Society opposes MHRA stance on pseudoephedrine
Pharmacy bodies, including the Royal Pharmaceutical Society, have opposed a Medicines and Healthcare products Regulatory Agency proposal to take larger packs of pseudoephedrine- and ephedrine-containing products off
the pharmacy market earlier than originally recommended by the Commission on Human Medicines (PJ, 6 October, p373).
The Society’s response to an MHRA consultation on the matter points
out that the CHM said that all packs of products containing more than
720mg of pseudoephedrine or 180mg of ephedrine should be restricted to
supply on prescription from July 2009 if voluntary steps to constrain
the risk of their use in the illicit manufacture of methylamphetamine
failed.
As a result, the Society wants to know why the MHRA proposed
reclassification from 1 April 2008, with a transitional period.
The Society is also opposed to a proposal to make it a criminal offence
to sell more than one pack at a time, regardless of its content. This,
the Society says, would prevent a pharmacist from selling adequate products
to anyone who needed a decongestant for themselves and a child together.
“Pharmacists should be able to exercise their professional judgement
and consider supplying both products without having committed a criminal
offence,” the response says.
An MHRA spokesman said that it had always been the intention that packs
containing more than 720mg of pseudoephedrine or 180mg of ephedrine should
become prescription-only. It was only smaller packs that would have a
decision deferred until 2009. If control measures failed to prevent illicit
conversion to methylamphetamine, then smaller packs would become prescription-only
too.
The Pharmaceutical Services Negotiating Committee suggested that a limit
only on the total amount of pseudoephedrine or ephedrine content that
may be sold would be a better approach. “There would then be little
need also to restrict the number of packs,” the PSNC said.
It added
that the 720mg limit might be too low if people need to buy different
formulations for daytime and night-time use. Both pharmacy bodies are
also of the view that a longer transitional period will be necessary
if pharmacies are not to be left with unsaleable stock.
The National Pharmacy Association, too, says that pharmacists need to
be able to exercise professional discretion over the supply of multiple
packs where there is a genuine clinical need. Colette McCreedy, NPA director
of practice, said: “Restricting sales of all types of medicine
containing pseudoephedrine to one packet per transaction will cause widespread
confusion to patients and may result in them being unable to purchase
the medicines that they and their families genuinely need.”
She added that the NPA was concerned that pharmacists might be prosecuted
if they, or their staff, supplied multiple packs.
“We believe that it is unacceptable for the legislation to seek
to criminalise the profession, rather than the people who purchase these
products for
the manufacture of illegal drugs,” she said. |
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