Guidance on consent February 2012
Guidance on consent
February 2012
The General Pharmaceutical Council is the regulator for pharmacists, pharmacy technicians and registered pharmacy premises in England, Scotland and Wales. As part of our role, we set the standards which govern the practice of pharmacists and pharmacy technicians.
Guidance on consent 3
About this guidance
This guidance should be read alongside the standards of conduct, ethics and performance which all pharmacists and pharmacy technicians must apply to their practice. This document gives guidance on standard 3.6 of the standards of conduct, ethics and performance, which says:
• You must get consent for the professional services you provide and the patient information you use.
Guidance on consent4
The status of this guidance
This document gives guidance to pharmacy professionals on how to meet the standard of consent. The guidance is not intended to cover every situation and it does not give detailed legal advice. However, it reflects the current law in Great Britain.
Pharmacy professionals work in many different settings, so how relevant this guidance is to you may vary depending on your role and the type of patient contact that you have. You should use your professional judgement in applying this guidance in your own practice. You must make sure that you keep up to date and comply with the law, and with any NHS or employment policies for consent that apply to your particular area of work.
You must make sure that all staff members you are responsible for are aware of this guidance and are appropriately trained in all areas that are relevant to their duties.
If you are not sure about how the law applies in a specific situation, you should always ask for advice from appropriate professional colleagues, your employer, your professional indemnity insurance provider, your professional body or other pharmacy organisation, or get independent legal advice.
We have produced more guidance to help pharmacy professionals apply our standards of conduct, ethics and performance. You can find this on our website. In particular, when reading this guidance you should also see our ‘Guidance on patient confidentiality’.
Guidance on consent 5
Guidance on consent6
1 Consent
1.1 What is consent?
1.1.1 TheOxfordEnglishDictionarydefines‘consent’as‘toexpresswillingness,givepermission,agree’.
1.1.2 Patientshaveabasicrighttobeinvolvedindecisionsabouttheirhealthcare.Theprocessofobtainingconsentisafundamentalpart ofrespectforpatients’rights.
1.1.3 Obtainingconsentisalsoessentialinformingandmaintainingeffectivepartnershipsbetweenyouandyourpatients.
1.1.4 Youhaveaprofessionalandlegaldutytogetapatient’sconsentfortheprofessionalservices,treatmentorcareyouprovide,ortousepatientinformation.
1.1.5 Youmustknowandcomplywiththelawandthegoodpracticerequirementsaboutconsentwhichapplytoyouinyourday-to-daypractice.
Guidance on consent 7
1.2 Types of consent
1.2.1 Therearetwotypesofconsent:
• explicit(or‘express’)consent:whenapatientgivesyouspecificpermissiontodosomething,eitherspokenorwritten
• impliedconsent:whenapatientindicatestheirconsentindirectly,forexamplebybringingtheirprescriptiontoyoutobedispensed.Thisisnotalesserformofconsentbutitisonlyvalidifthepatientknowsandunderstandswhattheyareconsentingto.Ifyouare notsurewhetheryouhaveimpliedconsent,youshouldget explicitconsent.
1.2.2 Youmustuseyourprofessionaljudgementtodecidewhattypeofconsenttoget.Youshouldtakeintoaccountlegalrequirements, NHSservicerequirements,andpolicieswhereyouworkthatmay setthisout.
1.2.3 Whenappropriate,youshouldrecordthefactthatthepatienthasgivenexplicitconsentandwhattheyhaveconsentedto.
1.3 Obtaining consent
1.3.1 Forconsenttobevalidthepatientmust:
− havethecapacitytogiveconsent
− beactingvoluntarily–theymustnotbeunderanyunduepressurefromyouoranyoneelsetomakeadecision
− havesufficient,balancedinformationtoallowthemtomakeaninformeddecision
− becapableofusingandweighinguptheinformationprovided.
1.3.2 Theinformationyouprovidetothepatientmustbeclear,accurateandpresentedinawaythatthepatientcanunderstand.Forexample,youmustconsideranydisabilities,orliteracyorlanguagebarriers.
1.3.3. Youshouldnotmakeassumptionsaboutthepatient’slevelofknowledgeandyoushouldgivethemtheopportunitytoaskquestions.
1.3.4 Youareresponsibleformakingsurethatapatienthasgivenvalidconsent.Youmustuseyourprofessionaljudgementtodecidewhetheryoushouldgetconsentfromthepatientyourself,orwhetherthistaskcanbeproperlydelegated.Ifyoudodelegatethetaskyoumustmakesurethatyoudelegateittoacompetentandappropriatelytrainedmemberofstaff.
