Minimising the risk of transmissible spongiform encephalopathy
(TSE)
The Unlicensed Medicinal Products for Human Use (Transmissible Spongiform
Encephalopathies) (Safety) Regulations 2003, which came into force on
30 July 2003, regulate
the import and marketing of unlicensed medicinal products for human use to
minimise the risk posed by transmissible spongiform encephalopathies.
Unlicensed medicinal products must be manufactured in accordance with the TSE
guidelines, for which the Medicines and Healthcare products Regulatory Agency
is the enforcement authority.
Some medicines are excluded from these Regulations, and the main products that
apply to pharmacists are those manufactured under Section 10 of the Medicines
Act 1968. The exemption from licensing under this section includes the preparation
and dispensing, by or under the supervision of a pharmacist, of products in response
to patient symptoms, or in accordance with a prescription, or extemporaneous
products and “nostrums”.
Although medicines manufactured by pharmacists under the Section 10 exemption
are exempt from the TSE Regulations, pharmacists have a professional requirement
to comply. The Society’s inspectors will monitor pharmacies to ensure that
standards are met.
Particular areas of risk in the supply of these unlicensed products include the
use of products that have been directly imported into the pharmacy, the use of
uncontrolled starting materials obtained from wholesalers, the use of capsule
shells or other materials that have been in the pharmacy for some time, and the
use of raw materials labelled as “not for medicinal use”.
Pharmacists need to ensure that steps are taken to reduce the risk of TSE in
starting materials. This may include obtaining all starting materials from approved
manufacturers and suppliers. The MHRA has stated that where conventional starting
materials are used the actual manufacturer needs to be identified rather than
the supplier. The pharmacist needs to be satisfied that the manufacturer has
continued to manage the risk of TSE transmission, and has obtained a certificate
of approval from the European Directorate for Quality of Medicines. If the starting
material is of animal origin or has been exposed to risk of cross contamination,
there should be clear assurance that the materials do not pose a risk. Records
of evidence of compliance have to be kept for five years.
The Regulations are available from the Government’s Statutory Instruments
website.
Information is
also available from the MHRA (tel 020 7084 2000; or as a PDF file
(190K))
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Ensuring accuracy in the supply of the balance of a
part-dispensed prescription
Pharmacists are reminded of the importance of ensuring that,
when there has been insufficient stock to dispense a prescription in
its entirety
at the time of first dispensing, the balance of the prescription is dispensed
accurately.
A legible owing slip detailing the name and quantity of the medicine
outstanding must be provided on each occasion and a record kept in the
pharmacy. If the owing slip is computer generated, pharmacists should
be particularly vigilant to ensure that the correct product code is entered
and subsequently the correct product is printed on the balance slip.
Pharmacists are advised to double check the owing slip produced, so as
to prevent any error by pharmacists who dispense the balance owing.
Where balances are dispensed when the pharmacist no longer has the original
prescription, a suitable procedure should be in place to verify what
was ordered. This may include preparing a photocopy of the prescription
before its submission to the prescription pricing bureau, so that the
owing and directions can be checked against the copy.
Further guidance appears in the revised Code of Ethics, Part 3, paragraph
4.1(h). |
The
Pharmaceutical Journal