Section B Medication Facts and National Guidance

Medication licensing

In the UK, medicines must be licenced for use and it is recommended that where possible medication is used for the specific medical condition it has been licensed for. Licenced medications must meet a set of standards including that they work for the purpose they are intended for, state what dose should be taken, and include warnings about safety issues. This information is usually included in the patient information leaflet that you receive with a medication. Licencing makes sure that the public do not take unsafe medications or those that are not effective.

However, doctors can prescribe a licenced medication ‘off-label’. This means that medication can be prescribed for something that was not its original purpose. For example, many psychotropic medications are licensed to treat conditions such as schizophrenia, bipolar disorder or depression but may be prescribed off-label for challenging behaviour. If this is the case, the prescriber must follow clear guidance to ensure this unlicensed use is fully discussed with the person, their carers and support provider, and is clearly documented in the clinical record.

You can find information about licensing, including possible side effects and which conditions a medication is designed to treat through the Medicines & Healthcare products Regulatory Agency.