Dispensing Environment

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    Design for patient safetyA guide to the design ofthe dispensing environment

    Edition 12007

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    About this publicationThis guide to the safer design of the dispensingenvironment is one of a series of design publications

    produced by the National Patient Safety Agency (NPSA).

    Other publications in the NPSA Design for patientsafetyseries:

    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. Future ambulances. (2007).

    NPSA in collaboration with Lucid Design. A guide to thedesign of dispensed medicines. (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-yearperiod and involved a NPSA team of pharmacists and apharmacy technician with combined experience in

    community, primary care, hospital and academicpharmacy. Publications from within and outside the

    healthcare industry were reviewed in preparing thisguide. The project team also included two designers from

    Lucid Design who had experience of undertaking design

    projects across a range of industries, including healthcare.

    A wide range of stakeholders including individualhealthcare professionals, professional and commercial

    organisations, patients, carers and patient organisationscontributed to this research. Visits were undertaken to a

    number of community and hospital pharmacies that hadbeen identified as using design effectively to support

    innovative practice.

    The outcome was a design guide applying the principlesof human factors design, mistake-proofing, poka-yokeand customer services to the dispensing environment.

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    Foreword 3

    Introduction 7

    1 Changes in the general dispensing environment that can improve patient safety 151.1 The general dispensing environment 171.2 Workflow 18

    1.3 Working environment 20

    1.4 Ergonomic issues 22

    1.5 Delivery of stock 24

    1.6 Storage of medicines 26

    1.6.1 Refrigerators 26

    1.6.2 Controlled drug (CD) cupboards 281.6.3 Waste and returns 30

    1.6.4 Separation of stock 32

    1.6.5 Location of stock 34

    1.7 Patient areas 36

    2 Design changes to stages in dispensing a prescription that can help reduce errors 392.1 Stages in dispensing a prescription 40

    2.2 Prescription reception and clinical check 422.3 Generating medicine labels 44

    2.4 Assembling medicine products and labels 46

    2.4.1 Accuracy check and use of auto-id technologies 48

    2.4.2 Use of automation 50

    2.5 Dispensed and to follow medicines awaiting collection 52

    2.6 Medicines collection 54

    2.7 Final accuracy check and patient counselling 56

    2.8 Patient consultation and advanced/enhanced services 58

    2.9 Supervised consumption 60

    3 Summary and conclusion 63

    4 References and acknowledgements 65

    A guide to the design of the dispensing environment | 1

    Contents

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    A guide to the design of the dispensing environment | 3

    Foreword

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    Organisations, managers and

    healthcare workers involved indispensing medicines shoulduse this booklet as a resourceto help introduce new initiatives

    to further minimise harmsfrom medicines.

    Foreword

    4 | A guide to the design of the dispensing environment

    Hemant Patel, President,Royal Pharmaceutical Society

    of Great Britain

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    A guide to the design of the dispensing environment | 5

    Foreword

    Sir Liam Donaldson, Chief MedicalOfficer for England, in his introductionto the report Safety First1, identifiedthat the pace of change to embedpatient safety as a core principle inthe NHS has been too slow. He

    recommends that the NHS redoublesits efforts to implement systems andinterventions that actively andcontinuously reduce risks to patients.

    Healthcare will always carry risks,human beings are fallible. However,harm to patients should not beviewed as an acceptable part of

    modern healthcare. He alsorecommends the need to encourageand support competent,conscientious and safety-conscioushealth workers in the frontlineservices. He supports the creation ofan environment that motivates andindeed inspires healthcare workers toinsist that all care must be as safe aspossible.

    Other safety critical industries haverecognised that design is a veryeffective method of improving thesafety, effectiveness and efficiencyof their activities. Healthcare hasbeen slow in using design to improve

    delivery of care to patients.

    The National Patient Safety Agency(NPSA) is promoting design as aneffective method to improvehealthcare in a series of Design forpatient safetybooklets for a range ofhealthcare products and activities.

    This booklet presents informationconcerning how better design can beused to make the dispensing processsafer in community pharmacies,dispensing doctor practices andhospital pharmacies. There are anumber of new factors that willimpact on the dispensing process,such as: electronic prescription

    services; auto-id and automationtechnologies; more responsibilities forpharmacy technicians; and enhancedpharmacy services. These factorshave been incorporated into thesesafer design recommendations.

    Organisations, managers andhealthcare workers involved indispensing medicines should use thisbooklet as a resource to helpintroduce new initiatives to furtherminimise harms from medicines. Not

    all of the recommendations in thisbooklet will be applicable to everysituation, and so it is envisaged thatorganisations will implement thosesuggestions most applicable to theirown circumstances as they plan forthe future.

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    A guide to the design of the dispensing environment | 7

    Introduction

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    Introduction

    8 | A guide to the design of the dispensing environment

    Human beings usually makemistakes because the systems,

    tasks and processes they workwithin are poorly designed.

    Effective design can deliverproducts, services, processes

    and environments that areintuitive, simple to understand,simple to use, convenient and

    comfortable, and consequentlyless likely to lead to errors.

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    The problemEvery year, more than 900 millionitems are dispensed in England andWales from hospitals, communitypharmacies and doctors surgeries.The vast majority of these aredispensed accurately and patients arecounselled about how to use theirmedicines safely and effectively.

    However, occasionally preventableerrors do occur.

    Research has found that on average26 (0.1%) dispensing incidents occurfor every 22,000 items dispensed incommunity pharmacies.2 Of theseincidents, 22 were classified as nearmisses, where the error was

    discovered before the medicine was

    supplied to the patient. Theremaining four (0.02%) wereclassified as dispensing errors, whenthe incorrect medicine was suppliedto the patient. Extrapolating thesefigures to determine the rate forEngland and Wales indicates thataround 134,314 dispensing incidentsoccur in community pharmacies each

    month; 113,953 near misses, and20,361 dispensing errors.

