Move to sell statins over the counter raises concerns

Doctors' leaders and consumer bodies have raised concerns about the UK government's decision to allow the cholesterol lowering agent, simvastatin, to become available without prescription in pharmacies.

The reclassification, announced last week by the Department of Health to increase patients' choice and to help reduce coronary heart disease, will be the world's first for a statin. About 1.8 million people in England are prescribed statins, costing the NHS around £700m ($1200m; €1000m) a year. Some £309m is spent on simvastatin alone.

The over the counter product, to be called Zocor Heart-Pro (10 mg), will be aimed at people with a moderate risk of developing coronary heart disease (having a chance of developing it of between 1 in 10 and 1 in 7). The department says that, under present guidelines, patients who have a 30% chance of a heart attack in the next 10 years are eligible for statins on prescription.

Before the over the counter product can be sold the pharmacist must undertake a risk assessment of the person. Patients considered at moderate risk would include men aged 55 years or more, or men aged between 45 and 54 years and women aged over 55 who have one or more risk factors (for example, a family history of coronary heart disease or being a smoker, overweight, or of South Asian ethnicity).

Although a cholesterol test would not be obligatory before the product could be bought, Johnson & Johnson MSD, the company that will be marketing it, expects that most patients will have one. It plans to market a test to complement the product.

Before simvastatin (pictured) is sold to a patient over the counter, the pharmacist will have to do a risk assessment

Credit: JAMES KING-HOLMES/SPL

While pharmacists' groups and the British Heart Foundation backed the reclassification, others have not been so supportive. Dr John Chisholm, chairman of the BMA's General Practitioner Committee, was concerned that patients would not have a thorough risk assessment, that the dose may be too low, and that there was potential for side effects.

“If a drug treatment is worth taking it should be provided equitably and available to all patients at NHS expense and on the basis of need, not their ability to pay,” he said. The King's Fund, a charitable health research foundation, said it was another example of “creeping charges” in the NHS.

The Consumers' Association said no specific clinical trials had proved that selling the product over the counter was effective in the target population. It also said that the real reason behind the switch was that simvastatin lost its patent protection in May 2003.

The over the counter product is to be launched in the summer. Meanwhile, Merck is planning to refile an application in the United States in the next 12 months to switch lovastatin to an over the counter drug. The US Food and Drug Administration rejected its first application in 2000 (BMJ 2000;321: 198).