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Edition 12007
Design for patient safetyA guide to the design ofdispensed medicines
About this publicationThis guide to the design of dispensed medicines is one of
a series of design publications produced by the NationalPatient Safety Agency (NPSA).
Other publications in the NPSA Design for patient safety series:
NPSA in collaboration with the Helen Hamlyn Centre,Royal College of Arts. A guide to the graphic design of medication packaging (second edition). (2007).
NPSA in collaboration with Lucid Design. A guide to thedesign of the dispensing environment. (2007)
NPSA. Future ambulances. (2007).
NPSA in collaboration with the Helen Hamlyn Centre,
Royal College of Arts. A guide to the design of injectablemedicines. (2008).
Research and methodologyInformation in this guide was collated over a 2-year
period and involved a NPSA team of pharmacists and apharmacy technician with combined experience incommunity, primary care, hospital and academic
pharmacy. Publications from within and outside thehealthcare industry were reviewed in preparing thisguide. The project team also included two designers from
Lucid Design who had experience of undertaking designprojects across a range of industries, including healthcare.
A wide range of stakeholders including healthcareprofessionals, representatives of professional andcommercial organisations, patients, carers and patient
organisations contributed to this research. Visits wereundertaken to community and hospital pharmacies, anumber of which had been identified as using design
effectively to support innovative practice.
Foreword 3
Introduction 7
1 The dispensed medicines flow diagram 11
2 Setting up your label 152.1 Essential information 16
2.2 Label size 18
2.3 Font selection 20
2.4 Label layout 22
2.5 Paper quality 26
2.6 Print quality 28
3 Applying dispensing label(s) to medicines 313.1 Applying the label 32
3.2 Labelling tablet and capsule cartons 34
3.3 Oral liquid medicines 42
3.4 Topical products 44
3.5 Inhalers 46
3.6 Eye products 48
3.7 Labelling other small containers 50
3.8 Use of print labels 52
3.9 Dispensing bags 56
4 Aids to help patients use their medicines 594.1 Patient held information 62
4.2 Auxiliary aids – dosage 64
4.3 Auxiliary aids – measuring and administering medicines 66
4.4 Auxiliary aids – opening medicine containers 68
5 Summary and conclusions 71
6 References and acknowledgements 73
A guide to the design of dispensed medicines | 1
Contents
A guide to the design of dispensed medicines | 3
Foreword
Foreword
4 | A guide to the design of dispensed medicines
We need to take an overview of
safe systems and how medicines
are used in practice. This series of
design guides provides practical
examples of how professionals
working in dispensaries can put
this into practice.
Hemant Patel, President,Royal Pharmaceutical Societyof Great Britain
A guide to the design of dispensed medicines | 5
Patient safety needs to be thenumber one priority in alldispensaries, regardless of the sectorin which they operate. The care andsafety of patients and the public hasalways been of prime concern. It iswith this in mind that I welcome thisguide as one of a series of designpublications produced by the NationalPatient Safety Agency (NPSA).
Other safety critical industries haverecognised that design is a veryeffective method of improving thesafety, effectiveness and efficiencyof their activities. The healthcareindustry has been slow in usingdesign to improve delivery of care topatients; it needs to learn fromthese other industries and applysome of their principles to the safedelivery of medicines.
Healthcare will always carry risks,human beings are fallible. However,harm to patients should not beviewed as an acceptable part ofmodern healthcare. Sir LiamDonaldson, Chief Medical Officer forEngland, recommends the need toencourage and support competent,conscientious and safety-conscioushealth workers in the frontlineservices. He supports the creation of
an environment that motivates andindeed inspires healthcare workersto insist that all care must be as safeas possible.
Dr Keith Ridge, Chief PharmaceuticalOfficer for England, has said that weneed to take an overview of safesystems and how medicines are usedin practice. This series of designguides provide practical examples ofhow professionals working indispensaries can put this into practice,in ways that are already in evidence inforward-thinking organisations acrossthe country.
This booklet presents informationconcerning how better design can beused to make dispensed productssafer for patients, whether they aredispensed from communitypharmacies, doctor dispensingpractices or hospital pharmacies.There are a number of new factorsthat will impact on the dispensingprocess, such as; electronicprescription services; auto-id andautomation technologies; moreresponsibilities for pharmacytechnicians; and enhanced pharmacyservices. The NPSA has tried toincorporate these factors into thedesign guides.
Organisations, managers andhealthcare workers involved indispensing medicines should use thisbooklet as a resource to helpintroduce new initiatives to furtherminimise harms from medicines. Notall of the suggestions in this bookletwill be applicable to every situation,and organisations should implementthose suggestions most applicable totheir own circumstances as they planfor the future.
| 7
Introduction
A guide to the design of dispensed medicines | 7
Every year, more than 900 millionitems are dispensed in England andWales from dispensaries in hospitals,community pharmacies and somedoctors’ surgeries.
The vast majority of these aredispensed accurately, in accordancewith patients’ needs and along witheffective written and verbalcommunication to enable patients touse the medicines safely andeffectively. However, harms frommedicines can occur if patientscannot easily identify their medicine,or how to use it safely andeffectively, and any specialprecautions required.1
The majority of medicines aredispensed for older people or peoplewith long-term medical conditions,including mental, sensory andphysical disabilities. Importantinformation on the dispensing labelshould be presented as legibly aspossible. The dispensing label shouldnot obscure important information onthe commercial medicine pack,including the Braille labelling intendedfor patients with poor vision.
The NPSA’s work to prevent harmfrom oral methotrexate treatmentrevealed that many patients wereunable to easily open medicinebottles with child resistant tops orremove medicines from blister packs.Patients are injured each year afterusing devices such as knives andscrewdrivers to open their medicines,which have been supplied incontainers that they find difficult toopen.2 These patients requireadjustments to the way theirmedicines are presented e.g. easytops, or removing medicines fromblister packs.
A design solutionThe Department of Health 2003report, Design for patient safety ,acknowledged that the use of designin other safety critical industries hadproduced significant improvements insafety, quality and efficiency.3,4
The report recommended that a similarapproach be taken within healthcare.
Human beings make mistakes becausethe systems, tasks and processes theywork within are poorly designed.Effective design can deliver products,services, processes and environmentsthat are intuitive, simple tounderstand, simple to use, convenientand comfortable, and consequentlyless likely to lead to errors. There is awealth of knowledge and methodsfrom the design world that can beapplied to improve healthcareproducts and processes.
