Minimising risk

When prescribing unlicensed medicines, healthcare professionals may have several alternative approaches available to them. They should choose the option which minimises the risk to the patient, bearing in mind the patient’s clinical need.

Although the MHRA does not recommend ‘off label’ use of products, they advise that if a UK licensed product can meet a patient’s clinical need, even ‘off-label’, it should be used in preference to an unlicensed product; their rationale being that licensed products available in the UK have been formally assessed for quality, safety and efficacy. Whilst some of this assessment may not apply when a licensed medicine is used ‘off-label’, much will still be valid. This is recommended as a better risk position than the use of an un-assessed, unlicensed product.

In those cases where it is essential to supply an unlicensed medicine, the Royal Pharmaceutical Society advises that the following options are considered when assessing the risk associated with the medicine’s supply⁶²:

• Importation of a product licensed in Europe, USA, Canada, Australia or in another MHRA recognised authority
• Purchase of a ‘Special’ from an external manufacturer with a Manufacturer’s ‘Specials’ Licence (consideration being given to batch manufacture compared to a bespoke, one-off order)
• Prescription and supply of an alternative licensed presentation such as a soluble or dispersible formulation, transdermal patch or suppository
• Extemporaneously dispensing in the pharmacy – this would include crushing of tablets if appropriate information is available.

If a UK licensed medicine cannot meet the patient’s need, then another (imported) medicinal product should be considered, which is licensed in the country of origin. Care should be taken to ensure that the regulatory standards of the country of origin are comparable to those of the UK and that the medicine is both licensed and available for use in that country, rather than manufactured exclusively for export. For further considerations see imported products.

If ‘off-label’ use or importation is not viable, then an unlicensed product may have to be used, for example, a UK manufactured ‘Special’. Whilst not subject to the same regulatory safeguards as licensed medicines, any medicine made under a manufacturing ‘Specials’ licence will have been made in accordance with the principles of good manufacturing practice (GMP).

The least acceptable option is the use of products that are unlicensed in the country of origin, and which are not classed as medicines in the country of origin (but are in the UK). Hence, for example, the use of melatonin products from the USA, where melatonin products are classed as supplements, not pharmaceuticals. As a result, they may not be made to expected standards of pharmaceutical GMP and should be avoided whenever possible.

Guide to product options when not supplying a licensed medicine ⁹⁷

To be used to aid decision making and for risk assessment only. Prescribing and supply decisions must be driven by individual patient need.

Note: the Royal Pharmaceutical Society has deleted crushing tablets and opening capsules from the hierarchy of risk which now relates only to the choice of medicinal product. The Society has since clarified that there may be some circumstances where crushing is clearly the preferred option such as when a stable oral liquid product can’t be formulated or made available when required, or if the patient finds an oral liquid unacceptable.