May 12 2004
Ministers have accepted the advice of the Committee on Safety of Medicines (CSM) that simvastatin 10mg (Zocor Heart Pro) could be safely sold through pharmacies to reduce the risk of a first major coronary event in people likely to be at a moderate risk of coronary heart disease (CHD).
Following a ten-week public consultation exercise (ARM 18) on a proposal to make simvastatin 10mg available over the counter in pharmacies, the responses were referred to the Committee on Safety of Medicines (CSM) for advice. No new issues were raised in the responses to consultation and CSM advised Ministers that simvastatin 10mg could be safely sold under the supervision of a pharmacist without a prescription.
The Secretary of State, John Reid said:
"CHD is the nation's biggest killer. Giving people the chance to buy a preventative medicine that they would not otherwise be able to get must be right. Just as people have the choice to give up smoking and improve their diet, we want them to be able to choose a medicine that will reduce the risk of CHD. The switch of Zocor Heart-Pro enhances the role of pharmacists and provides the opportunity to put to better use their skills. Most importantly the public benefit from access to primary prevention treatment without compromising on professional expertise or advice. Of course, those known to be at high risk will continue to be prescribed statins as appropriate".
Chairman of the Committee on Safety of Medicines (CSM), Professor Gordon Duff said:
"Patient safety is the prime consideration in the decision to make a medicine available over the counter. 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".
Outcome of the consultation exercise (ARM 18)
Consultation letter ARM 18 was issued on 17 November 2003 with a deadline for comments of 16 January 2004. It was circulated within the health services, to interested organisations and officials in the Scottish Executive, Welsh Assembly and Northern Ireland (devolved administrations). One hundred responses were received expressing a wide variety of views on the proposed reclassification. Key pharmaceutical bodies, such as the Royal Pharmaceutical Society of Great Britain were in favour of the reclassification with only minor comments. Other pharmacy professional bodies, some of the Royal Colleges, some clinicians and patient groups such as Heart UK were supportive in principle of simvastatin being available as a pharmacy medicine, but raised issues over the proposals as presented. About two thirds of respondents were in favour of the proposal.