j ou rna l h o me pag e :w w w . e l s e v i e r . c o m / l o c a t e / a a p
The
Spanish
pictogram
on
medicines
and
driving:
The
population’s
comprehension
of
and
attitudes
towards
its
use
on
medication
packaging
Inmaculada
Fierro, Trinidad
Gómez-Talegón,
F.
Javier
Alvarez
∗PharmacologyandTherapeutics,FacultyofMedicine,UniversityofValladolid,C/RamónyCajal7,47005Valladolid,Spain
a
r
t
i
c
l
e
i
n
f
o
Articlehistory: Received9March2012
Receivedinrevisedform3August2012 Accepted6August2012
Keywords: Automobiledriving Drugprescription Drugutilization Patientinformation Pictograms Riskassessment
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TheSpanishpictogramonmedicinesanddrivingislegallybinding since2011.Wehaveevaluated patients’comprehension,changeindrivingfrequencyandtheperceivedusefulness,information, com-prehensibility,andsimplicityofthispictogramon1385SpaniardsusersoftheNationalHealthService (pharmacies,primarycareandhospitalcentres).Most,85.7%,correctlyrelatedthesymbolwiththe pos-sibleeffectsofthemedicineondrivingandthe83.9%ofthedriverswouldreducethefrequencywith whichtheydrivewhenprescribedamedicinewithsuchpictogram.Thepictogramwasfound,ina 10-pointLikert,useful(8.3±1.7),informative(7.7±1.9),comprehensible(7.8±1.9)andsimple(7.8±1.9). TheSpanishpictogramonmedicinesanddrivingisunderstoodbythegreatmajorityofthose inter-viewed;iswellconsideredbytheusersoftheNationalHealthService;andoffersgoodprospectsfor reinforcetheawarenessofhealthcareprofessionalsandpatientsontheeffectsofmedicinesondriving.
© 2012 Elsevier Ltd. All rights reserved.
1. Introduction
Theuseofmedicineshasbeenassociatedwithanincreaseinthe riskofinvolvementintrafficaccidents(Orriolsetal.,2009,2010; Engelandetal.,2007).Forseveralyears,therehavebeennumerous attemptstoclassifymedicationsaccordingtothedegreeof dete-riorationthattheymayproduceinfitnesstodrive(Raveraetal., 2012).Inordertowarnusersofmedicinesaboutthispossiblerisk, somecountries(recentexamplesareFranceandSpain)haveopted forprintingapictogramonthemedicine’spackaging(Ministèrede laSantéetdesSolidarités,2005;MinisteriodeSanidadyConsumo, 2007).
According to the United States Pharmacopoeia (USP, 2011), pharmaceuticalpictogramsare“standardizedgraphicimagesthat helpconveymedicationinstructions,precautions,and/orwarnings topatientsandconsumers”.
Theuseofsymbols/pictogramsallowsamessagetobeexpressed ina compact way,which isalsoquickly identifiableand elimi-nateslanguagebarriers.Itwould thusseemreasonabletothink thatthemostdesirablepictogramswouldbethosewithan interna-tionalvalidityandwhichareeasilycomprehendibleforthegreatest possible number of people. Both the design and evaluation of
∗Correspondingauthorat:PharmacologyandTherapeutics,FacultyofMedicine, University of Valladolid, Ethics ReviewBoard, Hospital Clínico Universitario, C/RamónyCajal7,47005Valladolid,Spain.Tel.:+34983423077;
fax:+34983423022.
E-mailaddress:alvarez@med.uva.es(F.J.Alvarez).
pictogramsarecomplextasks(Wogalteretal.,2002),andtheyare oftencarriedoutinseveralstagesthatevaluateeachmodificationof theoriginaldesign.Eventhoughtheproliferationofsymbolswith identicalorsimilarmeaningsmayleadtosituationsofconfusion (Daviesetal.,1998),thepresenceofpictogramsonthelabelling ofmedicinesimprovesthecomprehensionoftheinstructionsfor theuseofthemedicine(Houtsetal.,2006)andcontributestoits acceptance(DowseandEhlers,2005).
