information design for patient safety -...

Information design for patient safety

A guide to the graphic design of medication packaging

Information designfor patient safetyA guide to the graphic design of medication packaging

About this publicationInformation design for patient safety is based on the resultsof a design research collaboration between the NationalPatient Safety Agency (NPSA) and the Helen Hamlyn ResearchCentre (HHRC) at the Royal College of Art, London. Editing,design and production of the document by the NPSApublishing department.

The purpose is to allow busy designers, purchasers and otherswith an interest in package legibility and comprehensibility toquickly and simply understand how and why good design cancontribute to patient safety through the clear labelling of medicines.

Research and methodologyThe study was carried out over a one-year period by Thea Swayne, a postgraduate specialist in information and graphic design, working to a brief set by the NPSA and the HHRC. Existing design guidance was reviewed and consultations were undertaken with experts in graphicand information design, and in design for patient safety.

A wide range of stakeholders contributed to the research –including patients, pharmaceutical industry personnel, NHSagencies, nurses and pharmacists. Observational research wasundertaken in key end-use environments, such as wards,pharmacies and patients’ homes. A collection of currentmedicine packages was assembled as part of the study, andan analysis was carried out of common problem factors forwhich design solutions were proposed. The outcome was adesign rationale to enhance patient safety and a fullyillustrated set of design considerations with both good andbad examples.

Contents

Foreword 9

Introduction 11

Stakeholder review panel 13

1 User testing 15

2 Packaging design checklist 18

3 Design recommendations 22

for secondary packaging

Dispensing label 23

Faces of the packaging 27

Hierarchies of information 31

Name of medicine 35

Strength of medicine 37

Typography 41

4 Using colour 59

5 Design recommendations 66

for primary packaging

Further reading 78

Foreword

Information design for patient safety – Foreword | 5

In the Department of Health’s 2003 report, Design forpatient safety, I offered a new perspective on improvingpatient safety and set out how we should be making useof the many opportunities for effective design inhealthcare to address some of the safety challenges weare facing. Concentrating on design for safer packaging ofprescription medicines, this latest publication seeks toresolve some of the risks associated with medication errorand, once again, draws attention to the need for aninclusive and systems-wide approach. Ensuring the safety of patients must become a highvisibility issue for anyone involved in the delivery ofhealthcare. This publication is a further contribution tothe important work that is taking place in this field.

Professor Sir Liam Donaldson, Chief Medical Officer

Introduction

Information design for patient safety – Introduction | 7

Information design for patient safety shows how graphicdesign on medicine packaging can enhance patientsafety and details best practice based on establishedguidelines. It is aimed at packaging designers andpharmaceutical companies. It will also be of interest tothose in the NHS who regulate and purchase medication.

There are an estimated 900,000 recorded adverse eventsin the NHS every year.1 Improvements to the design ofmedicine packaging could reduce this figure whilst alsoimprove medication compliance. It is estimated that athird of medication errors are caused by confusion overpackaging and labelling instructions.2 Healthcare isdelivered in many different contexts and patients’sensory, physical and mental capabilities vary greatly.Design solutions have to address these factors.

Information design for patient safety focuses on:

• blister packs: the most common type of primarypackaging for prescription medicines;

• secondary packaging used to contain blister packs;

• the label attached to secondary packaging in pharmacies.

The design considerations and principles outlined can beapplied to other products such as patient informationleaflets and tablet bottles.

There is a comprehensive checklist that details the keyfactors that impact on patient safety. In line with theMedicines and Healthcare products Regulatory Agency(MHRA) guidance document,3 user research andevaluation is recommended when significant changes are made to any packaging. The checklist can help ensure that any testing of individual designs is thoroughand effective.

The examples of best practice have taken into accountthe views of patients as well as those of pharmaceuticalindustry personnel, NHS agencies, nurses andpharmacists. They have also been researched in key end-use environments including hospital wards, pharmaciesand patients’ homes.

