MENTAL HEALTH ACT, MENTAL CAPACITY ACT JOINT PROCEDURE No 2 CONSENT TO TREATMENT AND COVERT ADMINISTRATION OF MEDICATION CONTENTS

Transcription

1 MENTAL HEALTH ACT, MENTAL CAPACITY ACT JOINT PROCEDURE No 2 CONSENT TO TREATMENT AND COVERT ADMINISTRATION OF MEDICATION CONTENTS SECTION ONE Consent to Treatment Page I Introduction Why Consent is Crucial 3 This Procedure 3 What Consent is and isn t 3 Guidance on Consent 4 Guidance on Children and Young People 5 II Documentation Written Consent 5 Procedures to Follow When Patients Lack Capability to Give or Withhold Consent 7 III When should consent be sought Single Stage Process 7 Two or More Stage Process 8 Seeking Consent for Anaesthesia 8 Emergencies 9 Treatment of Young Children 9 IV Provision of information Provision for Patients Whose First Language is Not English 13 Access to More Detailed or Specialist Information 13 Access to Health Professionals Between Formal Appointments 14 Open Access Clinics 14 V Who is responsible for seeking consent? Completing Consent Forms 14 Responsibility of Health Professionals 15 VI Refusal of treatment 15 VII Tissue 16 VIII Clinical photography and conventional or digital video 16 recordings 1

2 IX Training 17 SECTION TWO Covert Administration of Medicines Introduction Aim Objectives Overview General principles Consent Patients with a mental illness Children Clinical supervision 24 APPENDIX A Key Points on Consent: the Law in England APPENDIX B Record of Patient s mental capacity and consent to treatment 27 APPENDIX C 25 DoH Consent Form 2 - Parental agreement to investigation 29 or treatment (where consciousness may be impaired). DoH Consent Form 3 Patient/parental agreement to 34 investigation or treatment for a child or young person (where consciousness may not be impaired). APPENDIX D Useful Websites 38 2

3 NOTE: THIS PROCEDURE DOES NOT COVER THE SPECIFIC CONSENT ISSUES FOR THE ADMINISTRATION OF ECT. PLEASE REFER TO ECT POLICY. I Introduction Why consent is crucial 1. Patients (like all citizens) have a fundamental legal and ethical right to determine what happens to their own bodies. Valid consent to treatment is therefore absolutely central in all forms of healthcare, from providing personal care to undertaking major surgery. Seeking consent is also a matter of common courtesy between health professionals and patients. Recording consent for detained patients is particularly important and is a Care Quality Commission/ Code of Practice requirement. This procedure 2. The Department of Health has issued a range of guidance documents on consent, and these should be consulted for details of the law and good practice requirements on consent. This policy sets out the standards and procedures in the Black Country Partnership NHS Foundation Trust, which aim to ensure that health professionals are able to comply with the guidance. While this document is primarily concerned with healthcare, social care colleagues should also be aware of their obligations to obtain consent before providing certain forms of social care, such as those that involve touching the patient or client. What consent is and isn t 3 Consent is a patient s agreement for a health professional to provide care. Patients may indicate consent non-verbally (for example by presenting their arm for their pulse to be taken), orally, or in writing. For the consent to be valid, the patient must: Be competent to take the particular decision; Have received sufficient information to take it; and Not be acting under duress. 4. The context of consent can take many different forms, ranging from the active request by a patient of a particular treatment (which may or may not be appropriate or available) to the passive acceptance of a health professional s advice. In some cases, the health professional will suggest a particular form of treatment or investigation and after discussion the patient may agree to accept it. In others, there may be a number of ways of treating a condition, and the health professional will help the patient to decide between them. 3

4 Some patients, especially those with chronic conditions, become very well informed about their illness and may actively request or decline particular treatments. In many cases, seeking consent is better described as joint decisionmaking : the patient and health professional need to come to an agreement on the best way forward, based on the patient s values and preferences and the health professional s clinical knowledge. 5. Where an adult patient lacks the mental capacity (either temporarily or permanently) to give or withhold consent for himself or herself, no one else can give consent on their behalf. However, treatment may be given if it is in their best interests, as long as it has not been refused in advance in a valid and applicable advance directive or they have made a lasting power of attorney giving another person the ability to make decisions on their behalf. For further details on advance directives see the Department of Health s Reference guide to consent for examination or treatment (chapter 1, paragraph 19) and the Trust s procedures. Guidance on consent 6. The Department of Health has issued a number of guidance documents on consent, and these should be consulted for advice on the current law and good practice requirements in seeking consent. Health professionals must also be aware of any guidance on consent issued by their own regulatory bodies. Reference guide to consent for examination or treatment (2 nd Edition) provides a comprehensive summary of the current law on consent, and includes requirements of regulatory bodies such as the General Medical Council where these are more stringent. Copies are available from the Governance and Risk Department and may also be accessed on the internet at digitalasset/dh_ pdf 12 key points on consent: the law in England has been distributed widely to health professionals working in England. This one-page document summarises those aspects of the law on consent which arise on a daily basis and is attached at Appendix A. Further copies are available from olicyandguidance/dh_ Specific guidance, incorporating both the law and good practice advice, is available for health professionals working with children, with people with learning disabilities and with older people. Copies of these booklets are available on the internet at:- For children:- 4

