Polypharmacy prescribing guidance - draft: consultation

21. Appendix I: Unlicensed, and off-label use, medicines (when a medicine is used for a condition outside its Marketing Authorisation)

This guidance contains advice on a range of common medicines regularly used in day-to-day practice. It includes medicines used outwith the terms of their licence, where evidence suggests it may be appropriate in individual circumstances.

The terminology here can be confusing. Very few medications should be used if unlicensed for any indication, apart from in very exceptional circumstances. More common is the situation where a medicine is licensed for one indication or age group but used for another indication or group. This can be referred to as ‘off-label prescribing’.

Healthcare professionals need to be aware of their responsibilities in these situations, both in terms of prescribing and in communication to individuals. These responsibilities are outlined by the Medicines and Healthcare products Regulatory Agency.

The advice states that prescribers should:

• be satisfied that an alternative, licensed medicine would not meet the individual’s needs before prescribing an unlicensed medicine
• be satisfied that such use would better serve the individual’s needs than an appropriately licensed alternative before prescribing a medicine off-label
• before prescribing an unlicensed medicine or using a medicine off-label you should:

• be satisfied that there is a sufficient evidence base and/or experience of using the medicine to show its safety and efficacy
• take responsibility for prescribing the medicine and for overseeing the individual’s care, including monitoring and follow-up
• record the medicine prescribed with clear clinical indication and rationale

• record that you have discussed the issue with the individual

Best practice for communication includes:

• patients, or those authorising treatment on their behalf, should be given sufficient information about the proposed treatment, including known serious or common adverse reactions, to enable them to make an informed decision
• where current practice supports the use of a medicine outside the terms of its licence, it may not be necessary to draw attention to the licence when seeking consent. However, it is good practice to give as much information as patients or carers require or which they may see as relevant
• explaining the reasons for prescribing a medicine off-label or prescribing an unlicensed medicine where there is little evidence to support its use, or where the use of a medicine is innovative

Healthcare professionals have a responsibility to help monitor the safety of medicines in clinical use through submission of suspected adverse drug reactions to the MHRA and CHM via the Yellow Card Scheme. Such reporting is equally important for unlicensed medicines or those used off-label as for those that are licensed.