BEST PRACTICE – USING UNLICENSED SPECIALS
IN THE RIGHT PATIENTS
The Specials sector is well regulated and guidelines for prescribers and dispensers demand careful
evaluation of patient need, identification of the lowest risk solution and ongoing monitoring.
• There are important caveats around the use of Specials5,6,7,8.
• Specials have no Summary of Product Characteristics (SmPC) outlining the dose, contra-indications, storage
and side-effect profile. This is because they have not been assessed by the MHRA in the same way as licensed
medicines.
• There is an appropriate position in the patient pathway to prescribe Specials, when a licensed product is not
available8 or the patient has difficulty in swallowing oral solid dosage forms such as tablets and capsules9.
Prescribers must work with the patient and their carers to address their clinical needs.
• Each patient’s circumstances will differ and practitioners must consider the potential risks, safety and liabilities
associated with both off-label dosage and with use of unlicensed Specials.
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• Specials can be obtained from a range of sources by pharmacists and it is critical that good manufacturing
practice has been followed and adhered to. To manufacture Specials in the UK, an MHRA manufacturer’s
Specials licence’ (MS) is required by law. However there has been no formal evaluation of efficacy or safety8.
• The Royal Pharmaceutical Society (RPS) has produced a risk hierarchy to help pharmacists assess the likely
benefits and risks – see figure 1 below. UK-licensed medicines carry the least risk whilst a non-UK-made
unlicense