the knowledge about the medication. This is why patient

empowerment is critical to improving patient compliance. The designer is suitably positioned to

create an intervention and it excites me to see how this approached in the coming years.

2.2 The Doctor/GP

I have conducted several interviews enquiring patients aged over fifty to begin to understand what

they feel is missing from their medication experiences and to what extent they feel their GP plays a

role in their adherence. In response to three questions this is what they had to say.

Is it clear what each medication aids with?

                                                                                                               11  Parsons,  Suzanne  and  Winterbottom,  Anna  and  Cross,  Peter  and  Redding,  Don.  “The  quality  of  patient  engagement  and    

involvement  in  primary  care.”  2010.    http://www.kingsfund.org.uk/sites/files/kf/field/field_document/patient-­‐engagement-­‐involvement-­‐gp-­‐inquiry-­‐research-­‐paper-­‐mar11.pdf  (Accessed  September  21,  2013)  

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‘Most of the time its clear but the explanation could be clearer as not all patients understands the

Medical terms.’ And ‘Yes, as GP explains to me what each medicine is for.’

Do you read the small print information that comes with the medication?

‘No I don’t read the small print as I don’t understand all the English and rely on my daughters to

explain.’ And ‘Yes I always read the small print but at times can be quite difficult to understand due to

the technical terms that are used, so that could be simplified.’

If you are confused or do not understand the medication, what support do you get?

‘If at anytime I need further support I will go back to see my GP or go to pharmacy.’ And ‘If I am

confused about aspect of my medication I would return to see my doctor.’

It was clear to me when speaking with Vincenzo that some patients rely heavily on their GP if there is

any confusion and to couple this with their busy lifestyles and fear of embarrassment, the likelihood of

them returning to the GP is time consuming to get an appointment and the chance of non-adherence

rises with the feeling of pressure to get their point across in a short appointment time.

 

This is something that I consider as an outcome of the system failing earlier in its cycle and that it is

important to look at what potentially is the root cause.

‘With an average slot of 5-8 minutes per patient, doctors protest that there is not enough time for

the increasing number of tasks involved in routine consultations. Shortage of time is considered a

major obstacle to the realisation of a more patient centred medical practice that actively involves

patients in treatment decisions.’12

                                                                                                               12  Pollock,  Kristian  and  Grime,  Janet.  “Primary  carePatients'  perceptions  of  entitlement  to  time  in  general  practice    

consultations  for  depression:  qualitative  studyCommentary:  Managing  time  appropriately  in  primary  care.”  BMJ  2002;325.  September  28,  2002.  http://dx.doi.org/10.1136/bmj.325.7366.687  (Accessed  September  19,  2013)  

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It may be beyond the call of the packaging designer but the chance to improve compliance through

GP notes on medicinal packaging could further improve user understanding and trust in medication.

2.3 The Nurse

When a patient has multiple medications to take, there are existing methods of breaking up the mass

of pills into daily intake; morning, evening and night consumption. Nurse Losa, offered an insight into

where there is an issue here, stating that although the plastic box is a good idea, especially for

polymedicated patients, it is difficult when the patient is asked, what pill they take, they often don’t

remember the name nor do they have the packaging due to the placement in the plastic box.13 (Fig.4)

Figure 4: Julia Losa, Plastic Pill Box, 2013

When asked in her experience as a nurse, what works and what does not work with current

packaging, Nurse Losa states:

“On one hand, as a nurse, the thing that is very helpful for us at the hospital is that the external

packaging of the medication is different and you can see totally in a clear way the administering use of

it. Some medications are very similar in packaging and it does not work, for example there are the

same medication (and the same packaging of it) with other concentration (like potassium chloride

                                                                                                               13  “Questions  for  a  Nurse  on  the  effectiveness  of  medicinal  packaging.”  Ashley  Wiltshire.  In-­‐depth  interview.  (Accessed    

May  24,  2013)  

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blisters) or some medications which at first view you can confuse because they are the same blisters, I

mean, you must read it for differentiate it (for example, the potassium chloride blisters and the

smaller saline solution blisters)

For me that is essential when we have an emergency, for take action fast. Moreover it works for us

for not commit a mistake.

On the other hand, in my opinion, a good and clear packaging works with patients as well, above all

when we are talking about polymedicated patients. Things like the days of the week in the metal film

that cover the pills are important in some drugs that they have to take day by day.”

2.4 The Friendly Pharmacist

Designers must look beyond just the patient to product compliant packaging, the pharmacist has a

growing role in the say of how pharmaceutical medicine is distributed and their insights and

experience cannot be overlooked, they are often the bridge between the patient, their medication

and the doctor or GP. If the designer took the approach of ‘designed with people’ and included

pharmacists in the design process I believe that outcome would tackle the issue with stronger insights.

Rob Darracott states that,

“Although we would like to see pharmacists on the governing bodies of clinical commissioning groups,

we are pleased that the important role of pharmacy has been acknowledged by the Government..

..Pharmacists see more people, more often, even more than GPs do so the advice and support they

will give to commissioners will be vital.14”

‘In addition, the research suggests that pharmacists can play a greater role in mitigating the

occurrence of error, through reviewing patients with complex medicines regimens at a practice level,

and in identifying and informing the GP of errors at the point of dispensing.15’

                                                                                                               14  Darracott,  Rob.  Government  acknowledges  pharmacists  role  as  an  important  source  of  expert  advice.  Pharmacy  Voice.    

June  21,  2011.  http://www.pharmacyvoice.com/press/government-­‐acknowledges-­‐pharmacists-­‐role-­‐as-­‐an-­‐important-­‐source-­‐of-­‐expert-­‐a.  (Accessed  May  20,  2013)  

15  Avery,  Tony  P.,  et  al.  “Investigating  the  prevalence  and  causes  of  prescribing  errors  in  general  practice:  The  PRACtICe    

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2.5 Hierarchal Decisions

By looking at a series of four different medications from the same supplier, ALMUS, in Fig. 5 it is

evident that consideration has been made to the order of information, at close inspection, the

audience for the medication is clear, GPs and Pharmacists as elements such as the name, dosage and

colour bands are the clearest attributes, not when or how often they should be taken.

There is however some consideration for the end user to differentiate between medications through

several indications. There is an image of the tablet type on the box, which serves as an aid if patients

keep their medication in a day-use box, and the colour of the tablet and also the name of the

medication in a white semi-bold typeface. In Fig. 5 the bottom right packaging, the label indicating the

most important information for the user is miniscule actually covers the dosage reflecting the lack of

attention to placement for end user instructions in this instance.

                                                                                                                                                                                                                                                                                                                             Study  (PRevalence  And  Causes  of  prescrIbing  errors  in  general  practiCe)  A  report  for  the  GMC.”  GMC.  May  2012.http://www.gmcuk.org/Investigating_the_prevalence_and_causes_of_prescribing_errors_in_general_practice___The_PRACtICe_study_Reoprt_May_2012_48605085.pdf  (Accessed  May  20,  2013)  

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Figure 5: Maria Florio, ALMUS medication packaging, 2013

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3.0 Design Philosophy

3.1 Assumptions

Pharma packaging companies have many considerations to take into account when researching and

designing their packaging and there are five modern trends to help create the best all round

packaging. These areas have a major impact and often cause much of the limitation to the packaging,

restricting designers from making change. The five areas include unit-dose packaging for greater

dosage control, packaging against counterfeiting, non-invasive permeation testing, child-resistant

packaging and eco-friendly pharma packaging.

