Pharmacists in health-system settings are ready to play an expanded role in patient care and medication therapy should the FDA choose to designate certain medications that are currently prescription-only as "behind-the-counter" drugs, ASHP told an FDA panel this morning.

During today's public meeting exploring the creation of an intermediate class of drugs, William A. Zellmer, MPH, ASHP Deputy Executive Vice President, pointed out that outpatient care is a major part of what hospitals do today, treating hundreds of thousands of patients each year. Nationwide, 28 percent of general and children's medical-surgical hospitals have an outpatient pharmacy.

Zellmer stressed that ongoing patient assessments and counseling are essential elements of pharmacists practice in providing BTC medications, including access to patient records and the ability to order and review laboratory tests. In response to a query from the panel expressing concerns about protecting patient privacy, Zellmer noted that ambulatory care pharmacies in hospitals are uniquely positioned to both gain access to this vital information while protecting patient privacy. This advantage would make these settings a natural choice for demonstration or pilot projects, he added.

In addition to helping individual patients gain access to medications that can make a tremendous difference in their health, pharmacists' ongoing monitoring of behind-the-counter medications can provide invaluable safety information that is lost when medications go to over-the - counter status.

ASHP has had policy calling for an intermediate category of drugs, since 1985. The Society believes that an evidence-based approach should be applied to select medications for this class of drugs and is currently developing a statement that recommends appropriate criteria.

To view Zellmer's testimony, click here.