5 olicyandguidance/dh_ For people with a learning disability:- olicyandguidance/dh_ For older people:- olicyandguidance/dh_ Guidance for Children and young people 7 Children and their parents or guardians should be involved in the research consent process in proportion to the child or young person s competence to weigh the risks and benefits, and they may need extra time to do so; the child must also indicate that they do not object to the research activity. Children can give consent to participate in research themselves provided they have the capacity to do so. This means they are able to understand the nature and consequences of their participation in the research. Young people aged 16 years and older are generally capable of giving their own consent, while many under 16 years of age are also able to give informed consent or be involved in the decision making process. It is necessary to assess the individual child s capacity, depending on their maturity and understanding. On many occasions this is best achieved with support from parents or guardians. Gaining a child s views and desires can require the use of creative ways of providing information and alternative means for them to express their thoughts. II Documentation 1. It is essential for health professionals to document clearly both a patient s agreement to the intervention and the discussions which led up to that agreement together with a clear statement that the patient has or has not the capacity to make that decision (see Capacity Act Policy). This would normally be done or through documenting in the patient s notes that they have given oral consent. A consent form may be used in the circumstances set out in paras 3 & 5 below. A locally developed form for recording capacity and consent is attached as appendix B. See also para 6 Written consent (when the patient has capacity) 2. Consent is often wrongly equated with a patient s signature on a consent form. A signature on a form is evidence that the patient has given consent, but is not proof of valid consent. If a patient is rushed into signing a form, on the basis of too little information, the consent may not be valid, despite the signature. Similarly, if a patient has given valid verbal consent, the fact that they are physically unable to sign the form is no bar to treatment. Patients may, if they wish, withdraw consent after they have signed a form: the signature is evidence of the process of consentgiving, not a binding contract. 5

6 3. It is rarely a legal requirement to seek written consent (The Mental Health Act 1983 and the Human Fertilisation and Embryology Act 1990 require written consent in certain circumstances) but it is good practice to do so if any of the following circumstances apply: The treatment or procedure is complex, or involves significant risks (the term risk is used throughout to refer to any adverse outcome, including those which some health professionals would describe as Side-effects or complications ) The procedure involves general/regional anaesthesia or sedation Providing clinical care is not the primary purpose of the procedure. There may be significant consequences for the patient s employment, social or personal life The treatment is part of a project or programme of research approved by Black Country Partnership NHS Foundation Trust. 4. Completed forms should be kept with the patient s notes. Any changes to a form, made after the form has been signed by the patient, should be initialled and dated by both patient and health professional. 5. It will not usually be necessary to document a patient s consent to routine and low-risk procedures, such as providing personal care or taking a blood sample. However, if you have any reason to believe that the consent may be disputed later or if the procedure is of particular concern to the patient (for example if they have declined, or become very distressed about, similar care in the past), it would be helpful to do so. 6. If the patient is detained under the Mental Health Act care should be taken to clearly record their consent or lack of consent to the treatment and also their capacity to make such decisions evidencing the opinion. (see MHA Code of Practice ). The Trust has devised a simple consent to treatment form which includes a mental capacity screening section. This form is reproduced as Appendix B and is available as a single document on the Intranet: revised-record-of-patients-mental-capacity-consent-to-treatment This form MUST be completed for every patient detained under the Mental Health Act and placed in the case notes with a divider. It is good practice but not mandatory to compete it for all other patients especially those whose consent might fluctuate or whose treatment plan is particularly complex. Also note that if the screening form points to a lack of capacity to consent to treatment decisions a full capacity assessment should be undertaken following the guidance in the Mental Capacity Act procedures. 6

7 Procedures to follow when patients lack capacity to give or withhold consent 7. Where an adult patient does not have the capacity to either give or withhold consent to a significant intervention, this fact should be documented in Appendix B, along with a full assessment of the patient s capacity (see mental capacity Act procedures), why the health professional believes the treatment to be in the patient s best interests, and the involvement of people close to the patient. For more minor interventions, this information should be entered in the patient s notes. 8. An apparent lack of capacity to give or withhold consent may in fact be the result of communication difficulties rather than genuine incapacity. You should involve appropriate colleagues in making such assessments of incapacity, such as specialist learning disability teams and speech and language therapists, unless the urgency of the patient s situation prevents this. If at all possible, the patient should be assisted to make and communicate their own decision, for example by providing information in nonverbal ways where appropriate. 9. Occasionally, there will not be a consensus on whether a particular treatment is in an incapacitated adult s best interests. Where the consequences of having, or not having, the treatment is potentially serious, a court declaration may be sought. In such circumstances advice should be sought from the Trust s legal advisors. III When should consent be sought? 1. When a patient formally gives their consent to a particular intervention, this is only the endpoint of the consent process. It is helpful to see the whole process of information provision, discussion and decision-making as part of seeking consent. This process may take place at one time (single stage process), or over a series of meetings and discussions, depending on the seriousness of what is proposed and the urgency of the patient s condition. Single Stage Process 2. In many cases, it will be appropriate for a health professional to initiate a procedure immediately after discussing it with the patient. For example, in an out patient clinic a Doctor may suggest a particular medication. After explaining the benefits and risks of the particular medication the patients consent should be sought and recorded and the procedure can go ahead immediately. In many such cases, consent will be given orally but note the consent is only valid if the benefits and risks have been explained and understood.. 7

