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Last week the Medicines and Healthcare products Regulatory Agency made
the decision to consult
on restriction of two nasal decongestants (PJ,
10 March, p269). It wants to reclassify from pharmacy to
prescription-only status all medicines containing pseudoephedrine and
ephedrine, alone or in combination, and to restrict pack size of the
prescription product to 720mg pseudoephedrine or ephedrine.
The consultation is in response to increasing pressure from the Association
of Chief Police Officers and the Serious Organised Crime Agency, which
fear OTC products containing these compounds will increasingly be used
to make the class A Controlled Drug methylamphetamine.
Known as crystal meth, tina, crank and ice, methylamphetamine has been
abused in the US, Canada, Australia and New Zealand, where locally bought
and imported medicines containing pseudoephedrine and ephedrine have
been used to make it in kitchen laboratories.
Anti-crime organisations want to prevent a similar problem here, although
current evidence suggests the UK has little problem with abuse of methylamphetamine.
June Raine, director of vigilance and risk management at the MHRA, said: “We
are acting early to avoid [methylamphetamine abuse] becoming a problem.
The US agencies tell us that this occurred where certain conditions prevailed
but we would not be doing this if we did not have cases already with
OTC medicines being used. This was the trigger, and the advice of the
ACPO and SOCA — they advised that conditions prevail in the UK
that developed in the US.”
She continued: “One of the challenges is that people can buy enough
by using different pharmacies. Even the most rigorous supervision by
pharmacists can’t stop people doing that. It is a fact of life.” However,
currently the agency has no details of large purchases via the pharmacy
route. “I believe the Home Office has got that type of evidence,” she
added.
Prevention better than cure?
Pharmacists would usually be the first to agree that prevention is
better than cure. But with 40 years of safe and effective use by patients,
many think watchful waiting would a better option in the case of pseudoephedrine
and ephedrine — not switching to POM.
Gopa Mitra, director of health policy and public affairs at the Proprietary
Association of Great Britain, points out that other countries which have
had problems of methylamphetamine abuse now have increased controls of
the two drugs to levels similar to the UK’s current provision (pharmacy
only, behind-the-counter sale). A disproportionate response
“In other countries there is a quantified, significant problem
whereas the evidence here has not been quantified. This is a disproportionate
response. There are an awful lot of things we could be doing apart from
this, such as reducing the pack size for pharmacy only sale, but there
is no option for this,” she said. And, she added, if the MHRA goes
ahead with its preferred option — to switch to POM by the end of
the year — it will come as a slap in the face to pharmacists and
patients, who jointly have been managing the use of this product safely
for self-limiting conditions for years.
The National Pharmacy Association agrees. Its director of practice, Colette
McCreedy, said: “We disagree with the implication that the only
way of controlling supply of pseudoephedrine is through prescription
only status. P sales could be limited to one pack per patient and the
pack size could be reduced — similar to the restrictions imposed
on paracetamol sales, which significantly reduced suicide since these
restrictions were imposed.”
She said the NPA was also concerned about reformulation of alternative
products because the main alternative ingredient, phenylephrine, has
questionable efficacy as a decongestant.
Community pharmacists have similar misgivings. Ash Soni, a pharmacist
in South London, said: “I think it is a retrograde step. It takes
what is a very good quality product and makes it POM, so reducing access
to an effective medicine. This is saying that we have a population that
is irresponsible and that we don’t trust our pharmacists.”
Jeremy Clitherow, a pharmacist in Liverpool, suggested that restricting
supply of the bronchodilator, ephedrine hydrochloride, might be a more
useful way of preventing illicit manufacture of methylamphetamine. “We
would normally have that in bulk in a pharmacy so it would be more sensible
to restrict that,” he said.
He remains hopeful that reclassification will not happen, noting that
the Government has already seen the value of P medicines.
This value is an economic one too because the switch back to POM could
increase public traffic to family doctors. Research carried out for the
PAGB in 2005 showed that 41 million people self medicate for colds every
year in the UK — a staggering two thirds of the entire population.
“If just a third of the people who currently self medicate were to
go to the GP, each GP would have an additional 389 patient visits a year,
costing the NHS £350m,” the PAGB said. Twenty-nine million
people self treat for colds and 12 million self medicate for blocked
sinuses, it notes. If they cannot access good products to treat symptoms
via their pharmacist, they are more likely to knock on their GP’s
door.
But Peter Fellows, chairman of the British Medical Association General
Practitioners Committee clinical and prescribing subcommittee, does not
think this would be the case. “The effect [on GP workload] will
be very small and I don’t think it will hurt pharmacists because
pseudoephedrine is not widely used. There are alternative nasal sprays
which are effective, such as xylometazoline and oxymetazoline. These
are used by adults for short-term nasal congestion and pseudoephedrine
is not used in children. Pseudoephedrine is a potentially dangerous drug,
not only because it is addictive but because it can interact with many
antihypertensive drugs and push up the blood pressure. I have no qualms
with it being a prescription-only drug and I think what the MHRA is doing
is sensible.” Anti-patient choice
But to Ms Mitra, the MHRA’s preferred option to switch to POM seems
contrary to Government policies around patient choice, prevention and
increasing pharmacists’ autonomy.
She explained that there are 10 million packs of pseudoephedrine-containing
products sold every year. So the people who self treat have confidence
in doing so and are able to do so by having access to pharmacists. “In
terms of people being able and empowered to look after their health,
this [consultation] is the opposite of what the Government is saying,” she
stressed.
But Dr Raine is adamant this is not the case. “We want to look
at all the options and are very much in listening mode. We want to hear
the views of pharmacists and hear them in an open way.”
She said it is not the intention of the MHRA to undermine pharmacists’ role. “What
we are doing it taking an early look at this to ensure we don’t
have the same situation as the US.” |
The
Pharmaceutical Journal