Drug Treatment in Dementia: the Law, Good Practice and Alzheimer Scotland’s Policy (June 2006)

1. Introduction

Any person with mental capacity has the right to agree to or refuse treatment proposed by a doctor on any particular occasion. Dementia is not in itself grounds for an assumption of diminished capacity. This policy is particularly concerned with people with a diagnosis of dementia who, because of their illness, may have diminished capacity to make decisions about drug treatments for physical or mental disorders. Those decisions might include whether a particular treatment is appropriate or necessary, whether the treatment should be administered on a particular occasion, or how it should be administered. The policy does not cover other treatments, but similar considerations apply.

Drugs are used in dementia in the following circumstances.

1. To slow down the progress of dementia – the ‘anti-dementia’ drugs.
2. Complementary medicines treatment for dementia, which are not covered by this policy, yet the same general principles apply with regard to their prescribing and administration.
3. To treat symptoms associated with dementia, such as depression, anxiety, irritability, restlessness (this could include the use of anti-dementia drugs as symptomatic treatment for hallucinations in Lewy body dementia, or for behavioural symptoms in more advanced Alzheimer type dementia).
4. To treat concomitant physical disorder or disability.
5. To treat concomitant mental disorders, not secondary to the dementia.
6. Drugs are also sometimes the subject of, or part of research trials: these may be for treatments of dementia or treatments of other conditions.

Different legal provisions cover these various categories. Some people will be able to consent to drug treatment. The common law rules about consent to treatment and the information the doctor should give the patient will apply. The Mental Health (Care and Treatment) (Scotland) Act 2003 covers only treatment for mental disorder (potentially categories 3 and 5 above). The Adults with Incapacity (Scotland) Act 2000 can cover any form of treatment in circumstances where the 2003 Act does not apply. There are special provisions under the 2000 and 2003 Acts for treatments for the reduction of sexual drive. In both Acts, the specific provisions on medication should be read along with the Principles of the Acts. The relevant Codes of Practice give important guidance on many aspects of drug treatment.

Article 5 of the European Convention on Human Rights (enacted in the Human Rights Act in the UK) provides that everyone has the right to liberty and security of person and Article 3 offers protection against inhumane and degrading treatments. Inadequate or inappropriate treatment may be challenged under Article 8, which is concerned with respect for private and family life. Article 6 provides a right to a fair trial.

There is guidance for those involved in the prescribing and administration of drugs and on issues of consent and compliance(1). Such guidance is available from, among others, the following bodies:

• The Scottish Intercollegiate Guidelines Network (SIGN)(2)
• British Medical Association / Law Society(3)
• The Royal College of Psychiatrists(4)
• The Nursing and Midwifery Council (NMC, previously UKCC) (5)
• The Mental Welfare Commission (6 & 7)
• The Scottish Executive(8)
• The Royal Pharmaceutical Society of Great Britain(9)

2. Issues

There are particular concerns about the prescribing and administration of all medications for people with dementia, compliance with treatment and the appropriateness of the choice of drug treatments in some cases. These concerns, discussed below, arise from the nature of dementia and the experiences of people with dementia and their carers.

1. Negative and stigmatising attitudes to people with dementia and their carers have led to insufficient priority being given to the subject of treatments for and during dementia. There is an inadequate evidence base in relation both to established and potentially important treatments and to a variety of drugs which, though in common use, may not be significantly effective, or may even be harmful. The consequences of this range from unavailability of medications or under-treatment to inappropriate use or over-treatment.
2. Dementia gradually diminishes an individual’s capacity to understand the nature of treatment on offer, to reason about its appropriateness, to consent to or decline the treatment on offer, and to communicate any views. Additionally, consent status may vary considerably, even over very short periods of time or in various circumstances.
3. The forgetfulness and decline in understanding associated with dementia bring special concerns about maintaining compliance with necessary drug treatments.
4. In addition to diminished intellectual capacity, dementia often leads to decline in the ‘executive functions’, which affects forward planning, standards, judgement and self-monitoring. These functions are difficult to define and assess without formal assessment.
5. The important distinctions between fully informed consent and passive acceptance and between refusal and resistance are often vague and difficult to formulate.
6. The care network which surrounds someone with dementia is likely to be complex, involving not only the person as a patient and their doctor as a prescriber of medication, but also informal (such as family members) and formal (such as home care staff) carers. There are specific concerns when the doctor is a visitor in a care home and the principal caregivers are the care home staff.
7. There has been evidence of the inappropriate prescribing of tranquillizing drugs for challenging behaviour (10 & 11). Guidance on the choice of treatments for psychological and behavioural problems during dementia is given by SIGN .(12)
8. There has been evidence of a failure to reassess the need for various drug treatments on a regular basis (13).

