Simvastatin could become a pharmacy medicine within the next six months
Simvastatin 10mg looks set to be reclassified as a pharmacy medicine
called Zocor Heart-Pro |
Simvastatin could be available over the counter within six months, the Health Secretary John Reid said earlier this week.
His announcement was made at the launch of a consultation by the Medicines
and Healthcare products Regulatory Agency on a proposal to reclassify
the drug from a prescription only to a pharmacy medicine.
Dr Reid said: “Giving people the chance to buy a preventive medicine
that they would not otherwise be able to get must be right. The case
for making statins over-the-counter needs to be looked at widely. But
if generally agreed, this would be a far reaching move and one that we
are keen to introduce.” He added that if the switch is successful,
it would be a world first.
The move has been welcomed by the Royal Pharmaceutical Society. Dr Gill
Hawksworth, President of the Society, said: “The Society will be
working to support its members in this important step. This will ensure
the public receives the maximum benefit from the safe use of these important
medicines.” Other national pharmacy bodies to welcome the proposed
switch include the National Pharmaceutical Association, PharmacyHealthLink
and the Proprietary Association of Great Britain.
The launch of the consultation indicates that the Committee on Safety
of Medicines deems that simvastatin is suitable for over-the-counter
use. Professor Gordon Duff, chairman of the CSM, said: “The first
consideration must always be patient safety and before a medicine can
be made more widely available, it is assessed against strict criteria
relating to its safety in the circumstances in which it will be used.”
The application for the proposed switch comes from Johnson & Johnson
MSD, manufacturer of Zocor. The company wants all people who are likely
to be at moderate risk of coronary heart disease to be able to buy its
product (Zocor Heart-Pro) direct from pharmacies. The consultation document
outlines how pharmacists will identify those people at moderate risk
and sets out the rationale for reclassification.
The results of the consultation exercise will be presented to the Committee
on Safety of Medicines for advice in early 2004. If the reclassification
is approved Zocor Heart-Pro could be available in pharmacies in the spring.
The full consultation document (ARM 18) is available on the MHRA website
(www.mhra.gov.uk). Comments should be sent to Amanda Lawrence, at the
MHRA, to arrive by 16 January 2004.
News feature, p705 |
