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John Blenkinsopp, principal research fellow, school
of pharmacy, University of Bradford
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Ask a group of pharmacists which prescription medicines they would like
to see reclassified for sale as a pharmacy (P) medicine and top of their
list will be chloramphenicol eye-drops. However, the interesting part
of this exercise is to see the diversity of products that the group raises
as their second and third choices for switching.
The reclassification
of medicines from prescription only medicines (POMs) by
making them available through pharmacies without a prescription provides the
potential opportunity for consumers to purchase, and pharmacists to supply, a
wider range of medicinal products. In the 10 years up to 2002 there have been
around 50 changes to the legal status of medicines that made them easier for
patients to access.
At first sight, the title of this article “Out of the dispensary and into
the pharmacy” might be assumed to refer to these medicines changing their
legal status as part of the current wave of new POM-to-P switches. But could
the title also refer to pharmacists as well? Might their professional future
lie more within the “public” area of the pharmacy, interacting with
patients and customers, rather than in the dispensary, where much of the work
can be undertaken by trained and supervised technicians? In this article, I will
explore the current trend of POM-to-P switching and examine its implications
for both the profession and health care in general.
Reclassification
The explicit policy in medicines licensing and reclassification in
Britain and throughout the developed world is that a medicine should
be made
freely available to patients unless a case can be made for its availability
being restricted. The UK Government clearly considers one of its priorities
to be the expansion of the range of medicines that pharmacies can provide
without prescription. In its document “Building on the best”,
published in February this year, the Government commits to doubling
the rate of switches from five per year to 10 per year.
In the same document, over-the-counter simvastatin is raised as an
example of a “world first” switch which marks a major step in
the Government’s commitment to expand the range of medicines available
for self-medication towards longer-term, chronic conditions and preventive
therapies. Indeed the document goes on to list conditions that might
be amenable
to treatment without the involvement of the GP. These include chronic
migraine, gastrointestinal conditions, skin conditions, asthma, pain
management and (to loud cheers from most pharmacists) eye infections.
In addition, minor ailments schemes and patient group directions allow
pharmacies to supply both OTC and prescription medicines without the
need to involve the GP in consultations. The future will now also increasingly
see an expanding range of health care professionals, including pharmacists,
who can prescribe within the NHS.
In 2002 the Application for Reclassification of a Medicine (ARM) procedures
were introduced to facilitate and streamline potential POM-to-P switches.
As stated previously the main ground for a medicines restriction as a
POM is safety. But the safety of a medicine requires an evaluation of
the molecule itself, how it is to be used as a medicine, how it could
be misused and how safety could be enhanced by providing better information
to the patient. With regards to the last of these points, the Medicines
and Healthcare products Regulatory Agency (MHRA) now puts greater emphasis
on the provision of information for patients in its assessment of applications
for drugs to be switched from prescription-only to pharmacy status. Drivers for POM-to-P switching
Medicines deregulation is occurring against a background of pressure
on the drugs bill. Self-care and self-medication with non-prescription
medicines may have been seen by the Government as an opportunity to
shift costs out of the NHS and onto the consumer. In addition increasing
pressure on NHS prescribing costs has pressured pharmaceutical companies
to protect their markets. Reclassification of a medicine not only creates
potential new business in the non-prescription marketplace but can also
promote an existing branded medicine that is also available on prescription.
Pharmaceutical companies have, unsurprisingly, embraced the opportunities
offered by self-medication, particularly at this time when the rate of
new discoveries is waning. However, although it may be relatively straightforward
for some products to be moved from POM to P it can be far more difficult
for companies to make a return on investment in this area. None the less,
with careful attention to the critical success factors the business case
for many switches can be made.
Indeed, once a molecule’s patent has expired it should be remembered
that companies other than the original discoverer could facilitate its
switch. One example of this is the recent move from POM to P status of
omeprazole. Here the discoverer (Astra-Zeneca) did not switch the molecule
in the UK. This was undertaken by Galpharm and a branded version of omeprazole
was recently launched by GSK, perhaps to the chagrin of the discoverers.
The Royal Pharmaceutical Society has also promoted the concept of POM-to-P
switching and has actively and consistently lobbied for moves from prescription-only
medicine to pharmacy status. This has been undertaken in a responsible manner
and has addressed any issues that such moves might raise. The Society also
provides practice guidance to assist pharmacists in the appropriate use of
newly switched medicines. This, together with training provided by the centres
for pharmacy postgraduate education, help to ensure that medicines are managed
appropriately. Indeed, the CPPE in England is currently running a module on
managing POM-to-P switches which aims to help pharmacists organise and systematise
the knowledge and skills required for a new POM-to-P switch. Concerns
A number of concerns from various quarters have been raised about reclassification.
The recent Which? Report on community pharmacy suggests that some pharmacists
are not managing their current P medicine portfolio optimally. However,
there is some evidence to suggest that emergency hormonal contraception
is a good example of a POM-to-P switch that has been handled well by
the profession. Companies planning new switches should learn from both
the mistakes made in the past and from good examples.
