In the past two weeks switches in legal classification of amorolfine and
sumatriptan from prescription-only medicines to pharmacy medicines have
been widely
welcomed.
“Improved access to sumatriptan will not only enhance patient care
and help to reduce the workload for GPs, it will give community pharmacists
more
opportunity to use their clinical skills and play a greater role in helping
people with an established pattern of migraine manage their condition,” Royal
Pharmaceutical Society President Hemant Patel said last week.
Sheila Kelly, executive director of the Proprietary Association of Great
Britain also praised the reclassifications. “Wider access to medicines
with a proven safety profile and greater patient choice allows patients
to take more control of their own health care,” she said. “We
are pleased that the list of potential candidates for switches, originally
developed by the Society, is being taken
into account with the steady stream of
reclassifications.”
Slippages
However, the close proximity of these two launches — and the fact
that this is in itself noteworthy — has highlighted how far the POM-to-P
switching programme has slipped behind the Government’s aims for
it. Since the Government committed through the NHS plan in July 2000 to
introducing
a wider range of over-the-counter medicines by 2002, plans for POM-to-P
switches have been suggested for a wide range of products.
In January 2002, a strategy document was produced by a working group
led by the Society and, in May 2002, the Government announced a plan
to double
the number of changes in legal status to 10 a year, an aim
repeated in “Building on the best” in December 2003.
Since then a number of POM-to-P switches have been completed successfully
(see Panel), but these have fallen considerably short of the Government’s
target and other people’s expectations.
Recent POM-to-P switches launched successfully
A number of reclassifications of prescription-only medicines to
pharmacy medicines have been completed successfully in the past few
years:
· Amorolfine Amorolfine 5 per cent nail lacquer for the treatment
of fungal nail infections was launched this month as Curanail by
Galderma
· Chloramphenicol Chloramphenicol eye drops 0.5 per cent were launched
as Optrex Infected Eyes in November 2005
· Omeprazole Omeprazole 10mg was launched as Zanprol by GlaxoSmithKline
Consumer Healthcare for the treatment of reflux-like symptoms in
adults from March 2004
· Simvastatin Simvastatin 10mg was launched as Zocor Heart-Pro by
Johnson&Johnson MSD in July 2004 and licensed for the prevention
of a first major coronary event in people at moderate risk of coronary
heart disease
· Sumatriptan Sumatriptan tablets 50mg are to be launched next month
as a treatment for the acute relief of migraine attacks, marketed
as Imigran Recovery by GlaxoSmithKline |
This shortfall has continued in spite of the Medicines and Healthcare
products Regulatory Agency introducing a new classification process in
May 2002
and bringing in efforts to encourage POM-to-P switching in August 2004
(PJ, 26 January 2002, p81, 4 May 2002, p598 and 7 August 2004, p175).
Delays
Part of the reason for this trickle is the number of applications requiring
detailed input, the MHRA says. “Companies are actively encouraged
to seek advice at an early stage in the process to stimulate submission
of a wide range of applications for consideration, including those in
new therapeutic areas,” a spokesman from the MHRA said.
“In recent years, the MHRA has successfully reclassified a number of
novel products for pharmacy availability. These have often required extra
time
and detailed input from experts and other stakeholders in progressing to
a successful outcome because of the complexity of the issues involved in
ensuring patient safety is protected,” he added.
The MHRA has recently received a number of such reclassification applications,
he said, and some of these have involved complex issues, which have required
significant additional time and resource to process.
“The MHRA is fully committed to forwarding these more complex applications,” he
said. “As part of the newly realigned VRMM (vigilance and risk management
of medicines) division of the organisation we have established a structure dedicated
to supporting reclassification across all therapeutic areas,” he added.
The complexity of applications may explain delays in POM-to-P switches, but
it can also lead to medicines not being switched at all. Wyeth, for example,
had hoped to launch lansoprazole as a pharmacy medicine in September 2004 ahead
of the product’s patent expiry that December, giving the company 16 months’ market
protection.
However, the licensing process took longer than expected, reducing the period
of market exclusivity and leading the company to decide against launching lansoprazole
as a pharmacy medicine (PJ, 23 April 2005, p481).
Marketing reasons have also led to other planned switches being put on ice.
For instance, although sumatriptan has completed the switching process, the
original consultation also included an application from AstraZeneca to license
zolmitriptan as a pharmacy-only medicine (PJ, 20 August 2005, p215).
AstraZeneca has decided to put its reclassification of zolmitriptan on hold,
a spokesman explained. “AstraZeneca has taken a step back for market
reasons,” he said. However, the switch may be pushed forward in the future,
he added. “The situation will continue to be closely monitored and evaluated,” he
said. Other problems
It has also been suggested that a lack of access to patients’ medical
records may limit the usefulness of pharmacy medicines (PJ, 2 February
2002, p131) and therefore the extent to which they are used — reducing
the likelihood of pharmaceutical companies applying for switches. Pharmaceutical
companies’ failure to drive switches through — and pharmacists’ reliance
on industry to do so — has also been blamed (PJ, 16 October 2004,
p575).
However, it may be that pharmacy-only medicines are in some way part
of pharmacy’s past, rather than its future. John Blenkinsopp, an independent
consultant to the pharmaceutical industry on POM-to-P switches, believes
that such reclassifications may simply act as a stepping-stone on the way
to wider prescribing capabilities.
“I see POM-to-P switches as being important, but they may act as a transition
phase as pharmacist independent prescribing becomes a reality over the
next five to 10 years,” he said. “At the moment, pharmacists
are finding their feet with prescribing. The future of POM-to-P switching
will really depend on what approach the pharmaceutical industry takes
and which products it applies to switch.” |
The
Pharmaceutical Journal