In the News: Pharmacy Organizations Urge DEA Not to Reschedule Hydrocodone Combination Products

The APhA, NACDS, NCPA, and others argue that rescheduling hydrocodone combination products will impede access to the medications by legitimate pain patients while failing to stem abuse.

A group of pharmacy organizations has submitted a joint pharmacy stakeholder comment letter to the Drug Enforcement Administration opposing its proposal to reschedule hydrocodone combination products from Schedule III to Schedule II. The letter was signed by the American Association of Colleges of Pharmacy, American College of Clinical Pharmacy, Academy of Managed Care Pharmacy, American Pharmacists Association, American Society of Consultant Pharmacists, National Alliance of State Pharmacy Associations, National Association of Chain Drug Stores, and National Community Pharmacists Association.

The letter notes that rescheduling will mean that prescriptions for the medications cannot be refilled nor can they be telephone or faxed to a pharmacy, which means that physician visits will be required for patients to refill prescriptions. As a result, those with legitimate pain complaints may be forced to suffer while waiting for an appointment or the ability to take time off work to go see a physician—consequences that will be compounded for those living in rural or medically underserved areas.

In addition, the letter notes that rescheduling may introduce inefficiencies into the health care system at a time when there is great emphasis on providing care more smoothly and reducing costs. Most patients taking hydrocodone combination products use the medication appropriately, it adds.

“With approximately 50 million patients taking [hydrocodone combination products], meeting the new demands associated with rescheduling [hydrocodone combination products] may cripple an already overtaxed system,” the letter reads. “Moreover, 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 [hydrocodone combination products].”

In January 2013, an FDA advisory committee voted to support rescheduling of hydrocodone combination products, and in December 2013, the Department of Health and Human Services sent the recommendation to reschedule to the DEA. On February 27, 2014, the DEA published a proposed rule to reschedule the medications in the Federal Register, with comments due by April 27. The agency is now evaluating the feedback it received from stakeholders.

To view a video debate on whether hydrocodone combination products should be rescheduled, click here. In the debate, which was filmed at the American Society of Health-System Pharmacists 2013 Midyear Clinical Meeting in Orlando, Mary Lynn McPherson, PharmD, professor and vice chair at the University of Maryland School of Pharmacy, argued in favor of rescheduling, and Jeff Fudin, PharmD, FCCP, adjunct associate professor at the Albany College of Pharmacy and adjunct assistant professor at the UCONN School of Pharmacy, argued against it. (Drs. McPherson and Fudin were assigned to take these positions, and their arguments do not necessarily reflect their personal positions on the issue.)