20/09/2022

The World Patient Safety Day’s theme this year is medication safety. According to the World Health Organisation, “Unsafe medication practices and medication errors are a leading cause of avoidable harm in health care across the world. Medication errors occur when weak medication systems, and human factors such as fatigue, poor environmental conditions or staff shortages, affect prescribing, transcribing, dispensing, administration and monitoring practices, which can then result in severe patient harm, disability and even death. The ongoing COVID-19 pandemic has significantly exacerbated the risk of medication errors and associated medication-related harm.”[1]

Covert medication can be a complex issue for health and social care professionals to grapple with. As it is a practice that is enmeshed with fundamental human rights and freedoms, it is unsurprising that it can be a topic that is debated. There are many factors that weigh into the balance of whether covert medication is proportionate in the particular circumstances of the individual; three key ones include:

  1. Necessity – it may be the only route through which a person will receive a life-changing or life-saving medication. It may be the tool that prevents an individual sustaining a serious and irreversible deterioration; or make the difference between surviving or dying;
  2. Safety - by administering medication covertly, it removes the safety net that the individual themselves can provide, as a final check and balance, flagging any potential errors. Covert medication cannot engage the person in efforts to reduce medication-related harm. As such, it is vitally important that the right systems and processes are in place; and
  3. Efficacy – this impacts on two levels:
    1. immediate effect - administering medication in food and/or drink can impact on its efficacy and/or alter the way in which the person responds to the medication;
    2. ongoing/longer-term– it is possible that individual becomes aware of the covert medication. This can pose risks to their engagement with their treatment and care as well as potentially undermining the therapeutic relationships that they may have forged with those supporting them.

For adults, two legal regimes within which covert medication may be used include the:

  1. Mental Capacity Act 2005 (the “MCA”) – where the person lacks capacity to make a decision about the medication and it is deemed to be in their best interests to receive it and to receive it covertly; and
  2. Mental Health Act 1983 (the “MHA”) – where covert medication forms part of the person’s treatment for their mental disorder.

Both of these frameworks properly require rigorous scrutiny of any decision to administer medication covertly.

It can, and often is, a finely balanced decision for professionals to include covert medication in a treatment programme or as part of a person’s care and support plan. They are faced with the dilemma of whether it could offer an effective treatment or cause more harm than good. Recognising these tensions, we consider whether there are any steps that can be taken to improve the safety of covert medication.

What is covert medication?

Covert medication refers to the administration of medication without the knowledge of the person receiving it, often disguised in food or drink.

Guidance

Covert medication is the subject of guidance from both regulators and the health and social care sector bodies; both the CQC[2] and NICE[3] offer helpful tools for professionals dealing with the administration of covert medication.

For those lacking capacity to make decisions about medication themselves, the use of covert medication has been scrutinised by the Court of Protection.  Case law including AG[4] and BHCC v KD[5] provides useful guidance to practitioners on the use of covert medication in a community setting.  Additionally, the case of An NHS Trust v XB & Ors [6] highlights the serious nature of the interference with an individual’s rights under Article 8 ECHR when involved in administering covert medication, and makes clear that in certain circumstances, consideration should be given as to whether an application to the Court of Protection is required.

What processes could be followed to improve safety?

Below we summarise a suggested process to follow when considering covert medication:

Consider all the options

As mentioned above, administering medication covertly is a significant interference with a person’s Article 8 ECHR rights and as such, it must be necessary and proportionate. Likewise, one of the principles of both the MCA and the MHA is that there must be consideration as to the least restrictive alternative.

  • Is the medication necessary? Does the underlying condition require medication? Can the condition be treated by non-pharmacological interventions?
  • Can you explore with the person why they are refusing the medication to see whether there is any way of resolving this without the need to administer it covertly?
  • What are the benefits of administering the medication covertly? What are the benefits of not administering it (either at all or covertly)?
  • What are the risks (both in nature and likelihood) of administering the medication covertly? What are the risks of not administering it (either at all or covertly)? What steps could be taken to mitigate those risks either way?

Authorisation from the prescriber

Covert medication can involve adding medication to food or drink. Some medication can become ineffective when mixed with certain foods or drink or indeed may change the person’s response to the medication. Crushing a tablet or opening a capsule may make its use “off-licence”. It is important that you obtain authorisation from the prescriber to ensure that the medication can be administered covertly.

The prescription itself should be clear that it is being prescribed to be administered covertly. The prescriber should be involved in the decision-making.

What legal framework is it proposed that covert medication will be administered under?

Mental Health Act 1983:

If the person is liable to be detained under the MHA, consider whether the medication is treatment for their mental disorder(s). If yes, it may be possible for the medication to be administered covertly under the MHA.

Mental Capacity Act 2005:

Ensure that a capacity assessment is undertaken in line with the principles set out in the MCA.

The starting point is that an adult who has capacity to make decisions about whether to receive a medication has a right to refuse them.

If the person lacks capacity to make such a decision, a best interest decision will be required under the MCA (see further below). If the person has a health and welfare deputy appointed under a lasting power of attorney/deputyship from the court, consideration will need to be given as to whether it is a decision that is within the scope of their authority.

Specific Care Plan

There should be a specific care plan setting out how covert medication will be managed, including:

  • Details of how and why it is necessary and proportionate for the medication to be administered covertly;
  • What medication is going to be administered, by whom, how and when?
  • Do those who are administering the medication covertly require any training?
  • How will it remain covert from the person?
  • What checks and balances are built into the processes to reduce the prospect of medication errors and mitigate the potential medication harms?
  • What records are going to be kept of covert medication? Who is going to review those records by way of audit to ensure that the correct processes are being followed? How frequently?
  • How will the person’s response to the covert medication be monitored? How will their potential to agree to the medication (therefore removing the need for it to be administered covertly) be monitored?
  • How will the efficacy of the medication being administered covertly be monitored? How will the type of medication and dosage be reviewed? By whom? How often?
  • How is the underlying condition (requiring medication) going to be monitored to ensure that the medication remains necessary/required? Who will be monitoring and reviewing at regular intervals the continued necessity for administering covert medication?
  • What is the contingency plan if the person becomes aware of covert administration?
  • Clearly defining the roles and responsibilities of all involved in creating, implementing, monitoring and reviewing the care plan;
  • How often will the care plan be reviewed?

The care plan should be kept under regular review with involvement from family members and health and social care professionals (as appropriate).

Best interests analysis

Is the medication, and its administration covertly, in the person’s wider “best interests”? For those where the MCA is the legal framework, a best interests decision is required. Whilst not a specific requirement of treatment administered under the MHA, clinicians consider “best interests” in a wider sense when determining the appropriateness of the treatment. The specific care plan should be considered as part of the analysis.

This should include consultation with others as is appropriate. Under the MCA, this could include:

  • Anyone with an interest in the person’s welfare – such as a family member, an IMCA/Advocate;
  • Whoever is prescribing the medication;
  • Whoever is administering the medication;
  • Whoever is reviewing the medication;
  • Anyone who the person has named to be consulted on matters of that kind; and
  • Any donee of a lasting power of attorney for health and welfare granted by the individual or a health and welfare deputyship appointed by the Court (noting that it may be a decision within the scope of their powers).

Under the MHA, those who are consulted may be impacted by the person’s wishes in relation to information sharing.

Under the MCA, there is a “checklist” of factors to take into account in best interest decision-making:

  • Whether it is likely that the individual will regain capacity to make this decision, and if so, when that it is likely to happen?
  • The individual’s past and present wishes and feelings.
  • The beliefs and values that would be likely to influence the individual’s decision if they had capacity.
  • Any other factors that they would be likely to consider if they were able to do so.
  • All the wider circumstances.

Are all requirements of the legal regime being discharged?

For treatment being provided under the MHA:

  • Are all of the requirements of Part IV MHA (for example, SOAD approval, if required) met?
  • Does the person remain eligible to be detained under the MHA? If their detention is considered by the Tribunal, is an application to withhold information about the cover medication appropriate?
  • If there is a disagreement as to whether the covert medication is in the person’s best interests, the Approved Clinician should assure themselves that the treatment remains appropriate.

For treatment being provided under the MCA:

  • Are all of the requirements met to achieve the protection of section 5?
  • Has a capacity assessment been conducted, by an appropriate professional, as to whether the person has capacity to make decisions about the specific medication?
  • Has all reasonable best interest consultation?
  • Have all of the factors in the section 4 checklist been considered?
  • Is an IMCA required?
  • Is there a significant dispute as to either the person’s capacity to make the decision themselves or their best interests? Can it be resolved – e.g. a second opinion or mediation? If not, is an application to the Court of Protection required?
  • Is the person subject to a deprivation of their liberty? Does the authorisation for their deprivation of liberty need to be updated with reference to the covert medication?

Record keeping and communication

Ensure that the appraisal of the potential options, the best interests analysis/decision and specific care plan and risk assessment are recorded in the person’s care records and medication records. Does the person’s GP need to be informed? Are there any other stakeholders involved in the person’s care that could/should be notified?

 

Summary

Fundamentally, whether or not to incorporate covert medication into a person’s treatment regimen, must be a decision that is taken on an individual basis. The person must remain at the heart of the decision-making. The benefit vs burden analysis must be tailored to their unique and individual circumstances. If covert medication is administered, it must be a practice and a decision that is kept under close and careful review.

This article is intended to provide an overview of the process to following when dealing with covert medication. This issue can often be complex to grapple and draws in many different legal strands together. Should you require any support or assistance in relation to this area, please do not hesitate to get in touch.

 


[1] WHO - Announcing World Patient Safety Day 2022 (4 March 2022) - WHO - Patient Safety Learning - the hub (pslhub.org)

[2] Covert administration of medicines - Care Quality Commission (cqc.org.uk)

[3] Overview | Managing medicines for adults receiving social care in the community | Guidance | NICE

[4] AG, Re [2016] EWCOP 37

[5] BHCC v KD [2016] EWCOP B2

[6] An NHS Trust v XB & Ors [2020] EWCOP 71

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