Government backs over the counter Zocor
pharmafile | November 21, 2003 | News story | |Â Â Â
The Government has declared its strong backing for statins to be made available to consumers over the counter as early as next summer.
Merck Sharp & Dohme's prescription only product Zocor (simvastatin) was the UK's number one selling drug in 2002 but came to the end of its patent life earlier this year.
Now sister company Johnson & Johnson MSD Consumer Pharmaceuticals plans to launch it as the first ever major cardiovascular drug to be sold through pharmacies direct to consumers.
The move, which seems unlikely to be blocked, will represent a transformation of the OTC market, and could have a number of far-reaching implications for the prescription only medicines market as well.
Health Secretary John Reid announced a six-week consultation on the drug's POM to P switch by declaring it a world first, and said it would, if successful, confirm the UK as a leader in making medicines available to patients through pharmacies.
"Independent expert advice suggests that many people could benefit greatly if statins were made more widely available, possibly saving hundreds of lives per year and preventing a higher incidence of coronary heart disease,"Mr Reid said.
The Department of Health says 1.5 million people are currently taking a statin, which it says could potentially save 6,700 lives a year and significantly reduce the number of heart attacks. The health secretary is now backing the OTC move, which is expected to reach people who may otherwise never visit a doctor for a prescription.
Mr Reid continued: "Giving people the chance to buy a preventative medicine that they would not otherwise be able to get must be right. Just as people have the choice to give up smoking and improve their diet, we want them to be able to choose a medicine that will reduce the risk of CHD.
"The case for making statins over the counter needs to be looked at widely. But if generally agreed, this would be a far reaching move, and one that we are keen to introduce.
Johnson & Johnson MSD Consumer Pharmaceuticals is one of the consumer market's biggest players, and has major brands such as antifungal product Daktarin Dual Action and acid reflux product Pepcid AC in its portfolio. The company is almost certain to launch a multimedia marketing campaign for Zocor Heart Pro, breaking new ground for a product which will still be central to NHS prescribing.
While many stakeholders have backed the plans, some have expressed doubts about the move.
Dr Jim Kennedy Prescribing Spokesperson The Royal College of General Practitioners said the society supported good access for patients, but said the 'significant step' raised a number of important questions.
He said the reclassification would mean the core health aims of prevention and treatment of heart disease or stroke would now be in the hands of the consumer.
"This raises the issue as to whether we, as a society, want healthcare costs to be financed by society as a whole or if we want some healthcare costs moved to patients as individuals.
He added that the proposal would also require greater sharing of relevant clinical information between pharmacists, GPs and other primary healthcare professionals.
"Pharmacists currently do not have access to a patient medical record which would help them judge whether statins were necessary. There would also need to be a system in place for pharmacists to inform GPs about patients to whom statinshave been prescribed," he said.
Joe Collier, professor of medicines policy at St George's Hospital medical school and editor of the Drugs and Therapeutic Bulletin told the Financial Times: "It seems to me a worrying precedent that patients will effectively diagnose themselves and will go on to treat themselves lifelong with drugs that do have side-effects and interactions. I am not sure that either the NHS or the public is mature enough at present to take this on."
The Consumers' Association, often staunch critics of the industry insisted it did not oppose all reclassifications, but said concerns remained about the appropriateness of the Zocor switch and the quality of training materials for pharmacists.
Wendy Garlick, Principal Policy Advisor at the Consumers' Association said the increasing number of POM to P switch and the shortness of the consultation periods were another concern.
She added: "We also think that this is another way of beginning DTC advertising through the back door, particularly in view of how quick the process is. I don't think you can underestimate the effect of the promotional opportunities that it brings with it."
The Zocor switch dovetails with a number of other pharmacy reforms, which will come together in the next few months to transform pharmacy-based healthcare. Community pharmacists across the country are already piloting extended services including medicines management, repeat and supplementary prescribing services which are intended to open the profession up to providing a complementary channel for patients in primary care.
Another related consultation on de-regulating advertising of OTC medicines is due to close at the end of December. If approved, restrictions on advertising medicines for a number of serious conditions – including heart disease – will be lifted paving the way for adverts promoting such as Zocor Heart Pro in all media including television and radio.
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