    One or more dispensing incidentswere identified at the final checkstage of 4,849 (2.1%) of 194,584items dispensed in a UK hospital.There were 39 (0.02%) items witha dispensing error that left the

    pharmacy department.3

    Introduction

    A guide to the design of the dispensing environment | 9

    Percentage of errors reported

    Wrong or unclear dose28.0%

    17.1% Omitted medicines

    11.5% Wrong medicine

    6.1% Wrong quantity

    4.9% Mismatching between patient and medicine

    32.4% Other

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    The detail of dispensing errorsreported to the NPSA via theNational Reporting and LearningSystem (NRLS), and information fromtwo major pharmacy indemnity

    providers, indicates that over 80% ofdispensing errors are picking errors.These errors involve the selection ofthe wrong strength or formulation ofthe correct medicine, or the wrongmedicine completely.4

    Effective communication withpatients as part of the dispensingprocess is important. There isevidence that patient-centred advicecan improve patients adherence tomedicines and prevent hospitaladmissions.5,6 There is a need forprivacy and confidentiality whenadvice about medicines is given.7

    Harms from medicines can occur ifpatients do not understand the

    purpose of their medicine, how touse it safely and effectively, and anyspecial precautions or monitoringrequirements. Failing to act oninformation in a patients medicationrecord or handing out an unopenedbag of medicines and not counsellingthe patient about those medicineswould also not be considered as

    good practice and could lead topatient safety incidents.

    Not all dispensing errors and failureto counsel patients about theirmedicines will cause harm, andthere are many other factors thatcontribute to patients being harmed

    from their medicines. However,information about the prevalenceof harms from medicines isbecoming clearer.

    Research to measure harms frommedicines in the community that causehospital admissions found aprevalence rate of 6.5% of alladmissions.8 In 2002, there were atotal of 3.8 million acute admissionsin England suggesting that harmsfrom medicines were causing247,000 hospital admissions andwere responsible for the death of5,700 patients every year. Harms arealso caused from medicines used inhospital; including these incidents is

    likely to increase the number ofdeaths to around 10,000 a year.8

    The median length of hospital stayfor a harm from a medicine was4.8 days and the projected annualcost of such admissions to the NHS is466 million each year.

    A design solutionThe Department of Health 2003report Design for patient safety9

    acknowledged that the use of designin other safety critical industries had

    produced significant improvements insafety, quality and efficiency. Thereport recommended that a similarapproach be taken within healthcare.

    Human beings usually make mistakesbecause the systems, tasks andprocesses they work within are poorlydesigned. Effective design can deliverproducts, services, processes andenvironments that are intuitive,simple to understand, simple to use,convenient and comfortable, andconsequently less likely to lead toerrors.10 There is a wealth ofknowledge and methods from thedesign world that can be applied toimprove healthcare processes.

    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 based

    on simplicity and ingenuity.

    Introduction

    10 | A guide to the design of the dispensing environment

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    Japanese industry is credited withcreating and formalising zero qualitycontrol (ZQC), an approach to qualitymanagement that relies heavily onthe use of poka-yoke (pronounced

    POH-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.11

    In his book, The design of everydaythings,12 Donald Norman uses theterm user centred design todescribe design based on the needsof the users. This 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 to thedispensing process. By working withstakeholders, including both patientsand health professionals, and by

    visiting dispensaries in both primaryand secondary care, the NPSA hasidentified good practice. There is verylittle research on the use of design inhealthcare, and research on design inthe dispensing process is noexception to this. This bookletidentifies the need for more researchin this area in the future.

    Detailed information onAccommodation for pharmaceuticalservices can also be found in theNHS Estates Health Building Note 29,which provides briefing and planningadvice on accommodation forpharmaceutical services in hospitals.13

    This contains many design principles

    that may be appropriate in allpharmacy sectors and settings.

    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 healthcareprocesses. (2004). Available at:www.npsa.nhs.uk

    A guide to the design of the dispensing environment | 11

    Introduction

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    Design of the general dispensing environmentand stages of the dispensing process

    The design of the general dispensing environment,encompassing how medicines are delivered, stored andthe layout of the dispensary, can have an effect onpatient safety.

    Dispensing a prescription involves many quite distinctstages. By breaking the dispensing process down into itsconstituent parts, each stage can be looked at individuallyand improved design applied to each one to make theprocess as safe as possible.

    Introduction

    12 | A guide to the design of the dispensing environment

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    A guide to the design of the dispensing environment | 13

    Introduction

    Research has shown that workflow redesign canpositively affect dispensing activity and allowpharmacists more time for patient counselling.14

    The diagram below shows the different stages within thedispensing process, and each one of these stages will belooked at in more detail in separate sections of this booklet.

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    A guide to the design of the dispensing environment | 15

    Changes in the generaldispensing environment thatcan improve patient safety

    1

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    IntroductionAs services and prescription volumesincrease, more and more stock andactivity needs to be crammed into afixed space.

    Increasing the size of a dispensarymay not always be feasible, and so itis essential that the available space isused in the most efficient waypossible. This may involve thinkingvery carefully about the flow of workas well as the general environmentand ergonomic issues that will makethe dispensary a safer place for bothpatients and pharmacy staff.

    This section takes these issues in turnand suggests practical improvementsthat can be made to the generaldispensing environment.

    Most recommendations could beimplemented at little or no cost,

    although others may require a degreeof practical and financial planning.

    A guide to the design of the dispensing environment | 17

    Dispensing environment

    1.1 The general dispensing environment

    Storage

    use of drawer systems benefit of shelf dividers medicines storage AZ

    by generic name refrigerated medicines -

    two fridges controlled drugs waste and returned

    medicines sharps

    Delivery

    separate delivery area room to unpack and check

    against delivery note transport to dispensary

    workflow signage, lighting, noise ergonomics managing patient waiting private areas supervised consumption counselling rooms

    access to terminals

    Layout

    Where we can use design to reduce errors

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    Issues A poorly-planned workflow can

    result in confusion, fatigue,muddled processes and increasedrisk of error.

    Dispensing a prescription involvesmany quite distinct stages. It isimportant to understand eachindividual stage.

    Dispensing environment

    18 | A guide to the design of the dispensing environment

    1.2 Workflow

    Receipt of prescriptionand clinical check

    Creation of label

    Medicines assembly

    Accuracy check

    Storing dispensed medicines

    Medicines collection andfinal accuracy check

    Patient counselling7

    6

    5

    4

    3

    2

    1

    Above Confusing workflow that mayincrease the risk of error.

