Statins without a prescription?

By Maryanne Demasi, PhD

Today, cardiologist Robert DuBroff and I, published a letter in the Journal of the American College of Cardiology (JACC), arguing against the use of non-prescription statin therapy.

Our letter was in response to a recent study which tested whether an at-home, web-based program could determine if consumers would be eligible for a statin without a doctor’s prescription.

The consumer navigates a series of screens until the software generates an eligibility outcome. Those who meet the criteria, would be permitted to make an online purchase of the statin and have it shipped directly to them.

The results of the web-based program found ‘high agreement’ between consumers who made self-selected decisions about their eligibility for 5mg rosuvastatin (Crestor) and a clinician’s assessment.

The premise of the technology is that it may, one day, be able to supplant physicians when it comes to prescribing statins for cardiovascular disease prevention.

The design of the study, the technology, and the funding was provided by AstraZeneca, the original manufacturer of Crestor (generic name rosuvastatin) which is the drug being evaluated.

Cleveland Clinic cardiologist Steve Nissen led the study and said that non-prescription statin therapy would encourage better compliance by the consumer, it would reduce inequalities in healthcare through improved access to medicines and positively impact public health.

We, however, argued that non-prescription statin therapy is misguided.

Pills over lifestyle

There is already a widely available, highly effective therapy for the prevention of heart disease, which has few harms. It’s called a ‘healthy lifestyle’ and this was completely ignored in Nissen’s study.

The simplicity of taking a statin pill is likely to fuel patients’ complacency about being ‘protected’ from heart disease, at the expense of engaging in more protective lifestyle interventions such as regular exercise, not smoking, eating a Mediterranean-style diet and maintaining an ideal body weight. 

Over-estimating risk

The web-based application used by the researchers relied upon the use of the American College of Cardiology/American Heart Association (ACC/AHA) “risk calculator” to estimate the consumer’s risk profile.

However, a study led by Stanford University researchers found that the risk calculator significantly overestimates a person’s cardiovascular risk, and therefore, is likely to lead to unnecessary statin treatment.

Further, the application was based on guidance from the official ACC/AHA guidelines for the management of cholesterol, but it has proven to be unreliable. 

For example, one study found that 44% of people who were eligible for statin therapy based on the ACC/AHA guidelines, actually had a coronary calcium score of zero (meaning, their risk of heart disease was very low), and therefore, unlikely to benefit from a statin.

Another study showed that a majority of young people, who presented with a heart attack for the first time, would not have met the eligibility criteria for statin therapy based on the ACC/AHA guidelines.

Lack of shared decision-making 

Dr Nissen argues that using the online decision aid for non-prescription statin therapy, will afford patients a sense of ‘self-empowerment’ and greater autonomy, making it easier for them to access drugs without physician involvement.

However, patient–physician communication improves adherence to medications. Studies show that adherence to statin treatment is usually quite poor, with less than 50% of patients still taking their pills, one year after initiation. 

Bypassing the doctor-patient relationship also diminishes informed consent and shared-decision making. To prevent one death in low risk populations, 244 people would need to take a statin daily for 5 years. 

This is important information that should be communicated to patients since most of the promotional materials report the 'relative risk reduction' (more impressive numbers) and ignore the more relevant 'absolute risk reduction.' 

Further, minimising doctor-patient interaction means there is less opportunity to monitor and discuss adverse events - 62% of statin users decide to stop taking their medication because of adverse events, mostly muscle aches and pains.

Previous experience

Allowing statins to be sold without a prescription has been widely debated in the UK, the US and Canada.

In July 2004, simvastatin (10mg) was reclassified in the UK from a prescription-only medicine to become the first statin in the world to be sold without prescription.

It required pharmacists to be involved in all initial sales and to assess each customer’s suitability for the medicine, with the aid of a questionnaire.

At the time, there was no published clinical studies to determined what effect 10mg simvastatin daily had on heart disease morbidity or mortality, nor was there any data on compliance with over-the-counter statins. 

It was based on “assumptions” that reductions in LDL-cholesterol concentrations in the population would produce a corresponding fall in coronary heart disease events.

At the time, researchers said, “the UK population has, in effect, now been enrolled in a large experiment without adequate monitoring of benefits or risks.”

Several years later, researchers published an analysis of the controversial decision and the results were sobering.

They found that less than 1% of the UK’s population were taking simvastatin over-the-counter, and that the majority of them (71%) were also taking a prescription-statin. They concluded that few individuals who actually needed the statins were using them over-the-counter.

This did not dissuade the UK's National Health Service (NHS) from announcing, in 2019, that it would consider making statins available direct from pharmacists as part of its “Long Term Plan” to “save thousands of lives from deadly heart attacks and strokes.”

The NHS did not respond to questions when asked if it could provide evidence for its public statements.