Covert Medication: Decisions Must Follow the Law and NICE Guidance

Dr Maria Dyban Offers an Overview of the Law on Covert Medication and Suggests Some Practical Steps for Considering the Issues

Covert medications are medications that are given to a patient without his/her knowledge and often disguised in food or drink. Mentally competent patients can refuse medical treatment including medications even if the refusal can cause harm or accelerate the patient’s death.

Treatment without consent is a breach of Article 8 of the European Convention on Human Rights, the right to respect for private and family life.^1,2 The exception is treatment for mental health disorder when a patient is detained under the Mental Health Act 1983.³

Therefore, covert medications can only be administered in the best interests of a patient who lacks mental capacity and otherwise refuses to take such medications.

Judge Bellamy stated in AG v BMBC & Anor:⁴

• ‘If a person lacks capacity and is unable to understand the risks to their health if they do not take their prescribed medication and the person is refusing to take the medication then it should only be administered covertly in exceptional circumstances.’

Legal Framework and National Guidance

The prescribing and administration of covert medications are subject to a legal framework and relevant professional guidance and standards.

The relevant legislation on covert medications administration in England and Wales are the Mental Capacity Act 2005⁵ and the Mental Health Act 1983.³ In Scotland, the relevant statutes are the Adults with Incapacity (Scotland) Act 2000⁶ and the Mental Health (Care and Treatment) (Scotland) Act 2003;⁷ in Northern Ireland the relevant statute is the Mental Capacity Act (Northern Ireland) 2016.⁸ Recent NICE Guideline 108 on Decision-making and mental capacity gives a good overview on how to apply the relevant legislation.⁹

NICE Social Care (SC) Guideline 1¹⁰ and NICE Quality Standard (QS) 85¹¹ on managing medicines in care homes, as well as the Bellamy judgment in the case of AG v BMBC & Anor¹² are all relevant and advise on the practical approach to management.

The Mental Capacity Act 2005 defines mental incapacity and how it should be assessed.¹³ The Act states that there must be a presumption of capacity even when a person makes an unwise decision, unless it has been established that the person lacks capacity to make a particular decision,¹⁴ and the treatment options must be the least restrictive possible on the person’s rights and freedom:¹⁵

• ‘Before the act is done, or the decision is made, regard must be had to whether the purpose for which it is needed can be as effectively achieved in a way that is less restrictive of the person’s rights and freedom of action.’

Lasting Powers of Attorney (LPAs) can be appointed by the patient, while he/she has mental capacity, to act on their behalf if they are no longer able to make decisions. Lasting Powers of Attorney are registered through the Office of the Public Guardian and can be appointed to deal with health and welfare, or finances, or both.¹⁶ An objection to covert medication by the LPA for health and welfare must be followed. However, if it becomes apparent that the LPA is not acting in the patient’s best interests, the concern should be referred to the Office of Public Guardian to be considered by the Court of Protection.^17,18

Covert Medication in Care Homes

NICE QS85 (derived from the NICE SC1¹⁰ guidance) advises on covert medications administration in care homes.¹¹ It states that in a care home, covert medication may only be given to adult patients who have been assessed as lacking capacity, and after a management plan has been agreed, following a best interests meeting.¹¹ The purpose of this meeting is to decide whether it is in the patient’s best interests to have his/her medications administered covertly. Best interests of mentally incompetent persons are described in the Mental Capacity Act 2005. They should include the person’s past and present wishes, feelings, beliefs, and other relevant factors.¹⁹ These can be ascertained from family, friends, LPAs, the relevant person’s representative, or an independent mental capacity advocate (IMCA). In England and Wales, if a patient made an advance decision (while they had had mental capacity to do so) to refuse a particular medical treatment, then that has to be followed, but refusal of life-sustaining treatment has to be in writing.²⁰

The Mental Capacity Act (Northern Ireland) 2016 will also include some provisions for advance decisions, when they come into force.²¹  The Adults with Incapacity (Scotland) Act 2000 includes provisions around advance directives; they are not legally binding, but can be helpful and should be taken into account when deciding on future treatment options.⁶

Best Interests Decision

NICE recommends that the following representatives are present at the best interests meeting:^10,11

• care home staff
• relevant health professionals (including the prescriber and pharmacist)
• a person who can communicate the views and interests of the resident (e.g. a family member, friend, or IMCA, depending on the resident’s previously stated wishes and individual circumstances)
• an LPA for health and welfare, if the patient has appointed one.

