The Specials sector can be a complex one to navigate and a key aim of the APSM is to provide advice and support to healthcare professionals throughout the prescribing and dispensing process.
The decision to prescribe a Special rests with the clinician and they take responsibility for the overall safety of the patient. They can prescribe an unlicensed medicine in the knowledge that it will be reimbursed, however, this is as long as there is no licensed alternative available.
The pharmacist is under an obligation to fulfill a prescription for any Special that is handed to them, but they may question a formulation or the availability of a licensed alternative.
A Specials manufacturer has expert customer services teams available to provide advice and guidance about any aspect of a Specials prescription and this resource is widely used by pharmacists. A list of customer services contacts for all APSM members can be found in our members section.
As an organisation, the APSM works closely with professional and government organisations to develop standardised guidelines and practices. For example, the APSM has recently worked with the Royal Pharmaceutical Society (RPS) to provide Specials guidance for pharmacists.
Below are links to some of the Specials Guidance documents and policies available to healthcare professionals:
The GMC are an independent regulation authority for doctors in the UK that were founded under the Medical Act of 1858. Their primary function is to ensure that high standards of practise are maintained in the medical profession. They control the UK’s medical register, so all practising doctors in the UK must be registered with the GMC. They are important for many reasons, but they are important for the Specials industry as they have produced a list of guidelines for both doctors that should be adhered to when dealing with Specials. Please click on the link below to view a highlight of these guidelines.
The General Medical Council (GMC) recommends the prescribing of unlicensed medicines as a last resort, i.e. only when an appropriate licensed medicine is unavailable for that individual's specific needs. They have generated guidance for both the prescribing doctors and the pharmacists that supply the Specials. Below are the guidelines that have been highlighted by the October 2010 issue of the 'Drug and Therapeutics Bulletin' (volume 48, p.112).
"The prescribing doctor must" :
- Be satisfied an alternative, licensed medicine would not meet the patient's needs;
- Be satisfied that there is a sufficient evidence base and/or experience of using the medicine to demonstrate its safety and efficacy;
- Take responsibility for prescribing the unlicensed medicine and for overseeing the patient's care, including monitoring and any follow-up treatment;
- Record in the patient's notes both the medicine prescribed and, where its use means not following common practice, the reasons for choosing it.
The GMC also states that doctors must 'explain the reasons for prescribing a medicine that is unlicensed or being used outside the scope of its license where there is little research or other evidence of current practice to support its use, or the use of the medicine is innovative.'
In supplying a Special, pharmacists must take all reasonable steps to ensure the following criteria are met:
- Procurement is from an appropriate source;
- The product is of an appropriate quality;
- The product meets the particular clinical needs of the patient;
- Relevant records are kept for at least five years. These should include details of the purchase/supply and the product specification agreed with the supplier; documentation verifying the specifications including batch number and expiry details; dates and the quantities sold or supplied; and patient details."
For more information about the GMC and the guidelines for prescribing specials, please see the link: