Glossary

Association of Pharmaceutical Specials Manufacturers (APSM):

is a not-for-profit trade association established to represent the interests of its members who supply Specials and unlicensed medicines in the UK.

Active Pharmaceutical Ingredient (API):

is the biologically active part in a pharmaceutical drug.

Dose:

is the quantity of medicine taken or recommended to be taken at a particular time.

Drug Tariff:

is a monthly UK publication which refers to the payment and repayment of NHS prescription costs in the UK.

Dysphagia:

is the difficulty or discomfort in swallowing.

Excipient:

is an inactive substance used as a medium alongside the active pharmaceutical ingredient in a drug.

Extemporaneous preparation:

Extemporaneous preparation refers to the process of preparing unlicensed medicines to fulfil a prescription in a registered pharmacy by a pharmacist, rather than by a Specials manufacturer.

Licensed medicine:

is a medical product prescribed by doctors to patients, which holds an MHRA (Medicines and Healthcare products Regulatory Agency) approved marketing authorisation.

MHRA:

The Medicines and Healthcare products Regulatory Agency (MHRA) are in control of the issue of a marketing authorisation. The MHRA are a government controlled organisation founded in 2003 and are responsible for making sure that medicine and medical devices work effectively and are safe to all users.

Nasogastric tube (NGT):

is a flexible rubber tube which is passed through the nose down to the stomach.

Net Ingredient Cost (NIC):

is the basic price of the drug either listed in the Drug Tariff or price list. This cost of the drug does not include any dispensing costs, fees or discount.

Off-Label use:

This term refers to a prescription for medication that will be used to treat an ailment that the particular medication does not have the marketing authorisation for.

Quality Assurance:

the maintenance of a desired level of quality in a service or product, especially by means of attention to every stage of the process of delivery or production.

Unlicensed medicines:

are only available by prescription and is known in the industry as a ‘Special’. They are specially formulated for a patient’s specific needs and this is why they remain unlicensed; there is no commercial interest for the medicine to be mass produced. 

Specials:

A Special is an unlicensed medicine prescribed to meet the individual clinical need of a patient when a suitable licensed medicine is not available.

Specials Manufacturer:

Where Specials are manufactured.

Specials Manufacturer's Licence:

is a license granted by the MHRA to manufacture Specials to companies.

Specials Tariff:

Part VIIIB of the Drug Tariff (the ‘Specials Tariff’) is a tariff of unlicensed Specials and imports, with set reimbursement prices.

The General Medical Council (GMC):

are an independent regulation authority for doctors in the UK that were founded under the Medical Act of 1858.

Yellow card scheme:

is a system used in the UK to allow the safety of medicines and vaccines that are on the market to be monitored. Anyone can report information on suspected adverse drug reactions (ADRs).