Covert administration of medicines: legal issues

A summary of key legal issues, a pathway of actions and links to national guidance that should be considered with covert administration of medicines.

Contents

1. Covert administration
2. Summary of key legal issues and pathway of actions
   1. Assess capacity
   2. Consider other options
   3. Best interests decision
   4. Best interests meeting
   5. Management plan
   6. Obtain prescriber authorisation
   7. Record keeping and documentation

   Covert administration

   Covert administration is when medicines are given in a disguised form without the knowledge or consent of the person receiving them.

   It is a complex issue. It involves a formal decision made between healthcare professionals and carers and should only take place in people who do not have capacity to consent to treatment (as defined in the Mental Capacity Act 2005).

   Covert administration should not be confused with disguising a medicine to give it against a competent patient’s wishes. This would constitute a tort or civil wrong of trespass to the person.

   Covert administration usually involves hiding oral medicines (tablets, capsules or liquids) in food or drink. But it can also apply to medicines by other forms of medicine administration, such as patches, injections, or medicines given by a feeding tube, if the person lacks capacity to consent and they don’t know they are taking that medicine.

   Summary of key legal issues and pathway of actions

   Before covert administration of medicines takes place, carers and healthcare staff should refer to national guidance (see links provided below) and local policies and procedures.

   Here we summarise some of the key legal issues for carers and healthcare professionals to consider, and provide a suggested pathway of actions to follow:

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   Assess capacity

   Covert administration should only take place in people who do not have capacity to consent to treatment

   Before considering covert administration, lack of capacity should be formally established. This is when individual does not have capacity to make a decision or consent to treatment in line with the Mental Capacity Act 2005.

   Individuals capable of making decisions have the right to refuse medicines, even if that refusal leads to a detrimental outcome (Human Rights Act 1998).

   Consider other options

   To avoid resorting to covert administration, explore and try and resolve reasons for refusal of medicines

   One of the key principles of The Mental Capacity Act 2005 is that, when deciding or acting on behalf of a person who lacks capacity, you must consider:

   • Is there a way that would cause less restriction to the person’s rights and freedoms of action?
   • Is there a need to decide or act at all?

   Covert administration is only likely to be necessary when:

   • an individual is actively refusing to take their medicines
   • the medicine is deemed necessary for their health and wellbeing

   It is important to explore why a person is refusing their medicines. If this can be resolved, covert administration may not be necessary.

   Seek advice from the prescriber to see if stopping the medicine (temporarily or permanently) is an option. Alternatively it may be possible to switch to a different form of the medicine, or to a different medicine completely, that the patient may find more acceptable.

   Best interests decision

   Any decision to administer medicines covertly needs to be formally agreed as being in the individual's best interests

   Care staff must not give, or make the decision to give, medicines covertly without clear authorisation and documented instructions to do so.

   The decision needs to be made by the prescriber along with a multidisciplinary team of healthcare professionals.

   The decision makers need to carefully consider what is in the patient’s best interests. The decision needs to be made objectively, and should not be based on personal opinions.

   Best interests meeting

   A best interests meeting should take place to discuss and record the decision.

   Further guidance on best interests meetings is available from

   • British Medical Association Toolkit for doctors: Best interest decision-making for adults who lack capacity (section 7)
   • British Psychological Society guideline: Supporting people who lack mental capacity: A Guide to Best Interests Decision Making

   Practical considerations for a best interests meeting

   In an urgent situation, NICE guidance on medicines management in care homes states that it is acceptable for a less formal discussion to occur between the care home staff, prescriber and family or advocate to make an urgent decision. A formal meeting should be arranged as soon as possible afterwards.

   The clinician in charge of the patient’s care should initiate the best interests meeting, although a family member or another healthcare professional can also request the meeting. Ideally, the meeting should also involve:

   • the patient: even if they can’t attend, any views they are able to express must be represented and considered
   • those close to the patient and/or appointed representatives: including their family or friends, any court-appointed deputies, anyone who has lasting power of attorney or, where appropriate, an independent mental capacity advocate (IMCA)
   • the healthcare team: those who are part of the multi-disciplinary team (MDT) involved in the patient’s care

   This meeting can take place remotely, but there should be clear records of who was involved and what was agreed.