Guidance on consent8
1.3.5 Gettingconsentisanongoingprocessbetweenyouandthepatient.Consentcannotbepresumedjustbecauseitwasgivenonapreviousoccasion.Youmustgetapatient’sconsentoneachoccasionthat itisneeded,forexamplewhenthereisachangeintreatmentorserviceoptions.
1.3.6 Patientswithcapacityareentitledtowithdrawtheirconsentat anytime.
2 Capacity
2.1 Whatiscapacity?
2.1.1 InEnglandandWales,undertheMentalCapacityAct(2005),a personlackscapacityifatthetimethedecisionneedstobemade, theyareunabletomakeorcommunicatethedecision,becauseof an‘impairmentordisturbance’thataffectsthewaytheirmindor brainworks.
2.1.2 InScotland,undertheAdultswithIncapacity(Scotland)Act(2000),apersonlackscapacityiftheycannotmakedecisionsorcommunicatethem,orunderstandorremembertheirdecisions,becauseofamentaldisorderorphysicalinabilitytocommunicateinanyform.
Guidance on consent 9
2.2 Assessing capacity
2.2.1 Youmustbaseanassessmentofcapacityonthepatient’sabilitytomakeaspecificdecisionatthetimeitneedstobemade.Apatientmaybecapableofmakingsomedecisionsbutnotothers.
2.2.2 Ingeneral,tomakeaninformeddecisionthepatientshouldbeableto:
− understandtheinformationprovided
− remembertheinformationprovided
− useandweighuptheinformationprovided,and
− communicatetheirdecisiontoyou(byanymeans).
2.2.3 Youmustnotassumethatbecauseapatientlackscapacityonone occasion,orinrelationtoonetypeofservice,thattheylackcapacitytomakealldecisions.
2.2.4 Apatient’scapacitytoconsentmaybetemporarilyaffectedbyotherfactors,forexamplefatigue,panic,ortheeffectsofdrugsoralcohol.Theexistenceofthesefactorsshouldnotleadtoanautomaticassumptionthatthepatientdoesnothavethecapacitytoconsent.Insteadyoushoulduseyourprofessionaljudgementtomakeadecisionbasedontheindividualcircumstances.
2.2.5 Youmustnotassumethatapatientlackscapacitybasedjustupontheirage,disability,beliefs,condition,orbehaviour,orbecausetheymakeadecisionyoudisagreewith.
Guidance on consent10
2.2.6 Youmusttakeallreasonablestepstohelpandsupportpatientstomaketheirowndecisionsortobeasinvolvedastheycanbeinadecision. Forexample:
− timethediscussionforwhenthepatient’sunderstandingmay bebetter
− useappropriatetypesofcommunication,simplelanguageor visualaids
− getsomeoneelsetohelpwithcommunicationsuchasafamilymember,supportworkerorinterpreter.
2.2.7 Ifyouareunsureaboutapatient’scapacityyoumustgetadvicefromotherhealthcareprofessionalsorpeopleinvolvedintheircare.
2.2.8 Ifyouarestillunsureyoumustgetlegaladvice.
2.2.9 Anyadviceyougetorassessmentscarriedoutshouldbeproperlyrecorded,alongwiththeoutcome.
2.2.10 Youcanfindmoreguidanceonhowpeopleshouldbehelpedtomaketheirowndecisions,andhowtoassesscapacity,intheCodesofPracticethataccompanytheMentalCapacityAct(2005)andAdultswithIncapacity(Scotland)Act(2000).
2.3 Adults with capacity
2.3.1 Everyadultispresumedtohavethecapacitytomaketheirowndecisions(thatis,theyarecompetent)andtogiveconsentforaserviceortreatmentunlessthereisenoughevidencetosuggestotherwise.
Guidance on consent 11
2.4 When a competent adult refuses to give consent
2.4.1 Ifanadultwithcapacitymakesavoluntary,informeddecisiontorefuseaserviceortreatmentyoumustrespecttheirdecision,evenwhenyouthinkthattheirdecisioniswrongormaycausethemharm.Thisdoesnotapplywhenthelawsaysotherwise,suchaswhencompulsorytreatmentisauthorisedbymentalhealthlegislation1.
2.4.2 Youshouldclearlyexplaintheconsequencesoftheirdecisionbutyoumustmakesurethatyoudonotpressurethepatienttoacceptyouradvice.
2.4.3 Youshouldmakeadetailedrecordifapatientrefusestogiveconsent. Thisshouldincludethediscussionsthathavetakenplaceandtheadvice yougave.
2.4.4 Ifyoubelievethatthepatientisatriskofseriousharmduetotheirdecisiontorefuseaserviceortreatment,youmustraisethisissuewithappropriatehealthcareorpharmacycolleaguesorpeopleinvolvedintheircare,andyouremployer(ifapplicable).Considergettinglegaladviceifnecessary.
