Chloramphenicol eye drops approved as pharmacy medicine for treatment of bacterial conjunctivitis
Patients with conjunctivitis will have quicker access to treatment |
Chloramphenicol 0.5 per cent eye drops have been reclassified as a pharmacy medicine.
The Medicines and Healthcare products Regulatory Agency announced the
POM to P switch earlier this week (PDF 30K) and the move has been applauded
by pharmacy organisations.
David Pruce, the Royal Pharmaceutical Society’s director of practice
and quality improvement, said: “Making chloramphenicol eye drops
available without a prescription is a safe, effective and convenient
route to treatment for the many patients who visit pharmacies every day
with acute bacterial conjunctivitis.”
The National Pharmaceutical Association welcomed the announcement. Colette
McCreedy, the NPA’s director of pharmacy practice, said: “We
are confident that this will be an extremely useful product and will
increase patients’ access to an effective treatment.” She
added that the NPA had hoped for a lower minimum age limit, given the
frequency of infective conjunctivitis in young children. The OTC products,
which went through the reclassification process concurrently, are indicated
for acute bacterial conjunctivitis in adults and children aged two years
and over.
MHRA chief executive Kent Woods said that the case for making
chloramphenicol eye drops available over the counter, both in terms of
patient safety
and the risk of emergent bacterial resistance, had been debated thoroughly. “We
are convinced that the potential health benefits outweigh any risks to
patients, or to the community at large,” he said.
Chairman of the Committee on Safety of Medicines Gordon Duff added: “Allowing
patients quick access to this treatment will help to speed their recovery,
lower the risk of spreading infections, of infection returning or of
further complications developing. As such, I welcome this move and believe
there is a clear public health benefit to be gained from making this
important medicine available through pharmacies.”
John Blenkinsopp, a senior research fellow at Keele University, worked
as a switch consultant for Galpharm. He told The Journal that
the switch process for OTC chloramphenicol had been notable. “The MHRA attempted
to ensure the companies made their applications consistent with each
other,” he said. This included the training packages that have
been prepared for pharmacists and pharmacy counter assistants.
Practice guidance for pharmacists has been produced by the Society and
is available as a PDF file
(60K). The guidance outlines indications for supplying the medicine
without
a prescription as well as points to
consider when counter prescribing. It provides information on whom to
refer, how to administer, how chloramphenicol works, cautions, adverse
effects and interactions.
Leading article p696
News feature p704
CPD p725 (PDF 270K)
OTC products
Three companies submitted switch applications to the MHRA. Optrex
Ltd launched Optrex Infected Eyes earlier this week (see p705).
It is expected to become available in the last week of June.
A Galpharm product will be launched later this year. The Boots
product
has yet to receive MHRA approval. |
|
The
Pharmaceutical Journal
Acrobat
Reader