Some would argue that having to include so much into a design of a product makes the packaging

companies some of the most innovative and in credit to the general success of the evolution and

development of packaging, it has been achieved. The change to single dose dispensing of medication

users is a big part of the shift towards self-managed care.

‘ "With more of a focus on outpatient care and the self-regulation of medicine, there's greater onus

on patients to take the right medications in the right amount," said Dow Chemical senior research

scientist Jill Martin at a medical devices conference on 13 February 2012, in Anaheim, California, laying

out the future trends of pharmaceutical packaging.’16

The US National Center for Biotechnology Information released an in depth study of the future

trends and future of pharmaceutical packaging17 which covers the five modern trends previously

mentioned. It goes into detail about how the graphics, printing and outer-carton packaging play a huge

role in keeping the medication secure from counter-fitting. Providing a wealth of information on

techniques a company may use but very little on how the future of packaging will effect or attempt to

effect patient compliance. The mention of how the rise of care managed at home will mean packaging

will take on a different form, such as prefilled syringes but nothing about creating engaging products.

                                                                                                               16  Butschli,  Jim.  “Dosage  control,  biologics,  driving  material  considerations.”  Pack  World.  February  13,  2012.    

http://www.packworld.com/applications/healthcare/dosage-­‐control-­‐biologics-­‐driving-­‐materials-­‐considerations.  (Accessed  September  22,  2013)  

17  Zadbuke,  Dr.  Nityanand,  et  al.  “Recent  trends  and  future  of  pharmaceutical  packaging  technology,”  J  Pharm  Bioall    Sci,  no.  5  (April-­‐June  2013):  98-­‐110.  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3697200/.    (Accessed  September  23,  2013)  

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The concluding thoughts of the study make clear a challenge for the designer in self-administered

therapies stating ‘When self-administered drugs are in lyophilized or dry powder form, manufacturers

must find methods or packaging systems that help prevent accidental needle stick injuries, inaccurate

dosing, and drug spray-back. Manufacturers familiar with the drug administration process must

provide delivery systems that simplify drug reconstitution, especially for non-professional caregivers.’18

3.2 Foundations

‘Healthcare is delivered in many different contexts and patients’ sensory, physical and mental

capabilities vary greatly. Design solutions have to address these factors.19’ This is the opening

statement from the guide to design for patient safety. Designers have tackled issues with medication

packaging by employing the international type language, often known as Swiss design. The potential

users for medication packaging have extended and the requirements of them as well.

The guide to patient safety highlights the potential problem with coloured packaging stating that ‘if a

single colour is used for a whole range of medicines it can be difficult to identify a specific product.

This is compounded if medicines with similar names are stored next to one another. If a patient is

prescribed a number of medicines with the same colour packaging, there is an increased chance of

them taking the wrong one.20’

3.3 Implications

The use of the international type style has given medication packaging a grid and a hierarchy to its

information ordering. This has made for easier reading and tackled the main issues of distinguishing

medication from other similar types. The use of this style has removed the feeling of empowerment

to the product which could be found in the design of cosmetic or cologne industry, this lack of

personality and drive for clean simplistic visuals may be a cause for patient non-compliance (Fig.2).

                                                                                                               18  Zadbuke,  Dr.  Nityanand,  et  al.  “Recent  trends  and  future  of  pharmaceutical  packaging  technology.”  J  Pharm  Bioall    

Sci,  no.  5  (April-­‐June  2013):  98-­‐110.  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3697200/.  (Accessed  September  23,  2013)  

 19    “Design  for  Patient  Safety.”  National  Patient  Safety  Agency.  2007.  Pg.7  http://www.hhc.rca.ac.uk/CMS/files/NPSA-­‐  

Design-­‐for-­‐patient-­‐safety-­‐.pdf,  pg.7,  (Accessed  April  18,  2013)  20  “Information  design  for  patient  safety:  A  guide  to  the  graphic  design  of  medication  packaging.”  HHRC.  2007.    

http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=129650&  pg.55(Accessed  May  20,  2013)    

  19  

It is well known that medical packaging cannot be seen to advertise directly to people but an emotive

reaction or belief in health improvement counts for a lot21. This is a question I raise, whether

disrupting and re-imagining the entire style used for medication may be a drastic move, it could raise

the opportunity to re-categorise the hierarchy, bring about a new sense of confidence in patients and

focus on improving patient compliance.

As the baby-boom generation ages, the likelihood of quick killers like cancer and heart attacks has

dropped22 and the biggest fear for the seniors of our time is the degradation of their mental health.

The increased likelihood of degradation of mental and physical health in later life in turn leads to an

increase in medication intake. ‘The average 75 year old has three chronic conditions and uses five

different prescription drugs.23’ This not only causes the patient to have a schedule to stick to but to

feel confident that taking five different drugs can help improve their health. In Fig. 6 you can see all the

medication that Vincenzo, the elderly gentlemen I interviewed takes everyday, eight different

medications, a day.

Figure 6: Maria Florio, Multiple medication use, 2013

                                                                                                               21  Boskey,  Elizabeth  Dr.  .  “Health  Belief  Model:  Use  of  a  condom  may  hinge  on  perceived  risk.”  About.  March  24,  2010.    

http://std.about.com/od/education/a/healthbelief.htm  (Accessed  September  20,  2013)  22  “The  Concern  With  Aging.”  BBC.  Audio  Programme.  March  2,  2013.  http://www.bbc.co.uk/programmes/p014wlnp    

(Accessed  May  20,  2013)  23  Moore,  Margaret  J.,  Moir,  Phyllis,  et  al.  “The  State  of  Aging  and  Health  in  America  2004.”  MIAH,  CDC.  2004.    

http://www.cdc.gov/aging/pdf/State_of_Aging_and_Health_in_America_2004.pdf,  (Accessed  May  20,  2013)  

  20  

4.0 Design Process

4.1 Current process approach

To be able to deconstruct the problems with patient compliance, it is helpful to understand how

packaging design works currently. Packaging plays an important role in the self-efficacy of a patient.

The language, the design including the colours, form, shapes are the patients first interaction with

their medication before consuming. Better understanding of packaging and a more positive interaction

with their medication can lead to better compliance.

This section encompasses two in-depth interviews with packaging designers and how they feel about

the history of packaging as well as their views on the room for innovation in packaging design. They

shares their opinions on the future of medicinal packaging and why it may not be as easy as changing

the packaging of a typical commercial product.

The interview started by raising questions over why patient non-compliance is on the rise and who is

to blame if any. Tomlinson’s response was that patients and the GP’s are to blame. Dispensers of

packaging should be accountable for the some of the issues raised with patient’s problems with taking

multiple medications. He states that there could be more done to differentiate the products under

current laws and legislation.

Further questioning in to why pharma packaging fails to engage with the end user as effectively as

progressive areas of design such as airport services or online shopping was explained as being two

fold. ‘Drugs aren’t packaged for the benefit of the end user’ with the dispenser as the main audience.

Pharma packaging has been ahead of the curve in regards to their efficient colour coding and symbol

systems but it in Tomlinsons words ‘it is unfair to suggest that drug packaging hasn’t progressed when

one looks at old pharmacies where the products might have been snake oil rather than a cure for

anything.’

Whilst Wilson argues that by stating “I believe this is because of how heavily regulated it is. The

patients safety is the number one priority for pharmaceutical companies and the MHRA (Medicines

and Healthcare products Regulatory Agency) who regulate medicines in the UK.

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Also, with so many guidelines on what can and cannot be done, you are limited with the design. Not

only does the packaging need to be easily readable and identifiable for the patient, but also for the

pharmacist dispensing the medicine to ensure the patient safety.”