3. Good practice within the current framework of legislation and guidance

1. Anyone who has concerns about possible dementia should have free access to full and proper assessment and, where a diagnosis of dementia is made, should have prompt and free access to any appropriate drug treatment without ‘rationing’.
2. During the course of dementia the person should have access to a regular review of their medical and psychiatric health status with extra attention paid to the particular symptoms associated with dementia, including behavioural and psychological symptoms. Doctors should be aware of the problems of under-reporting of both physical and psychological symptoms which often accompany dementia.
3. People with dementia should have the same access to potentially helpful drug treatments as the rest of the population, regardless of their consent status.
4. Throughout the course of dementia, any doctor treating someone with dementia should assess and regularly re-assess, whether the person has any diminution of capacity in relation to drug treatments. Carers and care home staff have an important role in relation to worrying changes or any changes that would indicate diminution of capacity in the person with dementia.
5. Any doctor treating someone with dementia should check with relatives or other informal and formal carers whether a proxy decision-maker (welfare attorney or welfare guardian) has been appointed and has appropriate authority and, where there is a welfare attorney, ascertain whether the power is currently effective. Welfare attorneys and guardians with health care powers must be consulted about any proposed drug treatment, and can (following the principles of the 2000 Act) consent to or refuse the treatment. They also have certain powers of appeal against decisions under the Act. In addition the doctor should check whether the person has made any advance statement relevant to the proposed treatment.
6. Non-pharmacological forms of management, for example nursing treatments, psychological approaches, changes to the environment, occupational or recreational approaches and various complementary therapies should be considered prior to drug treatments for behavioural and psychological problems arising during the course of dementia, which should only be prescribed after the non-pharmacological approaches have been tried and found to be ineffective or inappropriate and should be recorded in the patient’s notes. The exception to this is where a particular drug is the first treatment of choice (for example, when someone with dementia suffers a severe depressive episode).
7. Where possible, drugs for behavioural and psychological problems in dementia should only be prescribed where there is a sound evidence base for their use. The administration of tranquillizing or sedative drugs as general treatments to ‘quieten’ the person with dementia is normally wrong. The choice of a particular treatment should reflect the aim of targeting a particular symptom or underlying identified problem, such as depression.
8. The decision whether to treat a particular behavioural or psychological problem associated with dementia should not be made by the doctor alone. If it is not possible to consult fully with the person with dementia and to gain their full and informed consent, then informal and formal carers should be seen as vital to the decision-making process. Where there is evidence of diminished capacity, the provisions of the 2000 or 2003 Acts may apply. These Acts provide protection for doctors and carers as well as for those with diminished capacity. There is no excuse for evading their application in appropriate cases, however the argument of necessity may be used in an emergency situation to justify drug treatment necessary to save the person’s life or prevent serious deterioration or unnecessary suffering.
9. In considering drug treatment, the doctor should discuss with informal and formal carers, how the proposed treatment is to be administered.