Introduction
8 | A guide to the design of dispensed medicines
Mistake-proofing is the use ofprocess design to facilitate correctactions, make wrong actions moredifficult, make it easier to discovererrors that occur, and make itpossible to reverse or undo incorrectactions. Mistake-proofing tends to beinexpensive, very effective, and basedon simplicity and ingenuity.5,6
Japanese industry is credited withcreating and formalising zero qualitycontrol (ZQC), an approach to qualitymanagement that relies heavily onthe use of poka-yoke (pronouncedPOH-kah YOH-kay) devices. Poka-yoke is Japanese for mistake-proofing. A poka-yoke device is anymechanism that either prevents anerror from being made or makes theerror obvious at a glance.7
In his book, The design of everyday things, Donald Norman uses the term‘user centred design’ to describedesign based on the needs of theusers.8 It involves simplifyingstructured tasks and processes,making things visible, getting themapping right, exploiting the powersof constraint and designing tominimise error.
The information in this bookletapplies these design principles todispensed medicines. By workingwith stakeholders, including bothpatients and health professionals,and by visiting dispensaries in bothprimary and secondary care, we haveidentified best practice. There is verylittle research of the use of design inhealthcare, and research on thedesign of dispensed medicines is noexception to this. This bookletidentifies the need for more researchin this area in the future.
Websites
Darnell MJ. Bad human factors designs.(2006). Available at:www.baddesigns.com
Grout J. Mistake proofing center . (2006).Available at:www.mistakeproofing.com
Assured Quality. Company website.Available at: www.assuredquality.com
Norman D. Don Norman's jnd website.Available at: www.jnd.org
NPSA. Mistake proofing healthcare processes. (2004). Available at:www.npsa.nhs.uk
A guide to the design of dispensed medicines | 9
Introduction
The dispensedmedicines flow diagram
A guide to the design of dispensed medicines | 11
1
This booklet looks at some keyelements of the labelling andpresentation of a dispensedmedicine, including:
• setting up your label;• applying the label:• dispensing bags;• aiding the use of medicines.
The first sections provide advice thatwill assist professionals involved indispensing with making changes totheir practices to improve thereadability of labels and positioningof labels on medicines.
The dispensed medicines flow diagram
12 | A guide to the design of dispensed medicines
Labelling and presenting a dispensed medicine
Setting up your labelThis section provides guidance on setting up dispensing labels, the paper usedfor labels, printer technology, choosing the right font and improving the labellayout. It brings together ideas from printing and design, takes account ofguidance from the Royal National Institute of Blind People (RNIB) on printing,and acknowledges legal requirements and the general size of dispensing labels.
A guide to the design of dispensed medicines | 15
2
RequirementsDispensed medicines supplied as aresult of a prescription, written orderor patient group direction must belabelled before being given topatients. There is legislation statingwhat information must be includedon labels applied to dispensedmedicines.9 The boxes opposite showwhat information is a legalrequirement and what additionalinformation would be consideredgood practice.
Setting up your label
16 | A guide to the design of dispensed medicines
2.1 Essential information
Labelling of dispensed medicines: legal requirements
1 The name of the person to whom the medicine is to be administered.
2 The name and address of the person who sells or supplies themedicinal product.
3 The date of dispensing.
4 Where the product has been prescribed by a practitioner such of the followingparticulars as s/he may request:
a the name of the product or its common name;
b directions for use;
c precautions relating to the use of the product. If the pharmacist is of theopinion that any of those particulars are inappropriate and having takennecessary steps to consult with the practitioner, he is unable to do so, hemay substitute other particulars of the same kind.
5 The words ‘Keep out of the reach of children’ or words of direction bearing asimilar meaning; the Royal Pharmaceutical Society recommends that it is good
practice to use the phrase ‘Keep out of the reach and sight of children’ ondispensing labels.
6 Use the phrase ‘For external use only’ within a rectangle if the product is not ona general sale list and is an embrocation, liniment, lotion, liquid antiseptic orother liquid preparation or gel and is for external use only.
RecommendationAdditional informationconsidered good practice
Labelling of dispensed medicines mustbe clear and legible and include thedetails required by the labellingregulations under the Medicines Actand, where appropriate, cautionary andadvisory labels recommended by thecurrent British National Formulary.10
CommentSome pharmacies use ‘dispensed by’and ‘checked by’ labels to indicate thatthese actions have been performed,and who has performed them.
These labels do not differentiatebetween the various steps of theprocess, and could be redesigned tobetter match the dispensing process.11
A guide to the design of dispensed medicines | 17
Setting up your label
Additional information for safer dispensing
1 Dispensed and clinical check boxes
2 Pharmacy telephone number
3 For advice call
4 Where more than one medicine pack of the sameproduct has to be supplied, number these packs1 of 2, 2 of 3, 3 of 3, etc.
Clinical check Dispensed by
Accuracy check Counselling
Issues• Small labels inhibit the clear
communication of information.
• Labels are only just large enoughfor essential information at areasonable text size.
• Smaller labels mean smallertext sizes.
• 'Medicine name' in the drawingsthroughout this booklet isintended to indicate the genericname or, where appropriate, theproprietary name of the medicine.
Setting up your label
18 | A guide to the design of dispensed medicines
2.2 Label size
A guide to the design of dispensed medicines | 13
The dispensed medicines flow diagram
The final section provides suggestionson how to promote the safe use ofmedicines and enable patients toaccess their medicines more easily.
Recommendations• Dispensing labels should be no
smaller than 35mm x 70mm toenable the use of font sizes thatcan be easily read.
• The NPSA has recommended tothe Medicines and Healthcareproducts Regulatory Agency(MHRA) and the pharmaceuticalindustry that a space of 35mm x70mm should be available oncommercial patient packs toenable a dispensing label tobe applied.12
A guide to the design of dispensed medicines | 19
Setting up your label
Issues• Font selection may determine
whether a patient can read thelabel or not.
• If a patient and/or their carer isunable to read the label on theirmedicine, they may notunderstand, or remember, howto take it correctly.
• Some fonts are not freely availableor their use may incur a royalty fee.
• Some fonts are more difficult toread than others.
