Editor's Note: Creating an Intermediate Class of Drugs

FEBRUARY 01, 2008
James C. McAllister III, MS, FASHP

Mr. McAllister is a health-systems consultant based in Chapel Hill, North Carolina.

An FDA advisory panel has recommended for the third time in less than 10 years that lovastatin 20 mg not be made available as a nonprescription drug. That news follows testimony by the American Society of Health-System Pharmacists and the American Pharmacists Association, in a separate but related issue, strongly encouraging the FDA to create an intermediate class of drugs, sometimes referred to as "behind-the-counter" drugs. Both organizations submitted compelling arguments for the creation of a class of drugs that could be dispensed with appropriate patient education and monitoring but without a physician's prescription.

Benefits of creating such a class of drugs include improving access to care that would benefit public health, reducing health care costs, improving patient safety, avoiding overuse, improved patient adherence, and more fully engaging patients in managing their own health. From a selfish point of view the comments to the FDA leadership, the health care community, and the public again reflect that the pharmacy profession is fully capable of assuming these responsibilities.

Many hospital pharmacists have broader responsibilities than are routinely offered outside hospital care, including therapeutic substitution, dosage adjustment, therapeutic drug monitoring, and much more. This role expansion is the result of early pharmacy pioneers, collaborative practice, establishment of trust, shifting responsibilities from physicians who are already overworked, and, most importantly, because pharmacists have proven themselves capable of performing these important patient care functions and have asked for the opportunity.

Regrettably, I am skeptical that it will be adopted at the present time. I suspect that the office-based medical community will remain opposed to an intermediate class of drugs for a time. Doctors see this evolution through myopic eyes as a threat, rather than an opportunity to create relationships with pharmacists who, in many cases, would increase referrals to physicians rather than let patients go untreated for conditions that require physician care. We should remain optimistic since virtually all physicians train in hospitals and will be exposed to these expanded roles and appreciate their availability when they enter private practice.

I am confident that most pharmacists practicing in the retail setting generally would welcome the opportunity to expand their practice by managing patients receiving drugs from an intermediate class of drugs. I wonder whether corporate executives from the major chains are fully supportive. I understand the concerns of ensuring availability of appropriately trained pharmacists, the financial impact of taking on more work (especially initially), the risks associated with dealing with a litigious clientele, and more. We must reassure them that it is our destiny to play a more important role in our patients' health and we are committed and determined to do so.

Our associations are championing our collective cause, but our help is needed. We need to discuss this issue with our patients, our neighbors, and physiciansin- training. When the time is right, we need to educate legislators. For now, we need to be supportive of the concept and do what we can to support professional evolution.