By Sederstrom, Jill
Drug Topics , Vol. 156, No. 5
As the Food and Drug Administration (FDA) considers a new concept that would expand the definition of nonprescription drugs, healthcare experts say the proposed change could offer the healthcare industry both benefits and challenges.
The general idea
For some medications that usually require a prescription, FDA is considering a new paradigm that would allow those products to be distributed over the counter (OTC) if certain special conditions are met.
While the details of the proposed change are still unclear, these special conditions could require customers to speak with a pharmacist or submit to a diagnostic test before they could complete the purchase of the product. Another requirement under consideration would call for a patient to visit a physician in order to obtain an initial prescription; subsequent refills could be then made without additional office visits.
The types of medications that might fall under this new paradigm have not been determined; however, previous discussion has included emergency medications, antidotes, or medications that aid in management of chronic disease.
"It's all still to be determined, because anything that might fall into the potential new paradigm would be driven by the manufacturer or sponsor of that drug," said Marcie Bough, PharmD, senior director of government affairs for the American Pharmacists Association.
Healthcare experts say the advantage of such a paradigm could be a reduction in overall healthcare costs, improved patient access to healthcare, and improved efficiencies.
"The primary benefit that we see is rechanneling poorly treated individuals with chronic conditions back into the healthcare system," said Brian Gallagher, RPh, JD, senior vice president of government affairs for the American Pharmacists Association.
Cynthia Reilly, RPh, director of the practice development division of the American Society of Health-System Pharmacists, also sees the advantages of such a paradigm shift. The expansion could optimize the role pharmacists can play in patient care, she said.
Furthermore, Reilly pointed out, pharmacists may be uniquely qualified to play a greater role in medication management because they are easily accessible, often have already established relationships within the community, and are skilled in drug therapy.
However, she said, that is not to suggest that the proposal was intended to minimize the role of the primary care physician.
"It would be a collaboration, and the pharmacists would become simply another care provider. They would document care in terms of what was provided, what counseling was given, and they would share this information with the physician," Reilly said.
The National Community Pharmacists Association has also voiced its support of the concept.
"In general, I think pharmacists are poised with the systems they already have in place today to help the FDA, help manufacturers, and help physicians ensure that these products are used appropriately," said Ronna Hauser, PharmD. Hauser is vice president of policy and regulatory affairs for the National Community Pharmacists Association.
The approval of certain prescription drugs for nonprescription use, under conditions of safe use, could also have positive implications for health plans.
According to Marissa Schlaifer, RPh, MS, director of pharmacy affairs for the Academy of Managed Care Pharmacy, improved quality of life for patients is not the only benefit the new paradigm might provide. If patients are able to obtain access to medication such as an Epi -Pen in emergency situations, or to restart medication for chronic disease management, it could also help reduce hospital costs and admissions. …