FDA Considers a New Paradigm For Over-the-Counter Medications: More Power-but More Burdens-for Pharmacists and Pharmacies.

CSU” (OTC/CSU) drug and would be paid for time spent helping patients decide whether such a drug was appropriate, entering the drug into a patient’s medical record, and performing other administrative and counseling tasks. In February 2012, the FDA announced that it was considering this new paradigm for switching more prescription drugs to the OTC category. On March 22 and 23, the agency held a two-day public meeting at its White Oak headquarters in Silver Spring, Md. The idea was to increase access to prescription drugs that might not otherwise be approved for OTC status, minus the CSU that the FDA would attach to drugs in this new OTC class. The FDA is also considering whether the same drug could be available simultaneously as both a prescription and a nonprescription CSU product. If the FDA decides to proceed, pharmacists and pharmacies would play an important role in the success of this new paradigm. The discussion led to numerous questions from 12 FDA panelists about collaborative practice agreements and their potential application to the new paradigm. Reclassifying drugs that are “prescription only” as less expensive OTC/CSU drugs would be an important step, especially for the poor and uninsured; this move would also improve compliance for many other patients and would provide additional benefits such as easing the burden on emergency departments, reducing the impact of the shortage of primary care physicians, and lowering the costs of both private and federal health plans (e.g., Medicare and Medicaid). Types of medications that might fit in this new OTC/CSU class, according to the American Society of Health System Pharmacists (ASHP), include statins for cholesterol; inhaled corticosteroids and beta-2 agonists for asthma; vaccines; and drugs for hypertension, osteoporosis, and diabetes. A recent study by Booz & Company reported that 240 million people buy OTC medications each year; an estimated 60 million of these consumers do not otherwise seek treatment.1 OTC drugs save the U.S. health care system $102 billion annually. The study also notes that for every dollar spent on OTC drugs, the health care system saves $6 to $7. The paradigm, if accepted, would shift some of the balance of power in drug prescribing from the physician to the pharmacist. The FDA has outlined a potentially broad role for pharmacists in this new paradigm. For example, some diseases might necessitate confirmation of a diagnosis or routine monitoring using a diagnostic test (e.g., a blood test for cholesterol levels or liver function) that could be available in a pharmacy. The pharmacist or patient could then use the results to determine whether a certain drug is appropriate. The pharmacist might also determine whether the patient Mr. Barlas, a freelance writer based in Washington, D.C., covers topics inside the Beltway. FDA Considers a New Paradigm For Over-the-Counter Medications