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Letters to the Editor
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Drug classification
Proposals to declassify fluconazole to GSL status
From Dr P. Fellows
I was concerned to read the application
to reclassify the fluconazole
150mg tablet from a pharmacy (P) medicine to general sale list (GSL)
medicine (PJ, 1 October, p398) making it more available for women to
self-select.
Although I appreciate that there may be some advantages from deregulation,
such as the convenience of purchase and early treatment of a condition,
I believe these benefits are hugely outweighed by the safety issues of
self-selection.
First, switching fluconazole to GSL, enables the consumer to purchase
it from any shop at any hour of the day. However, I believe treatment
of thrush can wait until the morning and patients should wait until the
pharmacy opens to ensure the advice and protection of a pharmacist.
Fluconazole should not be used by women who are pregnant, may be pregnant
or are breastfeeding. There must be a number of women who go to the pharmacy
to purchase a fluconazole tablet, only to be advised by the pharmacist
that it is not to be taken under these circumstances. Will a pack on
a shelf in the supermarket allow this same level of advice and will women
read the packaging leaflet sufficiently to glean the right information?
Another concern is that fluconazole is only recommended if women know
they are suffering from thrush and have used it before. This is something
pharmacists will always ask their customers. With self-selection the
problem that can occur is incorrect diagnosis. Symptoms could in fact
be something more serious such as gonorrhoea or chlamydia.
For these women, self-treating with fluconazole is wholly inappropriate
and could delay them getting the right treatment for their specific condition.
Finally, fluconazole is also known to interact with some other medicines
due to its action on cytochrome P450. It has potential serious interactions
with other drugs, eg, some antihistamines.
I look forward to understanding how the Medicines and Healthcare products
Regulatory Agency intends to tackle these concerns. Meanwhile, I cannot
help thinking that taking medicines like fluconazole out of pharmacy
jurisdiction is removing an important safety net that is there to protect
the public’s health.
Peter Fellows
Chairman of the Clinical and Prescribing Subcommittee of the General
Practitioners Committee
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STEPHEN HALLWORTH, press officer at the MHRA responds:
The consultation
exercise (ARM 33) on the proposal to reclassify fluconazole 150mg
capsules from a pharmacy medicine to a general sale list medicine has
been ongoing
until 1 November. Reclassification is about widening choice and access
and the Medicines and Healthcare products Regulatory Agency is keen
to receive all comments and opinions. We will ensure that this letter
is
included as a response to the consultation exercise and is considered
along with all the other responses received. |
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The
Pharmaceutical Journal