n opposing DEA’s proposal to reschedule hydrocodone combination products from Schedule III to Schedule II, APhA’s government affairs team led the development and submission of a joint pharmacy stakeholder comment letter to the agency.
The joint pharmacy comments acknowledge the seriousness of prescription drug abuse but emphasize that rescheduling may not have an effect on decreasing abuse and would have a negative impact on legitimate patient access to these effective pain medications.
The letter was signed by the American Association of Colleges of Pharmacy, American College of Clinical Pharmacy, Academy of Managed Care Pharmacy, APhA, American Society of Consultant Pharmacists, National Alliance of State Pharmacy Associations, National Association of Chain Drug Stores, and National Community Pharmacists Association.
“It is important to remember that the vast majority of patients taking hydrocodone do so legitimately,” wrote the pharmacy associations. They highlighted that stricter requirements for Schedule II drugs related to prescribing and dispensing would restrict patient access and delay relief of pain, and that rescheduling hydrocodone combination products would introduce inefficiencies into the health care system and increase costs “at a time when policy makers are seeking ways to streamline processes and reduce costs.”
DEA rulemaking under way
DEA has begun the formal rulemaking process following a reclassification recommendation from the U.S. Department of Health & Human Services (HHS). The rescheduling of hydrocodone combination products was initiated by a petition from a physician in 1999, according to a DEA news release. In January 2013, an FDA advisory committee voted in favor of reclassification. In December 2013, HHS sent that recommendation to DEA.
On February 27, DEA published in the Federal Register a proposed rule concluding that such medications “have a high potential for abuse, and abuse may lead to severe psychological or physical dependence.” Comments were due April 27. DEA is now evaluating the feedback from stakeholders.
NACDS joint letter
Also in response to the proposed rule, the Association signed the National Association of Chain Drug Stores’ (NACDS) joint letter that was cosigned by a number of pain-related advocacy groups outside of pharmacy.
Zohydro ER controversy continues
FDA’s approval of hydrocodone bitartrate extended-release capsules (Zohydro ER—Zogenix), a single-ingredient opioid without an abuse-resistant formulation, as a Schedule II controlled substance came on October 25, 2013—a day after the agency announced its intent to recommend that DEA reschedule hydrocodone combination products. On December 7, 2012, FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 11–2, with 1 abstention, against approval of the drug.
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