Setting up your label
20 | A guide to the design of dispensed medicines
2.3 Font selection
Univers Extended. Font Size 12pt
Eurostile Extended Two. Font Size 12pt
Above Extended fonts take up too much space
Haettenschweiler. Regular. Font Size 12pt
Bodoni poster compressed. Font Size 12pt
Above Condensed fonts are difficult to read
Shelly allegro script. Font Size 12pt
Palette. Font Size 12pt
Above Display fonts are less legible
Recommendations• The font used should give the
patient the greatest possible chanceof reading the label correctly.
• Choose a clear, easy-to-read font,such as Arial.
• The choice of font size shouldindicate the importance of theinformation. The direction on howto take the medicine is the mostimportant information on thedispensing label and should be inthe largest font size (at least 12pt).
• The name of the medicine is thenext most important informationand will be repeated on themanufacturer’s pack, when amanufacturer’s patient packis dispensed.
A guide to the design of dispensed medicines | 21
Setting up your label
Take one, three times dailyArial regular 12pt
Above Arial is easy to read and is standard on all personal computers (PCs)
Action
• Check which font your printer isusing and change it to a morelegible font where necessary.
Text that is centred is more difficultto read than left-aligned text.
Issues
The most important informationshould stand out the most.
Using one size and weight of fontmakes it difficult to find the mostimportant information.
Ghost logos can obscureessential information.
Setting up your label
22 | A guide to the design of dispensed medicines
2.4 Label layout2.4.1 Bad examples
28 Medicine Name 200mg tablets
Take ONE tablet THREE times a day
Warning avoid alcoholic drink
Take with or after food
Take regularly and complete the course
Mrs A. Patient 12 Jul 2007
For advice 020 7000 0000Keep out of the sight and reach of childrenA. Pharmacy 123 Pharmacy Street, Town, AB1 C34
BRAND
28 Medicine Name 200mg tablets
Take ONE tablet THREE times a day
Warning avoid alcoholic drink
Take with or after food
Take regularly and complete the course
Mrs A. Patient 12 Jul 2007
For advice 020 7000 0000Keep out of the sight and reach of childrenA. Pharmacy 123 Pharmacy Street, Town, AB1 C34
Issues
A guide to the design of dispensed medicines | 23
Setting up your label
Capitals are difficult to read.
Ensure your paper is properly alignedso that information is not missed off.
Brand marks take up useful spaceand mean that type has to bereduced in size.
28 MEDICINE NAME 200MG TABLETS
TAKE ONE TABLET THREE TIMES A DAY
WARNING AVOID ALCOHOLIC DRINK
TAKE WITH OR AFTER FOOD
TAKE REGULARLY AND COMPLETE THE COURSE
MRS A. PATIENT
For advice 020 7000 0000Keep out of the sight and reach of childrenA. Pharmacy 123 Pharmacy Street, Town, AB1 C34
12 JUL 2007
8 Medicine Name 200mg tablets
ake ONE tablet THREE times a day
arning avoid alcoholic drink
ake with or after food
ake regularly and complete the course
rs A. Patient 12 Jul 2007
For advice 020 7000 0000Keep out of the sight and reach of children
A. Pharmacy 123 Pharmacy Street, Town, AB1 C34
For advice 020 7000 0000Keep out of the sight and reach of childrenA. Pharmacy 123 Pharmacy Street, Town, AB1 C34
28 Medicine Name 200mg tablets
Take ONE tablet THREE times a day
Warning avoid alcoholic drink
Take with or after food
Take regularly and complete the course
Mrs A. Patient 12 Jul 2007
BRAND
Recommendations• Consider the heirarchy of
information and make sure that themost important information standsout more clearly than the rest.
• Align information to the lefthand side.
• Avoid using ghost logoson labels.
• Do not overuse capital letters.
• Ensure paper is properly aligned.
• Avoid brand marks that takeup valuable space.
Setting up your label
24 | A guide to the design of dispensed medicines
2.4 Label layout2.4.2 Good examples
Recommendations• Increasing the size or the boldness
of the most important informationmakes it more accessible.
• Make the most importantinformation stand out.
A guide to the design of dispensed medicines | 25
Setting up your label
Arial 10pt
Arial 12pt
Arial 8pt
Arial 7pt
Arial bold
Medicine Name One row. 35 charactersDirections. Two rows. 29 charactersper row. 58 characters in total.Alerts. Three rows.43 characters per row.129 characters in total. Patient’s Name Date
Dispensary contact details. Three rows.49 characters per row.147 characters in total.
Arial 10pt, one row,35 characters per row,35 characters in totalArial 12pt
Arial 8pt
Arial 7pt
Minimum label size 70mm x 35mm
Medicine Name Two rows. 35 charactersper row. 70 characters in total.
Directions. Two rows. 29 charactersper row. 58 characters in total.Alerts. One row. 43 characters per row.Patient’s Name Date
Dispensary contact details. Three rows.49 characters per row.147 characters in total.
Arial 10pt
Arial 12pt
Arial 8pt
Arial 7pt
Minimum label size 70mm x 35mm
Action
• Check your current labelsagainst the examples on thispage and consider how you canimprove the layout.
• Contact your software supplierto change the look of yourdefault label.
1
2
Issues• The quality of paper chosen for
printing labels can have asignificant impact on thereadability of the label.
• Yellowing paper that is thin willmake information unreadablewhen combined with poorprinting technology.
• Placing a label made of poorquality paper on a pack where theonly space for labelling has abarcode in it will make the labelinformation more difficult to read.
Setting up your label
26 | A guide to the design of dispensed medicines
2.5 Paper quality
For advice 020 7000 0000Keep out of the sight and reach of childrenA. Pharmacy 123 Pharmacy Street, Town, AB1 C34
Recommendation• Use good quality white paper
for labels.
A guide to the design of dispensed medicines | 27
Setting up your label
Action
• Next time you purchase labelslook at the paper qualityoptions and consider upgradingto a better quality paper.
Issues• The quality of printing makes a big
difference to label readability forpatients and carers.
• Dot matrix printers are still in usein parts of the NHS. The quality oflabel these printers produce is verypoor compared with laser orthermal printers. The print ondot matrix labels can become veryfaint and difficult to read if theribbon is not changed regularly.
