Use Of Unlicensed Medicines

Where possible, it is best practice always to use medications that are licensed in the United Kingdom. However, this is not always possible. For example, procaine benzylpenicillin is an antibiotic used as first-line treatment for syphilis in the UK, but is unlicensed and thus needs to be imported from abroad. The

Medicines and Healthcare products Regulatory Agency (MHRA) are responsible for regulating medical products for human use, and they have produced guidance on the usage of unlicensed medications. There are a number of points to consider.

Unlicensed medications need to be ordered on an individual 'named patient' basis. Drugs can be 'named patient' for a number of reasons, for example discontinuation of previously licensed medications or temporary supply problems with UK-licensed versions of a drug, or drugs that are not yet licensed within the UK. The patient should be informed that the medication is unlicensed, without causing undue alarm. It is a legal requirement to maintain records with patient details, prescribing physician, supplier and manufacturer of the product and batch and expiry date of the product. These records need to be held for at least two years.

Any adverse reactions to named-patient drugs can still be reported to the Committee on the Safety of Medicines (CSM) using the yellow-card reporting scheme.

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