The Specials Industry

The Specials Industry

Shared roles and responsibilities

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 fulfil 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:

Regulation - Manufacture

Companies producing Specials must operate a clean manufacturing facility which has been licensed and regulated by The UK Medicines and Healthcare products Regulatory Agency - the same government organisation that regulates the manufacture and sale of all medicines in the UK. Companies must hold a 'Specials Manufacturer's Licence', which is issued by the MHRA under Section 5 of the Medicines Act, which is further explained in Guidance Note 14. This covers all aspects of manufacture and quality processes and companies are regularly inspected to ensure compliance with a comprehensive set of standards and requirements.

For further information about the manufacture and supply of Specials for individual patients and the importation/export of unlicensed medicines, please contact the Policy Unit, Inspection, Enforcement and Standards Division, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ, telephone 020 3080 6131/6573/6595, email info@mhra.gsi.gov.uk

http://www.mhra.gov.uk/Howweregulate/Medicines/Doesmyproductneedalicence/Medicinesthatdonotneedalicence/index.htm

Although wholesale companies can re-sell Specials, only a small number of companies in the UK hold a licence to manufacture. Most of these companies are members of the APSM, Association of Pharmaceutical Specials Manufacturers.

One of the key aspects of Specials manufacture is that we cannot promote the drugs and medicines we manufacture or give any unsolicited information about our Specials. However, companies can publish price lists.

In addition, APSM members sign up to a code of conduct which sets best practice standards for staff training, pharmacy advice and help lines, clear patient information and product labelling to support compliance.

For more information regarding licence activity, please click on the link below.

http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Manufacturersandwholesaledealerslicences/index.htm#2

The responsibility for patient safety for a Special rests with the prescribing clinician. So any side effects or adverse reactions are the responsibility of the doctor. However, prescribing doctors are very experienced and knowledgeable in the use of Specials for types of patients and illness so the risks to patients are minimal.

Many Specials manufacturers voluntarily subscribe to good practice such as adverse event reporting, via the MHRA's yellow card scheme. This is where manufacturers, healthcare professionals and the general public can report on any side effects that they encounter with use of medicines.

For more information about the Yellow Card Scheme, please follow the link below

http://www.mhra.gov.uk/Safetyinformation/Howwemonitorthesafetyofproducts/Medicines/TheYellowCardScheme/index.htm

Quality