ItiscompulsoryforpharmaceuticalcompaniesintheEuropean Uniontoprovidedataconcerningtheeffectsofeachmedication onpatients’abilitytodriveandusemachines,priorto commer-cialisation(SummaryofProductCharacteristics,Section4.7)(ECD, 1983)Theinsertprovidedinamedicine’spackaging(ECD,1983) containsinformationwarningofthepossibleeffectspatientsmay noticewhendrivingorhandlingdangerousmachinery,sincethere isampleevidencethatsomeoftheadversereactionstomedications (somnolence,dizziness,blurredvision)mayconsiderablyreduce fitnesstodriveandincreasingtheriskofinvolvementinaccidents (Orriolsetal.,2009,2010;Engelandetal.,2007).However,notall usersofamedicinereadthepackageinsert(Bernardinietal.,2000; Nathanetal.,2007),andmanyusersdonotconsiderthepackage inserttobeverycomprehensible(Barrio-Cantalejoetal.,2008).
The Royal Decree 1345/2007 regulating the procedure for authorising,registering,anddispensingindustriallymanufactured medicinesforhumanusewaspublishedinSpaininNovember2007 (MinisteriodeSanidadyConsumo,2007).ThisDecreeestablishes that newlyauthorised medicines thatmaynegatively affect fit-nesstodrive,ortheabilitytohandledangerousmachinery,must includeawarningsymbol(orpictogram)onthepackaging.From
0001-4575/$–seefrontmatter© 2012 Elsevier Ltd. All rights reserved.
Fig.1. Spanishpictogramonmedicinesanddriving:picturesofsomeavailablemedicinesintheSpanishmarkedwiththelegallybindingpictogramonmedicinesanddriving.
2011onwards,allmedicinesonsaleinSpainthatmayhavean effectonfitnesstodrivehaveincludedapictogramonthe pack-aging(AEMPS,2012).The saidsymbolmusthave thefollowing characteristics(Fig.1):
(i)Aredequilateraltrianglewiththevertexintheupperpartona whitebackgroundandablackcarinsidetheredtriangle,inthe mannerofaroadtrafficsign,andthelegendbelowit,which reads:“Driving:Seepackageinsert”.
(ii)ThesizeofthePictogramshouldbeadaptedtothesizeofthe package, but in nocase shouldeach sideof thetriangle be shorterthan10mm.
Theaimofthepictogramorsymbolistoattracttheuser’s atten-tionsothathe/shewillreadthecorrespondingpatientinformation insert.Theinsert foundinthe medicationpackage (ECD, 1983) alreadycontainsawarningabouttheeffectsitmayhaveonthose whodriveorusemachinery(sectiondrivingandusingmachines). Theaimofthisstudyistoevaluatepatients’comprehensionof theSpanishpictogramconcerningmedicinesanddrivingprinted onthe packagingof certain medications, as well asto analyse theinfluencethissymbolmayhaveontheattitudeoftheusers towardsdriving(changeindrivingfrequency)andtheperceived usefulness,information,comprehensibility,andsimplicityofthis pictogram.Inthisstudydriversandnon-driverswereincludedas anypatient/medicineconsumercouldfindsuchpictograminthe medicine’spackaging.
2. Materialandmethods
2.1. Targetpopulation
Non-institutionalizedgeneralSpanishpopulation,driversand non-drivers,aged18andover,whoresideinValladolidprovince (Spain),andareusersoftheNationalHealthService(theNHSisa universalwithpublicfundinginSpain)whenthesurveywascarried
outand,therefore,possibleconsumersofmedicamentsinthenear future.
2.2. Samplesizeandsettings
Questionnaireswerefilled inthroughindividualrandomized interviewsamongthosewhoattend:(i)PrimaryHealthcareCentres in6surgeries,(ii)pre-anaesthesiasurgeryintheHospitalClínico Universitarioand(iii)consumersfromfivepharmacies.Therewere 1385validinterviewsmadein2010fromMaytoOctober.
ThisstudywasapprovedbytheClinicalResearchEthics Com-mitteeoftheFacultyofMedicineoftheUniversityofValladolid, Referencenumber2010/30.
2.3. Questionnaire
Thefollowingquestionswereincluded:
Sociodemographic variables. (i) gender, (ii) age, (iii) driving license,(iv)kilometresdrivenperyearand(v)educationallevel.
Background.Inthefollowingitem,theintervieweeswereasked iftheyknewthatsomemedicinescaninfluencefitnesstodrive.
Pictogramcomprehension.Theintervieweewasshownthe pack-agingofrealmedicationwithapictogram,acquiredinapharmacy. He/shewasthenasked,“Whatdoyouthinkthissymbolmeans?” Theopenanswers were groupedinto fivecategories, following themodelproposedinISO9186-1:2007(ISO,2007):1=correct, 2=wrong, 3=wrong and the response given is the opposite of intendedmeaning,4=theresponsegivenis“Don’tknow”,5=no responseisgiven.Thepercentageswerecalculatedoverthetotal number ofrepliesin thecategories 1–4(ISO, 2007).The oppo-sitemeaningwas,inthiscase,“nottotake,ortostoptaking,the medicineifyoudrive”.
Gender
N(%)
Male 53(18.5) 607(55.3) 660(47.7) X2=123.63;
p<0.0001
Female 234 (81.5) 491 (44.7) 725 (52.3)
Educationallevel
N(%)
Didnotfinishprimaryschool 38(13.4) 49(4.5) 87(6.3)
X42=100.75;
p<0.0001 Finishedprimaryschool 144(50.9) 334(30.4) 478(34.6)
Finishedsecondaryschool 38(13.4) 142(12.9) 180(13.0) Completed“A”level(age18) 35(12.4) 260(23.7) 295(21.4) Universitydegree/diploma 28(9.9) 312(28.4) 340(24.6)
Age:Mean±SD(N) 55.23±17.61
(287)
47.27±14.72 (1098)
50.50±15.55 (1385)
T=5.777;
p<0.0001 Thousandsofkm/year:
Mean±SD(N)
14.83±26.23 (952)
fortheanswer:“highrisk”;“moderaterisk”;“lowrisk”;“norisk” and“Idon’tknow”.
Intendedchangeofbehaviour–changeindrivingfrequency.“How frequentlywouldyoudriveduringtheperiodinwhichyouwere takingthemedicine?”Theoptionsforansweringwere:“withthe samefrequency”;“lessfrequently”;“alotlessfrequently”;“Iwould hardlydriveatall”and“Iwouldnotdriveatall”.
Evaluation of the pictogram. Four aspects of the pictogram shown are scored separately from 1 to 10 (10-point Likert scale): “usefulness” (1=unnecessary to 10=useful); “informa-tion”(1=notinformativeto10=informative);“comprehensibility” (1=notunderstandableto10=comprehensible);and“simplicity” (1=complexto10=simple).Theintervieweeswerealsoaskedfor aglobalevaluationofthepictogramshown,onascaleof1 (mini-mum)to10(maximum).
2.4. Statisticalanalysis
Forthecontinuousvariables,themean±SDandthefrequencies forthecategoryvariablesareshown.Thecomparisonsbetween twogroupsweremadethroughthe“Studentt”inthecaseofthe continuousvariables,and forthecategoricalvariablesPearson’s chi-squaretestwasused.
Logistic regression was used to determine the sociodemo-graphicvariablesthatinfluencecomprehensionofthepictogram. Thevariablewith5categories(accordingtoISO9186-1:2007)(ISO, 2007)wasrecodedasadichotomyvariableinordertocomparethe groupthatansweredcorrectlywiththerest.Theindependent vari-ablesintroducedintotheanalysiswere:age,gender,educational level,drivinglicense,knowledgethatsomemedicinescaninfluence driving,andpriorknowledgeofthepictogram.
Logisticregressionwasalsousedtoevaluatetheimpactofthe pictogramondrivers’attitudes,analysingthepossiblechangein drivingfrequency.Todoso,the4categoriesofthevariablethat impliedadecreaseinthefrequencyofdrivingweregroupedinto one, obtainingthe dichotomy variable: Does driving frequency decreaseyesorno.Theinfluenceoftheabove-mentionedfactors wascontrolledforand,inaddition,sowasthethousandsof kilome-tresdrivenperyearandthedifferentperceptionoftheriskwhen takingamedicinewiththepictogramonitspackaging.
A10-pointLikertscalewasusedtoevaluatethepictogramin four differentparameters: usefulness, information, comprehen-sibility,and simplicity.TheCronbach’salphavaluewasusedto provethereliabilityofthescale.Theinfluenceofthevariables,age (ranges,<25;25–34;35–44;45–54;55–64;>64),gender, educa-tionallevel,andpossessingadrivinglicense,onthescoresobtained in the evaluation of theseparameters of thepictogram and in theglobalevaluation were analysed throughtheuseof a non-parametrictest(U-Mann–WhitneyorKruskal–Wallistests).
Ap-value≤0.05(95%confidenceinterval)wasconsidered sig-nificant.
The analyses were carried out using the statistical package PAWS(PredictiveAnalyticsSoftWare,v.18.0SPSSInc.,Chicago,IL, USA).Thelevelofstatisticalsignificancewasestablishedatp≤0.05.
3. Results
A total of 1385 interviews were carried out, 47.7% were men(n=660)and52.3%werewomen(n=725),withanaverage ageof50.50±15.55years(54.25±15.70yearsfor themenand 47.09±14.61yearsforthewomen).Significantdifferenceswere observedin themeanages(t=8.758[5.553;8.759];p<0.0001). 79.3%hadadrivinglicense(n=1098)and20.7%didnot(n=287).
93.9%ofthoseinterviewed(95.4%ofthedriversand88.5%of thenon-drivers,X2=18.76;p<0.05)knewthatsomemedicinescan
influencefitnesstodrive(Table1).
3.1. Pictogramcomprehension
Ofthe1363peopleinterviewedwhoansweredthequestion, “Whatdoyouthinkthesymbolmeans?”85.7%(90.5%ofthedrivers and67.4%ofthenon-drivers)correctlyrelated thesymbolwith thepossibleeffectsofthemedicineondriving.9.3%gaveawrong response:5.1%statedthattheywouldnottakethemedicineifthey weregoingtodrive,justthemeaningoppositetothatintended, and4.2%gaveotheranswers(Table2).Significantdifferenceswere observedbetweendriversandnon-driversinthecomprehension ofthepictogram(X32=115.24;p<0.0001).
Theprobabilityofacorrectinterpretationdecreasesinlinewith theincreaseinageofthoseinterviewedOR=0.969[0.957–0.980] andincreasesinlinewiththeincreasingeducationallevelofthe intervieweesOR=1.213[1.047–1.405].Theseprobabilitiesincrease amongthosewhohaveadrivinglicenseOR=3.268[2.315–4.630] andamongthosewhoknowthatsomemedicinesmayaffectfitness todriveOR=2.004[1.163–3.448].
3.2. Estimationofthelevelofdangerofthepictogramon medicinesanddriving
Table2
Spanishpictogramonmedicinesanddriving:patients’comprehension,perceivedlevelofdangerandintendedchangeindrivingfrequency.
DriverlicenseN(%) X2;p
No Yes Total
Doyouknowthatsomemedicinescaninfluencefitnesstodrive?
Yes 254(88.5) 1047(95.4) 1301(93.9)
X2=18.76;p<0.0001
No 33(11.5) 51(4.6) 84(6.1)
Whatdoyouthinkthesymbolmeans?
Correctunderstanding 190(67.4) 978(90.5) 1168(85.7)
X32=115.24;p<0.0001
Wrong:Anyotherresponse 22(7.8) 35(3.2) 57(4.2)
Wrong:Themeaningwhichisstatedistheoppositetothatintended 26(9.2) 43(4.0) 69(5.1) Theresponsegivenis:“Don’tKnow” 44(15.6) 25(2.3) 69(5.1)
Howwouldyouevaluatethedegreeofinfluenceofthismedicineondriving,i.e.,theriskyourunusingthismedicinewhendriving?
Highrisk 172 (60.1) 495 (45.2) 667 (48.3)
X42=41.77;p<0.0001
Moderaterisk 71(24.8) 397(36.3) 468(33.9)
Lowrisk 11(3.8) 51(4.7) 62(4.5)
Withoutrisk 0(0.0) 9(0.8) 9(0.7)
Don’tKnow 32(11.2) 142(13.0) 174(12.6)
Supposingyouwereprescribedthismedicinewhichhasthepictogramconcerningdrivingonthepackaging.Howfrequentlywouldyoudriveduring theperiodinwhichyouweretakingthemedicine?