8 3. If a proposed procedure carries significant risks, it will be appropriate to seek written consent and health professionals must take into consideration whether the patient has had sufficient chance to absorb the information necessary for them to make their decision. As long as it is clear that the patient understands and consents the health professional may then proceed Two or More Stage Process 4. In most cases where written consent is being sought, treatment options will generally be discussed well in advance of the actual procedure being carried out. This may be on just one occasion, or it might be over a whole series of consultations with a number of different health professionals in the Multidisciplinary team. The consent process will therefore have at least two stages: The first being the provision of information, discussion of options and initial (oral) decision, and the second being confirmation that the patient still wants to go ahead. The consent form should be used as a means of documenting the information stage(s), as well as the confirmation stage. 5. Patients receiving treatment or investigations for which written consent is appropriate should be familiar with the contents of their consent form before they arrive for the actual procedure, and should have received a copy of the page documenting the decision-making process. They may be invited to sign the form, confirming that they wish treatment to go ahead, at any appropriate point before the procedure: at a pre admission clinic, or when they arrive for treatment. If a form is signed before patients arrive for treatment, however, a member of the healthcare team must check with the patient at this point whether they have any further concerns and whether their condition has changed. This is particularly important where there has been a significant lapse of time between the form being signed and the procedure. When confirming the patient s consent and understanding, it is advisable to use a form of words which requires more than a yes/no answer from the patient: for example beginning with Tell me what you re expecting to happen, rather than Is everything all right? 6. While administrative arrangements will vary, it should always be remembered that for consent to be valid, the patient must feel that it would have been possible for them to refuse, or change their mind. It will rarely be appropriate to ask a patient to sign a consent form after they have begun to be prepared for treatment (for example, by changing into a hospital gown), unless this is unavoidable because of the urgency of the patient s condition. Seeking Consent for Anaesthesia 7. Where an anaesthetist is involved in a patient s care, it is their responsibility (not that of a surgeon) to seek consent for anaesthesia, having discussed the benefits and risks. With respect to the special case of ECT (Electro Convulsive Therapy), anaesthesia is an integral part of contemporary modified ECT. Consent to be anaesthetised is implicit in the consent for ECT obtained by the consultant. It 8

9 is the consultant s responsibility to obtain informed consent for ECT including the anaesthetic element. All patients will be given information about anaesthesia in the ECT Information Leaflet. See the Trust s ECT policy. Emergencies 8. Clearly in emergencies, the two stages (discussion of options and confirmation that the patient wishes to go ahead) will follow straight on from each other, and it may often be appropriate to use the patient s notes to document any discussion and the patient s consent, rather than using a form. The urgency of the patient s situation may limit the quantity of information that they can be given, but should not affect its quality. Treatment of Young Children 9. When babies or young children are being cared for in hospital, it will not usually seem practicable to seek their parents consent on every occasion for every routine intervention such as blood or urine tests or X-rays. However, you should remember that, in law, such consent is required. Where a child or young person is admitted, you should therefore discuss with their parent(s) what routine procedures will be necessary, and ensure that you have their consent for these interventions in advance. If parents specify that they wish to be asked before particular procedures are initiated, you must do so, unless the delay involved in contacting them would put the child s health at risk. 10. Only people with parental responsibility are entitled to give consent on behalf of their children. You must be aware that not all parents have parental responsibility for their children (for example, unmarried fathers do not automatically have such responsibility although they can acquire it). If you are in any doubt about whether the person with the child has parental responsibility for that child, you must check. 10. Parental Responsibility (as defined in Children Act 1989): Mothers automatically have parental responsibility Fathers also have parental responsibility if they were married to the mothers when the child was conceived or born, or if they got married to her later listed on the birth certificate (after a certain date, depending on which part of the UK the child was born in) Unmarried fathers do not automatically have parental responsibility for their child, but a court order or a parental responsibility agreement given by the mother can be arranged 11. The Dept of Health have written 2 standard consent forms for Children (one where consciousness will be impaired and one when not). These are reproduced as appendix C and their use is recommended. 9

10 (Up to Age 18) Consent has to be explicit, treatment specific and involve the child or young person. Consent Procedure Oral or written consent must be obtained from one of the following: the parent or person with parental responsibility competent 16 & 17 year old Fraser competent child under 16 and recorded in the patient s Health Records. Details of all screening, assessments, examinations, investigations, invasive or non-invasive treatments and procedures must be recorded in the health records together with details of the advice and information leaflets given to the patient and parent. It is good practice to have consent paperwork in place for specific regularly occurring situations. The NHS recommended forms are not always appropriate Consent may be implied if, after received advice on the screening / assessment / examination to be carried out, the parent / person with parental responsibility and/or child present themselves for it to take place. Assumed consent is based on the principle that proposed interventions are described in advance and consent is assumed unless practitioners hear to the contrary from the parents. It is regarded as dangerous practice to assume consent. If a child or parent brings a claim on the basis no consent was given, the health professional would not be able to demonstrate that consent from the parent/guardian was received. This means that in practice consent is required for each intervention that takes place. For children under a care order, Social Services will share parental responsibility. People looking after a child, e.g. grandparents, child minders, can be authorized by the mother to take medical decisions for the child In loco parentis(in place of parents) This assumes custodial/parental responsibility and authority and forms the basis of a duty of care the same as that of a parent in relation to the child, and may be higher than that exercised by the parent. Although this can be established by written contract it is often assumed in common situations e.g. siblings, teachers. They will have limited rights to act in loco parentis until the person with parental responsibility can be contacted. Reasonable effort must be made to make contact with parents and make reasonable decisions based on the circumstances of the case for the purpose of safeguarding or promoting the child s welfare. Competent 16 & 17 year olds Young people aged 16/17 may have the capacity to consent to treatment but they are not necessarily able to refuse treatment. A refusal can be overruled and all that is required to proceed is a valid consent and this may be obtained from: Competent young person OR A holder of parental responsibility OR The Court can consent on behalf of those patients who are 17 and under 10

