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Use of medicines without a marketing authorisation

Prescribers should usually prescribe licensed medicines in accordance with the terms of their licence. However, unlicensed /off label medicines may be prescribed where, on the basis of an assessment of the individual patient it is concluded, for medical reasons, that it is necessary to do so to meet the specific needs of the patient. In these circumstances prescribing would usually be in accordance with the practice of a reasonable/responsible group of peers and have an evidence base. Requests for prescribing unlicensed medicines should be made on a non-formulary medicine request form unless exceptions have been agreed e.g. when a licensed preparation is temporarily unavailable and an unlicensed alternative is being sourced.

Please refer to HPFT medicines policy for use of unlicensed medicinal products and medicinal products used outside their terms of license. Where possible, service users should be informed of unlicensed or off-label use of medicines and a record of consent made in their care record. The rationale for selecting this treatment must also be documented.

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