Withthesamefrequency 24(8.6) 172(16.1) 196(14.6)
X42=41.78;p<0.0001
Lessfrequently 46 (16.4) 213 (20.0) 259 (19.2)
Alotlessfrequently 23(8.2) 157(14.7) 180(13.4)
Iwouldhardlydriveatall 58(20.7) 232(21.7) 290(21.5)
Iwouldnotdriveatall 129(46.1) 293(27.5) 422(31.3)
3.3. Intendedchangeofbehaviour
Changeindrivingfrequency.AsshowninTable2,only14.6% ofthoseinterviewedwouldnotreducetheirdrivingfrequencyif theywereprescribedamedicinewithapictogramaboutdrivingon thepackaging.Differenceswereobservedbetweenthetwogroups; thedriversbeinglessinclinedtochangetheirhabits(X42=41.78; p<0.0001).Thedecreaseinthefrequencyofdrivingamongdrivers ismoreprobabletheolderthedriveis,OR=1.022[1.008–1.037], andlessprobablethemore kilometrestheynormallydroveper year,OR=0.989[0.983–0.994].Furthermore,takinginto considera-tionthosewhobelievedthatdrivingaftertakingofamedicinewith apictogram“didnotimplyanyriskorthattheriskwaslow”,the greatertheprobabilityofdecreaseinthefrequencyofdrivingifthe attributedriskis“veryhigh”,OR=16.500[8.340–32.645],orwhen theriskisconsideredtobe“moderate”,OR=3.557[1.923–6.577].
3.4. Evaluationofthepictogram
Thepictogramwasfoundtobeuseful,informative, comprehen-sibleand simple.Table3showstheaveragescores(Mean±SD) giventodifferentparametersofthepictogram(usefulness, infor-mation,comprehensibilityandsimplicity).TheCronbach’salpha valueof0.837provesthereliabilityofthe10-pointLikertscaleto evaluatetheseparametersofthepictogram.
Theinfluenceofthevariablesage,gender,educationallevel,and possessingadrivinglicenseonthescoresobtainedinthe evalua-tionofusefulness,information,comprehensibility,andsimplicity wasanalysedusingnon-parametrictests(Table3).Genderhadno influenceonthescores.Significantdifferenceswereobservedinthe meanscoregiventothedifferentaspectsofthepictogram accord-ingtotheagerangeofthoseinterviewed:thehighestmeanswere observedforallthescoresinthoseintervieweesaged25–34and 35–44,whilethelowestmeanswereobservedinthoseagedover 64.Ingeneral,thehighertheeducationlevel,thehigherthescores ofalltheparameters ofthepictogram.Thedriversgave higher scoresthanthenon-driverstothecomprehensibilityandsimplicity ofthepictogram(Table3).
AsfortheGlobalEvaluationofthepictogram,theaveragescore obtainedwas7.98±1.58points.Theglobalscoregiventothe Span-ishpictogramisindependentof:theageofthoseinterviewed,their
gender,theireducationallevel,andwhetherornottheypossessed adrivinglicense(Table3).
4. Discussion
TheresultsofthestudyshowthattheSpanishpictogramon medicinesanddrivingis,ingeneral,wellvaluedbytheusersof medicinesanditsmeaningiscomprehendedbyahigh percent-ageofthoseinterviewed.Thisisespeciallytrueamongthosewho possessadrivinglicense,acircumstancethatisfavourableasthis questionmainlyaffectsdrivers.Thebettercomprehensionofthe pictogrambydriversmaymostlybeduetothedesigntypeofthe pictogram,whichiscloselyrelatedtothatoftrafficsigns.Although inpreviousstudies,ithasalsobeenobservedthatdriving experi-enceimprovesaperson’scapacitytointerpretothertypesofsigns, suchas,forinstance,thoserelatedwithindustrialsafety(Chanand Ng,2010).
