Hydrocodone Rescheduling Becomes Official

 

 

   The U.S. Drug Enforcement Administration’s (DEA) reclassification of hydrocodone-combination products from Schedule III agents to the more restrictive Schedule II is scheduled to go into effect today, Oct. 6.
   The rescheduling of the combination agents, which often include the opioid analgesic hydrocodone (a Schedule II drug) and an over-the-counter pain reliever like acetaminophen, has been written in the stars for some time. The DEA made the move official by publishing the Final Rule in the Federal Register on Aug. 22, which was scheduled to take effect in 45 days and apply to “all pharmaceuticals containing hydrocodone currently on the market in the United States”
    “Almost 7 million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents,” said Michele Leonhart, DEA administrator, in a press release to introduce the Final Rule. “Today’s action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available.”
Schedule II drugs are substances with accepted medical uses that have a high potential for harm and abuse, according to the Controlled Substances Act. 

A 15-Year Process
The roots of the hydrocodone-combination product rescheduling date all the way to back to 1999 when it was initiated by a lone physician’s petition to the DEA. The agency in turn asked the U.S. Department of Health and Human Services (HHS) to compile medical and scientific data on the safety of combination products and come up with a scheduling recommendation. The data ultimately showed that adding other drugs did not diminish the abuse potential of hydrocodone-combination products.  

   In October 2013, an FDA advisory committee reviewed the proposed rescheduling and recommended it by a 19-10 vote. The recommendation was endorsed by the full FDA and passed on to the HHS in December.

 

Reaction

   Charles Argoff, MD, a pain management expert at the Albany Medical Center in New York and a Pain Medicine News editorial board member, sees the logic behind the move, but worries about a potential negative clinical effect.
”From a purely scientific viewpoint, considering the potency of hydrocodone—actually more potent than morphine which is Schedule III—the rescheduling of hydrocodone products as Schedule II agents is logical,” he said. “What is not clear is its impact on patient access to this specific group of analgesics [hydrocodone-containing agents] as the rescheduling may dampen certain prescriber's comfort in prescribing these agents.”
   “As the implications of this decision play out, it will be important that due consideration continue to be given as to what is best for patients, what is good health policy and what is based on the best available science,” wrote Phil Saigh, executive director of the American Academy of Pain Medicine (AAPM) and Sean Mackey, MD, AAPM president, in a statement on behalf of the AAPM.
   Pharmacy groups such as the American Pharmacists Association (APhA) have been against the DEA’s move since it was first suggested. In April 2014, the APhA—along with the 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—sent a letter to the DEA on behalf of “100,000 pharmacists across the full spectrum of practice settings.” The letter decried the proposed rescheduling.
    “Only prescriptions issued before October 6, 2014, and authorized for refills may be dispensed, as long as such dispensing occurs before April 8, 2015,” wrote the APhA in a press release criticizing the rescheduling Final Rule.  It added, however, that the DEA does state that a practitioner may issue multiple Schedule II prescriptions to provide up to a 90-day supply of medication. The 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.
    The APhA also is concerned about the effect the rule will have on patients’ need for physician office visits, according to Michael H. Ghobrial, PharmD, JD, APhA associate director of health policy. “Other concerns include the short amount of time to implement the new requirements, including updating ordering systems with the new National Drug Code numbers and more stringent Schedule II record-keeping and storage requirements.”

 
—Donald M. Pizzi and Martin Leung