Information design for patient safety is the result of acollaboration between the National Patient SafetyAgency (NPSA) and the Helen Hamlyn Research Centre(HHRC) at the Royal College of Art, London. It builds onthe Designing for patient safety study commissioned bythe Department of Health and the Design Council, andundertaken jointly by the HHRC, the University ofCambridge and the University of Surrey.4

Although the ideas in this publication require furtherresearch, they provide the foundations for establishinggraphic design best practice guidelines that have thepotential to increase patient safety.

Ideas for further research include looking at:

• how design can help patients on multiplemedication schedules;

• information on the tablet itself;

• adding a picture of the tablet on secondary packaging;

• matching machine-readable codes on packaging and dispensing labels;

• putting small products in larger packaging for, in particular, ophthalmic products;

• a ‘header’ area away from the tablets on blister strips where all critical information would remain intact.

References

1 www.npsa.nhs.uk/about

2 ‘Reducing Medication Errors Through Naming,Labeling and Packaging’, Berman A., Journal ofMedical Systems, Volume 28, Issue 1, 2004

3 Best practice guidance on labelling and packagingof medicines, Medicines and Healthcare productsRegulatory Agency, London, 2003

4 Designing for patient safety: a scoping study toidentify how the effective use of design could help toreduce medical accidents. Robens Centre for HealthErgonomics at the University of Surrey, EngineeringDesign Centre at the University of Cambridge andHelen Hamlyn Research Centre, 2003

Stakeholder review panel

Information design for patient safety – Stakeholder review panel | 9

Roger Coleman Professor of Inclusive Design and Co-founder, Helen Hamlyn Research Centre, Royal College of Art

Steven Drewett Outpatient, Haematology & Oncology, Hammersmith Hospital

Colum Menzies Lowe Head of Design and Human Factors, National Patient Safety Agency

Professor David Cousins Head of Safe Medication Practice, National Patient Safety Agency

Wendy Harris Head of Safety Solutions, National Patient Safety Agency

Professor Peter Buckle Director of Ergonomics, European Institute of Health and Medical Sciences, University of Surrey

Jonathan Milner Business Development Manager, InTouch PharmaMed, a Matthews Brand Solutions company

Stein Lyftingsmo Community and Hospital Pharmacist, Norway and Editor of website on labelling of medicines

Sue Kilby Head of Practice, Royal Pharmaceutical Society of Great Britain

Rachel Dean Acting Senior Graphic Designer, Royal National Institute of the Blind

Jeff Willis Deputy Head of Communication Art & Design Department, Royal College of Art

Careen Snadden Technical Director, Almus Pharmaceuticals

Howard Stokoe Principal Pharmacist, NHS Purchasing and Supply Agency

Brian Parkinson Making Sense Design and co-facilitator of Designers in Health Network

Idris Hughes Community Pharmacist and author

Yogini Jani Senior Pharmacist, UCLH NHS Foundation Trust

Grant Courtney Strategic Development Manager, GlaxoSmithKline

Jan MacDonald Medicine and Healthcare products Regulatory Agency

James Ward Senior Research Associate, Engineering Design Centre, University of Cambridge

Matt Kennedy-Martin Head of Government Relations, Design Council

A stakeholder review panel was formed to ensure Information design for patient safety addresses a wide and representative range of issues. The panel members are:

10 | Information Design for Patient Safety – Secondary packaging design checklist

User testingPackaging design should take into account the needs and capabilities of thewidest possible range of potential users, and in particular older and partiallysighted users, and how they interact with the medicine in the home.

It should also consider the needs of pharmacists and, in particular, how theyidentify, classify and differentiate between medicine packages.

1

Information design for patient safety – User testing | 11

Pharmaceutical companies should develop theirown methods for testing their packaging on users.

The example below is developed from A guideline onthe readability of the label and package leaflet ofmedicinal products for human use.1

Aim

There are a number of core tasks that are critical for thesafe use of pharmaceutical packaging. The aim is toassess how users find the information they need andhow they then interpret this information. The test shouldbe able to highlight any undesirable outcomes anddetermine the best combination of design elements.

Method

Test on a minimum of 20 people and a range of usersincluding patients, pharmacists and carers. This willvary for each product.

Manufacturers should carry out the testing. Designersshould be involved.

