FDA mulls over making some prescription drugs available over the counter
SILVER SPRING, Md. — The Food and Drug Administration is looking at the possibility of selling certain prescription drugs over the counter under specific circumstances, the agency said.
The FDA will have a meeting on March 22 to collect public opinion regarding what it called a "new paradigm" under which drugs for such conditions as cholesterol and diabetes that normally require prescriptions would be available without them under "conditions of safe use" that would be specific to each drug, such as assisting patients in drug selection, providing followup monitoring or requiring pharmacist intervention to ensure appropriate use.
Another possibility suggested was the use of technologies such as diagnostics used in the pharmacy or other settings. In the meeting notice, published in the Federal Register, the FDA said it was aware of new technologies that allow patients to self-screen for certain diseases. "For example, kiosks or other technological aids in pharmacies or on the Internet could lead consumers through an algorithm for a particular drug product," the notice read. "Such an algorithm could consist of a series of questions that help consumers properly self-diagnose certain medical conditions, or determine whether specific medication warnings contraindicate their use of a drug product."
Pharmacist intervention could include requiring confirmation of a diagnosis or routine monitoring using a diagnostic test such as a blood test for cholesterol levels or liver function that could be available in a pharmacy.
The announcement noted that "eliminating or reducing" the number of routine visits that patients must often make to their physicians, such as checkups for certain drug therapies, would allow those physicians to spend more time with more seriously ill patients, thereby reducing the burden on the healthcare system and reducing healthcare costs.
"In some cases, a visit to a practitioner would be required for the initial prescription, but a certain number of refills could be authorized beyond those that would normally be authorized without a return visit under specialized conditions of safe use," the notice read, mentioning rescue medications such as asthma inhalers or epinephrine for allergic reactions.
Q&A: Streamlining specialty
In January, specialty pharmacy group contracting organization Armada Health Care introduced ApproveRx, a Web-based system that it says will greatly streamline the prior authorization process and already has been adopted by Amber Pharmacy. Meanwhile, the company also is gearing up for the Armada Summit at the Wynn Las Vegas Hotel in May. Recently, Drug Store News spoke with Armada CEO Larry Irene about these recent developments.
DSN: How did Armada develop the ApproveRx system?
Larry Irene: ApproveRx was developed as an extension of Armada’s ReachRx Prior Authorization Service, which utilizes our expert staff to manage the prior authorization process and obtain approvals. ApproveRx meets the needs of healthcare professionals requiring a “do-it-yourself” solution to streamline and expedite prior authorizations. The free, Web-based tool can be accessed via a standard browser and used for all drugs, including specialty medications.
DSN: How will ApproveRx make a difference in how specialty pharmacies handle prior authorizations?
Irene: ApproveRx has a library of more than 6,000 prior authorization forms for virtually all drugs and insurance plans. With ApproveRx, healthcare professionals can quickly find prior authorization forms and submit them to prescribers or insurance plans in minutes. ApproveRx’s at-a-glance dashboard allows pharmacies and prescribers to efficiently track open and submitted prior authorizations so they can focus on caring for patients.
DSN: What issues do you foresee as the main focus at the Armada Summit in May?
Irene: The Armada Summit continues to deliver our attendees in-depth discussions and presentations that impact their daily business. Key areas of focus for the event in May will include technology’s evolving role in specialty, [risk evaluation mitigation strategies], the potential impact of potential managed care contracting strategies and the specialty pipeline.
MTM fights diabetes on the front lines
The number of patients with diabetes is not decreasing any time soon, and one of the most important fronts in the battle lies at the pharmacy counter.
Medication therapy management, one of the most effective ways that pharmacists can help patients manage their diabetes, got a major boost last year with the introduction of H.R. 891, the Medication Therapy Management Benefits Act, which would allow elderly people with at least one chronic condition to access Medicare Part D coverage for MTM; currently, only those with more than one condition are eligible. At press time, the bill’s sponsors — Reps. Mike Ross, R-Ala., and Cathy McMorris Rodgers, R-Wash. — were looking for cosponsors for the bill.
In the meantime, a number of retailers have taken the lead in providing care and services for diabetes patients. Kerr Drug, for example, a longtime leader in MTM, recently launched the “Just Ask” campaign in stores and across various marketing channels, focusing on 11 conditions, including diabetes. Also, Safeway joined the UnitedHealth Group’s Diabetes Prevention and Control Alliance and began offering the DPCA diabetes control program at Tucson, Ariz., area stores, with plans to extend it to Seattle-area stores. Other retailers in the program include Winn-Dixie, Walgreens, Albertsons, Kroger and Rite Aid.