11 Careful consideration needs to be given to the circumstances of a refusal by a patient under 18 years old. There may be circumstances where a minor is mature for their age and would forcibly resist treatment. In such cases or in the cases of any doubt, legal advice should be obtained as to the lawfulness of proceeding in the face of a minor s refusal, even if a holder of parental responsibility is in favour of the treatment. This is particularly the case if any force might have to be used. Although a young person may have the capacity to give consent, valid consent must be given voluntarily. This requirement must be considered carefully. Children and young people may be subject to undue influence by their parents, other carers, or a potential sexual partner, and it is important to establish that the decision is that of the individual him or herself. Fraser-Competent Child A young person under 16 years may consent to medical treatment if he/she is judged to be competent to give that consent. It is considered good practice for doctors and other health professionals to follow the criteria outlined by Lord Fraser in 1985, in the House of Lord s ruling in the case of Victoria Gillick v West Norfolk and Wisbech Health Authority and Department of Health and Social Security. These are commonly known as the Fraser Guidelines: the young person understands the health professional s advice; the health professional cannot persuade the young person to inform his or her parents or allow the doctor to inform the parents that he or she is seeking contraceptive advice; the young person is very likely to begin or continue having intercourse with or without contraceptive treatment; unless he or she receives contraceptive advice or treatment, the young person s physical or mental health or both are likely to suffer; The young person s best interests require the health professional to give contraceptive advice, treatment or both without parental consent. Although this ruling was around sexual health advice it has now been accepted that it can be applied to any situation requiring consent. The healthcare professional must be able to justify that the young person has sufficient maturity to understand the nature, purpose, hazards and benefits of the treatment in order to give a valid consent. A young person may have the capacity to consent to an uncomplicated procedure but not to a more complex one, e.g. request for emergency hormonal contraception as opposed to termination of pregnancy. A child s request for confidentiality must be respected even when this includes refusing permission to discuss the treatment with his/her parents. However, the healthcare professional should seek to persuade such a young person to tell his/her parents or allow the healthcare professional to do so. If the healthcare professional is to proceed with the treatment without parental involvement he/she must be able to justify that the best interest of the childcare being served. When such situations arise, it may be helpful to obtain advice from senior colleagues. 11

12 In the majority of cases where there are no issues between child and parent, it is advisable to obtain both the child s and the parental consent. Problems may arise if assessment of competence is disputed by parents/guardians. Some parents believe that children under the age of 16 should not have the right to consent to any treatment on their own behalf. This is not a correct statement of law. The test is not one a parent can make. Where such a disagreement arises, the health professional should explain the legal position to the parent. Children who are not Fraser-Competent (aged under 16) In the case of a child who is under 16 and not Fraser competent, a valid consent to proceed with treatment must be obtained from a holder of parental responsibility. Refusal The law is not clear. There is no logical reason why a child who has capacity to consent to treatment should not also have an equal right to refuse that treatment. Others can override a young person s wish to refuse treatment, even if they are 16/17 years of age. There have been several court cases, which indicate that a child who refuses treatment can have that refusal overturned by a parent or guardian if it is in the best interests of the child to do so. This power to overrule must be exercised on the basis that the welfare of the child is paramount. This does not just mean physical health. Where there is a difference of opinion between child and parents or between parents this should be clearly recorded in patients notes. If staff are faced with a situation in which a child refuses treatment, which may endanger life or health, they should take legal advice. Staff will always have to exercise professional judgment when considering the use of supportive holding and undertake and document a risk assessment. Restraint is considered to be the positive application of force, with the intention of overpowering the child, (DoH 1993) applied without the child s consent (RCN 2003). In practice restraint is used to administer medication or carry out a procedure to which the child objects, and is carried out in what is considered to be in the child s best interest. Holding Still means the immobilization by splinting or using limited force. It may be a method of helping children, with their permission, to manage a painful procedure quickly or effectively. Holding is distinguished from restraint by the degree of force required and the intention. - No child should be restrained/held without considering why, when and how this should happen. - It is important that a process of questioning is undertaken every time restraint/ holding is deemed necessary. IV Provision of information 12

13 1. The provision of information is central to the consent process. Before patients can come to a decision about treatment, they need comprehensible information about their condition and about possible treatments/investigations and their risks and benefits (including the risks/benefits of doing nothing). They also need to know whether additional procedures are likely to be necessary as part of the procedure, for example a blood transfusion, or the removal of particular tissue. Once a decision to have a particular treatment/investigation has been made, patients need information about what will happen: where to go, how long they will be in hospital, how they will feel afterwards and so on. 2. Patients and those close to them will vary in how much information they want: from those who want as much detail as possible, including details of rare risks, to those who ask health professionals to make decisions for them. There will always be an element of clinical judgement in determining what information should be given. However, the presumption must be that the patient wishes to be well informed about the risks and benefits of the various options. Where the patient makes clear (verbally or non-verbally) that they do not wish to be given this level of information, this should be documented. Provision For Patients Whose First Language is Not English 4. Black Country Partnership NHS Foundation Trust is committed to ensuring that patients whose first language is not English receive the information they need and are able to communicate appropriately with healthcare staff. It is not appropriate to use children to interpret for family members who do not speak English. Helpful guidance is found in the toolkit Bridging the Gap produced by Sheffield Health Authority and the Commission for Racial Equality For clients who do not have English as their first language, an interpreting and translation service is provided by the Trust via external organisations. See link on the Intranet for contact details. Access To More Detailed or Specialist Information 5. Patients may sometimes request more detailed information about their condition or about a proposed treatment than that which is provided in general leaflets. Black Country Partnership NHS Foundation Trust has made the following arrangements to assist patients to obtain such information: The Trust now subscribes to the Choice and medication website which has a range of information about medication including patient information leaflets. This website can be accessed via the link on both the Internet and Intranet Trust sites : The following web site links may be helpful: 13