Setting up your label
28 | A guide to the design of dispensed medicines
2.6 Print quality
For advice 020 7000 0000Keep out of the sight and reach of childrenA. Pharmacy 123 Pharmacy Street, Town, AB1 C34
For advice 020 7000 0000Keep out of the sight and reach of childrenA. Pharmacy 123 Pharmacy Street, Town, AB1 C34
Above Dot matrix print
Above Dot matrix print with an old ribbon
Recommendations• Use thermal or laser printers where
you can.
• If you must use dot matrix, changethe ribbon regularly to avoidfaint type.
A guide to the design of dispensed medicines | 29
Setting up your label
For advice 020 7000 0000Keep out of the sight and reach of childrenA. Pharmacy 123 Pharmacy Street, Town, AB1 C34
Above Laser
Above Thermal
Actions
• If using a dot matrix printer,review how often you changeyour printer ribbon.
• If upgrading your computersystem, consider the positiveimpact for patients of using alaser or thermal printer.
Applying dispensinglabel(s) to medicinesThis section provides a set of general principles for applying dispensing labelsto medicines. There is advice on placement of dispensing labels on a variety ofmedicine packages, including tablets and capsules, liquid medicines, inhalers,creams and ointments, and small packs.
It addresses the practical issues that result from the lack of suitable space fora dispensing label on many manufacturers’ packs, the use of secondarypackaging such as boxes over bottles of liquid medicines, the size and shapeof medicines packs, and the use of Braille. It also highlights the benefits andchallenges associated with the use of large print labels.
A guide to the design of dispensed medicines | 31
3
IssuesObscuring important informationManufacturers do not always provideadequate space for the application ofa dispensing label.
When dispensing labels are appliedto these packs, importantinformation such as the expiry date,warnings or advice to store themedicine in a refrigerator may beobscured from view.
Tiling labelsSome label-printing systems have alarge print or zoom function to printlarger font labels for patients withpoor sight. These may run to two ormore labels making it difficult tolabel smaller packs without coveringimportant information
Multiple packsMedicines supplied in multiple packsmay result in patients not realisingthat each pack contains the samemedicine. Multiple packs canbecome separated if taped or boxedtogether, potentially resulting inunlabelled containers.
Applying dispensing label(s) to medicines
32 | A guide to the design of dispensed medicines
3.1 Applying the label
28 Medicine Name200mg tablets
TakeONE tabletTHREEtimes a dayWarningavoid alcoholic drinkTake with or after foodTake regularly and complete the course
Mrs A. Patient 12 Jul 2007
For advice 020 7089 2627Keep out of the sight and reach of childrenA. Pharmacy 123 Pharmacy Street, Town, AB1 C34
RecommendationsDo not obscureimportant informationWhere there is sufficient space, placethe dispensing label so that it doesnot obscure important information.Where this is not possible, considerthe use of a flag label so thatimportant information remains legible.
BarcodesAvoid placing dispensing labels overbarcodes. In the future, barcodes willbe used after a medicine is dispensedto identify it when recording amedicine history and prior tomedicine administration in hospitals.Medicine manufacturers should notinclude barcodes in the spacereserved for placement of thedispensing label.
Place label on a flat surfaceWhere possible place the label onthe flat surface of a box. Avoidwrapping it around the box.
Label the primary containerLabelling the primary container (e.g.bottle or inhaler) avoids confusion byensuring that information about thename of the patient and directionsfor use are always available and notdiscarded with the secondarycontainer (outer carton).
Breaking sealsIf you need to break the seal of asecondary pack to enable labelling ofthe primary pack, this informationshould be conveyed to the patient ortheir carer when the medicine isgiven to them.
Poor eyesightFor patients who have poor eyesight,if a box has Braille lettering on it doNOT place the dispensing label overthe Braille.
Multiple packsAlways label each container when amedicine is supplied in multiplepacks. Include information to indicatethat each container is one of anumber holding the same medicine.
A guide to the design of dispensed medicines | 33
Applying dispensing label(s) to medicines
Actions
• Review your standard operatingprocedures (SOPs) to reflectthese general principles.
Issue• The space for the dispensing label
that the manufacturer hasprovided is not used and theplacement of the dispensing labelcovers important information onthe manufacturer’s pack.
Applying dispensing label(s) to medicines
34 | A guide to the design of dispensed medicines
3.2 Labelling tablet and capsule cartons3.2.1 Where space is made available
Recommendation• Label using the space provided.
This is usually on the back ofmanufacturer’s patient packs.
A guide to the design of dispensed medicines | 35
Applying dispensing label(s) to medicines
Note: The NPSA has issuedguidance to the pharmaceuticalindustry recommending that theyshould provide a space for the mostcommon label size: 70mm x 35mm.
This space should not have abarcode in it.
Actions
• Where possible, label the back ofthe box in the space provided.
Issues• The manufacturer’s pack has
insufficient space for thedispensing label and containsbarcode information that may berequired after the medicine hasbeen dispensed.
• The placement of the dispensinglabel has covered importantinformation on themanufacturer’s pack.
Applying dispensing label(s) to medicines
36 | A guide to the design of dispensed medicines
28 Medicine Name 200mg tablets
Take ONE tablet THREE times a dayWarning avoid alcoholic drinkTake with or after foodTake regularly and complete the course
Mrs A. Patient 12 Jul 2007
For advice 020 7000 0000Keep out of the sight and reach of children A. Pharmacy 123 Pharmacy Street, Town, AB1 C34
3.2 Labelling tablet and capsule cartons3.2.2 Where space is inadequate
Recommendations• Place the label on the front of the
box so that important information,that is not available elsewhere onthe manufacturer’s pack, is notcovered.
• Place the label on a flat surfaceunder the name of the product.
A guide to the design of dispensed medicines | 37
Applying dispensing label(s) to medicines
Actions
• Review where you place yourdispensing labels on packagesand consider whether they couldbe placed more effectively.
• Review your SOPs to reflectthese changes
Issue• Space provided by the
manufacturer is so small that thedispensing label has to be foldedaround the box. Information onlabels that are folded around themedicine pack is difficult to read.
Applying dispensing label(s) to medicines
38 | A guide to the design of dispensed medicines
3.2 Labelling tablet and capsule cartons3.2.3 Where space is inadequate
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Recommendations• Manufacturers should provide
space for a minimum label size of70mm x 35mm
• If there is insufficient spaceprovided by the manufacturer,place the label on the front underthe name of the product, so thatessential information that is notavailable elsewhere on the pack isnot covered.