Participants

Start by testing the products on 10 critical users whoare likely to encounter problems. This should includeusers with lower visual abilities and reduced cognitiveand dexterous functions.

If a user becomes confused, note how they deal withthe difficulty.

If a user does not understand a question, avoid givingthe answer. Instead, ask them what they think it means.

Testing procedure

Test one user at a time, allowing at least half an hourfor each person. They can be asked about using morethan one packaging, but do not ask more than 15questions in a single session. Two questions concerningthe same information should not follow one another.

Ask users to carry out their normal routine for readinginformation on packaging:

1 Observe and write down what they do.

2 Ask users to write down in their own words whatthey did.

3 Ask questions that might extend the informationgathered.

4 Ask specific questions about the legibility ofparticular design elements on the packaging.

5 Determine if specific information on the packagingcan be found quickly and easily.

6 Determine if information on the packaging isunderstandable and informative.

7 Ask users to find a particular piece of informationand explain it in their own words. This will revealhow well they understand the information. If thisinvolves a physical activity such as mixing somethingtogether, they should be asked to do this andactually go through the procedure on the package.

Results

Reviewing the data should reveal any major problemswith the legibility of information on the packaging. Atthis stage, it is possible to redesign or rewrite theinformation before further testing.

Once satisfactory data has been obtained from 10users, a further 10 should be tested. The objective is tohave at least 16 users out of 20 able to answer eachquestion correctly. It may be necessary to clarify theperformance of the questionnaire, which may includerewriting and remodelling the questions to achieve abetter level of performance.

Reference

1 A guideline on the readability of the label andpackage leaflet of medicinal products for humanuse, European Commission, Belgium, 1998

Packaging design checklist

2

14 | Information design for patient safety – Packaging design checklist

Packaging design checklist

Issue Recommendation Page

Secondary packaging

Medicine name and strength obscured Allocate 70 x 35mm white space for dispensing label 23

Dispensing label and medicine name mismatched

Position the generic name and medicine strength above or next to the space for the dispensing label 25

Critical information does not appear in the same field of vision

Put critical information in the same field of vision on at least three non-opposing faces 27

Some text can only be read by flipping the pack or reading upside down

Orientate text in the same direction 29

Difficult to recognise important information Use blank space to emphasise critical information 31

Brand name confused with the generic name of a medicine Emphasise generic medicine name 33

Medicines with similar namesconfused for one another

Use Tallman lettering to emphasise the difference between look-alike or sound-alike medicine names 35

Wrong strength of a medicine selected Differentiate between strengths of the same medicine 37

Easy to miss the decimal point in numbers with a trailing zero Do not add trailing zeros to numbers 39

Small type size is difficult to read Body text in a minimum of 12 point 41

Sentences in capital letters or italic type are hard to read Use upper and lower case 43

Simulated handwriting and ornate typefaces are hard to read Use sans serif typefaces 45

Information design for patient safety – Packaging design checklist | 15

Issue Recommendation Page

Secondary packaging

Lightweight typeface is hard to read Use bold or semi-bold type 47

Condensed typeface is hard to read Do not use condensed typefaces 49

Squashing lines of text closer together orreducing the distance between individualletters makes text difficult to read

Do not squash lines of text closer together or adjust the spaces between letters 51

Irregular amount of space between words Align text to the left 53

Text illegible over an image or logo Do not place text over images or logos 55

Insufficient contrast between backgroundand type

Create a strong contrast between type and background colour 57

Using colour

Colour differentiation inadvertentlyassociated with a particular feature Use colour differentiation to highlight information 61

Colour does not help distinguish betweenproducts in a manufacturer’s range Use opposing, meaningless colours 63

Primary packaging

Glare caused by light reflecting on the foil Use non-reflective foil 67

Text damaged when blister strip is cut Put medicine name and strength clearly on each pocket 69

Reduced legibility due to combined effectof foil material, small type size andbackground colour

Create a strong contrast between type and background colour 71

Reduced legibility due to combined effectof a small type size and lightweight fonton a foil background

Use bold or semi-bold type 73

Blister strip with the wrong secondary packaging Match the styles of primary and secondary packaging 75

3

Design recommendationsfor secondary packagingThe term secondary packaging describes the outer package of a pharmaceuticalproduct. It holds the primary packaging and does not touch the medicine. The combined impact of all design elements, such as colour and typography, should be evaluated.