14 National electronic Library for Health NHS Direct Online Access to Health Professionals Between Formal Appointments 6. After an appointment with a health professional in primary care or in outpatients, patients will often think of further questions, which they would like answered before they take their decision. Where possible, it will be much quicker and easier for the patient to contact the healthcare team by phone than to make another appointment or to wait until the date of an elective procedure (by which time it is too late for the information genuinely to affect the patient s choice). Any questions regarding procedures should be referred to the treating team who can be contacted by phone or letter (see appointment letter for address, telephone number) Open Access Clinics 7. Where patients access clinics/teams directly, it should not be assumed that their presence at the clinic implies consent to particular treatment. You should ensure that they have the information they need before proceeding with an investigation or treatment. V Who is responsible for seeking consent? 1. The health professional carrying out the procedure is ultimately responsible for ensuring that the patient is genuinely consenting to what is being done: it is they who will be held responsible in law if this is challenged later. 2. Where oral or non-verbal consent is being sought at the point the procedure will be carried out, this will naturally be done by the health professional responsible. However, teamwork is a crucial part of the way the NHS operates, and where written consent is being sought it may be appropriate for other members of the team to participate in the process of seeking consent. Completing consent forms 3. The consent form (appendix B) provides space for a health professional to provide information to patients and to sign confirming that they have done so. The health professional providing the information must be competent to do so: either because they themselves carry out the procedure, or because they have received specialist training in advising patients about this procedure and have been assessed. They must also be are aware of their own knowledge limitations and be subject to audit. 14

15 4. If the patient signs the form in advance of the procedure (for example in outpatients or at a pre-assessment clinic), a health professional involved in their care on the day should sign the form to confirm that the patient still wishes to go ahead and has had any further questions answered. It will be appropriate for any member of the healthcare team (for example a nurse admitting the patient for an elective procedure) to provide the second signature, as long as they have access to appropriate colleagues to answer questions they cannot handle themselves. Responsibility of Health Professionals 5. It is a health professional s own responsibility: To ensure that when they require colleagues to seek consent on their behalf they are confident that the colleague is competent to do so; and To work within their own competence and not to agree to perform tasks which exceed that competence. If you feel that you are being pressurised to seek consent when you do not feel competent to do so contact your line manager in the first instance. IV Refusal of Treatment 1. If the process of seeking consent is to be a meaningful one, refusal must be one of the patient s options. A competent adult patient is entitled to refuse any treatment, except in circumstances governed by the Mental Health Act The situation for children is more complex: see the Department of Health s Seeking Consent: working with children for more detail. The following paragraphs apply primarily to adults. 2. If, after discussion of possible treatment options, a patient refuses all treatment, this fact should be clearly documented in their notes. If the patient has already signed a consent form, but then changes their mind, the clinician (and where possible the patient) should note this on the form. 3. Where a patient has refused a particular intervention, the clinician must ensure that any other appropriate care to which they have consented is provided. The clinician must also ensure that the patient realises they are free to change their mind and can accept treatment if they wish to do so later. Where delay may affect their treatment choices, they should be advised accordingly. 4. If a patient consents to a particular procedure but refuses certain aspects of the intervention, the possible consequences of their partial refusal should be explained to the patient. If the clinician genuinely believes that the procedure cannot be safely carried out under the patient s stipulated conditions, they are not obliged to perform it. Any other appropriate care must continue to be offered. Where another health professional believes that the treatment can 15

16 be safely carried out under the conditions specified by the patient, the clinician must on request be prepared to transfer the patient s care to that health professional. VII TISSUE Black Country Partnership NHS Foundation Trust do not undertake surgery as part of its services; contribute knowingly to public health surveillance; or use human organs and tissue for quality assurance purposes so a local procedure is not required. Black Country Partnership NHS Foundation Trust does undertake routine and low risk procedures, such as providing personal care and a taking blood sample. It will not usually be necessary to document a patient s consent to routine and low-risk procedures such as providing personal care or a taking blood sample. However if you have any reason to believe that the consent may be disputed later on or if the procedure is of particular concern to the patient (for example if they have declined or become very distressed about, similar care in the past), it would be helpful to do so. (See Part 2 Documentation, section 5 p 6 Reference: Department of Health Good Practice in consent implementation guide: consent to examination or treatment: page 23). VIII Clinical photography and conventional or digital video recordings 1. Photographic and video recordings made for clinical purposes form part of a patient s record. Although consent to certain recordings, such as X-rays, is implicit in the patient s consent to the procedure, health professionals should always ensure that they make clear in advance if any photographic or video recording will result from that procedure. 2. Photographic and video recordings which are made for treating or assessing a patient must not be used for any purpose other than the patient s care or the audit of that care, without the express consent of the patient or a person with parental responsibility for the patient. The one exception to this principle is set out in paragraph 3 below. If you wish to use such a recording for education, publication or research purposes, you must seek consent in writing, ensuring that the person giving consent is fully aware of the possible uses of the material. In particular, the person must be made aware that you may not be able to control future use of the material once it has been placed in the public domain. If a child is not willing for a recording to be used, you must not use it, even if a person with parental responsibility consents. 16