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    Recommendations Research has shown that workflow

    redesign can positively affectdispensing activity andallow pharmacists more time for

    patient counselling.14

    By breaking the process down intoits constituent parts, each stagecan be looked at individually andunique methods applied to eachone to make the process as safeas possible.

    Action

    Draw a similar diagram thatreflects the workflow in yourparticular dispensing environment.

    A guide to the design of the dispensing environment | 19

    Dispensing environment

    AboveAn uninterrupted and logical workflowwill help to reduce errors.

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    IssueThe general environment within thepharmacy can have a very largeinfluence on how well staff copewith the pressures of working in a

    busy dispensary.

    RecommendationsThe following points, in addition togeneral maintenance and cleanlinessissues, should all be considered whendesigning a dispensary that will be

    safe for both staff and patients:

    Signing if patients know where togo to hand in or collect prescriptions,or to ask for advice, there will beshorter queues, less confusion andimproved communication. This inturn will put pharmacy staff underless pressure and allow them to

    concentrate without interruption.Clear signing and colour contrast toimprove communcations withpatients with impaired vision isparticularly important.

    Lighting daylight bulbs give out amuch better light to work by andshould be used wherever possible in

    the dispensary. Good lighting isparticularly important directly abovedispensing benches and near screens.Research has demonstrated that anillumination level of 146 foot-candles(approximately 1,460 lux) isassociated with a significantly lowerrate of dispensing errors comparedwith baseline illumination of 45 foot-

    candles (approximately 450 lux).15

    Lighting is therefore vitally importantif error rates are to be reduced.Background light should however notbe as bright as that required directlyover work areas, as this can lead to

    symptoms such as headaches andcan also decrease contrast, which isneeded to help direct focus on criticalareas. Issues of lighting thereforeneed to be considered carefully.

    Noise background noise, e.g.tannoys, checkout till noise, music,etc. should be kept to a minimum byusing design methods to screen staffand patients from distracting noise.

    Security staff and patients need toboth be and feel secure, although abalance must be achieved betweensecurity and communication. Wherethis balance lies will perhaps dependon the type of dispensary concerned.For example, in a dispensary that

    deals with a lot of substancemisusers, higher counters may beappropriate. However, increasedsecurity measures, such as glassscreens or hatches, may hindercommunication and be considered asless appropriate in other situations.Panic buttons and closed-circuittelevision (CCTV) may also help staffto feel at ease and hence more

    Dispensing environment

    20 | A guide to the design of the dispensing environment

    1.3 Working environment

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    able to communicate effectivelywith patients.

    Privacy many of the issues thatpatients will want to discuss will beconfidential, so it is essential that

    they can receive advice without beingovertly overheard.

    Flooring cushioned flooring willhelp to alleviate tiredness which inturn will help staff to maintain levelsof concentration.

    Temperature and ventilation staffneed to be comfortable if they areto work safely. Health and safetyrecommendations are that workingtemperatures should be no less than16C. Also medicines should not bestored at temperatures greaterthan 25C.

    Seating many pharmacies provideseating for elderly or disabled

    customers. This area should be sitedso that confidential conversations atthe prescription receipt or handoverareas cannot be overtly overheard.

    Telephone give some thought towhere this should be sited in order toallow confidential conversations tobe held without being overheard andto provide minimum disruption to the

    dispensing process. Research hasshown that interruption anddistractions are associated with anincrease in dispensing errors, and sosome thought should be given towho answers telephone queriesand when.16

    Colour of dispensary benches white benches provide a difficultbackground on which to see whitepackaging and medication. Considerother colours such as grey or cream.

    Action

    Review all of the above issuesin your dispensary and consider

    if altering any of them needsto be built into future plans.

    A guide to the design of the dispensing environment | 21

    Dispensing environment

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    1.4 Ergonomic issues

    Dispensing environment

    22 | A guide to the design of the dispensing environment

    Issues Computer screens and keyboards

    laid out in a haphazard manner.

    Very low dispensary work surfaces.

    Dispensary staff expected to climbshelves or benches to reach stockin high storage locations.

    Monitor

    Prescription

    Above Poor consideration of ergonomic issuescan lead to poor posture, stress and increasethe chance of error through tiredness.

    Action

    Check the ergonomic issues in

    your dispensary against theHealth & Safety Executive (HSE)recommendations(www.hse.gov.uk)

    Make use of prescriptionholders to ensure prescriptionsare at eye level when labelling.

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    A guide to the design of the dispensing environment | 23

    Dispensing environment

    Recommendations Computer ergonomics, printer

    position, shelf heights, worksurface height, and the positionand working height of dispensary

    fittings and equipment shouldfollow the advice of the HSE.

    Particular attention needs to bepaid to stations where staff workfor long periods, such as labellingor prescription reception areas.

    Computer screens and keyboardsshould not be laid out in ahaphazard manner.

    Very low dispensary work surfacesshould not be used.

    Dispensary staff should not beexpected to climb shelves orbenches to reach stock in highstorage locations.

    Short person

    860965 mm

    Eye height

    Eye height

    Tall person

    Prescription holder

    Top of monitor at eye height

    Poor/hazardous storage

    Eye height 1430 mm

    860965 mm

    Eye height 1750mm

    Tall male Short female

    Heavy items

    Above Screens should be at arms length.Screens should have prescription holders, which

    should be at eye height so that staff do nothave to continually look up and down.

    There should be space under the desk for legs.Simple ergonomic solutions can makeworkstations suitable for employees ofdifferent heights.

    RightThe bulk of medicines should be kept ateasy reaching distance, taking into account

    staff height variations.

    Errors are more likely if stock is difficult toreach; heavy items should be kept at a heightthat reduces the need to bend down to lift.

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    Issues If newly delivered stock is mixed

    with current stock before it ischecked off, there is a risk of itbeing put away in the wrong

    storage area.

    Involuntary automaticity (theskilled action that people developthrough repeatedly practising thesame activity, e.g. driving a car,which takes place largelyindependent of conscious controland attention) increases the risk

    of these medicines beingmis-selected.17

    Dispensing environment

    24 | A guide to the design of the dispensing environment

    1.5 Delivery of stock

    Above Tote boxes in the way are a distractionand potential hazard.

