§ Dr. MurrisonTo ask the Secretary of State for Health (1) what assessment he has made of the implications for the workload of community pharmacies of delivering over-the-counter statins; [141042]
(2)what consultation he has had with pharmacists on the dispensing of over-the-counter statins; [141043]
(3)what checks will be carried out by pharmacists dispensing over-the-counter statins; [141044]
(4)what assessment he has made of the number of lives likely to be saved each year through over-the-counter availability of statins. [141045]
§ Ms Rosie WintertonNo assessment is routinely made by the Medicines and Healthcare products Regulatory Agency (MHRA) on the workload of community pharmacists when the legal status of a product is changed from a prescription only medicine to a176W pharmacy only medicine, nor when a product changes from a pharmacy only medicine to general sale list availability.
The consultation document (ARM 18) on a proposal to allow simvastatin 10mg to be available over the counter through pharmacies rather than on a prescription has been distributed widely, including to the Royal Pharmaceutical Society of Great Britain (RPSGB) and the National Pharmaceutical Association (NPA). All pharmacists have been made aware of the consultation exercise via the Pharmaceutical Journal, which directed pharmacists to the consultation document displayed on the MHRA's website. At the end of the consultation period, the responses received will be considered by the Committee on Safety of Medicines (CSM) which will advise Ministers.
The applicant company for the proposal to supply simvastatin 10mg over the counter is proposing to conduct a pre-launch pilot study in a number of pharmacies to test the feasibility of the pharmacy protocol. This will provide valuable information about the supply of the product, will highlight areas for improvement and will test the overall feasibility of pharmacy availability. The proposed protocol, including a questionnaire, will be introduced for first time purchasers of simvastatin 10mg to be completed at the start of the supply process. It is proposed that the questionnaire focuses initially on age and then where appropriate, other risk factors for Coronary heart Disease (CHD) i.e. age (if below 55), family history, smoking, ethnicity, obesity. Based on the responses to the questionnaire, the pharmacist will be able to identify individuals for whom simvastatin 10mg would be suitable. An education and training package is being developed to support the pharmacist in the sale and supply of simvastatin 1Omg. Pharmacy bodies including the RPSGB, the NPA and the Centre for Postgraduate Pharmacy Education (CPPE) are being consulted on this material.
The RPSGB's code of ethics and standards sets out the professional standards all pharmacists are expected to follow when dispensing medicines against a prescription or when selling pharmacy medicines. The code is published as part of the Society's Medicines, Ethics and Practice, A Guide for Pharmacists which is available on its website at www.rpsgb.org.uk.
Pharmacists will be able to offer cholesterol testing to people who choose to take up this option. The CSM has advised that it is beneficial to reduce cholesterol levels regardless of the starting level of cholesterol. The safety profile of statins at a low dose is such that CSM advised that there is no need for routine liver function tests once treatment has started.
The number of lives likely to be saved each year through over-the-counter availability of statins will depend on the level of take up of the product that would not otherwise he available on prescription. Individual risk reduction could be by as much as a third after three years of treatment.