Most major switches include a period of public consultation during
which the MHRA invites comment from interested parties. It is always
illuminating
to see how other professional bodies view pharmacy and the capabilities
of pharmacists. These comments have not, by and large, prevented too
many switches. However, the profession is under scrutiny at the moment
to see if it can rise to meet the challenges and opportunities of the
current wave of switches and I anticipate a number of new “mystery
shopper” initiatives.
By and large the safety record for switched medicines remains unblemished.
It should, however, be noted that some early POM-to-P switches (astemizole
and terfenadine) did revert to POM status. These instances serve as a
reminder that new medicines should serve a sufficient period as POMs
to allow for any unexpected side effects or interactions to reveal themselves.
It would be most unusual for a medicine still in the “black triangle” phase
of its life cycle to be considered suitable for switching.
Not all pharmacists are sure that medicines reclassification is a good
idea. A number of valid concerns have been raised by members of the profession
and these issues must be addressed to ensure that the profession is on
board with any changes.
Adverse reactions caused by over the counter medicines are less likely
to be reported than those associated with POM medicines. To improve the
reporting of adverse reactions to OTC medicines, both consumers and pharmacists
must be educated about the importance of monitoring the safety of medicines,
particularly those that have been deregulated recently. The extension
of the “yellow card” scheme to allow pharmacists to report
adverse effects is important and numbers of reports from community pharmacists
are still low.
As the scope for self-medication increases, so does the potential for
medicolegal problems for doctors and pharmacists. Consumers who have
a problem with an OTC medicine could attempt a claim against the pharmacist.
This is where record-keeping becomes vital as a part of clinical governance,
particularly where POM-to-P moves progress from acute to longer-term
treatments. Pharmacists should embrace the need for record-keeping because
this will form part of their defence in an increasingly litigious society.
In addition GPs and community pharmacists must interact and work more
closely together to facilitate the appropriate use of the new wave of
OTC medicines and to monitor their use. Doctors and pharmacists need
to clarify their attitudes towards deregulation and try to reach a consensus
about how their shared goal of the safe and effective use of medicines
can be achieved. This will require more, rather than less, communication
between the two professions.
Manufacturers of newly switched P medicines should consider the possibility
of incorporating a patient-held record card within the pack. This card
should also allow other medicines currently being taken to be recorded
on it. It could then be shown to health professionals (dentists, opticians,
pharmacists and doctors) to assist them in recording a full medicines
history in the notes they are making of the consultation. From P to GSL
One issue that is always raised by pharmacists when discussing P medicines
is the belief that manufacturers will use P status as a “stepping
stone” to achieve General Sale List (GSL) status for their product.
There are certainly plenty of examples in the past of this occurring.
However, these were medicines that were used to treat minor and self-limiting
conditions. In the new wave of POM-to-P switches, the pharmacist will
have a much greater role that adds value to the consultation and sale
of an appropriate medicine. This interaction cannot be usurped and therefore
will be the reason that some future P medicines will not move to GSL
status.
Pharmacists should ask hard questions about their customer interactions |
Pharmacists should ask themselves some hard questions about their interactions
with customers. If they can answer “yes” to the question, “were
my professional knowledge and skills required for that intervention with
a customer?”, then how could it be argued that the medicine which
was sold should be made available from outlets other than pharmacies? Looking to the future
For pharmacists, the widening scope for self-care brings different
challenges. It might seem to create the possibility of good business
opportunities
through increased sales. However, there may be instances where an OTC
purchase will replace a prescription. It has been argued that consultations
for OTC simvastatin will, in fact, identify a number of individuals
who should be referred to their GP as their risk of developing coronary
heart disease is sufficiently high to warrant medical management. This
will, in turn, increase the chances of a real impact upon the current
epidemic of heart disease in the UK. However, these new patients will
require treatment, thus paradoxically increasing the number of prescriptions
for statins rather than reducing them.
Certainly the pharmaceutical industry is busy at the moment identifying
potential POM-to-P switches. Many of these are novel and would enhance
both self-care and the profession’s ability to manage a wider portfolio
of products safely and effectively. The Royal Pharmaceutical Society
and the centres for pharmacy postgraduate education understand that training
is the key to this move. They are putting in place measures to ensure
that the profession is ready for these future switches.
Most importantly, however, the professional input into the patient’s
choice of medicine could be lost unless mechanisms can be found for rewarding
professional advice rather than just the dispensing of medicines. Clearly
the income from sales of OTC medicines is an important component. However
the NHS also needs to contribute to the pharmacist’s role in supporting
self-care if it wishes to divert people from GP consultations for both
minor ailments and some long-term conditions.
This is part of the challenge of the new contract and, I hope, brings
us back to the title of this article and a question to the profession: “ Does
your future lie outside the dispensary and in the pharmacy?” |
The
Pharmaceutical Journal