Q&A 365.3
What legal and pharmaceutical issues should be considered when administering medicines covertly?
Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals
Before using this Q&A, read the disclaimer at
Date prepared: 20th August2014
Background
Covert administration of medicines is a complex issue and involves the administration of a medicine disguised in food or drink to a patient without their knowledge or consent (1).
This Medicines Q&A discusses some of the legal issues that need to be considered before medicines are given covertly. Also, whilst it is not possible to evaluate every medicine individually for covert administration, this Q&A addresses some of the pharmaceutical issues (e.g. absorption, incompatibility, interactions) and patientfactors (e.g. acceptability) that need to be considered when deciding whether to administer medicines in this way.
Answer
Legal issues
The Nursing and Midwifery Council (NMC), the British Medical Association (BMA) and the National Institute for Health and Care Excellence (NICE) have produced guidance on issues to be considered when medicines are given covertly (2,3,4).
Note that covert administration should not be confused with disguising the administration of a medicine against a competent patient’s wishes, which would constitute a tort or civil wrong of trespass to the person (5).
The NMC guidance states that nurses and midwives involved in administering medicines covertly must act within the principles of the 2008 NMC Code, and ascertain and record the support, or otherwise, of the rest of the multidisciplinary team, and where appropriate, family members, carers and others (2). The NMC states that it is inadvisable for nurses and midwives to make a decision to administer medication covertly in isolation (2). The NMC requires that nurses and midwives refer to local and national policies and apply the requirements of the law, particularly in relation to capacity (2). The NMC states that covert administration of medicines is only likely to be required or appropriate where patients refuse medication but are judged not to have the capacity to understand the consequences of refusal (2).InEngland and Wales, the relatives of an incapable patient do not have a legal right to consent, so the decision for acting in the patient’s best interests lies with the person responsible for the patient’s care (5).
The BMA advises that a decision to administer medicines covertly to patients who lack mental capacity should be taken by the clinician in overall charge of the incapacitatedpatient’s medical care, in consultation with the multi-disciplinary care team (3). People close tothe patient should be involved in the decision. This includes proxy decisionmakers and independent mental capacity advocates where relevant. The reasons for a decision to give drugs covertly should be recorded in the patient’s care plan and regularly reviewed(3). In making the decision, consideration should be given to:
- Whether the patient genuinely lacks capacity to consent to or refuse treatment
- Why covert medication is proposed and whether it is in the patient’s best interests
- Whether there are feasible alternatives that are more respectful of the individual’s
choice.
Similarly, in their guidance on managing medicines in care homes, NICE has also stated that health and social care practitioners should not administer medicines to a patient without their knowledge if the patient has capacity to make decisions about their treatment and care (4). Practitioners should ensure that covert administration only takes place in the context of existing legal and good practice frameworks to protect both the patient and care home staff involved in medicines administration (4). Practitioners should also ensure that the process for covert administration of medicines to adult patients in care homes includes:
- Assessing mental capacity.
- Holding a multidisciplinary best interest meeting, involving care home staff, the prescriber, pharmacist and family member or advocate to agree whether covert administration is in the patient’s best interests.
- Recording the reasons for presumed mental incapacity and the proposed management plan.
- Planning how best to administer the medicines covertly
- Regularly reviewing covert administration.
NICE recommends that commissioners and providers of care home services consider establishing a wider policy on covert administration across several health and social care organisations (4). Covert administration must comply with any local written policy (6). In England and Wales, a Mental Capacity Act (2005) best interests’ checklist should be completed before administering medicines covertly (1).
Some authors have suggested that altering medicinal products (for example crushing tablets) is usually an unlicensed (off-label) activity (5,6,7,8,9). It has also been suggested that adding medicines to food is usually outside the terms of the product licence (7).
Pharmaceutical issues
Very often, there might not be information available regarding the stability of medicines when mixed with food or drink. However, it is useful to consider the risks of the medicine degrading in food/drink versus the risks of not giving the medicine at all. When medicine is added to food, it is recommended that it is added to the first mouthful of food, so that the full dose is received (7).
