Consumers' Association voices concern at over the counter statinsBMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7461.310-e (Published 05 August 2004) Cite this as: BMJ 2004;329:310
As statins went on sale without prescription in British pharmacies last week, the Consumers' Association argued that the public is being used as guinea pigs.
Simvastatin, one of the earliest and most used statins, is the first to be approved and will be sold in a low dose (10 mg) formulation under the brand name Zocor Heart-Pro, by Johnson & Johnson MSD.
Existing NHS guidelines say that statins should be prescribed only to patients who face a 30% risk of a heart attack over 10 years, but over the counter sales will be aimed at a lower risk category. Pharmacists will be expected to assess cardiovascular risk by asking questions, but they will not perform blood tests or seek a detailed family history.
The move was announced by Health Secretary John Reid in May, after public consultation, and with backing from the Committee on Safety of Medicines. Currently, about 1.8 million people in Britain are receiving statins, and the Department of Health estimates that the drugs save 7000 lives each year.
The Consumers' Association argues that no clinical trials have established statins' efficacy when they are targeted at people with moderate risk of heart disease. Spokeswoman Wendy Garlick said: “Not only is the government's move of concern from a safety point of view, but the availability of Zocor over the counter also moves the financial burden away from the NHS and on to the public as well as allowing drug companies to directly advertise statins to the public.”
The King's Fund welcomed the decision to make statins available without prescription, but not the decision to make patients pay for them. Its chief executive, Niall Dickson, said: “The cost of statins should not be passed from the NHS on to the patient. This is another example of the creeping charges emerging in the NHS. These charges have developed with no clear explanation of why they exist and we are now left with a complex system, riddled with unfairness and inconsistencies, that compounds existing health inequalities and penalises the poor.”
Dr Jim Kennedy, prescribing spokesman of the Royal College of General Practitioners, said he was concerned that the pharmacists are not obliged to conduct extensive tests and have no access to medical records. “Unless the system is rigorously managed, simvastatin could be made available to those who do not need it and the risk of the drug may then outweigh the benefits.”
But pharmacists welcomed the extra responsibilities. Dr Gillian Hawksworth, president of the Royal Pharmaceutical Society of Great Britain, said over the counter stain sales would “enhance patient care and give pharmacists more opportunity to use their skills.”
The British Heart Foundation's associate medical director, Tim Bowker, said the change “will help improve many people's lives and reduce their risk of suffering a heart attack or stroke.”