Government proposes that pharmacists could prescribe unlicensed
medicines
Giving medicine to a child: the prescribing of unlicensed products is
necessary for supplementary prescribing to work in paediatric practice |
Pharmacist prescribers should be able to prescribe unlicensed medicines, according to a consultation letter issued by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health jointly on 31 December 2003.
The proposal (MLX298) advises the Government to remove existing restrictions
that prevent supplementary prescribers from prescribing unlicensed medicines
(including specials and medicines extemperaneously prepared from active
ingredients in a pharmacy), except in the context of a clinical trial.
It points out that allowing pharmacists to prescribe unlicensed medicines
will be particularly useful in paediatrics, dermatology, oncology, palliative
care and where unlicensed products such as folic acid or magnesium sulphate
need to be added to total parenteral nutrition preparations.
Widespread use of unlicensed medicines is not advocated and the usual supplementary
prescribing safeguards remain in place –– the prescribing of
unlicensed medicines will need to be agreed by the independent and supplementary
prescribers and included in the clinical management plan. In addition,
the proposal acknowledges that the particular expertise of pharmacists
in formulating, preparing and supplying unlicensed products acts as an
additional safeguard to ensure that they are used correctly.
According to the proposal, the prescribing of “off-label” medicines
(ie, licensed medicines used outside their licensed indications) is already
permitted under the existing legislation, providing certain conditions
are met. Reformulating a licensed product (ie, crushing or opening tablets)
to administer to a particular patient is also allowed. Although MLX298
technically covers England only, similar consultations are being carried
out in Wales, Scotland and Northern Ireland.
Regarding prescribing for children, Judith Cope, chief pharmacist at Great
Ormond Street Hospital, London, told Hospital Pharmacist that the current
restrictions make it impossible to have supplementary prescribers in paediatrics.
For example, children with chronic lung disease often need to take spironolactone
suspension (an unlicensed product) over a long period of time. She also
pointed out that removing the restrictions would allow a holistic approach,
with pharmacists being able to manage all medicines associated with a particular
childhood disease, within the context of a clinical management plan. “It
puts the patient back in the centre, rather than the product,” she
said.
The proposals are likely to be implemented during the middle of 2004. Copies
are available as a PDF file
(90K).
Improving patient choice
Prescribing by pharmacists (and other health professionals) is among
the measures to increase patient choice set out in the recent White
Paper, “Building on the best — choice, responsiveness
and equity in the NHS”. The White Paper followed a consultation
process involving 110,000 members of the public and NHS staff.
Other pharmacy-related initiatives, aimed at increasing access to
medicines, focus mainly on community pharmacy and primary care.
The full document is available from the DoH website |
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Hospital Pharmacist