FDA’s Drug Safety and Risk Management Advisory Committee has voted to recommend rescheduling of hydrocodone from Schedule III (C-III) to Schedule II (C-II). The January 25 vote was 19–10 in favor of the change.
The next steps are that FDA will consider its advisory committee’s recommendation as the agency determines its final recommendation to DEA. Then DEA would have to go through a rulemaking process to propose rescheduling “if it goes that far,” explained APhA Senior Director of Government Affairs Marcie Bough, PharmD.
Bough and APhA President-elect Steve Simenson, BSPharm, FAPhA, DPNAP, testified on January 24 of the 2-day hearing of the advisory committee. APhA did not take a position, but rather provided information on pharmacist and pharmacy issues—including impact on patient access—for committee members to consider as they decided their votes.
“APhA will continue to monitor the activities and engage when appropriate, as it moves through the regulatory process,” Bough said.
Bough drew a distinction between FDA holding the advisory committee meeting and Congress considering an amendment, with language on hydrocodone rescheduling, on last year’s Prescription Drug User Fee Act reauthorization legislation; APhA had joined May 30 letters to Senate and House offices signed by pharmacy groups opposing the amendment. “In general, the congressional amendment process is not the venue to consider rescheduling a product,” she said. “Going through the regulatory process is the appropriate venue to consider rescheduling and allows more time for stakeholder input.”
All hydrocodone products on the market are combination products, Bough said. FDA’s briefing materials indicated that in 2011, there were approximately 131 million prescriptions, and 47 million patients received hydrocodone-containing products. Given the number of prescription orders, APhA highlighted the impact on patient access due to the differences in pharmacy operations and logistics if that many prescriptions shifted from C-III procedures to C-II, she noted.
Under a reclassification, there would be no refills, the patient would need to obtain a new prescription, and the entire pharmacy supply chain and pharmacy operations would be affected.
Pharmacy impact points would include extra steps in the administrative process and time to process prescription orders that then translates to an impact on patient care and access to pain management, including the capacity of medicine to accommodate more monthly office visits for new C-II prescriptions, the capacity of pharmacy to manage more new monthly C-II prescriptions, the lack of C-II prescription refills and no C-II fax refill reminders and requests to medical offices, and the very limited use of a DEA regulation allowing a 90-day supply of C-IIs via postdated prescription orders. There are additional considerations for long-term care and assisted living practice settings. In fact, rescheduling affects the various pharmacy practice settings in different ways.
In testimony, APhA also discussed important areas of evolving work related to other efforts to address prescription drug abuse and patient safety, such as prescription drug monitoring programs (PDMPs) and e-prescribing of controlled substances, state-specific C-II laws, the pharmacist’s role in patient care activities and in working with medicine to improve management of pain patients, and the example of Simenson’s practice in Minnesota, in which pharmacists work up patients, review the PDMP, provide the information to the physician, and work together through a collaborative practice agreement. APhA additionally supported efforts to improve medication disposal.
On January 25, testimony by the National Community Pharmacists Association (NCPA) and the National Association of Chain Drug Stores (NACDS) raised concerns about patient access and pharmacy operations, expressed opposition to rescheduling, and discussed other efforts to address prescription drug abuse and diversion.
NCPA and NACDS were 2 of the 18 organizations to sign a February 1 letter to FDA Commissioner Margaret A. Hamburg, MD, that shared concerns about the January 25 vote. “No evidence currently exists to show that reclassifying hydrocodone will curb misuse and abuse of pain medications,” the groups wrote. “In contrast, there is evidence that rescheduling medications to higher classifications can reduce patient access to medications and cause harm.”