Minimising risk

When prescribing unlicensed medicines, healthcare professionals may have several alternative approaches available to them. They should choose the option that 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.

Figure 4. Hierarchy of risk on basis of product origin (adapted from MHRA guidance)

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.