|  Sticky,
red eyes need no longer be an irritation and source of frustration for
pharmacists and patients. Chloramphenicol eye drops,
a medicine effective
against conjunctivitis, has been reclassified (some may say at last)
as a pharmacy medicine. The first reclassification of a prescription
only antibiotic eye treatment is a significant switch for pharmacy and
is likely to be widely welcomed.
Richard Eggleston, director of research and development, Galpharm International
Ltd, says pharmacists have been crying out for the switch for years. “Pharmacists
probably see a couple of cases of infective conjunctivitis each week
and the lack of an effective over-the-counter treatment is frustrating.”
He believes pharmacists are as well placed as GPs to supply treatment. “Supply
by a pharmacist will reduce delay in receiving treatment,” he says.
An added benefit will be that those patients who need to be referred
to a GP or ophthalmologist are more likely to be seen quickly and their
condition assessed with more urgency. Having been seen by a pharmacist,
patients with more serious eye problems will not have to go through the
GP’s differential diagnosis. “There will be an overall improvement
in the management of eye conditions,” says Mr Eggleston.
Safety concerns
CPD and practice guidance
A CPD centre pull-out (PDF 270K)
in The Journal this week examines use of
chloramphenicol for treating acute bacterial conjunctivitis.
Practice
guidance (PDF 60K)
has been published by the Royal Pharmaceutical Society and will
be distributed to pharmacists
with The
Journal shortly. |
Chloramphenicol has been associated with a number of safety concerns — specifically
bone marrow toxicity and grey baby syndrome.
According to the Medicines and Healthcare products Regulatory Agency,
use of the drops does not increase the risk of aplastic anaemia above
that observed in the general population. However, the advice relating
to the OTC product is that it should not be used by people with a personal
or family history of blood abnormalities, since these are predictors
of aplastic anaemia.
Grey baby syndrome was another safety concern highlighted during the
reclassification process. Although life-threatening, this syndrome is
associated with high systemic concentrations of chloramphenicol in newborns.
The lack of significant systemic absorption from chloramphenicol eye
drops and the age restriction of two years that has been placed on the
OTC product mean that the risk of grey baby syndrome is extremely low.
Marvyn Elton, a pharmacist and practising optometrist, is assured of
chloramphenicol’s safety. “Chloramphenicol eye drops have
been in use for decades. This product is effective and very safe,” he
says.
Misdiagnosis needs to be considered since customers with more serious
eye infections need to be seen by a GP, optometrist or ophthalmologist.
John Blenkinsopp, a consultant to the pharmaceutical industry and senior
research fellow at Keele University, does not think diagnosis will be
a stumbling block for pharmacists. “Pharmacists already deal with
conjunctivitis and are used to asking the sorts of questions that differentiate
between allergic and infective conditions,” he says.
There are useful questions that can be asked. Has the infection crossed
from one eye to the other? Are other family members affected? Is there
a sticky, yellow discharge?
“
Like doctors, pharmacists are not going to be right every time, so there
needs to be safeguards built in,” adds Dr Blenkinsopp. This means
giving patients instructions on what to do if there is no improvement
after the drops are used.
Mr Elton agrees that diagnosis is straightforward. “As a pharmacist,
if one of my customers tells me they have conjunctivitis I ask whether
their eye lashes were stuck together with yellowy discharge in the morning.
If the answer is ‘yes’ then it is usually bacterial conjunctivitis.”
Not everyone is as confident that the switch to pharmacy status is without
any real safety concerns. The Royal College of Ophthalmologists and the
College of Optometrists both believe that accurate diagnosis of bacterial
conjunctivitis requires use of a slit-lamp microscope, something that
only some GPs and few pharmacists are likely to have access to.
“The most obvious primary care professionals to [perform a slit-lamp
assessment] are optometrists or ophthalmic medical practitioners,” Bryony
Pawinska, chief executive of the College of Optometrists, says. Resistance
Any move to increase the availability of an antibiotic is bound to
raise eyebrows as far as resistance is concerned. It is a political as
well
as a clinical issue and attempts by pharmaceutical companies to reclassify
antibacterials in the past have failed. “We thought we might
never get past this issue for OTC products,” says Mr Eggleston.
But the climate has changed and there is now a willingness to increase
access to medicines and to encourage self-care.
Resistance appears not to be a problem for chloramphenicol. Systemic
absorption following ocular use is low and decades of use have not resulted
in any clinically significant effect on resistance, says the MHRA.
The Royal College of Ophthalmologists has some concerns about resistance
although is not opposed to the switch. “In its systemic form chloramphenicol
is still effective against some life-threatening pathogens, including
some strains of methicillin resistant Staphylococcus aureus. More indiscriminate
use of the drug could lead to resistance despite the general assurances
given,” says Brenda Billington, vice-president of the Royal College
of Ophthalmologists and chairman of its professional standards committee. Storage
The summary of product characteristics for OTC chloramphenicol eye
drops states that the drops should be stored in a refrigerator. This,
says
Mr Elton, applies to storage in the pharmacy and is best practice for
patients who buy the product.
However, this is hardly a practical solution for a treatment that is
used every two hours for the first 48 hours of the course. “During
use, which would be for five days, it would not need to be stored in
a fridge,” he says. “Obviously, it should not be kept exposed
to sunlight and while it may be good practice to store the product in
the fridge, it is not necessary.”
Mr Eggleston echoes this view and hopes that pharmacists will give customers
pragmatic advice. “In a hospital setting, after being dispensed
from the pharmacy, chloramphenicol is kept in the ward’s drug trolley
for up to one month,” he says.
When can pharmacists expect to see OTC chloramphenicol eye drops? The
first product expected to reach pharmacy shelves is Optrex Infected Eyes,
launched earlier this week. It will be available from late June. A Galpharm
product will be launched later this year. |
The
Pharmaceutical Journal