Council decides restricting sale of pseudoephedrine would be overkill
The Council of the Royal Pharmaceutical Society has formed the view that it is not necessary to restrict the sale of medicines containing pseudoephedrine or ephedrine to personal sale by a pharmacist.
The Council made this decision at the October
Council meeting in response
to a recommendation from the Medicines and Healthcare products Regulatory
Agency that such sales should be carried out solely by a pharmacist.
The MHRA made that recommendation after a consultation on its proposal
to make products containing pseudoephedrine or ephedrine prescription-only
medicines in 2009 ended in August.
Addressing the Council, David Pruce, the Society’s director of
practice and quality improvement, explained that the Society would not,
at the moment, expect pharmacists personally to make sales of pseudoephedrine-
or ephedrine-containing products, and it was normal for these to be sold
by trained support staff within the pharmacy.
“The issue we have to think about is whether we think this is such
an important issue that pharmacists only should make
the sale, bearing in mind that it will take
them away from other clinical work.”, he
said.
With regard to the actual making of illegal methylamphetamine from products
containing pseudoephedrine, there had been only one instance in the UK,
which was in the Isle of Wight, he said.
He told the Council that the discussion the Society had had with other
pharmacy bodies was that restricting these products to pharmacist sale
only seemed like overkill and was not warranted. The Society had agreed
a series of awareness raising campaigns and expected pharmacists to make
all staff aware of pseudoephedrine issues.
The President said that these measures managed to protect the public
and it was the Council’s job to make sure that the public is protected
from harmful effects. At the same time, the MHRA’s recommendation
allowed access to the products in a more controlled way than before.
“I
think it is a test for pharmacy. Can we demonstrate a stricter control
over medicines? If these products are reclassified from P to POM that
would disadvantage the public and the pharmacy profession,” he
said.
Gerald Alexander said that although the Council might
not like what the MHRA is saying — because it thinks some sort of delegated responsibility
might be better — he believed the Council had to think about patients
and the long term. The disadvantage of the preparation of methylamphetamine
is a great imposition on the profession, and it would cause disadvantage
to the public in getting access to these important medicines for symptomatic
relief. “So although pharmacists might not like to sell those medicines
as individuals, and would prefer to ask their staff to do it on their
behalf, if we put up a rearguard action at this point saying we should
use the protocols that are already in place, it would mean potentially
in two years’ time the public would be completely disadvantaged.” he
said.
He thought the overriding consideration was the patients and the public,
that they could at least access these medicines through the intervention
of a pharmacist, and the Council should support that.
Brian Curwain agreed that the MHRA’s proposal was a sledgehammer
to crack a nut, particularly in pharmacies where staff may know customers
better than the pharmacist locums. He believed the proposal disempowered
the team within the pharmacy and added a further piece of rope to tie
the pharmacist in knots.
Steven Acres said that pharmacists should be clinical, not involved in
supply-related activity, and this was a supply-related activity.
Sue Kilby said that she would expect somebody who was appropriately trained
as a counter member of staff to inform her, when she was working as a
pharmacist in a community pharmacy, if they had concerns about any sales,
and that they would follow the standard operating procedures that were
in place. “So I do not believe we should single pseudoephedrine
out.” she said.
John Gentle said that the MHRA had come up with an inflexible proposal
because a quiet village pharmacy would have different working conditions
from a big supermarket inner city store. It was up to the pharmacist
concerned to decide on the working conditions and on how sales would
be made with the trained and qualified staff that he had.
“It seems
to me that this particular Society should start to trust its members
and back the systems that we have put in place over the years … and
trust our members to do a good job,” he said.
John Jolley said the Council had to recognise clearly that the MHRA was
responding to a global action that is being taken. The problem was principally
within the US. “Regardless of how extensive the problem might be
within the UK, I think we have to recognise that either we respond favourably
to this request, or we will lose the product altogether and it will become
a POM,” he said.
“Unfortunately there is no democracy about this. It is a fact that
this is what will happen. So I would certainly favour, however inconvenient
it may be, that we at least retain responsibility for allowing pharmacists
to make sales of pseudoephedrine, thereby
keeping it available for members of the
public.”
Jonathan Buisson pointed out that the MHRA had put the ball pretty firmly
back in the Council’s court. “If something goes a bit pear-shaped
after this, they will be saying, ‘we told you so’, and it
will not look good for us.” He suggested that the Council’s
decision be reviewed in six months.
Closing the debate the President reminded the Council that the MHRA originally
intended to transfer the medicine from P to POM. Instead, a halfway house
arrangement had been proposed. He urged the Council to bear in mind the
concession made by the MHRA to ensure that good access was not compromised
by poor quality service.
The Council decided not to support the MHRA recommendation that sales
of medicines containing ephedrine or pseudoephedrine be made solely
by a pharmacist. However, it agreed to review its decision in six months’ time. |
The
Pharmaceutical Journal