An occasional feature, prepared in the Royal Pharmaceutical Society’s Professional Standards Directorate, to highlight problems and inquiries currently being handled
The Medicines Control Agency has issued guidance (PJ, May 6,
p684) on the use of “specials” — products made up by a licensed
manufacturer for treatment of individual patients, on the order of a doctor
or dentist. The guidance suggests that specials should be used only where there
is no suitable licensed product available.
As the request for a special can be made only by a doctor or dentist, pharmacists
are under no legal obligation to establish that there is a need for a special
or that licensed products available are not suitable. However, the pharmacist
should alert the prescriber to the unlicensed status, preferably before the
product is ordered, and in any event before the product is administered.
The MCA, as licensing authority, has stated that a pharmacist, when supplying
a special, should keep for a period of five years a record of: the source; the
person to whom the product was supplied; the date of supply; the quantity supplied;
the batch number; details of any adverse reactions to the product of which the
pharmacist is aware. These records should be available on request for inspection.
Pharmacists who supply specials should report any suspected serious adverse
drug reactions to the MCA via the yellow card scheme (copies of the
report form are in the British National Formulary, Mims and the ABPI Compendium
of Data Sheets and Summaries of Product Characteristics). The report should
state the name of the manufacturer and indicate that the product is unlicensed.
The guidance notes (MCA Guidance Notes No 14) can be obtained from the Information
Centre, Medicines Control Agency, Market Towers, 1 Nine Elms Lane, London SW8
5NQ (tel 020 7273 0352).