   The meeting should include discussion and agreement of:

   • all options: as per step 2 above, covert administration should be deemed necessary and be the least restrictive option for the patient. The option of stopping the medicine should always be considered, as this would be the least restrictive option, particularly if there is a risk of food or drink being refused.
   • management plan: (see step 5 below for more detail)
   • review of decisions: the criteria and review date of decisions should be decided and recorded at the meeting. The need for covert administration must be reviewed regularly as an individual’s capacity and circumstances can change over time.

   Management plan

   Agree and document a management plan at or shortly after the best interests meeting

   The management plan would usually include:

   • a doctor’s review of the patient’s medicines
   • a pharmacist’s review to advise whether the medicine is suitable to be given covertly, and if so how to do so safely. This review will need to consider pharmaceutical issues. This is covered in more detail in the accompanying article in this series: Covert administration of medicines in adults: pharmaceutical issues
   • the schedule and criteria for review of the need to continue covert administration (as agreed at the best interests meeting). This should include details of what to do if the patient regains capacity.

   Obtain prescriber authorisation

   A prescriber must authorise covert administration of medicines

   Covert administration usually involves altering medicines, for example crushing tablets or opening up capsules, and/or adding medicines to food or drink.

   Altering medicines is usually an unlicensed (off-label) activity. It is important to get authorisation, preferably in writing, from a relevant prescriber to do this.

   Prescribing medicines for off-label use affects, and probably increases, the prescriber’s professional and legal responsibility (liability).

   Any changes to medicines or how they are given comes with risks.

   Covert administration should only be carried out if the prescriber can justify, and is confident in, the use of the medicine in this manner. At present only an independent prescriber can authorise off-label use of medicines. Although other healthcare staff or professionals may be able to offer advice, they cannot authorise the action.

   Giving a medicine in an off-label way without a prescriber’s authorisation could result in a finding of professional misconduct.

   Record keeping and documentation

   Good record keeping throughout the process is essential.

   Inspecting bodies such as the Care Quality Commission will challenge covert administration of medication so it is important to make sure there are proper records to support the process.

   The mental capacity assessment, best interest decision and management plan should be recorded in the patient’s GP records and transferred to other healthcare settings when necessary.

   Care home staff should clearly document each time they give a medicine covertly, as well as any unsuccessful attempts to give a medicine covertly.

   National guidance

   National guidance on covert administration of medicines provides more detail and is available from:

   • National Institute for Health and Care Excellence (NICE) Guideline (NG67): Managing medicines for adults receiving social care in the community. Section 1.8 provides guidance to support care workers with the decision-making and process for covert administration of medicines. Refer to the full document for further detail.
   • National Institute for Health and Care Excellence (NICE): Social care guideline (SC1): Managing medicines in care homes. Section 1.15 of this guideline provides advice for care home staff on covert administration of medicines to residents. Refer to the full document for further detail.
   • National Institute for Health and Care Excellence (NICE) Quality Standard (QS85): Medicines management in care homes. Quality statement 6 advises that medicines must only be given covertly to adult care home residents assessed as lacking capacity if a management plan is agreed after a “best interests” meeting. Refer to the full document for further detail including the rationale, quality measures and what this means for different audiences (e.g. care homes, health and social care staff, local authorities, care home residents).
   • PrescQIPP Bulletin 269: Care homes – covert administration (requires subscription to access). This bulletin and briefing, with supporting resources, provides an overview of the legal considerations, along with guidelines and a pathway for healthcare staff to follow to support with a decision to give a medicine covertly.
   • Care Quality Commission: covert administration of medicines. Provides guidance and a summary of the legal issues to consider for adult social care organisations (care homes and home care services).

   Although the above guidance are intended mainly for covert administration in care home settings, the legal issues are similar in other care settings.

   Any organisation where covert administration of medicines may take place should make sure they have local policies in place to support best practice.

   Pharmaceutical issues

   As well as the legal issues surrounding covert administration of medicines, there are also medicine factors to consider:

   Update history

   23 April 2024
   1. Title and URL shortened.