Dispensing label

Issue

Pharmacists produce alabel that exactly repeatsthe prescriber’sinstructions and attach itto the secondarypackaging.

If space is not allocatedfor the label, it isfrequently placed overthe manufacturer’s textobscuring the medicinename and strength.

The underlying text mayalso show through thelabel making theinstructions difficult to read.

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18 | Information design for patient safety – Design recommendations for secondary packaging

RecommendationAllocate 70 x 35mm white space for dispensing label

Have a clearly designatedspace for the dispensinglabel. This should be awhite space in whichthere is no text or image.

Dispensing labeldimensions vary, but aminimum of 70 x 35mmis suggested as this is themost common size fordispensing labels.

Information design for patient safety – Design recommendations for secondary packaging | 19

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Generic Name 10 mg

Patient name

Each tablet contains ingredient 0mg. Also contains ingredient.

For oral administration. Take as directed by your doctor.

Please read enclosed leaflet carefully.

Store below 25ºC in a dry place. Protect from light.

Keep out of sight and reach of children.

Dispensing label

Issue

In the pharmacy, theprescription is read; themedicine is picked fromthe shelf; the medicinetype and dosage arechecked against theprescription; and adispensing label isproduced by thedispensary system andattached to thesecondary packaging.

Occasionally, due tohuman error, thedispensing label andmedicine name on thesecondary packaging aremismatched.

Address of manufacturer123 Any StreetAny Town ABC000

Place dispensing

label here

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The generic name andstrength of the medicineshould be directly aboveor beside the spaceprovided for thedispensing label.

Pharmacy staff can theneasily check that themedicine description onthe dispensing labelcorrectly matches that onthe secondary packaging.

RecommendationPosition the generic name and medicine strength above or next to the space for the dispensing label

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Faces of the packaging

Issue

The following criticalinformation does notalways appear in thesame field of vision:medicine name, variant,strength, form andnumber of tablets orcapsules.

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RecommendationPut critical information in the same field of vision on at least three non-opposing faces

A standard packagingbox has six faces onwhich information canbe displayed. Criticalinformation should be inthe same field of visionon at least three non-opposing faces of thesecondary packaging.

This means putting theinformation on the topor bottom face, one ofthe side faces, and onone of the end faces. Ifit is feasible, display aproduct description onmore than three non-opposing faces.

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Faces of the packaging

Issue

If text is not orientatedin the same direction,the pharmacist andpatient have to eitherread upside down or flipthe pack to read theinformation.

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RecommendationOrientate text in the same direction

The text on every face,excluding the ends,should be orientated inthe same direction.

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Hierarchies of information

Issue

If secondary packaging iscluttered with text andimages, it can be difficultto recognise importantinformation and identifythe correct packaging.

28 Tablets

Distributed by Company Pharmaceuticals123 Any RoadAny townAny postcode

Products license holder123 Any RoadAny townAny postcodeCode 00/00000/0000/0000/00 00/00000/0000/0000/00

Each tablet containsingredient equivalent to 0mg of ingredient and omg ingredient

BRAND NAMEgeneric namecontains 0mg ingredient and ingredientSe

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RecommendationUse blank space to emphasise critical information

Use blank space toemphasise criticalinformation such as the medicine name and strength.

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Hierarchies of information

Issue

Patients can be givendifferent brands of thesame medication whichcan lead to themconfusing brand nameswith generic names.

This can result in themtaking multiple doses ofthe same medication.This risk is increased ifthe brand name hasmore emphasis than thegeneric name.

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RecommendationEmphasise generic medicine name

The generic name should be in 16 pointsize or greater.

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Name of medicine

Issue

Medicine names that arespelt in a similar way,with the same number ofletters and word shape,can be easily mistakenfor one another.

