Special unlicensed medicines: what we do and do not know about them

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Abstract
The MHRA recommends that unlicensed medicines should only be used when existing licensed medicinal products are not appropriate to meet patient needs2 and this is also echoed in guidance from the General Medical Council.3 An example of this situation often arises in paediatric medicine due to smaller or unusual doses being required, which cannot normally be administered using standard solid oral dosage forms. Other examples include patients with difficulty swallowing solid oral dosage forms and patients needing to receive medicines through enteral feeding tubes. Medicines that have received marketing authorisations in countries other than the UK are another example of unlicensed medicines that may be employed where licensed preparations have been unsuccessful or unsuitable.4 Midodrine tablets for example, which are licensed in the US but not in the UK, may be used for the treatment of orthostatic hypotension where treatment with fludrocortisone has been unsuccessful, or use of a steroid is unsuitable for the patient. There is also significant prescribing of products classed as ‘food supplements’ that do not hold a marketing authorisation.5

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