Guidance on consent12
?1 Mental Health Act 2003 (as amended by the Mental Health Act 2006), and the Mental Health (Care and Treatment) (Scotland) Act 2003.
2.5 Adults without capacity
2.5.1 Ifthepatientisnotabletomakedecisionsforthemselves,youmustworkwithpeopleclosetothemandwithothermembersofthehealthcareteam.
2.5.2 TheMentalCapacityAct(2005)andAdultswithIncapacity(Scotland)Act(2000)setoutthecriteriaandtheprocessestobefollowedinmakingdecisionsandprovidingcareserviceswhenapatientlacksthecapacitytomakesomeoralldecisionsforthemselves.Theyalsograntlegalauthoritytocertainpeopletomakedecisionsonbehalfofpatientswholackcapacity.
2.5.3 Ifyoubelievethatapatientlackscapacitytomakedecisionsforthemselves,consulttheCodesofPracticethataccompanytheMentalCapacityAct(2005)orAdultswithIncapacity(Scotland)Act(2000).Thesesetoutwhocanmakedecisionsonthepatient’sbehalf,inwhichsituations,andhowtheyshouldgoaboutthis.
Guidance on consent 13
2.6 Young people and children
2.6.1 Thecapacitytoconsentdependsmoreonthepatient’sabilitytounderstandand consider their decision than on their age.
2.6.2 Inthisguidanceayoungpersonmeansanyoneaged16or17andachildmeansanyoneagedunder16.However,peoplegainfulllegalcapacityinrelationtomedicaltreatmentatadifferentageinScotlandthaninEnglandand Wales.
2.6.3 Aswithanypatient,ayoungpersonorchildmayhavethecapacitytoconsenttosomeservicesortreatmentsbutnottoothers.Thereforeitisimportantthatyouassessmaturityandunderstandingindividually,andbearinginmindthecomplexityandimportanceofthedecisiontobemade.
2.6.4 Ifapersonwithparentalresponsibilityisrequiredtoprovideconsent,youmayneedtogetlegaladviceif:
– youareinanydoubtaboutwhohasparentalresponsibilityfortheindividual,or
– theviewsofthosethathaveparentalresponsibilitydiffer.
2.6.5 Youngpeopleandchildrenshouldbeinvolvedasmuchaspossibleindecisionsabouttheircare,evenwhentheyarenotabletomakedecisionsontheirown.
Guidance on consent14
2.7 Young people with capacity
2.7.1 Youngpeoplearepresumedtohavethecapacitytomaketheirowndecisionsandgiveconsentforaserviceortreatment,unlessthereisenoughevidencetosuggestotherwise.
2.7.2 Todecidewhetherayoungpersonhasthecapacitytoconsenttoaserviceortreatment,usethesamecriteriaasforadults(seesection2.2‘Assessingcapacity’).
2.7.3 Youshouldencourageyoungpeopletoinvolvetheirparentsinmakingimportantdecisions.However,youshouldrespectacompetentyoungperson’srequestforconfidentiality.
2.8 Children with capacity
2.8.1 Childrenarenotpresumedtohavethecapacitytoconsent.Theymustdemonstratetheircompetence.
2.8.2 Achildcangiveconsentifyouaresatisfiedthatthetreatmentisintheirbestinterests,andthattheyhavethematurityandabilitytofullyunderstandtheinformationgivenandwhattheyareconsentingto.Inthiscaseyoudonotalsoneedconsentfromapersonwithparentalresponsibility.
Guidance on consent 15
2.9 When competent young people and children refuse to give consent
England and Wales2.9.1 Insomecircumstances,thecourtscanoverridetherefusalofconsentofa
youngpersonorchild.Youshouldgetlegaladviceifneededonthisissue.
2.9.2 Thelawiscomplexwhenacompetentyoungpersonorchildrefusestogiveconsentforatreatmentorserviceandsomeonewithparentalresponsibilitywantstooverridetheirdecision.Youshouldgetlegaladviceifyouarefacedwiththissituation.
Scotland2.9.3 Whenayoungpersonorchildhascapacitytomakeadecision,thenthe
law2saysthattheirdecisionshouldberespected.Thisappliesevenifthedecisiondiffersfromyourview,orfromtheviewsofthosewithparentalresponsibility.
2.9.4 However,thispositionhasnotyetbeenfullytestedintheScottishcourts,andnorhastheissueofwhetheracourtcanoverrideayoungperson’sorchild’sdecision.Youshouldthereforegetlegaladviceifyouarefacedwiththissituation.