    Newly-delivered medicine in the dispensarycould potentially be incorrectly selected andmixed with medicines to be dispensed.

    Di i i

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    Recommendations Assign a temporary storage area

    for delivered stock before it isput away.

    Have a dedicated bench, or partbench, where unpacking andchecking off can occur.

    Some stock replenishment systemsare direct-to-shelf, requiring nochecking off space.

    A guide to the design of the dispensing environment | 25

    Dispensing environment

    Action

    Identify an area (preferablyoutside the dispensary) wheredelivered stock can betemporarily stored and thenchecked off before being putinto the dispensary for use.

    AboveAllocated storage for empty tote boxesreduces the risk of distraction and accidents.

    A separate area for checking deliveries reducesthe possibility of a mix-up.

    Di i i t

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    Issues Cluttered and overstocked

    refrigerators make selecting thecorrect medicine for dispensingvery difficult.

    Completed prescriptions could getmixed up with stock if kept in thesame refrigerator.

    Dispensing environment

    26 | A guide to the design of the dispensing environment

    1.6 Storage of medicines1.6.1 Refrigerators

    AboveAn overcrowded refrigeratorcontaining inappropriate items, such as food,makes the probability of picking the wrongmedicine more likely.

    RightA carefully stocked, glass-frontedrefrigerator makes the selection of the rightmedicine easier.

    Di i i t

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    Recommendations Have separate refrigerators for

    stock and completed prescriptions.

    Glass-fronted refrigerators allowyou to easily see what is inside.

    Have the second refrigeratorcontaining dispensed itemsawaiting collection near thedispensed medicines collectionpoint. (If space is an issue find aneffective way of separatingdispensed medicines from stock,such as the use of a refrigerator

    with sliding drawers.)

    Remember to monitor and recordrefrigerator temperatures daily.

    A guide to the design of the dispensing environment | 27

    Dispensing environment

    Action

    Plan to purchase or replace

    refrigerators where necessary. Consider moving existing

    refrigerators to improveworkflow and safety.

    Refrigerator fordispensed items

    awaiting collection

    Refrigerator forstock

    Above Separate refrigerators for stock andmedicines awaiting collection keep the processof assembly and collection apart, reducing the

    possibility of error.

    Dispensing environment

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    Issue Overcrowded CD cupboards make

    it difficult to see stock properly,leading to a possible increase inselection errors.

    Dispensing environment

    28 | A guide to the design of the dispensing environment

    AboveAn overstocked and disorganised CDcupboard makes picking errors more likely.

    1.6 Storage of medicines1.6.2 Controlled drug (CD) cupboards

    Dispensing environment

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    Recommendation Ensure that CD cupboards are

    large enough to meet theworkload of the dispensary andallow stock to be well spaced and

    easily seen.

    A guide to the design of the dispensing environment | 29

    Dispensing environment

    Action

    Review size of CD cupboard inline with workload.

    Above Increasing the size of your CDcupboard allows stock to be clearly separated,reducing the possibility of picking errors.

    Dispensing environment

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    Issue Returned or expired medicines

    may be confused for medicinestock if stored in the same areaof the dispensary.

    Dispensing environment

    30 | A guide to the design of the dispensing environment

    1.6 Storage of medicines1.6.3 Waste and returns

    Dispensing environment

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    Recommendations Returned or expired stock

    should be stored in a separatesection of the dispensary toclearly differentiate it from

    medicine stock.

    If possible, keep waste and returnsin a separate room from the mainstock or in designated cupboardsor under bench areas.

    Sharps bins, etc. should also havea designated area for storage andshould be separated from stock.

    A guide to the design of the dispensing environment | 31

    Dispensing environment

    Action

    Review the layout of yourdispensary and consider if youcan make improvements in yourhandling of waste.

    If feasible, consider making use

    of a separate room.

    Dispensing environment

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    Issue Stock that is unseparated and

    muddled can increase the risk ofselection errors.

    Dispensing environment

    32 | A guide to the design of the dispensing environment

    RightMixed-up stock increases thepossibilty of picking errors.

    RightDomestic drawer units tend tobe easily cluttered.

    1.6 Storage of medicines1.6.4 Separation of stock

    Dispensing environment

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    Recommendations The use of shelf dividers helps

    ensure that different products,strengths and formulations do notbecome mixed and confused.

    The use of sloping pull-outdrawers that enable stock to beseen and easily retrieved may alsohelp reduce selection errors.

    A guide to the design of the dispensing environment | 33

    Dispensing environment

    Action

    Ensure that medicines are well

    differentiated in medicinestorage areas to avoid selectionerrors. Consider purchasingshelf dividers for shelves,drawers, fridges, etc.

    When next refitting thedispensary, review the benefitsof using sloping open drawer

    systems.

    RightFlexible shelf dividers separate the stock.

    RightSloping pull-out drawers make selectioneasier and medicines easily accessible.

    Dispensing environment

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    Issues Not being able to find medicines

    may contribute to selection errors.

    Dispensaries often have randomareas allocated to differentcategories of stock.

    Dispensing environment

    34 | A guide to the design of the dispensing environment

    Fast moving lines Dressings

    Large containers

    InhalersTopical medicines

    Back-up stock

    Generics

    Eye preparation

    Above Idiosyncratic storage of stock takestime for new employees or locums to becomefamiliar with, and can lead to more pickingerrors.

    1.6 Storage of medicines1.6.5 Location of stock

    Dispensing environment

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    Recommendations As far as possible, use a simple

    AZ stock storage system.

    Use AZ by proprietary or genericname as appropriate for yourparticular sector. (Some medicinessuch as oral hypoglycaemicsshould be stored separately inmarked areas, as recommended bythe Royal Pharmaceutical Societyof Great Britain (RPSGB)).

    A guide to the design of the dispensing environment | 35

    Dispensing environment

    Action

    Review the layout of stockin your dispensary.

    AboveA simple, consistent system is easyto understand, pick from and stock.

    Dispensing environment

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    Issues Confidentiality is essential

    when talking to patientsabout their medicines.

    Waiting patients should not becrowding the counter and beable to overtly overhearconfidential conversations. Thismay also inhibit both staff andpatients, preventing them fromcommunicating effectively.

