HL Deb 29 March 2004 vol 659 cc140-1WA
Lord Clement-Jones

asked Her Majesty's Government:

What clinical evidence exists concerning the efficacy of statins for those at lower risk of cardiovascular disease in a self-treating population; and [HL2025]

How the impact on cholesterol levels of simvastatin provided in a pharmacy setting would be monitored; and [HL2026]

Whether provision of simvastatin in a pharmacy setting would increase the potential for adverse interaction with other medicines prescribed by a patient's general practitioner. [HL2027]

Lord Warner

The Government have consulted publicly on a proposal to make simvastatin 10mg available over the counter in pharmacies, to reduce the risk of a first major coronary event in people who are likely to be at a moderate risk of coronary heart disease. The Committee on Safety of Medicines (CSM) will advise Ministers on the proposals in the light of the responses to consultation.

Although there have been no direct studies carried out with simvastatin 10mg in the proposed population, there is a very substantial body of evidence that supports the efficacy of statins in reducing cardiovascular risk. CSM was satisfied that simvastatin 10mg was effective in the proposed population.

Current evidence suggests that, for adults in Western societies, it can be beneficial to reduce cholesterol levels whatever the starting point and on this basis, the measurement of cholesterol is not a prerequisite for a decision on the potential benefit of taking a statin. The intention is that pharmacists will be able to offer cholesterol testing to people who want it—including follow-up testing at defined intervals.

Pharmacists will be trained to ask the right questions to make sure that they only sell statins to people who will benefit from them—in the same way as they manage the sale of all other pharmacy-only drugs. Pharmacists will be trained to ask patients about their previous medical history and any other medicines that they may be taking. The potential for drug interactions will also be addressed in the patient information leaflet and patients will be encouraged to inform their general practitioner of their use of a statin.

The MHRA/CSM operates the Yellow Card Scheme by which doctors and pharmacists report suspected adverse drug relations to medicines. This system applies to both prescription and nonprescription medicines and will enable the continued monitoring of the safety of the medicine in pharmacy use.

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