Consent and Capacity PDF

WEEK 11 MPharm Programme Consent and Capacity Adam Oxberry [email protected] Dale 113 Slide 1 of 40 PHA221 – Consent and Capacity WEEK 11...

WEEK 11 MPharm Programme Consent and Capacity Adam Oxberry [email protected] Dale 113 Slide 1 of 40 PHA221 – Consent and Capacity WEEK 11 Learning Objectives On completion of this lecture, you should be able to: – Use a case study to describe the importance of taking reasonable care to ensure a patient is aware of material risks – Describe what is meant by a ‘material risk’ and how to assess if a patient understands ‘material risks’ – Describe key principles and definitions of consent in relation to explicit and implied consent – Describe the relationship between informed consent and Tort of Battery – Define ‘capacity’ according to the Mental Capacity Act 2005 – Describe key situations where pharmacist independent prescribers will need to consider capacity – Describe how to assess capacity Slide 2 of 40 PHA221 – Consent and Capacity WEEK 11 A CASE STUDY AND MATERIAL RISK Slide 3 of 40 PHA221 – Consent and Capacity WEEK 11 Montgomery Judgement Montgomery v Lanarkshire Health Board (Scotland) 2015 Nadine Montgomery, a woman of small stature had diabetes and was pregnant During childbirth she had complications that resulted in the baby being born with cerebral palsy Her obstetrician had failed to inform her of the risks of vaginal delivery associated with her stature (9-10% risk of shoulder dystocia) and diabetes and did not discuss the alternative option of a caesarean delivery Slide 4 of 40 PHA221 – Consent and Capacity WEEK 11 Montgomery Judgement In this case, the doctor believed the risk was small and did not believe a caesarean section was in the patient’s interest The patient sought financial compensation for Health Board for the injuries caused to her son In the lower courts, the ‘Bolam Principle’ was applied and she was unsuccessful as it was held the doctor acted ‘in accordance with a reasonable body of medical opinion’ Slide 5 of 40 PHA221 – Consent and Capacity WEEK 11 Montgomery Judgement On appeal to the supreme court, the application of the ‘Bolam Principle’ was rejected and it was held ‘the doctor is under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatment’ The court awarded significant damages to Mrs Montgomery on the basis that her consent was not informed and therefore the obstetrician was negligent Slide 6 of 40 PHA221 – Consent and Capacity WEEK 11 Montgomery Judgement Hailed as the most important UK judgement on informed consent for 30 years by the BMJ Indicates the patient is at the centre of the decision-making process where treatment options are concerned, and decisions should be made in partnership with a healthcare professional This applies to any consultation where a treatment is supplied Slide 7 of 40 PHA221 – Consent and Capacity WEEK 11 Montgomery Principle Montgomery: ‘A healthcare professional is under a duty of care to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatment’ Slide 8 of 40 PHA221 – Consent and Capacity WEEK 11 Material Risk The test of materiality (material risk) has two aspects: 1. Whether in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk 2. Whether the healthcare professional is, or should reasonably be aware that the patient would attach significance to the risk Slide 9 of 40 PHA221 – Consent and Capacity WEEK 11 Examples of Material Risks A v East Kent Hospitals University NHS Foundation Trust – Clinical risk of 1/1000 was only theoretical and not material to the patient’s informed consent Spencer v Hillingdon NHS Trust – Clinical risk of PE of 1/50 000 but here it has a very severe potential clinical hazard and hence it was material Duce v Worcestershire Acute Hospitals NHS Trust – If a hospital surgical team is not aware of a clinical risk at the time of a clinical procedure, then it will not be material Slide 10 of 40 PHA221 – Consent and Capacity WEEK 11 INFORMED CONSENT Slide 11 of 40 PHA221 – Consent and Capacity WEEK 11 Informed Consent Introduction A healthcare professional is expected to work in partnership with the patient when taking informed consent Consequently, the healthcare professional must: – Listen to the patient – Respect the patient’s view – Discuss the diagnosis, prognosis, clinical treatment and care plan – Share all relevant clinical information – Maximise opportunities for the patient’s decision-making – Respect the patient’s decision The healthcare professional-patient’s clinical relationship should be based on openness, mutual trust and good communication skills Slide 12 of 40 PHA221 – Consent and Capacity WEEK 11 Acquisition of Consent If a patient has mental capacity, the basic clinical process of obtaining informed consent is to: – Ensure the patient understands the nature of the process and the patient’s role in it – Provide the patient with the opportunity to consider all relevant information – Establish a shared understanding of the clinical expectations and limitations of the investigation(s)/treatment(s) Slide 13 of 40 PHA221 – Consent and Capacity WEEK 11 Consent There are two forms of informed consent Explicit (or express) consent – When the patient clearly states in both verbal and written form that they are willing to undergo the proposed clinical investigation or treatment/procedure as part of the care plan Implied consent – Extends to the realms of clinical examination, investigation and treatment – Examples include holding an arm out for a BP