17 3. Photographic and video recordings, made for treating or assessing a patient and from which there is no possibility that the patient might be recognised, may be used within the clinical setting for education or research purposes without express consent from the patient, as long as this policy is well publicised. However, express consent must be sought for any form of publication. 4. If you wish to make a photographic or video recording of a patient specifically for education, publication or research purposes, you must first seek their written consent (or where appropriate that of a person with parental responsibility) to make the recording, and then seek their consent to use it. Patients must know that they are free to stop the recording at any time and that they are entitled to view it if they wish, before deciding whether to give consent to its use. If the patient decides that they are not happy for any recording to be used, it must be destroyed. As with recordings made with therapeutic intent, patients must receive full information on the possible future uses of the recording, including the fact that it may not be possible to withdraw it once it is in the public domain. 5. The situation may sometimes arise where you wish to make a recording specifically for education, publication or research purposes, but the patient is temporarily unable to give or withhold consent because, for example, they are unconscious. In such cases, you may make such a recording, but you must seek consent as soon as the patient regains capacity. You must not use the recording until you have received consent for its use, and if the patient does not consent to any form of use, the recording must be destroyed. 6. If the patient is likely to be permanently unable to give or withhold consent for a recording to be made it is unlikely that the recording should be made. You should also not make, or use, any such recording if the purpose of the recording could equally well be met by recording patients who are able to give or withhold consent. IX TRAINING 1. Training is available on issues covering consent and the specific procedures for which written consent is required. Details of training for non-medical staffing from your modern matron Details of training and induction programmes for medical staff from the Clinical Tutor. Details of training for ECT and accessed through the ECT Manager. 17

18 ECT consultants are involved in practical and theoretical teaching of Junior Doctors during their rotation 18

19 Section 2 Covert Administration of Medicines 1.0 INTRODUCTION There has been a pressing need to provide clear guidelines around the practice of covert administration of medication which takes into account the individual patients right to refuse treatment alongside issues relating to patients capacity to consent. 2.0 AIM The aim of this procedure is to provide clear guidelines and considerations, which must be taken into account before the decision to covertly administer medication is made. 3.0 OBJECTIVE This should not be confused with the administration of medicines against someone s will, which in itself may not be deceptive, but may be unlawful. To ensure that the practice of disguising medication in food or drink does not infringe the human rights of the individual and is carried out in the best interest of the patient. 4.0 OVERVIEW FROM THE NURSING AND MIDWIFERY COUNCIL Disguising medication in the absence of informed consent may be regarded as deception. However, a clear distinction should always be made between those patients or clients who have the capacity to refuse medication and whose refusal should be respected, and those who lack this capacity. Among those who lack this capacity, a further distinction should be made between those for whom no disguising is necessary because they are unaware that they are receiving medication and others who would be aware if they were not deceived into thinking otherwise. The Nursing and Midwifery Council s (NMC) Code of professional conduct requires each registered nurse, midwife and health visitor to act at all times in such a manner as to justify public trust and confidence. Registered practitioners are personally accountable for their practice and, in the exercise of professional accountability, must work in an open and co-operative manner with patients / clients and their families, foster their independence and recognise and respect their involvement in the planning and delivery of care. By disguising medication in food or drink, the patient or client is: Being led to believe that they are not receiving medication, when in fact they are. The registered nurse, midwife or health visitor will need to be sure that what they are doing is in the 19

20 Best interests of the patient or client, and be accountable for this decision. The registered practitioner will need to ascertain whether they have the support, or otherwise, of the rest of the multi-professional team, and make their own views clear. It is inadvisable for the nurse, midwife or health visitor to make a decision to dispense medication in this way in isolation. Even with completed risk assessments and guidelines, and following the involvement of all relevant parties, it is imperative that good record keeping should support duty of care arguments. 5.0 GENERAL PRINCIPLES THE COVERT ADMINISTRATION OF MEDICINES The covert administration of medicines is only likely to be necessary or appropriate in the case of patients or clients who actively refuse medication but who are judged not to have the capacity to understand the consequences of their refusal. Note: Medicines cannot be given covertly to a patient who has the capacity to refuse those medications. In such cases the use of the Mental Health Act should be considered. This procedure recognises that there may be certain exceptional circumstances in which covert administration may be considered to prevent a patient or client from missing out on essential treatment. In such circumstances and in the absence of informed consent, the following considerations may apply: The best interests of the patient or client must be considered at all times. The medication must be considered essential for the patient s or client s health and well being, or for the safety of others. The decision to administer a medication covertly should not be considered routine, and should be a contingency measure. Any decision to do so must be reached after assessing the care needs of the patient or client individually. It should be patient- or client-specific, in order to avoid the ritualised administration of medication in this way. There should be broad and open discussion among the multiprofessional clinical team and the supporters of the patient or client, and agreement that this approach is required in the circumstances. Those involved should include carers, relatives, advocates, and the multi-disciplinary team (especially the pharmacist). The decision and the action taken, including the names of all parties concerned, should be documented in the care plan and reviewed at appropriate intervals. 20