    Disorderly queuing can causeconfusion and distract both

    patients and staff.

    p g

    36 | A guide to the design of the dispensing environment

    1.7 Patient areas

    Above Patients are not sure where to stand,confidential conversations may be overheard.

    Dispensing environment

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    Recommendations Ensure that patient waiting areas

    are away from areas whereconfidential conversations maytake place.

    Use good signage, and techniquessuch as different coloured flooringand counter dividers, to demarcateareas where confidentialconversations will take place.

    A guide to the design of the dispensing environment | 37

    p g

    Action

    Review signage, flooring andcounter dividers, to demarcateconfidential counselling areas.

    Separate the patient waitingarea from the prescriptionreceipt and medicinescollection areas.

    Above Clear signposting eases congestion,and counter dividers help to separate handoverand collection whilst supporting confidentiality.

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    2

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    Design changes to stages indispensing a prescription thatcan help reduce errors

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    2

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    Stages in dispensing a prescription

    Use design to minimise errors ateach stage of dispensing a prescriptionfor medicines.

    40 | A guide to the design of the dispensing environment

    2.1 Stages in dispensing a prescription

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    A guide to the design of the dispensing environment | 41

    IntroductionOnce a patient has presented aprescription for dispensing, thatprescription will go through a seriesof stages before the medicine isfinally handed to the patient. It isimportant that these individual stagesare well thought out and flow in alogical and efficient manner aroundthe dispensary.

    This chapter takes each of thesestages in turn and looks at the designfeatures that may help produce anefficient and ordered process,

    resulting in the patient receiving thecorrect medication and the correctadvice on how to use that medicine.

    Electronic prescription systemsElectronic prescription systems (EPS)will soon be introduced into practice.For a time this may result indispensaries having to run two

    separate systems (paper andelectronic).

    Most of the design ideas in this chapterwill apply to both paper and electronicprescription processing. However, itmay be that as EPS becomecommonplace, workflow will need tobe adapted to allow for the fact that a

    hard copy prescription will not exist.

    This may require additional orrepositioned computer terminals toallow access to an electronic copy ofthe prescription at each stage of thedispensing process.

    Electronic prescribing systems willalso introduce different models ofinteraction with patients, for examplepatients collecting medicines with noprescription or a prescription token.

    Consideration will need to be given toensuring that any processes takeaccount of these different models, in

    particular when handing outmedication, and that the potential forthe wrong patient to receive thewrong medicines does not increase.

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    Issues Having a single point for prescription

    reception and medicines collectioncan lead to overcrowding, lack ofconfidentiality, and customer and

    staff frustration. Clinical checking, if carried out at the

    start of the dispensing process:allows conversation between thepharmacist and the patient; identifiesqueries early; allows separation of theclinical and the accuracy check; andresults in less rework when amended

    prescriptions have to be redispensed. Lack of information at prescription

    reception points makes clinicalchecking at this stage more difficult.

    Prescription workload can be poorlyprioritised and planned at this stage.

    42 | A guide to the design of the dispensing environment

    2.2 Prescription reception and clinical check

    Above Clearly delineated areas forprescription reception and collection.

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    Recommendations Separate prescription reception

    from medicine collection areasusing signage, counter dividers,coloured flooring, etc.

    Make a pen and paper availablefor those unable to clearly expressthemselves verbally.

    Carry out clinical checks at theprescription reception point inconsultation with the patient.

    Ensure computer terminals and

    up-to-date reference sources areavailable at the prescription receiptpoint, making sure computerscreens are not visible to othermembers of the public.

    Consider taking patients who mayhave difficulty communicating to aquiet area to discuss their needsand requirements.

    Plan and prioritise prescriptionworkload to make effective use ofdispensing resources.

    A guide to the design of the dispensing environment | 43

    Action

    Review the design of yourprescription reception andmedicines collection points.

    Review where you carry outclinical checks and decide if it ispossible to complete them at

    the prescription reception point.

    Above Clinical checks carried out atprescription reception allow queries to be

    identified early, avoiding rework andreducing the probability of error.

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    Issues Transcription and selection errors

    may occur when generating adispensing label.

    Generating a batch of dispensinglabels for multiple patients maylead to the wrong label beingattached to a medicine or apatient receiving a medicineintended for another patient.

    44 | A guide to the design of the dispensing environment

    2.3 Generating medicine labels

    Above Not all the components for thegeneration of the label are to hand; the

    workstation is unsuitable for prolonged working.

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    Recommendations Dispensing labels should normally

    be printed before the medicinepacks are selected for assembly.

    Generate dispensing labels for onepatient at a time. Avoid batch-printing of dispensing labels formultiple patients.

    Use baskets to keep prescriptionsand labels together. (For EPS seecomments on pages 41 and 47)

    Ensure labelling station complies

    with HSE ergonomic regulations. Use prescription holding clips to

    ensure prescription is at eye levelwhen typing dispensing labels.

    A guide to the design of the dispensing environment | 45

    Action

    Review position oflabelling station.

    Explore purchase and useof baskets and prescriptionholding clips.

    AboveAll the components for thegeneration of the label should beclose at hand.

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    Issues Using dispensing labels rather than

    the prescription form to selectmedicine products for assemblymay increase risk if a labelling

    error has been made. If an electronic prescribing system

    is in use there is no paperprescription form to use in theassembly stage and this mayincrease the risk of mis-selection.

    The area for assembling medicinesshould be a suitable size to

    minimise overcrowding andensure a safe method ofworking at this stage.

    If one dispenser assembles themedicines for multiple patients atthe same time, this increases therisk of the wrong medicine beingassembled and labelled.

    There is a risk that assembled andlabelled items will beunintentionally put back into stockand the medicine will not besupplied to the patient.

    46 | A guide to the design of the dispensing environment

    2.4 Assembling medicine products and labels

    Above Do not assemble the medicines from labels.

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    Recommendations Use the prescription form to select

    the correct medicine products forassembly.

    For electronic prescription systems,

    use a computer screen, or anappropriate hard copy, to confirmthe correct medicine product forassembly.

    The dispenser assembling themedicine should check theaccuracy of the dispensing labelagainst the prescription before

    applying the dispensing label tothe medicine product.

    Assemble the medicines for onepatient at a time.