The possibility of error isincreased if medicines arestored alphabetically andthese medicines are nextto one another.

Chlorpropamide10 mg

Chlorpromazine10 mg

28 Capsules28 Capsules

28 Capsules28 Capsules

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RecommendationUse Tallman lettering to emphasise the difference between look-alike or sound-alike medicine names

Use Tallman (capital)letters to highlight thosesections of similarmedicine names thatcontain the characteristicof the medicine.

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Strength of medicine

Issue

If the strength of amedicine is not clearlydisplayed, the wrongstrength can be selected.

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RecommendationDifferentiate between strengths of the same medicine

Make medicine strengthsstand out throughtypeface, type weight,colour and shape.

This is particularlyimportant if allsecondary packagingfrom a manufacturerlooks similar.

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Strength of medicine

Issue

If numbers have atrailing zero (a decimalpoint followed by a zero)it is easy to miss thedecimal point anddispense a tenfoldoverdose.

For example,administering 50mginstead of 5mg.

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RecommendationDo not add trailing zeros to numbers

Where possible, alwaysuse whole numbers.

Different strengths of thesame medicine should beexpressed in the sameway, such as 250mg,500mg, 750mg.

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Typography

Issue

Small type size is difficult to read.

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Minimum recommendedtype size is 12 point.

However, 14 point ismore accessible forpatients with sightdifficulties.

RecommendationBody text in a minimum of 12 point

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Typography

Issue

Entire sentences incapital letters or italictype are hard to read.

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RecommendationUse upper and lower case

Do not use capitals forgeneric medicine names(other than selectiveTallman lettering, seepage 36), brand names,sentences or paragraphs.

Italic type should not beused where there is analternative method ofemphasis such as boldtype. Upper and lowercase should always beused for sentences.

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The choice of typefaceinfluences legibility.Simulated handwritingand ornate typefaces aredifficult to read.

Serif typefaces, that istypefaces with smallterminal strokes addedto the end of the mainstroke or line of acharacter, are harder toread on medicationpackaging than sans seriftypefaces, that istypefaces without serifs.

Serif typefaces are idealfor large bodies of textsuch as books andnewspapers, where theserifs aid the reader infollowing andrecognising lines of textat speed.

They are not suitable formedication packaging,where clarity, accuracyand legibility must beparamount.

Issue

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RecommendationUse sans serif typefaces

Use a sans serif typeface,such as Arial, Helveticaor Univers.

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Typography

Issue

Lightweight typereduces legibility.

Patients, especially thosewho are partially sighted,find bolder type easier to read.


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RecommendationUse bold or semi-bold type

Use bold or semi-boldtype and avoidlightweight type.


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Typography

Issue

Condensed typefaces reduce legibility.

Generic NameCapsules

28 Capsules

10 mglogo

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RecommendationDo not use condensed typefaces

Do not use condensed typefaces.

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Typography

Issue

Reducing the spacebetween lines, known asthe leading, andreducing the spacebetween letters, knownas the kerning, affectslegibility.

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RecommendationDo not squash lines of text closer together or adjust the space between letters

Do not squash lines oftext closer together. Iftext is in 12 point size,the leading should be 16 point. If text is in 14 point size, the leadingshould be 18 point.

Do not adjust the spacebetween letters unlessdoing so will enhancelegibility.

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Typography

Issue

An irregular amount ofspace between words affects legibility.

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RecommendationAlign text to the left

Align text to the lefthand margin and do notjustify text.

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Typography

Issue

Fitting text around orover images or logosbreaks the flow ofinformation.

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RecommendationDo not place text over images or logos

Text should remainunbroken.

Images or logos shouldbe placed at thebeginning or end of the text.

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Typography

Issue

Insufficient contrastbetween the backgroundand the type reduceslegibility.

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RecommendationCreate a strong contrast between type and background colour

There should be a strongcontrast between thetype and backgroundcolours.

Dark coloured type (e.g.black, dark blue) shouldbe on a light colouredbackground (e.g. white,pale pink, pale yellow).

