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This week’s launch of over-the-counter simvastatin is a big first
for pharmacists in the UK. For one thing, it is the first OTC statin
in the world. But perhaps even more importantly it marks a new step in
pharmacists’ role in preventing chronic disease: for the first
time, they will be able to recommend starting a pharmacy medicine that
can reduce the risk of heart disease occurring.
Reducing heart disease risk is what OTC simvastatin is all about. This
is something that Johnson&Johnson MSD, the manufacturer of the OTC
product (Zocor Heart-Pro), is keen to stress. And it is an important
distinction to make. “We don’t want people to get too fixated
on numbers: this is about risk reduction not cholesterol reduction,” says
Stephen Mann, the company’s vice-president of
research and development in Europe.
This explains why the pharmacists’ assessment of whether or not
Zocor Heart-Pro is appropriate will be made on a person’s risk
factors rather than the results of a cholesterol test. It is probably
good news since accurate cholesterol testing requires the patient to
have fasted for 12 hours before the test and for a full lipid profile
to be measured. Offering this kind of assessment before selling simvastatin
would not be easy for many pharmacists, or convenient for patients. Even
with an accurate test, pharmacists will still need to carry out the risk
assessment.
The company’s justification for basing the assessment on risk factors
is that the beneficial effect of reducing low density lipoprotein (LDL)-cholesterol
on CHD risk holds
true regardless of the starting level of LDL-cholesterol. “Serum
cholesterol alone is a poor predictor of risk because of the number of
other factors which contribute to overall CHD
risk,” it states. However, Dr Mann adds: “But this is not
to say that cholesterol testing isn’t useful. People can use tests
to see how they are progressing, which can help with compliance. Tests
will also pick up the odd person who is inadequately treated.”
So what are the risk factors?
Zocor Heart-Pro is indicated for people at moderate risk of a major
coronary event,
defined as a 10–15 per cent risk of an event in the next 10 years.
These categories are
described in detail in practice guidance produced by the Royal Pharmaceutical
Society and published in this week’s Journal (see p169). But to
summarise, all men aged between 55 and 70 years are eligible for treatment
along with men aged between 45 and 55, and women aged over 55, who have
one or more of the following risk factors: family history of CHD, smoker,
overweight or of South Asian family origin. The company estimates that
seven million people in the UK fall into this “moderate risk” category.
Pharmacists will use a tick-box questionnaire supplied by the company
to determine whether or not simvastatin is suitable for a customer. The
form covers risk factors, medical history and other medicines. “A
pilot of the form showed that for a fair proportion of people, it could
be completed in four minutes. For the bulk, it could be completed in
eight minutes,” says Dr Mann. The form has two copies: the top
copy is given to the
customer in a plastic wallet to be produced for repeat purchases so that
sales can be made without the need for the detailed questions. The second
copy is for the pharmacist to keep. One area of concern is the fact that
pharmacists do not have access to patients’ medical records. This
means that they cannot record that a person is taking OTC simvastatin
in a place that other health professionals can see; encouraging customers
to inform their GP is the best alternative.
Despite cholesterol tests not being necessary, a branded Zocor Heart-Pro
home
cholesterol test has been developed. It is a
finger-prick test, is sold through pharmacies, and the blood sample is
sent away for analysis. According to the company, the test provides a
full lipid profile, is as accurate as tests carried out by GPs and is
returned to the customer with an explanation of what the results mean.
Customers are given the option of a copy of the results to be sent to
their GP.
In the run-up to the launch of OTC simvastatin, questions have been raised
over the efficacy of the10mg dose. Dr Mann responds: “Simvastatin
has a log-linear dose response.” This means that the 10mg dose
achieves 75 per cent of the response achieved with the 40mg dose, he
explains.
There is also a trade-off with safety. On the whole, simvastatin has
a good safety
profile but, in rare cases, serious side effects do occur. These tend
to be linked either to high doses or to interactions with other drugs. “So
the 10mg dose gives the bulk of the effect with the lowest risk of adverse
events,” says Dr Mann. Some concerns have been raised over interactions.
Dr Mann says that the only commonly used medicines that statins interact
with are antibiotics. “You have to remember what the interaction
does — it boosts the effect of the statin,” he says. So the
possibility of an interaction resulting in a toxic level of statin is
greater at higher doses. Educational and extended role
However effective statins are, they are not the only answer to reducing
CHD risk. Lifestyle changes are hugely important. This is something
that Johnson&Johnson MSD has recognised. “It is not just
about selling tablets. There is a big educational job, too,” says
Dr Mann. So when a consumer starts taking Zocor Heart-Pro, he or she
is invited to join a free educational programme in which a personal
action plan is developed. This includes exercise plans, steps to adopting
a healthier diet and advice on stopping smoking, including referral
to a pharmacist for nicotine replacement therapy. Pharmacists are also
encouraged to provide lifestyle advice.
The launch of OTC simvastatin provides a new choice. For patients,
it is a new
approach to reducing their risk of heart disease. Although for some people,
the price — at £12.99 a month or around 45p a day — will
be prohibitive, many people will be
persuaded that spending the equivalent of the price of a couple of cigarettes
or a packet of crisps each day on a tablet that could save their lives
is a price worth paying. And for pharmacists, it marks the start of a
new chapter in managing chronic disease in the pharmacy.
Pharmacist Noel Wicks was a member of the panel that advised Johnson&Johnson
MSD on the switch. “It is a new step for pharmacists. We are seen
as the guys for minor ailments but we are moving towards having a much
greater role in chronic disease management,” he says. Part of this
role is managing repeat prescriptions but the introduction of OTC simvastatin
adds a new
dimension. “In pharmacy, we tend to be reactive rather than proactive.
So our biggest challenge is to be proactive in identifying who will benefit
from simvastatin.”
But the responsibility of ensuring OTC simvastatin is used correctly
is not a light one. Tim O’Donoghue, a pharmacist at Greenlight
Pharmacy in London, says that pharmacists need to rise to the challenge
of demonstrating their skills. “This new category offers pharmacists
the chance to develop long-term customer relationships,” he comments. “This
is a landmark switch and one that could change the pharmacy arena forever.” |
The
Pharmaceutical Journal