Covert medicines guidance

For all care home staff, pharmacists and GP’s in Buckinghamshire.

You can download a full pdf version of this document by following the link on the right.

What is covert medication?

It’s when you give pharmaceutical treatment for mental or physical health problems disguised in food or drink to a service user without their knowledge. This is because they lack the capacity to consent.

When should it be used?

Covert administration of medication is controversial and hasn’t always been specified in care plans.

It should be a last resort limited to incapacitated service users where the treatment is necessary. It must also be in the service user’s best interests under the Mental Capacity Act 2005 (MCA or else authorised by mental health legislation or an appropriate court declaration.

When shouldn’t it be used

It’s unethical, and may even be unlawful, to covertly administer medication to a person with mental capacity.  This guidance doesn’tt apply where a person has consented to medication given in food or drink due to difficulty swallowing or due to unpleasant taste.

The National Institute for Clinical Excellence has produced guidance for managing medicines in care homes which explicitly refers to covert administration stating:

The covert administration of medicines should only be used in exceptional circumstances when such a means of administration is judged necessary, in accordance with the Mental Capacity Act 2005.

Both the Nursing and Midwifery Council and the Royal College of Psychiatrists have produced guidance on issues you must consider when giving medicines covertly. The Care Quality Commission Regulation 12(2)(b) includes the use of covert medicines.

Aim

This document is for guidance only to care homes, pharmacists and GP’s in Buckinghamshire. It’s for service users aged 18 years or over only.

It isn’t intended to replace or add to care homes own policies and procedures for medicines management, covert or otherwise. You may use it to inform decision making.

All practitioners remain individually accountable for their actions under the law, and where applicable, to their professional body.

In general terms, if a resident has the mental capacity to refuse medical treatment, you must respect their decision. Covert administration of medication in this case would be unlawful.

It is necessary to distinguish between:

• concealing medication in food or drink
• a co-operative process where consenting patients who find taking medication difficult have the medication delivered in food or drink for ease of ingestion/swallowing.

A co-operative process means the medication hasn’t been given covertly.

Medication non concordance

Many people with or without a mental illness, don’t want to take medication or fail to comply with the treatment regime advised by health professionals. You must  ask why someone doesn’t to take medicatio. Is it a total refusal or for another reason?

Studies into non-concordance have shown reasons such as:

• lack of information about why a medication is prescribed/administered
• the person feels their symptoms are mild
• the treatment is preventative and the person doesn’t feel it’s essential
• the medication has unpleasant side effects
• the reputation of certain medications
• concerns about dependency/addiction.

Other reasons include:

• difficulty swallowing (consider offering liquids, creams, patches)
• cultural or spiritual beliefs about medication
• relationship with the person prescribing or administering the medication
• beliefs about medication in general
• forgetting how to take the medication.

By exploring the reasons for not taking medication with the person, you’re making every attempt to support and encourage them to take the medication.

Refusing to take a medicine shouldn’t automatically be seen as a lack of mental capacity or a part of mental illness. The World Health Organisation advises practitioners need to support people who don’t want to take their medication, instead of imposing their own views and beliefs or blame them for not following advice.

The use of covert medication

The use of covert medication should be a last resort and not a routine measure. There are certain circumstances where covert medicine can be legally and ethically justified, provided that certain requirements, incorporated into this guidance, have been met beginning with establishing whether a person has mental capacity.

Mental capacity and covert medication

Every individual should have support to make their own decisions about taking medication. If the person has a condition affecting the mind or brain that may also affect the ability to consent to, or refuse, treatment, you need to do an assessment of capacity in relation to this decision and document the outcome.

All completed capacity assessments are time and decision specific.  The MCA states we’re all assumed to have capacity where it’s been assessed. An individual lacks capacity relating to one decision doesn’t automatically mean they lack capacity for other decisions.

People who are unwell may experience fluctuating or temporary loss of capacity. In these cases, you must establish whether the decision can wait until the person regains capacity and decide for themselves.

The free resource ‘Assess Right’ provides information and guidance about capacity assessments for professionals and the public.

You cant establish a lack of capacity by:

• a person’s age or appearance
• condition of their, or an aspect of their behaviour which might lead others to make unjustified assumptions about their capacity
• making of an unwise decision.

The two stage functional test

The MCA has a framework for assessing an individual’s capacity where they’ve been unable to make a decision with support.  To assess whether someone has the capacity to make a particular decision you must follow the two stages.

1. Is there a disturbance in the functioning of the person’s mind or brain? If the answer to this question is yes, progress to stage two
2. Does the impairment or disturbance mean that the person is unable to make a specific decision when it needs to be made?

The Mental Capacity Act states that a person is unable to make their own decision if they can’t do one of the following:

• understand the information provided and how this was assessed
• retain the information and how this was assessed
• weigh up the information to make a decision and how this was assessed
• communicate their decision by any means they can and how this was assessed.

If the person can do those four things with or without support, they’re assumed to have capacity to make the decision. You must respect this even if it appears unwise. You must document this in the persons care plan and record it.

