Abstract

Simvastatin 10mg (Zocor Heart Pro®) became available for purchase under the supervision of a pharmacist (i.e. as a ‘P’ medicine) in the UK in 2004 and remains the only statin available for self medication worldwide.

This ‘switch’ from prescription only (POM) status was regarded as a landmark for self care, principally because the aim, for the first time, was self-management of risk: in this case moderate risk of a cardiac event in the next 10 years. Despite backing from specialists in cardiovascular diseases, the move was controversial, attracting adverse comments from general practitioners (GPs) in particular, and it consequently received a nervous and lukewarm response from pharmacists.  Several aspects of the switch were criticised: the dose was thought too low; the evidence-base in the target population was said to be inadequate; the lack of mandated cholesterol testing worried others and some simply considered the safety profile of statins as unsuitable for self care.

Now, 6 years on, usage of simvastatin for self care is very low, but statin use on prescription has continued to expand in the UK and elsewhere. This case study examines the rationale which drove the switch model and the reasons why, in the light of prevailing guidelines, the switch faced such opposition and criticism. The possible lessons to be learned and applied to future complex switch proposals are also discussed.