    There must be sufficient space toassemble medicines safely.

    Use baskets to keep all items for

    an individual patient together. Once medicines have been

    assembled they should be movedto the accuracy checking area.

    Use boxes or baskets for itemsof stock to be returned to shelvesor drawers.

    Return stock to shelves or drawersas soon as possible after use.

    A guide to the design of the dispensing environment | 47

    Action

    Review standard operatingprocedures (SOPs) to ensurestock is selected usingprescription form or computerscreen as a basis for selection.

    Consider use of baskets forindividual prescriptions andreturning stock to shelves or

    drawers.

    AboveAssemble the medicines from theprescription.

    Above Trays or baskets can be used to keepitems together.

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    Issues Clinical checking and dispensing

    accuracy checking are differentstages in the process. If thesestages are combined, there is a risk

    that the focus will be ondispensing accuracy checkingrather than on clinical checking(the appropriateness of what hasbeen prescribed for the individualpatient).

    The most frequently reporteddispensing errors involve wrong

    dose, medicine and formulation. The pharmaceutical industry

    provides the majority of themedicine packs with a linearbarcode containing a GS1 (EAN)code, which is seldom used indispensing software systems toensure that the correct productis dispensed.

    Barcodes are often overlabelledwith the dispensing label. In thefuture these barcodes may be usedto identify medicines after theyhave been dispensed.

    48 | A guide to the design of the dispensing environment

    AboveA misplaced label will make itimpossible to check the barcode.

    2.4 Assembling medicine products and labels2.4.1 Accuracy check and use of auto-id technologies

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    Recommendations Separate clinical and dispensing

    accuracy checks.

    Wherever possible, the dispensingaccuracy check should be

    undertaken by a differentdispenser to the one whoassembled the medicine.

    Do not overlabel barcodes withdispensing labels wherever possible.

    Greater use should be made ofbarcodes incorporating GS1 codes

    on medicine products to confirmthat the correct medicine is beingdispensed for the patient.18

    The use of 2D barcodes and radiofrequency identification (RFID)tags in the future should enableexpiry date, batch number andunique serial numbers of medicinepacks to be scanned and checkedas an intergral part of thedispensing process.

    A guide to the design of the dispensing environment | 49

    Action

    Review SOPs to ensure clinicaland dispensing accuracy checksare separate processes.

    Consider the use of dispensingsoftware that allows the use ofauto-id technologies as part ofthe accuracy check.

    Above Barcode readers can quickly andaccurately confirm the correct medicine isbeing dispensed.

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    Recommendations The use of automation may reduce

    picking errors and have a role toplay in the storage of medicines.

    Automated loading, incorporating

    auto-id technology, may helpreduce errors in stock location.

    Automated labelling withautomated stock selection andauto-id technology can helpreduce both selection and labellingerrors.

    50 | A guide to the design of the dispensing environment

    Action

    Investigate the feasibility ofincorporating automation intoyour dispensary.

    Carefully consider differenttypes of automation and theiradvantages and disadvantages.

    Issues Automated dispensing systems are

    being introduced into largedispensaries in both primary andsecondary care.

    The majority of dispensing errorsare picking errors.

    Manual loading of stockinto a robot can be a source oferror where putting the product ina particular location is dependenton the operator.

    Few automated systems attachdispensing labels and mislabellingstill remains a source of error.

    2.4 Assembling medicine products and labels2.4.2 Use of automation

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    A guide to the design of the dispensing environment | 51

    Above Incorporating a robot into thedispensing process can help reduce picking

    errors. Thought must be given to its locationand integration within the workflow.

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    Issues Patients may receive the wrong

    medicines or those intended foranother patient.

    Medicines may be supplied before

    outstanding queries have beendealt with.

    Patients may not receive all themedicines prescribed. This may becaused by medicines awaitingcollection being stored in multiplelocations in the dispensary (e.g.refrigerator and controlled drug

    cupboard) or additional medicineshaving to be ordered.

    Prescriptions may be separatedfrom the bag of dispensedmedicines, making the final checkwith the patient more difficult.

    52 | A guide to the design of the dispensing environment

    2.5 Dispensed and to follow medicinesawaiting collection

    Recommendations Keep prescriptions attached to the

    bag of medicines awaitingcollection check patient identityagainst the information on the

    prescription. Use some method, such as

    moveable lettered cubes, toindicate the initial letters ofsurnames to aid finding acompleted dispensed itemwhen a patient returns.

    BelowEnsure prescriptions that are ready forcollection are stored separately in thedispensary and that they are not visible to the

    patients.

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    A guide to the design of the dispensing environment | 53

    Action

    Review location and separationof items awaiting collection.

    Review how dispensed itemsstored in a separate location arelinked to other dispensed itemsfor an individual patient.

    A

    B

    C

    D

    E

    Prescri

    ption

    sfor

    chec

    king

    H

    G F

    Itemstofollow

    Queries

    G

    Recommendations(continued) Keep prescriptions attached to bag

    of dispensed medicines to enablefinal check with patients during

    medicine collection (see section2.7).

    Have a separate storage area orshelf for dispensed items withoutstanding queries that requirefurther discussion with theprescriber or patient.

    Use some form of marker(e.g. coloured stickers) toindicate additional stock ina separate location.

    RightDifferentiate medicinesawaiting collection to indicatethose with queries or to follows.

    Use coloured stickers to indicateadditional refrigerated lines orcontrolled drugs.

    Use movable blocks to indicatethe initial letter of surname.

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    Issues Having a single point for

    prescription reception andmedicines collection leads toconfusion, overcrowding and lack

    of confidentiality, which can inhibiteffective communication.

    When medicines are not collectedby the patient, importantinformation may not beexchanged.

    54 | A guide to the design of the dispensing environment

    2.6 Medicines collection

    Above Patients are not sure where to stand;confidential conversations may be overheard.

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    A guide to the design of the dispensing environment | 55

    Recommendations

    Separate medicine collection fromprescription receipt areas usingsignage, counter dividers, colouredflooring, etc.

    Utilise design to achieve differentlevels of privacy depending on thelevel of confidentiality required.