A guide to the design of dispensed medicines | 39
Applying dispensing label(s) to medicines
Actions
• Where possible, buy packs withsufficient space for yourdispensing labels.
Issue• Products that have Braille labelling
tend to have Braille on the front ofthe box. Placing the label overBraille will obscure it, making itmore difficult for patients who readBraille to identify their products.
Applying dispensing label(s) to medicines
40 | A guide to the design of dispensed medicines
3.2 Labelling tablet and capsule cartons3.2.4 Braille
Recommendations• If the patient needs Braille, do not
place labels over Braille.
• Best practice is to have amanufacturer’s pack where thereis space, free from Braille, wherethe dispensing label can be placed.
A guide to the design of dispensed medicines | 41
Applying dispensing label(s) to medicines
05576 3325 66 2235 636 221
Actions
• When labelling a medicine fora blind or partially sightedperson, check if they readBraille. If they do, ensure thatyou place the label away fromthe Braille embossing.
• Where you cannot follow allNPSA recommendations, placethe label on the medicine packin a way that best meets theneeds of the patient.
Issues• Labels covering essential
information, including theproprietary and/ornon-proprietary name.
• Label is placed on the box,which is then thrown away.
• Label placed over safetyinformation, such as'For external use only'.
Applying dispensing label(s) to medicines
42 | A guide to the design of dispensed medicines
3.3 Oral liquid medicines
Recommendations• Label the bottle: this allows for
physical checks used as part of thechecking process with the patient.For example, is this liquidsupposed to be clear or should itlook opaque? It also ensurespatients do not throw away thelabel with the outer packaging.
• The dispensing label should beplaced so that it does not coverinformation, for example,indicating that a liquid is 'Forexternal use only'.
A guide to the design of dispensed medicines | 43
Applying dispensing label(s) to medicines
Actions
• Label the bottle not the box.
• Do not place dispensing labelsover important information suchas 'For external use only'.
• Review your dispensing SOPs toreflect these recommendations.
Issues• Dispensing labels that cover
essential information, includingthe proprietary and/or non-proprietary name.
• If medicine tubes are labelled inthis way, the label will be obscuredif the tube is rolled up during use.
Applying dispensing label(s) to medicines
44 | A guide to the design of dispensed medicines
3.4 Topical products
A guide to the design of dispensed medicines | 45
Applying dispensing label(s) to medicines
Recommendation• Place the label longitudinally on
the primary packaging (i.e. thetube or jar), on the front of thepack under the medicine name.
Actions
• Label the tube or jar.
• Do not place dispensing labelsover important information suchas 'For external use only'.
• Review your dispensing SOPs toreflect these recommendations.
Issues• Important information on the
dispensing label may be lost if theouter carton is discarded. This isparticularly true if a child takes aninhaler to school. It may also be asignificant problem where patientshave more than one inhaler or inhouseholds where more than oneperson uses inhalers.
• If the label is discarded with theouter packaging, there may be noindication of the date ofdispensing and dosage instructionsthat could be used by healthprofessionals to assess usage ofthe inhaler.
Applying dispensing label(s) to medicines
46 | A guide to the design of dispensed medicines
3.5 Inhalers
A guide to the design of dispensed medicines | 47
Applying dispensing label(s) to medicines
Recommendations• Place the label on the inhaler. This
may require breaking the outerseal of the container. Explain thiswhen counselling the patientabout their medicine.
• Flags can also be attached toinhalers where their shape meansa conventional label cannot beattached, or where it is importantthat vital recognition symbols arenot obscured.
• It is important that the correct useand dose is reinforced by placingthe dispensing label on the inhaler.
• It is also important to have thedispensing date on the inhaler tohelp determine how long thepatient has been using theindividual inhaler.
Actions
• Review SOPs to reflect therecommendations above.
Issues• Eye drop bottles are very small:
using the standard pharmacylabel and placing it on the packcan cover all of the informationon the pack.
• Covering all the information onthe pack means there are novisual clues for the personchecking the dispensed item or forthe patient or carers who mayhave to select the item from anumber of similar products.
• Many patients being treated forlong-term eye conditions, such asglaucoma, may use two or moredifferent eye drops on a regularbasis. Other patients may haveboth eye and ear drops.
• In some families where more thanone person is using eye or eardrops, there may be confusionover which product is intended foruse by which patient. Expiry dateinformation will also be verydifficult to read.
Applying dispensing label(s) to medicines
48 | A guide to the design of dispensed medicines
ot to be tak
3.6 Eye products
RecommendationsUse of flagged labels ensures that:
• important information on thedispensing label can be read easily;
• essential information on the eyedrop bottle is not covered;
• expiry date information can beclearly displayed;
• design and colour differentiation ofindividual eye drops reinforces theinformation on the dispensing labelto enable correct product selection.
A guide to the design of dispensed medicines | 49
Applying dispensing label(s) to medicines
Not to be taken
Actions
• Consider using flag labels whereappropriate for your patients.
• Review SOPs to reflectthis recommendation.
Issues• Dispensing labels can obscure
essential information for patients.
• Information on folded dispensinglabels is difficult to read.
• Labels can cover information thathelps with accuracy checking andproduct selection when themedicine has been dispensed.
• Expiry date information will also bedifficult to read.
Applying dispensing label(s) to medicines
50 | A guide to the design of dispensed medicines
3.7 Labelling other small containers
Recommendations• Use flags to label small packs, such
as tiny tubes of creams/ointmentsor even small tablet boxes.
• The use of flags aids visibility ofinformation and recognition ofthe product.
• If using flags for small packs for apatient who is a Braille reader, doNOT place the flag over Braille.
• Expiry date information can bedisplayed clearly.
A guide to the design of dispensed medicines | 51
Applying dispensing label(s) to medicines
5% 2g
Actions
• Adjust SOPs to accommodateuse of flagged labelswhere appropriate
Issues• Some patients have difficulty
reading standard sized fonts ondispensing labels.
• Some labelling systems have alarge font option in the software,which may result in informationflowing onto two labels.
• The RNIB, in its document ‘See itright’, recommends a 12–14 pointTYPE for ordinary print, which islarger than most standardlabelling fonts.
• Most patients are unaware thatlarge font labels are available.