Useful reference sources for advice on the administration of medicines with food or drink include The NEWT Guidelines (7) and the Handbook of Drug Administration via Enteral Feeding Tubes which although directed towards enteral feeding does contain useful information that might be necessary to consider (10). The medicine’s manufacturer may also be contacted for advice (8).
Factors that need to be considered include:
- Acceptability to the patient: for example, sertraline tablets can be crushed and mixed with food for administration, but have a bitter taste and an anaesthetic effect on the tongue which might not be acceptable to the patient.Care also needs to be taken with hot foodafter administration (7). A liquid special is available; alternatively, changing to a different therapy available in liquid formulation (such as fluoxetine or paroxetine) might be considered (7).
- Absorption of the medicine when administered with food: for example phenoxymethylpenicillin should be taken an hour before food or two hours after food as absorption may be reduced by food (11). Individual drug monographs and Appendix 3 of the BNF advise on the recommended cautionary labels that need to be applied to dispensed medicines: this might be helpful in order to determine whether a medicine needs to be administered with or without food, and could therefore affect the decision to administer medication covertly.
- Incompatibility of medicines with foods or beverages: for example tea and coffee can cause some drugs to form a precipitate in vitro (such as some antipsychotics including chlorpromazine and haloperidol) (12). However, the limited clinical information suggests that both tea and coffee do not alter the plasma concentrations of chlorpromazine, haloperidol, fluphenazine or trifluoperazine. There is therefore no direct evidence that this in vitro interaction is normally of any clinical importance (12). Phenytoin absorption can be affected by some foods and this may affect the plasma phenytoin concentration (12).
Similarly, some medicines may be pharmaceutically incompatible with calcium, iron, magnesium and zinc and absorption may be reduced (11) (for example tetracyclines and ciprofloxacin): milk and dairy products can also decrease absorption of some medicines which might affect the decision to administer the medicine covertly.
- Interactions with food: for example in patients taking warfarin the variable vitamin K content in the diet can cause INR to fluctuate. Other food components might interact with warfarin; however it is not known how significant this is in clinical practice (10).
It is recommended that medicines should not be added to grapefruit juice due to the risk of drug interactions (7).
- Safety of crushing tablets (if this is required to covertly administer a medicine): for example there have been concerns regarding crushing hormonal, cytotoxic or steroid formulations due to the potential risk of a small amount of the resulting powder coming into either direct contact with the administrator, or through dust being aerosolised (8).
- It is recommended that tablets are not crushed if there is a safer alternative available (6,8), such as a liquid preparation (5). There is a Medicines Q&A available discussing therapeutic options for patients unable to take solid oral dosage forms, which is available here (13). The crushing of tablets or opening of capsules should be considered as the last resort (5) and it is important to be aware that this may affect the bioavailability of the drug hence the dose may need adjusting (6). Note that some preparations should not be crushed e.g. slow-release or enteric-coated formulations (8) as this might affect the absorption profile of the drug. Pharmacists need to consider the availability of alternative licensed preparations when dispensing products for covert administration (6).
Summary
Covert administration of medicines is a complex issue and involves the administration of a medicine disguised in food or drink to a patient without their knowledge or consent (1). It should only be considered, within the appropriate legal framework, for patients who lack capacity and should not be undertaken without being discussed between various healthcare professionals and the family/carer of the patient (1).
The Nursing and Midwifery Council, the British Medical Association and NICE have produced guidance on issues to be considered when medicines are given covertly (2,3,4).
This Medicines Q&A document discusses some of the legal issues that need to be considered before medicines are administered covertly.
Pharmaceutical issues (e.g. absorption, incompatibility, interactions) and patient factors (e.g. acceptability) also need to be considered when deciding whether to administer medicines in this way.
There may be limited pharmaceutical information on the stability of medicines hidden in food or drink.
Limitations
This document cannot list all the specific legal issues surrounding covert administration. If you have any concerns, you are advised to speak to a senior colleague, your professional body or a legal representative.