Assent – incapacitated patients who comply with treatment

Compliant patients without capacity are perhaps the most vulnerable.  Although they won’t need to have medication administered covertly, they’re not aware of the medications purpose and side effects and can’t give valid consent.

You must follow the MCA to ensure lawful treatment for these patients.

Advance decisions to refuse treatment

It’s a general principle of law and medical practice that people have a right to consent to or refuse treatment.

The courts recognise that adults have the right to say in advance that they want to refuse treatment if they lose capacity in the future, even if this results in their death. A valid and applicable advance decision to refuse treatment has the same force as a contemporaneous decision.

The MCA makes provision for this in sections 24 to 26 of the Act explaining when a person can make an advance decision to refuse treatment.

Get further guidance for medical professionals.

Power of attorney

A lasting power of attorney (LPA) is when someone with capacity appoints another person to act for them in the eventuality that they lose capacity at some point in the future. This is significant for healthcare workers because the MCA extends the decision making ability of people using services to a time when they lack capacity.

The court can create deputyships where a person lacks capacity to create an LPA. LPAs and deputyships can be created separately for:

• property and affairs LPA for financial and property matters
• personal welfare LPA for decisions about health and welfare, where you live, day to day care or medical treatment.

This must be recorded in the person’s file where there’s knowledge of it. An LPA or deputy can only act within the remit of their authority and must provide proof that their power is registered with the Office of the Public Guardian.

Best interests

The best interest’s principle underpins the Mental Capacity Act. It’s set out in section 1(5) of the Act.

An act done, or decision made, under this Act for or on behalf of a person who lacks capacity must be done, or made, in his best interests.

The prescriber should do a medicines review to make sure all prescribed medicines are required.  The medication must be essential for the person’s health and well-being and considered so essential that the person needs to be deceived to receive it.

Medication mustn’t be given to benefit others, for example, medication with controlling and sedative effects. If such medication needs to be given covertly, a discussion is needed with the Local Authority Deprivation of Liberty Safeguards Team about whether authorisation from the Local Authority is required.

You must explore and document alternatives to manage challenging behaviour or confusion in people with mental illness, dementia or those with learning disabilities. Choose the least restrictive option.

Establishing best interests

The best interests of the person must be paramount. Chapter 5 of the MCA Code of Practice sets out the best interests principles you must follow. There should be an open and inclusive discussion including members of the multidisciplinary team, care worker, family and friends. If the person has no one close to them, you must consult an Independent mental capacity advocate (IMCA).

When making a best interest decision on behalf of another, you must consider the best interest check list (see Appendix 2). Where there’s a power of attorney over personal welfare and there’s conflict, this will need referring to the Court of Protection to establish best interests if the dispute is significant and can’t be resolved.

The pharmacist

You must get advice from the pharmacist when altering a medication or mixing it with another substance such as food or drink. This is to ensure the medication is safe to take in this way and to gain expert advice about alternative formulations or medications to improve the possibility of consent.

You must also talk to the pharmacist in advance if there’s any addition or changes to a person’s medication after the plan for covert medicine is put in place.

It is not safe practice to open capsules or crush tablets unless a pharmacist has told you that it’s safe to do so.

This is because:

• altering medicinal products (for example crushing tablets, opening capsules or adding to food/drink) is usually an unlicensed (off-label) activity
• medicines administered in this way must be authorised by a relevant prescriber
• the medication won’t be covered by the manufacturer’s product license and increases the prescriber’s professional responsibility and liability.

This should only be conducted if the prescriber can justify, and is confident in, the use of the medicine in this way.

There are also pharmaceutical issues to consider when administering medications.

Pharmaceutical issues and administration

There may not be any information on the stability of a medicine when it’s mixed with food or drink or crushed. The medicine may not be stable and may degrade. It’s important to assess the risk of not giving the medicine at all compared to giving the medicine which may degrade when mixed with food and drink.

Factors to consider when giving medications covertly

Mixing in food

The person may not get the full dose if they don’tt finish their food. You should add the medicine to the first mouthful of food, so that they get the full dose.

Unacceptable taste

Crushing and mixing of some medicines can have a bitter taste and an anaesthetic effect on the tongue. Consider liquid formulations if available.

Incompatibility with food and drink causing altered absorption

Some medicines must be taken before food or after food as this may affect absorption. This includes:

• calcium
• iron
• magnesium
• zinc
• dairy products such as milk.

Safety of crushing tablets

Crushing cytotoxics, hormonal and contraceptive medicines isn’t advised due to the potential risk to the administrator coming into direct contact with the crushed medicine. Or the risk of inhaling aerosolised dust.

It’s important that the person administering the medication can do so safely and effectively. They should have the appropriate level of training and supervision.  The Care Quality Commission has essential standards for the management of medicines (outcome 9).

Regular reviews

As a person’s mental capacity can change, as well as the need to continue a treatment, it’s important to set regular review meetings for covertly administered medication to ensure it’s still necessary.

The timescales of reviews should reflect:

• the person’s condition
• what medications are being administered
• whether this is it for a short or long term condition.

Initially, reviews should be frequent, for example, weekly when starting a covert medication. It’s essential to provide evidence of on-going attempts to encourage compliance.

