The British National Health Service provides all treatments and procedures without out-of-pocket costs—but often with significant delay. To reduce health system costs, the British government decided to permit over-the-counter (OTC) sale of simvastatin, which had lost patent protection in the United Kingdom. Because the patient makes the decision to buy and take the pill, it is no longer the government’s responsibility to pay for it. British patients do not need a prescription to purchase simvastatin, but they are provided with education material that describes contraindications, such as pregnancy, liver disease, allergies, and interacting medications.
Who then is likely to buy the statin? The persons most likely to benefit are those at intermediate risk for vascular disease (ie, a less than 20% risk in 10 years). Many lipid specialists in the United States recommend treating patients at lower risk depending on a variety of factors, including patient preference, family history of cardiovascular disease, and perhaps inflammatory markers.
There is growing interest in similar plans to make statins available OTC in the United States. The aim is to improve public health by wider distribution of these medications. But do the benefits of OTC availability outweigh the drawbacks? Here, I examine the pros and cons.
Lower prices. An immediate benefit of making statins available OTC would be a reduction in cost. Currently, most statins retail for several dollars per pill, with special discounts to large consumer groups, including HMOs, the VA system, and Medicaid. Early data suggest that generic OTC statins will cost much less: about 66 cents per day or roughly $200 per year. The lower price and easier availability could lead to wider use.
Better compliance. Another possible benefit is that persons who make the decision themselves to take a statin will be more compliant with therapy. Many patients prefer to take control of their own health care; this is an advantage for those who are uncomfortable with or who may not be able to afford a physician’s care.
Lower LDL levels. If more persons do take statins, the average low-density lipoprotein (LDL) level of the population should be reduced; thus, more persons would benefit from primary and secondary cardiovascular risk reduction.1-4 Other benefits attributed to statins include a reduction in the levels of inflammatory markers of rheumatoid arthritis5 and reduced risks of Alzheimer disease,6 bone fractures,7 pulmonary embolism,8 and congestive heart failure.9 Statins also appear to decrease levels of C-reactive protein, a substance with proatherosclerotic effects of its own.10
No “team leader.” The lack of monitoring by a health care provider is likely to lead to over-treatment or under-treatment in many patients. Because the OTC statins will be available in a fixed dose, some patients with high LDL levels may not reach their targeted goal, while others with relatively low LDL levels may take statins for years without demonstrable gain.
No coverage. Although the cost per pill will be less, medical insurers usually do not pay for OTC medications. Thus, some persons will wind up paying more. If the OTC program is modified to require monitoring of LDL level and liver functions, the cost savings evaporate. Currently, the British program does not require repeated testing for liver impairment.
Physician backlash. Arguments that OTC use will enhance patient compliance are speculative and not proven. And although patients may feel empowered by the OTC availability of statins, many physicians will be justifiably concerned. Significant liability issues remain. For example, if a physician prescribes a medication but is unaware that the patient is using an OTC statin, the physician may be liable if a drug interaction causes significant toxicity. The patient may seek legal redress, and the courts do not necessarily recognize good science or patient responsibility. If a class action suit follows, the outcome could be costly to the physician, the industry, and society.
A tarnished patient-physician relationship. A further disadvantage is the blurring of the physician-patient relationship. A convincing and effective advertising campaign could lead to conflict if it causes patients to disregard their doctor’s advice and judgment.
TIME FOR A NATIONAL DEBATE
Permitting the OTC sale of statins may open a Pandora’s box. If OTC availability of statins proves safe and effective, this approach might extend to include other asymptomatic diseases, such as hypertension. This would further reduce physician input in selecting who requires therapy and at what dosage.
The use of OTC medications by laypersons raises concerns about casual dosing, drug-drug interactions, and the failure to adhere scrupulously to printed warnings. There are little long-term data on this subject, although studies are currently under way. The liability issue may be defused by the addition of informed consent and the acceptance of arbitration in the case of injury.
Many powerful drugs are currently sold OTC in the third world. Scant information is available on the risk-benefit ratio in these countries.
We know that statins are safe and effective. I am interested in your feedback about whether you believe, as I do, that the time is ripe for a national debate on the pros and cons of OTC statin use. Please e-mail your comments to me at [email protected].