    For home deliveries, or where arepresentative collects aprescription, the pharmacist has aresponsibility to ensure that theycomply with guidance set out bythe RPSGB.19 To help in thisrespect, it should be made veryclear, perhaps by drawingattention to it on the bag ofdispensed medicines, that thepharmacist is available for adviceabout the dispensed medicines.Details of how they can be

    contacted should be provided. MUR may be of particular use

    for patients receiving homedelivery who have not had anopportunity for counselling atthe point of collection.

    Action

    Review the layout, signage anddemarcation of your medicinescollection point.

    Build the additional provisionof semi-private counsellingpoints into your business plan

    where necessary.

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    Issues Checking dispensed medicines

    with the patient or representativeis the final accuracy check.

    This final accuracy check is

    bypassed every time a bagof medicines is handed to apatient or representativeunopened.

    Even when a patient has been onthe same repeat prescription formany years, it is still worthwhilechecking that the medicines being

    dispensed are what is expectedand that the patient is notexperiencing any problems usingtheir medicines.

    Issues that arise at this stage include:

    confusion following a change oflabelling and packing of medicine;

    proactively ensuring that thepatient can open and use theirmedicine as intended;

    identification and management ofside effects of medicines.

    56 | A guide to the design of the dispensing environment

    2.7 Final accuracy check and patient counselling

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    Recommendations Routinely open the bag of

    dispensed medicines.

    Check the dispensed medicineswith the patient or representative.

    Counsel the patient abouttheir medicine.

    Offer to make simple adjustmentsto make medicine taking easier forpatients with physical or sensorydisabilities.

    A guide to the design of the dispensing environment | 57

    Above Make sure you show the medicines tothe patient and discuss them with the patient.

    Action

    Audit the extent to whichmedicines are shown to anddiscussed with patients.

    Update SOPs to promote andprioritise these recommendations.

    Review the reference sources

    readily available to the pharmacist.

    Consider making the offer ofadvice and contact detailsprominent on the dispensing bag.

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    Above The provision of semi-private areascan be aided by good queue control and theuse of counter dividers and signage, etc. todemarcate areas for specific activities.

    Issues Different types of consultation

    require different facilities.

    Requirements for space in which aMUR can take place are different to

    those required for routineprescription handover.

    58 | A guide to the design of the dispensing environment

    2.8 Patient consultation andadvanced/enhanced services

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    Recommendations Consider design changes to enable

    different types of consultation e.g.include seating where an extendedconsultation is being conducted.

    Semi-private areas can be aided bygood queue control and the use ofcounter dividers, etc. to demarcatespecific areas.

    MURs must be carried out in aseparate consultation area thatconforms to requirements forconfidentiality, etc. as set out in

    the Directions for enhanced andadvanced services. Future servicesmay also require use of this facility.

    BelowMURs must be carried out in a separateconsultation area.

    A guide to the design of the dispensing environment | 59

    Action

    Consider how existinginfrastructure could be adaptedto provide a range of

    counselling areas allowing fordiffering levels of privacy.

    Build substantial modificationsinto future business plans andconsider at next refit.

    Consider future possibleenhanced services when

    developing plans.

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    Issues It may not be possible to provide a

    sufficient level of privacy for theself administration of medicines inthe pharmacy.

    Poor communication may becaused by patient overcrowdingand poor design.

    Patient and staff security maybe inadequate.

    60 | A guide to the design of the dispensing environment

    2.9 Supervised consumption

    Prescriptions&advice

    PrecriptionIN

    MedicineOUT

    AboveA larger number of patients requiringsupervised consumption may necessitateproviding a more separate area.

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    Recommendations Ideally have a separate area for

    supervised consumption and otheractivities associated with substancemisusers e.g. needle exchange.

    Consider the provision of securitymeasures, such as panic buttonsand CCTV.

    Consider higher counters in theseareas whilst not compromisingcommunication between staffand patients.

    Ensure sharps bins, etc. areinaccessible to other patients.

    A guide to the design of the dispensing environment | 61

    Above Separate areas for supervisedconsumption provide greater securityfor staff by using higher counters.

    Action

    Ensure you have the capacity (interms of premises, staff numbersand equipment) appropriate tothe volume of activity.

    Consider any physical changesyou can make to yourdispensary that will allow you toprovide services for substancemisusers in a way that is safefor both patients and staff.

    Build any required investmentinto future business plans.

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    Summary and conclusion

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    3

    Summary and conclusion

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    This design guide has identified risksand design initiatives associated withthe design of the dispensingenvironment and stages in thedispensing process.

    The NPSA recommends that, afterreading this booklet, you look at yourown dispensing environment with acritical eye. Think about the smallchanges that you can make and planfor some of the larger ones.

    Many of the recommendations madein this booklet can be implementedquickly and at little cost. By makingsome of these relatively easy changes,a real difference can be made to thesafe functioning of a dispensary.Good design reduces errors inpractice, as has been demonstrated inmany other industries, and thesedesign principles apply equally todispensing as to other environments

    and processes.

    There is often no single correct wayof operating a dispensary. It is up toindividuals and organisations howthey choose to adopt theserecommendations and adapt them totheir particular circumstances.

    If some of the designrecommendations in this booklet areput into practice the NPSA believes asignificant contribution can be madetowards improving patient safety.

    The NPSA would be keen to receiveyour feedback on this publication tobuild on its knowledge and informfuture revisions.

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    References and acknowledgements

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    4

    References and acknowledgements

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    1 Department of Health. Safety First A report for patients, clinicians andhealthcare managers. (2006).

