APhA, other pharmacy groups oppose rescheduling hydrocodone in letter to HHS

ASHP supports rescheduling in letter to HHS

APhA was joined by other national pharmacy groups in opposing rescheduling of hydrocodone combination products in a November 11 letter to U.S. Department of Health & Human Services (HHS) Secretary Kathleen Sebelius.

Other 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, 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.”

On October 25, FDA recommended rescheduling of hydrocodone combination products from Schedule III to Schedule II following its advisory committee’s vote in favor of rescheduling. In a statement on its website, FDA anticipated that the National Institute on Drug Abuse would agree with the recommendation and that HHS would then submit its recommendation to DEA, which would make the final decision on appropriate scheduling of those products.

According to the November 11 letter, rescheduling hydrocodone would create serious barriers to patient access such as the inability to refill 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 benefit 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 refills would have a broad impact on patient access.”