Society to oppose POM control for decongestants
The Royal Pharmaceutical Society is to express strong opposition to a Medicines and Healthcare products Regulatory Agency proposal
to restrict the supply of pseudoephedrine and ephedrine to prescription because of reports that they can be extracted from nasal decongestant products and used in the manufacture of methamphetamine (“crystal meth”)
(PJ, 10 March, p269).
Making its decision at the March
Council meeting, the Society’s
Council agreed that any potential for misuse should be controlled by
tighter restrictions on supply as pharmacy medicines — for example,
by limiting the maximum pack size and restricting sales to one pack per
purchase. It was also agreed that the MHRA should keep the two drugs
on a watch list, so that it could take appropriate action if things developed
in the way it feared.
The Society’s director of practice and quality improvement, David
Pruce, told the Council that the MHRA consultation letter had been debated
by the Practice Committee, which opposed the agency’s preferred
option of POM control combined with a pack size restriction. The committee’s
argument was that in the UK patient safety and public safety could be
provided by tighter control through pharmacy, with a maximum pack size
of 720mg total drug and a limit on sales of one pack per purchase.
Sid Dajani said that the MHRA proposal would inhibit patient choice,
since many P products would be lost to the market if pseudoephedrine
became POM only. This would have an add-on effect on GPs’ workload.
The Practice Committee had seen no evidence of widespread misuse. It
realised there was a public protection issue but there would be more
disadvantage by reversal to POM. Sales should be restricted in a more
controlled manner.
The President, Hemant Patel, said that the proposal was a gross overreaction
to the size of the UK problem.
The Vice-President, Gerald Alexander, said that the proposal was an attempt
to stem the tide of illicit drugs without paying attention to the public
need. It was also an overreaction to problems elsewhere in the world.
David Carter said that the problem appeared to be in the US, which did
not have the pharmacy-only category as a safety net.
John Gentle said that he was sceptical about how many manufacturers of
crystal meth would visit his pharmacy to try to buy Sudafed by the wheelbarrowful — because
that was what they would need. It would be expensive as well as impractical.
Further to that, the Pharmaceutical Services Negotiating Committee conference
had opposed the move from P to POM, as had branches he had spoken to.
There was a feeling in the profession that it was almost a professional
insult.
Paul Bennett, chairman of the English Pharmacy Board, said that, when
challenged, the MHRA had been unable to say whether American states that
had restricted supply to prescription had seen any effect on crystal
meth production.
Jonathan Buisson said that at a recent Company Chemists Association meeting
he had heard some interesting background information. In America, the
federal response had been to restrict sales by introducing the equivalent
of a P category. This had apparently been effective in reducing local
crystal meth production but had made sure that crystal meth was imported
wholesale from Mexico. He understood that in the UK the police had only
found only one laboratory and most of the UK’s crystal meth was
imported wholesale from the Netherlands.
Mr Gentle said that, although he did not doubt that the UK would have
a crystal meth problem in the future, he seriously doubted whether pseudoephedrine
and ephedrine decongestant products would be the source. The MHRA proposal
should be strongly opposed.
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The
Pharmaceutical Journal