    2 Ashcroft DM, et al. Prospective studyof the incidence, nature and causesof dispensing errors in communitypharmacies. Pharmacoepidemiology

    and Drug Safety. 2005; 14: 327-332.3 Beso A, et al. The frequency and

    potential causes of dispensing errorsin a hospital pharmacy. PharmacyWorld & Science 2005; 27: 182-190

    4 NPSA. Patient safety observatoryreport - Safety in doses: medicationsafety incidents in the NHS. (2007).

    5 Clifford S, et al. Patient-centred

    advice is effective in improvingadherence to medicines. PharmacyWorld & Science. 2006; 28: 165-170

    6 Royal S, et al. Interventions inprimary care to reduce medicationrelated adverse events and hospitaladmissions: systematic review andmeta-analysis. Quality and Safety inHealth Care. 2006; 15: 23-31

    7 Anderson C, et al. Feedback fromcommunity pharmacist users on thecontribution of community pharmacyto improving the publics health:a systematic review of the peerreviewed and non-peered reviewedliterature 1990-2002. HealthExpectations. 2004; 7: 191-202

    8 Pirmohamed M, et al. Adverse drugreactions as cause of admission tohospital: prospective analysis of18,820 patients. British MedicalJournal2004; 329: 15-19

    9 Department of Health. Design forpatient safety. A system-wide design

    led approach to tackling patient safetyin the NHS. (2003). Available at:awww-edc.eng.cam.ac.uk/medical/downloads/report.pdf

    10 Clarkson J, et al. Design for patientsafety. A scoping study to identifyhow effective use of design couldhelp to reduce medical accidents.Engineering Design Centre,University of Cambridge. (2004).

    11 Shingo, S. Mistake-proofing foroperators: The ZQC System.Productivity Press, Incorporated.(1997).

    12 Norman DA. The design of everydaythings. First Basic Paperback. (2002).

    13 NHS Estates.Accomodation forpharmaceutical services. HealthBuilding Note 29. (1997).

    14 Angelo LB, Ferreri SP. Assessment ofworkflow redesign in communitypharmacy.Journal of the AmericanPharmacists Association. 2005; 45:145-150

    15 Buchanan T et.al. Illumination anderrors in dispensing.AmericanJournal of Health-System Pharmacy.1991; 48: 2137

    16 Flynn E, et al. Impact of interruptionsand distractions on dispensing errorsin an ambulatory care pharmacy.American Journal of Health-SystemPharmacy. 1999; 56: 319-325

    17 Toft B, Mascie-Taylor H. Involuntaryautomaticity: a work system induced

    risk to safe health care. HealthServices Management Research.2005; 18: 211-216

    18 Department of Health. Coding forsuccess Simple technology for saferpatient care. (2007).

    19 Royal Pharmaceutical Society ofGreat Britain. Professional standardsand guidance for the sale and supplyof medicines. (2007). Available at:www.rpsgb.org/pdfs/coepsgssmeds.pdf

    Further reading

    Buckley RL, Buckley CL. No eraserneeded: mistake proofing your business.Shady Brook Press. (2006).

    Shimbun NK. Poka-yoke: improvingproduct quality by preventing defects

    (improve your product quality!)Productivity Press, Incorporated. (1989).

    66 | A guide to the design of the dispensing environment

    References

    References and acknowledgementss

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    Stakeholder consultation responders

    Alliance Pharmacy

    Almus Pharmaceuticals Ltd

    Associated Chemists (Wicker) Ltd

    Barking, Harvering & Redbridge

    NHS TrustBees Pharmacy

    Boots The Chemist

    British Association ofPharmaceutical Wholesalers

    British Thyroid Foundation

    Cegedim

    Commission for Social Care Inspection

    Deafblind UK

    Department of Health England

    Diabetes UK

    Essex Rivers NHS Trust

    Lloyds Pharmacy

    National Pharmacy Association

    Patients Association

    Pharmaceutical ServicesNegotiating Committee

    Pharmacists Defence Association

    Primary and Community CarePharmacy Network

    Royal Pharmaceutical Society of

    Great Britain

    Royal Pharmaceutical Society of GreatBritain Wales

    Sainsburys

    Scottish Intercollegiate Guidelines Network

    SIGN

    Systems Solutions LtdWales Hospital Pharmacy

    Patient workshop attendees

    Action against Medical Accidents (AvMA)

    Age Concern

    British Limbless Ex-Service Men'sAssociation

    British Thyroid FoundationCancerbackup

    Carers First

    Central Nottinghamshire MIND

    Deafblind UK

    Diabetes UK

    Multiple Sclerosis Society

    National Society for Epilepsy

    Parkinsons Disease Society

    Patient Information Forum

    Royal National Institute of Blind People

    SIGN

    Sunfield Childrens Homes

    The Royal National Institute for Deaf andHard of Hearing People

    Professional expert referencegroup attendees

    Association of Independent Multiples

    Association of Pharmacy Technicians UK

    Boots The Chemist

    British Association of PharmaceuticalWholesalers

    Company Chemists Association

    Co-op Chemists

    Dispensing Doctors Association

    Guild of Healthcare Pharmacists

    Lloyds Pharmacy

    Morrisons

    National Pharmacy Association

    Pharmaceutical ServicesNegotiating Committee

    Pharmaceutical Society ofNorthern Ireland

    Primary and Community CarePharmacy Network

    Rowlands

    Royal Pharmaceutical Societyof Great Britain

    Royal Pharmaceutical Society ofGreat Britain and Wales

    A guide to the design of the dispensing environment | 67

    Acknowledgements

    References and acknowledgements

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    We would also like to thank thefollowing individuals for their help indeveloping this resource:

    Amit ShahBees Pharmacy

    Barbara Parsons

    Pharmaceutical ServicesNegotiating Committee

    David PruceRoyal Pharmaceutical Societyof Great Britain

    Graham PhillipsManor Pharmacy

    Heidi WrightRoyal Pharmaceutical Society

    of Great Britain

    Jeanette HoweDepartment of Health England

    John EvansAsda Pharmacy

    John FormanGreenlight Pharmacy

    Keith Ridge

    Department of Health England

    Martin BennettAssociated Chemists (Wicker) Ltd

    Neil WilliamsonNational Pharmacy Association

    Paul BullockCharing Cross Hospital

    Paul KnightMurrays Pharmacy

    Ruth CarlisleCarlisles Pharmacy

    Steve EasthamBoots The Chemist

    Steve LutenerPharmaceutical Services NegotiatingCommittee

    Sue NewtonHammersmith Hospital

    Susan GrieveDepartment of Health England

    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 StreetLondon

    W1T 5HD

    Tel: 020 7927 9356Email: [email protected]

    68 | A guide to the design of the dispensing environment

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    The National Patient Safety Agency

    4 - 8 Maple StreetLondonW1T 5HD

    T 020 7927 9500F 020 7927 9501

    Ref: 0586a

    ISBN: 978-0-9556340-7-9

    National Patient Safety Agency 2007. Copyright and other