21 Family involvement in the care process should be positively encouraged. The method of administration of the medicines should be agreed with the pharmacist. Regular attempts should be made to encourage the patient or client to take their medication. This might best be achieved by giving regular information, explanation and encouragement, preferably by the team member who has the best rapport with the individual. The best interests of the patient or client are paramount (see the assessment of capacity procedure for a definition of Best Interests). The interests of the practitioner, team, or organisation should not determine any decision to administer medicines. There should be a framework within every clinical setting for open multiprofessional discussion and access to legal advice if necessary. These discussions and any possible resulting action must be documented in the current care plan. The guidance given in this position statement is presented on the understanding that registered practitioners administering medicines do so within the boundaries of the UKCC s: Code Of Professional Conduct, 1992 The Scope Of Professional Practice, 1992 Guidelines For Professional Practice, 1996 Guidelines For The Administration Of Medicines, 2000 Guidelines For Records And Record Keeping, Every registered practitioner involved in this practice should reflect on the treatment aims of disguising medication. Such treatment must be necessary in order to save life or to prevent deterioration or ensure an improvement in the patient s or client s physical or mental health. In other words, it must be in the best interests of the patient or client. Registrants involved in the practice of administering medicines covertly should be fully aware of the aims, intent and implications of such treatment. Disguising medication in order to save life, prevent a deterioration, or ensure an improvement in the person s physical or mental health, cannot be taken in isolation from the recognition of the rights of the person to give consent. It may, in such situations, be necessary to administer medicines covertly, but it is worth bearing in mind that, in some cases, the only proper course of action may be to seek the permission of the court to do so. Some forms of forced or disguised medication are recognised by law, for example : 21

22 Person is lawfully detained under a section of the relevant mental health legislation. When permission has been given by a Court (usually the Court of Protection). Consent Every adult must be presumed to have the mental capacity to consent or refuse treatment, including medication, unless he or she: is unable to take in and retain the information about it provided by the treating staff, particularly as to the likely consequences of refusal or is unable to understand that information or is unable to weigh up the information as part of the process of arriving at a decision. Or is unable to communicate their decision (even with assistance) The assessment of capacity is primarily a matter for the treating clinicians, but practitioners retain a responsibility to participate in discussions about this assessment. Where adult patients or clients are capable of giving or withholding consent to treatment, no medication should be given without their agreement. For that agreement to be effective, the patient or client must have been given adequate information about the nature, purpose, associated risks and alternatives to the proposed medication. A competent adult has the legal right to refuse treatment, even if a refusal will adversely affect his or her health or shorten his or her life. Therefore, registered nurses, midwives and health visitors must respect a competent adult s refusal as much as they would his or her consent Failure to do so may amount not only to criminal battery or civil trespass, but also to a breach of their human rights. The exception to this principle concerns treatment authorised under the relevant mental health legislation. When a patient or client is considered incapable of providing consent, or where the wishes of the mentally incapacitated patient or client appear to be contrary to the best interests of that person, the registered practitioner should provide an objective assessment of the person s needs and proposed care or treatment. He or she should consult relevant people close to the patient or client, such as relatives, carers and other members of the multi-disciplinary team, and respect any previous instructions that the patient or client gave. 22

23 In some cases the patient or client may have indicated consent or refusal at an earlier stage, while still competent, in the form of a living will or advance statement. Where the patient s or client s wishes are known, practitioners should respect them, provided that the decision in the living will or advance statement is clearly applicable to the present circumstances and there is no reason to believe that the patient or client has changed their mind. The ultimate decision to administer medicines covertly must be one that has been informed and agreed by the team caring for the patient or client and clearly recorded in the case notes. No one, not even a spouse, can consent for someone else, although the views of family and close friends may be helpful in clarifying a patient s or client s wishes and establishing his or her best interests. The administration of medicines to patients or clients who lack the capacity to consent and who are unable to appreciate that they are taking medication (unconscious patients or clients, for example) should not need to be carried out covertly. If such patients recover awareness, their consent should be sought at the earliest opportunity. A patient or client may be mentally incapacitated for various reasons. These may be temporary reasons, such as the effect of sedatory effect medicines, or longer-term reasons such as mental illness, coma or unconsciousness. It is important to remember that capacity may fluctuate, sometimes over short periods of time, and should therefore be regularly reassessed by the clinical team treating the patient or client. 6.0 PATIENTS OR CLIENTS WITH MENTAL ILLNESS For patients or clients detained under the relevant mental health legislation, the principles of consent continue to apply to any medication for conditions not related to the mental disorder for which they have been detained. The assessment of their capacity to consent to or refuse such medication therefore remains important. This assessment of capacity to make a decision applies equally to those people with a learning disability who may not have a mental illness. However, in relation to medication for the mental disorder for which the patient or client has been detained, medication can be given against a patient s wishes during the first three months of a treatment order or afterwards if sanctioned by a Second Opinion Approved Doctor (SOAD). This second opinion is provided within the legislation by medical practitioners appointed by the Care Quality Commission to provide second opinions on treatment under part VI of the Act. 23

24 The Code of Practice to the Mental Health Act makes it clear that consent to treatment should be sought even if the person is detained. Clear recording of attempts to obtain the consent should be recorded in the notes FOR EVERY DETAINED PATIENT. If the treating clinician considers that the person lacks the capacity to consent, that should also be recorded and evidenced. Lack of agreement by the patient to the treatment plan should not be assumed for all detained patients. See appendix B The principle of second opinion should be maintained for informal patients as this would be a sound endorsement of good practice and make it easier to defend. As previously stated, mental illness might cause temporary or fluctuating incapacity. This reinforces the need for regular re-assessment. 7.0 CHILDREN It cannot be assumed that children are unable to give consent. It is important that both legal and professional principles governing consent are applied equally to all, whatever the health care setting, but with the following significant restrictions: Children under the age of 16 are generally considered to lack the capacity to consent to or refuse treatment, including medication. The right to do so remains with the parents, or those with parental responsibility, unless the child is considered to have significant understanding and intelligence (sometimes referred to as the Fraser guidelines, formerly Gillick competence) to make up his or her own mind about it. Children of 16 or 17 are presumed to be able to consent for themselves, but the refusal of a child of any age may be overridden by the parents or those with parental responsibility. In exceptional circumstances, this may involve seeking an order from the court or making the child a ward of court. (see also appendix A para 5) 8.0 CLINICAL SUPERVISION Clinical supervision enables the registered nurse, midwife or health visitor to develop a deeper understanding of what it is to be an accountable practitioner and to link this to the reality of practice. The UKCC recommends that a practice dilemma such as the covert administration of medicines be discussed in this context. 24