Guidance on consent16
2 The Age of Legal Capacity (Scotland) Act 1991.
2.10 Young people without capacity
England and Wales2.10.1 Apersonwithparentalresponsibilityforayoungpersoncangiveconsenton
behalfofthatyoungpersontoinvestigationsandtreatmentthatareintheyoungperson’sbestinterests.
Scotland2.10.2 Therightsofapersonwithparentalresponsibilitytomakedecisionson
behalfofachildendswhenthechildreachestheageof16.
2.10.3 YoungpeoplewhodonothavethecapacitytoconsentshouldbetreatedasthoughtheyareadultsandinlinewiththeAdultswithIncapacity(Scotland)Act(2000).
2.11 Children without capacity
2.11.1 Whenachildlackscapacitytogiveconsent,anypersonwithparentalresponsibilityforthatchild,orthecourt,cangiveconsentontheirbehalf.
Guidance on consent 17
3 Advance decisions
3.1 Peoplewhounderstandtheimplicationsoftheirchoicescansayinadvancehowtheywanttobetreatediftheylatersufferlossofmentalcapacity.
3.2 Anunambiguousadvancerefusalforatreatment,procedureorinterventionwhichisvoluntarilymadebyacompetent,informedadultislikelytohavelegal force.
3.3 Anadvancerefusaloftreatmentcannotoverridethelegalauthoritytogivecompulsorytreatmentunderthementalhealthlaws.
3.4 Anyadvancedecisionissupersededbyacompetentdecisionbythepersonconcerned,givenatthetimeconsentissought.
Guidance on consent18
England and Wales3.5 AdvancedecisionsarecoveredbytheMentalCapacityAct(2005).Foran
advancerefusaloftreatmenttobelegallyvalid,itmustmeetcertaincriteriasetoutintheMentalCapacityAct(2005).
3.6 Ifanadvancedecisiondoesnotmeetthesecriteria,itisnotlegallybindingbutcanstillbeusedindecidingthepatient’sbestinterests.
3.7 Youmustfollowanadvancedecisionifitisvalidandapplicabletocurrentcircumstances.
Scotland3.8 TheAdultswithIncapacity(Scotland)Act(2000)doesnotspecifically
coveradvancedecisions.However,itsaysthathealthprofessionalsmusttakeaccountofthepatient’spastandpresentwishes,howevertheywerecommunicated.
3.9 Itislikelythatyouwouldbeboundbyavalidandapplicableadvancedecision.However,therehavebeennospecificcasesyetconsideredbytheScottishcourts.Ifinanydoubt,getlegaladvice.
Guidance on consent 19
4 Emergencies
4.1 Inanemergency,ifyoucannotgetconsent,youcanprovidetreatmentthatisinthepatient’sbestinterestsandisneededtosavetheirlifeorpreventdeteriorationinthepatient’scondition(thisappliestochildren,youngpeopleandadults).
4.2 Thereisanexceptionto4.1aboveifyouknowthereisavalidandapplicableadvancedecisiontorefuseaparticulartreatment.FormoreinformationseetherelevantincapacitylegislationanditsCodeofPractice,oraskyourprofessionalindemnityinsuranceprovideroralegaladvisor.
Guidance on consent20
5 Other sources of information
England and WalesMental Capacity Act 2005www.legislation.gov.uk/ukpga/2005/9/contents
Mental Capacity Act Code of Practicewww.publicguardian.gov.uk/mca/code-of-practice.htm
ScotlandAdults with Incapacity (Scotland) Act 2000 www.legislation.gov.uk/asp/2000/4/contents
Scottish Government site for the Actwww.scotland.gov.uk/Topics/Justice/Civil/awi
Guidance on consent 21
Guidance on consent22
More information
IfyouwouldlikecopiesofthisdocumentinWelsh,pleasegoto www.pharmacyregulation.org/standards/guidancewhereyoucandownloadaPDF.Ifyouareseekingthisdocumentinotherformats,pleasecontactourcommunicationsteam:Email:[email protected]
Ifyouhavequestionsorcommentsaboutthecontentofthisguidance,pleasecontactourStandardsTeam:
StandardsTeamGeneralPharmaceuticalCouncil25CanadaSquareLondonE14 5LQ
Phone:02037138000Email:[email protected]
Wehavealsoproducedguidanceonothertopicsthatyoumayfinduseful:www.pharmacyregulation.org/standards/guidance
Guidance on consent 23
©General Pharmaceutical Council 2014
General Pharmaceutical Council 25 Canada SquareLondonE14 5LQ
Phone: 020 3713 8000
www.pharmacyregulation.org
desi
gned
and
pro
duce
d by
wea
reta
nger
ine.
co.u
k 0
1622
623
790