Choosing a suitable product
The RPS Professional Guidance for the Procurement and Supply of Specials (2015) advocates a stepwise approach to choosing a suitable product5:
Step 1:
Use a licensed medicine in a suitable formulation wherever possible. Consider switching to a different therapeutic agent or a different route of administration if necessary.
Step 2:
Consider using a licensed medicine in an unlicensed manner e.g. crushing tablets. Not all medicines can be used in this manner and it is important to consider the patient's ability to administer in this way.
Step 3:
Consider using a special order product where the patient's needs cannot be met by the use of a licensed medicine.
This guidance, issued in December 2015 implies that off-licence use of a medicine is preferable to the use of a manufactured Special.
The RPS guidance proposes a hierarchy of risk on the basis of product origin:
*Countries with an equivalent regulatory framework are European Economic Area countries, and countries with mutual recognition agreements. Medicines licensed in other countries may not be subject to safeguards equivalent to GMP.
This guide should be used as an aid to decision making and for risk assessment only. In all cases the decision to prescribe and supply a Special must be driven by individual patient need.
Pharmacists should make it clear to patients and prescribers that there are risks inherent both in using a Special and in off-licence use of a medicine. The net risk will depend on the exact nature of the treatment option. Pharmacists should use their professional judgement when making a recommendation and reach a decision in the best interests of each patient with a view to optimising treatment and minimising harm.