measurement, or rolling up sleeve for a vaccination Slide 14 of 40 PHA221 – Consent and Capacity WEEK 11 Informed Consent and Tort of Battery To be effective, the informed consent of a patient must satisfy three legal requirements: 1. Informed consent must be given voluntarily 2. Patients must be capable of giving informed consent (i.e., have capacity) 3. Patients consent must be informed (i.e., the patient is provided with the necessary information to make an informed clinical decision as outlined on slide ‘acquisition of consent) Slide 15 of 40 PHA221 – Consent and Capacity WEEK 11 Explicit Consent A patient’s explicit consent should be acquired if: – The clinical investigation or clinical treatment/procedure is clinically complex and involves significant risks – There are significant personal implications for the patient e.g., Employment prospects or personal life – The provision of clinical care is not the primary purpose of the clinical investigation or clinical treatment/procedure – The clinical treatment/procedure is part of a research programme or an innovative clinical care plan for the patient’s personal benefit Slide 16 of 40 PHA221 – Consent and Capacity WEEK 11 PATIENT DECISION-MAKING PROCESS IS A CONTINUOUS PROCESS Slide 17 of 40 PHA221 – Consent and Capacity WEEK 11 When Should I Obtain Consent Again If a different clinical investigation or clinical treatment/procedure is required and urgent professional intervention is not required, then healthcare professionals should engage in a further patient consultation – If significant time has elapsed since original informed consent was obtained – Material changes to clinical condition/investigation/treatment – New information available e.g., Clinical hazards Slide 18 of 40 PHA221 – Consent and Capacity WEEK 11 When Should I Obtain Consent Again In Williamson v East London & City Health Authority – Held a healthcare professional must always stay within the terms of consent – A Surgeon took informed consent to replace a defective silicone breast implant, during surgery, the surgeon noted the situation was worse than anticipated – The surgeon conducted more extensive surgery (mastectomy) – It was held consent given by the patient did not cover this additional procedure Slide 19 of 40 PHA221 – Consent and Capacity WEEK 11 Consent Summary Does the patient know about the material risks of taking the proposed medicine? – What risks would a reasonable person want to know in this situation? – What sort of risks would this person want to know about this? Does the patient know about reasonable alternatives to this medicine? – Have I taken reasonable care to ensure that the patient knows all of this? – Have I ensured that the patient has understood? Do any exceptions apply? – Have I considered capacity, mental health issues and best interest? Have I documented the consent process? Slide 20 of 40 PHA221 – Consent and Capacity WEEK 11 ADVANCED CARE PLANNING Slide 21 of 40 PHA221 – Consent and Capacity WEEK 11 Advance Decisions People who understand the implications of their choices can say in advance how they want to be treated if later, they may lose mental capacity An unambiguous advance refusal for a treatment, procedure or intervention made by a competent informed adult is likely to have legal force – This must meet requirements set out by the Mental Capacity Act 2005 An advanced refusal for treatment cannot override compulsory treatment under the mental health laws An advanced refusal can however be overridden by a competent decision by the person concerned at the time consent is sought Slide 22 of 40 PHA221 – Consent and Capacity WEEK 11 Advanced Care Planning A healthcare professional will have to discuss advanced care planning with a patient if there is a significant clinical likelihood or the patient becoming mentally incompetent – A clinical condition that will impact on the length or quality of life – A clinical condition that will impair mental capacity – A clinical condition where mental incompetency is a foreseeable clinical possibility Slide 23 of 40 PHA221 – Consent and Capacity WEEK 11 Advanced Care Planning Consultation This must cover – Patient’s wishes, preferences and concerns – Patient’s personal beliefs and values governing the patient’s preferences and decision making – Family, close relatives, friends or personal representatives, e.g. Legal Power of Attorney – Clinical interventions likely to occur in a clinical emergency, e.g.Cardio-Pulmonary Resuscitation (CPR) Slide 24 of 40 PHA221 – Consent and Capacity WEEK 11 CAPACITY Slide 25 of 40 PHA221 – Consent and Capacity WEEK 11 Capacity Principles ‘The ability by someone to make a specific decision for themselves in a given situation. It is assumed that anyone aged 16 or over has capacity unless proven otherwise’ There are no degrees of capacity – Either a person has the capacity to make a particular decision or does not – People have the capacity to make some decisions and not others Children under 16 are assumed not to have capacity unless they have sufficient understanding and intelligence to enable them to understand fully what is proposed Slide 26 of 40 PHA221 – Consent and Capacity WEEK 11 Capacity Definition According to the Mental Capacity Act 2005 People who lack capacity: 1. For the purposes of this Act, ‘a person lacks capacity in relation to a matter if at the material time he is unable to make a decision for himself in relation to the matter because of an impairment or, or disturbance in the