10. In situations that necessitate the administration of a drug treatment without the knowledge of a person with diminished capacity (‘surreptitious’ or ‘covert’ administration), there should be a full review of the treatment involving all concerned, including the person with dementia as far as that is possible, with assistance in communication or advocacy where required. Full account should also be taken of any advance directive or other evidence of the person’s prior wishes. It should be established whether the proposed treatment is necessary, after all alternatives have been considered. Such administration should only be considered where there would be unacceptable risks to the person’s health or safety or to the safety of others if it were not given. The possible implications for the absorption, distribution and effects (including adverse reactions) of giving the drug by an unusual method should be considered and where appropriate discussed with a pharmacist. Potential ways of communication with the person should be reviewed. The legal status of the person (in terms of the 2000 and / or 2003 Acts) should be reconsidered. Where appropriate there should be consultation with the Care Commission or Mental Welfare Commission. All decisions and the reasoning behind them should be properly recorded. Any decision to give medication without consent should be the subject of continuing review. Professionals should refer to the guidance of their professional bodies in coming to these difficult decisions. The administration of drug treatment to a person who does not have diminished capacity in the absence of that person’s consent could in legal terms be an assault.
11. Where the 2000 Act does not apply because the safe administration of necessary medication would require force or restraint (not permitted under the 2000 Act except in a situation of necessity), the 2003 Act can be considered in the case of treatment for mental disorder. The option of approaching the court for proxy decision making under Part 6 of the 2000 Act is available where the 2003 Act does not apply, particularly for treatments for physical disorder. In all situations under both Acts, professionals should have full awareness of timescales and costs involved.
12. The prescribing of a drug and its safe and proper administration are two separate considerations. Particular concerns have been raised about the administration of drugs without the person’s knowledge (also known as covert or surreptitious medication), which are often hidden in food or drink. There have been few studies of this practice in the UK, however two studies conducted in south east England are notable. Macdonald et al. (2004) (14) found that 43% of non-specialist nursing homes surveyed sometimes administered medication covertly. Treloar et al. (2000) (15) found that 71% of residential, nursing and inpatient units providing care for people with dementia in south east England stated that medicines were sometimes given covertly. As the care settings in this study were mainly providing care for people with dementia, the likelihood of medication being administered covertly was enhanced, however the results confirm our concern that covert medication is an issue in the care of people with dementia. A recent newspaper article reported that 14 out of 101 (almost 15%) care homes in Scotland admitted to giving medications covertly (16). The extent of the issue in people’s own homes is not known, however Treloar et al. (17) found that 96% of carers of people with dementia thought the practice of hiding medications in food was sometimes justified. A Norwegian study (18) found that 17% of patients in special care units for people with dementia (91% of whom had a diagnosis of dementia) received medication administered covertly at least once during a period of seven days. Of the patients who received covert medication, they “more often received antiepiletics, antipsychotics, and anxiolytics compared with patients who were given their drugs openly”.
13. Where there is administration of medication without a person’s knowledge, recording tends to be inadequate or non-existent (eg 19) . It is possible that some of this under-recording is due to lack of concern about the issue, but some is probably due to a fear that such administration is improper and might lead to a complaint or disciplinary action. Care homes are required to notify the Care Commission at least once a year of “any instance in which medication has been administered to a service user without the consent of that service user or of a person duly authorised to consent on the service user’s behalf” (20). However, Alzheimer Scotland is concerned that service providers may not be complying with this requirement. The concern is based on an enquiry made to the Care Commission, which suggests that there is an inadequacy in the recording process.
14. Part 5 of the 2000 Act is still not being fully applied by some doctors(21) , thus its safeguards are not being fully utilised.
15. Part 5 certificates of the 2000 Act do not have to be registered or reported; this could easily lead to a lack of awareness of their existence at crucial times for the person’s treatment.