I questioned Wilson and Tomlinson on the current process of designing packaging and Tomlinson

started by offering an insight, stating,

“Unfortunately it has been quite a while since I worked on packaging. So can only really talk

accurately about marketing the drugs. The biggest ones are the amount of information that must be

displayed dependent on the type of advert produced.

All text must also be above 1mm in x-height and the language used on the ad can't say what the

product treats or encourage people to buy it. The adverts are therefore more intended to inform

pharmacists of its existence rather than promote it over competitors products.”

With Wilson responding by stating, “I have only worked in the industry for 6 years and haven’t seen

too much change in that time. Some of the key guidelines to follow are; to make sure the font size is

not below the minimum, ensure the correct space is allocated for the dispensing label, braille is

positioned correctly, pharmaceutical form and dosage is clearly identifiable and key warnings are

highlighted.”

There has been an increased interest in the analysis of pharmaceutical packaging over the last fifteen

years and the Helen Hamlyn Centre for design has produced two studies that cover the common

problems of legibility and clarity of information printed on packaging. These studies have helped

disseminate the existing challenges and have highlighted areas of improvement for interested parties in

pharmaceutical medication adherence. In recent years the media has brought to light the problem of

patient non-adherence24 and shown a greater interest in potential solutions25 to the issues faced.

                                                                                                               24  Ledwith,  Mario.  “One  in  three  patients  does  not  take  medication  properly  putting  their  health  at  risk  and  costing  the    

NHS  half  a  billion  pounds  every  year.”  Daily  Mail.  February  18,  2013.  http://www.dailymail.co.uk/health/article-­‐2280363/One-­‐patients-­‐does-­‐medication-­‐properly-­‐putting-­‐health-­‐risk-­‐costing-­‐NHS-­‐half-­‐billion-­‐pounds-­‐year.html,  (Accessed  May  20,  2013)  

25  Andrews,  Michelle.  “New  ideas  to  help  people  take  medications  correctly.”  LA  Times.  March  21,  2011.    

  22  

This investigation aims to question the role designers can create for themselves in pharmaceutical

packaging by deconstructing medication aesthetics, medication information and multiple medication

use. Understanding a patient’s position in all of this is essential to the study and will be referred to at

given stages of the case studies. Given that there is a minimal amount of user studies that have been

conducted regarding packaging interpretation, the approach taken by Helen Hamlyn’s studies will be

used as a guide. My aim is to learn first hand, where has it been going wrong and why, and to look at

the potential for how designers can create user-focussed solutions for individual medication

adherence.

The areas of focus for the issues are chosen with the intention of instigating direct changes or swift

alterations to existing design and investigative thoughts for long-term benefit to the patients of the

National Health Service.

‘Packaging design should take into account the needs and capabilities of the widest possible range of

potential users, and in particular older and partially sighted users, and how they interact with the

medicine in the home.26’ This point coupled with the aging baby-boom generation will only increase

pressure on pharmaceutical dispensers to provide a more bespoke medication experience and ensure

patient compliance.

Medication packaging has changed and has responded to feedback from patients, such as the

introduction of daily consumption labels on the foil seal (Fig. 7) and enlarged consumption

instructions printed onto the front and back of outer packaging. So where can these changes be

further improved? What could a designer implement to the design to raise patient compliance? Why

have improvements been limited to these minor changes, why such a conservative approach?

                                                                                                                                                                                                                                                                                                                             http://articles.latimes.com/2011/mar/21/health/la-­‐he-­‐medication-­‐labels-­‐20110314.  (Accessed  May  20,  2013)  

 26  “Design  for  Patient  Safety.”  National  Patient  Safety  Agency.  2007.  Pg.10  http://www.hhc.rca.ac.uk/CMS/files/NPSA-­‐  Design-­‐for-­‐patient-­‐safety-­‐.pdf,  (Accessed  April  18,  2013)  

  23  

Figure 7: Maria Florio, Daily use print on medication film, 2013

Fig. 8 is an example of the contemporary packaging provided by dispensers for a months’ use of a

drug. This is a relatively new form of packaging for a long dosage of a drug. Noticeably there is a use

of different colours for each week, as well as the strength labelled above the pills. The black bar to

the right gives indication of the dosage and is one of the clearer examples of prescribed drug for long-

term use.

Figure 8: Ashley Wiltshire, Modern Prescribed Medication Packaging, 2013

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4.2 What is missing?

What is missing from the packaging that is currently causing errors, miss-use or disuse of

pharmaceuticals? ‘Errors may occur when key information appears in an inconspicuous place on the

label, is presented in an ambiguous manner, or is overshadowed by less important information .The

print may be less than optimal in size, boldness, or contrast. Highly stylized graphics, superiorly

positioned corporate names, or logos may distract from the primary purpose of the label’27 This

uncovers an underlying problem that the priorities of information display and layout could be

considered to be in an ineffective order for the pharmacist and consumer.

Cohen also comments that, ‘complicating the situation is that labels are often read under less-than-

ideal conditions (e.g., in a patients room at night when lights are dimmed, or by paramedics working

on an accident victim).’28

The ISMP recommend that the drug name and strength are the most important pieces of information

and should appear close to one another in the same field of view. This recommendation is of huge

importance when considering the layout of information. But this does not account for consumer

scenarios. Pharmacy stock rooms and shop shelves are well lit and the medication is displayed in an

ordered fashion. This may not be the case with a home pharmacy cupboard or bathroom shelf.

There appears to be a lack of consideration for the situations, which the medication will be used

beyond the shelf or pharmacy shelf. This could be challenged with the use of colour, paper stock of

packaging and treatment of packaging.

With any changes made to the packaging, Dr Ted Lithgow comments stating ‘Pharmaceutical

packaging must adhere to stringent regulations that require material traceability, good manufacturing

practices (GMPs), consistent quality, product protection, and often child-resistance.29’

                                                                                                               27  Cohen,  Michael  R.,  The  role  of  Drug  Packaging  and  labeling  in  medication  errors,  Washington,  D.C.  American  Pharmacists    

Association,  2007,  p.111  28  Cohen,  Michael  R.,  The  role  of  Drug  Packaging  and  labeling  in  medication  errors,  Washington,  D.C.  American  Pharmacists    

Association,  2007,  p.111  29  Lithgow,  Dr.  Ted.  “Six  steps  to  pharmaceutical  packaging  sustainability:  Through  proactive  planning,  regulations  need    

  25  

The main objective of pharmaceuticals in general is ‘Sustaining positive patient outcomes. Being

socially sustainable also includes developing packaging that is effective, safe, and promotes medication

adherence.’

‘Effective adherence packaging has a positive impact on health outcomes. For example, convenience

blister packs are designed to remind patients to take medications correctly and on time, reducing

patient medication omissions and errors, and enhancing the treatment outcomes of those

medications.30’

When raising the question of whether there is room for innovation within pharma packaging and

improving patient compliance Tomlinson31 replied by talking about how more effort could go into

differentiating drug packets once they are out of their boxes. Suggesting that coloured foil could be

used on to break up the dosage of pills. Although he goes on to state that this would not work for

the demographic of hard of sight and blind so the solution would need to be more broad.

Designers must make the decision whether to follow the route of research and development, looking

at the short-term future, or to work through research, looking outside the contained principles of

existing products, with the ambition of creating something beyond.