Ontheotherhand,itmustbesaidthatwhentheinterviewswere held(MaytoOctober2010)fewmedicineshadthispictogramon thepackaging,and,therefore,ithadnotbeenwidelyseenamong thepopulation.Thisoffersagoodperspectivetothesymbol’s use-fulness,since,asobservedinvariousstudies,familiaritywiththe signsimprovescomprehension(Daviesetal.,1998;Easterbyand Hakiel,1981).Therefore,itisreasonabletoexpectthatthe com-prehensionofthissymbolamongthepopulationwillincreaseasit becomesmorewidelyusedandisincludedinpublicitycampaigns. Ourstudyrevealsthattheprobabilityofcorrectlyinterpreting thispictogramdecreasesastheageofthoseinterviewedincreases, andit increasesiftheintervieweehasahighertheeducational level.Italsoincreasesifthoseinterviewedhadpriorknowledge ofmedicinesthatcaninfluencefitnesstodrive.
Gender Male 8.25±1.72 7.69±1.87 7.79±1.86 7.80±1.94 7.90±1.59 Female 8.37±1.67 7.69±1.93 7.74±1.96 7.80±1.93 8.06±1.56
UMann–Whitney;p 223,189.50;p>0.05 231,618.00;p>0.05 228,845.00;p>0.05 229,331.50;p>0.05 210,161.00;p>0.05
Drivinglicence No 8.19±1.71 7.45±1.88 7.36±2.01 7.41±2.01 8.00±1.60 Yes 8.35±1.69 7.75±1.90 7.87±1.87 7.90±1.91 7.98±1.57
UMann–Whitney;p 223,189.50;p>0.05 231,618.00;p<0.01 228,845.00;p<0.0001 229,331.50;p<0.0001 210,161.50;p>0.05
Agerange <25 8.28±1.76 7.44±2.03 7.54±1.99 8.03±1.71 7.85±1.20 25–34 8.50±1.67 7.96±1.83 8.27±1.66 8.15±1.93 8.10±1.32 35–44 8.59±1.60 7.80±1.87 8.01±1.87 8.11±1.82 8.10±1.53 45–54 8.28±1.71 7.72±1.95 7.69±1.98 7.78±1.87 7.97±1.67 55–64 8.35±1.59 7.69±1.94 7.73±1.87 7.80±1.85 7.93±1.95 >64 7.92±1.82 7.43±1.84 7.36±1.96 7.24±2.13 7.88±1.67 Kruskal–Wallis;p 31.73;p<0.01 20.20;p<0.05 44.11;p<0.0001 46.16;p<0.0001 5.99;p>0.05
EducationalLevel Didnotfinishprimaryschool 7.49±1.88 7.36±1.73 7.32±1.96 7.02±2.25 7.93±1.91 Finishedprimaryschool 8.29±1.64 7.49±1.93 7.43±1.99 7.43±1.97 7.91±1.63 Finishedsecondaryschool 8.44±1.63 7.84±1.86 8.10±1.78 8.12±1.83 8.06±1.40 Completed“A”level(age18) 8.36±1.73 7.75±1.91 7.92±1.88 7.95±1.93 8.07±1.60 Universitydegree/diploma 8.44±1.70 7.91±1.89 8.02±1.82 8.20±1.71 7.97±1.47 Kruskal–Wallis;p 25.45;p<0.0001 17.42;p<0.01 35.21;p<0.0001 53.81;p<0.0001 2.52;p>0.05
Meanscores(±SD).ForeachCharacteristicandfortheglobalscorea10-pointLikertscalewasused(1:negative;10:positive).
consumers,observedthatconsumersovertheage55hadalower comprehensionofthesymbolsonthelabelsofdifferentproducts. Therearealsonumerousstudiesshowingthatcomprehension ofgraphicmessagesand,inparticular,comprehensionofwarning labelsonmedicinesimprovesinlinewiththeeducationallevelof theinterviewee(DowseandEhlers,2003;Davisetal.,2006). How-ever,itispreciselythosewithalowereducationallevelwhowould mostbenefitfromtheuseofpictograms(Michielutteetal.,1992). Pictogramscanbeofgreathelpintheacceptanceofmedication andinthecomprehensionoftheuseofaprescriptionforthose patientswithlowerlevelsofeducation,evenforthoseunableto readandwrite(DowseandEhlers,2005;Davisetal.,2006;Dowse andEhlers,2001).