functioning of, the mind or brain 2. It does not matter if the impairment or disturbance is permanent or temporary 3. A lack of capacity cannot be established merely by reference to: 1. A person’s age or appearance 2. A condition of his, or an aspect of his behaviours which might lead others to make unjustified assumptions about his capacity’ Slide 27 of 40 PHA221 – Consent and Capacity WEEK 11 Capacity is Assumed in Adults A healthcare professional must work under the presumption that a patient has capacity in the decision-making process A patient will be held to lack capacity once all information is provided and the patient is unable to: – Understand the information – Retain the information – Comprehend the information (use and weigh up information) – Communicate a decision (by any means) Slide 28 of 40 PHA221 – Consent and Capacity WEEK 11 Young People and Children Children under 16 are assumed not to have capacity unless they have sufficient understanding or intelligence to enable them to understand fully what is proposed A young person or child may have the capacity to consent to some treatments but not others In some cases, the courts can override the refusal of a young person or child – The law is complicated if a young person or child has capacity and refuses treatment which is against the wishes of someone with parental responsibility – Seek legal advice Slide 29 of 40 PHA221 – Consent and Capacity WEEK 11 YOUNG PEOPLE AND CHILDREN Slide 30 of 40 PHA221 – Consent and Capacity WEEK 11 Mental Capacity and Minor Patients For minors, informed consent is typically provided by parents or legal guardians In W v W the House of Lords ruled that a parent can give informed consent for a minor patient for any clinical procedure which a ‘reasonable parent’ would give Slide 31 of 40 PHA221 – Consent and Capacity WEEK 11 Gillick v West Norfolk and Wisbech Area Health Authority Mrs Gillick argued that as a parent, any GP should seek parental consent for contraceptive treatment to patients under the age or 16 Led to guidelines on minor consent whereby a healthcare professional could provide contraceptive treatment to a minor patient under 16 years of age if certain criteria are satisfied Guidelines also apply to terminations/abortions as well as diagnosis and treatment of sexually transmitted infections Slide 32 of 40 PHA221 – Consent and Capacity WEEK 11 Fraser Competence Recommendation from trial that are now implemented into practice for minors under 16 when obtaining contraception: – The minor will understand the advice – The healthcare professional cannot persuade the minor patient to involve parents – The minor will continue to engage in sexual intercourse with/without treatment – Unless treatment is provided, the minor’s physical or mental health is likely to suffer – The minor’s best interests requires contraceptive treatment or advice without parental involvement Slide 33 of 40 PHA221 – Consent and Capacity WEEK 11 When Does Parental Responsibility End? The right of parent(s) to give consent to medical treatment on behalf of their minor, including access to medical records continues until the child reaches the age of 18 This applies to both parents if they are named on the birth certificate regardless of whether they are married If infant child conceived by IVF treatment, this is decided upon a case-by- case basis For any minor subject to a care order, the local authority will share parental responsibility with the parents Legal rights end if the minor is adopted and in certain situations a school will have the right to consent for clinical treatment of minor ailments Slide 34 of 40 PHA221 – Consent and Capacity WEEK 11 ASSESSING CAPACITY AND PATIENTS WHO LACK CAPACITY Slide 35 of 40 PHA221 – Consent and Capacity WEEK 11 Assessing Capacity If there is doubt over capacity, a healthcare professional should consult with: – Members of the clinical team – Members of the nursing staff – Other healthcare professionals – Other clinical specialists A professional may seek advice from the legal services team and solicitors to determine mental capacity Slide 36 of 40 PHA221 – Consent and Capacity WEEK 11 Considerations When Assessing Capacity Healthcare professionals should consider: – Is the lack of capacity permanent or temporary? – Which clinical options provide optimal benefit for the patient? – Which clinical option is least restrictive of patient choices? – Any documents of advanced planning? – Who is the legal power of attorney? – What are the expressed views of the family / next of kin? – What are the professional opinions of the healthcare team? Slide 37 of 40 PHA221 – Consent and Capacity WEEK 11 Treating Patients Who Lack Capacity Healthcare professionals should: – Prioritise the patient’s best interests – Respect the patient as an individual – Encourage and support the patient in the decision-making process – Protect the patient from all forms of discrimination Slide 38 of 40 PHA221 – Consent and Capacity WEEK 11 CLINICAL EMERGENCY Slide 39 of 40 PHA221 – Consent and Capacity WEEK 11 Emergencies In an emergency, when a person needs urgent treatment and you are unable to get consent you may provide treatment provided that – It is in the person’s best interests – Is needed to save their life – Treatment will prevent deterioration in their condition Remember to consider if an advanced directive for the patient exists, they may have previously declined the treatment you wish to provide Slide 40 of 40 PHA221 – Consent and Capacity