4.3 Marketing power

Outside the realm of a designer’s role in creating compliance based packaging is the power of

marketing. Since the 1940s direct-to-consumer advertising has been banned for the simple reason

that it works: adverts distort doctors prescribing behaviour – by design – and increase costs

unnecessarily.32 After the relaxing of rules to allow side effects of drugs to be abbreviated, there was a

                                                                                                                                                                                                                                                                                                                             not  be  a  hindrance  to  environmentally  friendly  pharmaceutical  packaging  practices.”  Healthcarepackaging.  June  2009.  http://www.healthcarepackaging.com/sustainability/strategy/six-­‐steps-­‐pharmaceutical-­‐packaging-­‐sustainability.  (Accessed  May  25,  2013)  

30  Lithgow,  Dr.  Ted.  “Six  steps  to  pharmaceutical  packaging  sustainability:  Through  proactive  planning,  regulations  need    not  be  a  hindrance  to  environmentally  friendly  pharmaceutical  packaging  practices.”  Healthcarepackaging.  June  2009.  http://www.healthcarepackaging.com/sustainability/strategy/six-­‐steps-­‐pharmaceutical-­‐packaging-­‐sustainability.  (Accessed  May  25,  2013)  

31  Wiltshire,  Ashley.  Questions  on  the  challenges  designers  face  in  improving  patient  compliance  through  pharmaceutical  packaging.  In-­‐depth  interview.  September  2013.    32  Goldacre,  Ben.  "Bad  Pharma:  How  Drug  Companies  Mislead  Doctors  and  Harm  Patients."  London.  Fourth  State.  2012.    

  26  

rise in marketing budget from $200 million to $3 billion in just a space of a few years.33 With this huge

amount of money being put to marketing drugs opposed to the research and development of drugs it

is no wonder that there are many drugs misused. Almost twice as much is spent on marketing and

promotion as spent on research and development. 34

                                                                                                                                                                                                                                                                                                                             p.247  

33  Goldacre,  Ben.  "Bad  Pharma:  How  Drug  Companies  Mislead  Doctors  and  Harm  Patients."  London.  Fourth  State.  2012.    p.248  

34  Goldacre,  Ben.  "Bad  Pharma:  How  Drug  Companies  Mislead  Doctors  and  Harm  Patients."  London.  Fourth  State.  2012.      p.245    

  27  

5.0 Design delivery

5.1 Typo – Point Size & Language

It is the responsibility of pharmacies, chemists and general practices to print the instructive directions

for medication use. These instructions are the most important part of the medication, for the patient.

Yet in all of my experience and time spent using prescribed medication, the legibility of the type has

always been on the small side (fig.9) the legal minimum being point size 1, it is also stated as a

suggestion in the study for patient study, claiming to ‘use bold or semi-bold type and avoid lightweight

type. It is important to note, however, that too much bold or semi-bold type can also impair

readability if in a very small point size.35’ This not just the case for me, "Health literacy is a big issue,"

says Allen Vaida, Pharm.D., executive vice president of the Institute for Safe Medication Practices

(ISMP) in Pennsylvania. "Even college grads can have trouble when it comes to understanding terms

that health-care workers use."36

Figure 9: Ashley Wiltshire, Printed Label, 2013

It is not just the legibility or the size of the typography, which causes confusion or misuse of

medication, it is the language used as well. A 2007 study in the journal Patient Education and

                                                                                                               35  “Information  design  for  patient  safety:  A  guide  to  the  graphic  design  of  medication  packaging.”  HHRC.  2007  

http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=129650&  pg.69(Accessed  May  10,  2013)    36  “Can  you  read  this  drug  label?”  Consumer  Reports.  June  2011.  http://www.consumerreports.org/health/best-­‐buy-­‐  

drugs/prescription-­‐labels/overview/index.htm  (Accessed  May  20,2013)  

  28  

Counselling found that one-third of patients did not realize that "two tablets by mouth twice daily"

meant taking four pills in a 24-hour period. This is a clear indication of the gap between the

understanding of the medicinal organisations and the needs of patient themselves. Designers of

consumable products should always aim to communicate the product as clear as possible using the

most appropriate language, why has the MHRA responded to the rising waste of pills, material and

packaging? Why not focus on improving patient adherence to save not lives but precious millions the

NHS will be losing.37

5.2 Similar Name, Different Effect

I had the opportunity to interview a nurse to gain an insight and hear of medication handling by staff

for patients. Nurse Losa, told me of a tragic case where medication was needed in high pressure

situation and that through the similarity of aesthetic packaging, the wrong medication was

administered and the ultimate cost was paid in the loss of life of a baby. This was down to many

factors outside of the medication but right at the core was the painful reminder of human error and

in an environment like a hospital these cases cannot be allowed to happen, hence such a strict design

structure and storage system aimed at doctors, nurses and pharmacists to differentiate.

The PRACtICe study covered mis-prescribed medication and highlighted one potential development

in this field and that by ‘promoting the effective use of clinical computer systems for safe

prescribing,38’ the chances of misuse can be reduced. Doctors and nurses alike do not have the time

to administrate whole documents of personalised data but as I will go on to state, the future looks

prosperous if a humanised medication architecture is implemented, this is an interesting field for the

designer to become involved in, producing patient specific templates solely targeted at health-care

practitioners.

                                                                                                               37  McDowell,  Andrew  and  Barnett,  Nina.  How  improved  medication  adherence  can  prevent  costly  medicine  waste.  HSJ.    

February  9,  2012  http://www.hsj.co.uk/resource-­‐centre/best-­‐practice/qipp-­‐resources/how-­‐improved-­‐medication-­‐adherence-­‐can-­‐prevent-­‐costly-­‐medicine-­‐waste/5041067.article#.UkSu1mTWH48  (Accessed  September  20,  2013)  

38  Avery,  Tony  P,  et  al.  “Investigating  the  prevalence  and  causes  of  prescribing  errors  in  general  practice:  The  PRACtICe    Study  (PRevalence  And  Causes  of  prescrIbing  errors  in  general  practiCe)  A  report  for  the  GMC.”  GMC.  May  2012.http://www.gmcuk.org/Investigating_the_prevalence_and_causes_of_prescribing_errors_in_general_practice___The_PRACtICe_study_Reoprt_May_2012_48605085.pdf  (Accessed  May  20,  2013)  

  29  

5.3 The Information Problem

This leads on to “the problem of the modern world is not information poverty, after all, but

information overload, and even more precisely, what Clay Shirky calls ‘filter failure’…The exciting

future, for evidence based medicine, is an information architecture that can get the right evidence to

the right doctor at the right time.”39 Now what about getting the ‘right’ information to the ‘right’

patient on time?

Based on a study into how long it would take for a doctor to keep up to date with release of papers

on new drugs, it would take twenty-nine hours each weekday, which is, of course, not possible.40 This

in turn affects their knowledge of prescribing patients the most effective medication for their

condition. This missing information and potential knowledge could be a future pitfall for ensuring the

right medication is prescribed, without a designed information database for doctors, this simply will

not be possible.

Of course it isn’t just having a design system for all this information which could improve patient

compliance, there are ‘factors at a number of levels were identified as contributing to these errors.