Inourcase,andinviewoftheresults,thepresenceofthe pic-togramonmedicationpackagingmayplayafundamentalrolein changingdrivers’attitudes(83.9%ofthedriverswouldreducetheir drivingfrequency).ThesamewasnotobservedinaDutchstudy carriedoutwithdriverssufferingfromchronicpain.Inthiscase, theauthorsconcludedthatthewarninglabelsdidnotsignificantly modifytheattitudetowardsdrivingofpatientswhoweretaking medicineswithapsychotropiceffect(Veldhuijzenetal.,2006).
Ithasbeenobservedthatagreaterperceptionofriskimproved thedispositiontoreadwarningmessages(Wogalteretal.,1991, 1993),althoughthefinaldecisioncouldbeinfluencedmorebythe person’sownperceptionoftheriskthanbythewarningmessage (Daviesetal.,1998).Daviesetal.(Davisetal.,2006)demonstrate theinfluenceoftheperceptionofrisk whentheyobservedthat parents’finaldecisionsonwhethertopurchaseorrejectatoywere influencedmorebytheperceptionoftheproduct’s dangerthan bythewarningmessageonthepackaging.Theinfluenceofthe attributedriskofthepictogram,whichwasalsoshowninthisstudy, isanimportantvariablewhenconsideringaperson’swillingness tochangetheirattitudetowardsdriving.Thisfactordeservestobe takenintoaccountgiventhattheinterpretationoftheriskinthe Spanishpictogramcouldbehighlysubjective.Thisholdstruefor allmedicinesinregardstoinformingpatientsabouttheeffectsthat amedicationmayhaveonapatient’sfitnesstodrive.
Ourstudyhadseveralpotentiallimitations.Thisstudywas con-ceivedasanexploratorysurveytoevaluatethecomprehensibility ofthepictogramonmedicinesanddriving,whichiswhyitwas doneinalimitedgeographicalarea.Therefore,theresultsshould
notbeextrapolatedtothenationallevel.Furthermore,atthetime thesurveyswerebeingcarriedout,onlythepackagingofmedicines forthecentralnervoussystemhadbeenrevisedtoincludethe pic-togram.Thismayhavehadaninfluenceonsomeoftheresults, especiallyintheestimationofthelevelofdanger.Inthisstudy,we havetriedtoprovideanadequatecontextinwhichtoshowthe symbol,since,assomestudieshaveshown,comprehensionofa symboldependsonthecontext(Lehto,2000).However,thismeans thatthesymbol’s capacitytoattractattentioncannotbe evalu-atedsincethemedicine’spackagingwasshowntotheinterviewee asencouragementtoobservethepictogramwhenconductingthe survey.Thisfactcouldhavediminishedthesymbol’sreal effec-tivenessofreducingthenumberofaccidentsbecauseifithadnot beennoticed,itwouldnothavehadanaffectatallonthedriver’s attitude. On the other hand,since the symbolis already being usedonmedicationpackaging,certainfactorssuchastheinfluence ofthesize(ShiehandHuang,2003)thesetting,thedesign(ISO, 2004)etc.,ontheinterpretationofthepictogramhavenotbeen analysed.
5. Conclusion
TheSpanishpictogramonmedicinesanddrivingisunderstood bythegreatmajorityoftheinterviewees,iswellvaluedbyusersof theNationalHealthService.Thispictogramcanbeseenasatoolto improveprescribinganddispensingproceduresofmedicinesthat impairdrivingaswellasaninstrumenttomakepatientsawareof theroleofmedicinesplayintrafficsafety.
Conflictofinterest
Theauthorsdeclarednoconflictofinterest.
Acknowledgements
TheauthorsoftheSpanishstudywouldliketothankthepatients and health professionals (physicians, pharmacists and nursing staff)involvedinthestudyfortheirparticipation.Wewouldalso liketothankthehealthauthorities(JuntadeCastillayLeón, Conse-jeríadeSanidad,Sacyl,MinisteriodeSanidadyConsumo–Agencia Espa ˜noladeMedicamentosyProductosSanitarios(AEMPS)),the PrimaryHealth Care Centers, theHospital Clínico Universitario ofValladolid,theColegioOficialdeFarmacéuticosdeValladolid, SEMT,andSETfortheircollaborationatalltimes.Specialthanksto LurdesRicofortheircontributiontothestudy.
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