4. Alzheimer Scotland’s policy proposals

1. The Scottish Executive should provide guidance for practitioners on the boundaries between the provision of the 2000 and 2003 Acts, particularly with regard to the definition of ‘force or detention’ in Section 47 (7)(a) of the 2000 Act and on the boundaries between fully informed consent and passive acceptance and between refusal and resistance.
2. The Scottish Executive should reiterate their advice to doctors and other relevant practitioners that it is essential good practice to make use of the protections of Part 5 of the 2000 Act in all circumstances where people with dementia have significantly diminished capacity, and that such use is a requirement of the Code of Practice to Part 5 of the Act.
3. The training available for doctors in assessing capacity in relation to the 2000 Act, and in particular Part 5, is inadequate; the Scottish Executive should not only encourage improved training and better access to such training, but ensure that the required resources are available, both for the training programmes and for support to doctors attending.
4. The safeguards in Part 5 of the 2000 Act and associated Regulations are not yet adequate. Current guidelines and actual procedures across all care groups and settings should be reviewed. The practice of medication by covert means should be subject to a Part 5 certificate. Proper recording of the process and an introduction of the necessary regulations to ensure this is done are required.
5. There should be a requirement under the Code of Practice to Part 5 of the 2000 Act that all certificates should be sent to the Mental Welfare Commission, who have the power to enquire about any issues arising from the care of an individual patient.
6. The Care Commission should be more robust in requiring care providers to notify them at least once a year of medication, and give details in accordance with the regulations, given without the consent of service users or on their behalf.
7. The Code of Practice to Part 5 of the 2000 Act should require doctors and nurses to record any instances of administration of medication under the Act where force or detention is used, or without the person’s knowledge.
8. There should be more research into the prevalence of the administration of medication without the knowledge of people with dementia, in care homes, hospitals and in the community.

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1. Some prescribing can now be done by healthcare professionals other than a doctor, such as a registered nurse or a pharmacist independent prescriber.
2. SIGN (2006) Management of patients with dementia. Edinburgh
3. British Medical Association (2004) Assessment of Mental Capacity: Guidance for Doctors and Lawyers
4. The Royal College of Psychiatrists (2004) College Statement on Covert Administration of Medicines, Psychiatric Bulletin, 28, 385-386
5. Nursing and Midwifery Council (July 2006) Medicines Management Advice Sheet
6. Mental Welfare Commission for Scotland (2002) Rights, Risks and Limits to Freedom. Edinburgh
7. Mental Welfare Commission for Scotland (2004) Authorising Significant Interventions for Adults who Lack Capacity. Edinburgh
8. Scottish Executive (2005) National Care Standards: Care Homes for Older People. Edinburgh
9. Royal Pharmaceutical Society of Great Britain (2003) The Administration and Control of Medicines in Care Homes and Children’s Services
10. McGrath, A. & Jackson, G. (1996) Survey of Neuroleptic Prescribing in Residents of Nursing Homes in Glasgow. British Medical Journal, 312, 611-612
11. Oborne, C.A., Hooper, R., Li, K.C., Swift, C.G. & Jackson, S.H.D. (2002) An Indicator of Appropriate Neuroleptic Prescribing in Nursing Homes. Age and Ageing, 31, 425-439
12. SIGN (2006) op cit
13. Prentice, N., Mowat, D., Law, E. & Connelly, P. (2002) Antipsychotic Prescribing in Nursing Homes: An Ongoing Area of Concern. Royal College of Psychiatrists – Old Age Section Annual Residential Meeting in Jersey, March 2002
14. Macdonald, A.J.D., Roberts, A. & Carpenter, I. (2004) De Facto Imprisonment and Covert Medication Use in General Nursing Homes for Older People in South East England. Aging Clinical and Experimental Research, 16(4), 326-330
15. Treloar, A., Beats, B. & Philpot, M. (2000) A Pill in the Sandwich: Covert Medication in Food and Drink. Journal of the Royal Society of Medicine, 93 (8): 408-411
16. The Scotsman (Tuesday 2nd May 2006) Fears Over Secret Drugs for OAPs
17. Treloar et al. (2000) op cit
18. Kirkevold, O. & Engedal, K. (2005) Concealment of Drugs in Food and Beverages in Nursing Homes: Cross Sectional Study. British Medical Journal, 330, p20
19. Kirkevold & Engedal op cit
20. Scottish Statutory Instrument 2002 No. 114. The Regulation of Care (Requirements as to Care Services) (Scotland) Regulations 2002
21. Davidson, S., Wilkinson, H., Urquhart, G., Wasoff, F. & Mason, A. (2004) Review of the Implementation of Part 5 of the Adults with Incapacity (Scotland) Act 2000: A Qualitative Study of Implementation and Early Operation