25 Appendix A 12 KEY POINTS ON CONSENT THE LAW IN ENGLAND When do health professionals need consent from patients? 1. Before you examine, treat or care for competent adult patients you must obtain their consent. 2. Adults are always assumed to be competent unless demonstrated otherwise. If you have doubts about their competence, the question to ask is: can this patient understand and weigh up the information needed to make this decision? Unexpected decisions do not prove the patient is incompetent, but may indicate a need for further information or explanation. 3. Patients may be competent to make some health care decisions, even if they are not competent to make others. 4. Giving and obtaining consent is usually a process, not a one-off event. Patients can change their minds and withdraw consent at any time. If there is any doubt, you should always check that the patient still consents to your caring for or treating them. Can children give consent for themselves? 5. Before examining, treating or caring for a child, you must also seek consent. Young people aged 16 and 17 are presumed to have the competence to give consent for themselves. Younger children who understand fully what is involved in the proposed procedure can also give consent (although their parents will ideally be involved). In other cases, someone with parental responsibility must give consent on the child s behalf, unless they cannot be reached in an emergency. If a competent child consents to treatment, a parent cannot over-ride that consent. Legally, a parent can consent if a competent child refuses, but it is likely that taking such a serious step will be rare. Who is the right person to seek consent? 6. It is always best for the person actually treating the patient to seek the patient s consent. However, you may seek consent on behalf of colleagues if you are capable of performing the procedure in question, or if you have been specially trained to seek consent for that procedure. What information should be provided? 7. Patients need sufficient information before they can decide whether to give their consent: for example information about the benefits and risks of the proposed treatment, and alternative treatments. If the patient is not offered as much information as they reasonably need to make their decision, and in a form they can understand, their consent may not be valid. 25

26 8. Consent must be given voluntarily: not under any form of duress or undue influence from health professionals, family or friends. Does it matter how the patient gives consent? 9. No: consent can be written, oral or non-verbal. A signature on a consent form does not itself prove the consent is valid the point of the form is to record the patient s decision, and also increasingly the discussions that have taken place. Your Trust or organisation may have a policy setting out when you need to obtain written consent. Refusal of treatment 10. Competent adult patients are entitled to refuse treatment, even when it would clearly benefit their health. The only exception to this rule is where the treatment is for a mental disorder and the patient is detained under the Mental Health Act A competent pregnant woman may refuse any treatment, even if this would be detrimental to the foetus. Adults who are not competent to give consent 11. No-one can give consent on behalf of an incompetent adult. However, you may still treat such a patient if the treatment would be in their best interests. Best interests go wider than best medical interests, to include factors such as the wishes and beliefs of the patient when competent, their current wishes, their general wellbeing and their spiritual and religious welfare. People close to the patient may be able to give you information on some of these factors. Where the patient has never been competent, relatives, carers and friends may be best placed to advise on the patient s needs and preferences. 12. If an incompetent patient has clearly indicated in the past, while competent, that they would refuse treatment in certain circumstances (an advance refusal ), and those circumstances arise, you must abide by that refusal. This summary cannot cover all situations. For more detail, consult the Reference guide to consent for examination or treatment, available from the NHS Response Line and at: _ pdf This document can be accessed at nce/dh_

27 APPENDIX B RECORD OF PATIENT S MENTAL CAPACITY & CONSENT TO TREATMENT PLEASE PRINT DOUBLE SIDED -To be filed in the notes Name of Patient... Date of Birth... Ward.. Date of admission Status : Informal / Formal Responsible Clinician PRINT NAME Signature... Consultant/Associate Specialist/SpR/SHO Cross which is not applicable Does the patient have capacity to consent to the treatment proposed? ie Do they understand the information about the treatment Yes / No Can they retain the information long enough to make the decision Yes / No Can they use the information in order to make the decision Yes / No Communicate that decision (by any means) Yes / No (Give Details) If NO is the treatment being proposed in the patient s best interest? Yes / No (Note: A full capacity assessment will need to be completed) 1. The nature/purpose and possible side-effects of the proposed treatment(s) have been discussed and explained to me. Yes / No 2. I am satisfied with the explanations and information I have received. Yes / No 3. I consent to the proposed treatment(s). Yes / No Signature of Patient Date... Signature of Staff Member if patient refuses to sign : Signature of staff member.. Print Name and job title. 27 Date.

28 Treatment Reviews Date: Details of Proposed change in Treatment Signature of Patient 28

29 APPENDIX C CONSENT FORM 2 Parental agreement to investigation or treatment for a child or young person (where consciousness might be impaired) Patient details (or pre-printed label) Patient s surname/family name... Patient s first names.. Date of birth. Age. Responsible health professional. Job title. NHS number (or other identifier).. Male Female Special requirements (eg other language/other communication method) To be retained in patient s notes