Expansion paradigm of nonprescription drugs could improve efficiencies and access, but raises quality issues

June 1, 2012

As FDA considers a new paradigm that would expand the definition of nonprescription drugs, healthcare experts say the proposed paradigm could have its benefits and challenges for the healthcare industry.

As FDA considers a new paradigm that would expand the definition of nonprescription drugs, healthcare experts say the proposed paradigm could have its benefits and challenges for the healthcare industry.

The paradigm would allow some medications that would usually require a prescription to be distributed over-the-counter (OTC) if certain special conditions were 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 the product was available for purchase. They might also require that a person visits a physician to get an initial prescription but then would be able to get refills without an additional doctor's visit.

The type of medications that could fall into this new paradigm has not been determined; however, previous discussion has included emergency medications, anecdotes, or medications that aid in chronic disease management.

Healthcare experts said the advantage of such a paradigm could be a reduction in overall healthcare costs, improved patient access to healthcare, and improved efficiencies.

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, Reilly said.

However, she was quick to point out that the proposal was not meant to minimize the role of the primary care physician and called it a "collaboration."

The new paradigm could not only improve patient quality of life but it could also help reduce hospital costs and admissions if patients are able to access medication, such as an EpiPen, in emergency situations or restart medication for chronic disease management, according to Marissa Schlaifer, RPh, MS, director of pharmacy affairs for the Academy of Managed Care Pharmacy.

"The benefit for the health plan and for the patient is that in general patient access to medications they need is going to improve their health," she said.

But experts also said there are concerns with the proposed paradigm.

A primary concern for pharmacists is the potential impact it could have on workload. "Most pharmacists, even if they wanted to do this with 20 patients a day, couldn't find the time to do it," Gallagher said. "There's going to have to be a reimbursement model that would build bandwidth for pharmacists to hire additional staff to help them do this."

Standardized processes also would need to be in place so that every anti-hypertensive, for example, would not have separate, unique algorithms, Gallagher added.

Dr Bender favors a process similar to a behind-the-counter use, where patients need to consult with a pharmacist before they have access to the medication.