• Some computer systems condensewarnings or remove somewarnings on large print or zoomedlabels to ensure no more than twolabels are produced for eachproduct. This cannot be supported,as the removal of warnings orcautionary labels may lead tofurther risks for patients.
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52 | A guide to the design of dispensed medicines
3.8 Use of print labels3.8.1 Large print labels
Recommendation• Consider offering larger font labels
for patients with poor sight. Theuse of larger print labels maynegate the need for othercompliance aids.
A guide to the design of dispensed medicines | 53
Applying dispensing label(s) to medicines
Above Large print will often run to two or three labels.The above label is set in 14pt Arial
Actions
• Learn how to use the zoomfunction on your computer.
• Assess whether the zoomfunction removes warnings orcautionary labels.
• Assess the needs of yourpatients and use zoom labelswhen necessary.
Issues• Large print labels are useful tools
but can run over to two ORMORE labels.
• These may be too big for someproducts or cover the entiresurface of a pack so that accuracychecking is very difficult. Thepatient may be unable to see theoriginal pack to verify that it is thecorrect item for them or seeessential information such as theexpiry date of the product.
• Some medicines may have morealert warnings than will fit ontoone label using NPSArecommended font sizes. In thissituation, tiling labels may be onepotential solution.
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54 | A guide to the design of dispensed medicines
3.8 Use of print labels3.8.2 Multiple labels
Recommendation• One solution is to place a regular
size label on the pack with a largeidentifying number or colouredsticker. Place the multiple zoomedlabels on an A4 sheet or print allinformation on an A4 sheet andmark that sheet with thecorresponding identifier.
A guide to the design of dispensed medicines | 55
Applying dispensing label(s) to medicines
Note: A4 sheets cannot be usedas an alternative to the labellingof dispensed medicines becausea label is a legal and professionalrequirement.
Issue• Insufficient use is made of
dispensing bags to reinforce keysafety messages.
Applying dispensing label(s) to medicines
56 | A guide to the design of dispensed medicines
3.9 Dispensing bags
For advice 01234 123456Keep out of the sight and reach of childrenA. Pharmacy 123 Pharmacy Street, Town, AB1 C34
Recommendation• Key safety information should be
printed in large fonts ondispensing bags.
A guide to the design of dispensed medicines | 57
Applying dispensing label(s) to medicines
Actions
• When purchasing new bags formedicines, consider includingsafety messages or ‘forinformation’ telephone numberson the bags.
Aids to help patients usetheir medicinesThis section includes many suggestions of ways that professionals involved indispensing medicines can support patients with their medicine taking.These solutions are grouped into sub-categories of patient held information,opening medicine packaging, and measuring and administering medicines.
Some of these solutions will be helpful for patients with physical or sensorydisabilities. The key to finding an appropriate solution is the combination ofcommunication and assessment of patients’ needs.
A guide to the design of dispensed medicines | 59
4
Aids to help patients use their medicines
60 | A guide to the design of dispensed medicines
Giving people medicines inpackaging they cannot use mayprevent them from taking themedicines or lead them to developunsafe strategies for managing theirmedicines, e.g. leaving tops off loosetablets or liquids, or having medicinesremoved from blister packs by familyor friends and leaving them loose inthe box. There is anecdotal evidenceof patients putting medicines loose intheir pockets or in envelopes,pouring them into egg boxes orputting them on plates where theymight be picked up by children oreven the family pet.
Simple adjustments may makemedicine taking easier for patientswith physical or sensory disabilities.For example, people with dexterityproblems would find medicine takingeasier if they were supplied withmedicines they could easily open,e.g. in bottles with easy tops ratherthan child resistant closures.Pharmacists are able to do this.
Many of the adaptations and deviceson the following pages would comeunder the definition of reasonableadjustments under the DisabilityDiscrimination Act. Persons involved
in dispensing medicines should bewilling to make reasonableadjustments when they are in theinterests of patient care and safety.
The key to making adjustments forpatients is to ensure that they areappropriate. Just because monitoreddosage systems are available doesnot mean they meet the needs of allpatients. Sometimes it is the simpleadjustments, such as large printlabels, pushing medicines out ofblister packs or providing easy topson medicine bottles, that can helppatients manage their medicines.
Assessment tools to helpprofessionals measure the needs oftheir patients are available via thePharmaceutical Services NegotiatingCommittee and the NationalPharmaceutical Association. Someof the large pharmacy chains havedeveloped or adapted tools for usein their stores.
Action
• Be proactive in assessingpatients’ needs and presentingmedicines and information in away that ensures safe andeffective use.
• Do not wait for patients to askfor a simple adjustment afterthe medicine has already beensupplied.
• Check with the patient or carerwhen the medicine is beingcollected that they can opentheir medicine safely andeffectively.
• Where necessary, makeadjustments before the medicineis supplied.
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Aids to help patients use their medicines
Action
• Pharmacists and dispensingdoctors should put up postersto alert patients and carers tothe availability of easy tops andother simple adjustments.
• If dispensing medicines inbottles for patients likely tohave dexterity problems, ask thepatient if he/she wants easytops. Remember to advise themon the need for secure storageof medicines if they have youngchildren or grandchildren.
Above Patients sometimes use inappropriate devicesif they have difficulty opening their medicines
Aids to help patients use their medicines
62 | A guide to the design of dispensed medicines
Alert cards and booklets for patientsprovide an important contribution topatient safety. Three key bookletsrelating to medicines are anticoagulantbooks (yellow book), methotrexatepatient booklets and steroid cards.Dispensing staff should check thatpatients on these medicines havereceived these booklets.
They should also check and discusswith their patients information aboutmonitoring and dosage of thesemedicines in the patient held record.
If the patient has not received a copyof the patient held information, orissues arise from review of themonitoring and dosage information,the dispensing staff should arrangethe supply of this information. Theprescriber may also need to becontacted to arrange follow-upaction to ensure their patientsmaintained on this therapy are safe.
4.1 Patient held information
Action
• Ensure patient held informationhas been provided, reviewedand discussed with the patient.
• Ensure that any issues arefollowed-up by the appropriatepractitioner.
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Aids to help patients use their medicines
Information leaflets for thevisually impaired
The X-PIL website(www.xpil.medicines.org.uk) is aservice to help pharmacists and theircustomers to ensure that patientinformation leaflets (PILs) suppliedwith medicines are available toeveryone, including those with sightproblems.