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Using colourColour can help correctly identify, classify and differentiate between medicines.However, relying totally on colour to do this can lead to mistakes. This is becausecolours look different in different lighting conditions; people have differentperceptions of colour; and colour blindness means some people see colours differently.

4

If a single colour is used for a whole range ofmedicines it can be difficult to identify a specificproduct. This is compounded if medicines with similarnames are stored next to one another.

If a patient is prescribed a number of medicines withthe same colour packaging, there is an increasedchance of them taking the wrong one.

Colour coding

A colour coding system allows people to memorise acolour and match it to a function. However, creating ashortcut for identifying a medicine without having toread the label can lead to mistakes. No colour codingsystem could differentiate between all 12,000medicines authorised in the UK. Furthermore, in theabsence of a national or international colour code, anyUK system could become a barrier to trade.

One exception is the medicine warfarin, which isuniversally colour coded brown for strengths of 1mg, blue for strengths of 3mg, and red for strengths of 5mg.

Colour differentiation

Colour differentiation is the recommended method. It uses colour to make features on a packet stand out or to help distinguish one item from another. The chosen colour is not associated with a particularfeature. It is important that there is no pattern in the colour scheme.


Using colour

Issue

Colour differentiation isinadvertently associatedwith a particular feature.

56 | Information design for patient safety – Using colour

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RecommendationUse colour differentiation to highlight information

Do not colour codepackaging.

Use colour to distinguishbetween, for example,different strengths of thesame medicine andbetween similarly namedmedicines.

Information design for patient safety – Using colour | 57

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Using colour

Issue

The use of colour doesnot help distinguishbetween products in amanufacturer’s range.

58 | Information design for patient safety – Using colour

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RecommendationUse opposing, meaningless colours

Use opposing,meaningless colours to distinguish betweenmedicines with similar names in amanufacturer’s range.

An awareness of userswith limited colourperception should bedeveloped.

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Design recommendationsfor primary packaging

Blister strip

Issue

Blister strips arecommonly sealed withreflective foil. Glare caneasily be caused by lightreflecting on the foil.

This can reduce thelegibility of anyinformation printed onthe foil. If type is in alight colour orlightweight font,legibility can be further reduced.

62 | Information design for patient safety – Design recommendations for primary packaging

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RecommendationUse non-reflective foil

Use non-reflective, matt foil.

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Blister strip

Issue

Blister strips are takenout of the secondarypackaging to access themedicine and may notbe returned.

Single blister pockets,which hold one dose ofthe medicine, can be cutfrom the strip leavinginsufficient informationabout the medicine. Ifthe name and strengthare printed across theentire blister strip, thetext is damaged whenthe medication isremoved.

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RecommendationPut medicine name and strength clearly on each pocket

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

Generic Name 10mg

The medicine name andstrength should appearon each pocket of theblister strip.

If the size of the pocketis too small, theinformation should berepeated in a patternacross the entire strip.

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Blister strip

Issue

Legibility can be reducedby the combined effectof the foil material, asmall type size and abackground colour thatdoes not sufficientlycontrast with the typecolour.

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RecommendationCreate a strong contrast between type and background colour

Type colour shouldcontrast strongly withthe background colour.

For example, black ordark blue type on awhite, pale pink or paleyellow background. Iftext is reversed out of abackground colour, use abold typeface.

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Blister strip

Issue

Small type size and alightweight font on a foilbackground impairslegibility. Small type sizesare easier to read whenset in a heavier weighttypeface.

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RecommendationUse bold or semi-bold type

Use bold or semi-boldtype and avoidlightweight type.

It is important to note,however, that too muchbold or semi-bold typecan also impairreadability if in a verysmall point size.

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Blister strip

Issue

Patients taking morethan one medicine, orthe same medicine intwo or more strengths,must be able to identifywhich blister stripbelongs to which packetbecause the prescriptioninstructions are attachedto the secondarypackaging.

Mixing packages andblister strips up couldlead to the patienttaking the wrongmedication or evenoverdosing.

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RecommendationMatch the styles of primary and secondary packaging

A product’s primary andsecondary packagingshould have an identicalor linked visual stylecreated through, forexample, colour.

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