A change in medication or dosage should also prompt a structured medication review to assess:

• the need for the medications
• side effects
• benefits
• any ongoing monitoring needs, plus a review and a reassessment for any potential deprivation of liberty as a result.

Documentation

Each care provider should have a written policy for covert medication use, as part of their medicines policy.

The care plan and contemporaneous record of the person receiving a covert medication must contain all the information gathered during the decision making process. This must include the:

• mental capacity assessment
• pharmacy advice
• best interests decision making outcome
• paperwork relating to any deprivation of liberty request if applicable.

Any agreement for covert medication administration should be signed by all relevant parties involved in the decision. See appendix 4.

Specifically to medications

The method of administration must be agreed with the pharmacist and prescriber. You must keep a record with the medication administration record (MAR) chart. See appendix 4.

Prescriptions, MARs and individual medication boxes should be clearly labelled

Annotate with clear instructions on how each medication should be administered, for example, open capsule and sprinkle contents on specified amount of fruit puree, crush and add to 15ml of yoghurt or fruit puree.

Care staff must administer the entire dose

Where practical give within the first mouthful.

The covertly administered medication should always be freshly prepared and not made up previously.

Residents receiving covertly administered medication must be supervised by the carer/nurse responsible for administering the medication until the resident has consumed the medication.

Transfer of care

It’s essential that if the person receiving covert medication transfer to another care facility or to domiciliary care, the correct and relevant documentation accompanies them. This must include a verbal handover to the person or persons who will be responsible for their care.

On arrival at a new care venue, any covert medication should be reviewed and the necessary assessments, plans and documentation completed. Any existing deprivation of liberty authorisation isn’t transferable and will need re-application by the new care provider.

Legal and ethical considerations

Covert medication is a complex issue. It involves principles of service users’ autonomy and consent to treatment, set in common law and statute, underpinned by the MCA and the Human Rights Act 1998.

Any adult with mental capacity has the right to consent or decline treatment, or nursing intervention.

Persons detained under the Mental Health Act

The principles of consent still apply to conditions unrelated to the mental disorder they’re detained for.

For medications related to their condition, these can be given against a person’s wishes during the first 3 months, or afterwards if sanctioned by a second opinion approved doctor.

Deprivation of liberty safeguards (DoLS)

DoLS are part of the Mental Capacity Act but were introduced at a later date coming into operation in April 2009. The safeguards apply to people who lack capacity to consent to their care and treatment in hospitals and homes (whether privately or publicly funded). Their purpose is to prevent arbitrary decisions that deprive vulnerable people of their liberty.

A Supreme Court Judgment known as ‘Cheshire West’ on 19 March 2014, clarified that liberty means the same for all. This is regardless of disabilities or conditions and the deprivation of that liberty, and applies far wider than health and social care have previously recognised.

DoLS system is the current authorisation arrangement for adults either residing in a care home or hospital. The Court of Protection directly authorises all other care arrangements amounting to a deprivation of liberty that are not covered by DoLS, including those in community settings, as well as young people aged 16 to 17. The Liberty Protection Safeguards (LPS) will replace these existing processes to authorise a deprivation of liberty. The aim for full implementation of LPS is by April 2022.

DHSC’s MCA/DoLS COVID-19 guidance was updated on 15 October 2020. This included consideration of when face-to-face visits can take place in different tiers of the new alert system, and also the operation of self-isolation regulations in the context of those with impaired decision-making capacity.

The ‘acid test’ was devised by the court to help identify a deprivation of liberty:

• is this patient free to leave, whether they’re compliant or not) and
• are they subject to continuous supervision and control?

To covertly administer medication that has controlling or sedative effects may amount to a deprivation of the person’s liberty. We advise a discussion with the DoLS Team at Buckinghamshire County Council. The care provider, for example care home, will need to complete the appropriate authorisation request forms.

Contact the DoLS team

01296 382195
dols@buckscc.gov.uk

In the event of it being necessary to deprive a person of their liberty, safeguards give a person rights to representation, appeal and for any authorisation to be monitored and reviewed.

Developing case law regarding covert medication and DoLS offers further clarity.

Covert medication is a serious interference with a person’s autonomy and right to self-determination under Article 8. It’s likely to be a contributory factor giving rise to the existing DOL. Safeguards by way of review are essential.

[taken from AG v BMBC & Anor [2016] EWCOP 37]

Covert medication general principles

Mental capacity assessment

Establishing the person lacks capacity for this decision and all practicable steps taken to help the person make the decision.

Last resort

All other option should be explored.

Best interests

All decisions, based on a holistic assessment of the impact of covert medication on the person.

Inclusive

Decisions shouldn’t be made in isolation. Evidence of a team decision involving those closest to the person and the person themselves where, or as far possible.

Transparent

The decision making process should be simple to follow and clearly documented.

Regularly reviewed

The necessity must be reviewed formally.

Time limited

For a short a time as possible.

Appendix 1 to 5

This includes a:

• covert medication flowchart
• best interests checklist
• relevant articles from the Human Right’s Act
• covert medication risk assessment
• covert administration guidance.

Download the pdf document on the right for access to the appendices and a full version of this information.