The RNIB medicines information lineis free to use and available 24 hoursa day, 7 days a week. The number is:0800 198 5000. By calling thisnumber you can listen to and/orrequest PILs:
• in large/clear print;
• in Braille;
• on audio CD.
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64 | A guide to the design of dispensed medicines
Recording devices
Some patients who are blind orpartially sighted may benefit fromhaving information about theirmedicines recorded and available tothem. Some use portable recordingdevices, others would benefit from atalking label – a device that can beattached to a medicines box and hasa 60-second recording time. Talkinglabels have easy-to-use, large buttons,and are re-recordable and reusable.
Medicines reminder charts
Medicines reminder charts are auseful tool to support patients whoneed reminders to take theirmedicines. Some pharmacy computersystems can produce these forpatients whose details are recordedon the patient medication system.
Patient information leaflets
PILs are provided with medicines andshould be given to all patients.However, the font used in theseleaflets is sometimes small and canbe difficult for some patients to read,especially those whose sight is poor.A new service (see page 63) forleaflets endorsed by the RNIB, MHRAand Association of the BritishPharmaceutical Industry (ABPI) ensurethat PILs can be provided in largeprint or as audio.
4.2 Auxiliary aids – dosage
Patient information
A guide to the design of dispensed medicines | 65
Aids to help patients use their medicines
Pen and paper
A simple solution such as providing apen and paper can be a useful meansof communicating with people whohave hearing problems.
Tacki liquid
A liquid that enables pharmacists toproduce raised marks that can befelt; this may be useful for patientswith poor eye sight or for those whoare deaf-blind.
Compliance boxes andmonitored dosage systems
These may be useful for somepatients who regularly take tabletsand capsules and need a prompt toensure they have taken them.
Compliance boxes are inappropriatefor ‘when required’ medicines ormedicines that must be kept in glassbottles, e.g. glyceryl trinitrate.
Discussions with the patient or theircarer about the problems withmedicine-taking are essential forensuring the correct product for apatient’s needs.
R N I B
BEDTIM E TEA-TIMEMID-DAYMORNING
Liquids
Medicine spoons and oral syringesare essential tools for measuringliquid medicines. However, for somepatients 1ml oral syringes for verysmall doses, spoons that measure2.5ml or measuring cups may bemore appropriate.
Pill splitters
Where small doses are prescribedand tablets need to be halved thiscan cause difficulties for somepatients. These tablet splitters reducewaste and ensure consistency ofdosage because medicines areaccurately split.
Tube squeezers
Assistance with creams andointments is available in the formof tube squeezers. These can simplifysqueezing and reduce waste byensuring complete emptying ofthe tube.
Aids to help patients use their medicines
66 | A guide to the design of dispensed medicines
4.3 Auxiliary aids – measuring andadministering medicines
10
20
20
30
40
Inhalers
Choice of inhaler is key to effectiveuse. Incorrect use of an inhaler canresult in ineffective doses beingreceived and greater morbidity forpatients. Some patients may benefitfrom breath-activated inhalers;others will use spacer devices if theycannot co-ordinate pressing theinhaler and breathing in. There aredevices that can help people whocannot manually activate a metreddose inhaler.
Eye drops
There are numerous devices availableto assist in the use of eye drops;some of these are available onprescription. These devices canenable patients to hold eye dropbottles in the correct position andhelp with squeezing the bottle toapply drops to the eye.
A guide to the design of dispensed medicines | 67
Aids to help patients use their medicines
Aids to help patients use their medicines
68 | A guide to the design of dispensed medicines
Child resistant closures
There is no such thing as a childproofcontainer. There are howevernumerous child resistant closures(CRCs) that are used to reduce therisks of accidental poisoning. CRCswork in different ways.
Push and twist
Most CRCs are press and turn orpush and twist, requiring patients topress down as they turn the lids toenable the closure to be removed.
CRCs with keys
Some CRCs can be opened using akey. This offers the dual benefit ofprotecting children (if the medicineand keys are stored securely) andenabling the patient to have easyaccess to their medicines.
4.4 Auxiliary aids – opening medicine containers
A guide to the design of dispensed medicines | 69
Aids to help patients use their medicines
Snap-off
Other CRCs are snap-off tops thatinvolve matching triangles betweenlid and bottle. Once these trianglesare matched the lid snaps off.
Non-CRCs
Offering patients a choice of closure,including a non-child resistantclosure, is a simple solution toimprove access to medicines inbottles. Using medigrip lids andwinged caps or gripper devices maybe useful for some patients withdexterity problems.
Blister packs
For patients who are unable toremove medicines from blisterpackaging, professionals may removemedicines from the blisters and putthem in ordinary bottles. Alternatively,they might supply a pill popper devicesuch as the ‘Pill press’ or ‘Pill punchout’ for patients or carers to removethe medicines themselves.
Action
• Provide patients and carers withinformation about the auxillaryaids that are available to themto assist them with using theirmedicines safely and effectively.
5
Summary and conclusions
A guide to the design of dispensed medicines | 71
The NPSA recommends that, afterreading this booklet, you look at theway you dispense medicines with acritical eye. Think about the smallchanges that you can make and planfor some of the larger ones.
Many of the suggestions made in thisbooklet can be enabled quickly andat little cost. By making some ofthese relatively easy changes youcan make a real contribution towardskeeping your patients safe whilstthey are taking their medicines. Gooddesign saves lives, as has beendemonstrated in many otherindustries, and the NPSA believes thisprinciple applies equally to pharmacyas to any other situation.
There are many differing views abouthow medicines should be presentedto the patient, and it is up toindividuals and organisations todecide which suggestions areappropriate to their particularcircumstances. The NPSA believesthat the suggestions in this bookrepresent ideas that, if incorporatedinto standard operating proceduresand put into practice, would make asignificant contribution towardsimproving patient safety.
The NPSA would be keen to receiveyour feedback on this publication tobuild on its knowledge and informfuture revisions.
Summary and conclusions
72 | A guide to the design of dispensed medicines
6
References and acknowledgements
A guide to the design of dispensed medicines | 73
74 | A guide to the design of dispensed medicines
References and acknowledgements
References
1 NPSA Patient Safety Observatory Report 4: Safety in doses. (2007).Available at: www.npsa.nhs.uk
2 Royal Society for the Prevention ofAccidents. Available at:
www.rospa.com
3 Department of Health. Design for patient safety. A system-wide designled approach to tackling patient safety in the NHS. (2003). Available
at www-edc.eng.cam.ac.uk/medical/downloads/report.pdf
4 Clarkson J et al. Design for patient safety. A scoping study to identify how effective use of design could help to reduce medical accidents.Engineering Design Centre,University of Cambridge (2004).
