FDA recommends reclassifying hydrocodone to Schedule II

Abstract

& Human Services (HHS) Secretary Kathleen Sebelius by early December. FDA anticipates that the National Institute on Drug Abuse will agree with the recommendation. HHS will then submit its recommendation to DEA, which will make the fi nal decision on appropriate scheduling of these products. “FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse,” the agency wrote in an October 24 statement by Janet Woodcock, MD, Director of FDA’s Center for Drug Evaluation and Research. “This determination comes after a thorough and careful analysis of extensive scientifi c literature, review of hundreds of public comments on the issue and several public meetings, during which we received input from a wide range of stakeholders, including patients, health care providers, outside experts, and other government entities.” History of a complex issue In recent years, the issue has gathered momentum as deaths from overdoses of opioid pain relievers have surpassed deaths from overdoses of cocaine and heroin combined, according to CDC data. New York State became the fi rst (and to date, only) state to reschedule hydrocodone in a law that became effective February 23, 2013; the hydrocodone part of the law contains several patient access waivers. In addition, similar state efforts include no refi lls in Oklahoma and dispensing no more than a 30-day supply in Tennessee, according to the National Alliance of State Pharmacy Associations. On a federal level, recent activity in Congress included the introduction of hydrocodone rescheduling legislation on March 20, 2013 (additional attempts to reschedule legislatively are possible if lawmakers think DEA isn’t moving quickly enough). On the regulatory side, in 2009, DEA asked HHS for a recommendation on upscheduling hydrocodone combination products. On January 25, 2013, FDA’s Drug Safety and Risk Management Advisory Committee voted 19–10 in favor of reclassifying hydrocodone to Schedule II. Five of the 29 voting members on that advisory committee have pharmacy degrees, according to public materials on the FDA website; analyzing the vote, 4 of the pharmacists voted in favor of reclassifi cation and 1 voted against. The new statement from Woodcock explained that FDA was announcing its intent because of “the unique history of this issue and the tremendous amount of public interest.” (See page 48 for information on FDA’s new approval of Zohydro.) APhA opposes rescheduling APhA was joined by other national pharmacy groups in opposing rescheduling of hydrocodone combination products in a November 11 letter to Sebelius. In addition to APhA, pharmacy organizations cosigning the letter included the Academy of Managed Care Pharmacy, American Society of Consultant Pharmacists, National Alliance of State Pharmacy Associations, National Association of Chain Drug Stores, and National Community Pharmacists Association. “While we appreciate the efforts of the FDA to address the serious issue of prescription drug abuse, we believe rescheduling hydrocodone is not the solution,” APhA and the other groups wrote. “Rescheduling will have a profoundly negative impact on patients who legitimately need these medications and a negligible impact on drug abuse.” According to the November 11 joint letter, rescheduling hydrocodone would create serious barriers to patient access such as the inability to refi ll products in Schedule II; new burdens for an already overtaxed health care system; and new requirements for pharmacies, including the provision of additional secure storage, recordkeeping, and inventory management. In contrast, the American Society of Health-System Pharmacists (ASHP) sent a November 5 letter to the HHS Secretary supporting hydrocodone rescheduling. “ASHP called concerns regarding recordkeeping and security processes resulting from rescheduling ‘valid,’ but believes that they are outweighed by the public health benefi t arising from increased control of drugs with high abuse potential,” according to a related ASHP news release. ASHP “also countered concerns that the inability to prescribe refi lls would have a broad impact on patient access.” hydrocodone