Divergent views emerge over status of loperamide
Lea Paterson/Science Photo Library
IBS patients may have easier access to loperamide in future |
Differences of opinion between the Royal Pharmaceutical Society and the National Pharmacy Association have emerged over a proposal to add the treatment of acute diarrhoea associated with previously diagnosed irritable bowel syndrome (IBS) to the general sale list indications for the loperamide products Imodium capsules and Imodium Instants.
The Society’s position (PDF 40K) is that there are a number
of concerns that mean that the change should not go ahead, while the
NPA
says that
it
should, subject to some caveats.
The Society’s response to a Medicines and Healthcare products Regulatory
Agency consultation
on the proposal says that it will not be possible
to verify previous diagnosis of IBS if the product is available without
pharmacy controls. It also asks for evidence in support of the manufacturer’s
claim that “individuals will not continue to self-medicate unnecessarily”.
The Society makes it clear that pharmacists and pharmacy staff are able
to refer people with digestive symptoms of unknown cause to a doctor
if medicines are restricted to pharmacy sale, but that customers would
be left to make their own decision about seeking further advice if a
product was a GSL medicine.
“In non-pharmacies where GSL medicines are supplied, there is no
professional advice available to customers. Diarrhoea is not always treated
by loperamide.
If the licensed indication is widened, a self-misdiagnosis by the patient
in a non-pharmacy setting could lead to complications, dehydration and
so on.”
Ruth Wakeman, NPA information department manager, said: “The NPA
supports this change to the licensed indication as we are not aware of
any safety concerns due to the good safety profile of loperamide which
has been available as a GSL medicine for the treatment of acute diarrhoea
for a number of years. However, our view is based on the restrictions
which have been included in the proposal which we feel are important
to maintain patient safety.”
She added that the NPA might review its support for the change if any
proposals were made to remove any of those restrictions or changes to
the proposed pack size.
However, the NPA has warned that the proposed patient information leaflet
is unclear and gives misleading information.
|
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