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Statins
OTC simvastatin will benefit the public and the profession
From Mr H. R. Patel, FRPharmS
The Government has announced that the heart drug simvastatin will be
available without prescription after the Committee on Safety of Medicines
(CSM) recommended that simvastatin should be available over the counter
in a 10mg dose.
Ike Iheanacho, deputy editor of the Consumers’ Association Drug
and Therapeutics Bulletin, said in a press release: “Consumers’ Association
has major concerns about the move to make this statin available over
the counter, particularly given the lack of evidence on how effective
and safe this strategy will be. It could be that public health is being
put in jeopardy.”
Jim Kennedy, prescribing spokesperson, the Royal College of General Practitioners,
also showed concern at the move, saying in a press release: “Unless
the system is rigorously managed simvastatin could be made available
to those who do not need it and the risk of the drug may then outweigh
the benefits. Pharmacists will be under a lot of pressure to assess the
risk of cardiovascular disease.”
The facts of the case are:
· Statins are generally considered to be safe and are well tolerated.
There is a wealth of clinical trial evidence indicating a low level of
adverse effects. Elevations in liver transaminases occur in 1–2
per cent of patients and, hence, statins are contraindicated in those
with liver disease
· Statins (inhibitors of 3 hydroxy-3-methylglutaryl [MHG] coenzyme A
reductase) are effective agents in the primary and secondary prevention
of coronary heart disease in the general population, and in diabetes
· Statins can effectively address the problems of dyslipidaemia, lowering
triglyceride and low-density lipoprotein cholesterol, and increasing
high-density lipoprotein cholesterol
· The magnitude of the benefit from statin treatment appears to be independent
of a patient´s LDL cholesterol level, vascular history or global
risk status
· There is a gap between the principles and practice of coronary disease
prevention and the majority of high-risk individuals are either under-treated
or not treated at all
· Most of the commonly prescribed statins (simvastatin, pravastatin and
atorvastatin) have now been the subject of large, long-term clinical
trials, and have been used by millions of patients worldwide and hence
been subject to extensive post-marketing surveillance. This experience
has generated confidence in this class of drugs and the recognition that
they are both safe and efficacious
So, having raised the issue of improving public health through community
pharmacy and a need for pharmacists to develop clinical and diagnostic
expertise, I cannot allow the above comments to go unchallenged. The
nation needs to better focus on preventive aspects, and not just medical
aspects, of care to ensure that the health system of the future is able
to cope with the increasing workload due to preventable diseases — and
the nation is able to afford it.
What Dr Iheanocho and Dr Kennedy seem to ignore is that the results of
the landmark Heart Protection Study1 gave rise to an incredibly large
collection of candidates for statin therapy and led to the conclusion
that lipid-lowering therapy reduced the risk of cardiovascular events
regardless of baseline low-density lipoprotein cholesterol (LDL-C) levels
in a large cohort of relatively low-risk patients.
I urge all community pharmacists to ensure that this opportunity is welcomed
with open arms and that this safe and potent product is consistently
prescribed over the counter using a protocol designed to ensure patient
safety and protect pharmacy’s reputation. How long will it be before
the Consumers’ Association, which also publishes Which?, starts
looking for “defects in the system” to ensure that the conclusions
it published before the launch of the product, effectively passing a
vote of no confidence in pharmacy, are justified?
I believe that in due course the public and the pharmacy profession will
benefit. What the doctors have also not taken into account is the fact
that one in four customers (as compared with patients) leave pharmacies
with nothing more than good advice.
Hemant Patel
North-East London Local Pharmaceutical Committee
Reference
1. Mitchell LB, Powell JL, Gillis AM, Kehl V, Hallstrom AP, and the
AVID Investigators. Are lipid-lowering drugs also antiarrhythmic drugs?
An
analysis of the antiarrhythmics versus implantable defibrillators (AVID)
trial. Journal of the American
College of Cardiology 2003;42:81–7.
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