Introduction
The supply of unlicensed medicinal treatment is a regular occurrence for pharmacists and their teams. Whether it is an unlicensed medicine, off-licence use of a medicine, or an unlicensed indication, the legal, ethical and commercial issues associated with that supply are wideranging and varied. This module will provide an overview of the relevant issues with a focus on those directly impacting pharmacy; namely procurement, supply and remuneration.
An unlicensed medicine is one that is specially manufactured to meet a patient's clinical need where there is currently no licensed preparation available. This is known as a Special Order product or simply a 'Special'. Historically, Specials were manufactured extemporaneously in the pharmacy under an exemption to the manufacturing process known as the 'section 10 exemption'. It became increasingly common for pharmacists to outsource production of these medicines to a Specials manufacturer. This followed industry-wide concerns over the quality control and safety of extemporaneous dispensing, particularly in the wake of high-profile patient safety incidents such as the peppermint water case9.
In 2010, a review of the Prescription Costs Analysis reports for England showed that the cost of procuring Specials had increased from £57M to £160.5M over the course of four years.1
Concerns over the wide variability, as well as the general increasing trend in costs led the Department of Health to introduce a set tariff in England and Wales for the most widely prescribed Specials. The intention was to standardise costs across the NHS and make the remuneration process more transparent. Since its introduction medicines have been regularly added to the tariff and it now lists over 250 special products.2 Over the same time period the average cost per item for Specials has fallen by 33% from £180 to £121.3
Scotland has since followed suit by introducing its own Specials Tariff in February 2013. In Northern Ireland there is no set tariff (as yet) and the cost of Specials remain subject to purely market forces. Whilst there are differences across the UK on how pharmacies are reimbursed for Specials, the fundamental principles of supplying unlicensed medicines remain the same and will now be explored further.
OBJECTIVES
By the end of this module you will be able to:
- Describe licensed and unlicensed use of a medicine.
- Identify and advise on practical difficulties for patients and carers.
- Define a Special, a Special Import and a Special Obtain.
- List the benefits, in terms of product quality, of using a Specials manufacturer.
- Advise prescribers on choosing suitable treatment options.
- Accurately endorse a prescription for a Special and associated reimbursement.