From Mr J. Kneale
SIR,—In recent months, there have been indications in the columns of
The Pharmaceutical Journal and elsewhere that there is some uncertainty in the
profession about the records that need to be kept when pharmacists dispense
unlicensed medicines manufactured or imported for supply in response to the
order of a doctor or dentist for administration to an individual patient. These
products are widely known as “specials”. It may be helpful to set
out the relevant legal provisions, and the Medicines Control Agency’s guidance
note 14 on the implications they have for pharmacists. Contrary to what Mr Fenton-May
is reported as suggesting earlier (PJ, July 8, p65), this guidance is addressed
to all involved in the supply of “specials”, not only those who manufacture
them.
Paragraph 6 of Schedule 1 to the Medicines for Human Use (Marketing Authorisations
Etc) Regulations 1994 requires “any person” who supplies a “special”
to keep records showing, among other things, the source, quantity, and batch
number of the product, when and to whom the supply took place, and details of
any suspected adverse reaction. “Any person” will include a pharmacist
who dispenses or otherwise supplies a “special”.
Why are these records required? Simply, there is a need for effective pharmacovigilance
and the protection of public health. “Specials” are unlicensed medicinal
products, and an effective audit trail is required to ensure that if one should
present a risk to patients, it can be identified quickly and with certainty.
It may be that the records that a pharmacist keeps for other categories of medicines
also meet the requirements for “specials”, but that is for the pharmacist
to judge.
I hope this is helpful.
John Kneale
Head of Policy Unit,
Inspection and Enforcement Division,
Medicines Control Agency
See Law and Ethics Bulletin (p513).-EDITOR.