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LETTERS: D Graham Mackenzie, Sarah H Wild, and Philip Rutledge Are eligibility criteria for over the counter statins appropriate? BMJ 2006; 333: 704 [Full text]

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Are eligibility criteria for over the counter statins appropriate?: Royal Pharmaceutical Society of Great Britain responds

Sadia Khan   (6 October 2006)

Are eligibility criteria for over the counter statins appropriate?: Royal Pharmaceutical Society of Great Britain responds 6 October 2006
Sadia Khan, Lead Pharmacist for Self-Care Royal Pharmaceutical Society of Great Britain 1 Lambeth High Street, London, SE1 7JN Send response to journal: Re: Are eligibility criteria for over the counter statins appropriate?: Royal Pharmaceutical Society of Great Britain responds	Dear Sir, In response to the letter, Are eligibility criteria for over the counter statins appropriate? published in the BMJ (30 September), the Royal Pharmaceutical Society of Great Britain (RPSGB) would like to make the following points. The MHRA agreed a risk assessment model as part of the licensing process for simvastatin as a pharmacy medicine. This became part of the summary of product characteristics (SPC) and was referred to in the RPSGB’s practice guidance on the sale of simvastatin from pharmacies. It is based on a number of characteristics that in various combinations would suggest an individual is at moderate risk of coronary heart disease (10 year risk of coronary heart disease 10-15%). The Society’s guidance is available in both detailed [1] and concise [2]formats. The full guidance makes reference to other risk assessment calculators for coronary heart disease and highlights that since the “over the counter” version of simvastatin is being targeted at a specific group of moderate risk people the risk assessment process has been simplified somewhat. It highlights that pharmacists should consider whether to use a formal CV risk assessment tool in their practice. In approving simvastatin for sale as a pharmacy medicine, the MHRA did not make cholesterol tests and blood pressure monitoring prerequisites for sales of OTC simvastatin [3]. However, the Society advises that it is good practice for pharmacists to offer these tests if services are available. The importance of establishing local communications e.g., how GPs wish to be informed of purchases of simvastatin or test results and agreeing local policy for referrals is also mentioned in the Society’s guidance. The authors express concern that reclassification of simvastatin may result in under-treatment of high risk individuals. However, purchasing an OTC statin does not stop GPs inviting their patients to attend for risk assessment, nor does it stop this being performed by the practice. Indeed, pharmacists may help by identifying individuals at higher risk resulting in a referral for formal risk assessment and prescribed treatment for those who previously may not have even known to request this service, or considered it important. Yours faithfully Sadia Khan, Lead Pharmacist for Self-Care Royal Pharmaceutical Society of Great Britain [1]OTC simvastatin practice guidance, concise version http://www.rpsgb.org/pdfs/otcsimvastatinguid.pdf (accessed 5 October 2006) [2]OTC Simvastatin practice guidance, detailed version http://www.rpsgb.org/pdfs/otcsimvastatincardguid.pdf (accessed 5 October 2006) [3]Zocor Heart-Pro SPC Competing interests: None declared