These included a lack of training in the skill of prescribing, distractions and a failure to fully utilise

existing IT solutions for safer prescribing.41’

                                                                                                               39  Goldacre,  Ben.  "Bad  Pharma:  How  Drug  Companies  Mislead  Doctors  and  Harm  Patients."  London.  Fourth  State.  2012.    

p.241-­‐242    40  Alper  BS,  Hand  JA,  Elliott  SG,  Kinkade  S,  Hauan  MJ,  Onion  DK,  et  al.  “How  much  effort  is  needed  to  keep  up  with  the    

literature  relevant  for  primary  care?”  J  Med  Libr  Assoc.  2004;92;429-­‐37.  (Accessed  June  1,  2013)    41  Avery,  Tony  P.,  et  al.  “Investigating  the  prevalence  and  causes  of  prescribing  errors  in  general  practice:  The  PRACtICe    

Study  (PRevalence  And  Causes  of  prescrIbing  errors  in  general  practiCe)  A  report  for  the  GMC.”  GMC.  May  2012.http://www.gmcuk.org/Investigating_the_prevalence_and_causes_of_prescribing_errors_in_general_practice___The_PRACtICe_study_Reoprt_May_2012_48605085.pdf  (Accessed  May  20,  2013)  

  30  

6.0 Recommendations

6.1 Relevant to the Industry

Innovations aren’t necessarily just in the packaging of the medication but the makeup of the

medication itself. An Oxford Professor has been working on such a concept, proposing that it could

save the NHS and the pharma industry millions in waste medication.

“Professor Lionel Tarassenko CBE FREng FMedSci, from the Department’s Institute of Biomedical

Engineering, has been working with colleagues from the Medical Sciences Division on the first UK

clinical trials of a ‘texting pill’ that contains a tiny silicon sensor, which triggers the sending of a text to

say the pill has been swallowed. This follows a UK study, which found that £300  million a year is spent

on medicines that end up being thrown away. Part of the wastage is due to people not taking

medication, called ‘non-compliance’.”42

The product proposed may sound promising but there would need to be a system around it, who

pays for the texts, how to know if the pill was consumed and not placed in a glass of other liquid.

How to ensure an elderly person keeps their mobile charged. Many questions rise out of a product

that could be developed without working alongside the end-user themselves.

I believe that, a product will not solve the issue but a culmination of change, in attitude, dispensing

and consumption. There is however one product that has received a lot of praise recently, and that is

the Avive customized multi-medication 30 day dosing system goes some way to being a product that

starts to incorporate patient input, linking with doctors and dispensers and tackling the growing issue

of multi-medication dosages.

‘2012 Compliance Package of the Year: …Avive was developed with input from patients and

pharmacists, resulting in a patient-customized solution that simplifies daily dosing for patients on

multiple medications. The ready-to-dispense, script-filling pharmacy service is designed to increase

                                                                                                               42  University  of  Oxford.  “Tiny  sensor  in  pills  could  save  the  nhs  millions.”  University  of  Oxford.  2013.    

http://www.eng.ox.ac.uk/public-­‐relations/news/tiny-­‐sensor-­‐in-­‐pills-­‐could-­‐save-­‐the-­‐nhs-­‐millions  (Accessed  September  21,  2013)  

  31  

medication adherence, provide convenience for patients and allow more time for pharmacist-

customer counselling.43’

Figure 10: MWV, Avive Packaging, 2013

Observing the issues surrounding distinguishing medicine, it has been noted from the ALMUS figure

that packaging from the same company often uses different colours to distinguish between medicines

but the guide for patient safety covers the point that a colour coding system enables people to

memorise colour and match it to a function. ‘No colour coding system could differentiate between all

12,000 medicines authorised in the UK.. ..Furthermore, in the absence of a national or international

colour code, any UK system could become a barrier to trade.44’

Due to the effects of the drug, Warfarin, it is universally colour coded brown for strengths of 1mg,

blue for strengths of 3mg, and red for strengths of 5mg.45 Meaning that for the most important drugs,

designers should look to ‘use opposing, meaningless colours to distinguish between medicines with

similar names in a manufacturer’s range. An awareness of users with limited colour perception should

                                                                                                               43  “HCPC  Announces  This  Year's  Compliance  Package  of  the  Year  Winners!“  HCPC.  2013.    

http://www.hcpconline.org/compliance-­‐package-­‐winner.html  (Accessed  April  19,  2013)      

44  “Information  design  for  patient  safety:  A  guide  to  the  graphic  design  of  medication  packaging.”  HHRC.  2007    http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=129650&  pg.55(Accessed  May  24,2013)  

45  “Information  design  for  patient  safety:  A  guide  to  the  graphic  design  of  medication  packaging.”  HHRC.  2007.    http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=129650&  pg.55(Accessed  May  24,  2013)  

  32  

be developed.46’ Highlighting older generations whose vision is more likely to deteriorate is an area

where specific settings could be applied to the label and directions, this sort of data could be stored

on the patients electronic record notifying the pharmacist of the users visual requirements.

A solution to helping the hard of sight visually understand when medication has past its expiry won

the reddot design award 2013 in the packaging category. It notifies users with limited sight and those

who aren’t when a medication is past expiry date, by using layers of film on top of the blister pack,

the ink slowly seeps through over time from the moment it is first packaged to a point where it

signals the expiration of the medication.47

Figure 11: Kanupriya Goel, Gautam Goel, Self-Expiring Packaging, 2013

Blister packs have proved to be an effective form of packaging, sealed and airtight from production,

they provide a sense of individual use and visual direction. It is important to account for the strength

of the medicine and that it is clearly labelled throughout the use of the medication to ensure safe

use.48 Because without this taken into account ‘mixing packages and blister strips up could lead to the

patient taking the wrong medication or even overdosing.49

The visual requirements of pharmacists and dispensers have been met through an effective use of

symbols and colour coding. With the progression of our health records becoming digital, could there

                                                                                                               46  “Information  design  for  patient  safety:  A  guide  to  the  graphic  design  of  medication  packaging.”  HHRC.  2007.    

http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=129650&  pg.59(Accessed  May  24,  2013)  47  Goel,  Kanupriya  and  Goel,  Gautam.  “Self-­‐Expiring.”  RedDot.  2013.  http://www.red-­‐dot.sg/en/online-­‐  

exhibition/concept/?code=688&y=2012&c=14&a=0  (Accessed  September  20,  2013)  48  “Information  design  for  patient  safety:  A  guide  to  the  graphic  design  of  medication  packaging.”  HHRC.  2007.    

http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=129650&  pg.70(Accessed  May  24,  2013)  49  “Information  design  for  patient  safety:  A  guide  to  the  graphic  design  of  medication  packaging.”  HHRC.  2007.    

http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=129650&  pg.70(Accessed  May  25,  2013)  

  33  

be the option to have a digital health account with a limited level of customisation to the labels that

are in preference to the users visual needs but meet MHRA regulations. A commercial example of

customisation system working effectively with constraint is the Nike iD franchise, whereby a

customer can change the colours, materials and type applied to the shoes.

Figure 12: Brian Betschart, Nike iD website customisation page, 2007

Packaging has been titled as the problem of patient adherence for the last decade and only last year

was news of Smart Packaging, posted on Pharmaceutical-technology.com ‘Another intelligent

packaging system already proving popular on the market is the GlowCap from Vitality. Winner of the

HCPC's innovative design in its compliance packages of the year awards in 2009, the design has

attracted a lot of attention. It can illuminate, play a melody, send a text message or call a phone over

a wireless network to prompt patients to take their medicine. It also has an embedded 'push-to-refill'

button that connects to the pharmacy to automate refills.’ This is a great example of a customisable

and multi-faceted packaging device that begins to connect with modern life’s social tools and an

attempt to break down boundaries.

  34  

The progression in packaging design with the end-user in mind is slowly becoming a bigger issue for

pharmaceutical manufacturers and health services alike.

Overall, it appears as though the pharma companies and the research associates will continue to re-

invent the existing products and pills they already have on the market and a fresh outlook or

approach to how to improve patient compliance may come from the rise of wearable computing,

something the designer will find more accessible initially but problems arise when data collecting and

sharing with companies put patient confidentiality at risk.

