Hydrocodone moved to Schedule II in DEA final rule

APhA, other pharmacy groups have strongly opposed rescheduling

DEA today published a final rule moving hydrocodone combination products (HCPs) from Schedule III to Schedule II, effective October 6, 2014. APhA and most pharmacy groups strongly opposed the move.

The controversial scheduling change was recommended by the Assistant Secretary for Health of the U.S. Department of Health & Human Services (HHS) and supported by DEA’s own evaluation of relevant data, according to yesterday’s DEA news release.

Under the 21-page final rule, Schedule II requirements will apply to “all pharmaceuticals containing hydrocodone currently on the market in the United States.” These requirements include, but are not limited to, requirements related to security protocols, labeling and packaging, inventory, and recordkeeping and reporting, according to Jillanne Schulte, JD, APhA Director of Regulatory Affairs.

APhA will be working to inform members about the transition.

APhA’s concerns with final rule

Only prescriptions issued before October 6, 2014, and authorized for refills may be dispensed, as long as such dispensing occurs before April 8, 2015. DEA does state that a practitioner may issue multiple Schedule II prescriptions to provide up to a 90-day supply of medication. DEA cautioned, however, that practitioners must make their own decisions “based on sound medical judgment and in accordance with established medical standards” about whether multiple prescriptions are appropriate for a patient, according to Schulte.

APhA also is concerned about the effect the rule will have on patients’ need for physician office visits. Other concerns include the short amount of time to implement the new requirements, including updating ordering systems with the new NDC numbers and more stringent Schedule II record-keeping and storage requirements, according to Michael H Ghobrial, PharmD, JD, APhA Associate Director of Health Policy.

History of regulatory process

The rescheduling of HCPs was initiated by a petition from a physician in 1999. DEA submitted a request to HHS for a scientific and medical evaluation of HCPs and a scheduling recommendation. In 2013, an FDA advisory committee voted 19–10 to recommend rescheduling HCPs from Schedule III to Schedule II, and FDA passed the advisory committee’s recommendation to HHS. In December 2013, HHS recommended the rescheduling to DEA.

On February 27, 2014, DEA published a proposed rule on rescheduling HCPs. Almost 600 comments were received, and according to DEA, “a small majority of the commenters supported the proposed change.”

Joint letter from pharmacy groups

APhA and other pharmacy groups sent a joint letter to DEA on April 28, 2014. Noting that the organizations collectively represent more than 100,000 pharmacists across the full spectrum of practice settings, the joint letter was signed by APhA, American Association of Colleges of Pharmacy, American College of Clinical Pharmacy, 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.

“It is important to remember that the vast majority of patients taking hydrocodone do so legitimately,” the pharmacy groups wrote. “HCPs play a key role in acute and chronic pain management and helping patients engage in the activities of daily life. Rescheduling HCPs will have far-reaching consequences for millions of Americans who legitimately rely on them for short-term and chronic pain.”

The pharmacy groups also noted that rescheduling HCPs will add costs for patients as well as to the health care system. “Pharmacies and distributors will have to comply with stricter storage and handling laws for Schedule II controlled substances, and such requirements may cause delays in maintaining an adequate supply of HCPs.

This article was updated on August 25, 2014, to provide clarification on pending refills for hydrocodone.