The American Society of Health-System Pharmacists (ASHP) believes that existing models for over-the-counter (OTC) dispensing do not provide the safeguards required to ensure the safe and effective use of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (“statins”) as part of a multimodal approach to preventing coronary heart disease (CHD). ASHP supports the goal of more widespread use of CHD-preventive therapies, including statin therapy, and encourages consideration of alternative nonprescription dispensing models for statins that would advance CHD prevention.
Since 1985, ASHP has called for changes in federal statutes and regulations to establish an intermediate category of drug products that do not require a prescription but are available only from pharmacists and other licensed health care professionals authorized to prescribe medications.1 ASHP believes consideration of OTC reclassification for statins presents an opportunity to explore the creation of such a category of drugs. ASHP has suggested that the regulatory system for such an intermediate category of drug products would allow pharmacists to provide drugs in this intermediate category directly to patients without a prescription, on the basis of appropriate assessment and professional consultation, while ensuring that licensed health professionals who currently have prescribing authority would continue to have the ability to prescribe such medications. ASHP believes that under such a regulatory system, data from postmarketing surveillance, epidemiologic studies, and adverse-drug-reaction reporting should be collected to help determine a drug product’s eventual movement to nonprescription status, return to prescription-only status, or continuation in the intermediate category.1 ASHP believes statins are an ideal candidate for dispensing under such a model.
ASHP supports the use of statins to lower cholesterol and reduce morbidity and mortality in patients at risk for cardiovascular events.2 Elevated cholesterol, specifically low-density lipoprotein cholesterol (LDL-C), is an important risk factor for the development of CHD. ASHP has recommended that evaluation and management of lipid disorders be guided by the recommendations of the National Cholesterol Education Program (NCEP), the latest of which are contained in the Adult Treatment Panel III (ATP III) guidelines.3,4 Statins are considered the drug of choice for most patients with dyslipidemia who require lipid-lowering therapy. They are effective in lowering elevated LDL-C, and studies have demonstrated that statins reduce the risk of cardiovascular events in patients without known CHD (primary prevention). In addition, statins have been shown to reduce cardiovascular events and mortality in patients with CHD (secondary prevention). Cardiovascular disease is the leading cause of death for both men and women in the United States, and CHD is responsible for nearly 75% of all deaths from cardiovascular disease.5 Individuals with multiple cardiovascular risk factors and a low LDL-C derive an absolute benefit in reducing risk of CHD for a given milligram-per-deciliter lowering of LDL-C. However, for individuals with lower LDL-C levels and fewer risk factors for CHD, the benefits of lowering LDL-C level are less dramatic.6
Nonprescription Dispensing Models
The efficacy of statins in reducing LDL-C has prompted calls for more widespread use, including suggestions for a reclassification of statins as an OTC medication. Although ASHP does not support reclassification to OTC status as that status is currently constructed, alternative nonprescription models for dispensing these valuable medications should be explored.
To approve a reclassification to OTC status, FDA reviewers must find that (1) a drug is safe and effective in its proposed use(s), (2) the benefits of the drug outweigh its risks, and (3) consumers will be able to use the drug’s labeling (e.g., its package insert) to safely use the medication in an OTC setting.7 ASHP believes a decision to approve nonprescription dispensing models for statins should be based on evidence that, under the proposed model, the target population would receive a clinical benefit in primary prevention of CHD from the medication and patients can safely use the medication to achieve that clinical benefit. To achieve the goal of safe and effective use, any nonprescription dispensing model for statins should