| SIMVASTATIN looks set to become one of the next prescription only medicines
to become available over the counter. Earlier this week, Health Secretary
John Reid announced that the drug could be available without prescription
from pharmacies within six months. Such a move would open the way for
increased pharmacy input in the prevention of cardiovascular disease
and has been welcomed by the main pharmacy bodies.
David Pruce, director of practice and quality improvement, Royal Pharmaceutical
Society, says the implications for pharmacy are huge. “It is the
first real POM-to-P switch for a long-term condition, which puts it into
a different league. It is a vote of confidence for pharmacy. The Government
thinks pharmacy can handle it and handle it well.” Like the Society,
the National Pharmaceutical Association has welcomed the proposals. Colette
McCreedy, NPA director of pharmacy practice, says: “[Pharmacists]
will be willing and able to take on the responsibility of advising customers
on whether this product is right for them.”
As part of the announcement, the Medicines and Healthcare products Regulatory
Agency launched a consultation on the proposed reclassification. So what
exactly has been proposed and what are the details that need to be considered?
The manufacturer of Zocor, Johnson & Johnson MSD, wants all people
who are likely to be at moderate risk of coronary heart disease (see
Panel) to be able to buy its product (Zocor Heart Pro 10mg) direct from
pharmacies.
Target population
Zocor Heart Pro is intended to reduce the risk of a first major
coronary event in people who are likely to be at moderate risk of
coronary heart disease. This means all men aged 55 years and over.
It also includes men between the ages of 45 years and 54 years and
women over the age of 55 years who have one or more of the following
risk factors:
• Family history of CHD in a first degree relative; CHD in male
first degree relative below 55 years or female first-degree relative
below 65 years
• Current smoker (or has been smoker in past 12 months)
• Overweight
• South Asian ethnicity |
The rationale for reclassification is given in the consultation document.
It also gives some indication as to the sort of advice and additional
support that pharmacists would be required to provide.
The consultation document states that a training package for pharmacists
and medicines counter assistants is being developed. It is not clear
yet what the details will be but Johnson & Johnson is consulting
national pharmacy bodies regarding its content. In addition to this,
the Society plans to produce general guidance for pharmacists on the
supply of statins over the counter.
Perhaps surprisingly, the proposal suggests that there is no requirement
for people wanting to take OTC simvastatin to have their cholesterol
levels tested. A spokesman for Johnson & Johnson explains that the
assessment that pharmacists would make to determine whether someone might
be at moderate risk of cardiovascular disease is based on age and lifestyle
factors.
However, the company does recommend that people taking Zocor Heart Pro
test their cholesterol levels so that they can monitor their progress. “We
are exploring options that will allow individuals access to an advanced
home cholesterol testing kit,” he says.
Pharmacists have, in the past, expressed concerns about reclassifying
cardiovascular drugs. In a consultation on the POM-to-P strategy document
published last year, Kathryn Featherstone, prescribing adviser, South
Tyneside Primary Care Trust, said: “The PCT’s main concern
is who would be responsible for monitoring patients.”
However, Johnson & Johnson’s application to switch simvastatin
from POM to P status says there is no requirement for routine liver function
testing. “Pharmacists and individuals will be alerted to the symptoms
and signs of obstructive hepatotoxicity,” the consultation document
states.
Sheila Kelly, executive director, Proprietary Association of Great Britain,
believes the switch is great news for patients and pharmacy alike. She
says the fact that cholesterol testing will not be a prerequisite for
pharmacy sale of simvastatin makes things straightforward for pharmacists. “There
has been a lot of pragmatic thinking gone into how this is going to be
managed,” she adds.
Christine Bond, professor of primary care pharmacy, University of Aberdeen,
sees the proposed switch as an important step for community pharmacy
that could act as a bridge to independent prescribing.
However, she has concerns about patients taking potent medicines for
chronic conditions when such use is not documented. This leads to a fragmented
record of care, and has implications for safety monitoring, she says. “Reclassification
of simvastatin should prompt discussion about how we integrate records
of OTC drug use with prescription medication.”
Professor Bond does not think that proposals for pharmacists to have “read
access” to patient records go far enough. “Pharmacists should
be able to write to the patient record with details of selected OTC sales,” she
says.
The responses to the proposed POM-to-P switch for simvastatin have been
altogether more positive than reactions to the switching of Levonelle
for emergency hormonal contraception. Michelle Styles, the NPA head of
information services, says the circumstances surrounding the two switches
are different. The target audience for over-the-counter simvastatin falls
outside the group of patients identified by the National Service Framework
for Coronary Heart Disease as eligible for statin treatment. “The
NSF and National Institute for Clinical Excellence guidelines have been
set with cost limitations in mind,” she says.
However, for those who need emergency hormonal contraception there are
several access routes — prescription, patient group direction and
pharmacy supply. This would not necessarily be the case for people at
moderate risk of cardiovascular disease (current guidelines suggest that
statin prescribing should first be directed at patients at high risk),
which raises concerns about inequality of access. At this stage there
is no indication of how much Zocor Heart Pro will cost. However, Johnson & Johnson
says it aims for it to be “affordable to as many people as possible”.
David Pruce says he would be concerned if people were unable to get a
medicine that would benefit them. “Whether we will see worsening
of health inequalities I don’t know. Some patients, instead of
purchasing the medicines OTC, will go and talk to their GP. The National
Health Service will have to deal with this question.” |
