Use of medicines beyond their licence

Generally, most medicines used in the UK are approved for use by the government’s Medicines and Healthcare products Regulatory Agency (MHRA). This helps to ensure that medicines
• Are safe and effective
• Do not cause too many side effects
• Are manufactured appropriately
These medicines are called ‘Licensed Medicines’. Without such approval, manufacturers are unable to advertise and promote their medicines.
The licence specifies the conditions and patient groups for which the medicines should be used, and how it should be given.

Why are medicines sometimes used beyond their licence?
In palliative care, medicines are commonly used for conditions or in ways that are not specified on the licence. Your doctor will use medicines off licence only when there is experience and/or research to back up such use.
When medicine is used for a particular condition or given in a form/dose that is not specified by its current licence it is said that the medicine is used off licence or beyond its licence.
An example of this is the common use of antidepressants and antiepileptic medicines to help relieve certain types of pain.
Often instead of injecting drugs into your vein or muscles, medicines can be given under the skin (subcutaneously) e.g. in a syringe driver because this is more comfortable and convenient for the patient.

Patient information leaflets
Patient information leaflets supplied with your medicines will only reflect the licenced use of the drug. When medicine is used beyond its licence, the leaflet may not be relevant to your circumstances. Although this can be confusing, it is common practice for your doctor to prescribe medicines in this way.
When medicine is unlicensed (used beyond its licence) the information in the patient information leaflet may not be relevant to your circumstances.

Further information and advice
If you have concerns about any medicine, licensed or unlicensed, or you require further information and advice, please speak to your Doctor or Nurse responsible for your care.
Reference: Palliative Care Formulary 5th Edition Robert Twycross, Andrew Wilcock, Paul Howard (2014)