6.2 Relevant to the stakeholders

Designers have clearly played a role in the update of this packaging and taken measures to distinguish

one medication between another. But is there a way to incorporate the printed labels that come from

the pharmacy into the grid or format of the medication to provide a clearer understanding of the

purpose of the medication? These dot-printed labels could become a humanised part of the solution

by utilising the graphic language used in UX design. Web icons have become extremely useful and

familiar for users of the Internet so by taking inspiration from this language, could one be created for

labelling. For instance, introducing prompts or schedule icons for consumption (Fig. 13) could be used

to improve patient compliance.

Figure 13: Haejin Song, Medication Instruction Icons, 2013

  35  

From a patients’ perspective Ben Goldacre’s book, Bad Pharma, gives them a chance to grasp the not-

so-hidden agendas of pharmaceutical conglomerates like GSK and formulate their own opinion on

how to approach pharmaceutical use in the future. It shall be up to the designer to seek out

pharmaceutical companies that show willingness and an honesty to change current methods,

contribute funds to long-term benefits and give the minor and major changes suggested a chance to

flourish.

In the last few years we have seen electronic consumer products come on leaps and bounds with

improved wireless connectivity, increased tactile response in the products and more accurate

sensors. These progressions have brought a range of condition monitoring bands to the market.

Products like the JAWBONE UP and Nike Fuel are two popular examples of this where citizens

concerned with their health are taking an active decision to invest in a product to keep them on top

of their diet, sleep patterns and exercise plans. These devices also act as a clock, vibrating reminder

and data storage device to link with smartphones, PCs, etc.

Earlier this year, Jawbone launched an ecosystem for UP, letting other applications on the market

utilise the data collected by the fitness band50. This, in the first instance is extremely positive for the

cross-use of data in different products that has not been seen for much of the last decade in

consumer electronics. It also provides many opportunities for the designer to create and tailor an app

for medication adherence. Providing empowering tools for generations of smartphone users to track

their schedule and to keep them up to date when it slips the mind.

The team from the useful mobile application Med Helper Pill Reminder state that ‘Our belief is that

Better Healthcare Needs Better Tools... and better tools are best designed by those who use them.

Meaning YOU.’51 The application has been in use for over 2 years and has provided over 100,000

people with a way to track this information.

                                                                                                               50  D'Orazio,  Dante,  “Jawbone  launches  an  ecosystem  for  Up,  lets  other  apps  tap  into  your  fitness  data.”  The  Verge.  April  30,    

2013.  http://www.nytimes.com/2013/01/24/us/pentagon-­‐says-­‐it-­‐is-­‐lifting-­‐ban-­‐on-­‐women-­‐in-­‐combat.html.  (Accessed  September  21,  2013)  

51  “Med  Helper  Pill  Reminder.”  Earthflare,  Googleplay  Store.      http://play.google.com/store/apps/details?id=com.earthflare.android.medhelper.lite&hl=en  (Accessed  September  21,  2013)  

  36  

The individual has to have the positive mentality and commitment to purchase these sorts of product

and invest the time and effort to make it truly beneficial in their life. Speaking with optimism these

products could be potential game changers if it is represented or is advocated by health services and

administrations. Their application in aiding with a patients recovery or health and diet could be tied in

with the electronic health records as well as pharmaceutical purposes. Serving as an on-the-body

reminder of when to take medication set up with the GP or dispenser.

6.3 Co-creation – change the game

The optimism shown towards designers role and place in healthcare changes will quite suddenly come

up against hurdles that may seem like mountains in the first place but it is important that the designer

shows a high level of understanding of the current situation to make any ground in the first place.

Participatory design techniques used by Experientia are promising signs of patient-centric changes

happening in the administration and dispensing of pharmaceuticals as well as a platform to come up

with ideas and systems of potentially higher percentage of patient compliance.

6.4 How the process can be changed

Experientia, an Italian consultancy focussed on putting people first, worked with CVS Pharmacy, the

biggest pharmacy chain in the world. Experientia and the pharmacy workers collaborated on how the

pharmacy of the future should look, function and operate for the workers and the people who used

it. The outcome video highlights the benefit of bringing together designers of different kinds, staff and

a creative environment. Personal health records displayed and medication notifications are just two of

the highlighted developments.52

                                                                                                               52  Experientiasrl.  "Experientia  -­‐  The  Pharmacy  of  the  Future  -­‐  03  Alison  ."  YouTube.  Flash  video  file.    

http://www.youtube.com/watch?v=jHuQazVO4AQ  (Accessed  September  20,  2013).

  37  

Figure 14: Ashley Wiltshire, Screenshot of Experientia Concept Video, 2013

6.4 How the process can change

Rob Darracott, Chief Executive of Pharmacy Voice53 said: ‘There are lots of good ideas around for

how health professionals can provide better support for patients and the public to help them use

their medicines more effectively. What the NHS needs now is a real plan for embedding those ideas

in systems that historically have been more concerned with the product than the person.’

Darracotts statement that historically there has been more of a focus on the product than person, is

a case for why there is room for the designer to step in and not just create a packaging based heavily

on mid-century Swiss design, which is used for its high-clarity, readability and objective image54. But to

look at the innovation space within pharma packaging, where individualisation, a customisation of

printing labels, a combination package for multi-medication use could be implemented.

The issues posed on the designers’ role in medication packaging and what this means for the changing

face of healthcare are a few opportunities for the designer to have a greater influence on how

                                                                                                               53  “Pharmacy  Voice:  Speaking  up  for  community  pharmacy.”  Pharmacy  Voice.  http://www.pharmacyvoice.com  (Accessed    

April  18,  2013)  54  Meggs,  Phillip  B.  “Postwar  graphic  design  in  Japan.”  Britannica.  April  4,  2012.  

http://www.britannica.com/EBchecked/topic/1032864/graphic-­‐  design/242775/Postwar-­‐graphic-­‐design-­‐in-­‐Japan  (Accessed  April  18,  2013)  

  38  

pharmaceutical companies and health services tackle some of the biggest problems facing patient

compliance. With a supportive government, HMRA, Pharma authorities and packaging companies that

are willing to be part of a new paradigm towards a more holistic, patient-centric system the chances

for designer intervention will rise. It is looking unlikely that any of what was stated will happen any

time soon but first and foremost EU law on pharma packaging will have to be the first area of reform

before any minor changes to type, colour, size or major changes to packaging material, technologies

occur.

6.5 Interactive ways designers can improve adherence

Speaking as a designer, I have found by having the opportunity to work closely with those in the field

of healthcare and then to step back and speak with patients, it gives a more rounded understanding of

what is within my power at this current point and that by adopting the ‘design with people’ ethos.

‘One: Sharing knowledge and provoking new design thinking, Two: Providing practical resources for

different learning styles and levels and Three: Building an integrative platform for the future’ the

insights and ability to make a change seem much more achievable. 55

We as designers must not only follow in the footsteps of the guide to patient safety and provide

notes, suggestions and improved design for existing packaging but work alongside the different

channels and links of pharmaceuticals from the manufacturer, to the licenser, to the doctors and GPs

who prescribe to the dispenser to the end-user. By working along this line of contributors, we move

beyond solely visual communicators but a multi-faceted, multi-skilled leader in a field that is in danger

of its best interests becoming further corrupt and commercial, when the bottom line is, our health

and care should not be a for-profit opportunity.

