Off-label and off-licence prescribing
Posted by: TheEditor | on May 3, 2023
- 1 Off-label prescribing:
- 2 Off-licence prescribing:
- 3 ‘Unlicenced prescribing’
- 4 SPC
- 5 Relevance of approval of medications
- 6 Symptomatic treatment
- 7 Capacity/Consent
- 8 Relevance to prescribing in psychiatry
- 9 Conclusion
- 10 Supplemental References
In the UK, the terms “off-label” and “off-licence” prescribing are often used interchangeably, but they refer to slightly different concepts. The General Medical Council uses the term ‘unlicenced prescribing’. The terms describe situations where a medication is prescribed in a manner that is not explicitly approved by the regulatory authorities. However, the specific circumstances for each term are as follows:
This occurs when a medication is prescribed for a purpose, dosage, or patient group that is not included in the approved product label or Summary of Product Characteristics (SPC). The SPC is the official document that provides information about the approved uses, doses, and safety precautions for a medication. Off-label prescribing is based on the prescriber’s professional judgment and is often supported by clinical evidence, despite not being officially approved for that particular use.
The Mental Health Services Group (2021) in Scotland has given sound guidance on the matter. They correctly point out five domains where off-label prescribing can happen (and I quote):
1. Demographic: The age of the patient may lie outwith the recommended range e.g. the use of sertraline for depression in a 16 year old.
2. Disorder: Prescribing for a condition which is outwith the marketing authorisation e.g. the use of hyoscine hydrobromide for clozapine-related hypersalivation.
3. Dosage: Prescribing at a dose that is higher than recommended e.g. olanzapine prescribed at 30mg daily.
4. Duration: Prescribing for a longer period of time than is recommended e.g. a benzodiazepine prescribed for longer than 4 weeks.
5. Domain: Where a drug is licensed for a particular indication in one country and not another e.g. in some EU member states, valproate salts have a licence for prevention of migraine.
They make one significant error in quoting CR210 when they state, “There is no legal requirement to disclose the off-label use of a drug to a patient but such disclosure is advocated strongly.” The error arises because CR210 quotes Frank (2008) Sadly all authors are wrong, because the law says they are wrong. How? I could easily veer off into what a ‘legal requirement’ means, but I’ll keep it simple and tight. In the context of prescribing, the legal requirements based on duties of care, arise from several UK Statute and reams of case law. There are serious legal consequences for not disclosing to a patient the licensed use of medications prescribed (save minor exceptions in mental health law, and rare exceptions in emergency care). Therefore any doctor who cannot find a valid legal exception for non-disclosure of off-label (or unlicenced) prescribing to patients, is courting dire legal consequences.
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This term refers to the prescription of a medication that is not licensed for any use in the UK. This might occur if a medication has been licensed in another country but not in the UK, or if a medication has been withdrawn from the market for reasons unrelated to safety or efficacy. In these cases, the prescribing clinician must take full responsibility for the decision to use the medication, as it is not supported by a UK marketing authorization.
Despite the differences between off-label and off-licence prescribing, both practices can be legal and clinically justified in certain circumstances. Healthcare professionals must weigh the potential benefits and risks for individual patients and base their decisions on available evidence and professional judgment.
Off-licence prescribing is not typically defined by a single authoritative body, as it is a term used to describe a practice that arises in certain clinical situations. However, various organizations and governmental bodies provide guidance and recommendations related to off-licence prescribing. In the UK, the General Medical Council (GMC), the Medicines and Healthcare products Regulatory Agency (MHRA), and the National Institute for Health and Care Excellence (NICE) all offer guidance on prescribing, which includes discussions of off-licence and off-label prescribing.
The General Medical Council (GMC) at para 103 of Good Prescribing Guidance, considers the term to “[..]describe medicines, which are used outside the terms of their UK licence or that have no licence for use in the UK.” In other words, the GMC has fused the concepts of off-label and off-licence on grounds of the duties of care involved.
The Royal College of Psychiatrists issued guidance in CR210 (2017) on the use of unlicenced medications. This will not be summarised here. It needs to be read by, and implemented by all psychiatrists.
Very informative is the Mental Health Services Prescribing Management Group (Glasgow)  https://bit.ly/MHS-PMG-guidance.
[Note that the GMC has merged off-label and off-licence prescribing into ‘unlicenced prescribing’.]
- Off-label prescribing occurs when medication use falls outside the scope of the marketing authorisation with respect to one of five key domains:
- Demographic: The age of the patient may lie outwith the recommended range e.g. the use of sertraline for depression in a 16 year old.
- Disorder: Prescribing for a condition which is outwith the marketing authorisation e.g. the use of hyoscine hydrobromide for clozapine-related hypersalivation.
- Dosage: Prescribing at a dose that is higher than recommended e.g. olanzapine prescribed at 30mg daily.
- Duration: Prescribing for a longer period of time than is recommended e.g. a benzodiazepine prescribed for longer than 4 weeks.
- Domain. Where a drug is licensed for a particular indication in one country and not another e.g. in some EU member states, valproate salts have a licence for prevention of migraine.
- Prescribers must now ensure that patients (or their carers if the patient lacks legal capacity) are aware of any ‘material risks’ involved in a proposed treatment, and of reasonable alternatives, following the judgment in the Montgomery case (Montgomery v Lanarkshire Health Board 2015). ‘The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.’ (page 4)
- Robust record-keeping and documentation is fundamental to all prescribing practice. When commencing new treatments, patients should be provided with sufficient information to allow them to make an informed decision.
- Remember to RECoRD……
- Remember to RECoRD……
Choice and medication (NHS leaflet) https://bit.ly/factsheet-ul-medication
“The responsibility that falls on healthcare professionals when prescribing an unlicensed medicine or a medicine off-label may be greater than when prescribing a licensed medicine within the terms of its licence. Prescribers should pay particular attention to the risks associated with using unlicensed medicines or using a licensed medicine off-label. These risks may include: adverse reactions; product quality; or discrepant product information or labelling (eg, absence of information for some unlicensed medicines, information in a foreign language for unlicensed imports, and potential confusion for patients or carers when the Patient Information Leaflet is inconsistent with a medicine’s off-label use).”
While the BNF is an excellent resource for healthcare professionals, it does not contain the complete Summary of Product Characteristics (SPC) for each medication. The BNF is designed to provide a more concise overview of key information, while the SPC offers comprehensive information on a medication, as it is prepared by the pharmaceutical company and approved by the regulatory authorities.
To access the full SPC for a medication, you can visit the website of the European Medicines Agency (EMA) or the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Additionally, the Electronic Medicines Compendium (eMC) is a useful online resource that provides access to the SPCs for thousands of medicines approved for use in the UK. The eMC is available at https://www.medicines.org.uk/emc/.