Meeting the CBPM specials ordering requirements is particularly stringent, but the process follows much of the established guidance for any special order medicine.

The MHRA emphasises: “An unlicensed medicinal product may only be supplied in order to meet the special needs of an individual patient.” Considerations about special need should be around clinical need, and not about cost, convenience or operational needs.7

The main examples it gives of “special needs” include an intolerance or allergy to a particular ingredient, or an inability to ingest solid oral dosage forms.

In addition: “An unlicensed medicinal product should not be supplied where an equivalent licensed medicinal product can meet the special needs of the patient.”

The MHRA does not recommend ‘off-label’ use of licensed medicines but says that “if a UK-licensed product can meet the clinical need, even off-label, it should be used instead of an unlicensed product.” It adds: “If the UK product cannot meet the special need, then another (imported) medicinal product should be considered, which is licensed in the country of origin.”

It is only when a licensed product is not available or becomes unavailable that the MHRA recognises that an unlicensed equivalent may be necessary.

The Royal Pharmaceutical Society suggests a number of reasons for why a special might be appropriate. Core groups include:8

·       children where a liquid preparation may be required for a lower dose, or to achieve the optimal form for administration

·       dermatology

·       ophthalmology

·       Patient factors such as being able to administer a medicine via an enteral feeding tube, or where a patient has trouble with swallowing.

The British Association of Dermatologists updated its guidance in 2018 on specials recommended for skin disease. This revised the list of 40 BAD preferred specials in the 2014 guidelines, to recognise market authorisations being granted for certain formulations.9

The Royal College of Ophthalmologists and the UK Ophthalmic Pharmacy Group updated their Ophthalmic Specials Guidance document in 2016 to reflect changes to the products list. The College also produced guidance on prescribing unlicensed medicines in 2018.10