Ken Loach’s foreword in NHS SOS asks the questions, ‘Who puts forward the idea of working

together for the common good? That we should be our brothers and sisters keeper? That we have

the technology and the knowledge to provide a decent life for all but we are in the grip of an

economic ideology that makes that impossible?’56

                                                                                                               55  Lee,  Yankee  Dr.,  “Ethos,  Designing  With  People.”  http://designingwithpeople.rca.ac.uk/home/ethos.  (Accessed    

September  20,2013)  56  Loach,  Ken.  foreword  to  NHS  SOS:  How  the  nhs  was  betrayed  –  and  how  we  can  save  it.  by  Jacky  Davis  &  Raymond  Tallis(UK:  One  World,  2013),  xi.  

  39  

As designers, we are sometimes labelled as trying to do too much, to advise and be involved in fields

we are not skilled or trained in. If we relate this to looming reform of the National Health Service of

the United Kingdom, it is fair to say that designers will have plenty of opportunity to impose their

ideas and thoughts for change. Designers can collaborate to be the bridge between corporate care

institutions in the UK and the publics’ needs and concerns with how they handle and review self-

medication.

Ultimately it is up to designer how much they want to challenge the existing paradigm of

pharmaceutical services. Creativity is integral to the introduction of ideas that can have a lasting effect

on the way people interact and use products. In Adrian Shaughnessy’s ‘How to be a graphic designer

without losing your soul’ he presents his creativity equation as

“Risk + discomfort + sweat (±inspiration) = creativity”57

This simple yet hard to implement equation should be understood and utilised in the design process

of challenging pharmaceutical paradigms.

                                                                                                                                                                                                                                                                                                                               57  Shaughnessy,  Adrian  .  How  to  be  a  graphic  designer  without  losing  your  soul.  London.  Laurence  King.  2010.  p.112  

  40  

7.0 Conclusion

To close this dissertation, I believe that it is of the upmost importance that a designer does not solely

focus on the packaging as a means of solving the problem of patient compliance and that to truly make

an impact, they must involve themselves in a design process which brings together the many people

within the pharmaceutical context with a broad spectrum of patients and people with stories and

experience within pharmaceuticals.

I look forward to myself and others becoming self-managed patients who are part of a community of

caregivers, pharmacists, doctors and other medical care workers that ensure feedback and input

comes from all levels of interaction. With collaborative efforts from pharma, health services and local

communities we can create “collective intent care networks,” as a designers We shall involve

ourselves in improving patient compliance, partly in using the model (fig.3) and integrating ‘design with

people’ ethos into professional careers to go a way to understanding and effecting the changes in care

delivery.

Figure 3: Ernst & Young, Self-Managed Patient, 2012

  41  

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Appendix

Interview on Medication Use

Vincenzo Florio

1. Is it clear to you what each medication aids with?

Yes, as gp explains to me what each medicine is for.

2. Do you know whether one can be mixed with another?

I trust my doctor to prescribe me medication which cannot be mixed, but if it was up to me i

wouldn’t know as I don’t read English.

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3. Do you read the small print information document that comes with the medication?

No I don’t read the small print as I don’t understand all the English and rely on my daughters to

explain.

4. How do you ensure you do not mix up one medication with another?

I arrange my medication so that it is in order i.e. morning, lunchtime and evening and have them

sorted in my pill box.

5. If you are confused or do not understand the medication, what support do you get?

If I am confused about aspect of my medication i would return to see my doctor.

6. Are there any clear problems with packaging or defining the difference between medications?

The packaging is fine and marked clearly but as a suggestion a small picture on front of box could

make it clearer i.e. if a heart was printed on my heart medication i would know that it was for my

heart especially as I have to take lots of medication.

7. And finally, as it is usually the doctor who prescribes you with the drug, do you ever look beyond

their opinion or do you own study of the drug?

Yes my doctor prescribes all my medication, I don’t tend to look beyond as I trust my doctor to

prescribe me the correct drugs for my condition therefore I do not feel the need to carry out my

own studies, as a suggestion I personally think it would be a good idea if the leaflet enclosed with the

medication was in other languages just a brief explanation on medication and dosage would be most

helpful.

Maria Florio

1. Is it clear to you what each medication aids with?

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Most of the time its clear but the explanation could be clearer as not all patients understand the

Medical terms.

2. Do you know whether one can be mixed with another?

Yes I always read leaflet to make sure I am not taking medicines that cannot be mixed but then I

would expect my gp not to prescribe medicines that cannot be mixed.

3. Do you read the small print information document that comes with the medication?

Yes I always read the small print but at times can be quite difficult to understand due to the technical

terms that are used, so that could be simplified.

4. How do you ensure you do not mix up one medication with another?

I always keep my medication separate to ensure there is no mix up.

5. If you are confused or do not understand the medication, what support do you get?

If at anytime I need further support I will go back to see my gp or go to pharmacy.

6. Are there any clear problems with packaging or defining the difference between medications?

Personally I don’t have any issues as i am not taking any regular medication.

7. And finally, as it is usually the doctor who prescribes you with the drug, do you ever look beyond

their opinion or do you own study of the drug?

Yes my doctor prescribes my medicine and yes i do tend to carry out my own study of the drug as I

find it easier to understand than on the small printed information enclosed with the drug.

Interview questions for a Nurse on the effectiveness of pharmaceutical packaging

1. In your experience as a nurse, how understandable is pharmaceutical packaging?

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It depends of the medication and how you are familiarized with it, some packaging’s medication are

very clear and some not as clear, also some medicaments are more common than others.

2. What works, and what does not work?

On one hand, as a nurse, the thing that is very helpful for us at the hospital is that the external

packaging of the medication is different and you can see totally in a clear way the administering use of

it. Some medications are very similar in packaging and it does not work, for example there are the

same medication (and the same packaging of it) with

other concentration (like potassium chloride

blisters) or some medications which at first view you

can confuse because they are the same blisters, I

mean, you must read it for differentiate it (for

example, the potassium chloride blisters and the

smaller saline solution blisters) /Photo/

For me that is essential when we have an emergency, for take action fast. Moreover it works for us

for not commit a mistake.

On the other hand, in my opinion, a good and clear packaging works with patients as well, above all

when we are talking about polymedicated patients. Things like the days of the week in the metal film

that cover the pills are important in some drugs that they have to take day by day.

3. Have patients ever asked you to explain what the drug does and how it works?

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Yes. Some patients want to know the use, the reason and the effects of the drug that I am

administering.

4. What could be improved on the packaging of the drugs, either the cardboard package or the metal

film cover of the pills?

I think that a good idea for the patients to know how to take it would be personalized the cardboard

package of the drug with the personalized dosage of each patient in each case. I think in England you

have it sometimes putting a sticker on the package, but in Spain is not the same and I have seen a

handwritten (made it for the patient or for a relative) with the indication for what is the drug and the

recommended dosage for this person as well.

/Photo example/:

(1-1-1 = one pill in breakfast, one in lunch, one in dinner)

A good idea as well is the plastic box format for polymedicated people, it is a box with different

departments, usually divided in days of the week and times in the day (for example the food hours),

where you put inside the pills that you will need for each day. This is a great idea for ambulatory

polymedicated patients, because with some of these pillboxes the patients can take and bring “each

box day” in their bag.

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About the format or the design, I think is obvious, but I would like to add than always is very

important the big letters with the most important things and the colours as well. Maybe the format of

the pills as well, because I had many patients that when I asked to them “which pills do you usually

take?” they replied to me “I don’t remember the name of that one but, the little white one” or “the

one with a stripe in the middle”.

5. Are there any stories or anecdotes you can share of yours or someone else's experience?

I know a story of a Spanish nurse that she made a terrible mistake, much of it because the packaging

of the medication, because the patients' nutrition is many times a very similar packaging.

