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.

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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.

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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’.

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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.

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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.

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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.

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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.

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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.

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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.

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?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.

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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.

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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.

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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.

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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.

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3 Advance decisions

3.1 Peoplewhounderstandtheimplicationsoftheirchoicescansayinadvancehowtheywanttobetreatediftheylatersufferlossofmentalcapacity.

3.2 Anunambiguousadvancerefusalforatreatment,procedureorinterventionwhichisvoluntarilymadebyacompetent,informedadultislikelytohavelegal force.

3.3 Anadvancerefusaloftreatmentcannotoverridethelegalauthoritytogivecompulsorytreatmentunderthementalhealthlaws.

3.4 Anyadvancedecisionissupersededbyacompetentdecisionbythepersonconcerned,givenatthetimeconsentissought.

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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.

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4 Emergencies

4.1 Inanemergency,ifyoucannotgetconsent,youcanprovidetreatmentthatisinthepatient’sbestinterestsandisneededtosavetheirlifeorpreventdeteriorationinthepatient’scondition(thisappliestochildren,youngpeopleandadults).

4.2 Thereisanexceptionto4.1aboveifyouknowthereisavalidandapplicableadvancedecisiontorefuseaparticulartreatment.FormoreinformationseetherelevantincapacitylegislationanditsCodeofPractice,oraskyourprofessionalindemnityinsuranceprovideroralegaladvisor.

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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

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More information

IfyouwouldlikecopiesofthisdocumentinWelsh,pleasegoto www.pharmacyregulation.org/standards/guidancewhereyoucandownloadaPDF.Ifyouareseekingthisdocumentinotherformats,pleasecontactourcommunicationsteam:Email:communications@pharmacyregulation.org

Ifyouhavequestionsorcommentsaboutthecontentofthisguidance,pleasecontactourStandardsTeam:

StandardsTeamGeneralPharmaceuticalCouncil25CanadaSquareLondonE14 5LQ

Phone:02037138000Email:standards@pharmacyregulation.org

Wehavealsoproducedguidanceonothertopicsthatyoumayfinduseful:www.pharmacyregulation.org/standards/guidance

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©General Pharmaceutical Council 2014

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