One in four Canadians over the age of 20 are at a significant risk of developing cardiovascular disease. Despite their proven efficacy as a lipid-lowering therapy for patients at risk, statins continue to be under-prescribed and underused. Proponents of over-the-counter statins argue that increased accessibility will improve usage and lighten the economic burden of cardiovascular diseases. Furthermore, statins have proven to be clinically effective at low doses. Despite these potential benefits, statins should not be approved as over-the-counter drugs as they are accompanied by greater risks of misuse compared to prescription statins. Over-the-counter approval of statins would set precedence as the first approval of a drug made specifically for treating chronic diseases. This opens up the possibility for future prescriptions to be approved as over-the-counter drugs that will be accompanied with their unique benefits and inevitable risks.
Cardiovascular disease (CVD) is a class of heart diseases primarily caused by the narrowing of blood vessels. Elevated cholesterol, high blood pressure, and smoking status are some significant risk factors of CVD. The Framingham risk score, an assessment tool that estimates a patient’s risk of developing CVD over the next ten years, is computed using these risk factors. This score is then used by clinicians to determine whether a patient is at high, intermediate, or low risk of CVD. Usually, patients at intermediate and high risk are prescribed statins as a preventative therapy. Statins are prescription drugs that decrease the synthesis of cholesterol and can lower one’s risk of CVD by 20-25%. The clinical efficacy of statins has been shown in numerous studies and validated by the United States Food and Drug Administration (FDA). While 18 million Canadians are currently at intermediate risk of CVD, only four million receive cholesterol-lowering therapy. Those left untreated constitute one-third of Canada’s coronary artery disease cases. Herein lies the treatment gap.
Improvement of statin use in Canadians has been lackluster, increasing by only five percent in patients from 1992 to 2009. This poses a significant problem since statins are the primary method used by the healthcare industry to reduce CVD. Approval of over-the-counter (OTC) low-dose statins, which would not require prescriptions, presents a potential solution to narrowing the treatment gap. Through easier accessibility, OTC statins may effectively combat barriers to treatment, including long physician wait times and expensive physician visit costs.
Benefits of Bridging the Treatment Gap
A ten-year cost-effectiveness model of the United States drug market was used to predict the effects of a switch to OTC statins on usage, disease burden, and health care costs. The model found the introduction of OTC statins would result in a 27% increase in usage. Such a change would lead to 293,492 fewer major vascular events and 135,299 fewer revascularization procedures, a treatment to bypass blocked arteries, in the next decade. This would ultimately save 10.8 billion dollars in health care costs. The reduction in physician office visits would further save nine billion dollars.
Given these benefits, Merck & Co requested to have their OTC statin, Lovastatin, approved by the FDA. If Merck & Co received approval, it would have set precedence as the first pharmaceutical company to sell an OTC drug intended for treating chronic diseases, which could vastly affect future OTC drug approval.However, the FDA rejected this request due to a number of risks associated with unregulated statin use, sparking controversy around OTC statins. We believe that the FDA should not approve OTC statins due to the increased potential for misuse, low adherence, and adverse drug interactions involving statins.
Risk of Unregulated Accessibility
Clinicians play a key role in assessing a patient’s need for statins by considering blood test results in an overall risk assessment. They also educate patients on managing other risk factors such as physical inactivity and blood pressure. Without this intervention, individuals may misinterpret blood test results or forego cholesterol testing prior to their drug purchase. Hence, the use of statins by individuals at low risk of CVD might unnecessarily elevate the risk of side effects. A multi-centre study conducted in the United States in 2004 simulated an OTC setting to investigate potential consumer activity following the introduction of OTC statins. The results revealed that 20% of people purchasing statins were low-risk, while 25% did not undergo cholesterol testing.
High-risk patients are equally susceptible to statin misuse. Since low-dose OTC statins can only effectively treat intermediate-risk patients, high-risk patients should continue using their prescription statins and avoid using low-dose OTC statins. The aforementioned study showed 23% of low-dose statin consumers were either high-risk or had too high cholesterol levels to be effectively treated by low-dose statins. High-risk patients may substitute prescription statins for their OTC counterparts because they are cheaper and more accessible to the public. Since OTC statins’ dosages are too low to effectively reduce their risk of CVD,they may actually cause more harm than good due to side effects and ineffective treatment. Secondary prevention measures are also often required alongside prescription statins to manage the risk of CVD, indicating the need for direct physician-patient interaction.
Since OTC statins are used as a preventative therapy, they also raise the concern of low adherence. Current OTC drugs are intended for acute care, in which symptom relief is easily recognizable, encouraging people to use the drugs effectively to become healthy. Conversely, the benefit of OTC statins can only be tracked through regular blood tests. This inconvenience, combined with the lack of incentive to treat a potentially life-long asymptomatic disease, predicts low adherence to OTC statins. While they have wide safety margins, OTC statins also make it harder for physicians to track the medications their patients take and thus increases the possibility of adverse drug interactions. The risk of statin-induced rhabdomyolysis, a syndrome characterized by muscle necrosis, may increase significantly if statins are taken along with fibrates, another class of medication that reduces the risk of CVD. Patients may be incentivized to take OTC statins along with fibrates for a potential additive effect if they deem fibrates to be inadequate for treatment. The possibility of adverse drug interactions is already high with physician involvement. In fact, a study of statin prescriptions in hospitals found that 26. 1% of patients received co-prescriptions of statins with other medications known to cause dangerous interactions. Without physician involvement, the risk of adverse drug interactions may be even higher. The risks of misuse, low adherence, and additional adverse drug interactions may be potentially reduced through physician involvement in a patient’s statin therapy.
The prevention and management of CVD risk requires bridging the marked treatment gap in the Canadian population. Although OTC statins present a valid solution, the ability of patients to manage their own preventative care remains a predominant concern. It is crucial for statin consumers to understand the importance of clinician intervention so as to avoid possible misuse. There are safer alternatives to narrowing the gap, which include an introduction of patient education programs and stricter adherence to guidelines for physician prescription, both subject matters for future consideration.