Following the best interests meeting, the health and care practitioners should agree and clearly document the decision of the meeting, including reasons for proposing the patient’s mental incapacity, the management plan, and agreed regular review. The management plan should include medication review by the GP, medication review by the pharmacist to advise the care home on how the medication can be given safely, and a plan to regularly review the need for continued covert administration of medicines (see Box 1).^10,11

In some circumstances, if it is not possible or practicable to have a face-to-face meeting, then a decision regarding covert medication can be made as long as a discussion has taken place with all the relevant people. The Bellamy judgment, delivered 2 years after publication of NICE SC1,¹⁰ referenced the initial consultation process as a best interest decision ,²² although criticised it for not involving all required parties. Judge Bellamy does however cite in his conclusion NICE’s recommendations that a meeting should be held, except where the circumstances are urgent.²³

The Decision: Factors to Consider

Some suggested practical steps for clinicians are listed in Box 2.

In the case of AG v BMBC & Anor,¹² district Judge Bellamy clarified the factors that need to be considered before the decision for the covert administration of medication is made, especially with patients subject to Deprivation of Liberty Safeguards (DoLS).²⁴ DoLS may be authorised to reasonably restrict a person’s liberty in their best interests if they are under continuous supervision and control and lack mental capacity to decide on their care, accommodation, and treatment.²⁵ Deprivation of Liberty Safeguards are statutory checks that aim to ensure that any care which restricts a person’s liberty is both appropriate and in their best interests.²⁵ (Note that the Mental Capacity [Amendment] Bill published in July 2018, if passed through Parliament, may make some changes to the above provisions by replacing DoLS with Liberty Protection Safeguards.)

AG v BMBC & Anor¹² concerned a 92-year-old woman with Alzheimer’s dementia who resided in a care home and lacked capacity to decide about her care, treatment, and accommodation. She was subject to 1-year DoLS with no conditions attached to that authorisation. Her GP made a decision to administer covert medications that included thyroxine, promethazine, and diazepam. The decision was made based on the fact that the patient’s condition would otherwise deteriorate, with increased risk of harm to her if medication was not given.¹²

This patient’s GP records referred only to covert administration of thyroxine in November 2014, but not to promethazine, which was administered covertly from November 2014 to February 2015, nor to diazepam, which was administered covertly from February 2015 onwards.¹²

The best interest decision regarding covert medications did not involve a family member, relevant person’s representative, or social worker. There was no review of the decision to administer medications covertly. The decision to administer diazepam covertly in February 2015 had not been communicated to the supervisory body or relevant person’s representative, therefore no DoLS standard authorisation was reviewed at the time.

Judge Bellamy, at paragraph 25 of his judgment, confirmed that covert medication should involve consideration of the least restrictive option of the person’s rights and freedom of action. He advised that review of DoLS should be triggered by covert medication or any change in their administration regimen:²⁶

• ‘Insofar as the use of medication is relevant to the DOL then conditions around reviewing the use of medication and its impact on the person and the DOL with a view to reducing any restrictions are appropriate.’

He confirmed that NICE guidelines must be followed and that covert medication should be administered only in exceptional circumstances and after a best interests meeting has been held, with an agreed and recorded management plan, unless there were urgent circumstances.²³ He advised that the decision to administer covert medications should be subject to scrutiny, particularly when the medication can affect a patient’s behaviour, mental health, or act as a sedative.²⁷

He also advised that:²⁸

• ‘Any change of medication or treatment regime should also trigger a review where such medication is covertly administered.’

Useful Resources

­­The Mental Welfare Commission for Scotland published a good practice guide in 2017 on covert medication, which includes a care pathway and several good clinical scenarios.²⁹

Another useful resource, which includes covert medication guidance, and a decision-making tool and record, was developed in 2018 by Cardiff and Vale University Health Board, in which this author was involved.³⁰ If there is doubt about the patient’s mental capacity, then it should be formally assessed before deciding on the best interests, which is when the Mental Capacity Act toolkit,³¹  developed by the Royal College of General Practitioners, may be helpful.

Summary

A mentally competent patient has the right to refuse medical treatment. Covert medications can only be administered to mentally incompetent persons in exceptional circumstances. A pharmacist should be involved early on to advise on various alternative preparations and medication forms, as these may avoid the need for covert medications. A prescriber should conduct a review to determine which medications are essential. It should aim for the least restrictive management option in relation to the patient’s rights and freedom. 

Prescription of covert medication should be made only if the person lacks mental capacity and after a best interests decision is made, usually at a meeting unless there is an urgent need. All the relevant people should be present at the meeting to ascertain the patient’s present and past wishes, beliefs, values, and other relevant factors. The decision of the meeting needs to be documented and regular reviews scheduled. When covert medications are changed or added, DoLS (if in place) should be reviewed.

Dr Maria Dyban LLM, FRCGP, DFSRH, DRCOG

GP, Cardiff; Community Director and a lead Clinical Editor for HealthPathways in Cardiff and Vale UHB

Acknowledgements

The author would like to acknowledge Denise Shanahan—Consultant Nurse: Older and Vulnerable Adults in Cardiff and Vale Health Board—who was the driving force in creating the local health board guidance for covert medication and provided advice on this article.