Prescribing issues
On and off label prescribing
The Medicines and Healthcare products Regulatory Agency (MHRA) permits the manufacturer and/or distributor of a medicine to market and promote a product within the terms of a Marketing Authorisation (MA).
This is based on the quality, safety and efficacy of the product. A doctor’s prescribing is not limited to indications covered by the MA and you can prescribe any medicine that you judge to be in the best interests of your patient. You may be asked to justify your choice of treatment.
Any prescription that is not within the strict terms of the MA is termed “off-label” prescribing. This covers products that have an MA for other indications, or no MA at all, eg, many drugs prescribed for children are given “off-label”.
If you prescribe “off-label”, whilst the manufacturer retains strict product liability, ie, that the product is “fit for purpose”, you are responsible for both negligent and non-negligent harm to the patient. Before prescribing “off-label”, you should:
- Ensure you are prescribing the most suitable drug for your patient, and that there is no reasonable alternative that has marketing authorisation.
- Satisfy yourself that there is a sufficient evidence base or experience of using the medicine to demonstrate its safety and efficacy.
- Understand the known attributes of the drug and your responsibility for monitoring and follow up.
- Record your decision in the patient’s notes.
In addition, patients may request a continuation of treatment that has been suggested or initially prescribed abroad, which are either not licensed in the UK, or are licensed for different purposes, eg, a drug licensed as an anticonvulsant in the UK but used, at a high level, as an antidepressant in the US. A GP would be able to prescribe off licence, if he or she wished, but would need to stay within his or her knowledge and understanding of the drug and its effects and side effects. The GMC’s Good Practice in Prescribing Medicines (2008) also states: “You should be satisfied that an alternative, licensed medicine would not meet the patient’s needs.”