The legal considerations for covert medicines administration in Scotland have not been addressed in this Medicines Q&A. The guidance issued by the Mental Welfare Commission for Scotland provides detailed guidance on the legality and practicalities of covert administration for patients in Scotland (1).
As it is not possible to list all the pharmaceutical issues for each medicine, the useful references discussed above should be consulted.
The covert administration of medicines to patients detained under mental health legislation is beyond the scope of this Medicines Q&A.
In patients with fluctuating mental capacity, decisions may be even more complicated and are beyond the scope of this Medicines Q&A. Doctors may wish to consult the BMA guidance published in Medical Ethics Today for further advice (3). Furthermore, the BMA’s Mental Capacity Act Toolkitmay be helpful and can be accessed via thislink (3).
The covert administration of medicines to children has not been considered.
Local Trust guidelines on the covert administration of medicines may differ from the information provided in this Q&A and should be consulted.
References
- Haw C, Stubbs J. Covert administration of medication to older adults: a review of the literature and published studies. Journal of Psychiatric and Mental Health Nursing 2010;17:761-768.
- Nursing and Midwifery Council. Covert administration of medicines: Information on the relevant resource and processes regarding the covert administration of medicines. Modified June 2012. Reviewed September 2013. Accessed via: on 11/8/14.
- Personal Communication with Public Information, British Medical Association. 16/12/14
- National Institute for Health and Care Excellence. Managing medicines in care homes.Guideline SC1. March 2014. Accessed via on 11/8/14.
- Griffith R. Tablet crushing and the law. Pharm J 2003;271:90-91.
- Law and Ethics Bulletin: Covert administration of medicines. Pharm J 2003;270:32.
- Smyth J, editor. The NEWT Guidelines for Administration of Medication to Patients with Enteral Feeding Tubes or Swallowing Difficulties. BetsiCadwaladrUniversity Local Health Board (East). Accessed via on 11/8/14.
- Wright D. Tablet crushing is a widespread practice but it is not safe and may not be legal. Pharm J 2002;269:132.
- Colquhoun A. The legal and ethical issues of tablet crushing. In:Special measures – time for a healthy debate on specials procurement. Pharm J 2010;285;481-486.
- White R, Bradnam V. Handbook of Drug Administration via Enteral Feeding Tubes. Accessed via on 6/10/14.
- Joint Formulary Committee. British National Formulary. London:BMJ Group and Pharmaceutical Press; 2014. Electronic edition. Accessed via 6/10/14.
- Baxter K, Preston CL,editors. Stockley’s Drug Interactions: A source book of interactions, their mechanisms, clinical importance and management. Electronic edition. London: Pharmaceutical Press. Accessed via on 11/8/14.
- Brennan K. What are the therapeutic options for patients unable to take solid oral dosage forms? Medicines Q&A 294. Accessed via 13/10/14.
Quality Assurance
Prepared by
Alex Weston, Senior Medicines Information Pharmacist, Wessex Drug and Medicines Information Centre, UniversityHospitalSouthampton NHS Foundation Trust
Date Prepared
20th August 2014
Checked by
Kate Pickett, Lead Pharmacist - Formulary and Medicines Q&As, Wessex Drug and Medicines Information Centre, UniversityHospitalSouthampton NHS Foundation Trust.
Date of check
24th November 2014
Search strategy
- Embase accessed via NICE EvidenceSearch on 20/8/14:
Search History:
1. EMBASE; covert.ti,ab
2. EMBASE; 1 [Limit to: Human and English Language and Publication Year 2010-Current]
- In house database
- Nursing and Midwifery Council (NMC) website: search “covert”
- Royal College of Psychiatrists website search “covert”
- Medicines and Healthcare Products Regulatory Agency (MHRA) website
- Care homes pharmacist (for 2010 version)
- Medicines Q&As. Accessed via
- Taylor D, Paton C, Kapur S. The Maudsley Prescribing Guidelines. 11th edition. London: Informa Healthcare; 2012.
- NICE website. Accessed via
- Personal communication with the British Medical Association
1
Available throughNICE Evidence Search at