She was doing the night shift in a Neonatal ward of a Hospital of Madrid and she confused the way

drugs are administered; she administered enteral nutrition by venous catheter, as a parenteral

nutrition, which the directions strictly say not to, and it cost the life of the baby.

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Interview questions on the challenges designers face in improving patient compliance through pharmaceutical

packaging. – Alex Tomlinson

1. Increasingly in the UK, patient non-compliance has been on the rise, costing the National Health

Service around a £billion annually not taking into account medical costs of further treatment,

operations and consultations. Why is this so? Who is to blame if any?

Personally I would place the blame with patients themselves and GPs. Potentially pharmacists. The

question is whether or not the patient understands the amount of each prescribed drug that they

should take. Perhaps more could be done to differentiate the products with multiple prescriptions but

I think this is something that dispensers rather than producers should be looking at.

2. Why in your opinion has pharmaceutical packaging remained one of the only areas design to fall

behind in engaging its end user whilst others are excelling in user experience, e.g. airport services,

online shopping, GUI’s?

I think the issue is two fold. Drugs aren't packaged for the benefit of the end user. They are packaged

for the benefit of the dispenser. In that respect I think pharma packaging was probably ahead of the

curve with regards to colour coding and efficient coding systems for their packaging. Airports and

gui's by comparison to drug packaging are relatively new in the realm of human production. I think it

is unfair to suggest that drug packaging hasn't progressed when one looks at old pharmacies where

the products might just as easily have been snake oil rather than a cure for anything.

The second issue is regulation. Because packets for prescription only are banned from advertising to

patients they can't be seen to entice the end user. There are also usability constraints I.e. How big

and where Braille must appear, spaces for dispensing information etc.

3. What is the chain or process a pharmaceutical company has to go through to change an aspect of

its design, whether it is colour, shape, material used, productions, etc.?

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Any change to a pharmaceutical product, whether it relates to packaging or production, that is not

included in the license already granted by the governing body (in the uk this is the MHRA) must be

submitted as a variation.

For instance if I wanted to change my box from blue to green I would have to draw up the artwork,

okay it with my production chain and then get relevant cutter guides etc. once the artwork is finalised

it would be submitted to the MHRA as a variation. Once this is approved the product is put into full

production with the changes applied. There is normally a time frame of around 6 months that any

required changes must be applied by depending on the change. I.e. If the company had moved

addresses a variation wouldn't need to be submitted to change the contact address on every product,

however it would need to be changed in a timely manner to keep products compliant.

4. What are some of the current guidelines a designer has to abide by when creating pharmaceutical

packaging? How do the guidelines differ from when you first worked on pharma packaging?

Unfortunately it has been quite a while since I worked on packaging. So can only really talk accurately

about marketing the drugs. The biggest ones are the amount of information that must be displayed

dependent on the type of advert produced.

All text must also be above 1mm in x-height and the language used on the ad can't say what the

product treats or encourage people to buy it. The adverts are therefore more intended to inform

pharmacists of its existence rather than promote it over competitors products.

5. Do you agree with the statement that currently, pharmaceutical packaging is predominantly aimed

at aiding the pharmacist and chemist as opposed to the patient/person who needs the medication?

Absolutely. The only part of a drug packet that is for the benefit of the end user is the space for

dispensing labels (which are often ignored by dispensers who put the label wherever they feel like it at

the time)

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6. Where do you consider there to be room for innovation in improving patient compliance through

pharmaceutical drug packaging? Please answer with a short-term solution and if possible, a radical

change with money and regulation not as barriers.

More effort could go into differentiating drug packets once they are outside of their boxes. This could

help patients especially if prescription instructions were provided in a relevant way to coincide with

this difference. A simple example would be to colour the foils on each set of tablets, prescription

information would then be "take two blue foil pills and 3 green" of course this doesn't help for certain

demographics like blind people or colour blind people so a solution would need to be more broad.

Interview questions on the challenges designers face in improving patient compliance through pharmaceutical

packaging. – Daniel Wilson

1. Increasingly in the UK, patient non-compliance has been on the rise, costing the National Health

Service around a £billion annually not taking into account medical costs of further treatment,

operations and consultations. Why is this so? Who is to blame if any?

Couldn’t answer this one I’m afraid.

2. Why in your opinion has pharmaceutical packaging remained one of the only areas design to fall

behind in engaging its end user whilst others are excelling in user experience, e.g. airport services,

way finding, GUI’s?

I believe this is because of how heavily regulated it is. The patients safety is the number one priority

for pharmaceutical companies and the MHRA (Medicines and Healthcare products Regulatory

Agency) who regulate medicines in the UK.

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Also, with so many guidelines on what can and cannot be done, you are limited with the design. Not

only does the packaging need to be easily readable and identifiable for the patient, but also for the

pharmacist dispensing the medicine to ensure the patient safety.

3. What is the chain or process a pharmaceutical company has to go through to change an aspect of

its design, whether it is colour, shape, material used, productions, etc.?

As a global company the design of the packaging has been rolled out on a global level and follows

strict branding guidelines, which is then adapted to suite the individual countries regulations.

In the UK, if you want to make a change on a National level, UK only, then a variation must be

submitted to the MHRA. Depending on the extent of the change and which category it falls under,

this can take anywhere from a few weeks to years to be assessed and approved by the MHRA.

Also, depending on the category of variation, a fee is paid for each product licence that the change

affects.

So, the Regulatory Affairs team within in the company will prepare the submission package and submit

the change to the MHRA. During the time the MHRA asses the change they may have questions or

request further changes that Regulatory Affairs team will need to respond to.

Once the MHRA approve the change they will notify us of the approval and the date it was approved.

We, the pharmaceutical company will then have 6 months to implement that change. The 6 months is

deemed as the date the first batch is released following approval. So, if the implementation date was

30/09/2013. Any batches released after this date must include new artwork.

To implement the new artwork we have a change procedure we must follow. This requires

generating a change document and tracking the change with the suppliers who are located throughout

the EU. We liaise with them to communicate when the new artwork must be used depending on our

orders and demand.

Finally when the product is release onto the market with the new artwork we can close out the

change to make sure the artwork has been implemented within the six month timeframe.

4. What are some of the current guidelines a designer has to abide by when creating pharmaceutical

packaging? How do the guidelines differ from when you first worked on pharma packaging?

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I have only worked in the industry for 6 years and haven’t seen too much change in that time. Some

of the key guidelines to follow are; to make sure the font size is not below the minimum, ensure the

correct space is allocated for the dispensing label, braille is positioned correctly, pharmaceutical form

and dosage is clearly identifiable and key warnings are highlighted

5. Do you agree with the statement that currently, pharmaceutical packaging is predominantly aimed

at aiding the pharmacist and chemist as opposed to the patient/person who needs the medication?

Personally, I would say that I wouldn’t agree with that statement as at Sandoz we aim to aid all

interested parties, whether it be the pharmacist, patient or any other stakeholder that comes into

contact with our packaging. See our website for more information on this

http://www.uk.sandoz.com/site/en/quality_generics/packaging_design/index.shtml

Also, in recent years, the MHRA has ensured all packaging includes braille and that all patient

information leaflets undergo user testing. This highlights that even more focus is being put upon the

patient than was before.

6. Where do you consider there to be room for innovation in improving patient compliance through

pharmaceutical drug packaging? Please answer with a short-term solution and if possible, a radical

change with money and regulation not as barriers.

I believe with technology there is room for innovation, a lot of support materials for products come

in the form of apps and online learning portals, etc. However, I believe this to be more difficult for the

packaging itself as it is a requirement for patients to have access to critical safety information on the

medicine they are taking. Therefore, not everyone has access to the internet and such technologies.