Over-the-counter simvastatin given the go-ahead
Simvastatin will become a pharmacy medicine this summer, it was announced on 12 May.
The Health Secretary, John Reid, said that he accepts the recommendation
of the Committee on Safety of Medicines that 10mg simvastatin (Zocor
Heart-Pro) should be switched to reduce the risk of a first major coronary
event in people at moderate risk of coronary heart disease. Before the
P medicine can be marketed, it must gain a licence from the Medicines
and Healthcare products Regulatory Agency. But now that Dr Reid, who
as Secretary of State for Health is the
licensing authority, has given his approval this step is only a formality.
“This move will allow more people to protect themselves from the
risk of coronary heart disease and heart attacks. By extending access
to this
drug we are giving people more choice about how they protect their health,” commented
Dr Reid.
The exact indication for Zocor Heart-Pro will not be known until the
licence is issued. However, a spokesman for Johnson&Johnson MSD said
that the licence application is based on the categories set out in the
consultation on the switch published last year. These are all men aged
55 years and over, and men aged between 45 and 55 years and women aged
over 55 years with certain risk factors (family history of coronary heart
disease, smoker, obese or of South Asian ethnicity).
Pharmacists will determine risk factors |
“Pharmacists will ask people a series of questions and, where appropriate,
offer a range of health tests to ensure that it is safe to issue this
drug,” said Dr Reid. A pharmacy protocol has been developed to
assist pharmacists in this process. It includes guidance on avoiding
drug interactions, according to a Department of Health spokeswoman.
Gordon Duff, chairman of the CSM, commented: “The safety of carrying
out this switch has been debated thoroughly and the case made convincingly
that the balance of potential health benefits and any possible risks
is overwhelmingly positive.”
The DoH spokeswoman said that final determinations over the licence will
be made in the next few weeks and simvastatin should be available over
the counter in the summer, probably in July. This was confirmed by Johnson&Johnson
MSD. A company spokesman added: “We are unable to comment on the
price until a licence is granted but I can say it will be affordable
and would equate it to around the price of a loaf of bread a day.”
The decision has been widely welcomed. Gill Hawksworth, President of
the Royal Pharmaceutical Society, said: “The Society believes that
there is a clear public health benefit to be gained from making this
important medicine available through pharmacies. The switch will give
pharmacists more
opportunities to use their skills.”
Sheila Kelly, executive director of the Proprietary Association of Great
Britain, said: “It is great that we now have an OTC medicine that
is for the prevention of serious illness. It takes self-care to a different
level.”
However, the Consumers’ Association warned: “The switch is
tantamount to using the UK public as guinea pigs and smacks of a cost-cutting
exercise.” |
The
Pharmaceutical Journal
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