5 Shingo S. Mistake-proofing for operators: The ZQC System.Productivity Press, Incorporated. (1997).
6 Buckley RL, Buckley CL. No eraser needed: mistake proofing your business. Shady Brook Press. (2006).
7 Shimbun NK. Poka-yoke: improving product quality by preventing defects(improve your product quality)Productivity Press, Incorporated.(1989).
8 Norman DA. The design of everyday things. First Basic Paperback. (2002).
9 Royal Pharmaceutical Society of
Great Britain. Medicines ethics, and practice. A guide for pharmacists and pharmacy technicians. Number 31
(July 2007).
10 British National Formulary. Edition53. (2007).
11 NPSA. Design for patient safety: a guide to the design of the dispensingenvironment. (2007).
12 NPSA in collaboration with the HelenHamlyn Centre, Royal College of
Arts. A guide to the graphic designof medication packaging (second edition). (2007).
A guide to the design of dispensed medicines | 75
Stakeholder consultation responders
Association of BritishPharmaceutical Industry
Alliance Pharmacy
Almus Pharmaceuticals Ltd
Associated Chemists (Wicker) Ltd
Bees Pharmacy
Boots The Chemist
British Association ofPharmaceutical Wholesalers
Diabetes UK
British Thyroid Foundation
Cancerbackup
Cegedim
Commission for Social Care Inspection
Deafblind UK
Department of Health – England
Essex Rivers NHS Trust
Lloyds Pharmacy
National Pharmacy Association
Patients Association
Pharmaceutical ServicesNegotiating Committee
Pharmacists’ Defence Association
Primary and Community CarePharmacy Network
Royal Pharmaceutical Societyof Great Britain
Royal Pharmaceutical Societyof Great Britain – Wales
Sainsbury’s
Scottish IntercollegiateGuidelines Network
SIGN
Systems Solutions Ltd
Wales Hospital Pharmacy
Patient Workshop attendees
Action against Medical Accidents (AvMA)
Age Concern
British Limbless Ex-ServiceMen's Association
British Thyroid Foundation
Cancerbackup
Carers First
Central Nottinghamshire MIND
Deafblind UK
Diabetes UK
Multiple Sclerosis Society
National Society for Epilepsy
Parkinson’s Disease Society
Patient Information Forum
Royal National Institute of Blind People
SIGN
Sunfield Children’s Homes
The Royal National Institute forDeaf and Hard of Hearing People
Professional Expert ReferenceGroup Attendees
Association of Independent Multiples
Association of Pharmacy Technicians UK
Boots The Chemist
British Association of PharmaceuticalWholesalers
City and Hackney TeachingPrimary Care Trust
Company Chemists Association
Co-op Chemists
Dispensing Doctors Association
Guild of Healthcare Pharmacists
Lloyds Pharmacy
Morrison’s
National Pharmacy Association
Pharmaceutical ServicesNegotiating Committee
Pharmaceutical Societyof Northern Ireland
Primary and CommunityCare Pharmacy Network
Rowlands
Royal Pharmaceutical Societyof Great Britain
Royal Pharmaceutical Societyof Great Britain – Welsh Executive
References and acknowledgements
Acknowledgements
76 | A guide to the design of dispensed medicines
We would also like to thank thefollowing individuals for their help indeveloping this resource:
Adrian PriceNational Co-operative Chemists
Amit ShahBees Pharmacy
Barbara ParsonsPharmaceutical Services NegotiatingCommittee
Careen SneddenAlmus Pharmaceuticals Ltd
Carole DaviesLloyds Pharmacy
Catherine DaviesAssociation of Pharmacy Technicians
David PruceRoyal Pharmaceutical Society ofGreat Britain
Diane HeathPrimary and Community Care PharmacyNetwork
Dinesh MehtaBritish National Formulary
Geraldine YatesCommission for Social Care Inspection
Graham PhillipsManor Pharmacy
Hazel SummervilleCommission for Social Care Inspection
Heidi WrightRoyal Pharmaceutical Society ofGreat Britain
Jeanette HoweDepartment of Health – England
John EvansAsda Pharmacy
John FormanGreenlight Pharmacy
John MacDonaldSystems Solutions Ltd
Jonathan EllisHelp the Aged
Keith RidgeDepartment of Health – England
Laura CohenAstraZeneca Ltd
Martin BennettAssociated Chemists (Wicker) Ltd
Michael StylesNational Pharmaceutical Association
Nuala BrennanRoyal Pharmaceutical Society (Wales)
Paul BullockCharing Cross Hospital
Paul KnightMurray’s Pharmacy
Rachel ClementsCegedim
Richard TinerAssociation of the BritishPharmaceutical Industry
Ruth CarlisleCarlisle’s Pharmacy
Siobonne BrewsterRoyal National Institute of Blind People
Steve EasthamBoots The Chemist
Steve LutenerPharmaceutical ServicesNegotiating Committee
Sue NewtonHammersmith Hospital
Susan GrieveDepartment of Health – England
Theo RaynerUniversity of Leeds
Tony GarlickBritish PharmaceuticalWholesalers Association
NPSA project team
Bruce Warner
Catherine Dewsbury
Colum Lowe
David Cousins
Isobel Nesbit
Linda Matthew
Peter Mansell
Colin Goodhew (Lucid Design)
Tim Farrer (formally of Lucid Design)
For further details or commentsregarding this resource pleasecontact:
Safe Medication Practice TeamNational Patient Safety Agency4-6 Maple StreetLondonW1T 5HD
Tel: 020 7927 9356Email: [email protected]
References and acknowledgements
www.npsa.nhs.uk
The National Patient Safety Agency4 - 8 Maple StreetLondonW1T 5HD
T 020 7927 9500F 020 7927 9501
Ref: 0585
ISBN: 978-0-9556340-6-2
© National Patient Safety Agency 2007. Copyright and otherintellectual property rights in this material belong to the NPSA and allrights are reserved. The NPSA authorises healthcare organisations toreproduce this material for educational and non-commercial use.