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Pseudoephedrine products
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Pharmacists will have to shoulder the burden of ensuring that new restrictions
announced last week relating to products containing pseudoephedrine and
ephedrine work so that these products continue to be available over-the-counter,
the Medicines and Healthcare products Regulatory Agency says.
Speaking about the pack size and sales restrictions, June Raine, director
of vigilance and risk management of medicines at the MHRA, elaborates: “The
new measures are part of a comprehensive package advised by the Commission
on Human Medicines.
“At the end of a two-year period, a decision will be made as to
whether those measures have had the desired effect and are retained,
or whether
it is necessary for these products to be reclassified to prescription-only
medicines.”
She explains that the MHRA has listened to pharmacists who are confident
that the risk can be managed in pharmacy. “Now it is over to pharmacy
to make the measures work.”
Commenting on the voluntary nature of the controls and the deferral of
reclassification, Dr Raine says: “This is a strong signal from
Government in support of the role of pharmacists in medicines supply.”
She adds that the MHRA will liaise with the Royal Pharmaceutical Society
to make sure that pharmacists have the guidance that they need to control
sales effectively.
“Pharmacists need to take advantage of the training packages that
are becoming available, follow the guidance and be alert and responsive,” Dr
Raine says. But she admits: “No-one thinks that an entire methylamphetamine
epidemic will be created from OTC sales.”
Dr Raine also suggests that other controls might be considered before
triggering full prescription control of pseudoephedrine, if the current
proposed restrictions prove to be insufficient.
One possibility will be to use the Misuse of Drugs Regulations to require
records of sales to be kept and to restrict the total amount that individuals
can buy over a period of time. This would shift the threat of prosecution
away from pharmacists making supplies and on to individuals who might
buy too much.
Sadia Khan, the Society’s lead pharmacist for self care, stresses
that pharmacists should, with immediate effect, be ensuring that sales
of any pseudoephedrine- and ephedrine-containing medicines are restricted
to one pack per sales transaction.
“Adequate procedures to prevent multiple pack sales should be implemented
and all staff involved in the sale or supply of these products should
also be appropriately trained,” she says. “The Society will
be giving urgent consideration to the issue of personal sales by a pharmacist
and will provide further guidance once the implications of the CHM advice
have been fully considered”.
The restrictions (PJ, 1 September 2007, p221) were proposed
in response to concerns that decongestant products containing pseudoephedrine
and
ephedrine
could be used in the illegal manufacture of methylamphetamine (crystal
meth).
Colette McCreedy, director of practice at the NPA, believes that the
way in which pharmacy deals with these restrictions will have long-term
implications for the profession. “If we can demonstrate that we
can handle this public health issue, it will demonstrate to the MHRA
and Committee on Human Medicines that they can have faith in pharmacy,” she
says.
Although dates for phasing out pack sizes larger than 720mg have yet
to be determined, Sheila Kelly, executive director of the Proprietary
Association of Great Britain, believes that a number of factors will
have an impact on this. These include the need to ensure supplies are
not disrupted during the cold season and legal requirements for a 12-week
consultation process and a 42-day period while the Regulations lie before
parliament.
A Commission on Human Medicines working group is being established to
advise on the practical aspects of the measures proposed (see Panel below).
Monitoring the new restrictions
New controls over the sale of products containing
pseudoephedrine and ephedrine are to be monitored by an expert
group of the Commission
on Human Medicines to see whether they are sufficient to stop
a threatened prohibition on over-the-counter sales of all such
products.
June Raine, director of vigilance and risk management of medicines
at the Medicines and Healthcare products Regulatory Agency, says
that the group, in conjunction with enforcement agencies, will
first consider what information will be available after the
new controls
come into effect and then define indicators that could be used
to monitor their effectiveness. These would then be used to
decide whether
to trigger the threatened POM reclassification of all pseudoephedrine
products in 2009.
The expert group is expected to be up and running by October, with
its membership being finalised in September. |
Scottish controls
Community pharmacists in Scotland have also been urged to ensure that
sales of nasal decongestant products containing pseudoephedrine and
ephedrine are more tightly controlled. As part of this, Community Pharmacy
Scotland is encouraging pharmacists to carry out the sale themselves,
or at least to supervise the sale closely, to minimise the inappropriate
use of the products.
Harry McQuillan, chief executive of CPS, comments: “We would like
to see pharmacists implement immediately the proposed measures to restrict
and control sales, and we will be strongly encouraging our members to
do so.
“The alternative — to make these products prescription only
medicines, only able to be prescribed by a GP — would have had a
detrimental effect on all of the efforts to improve patient access to pharmaceutical
care and medicines for minor ailments, and in doing so would have increased
the pressure on GPs.
“In our view pharmacists are the right people to ensure and control
the sale of these products.” |
The
Pharmaceutical Journal