ASAM doctors strongly back move toward rescheduling hydrocodone products

The occasional clash of interests between addiction specialists and professionals in other branches of healthcare has surfaced over federal policy direction on the classification of hydrocodone combination medications.

The Food and Drug Administration (FDA) formally indicated last month that by December it will ask the Department of Health and Human Services (HHS) to move toward a reclassification of hydrocodone-containing products such as Vicodin from Schedule III drugs to Schedule II, which would place significantly tighter restrictions on the prescribing of the medications. Groups such as the American Society of Addiction Medicine (ASAM), representing physician specialists in addiction, have solidly backed the reclassification, but other medical and pharmacy groups see the possible change as creating difficult barriers to needed patient care.

The final decision on a reclassification ultimately rests with the Drug Enforcement Administration (DEA).

“We are hopeful that tighter restrictions on the prescribing of these drugs sends a message to prescribers and patients alike that hydrocodone is a powerful drug that could have unintended, deadly consequences if misused,” ASAM president Stuart Gitlow, MD, said in an Oct. 31 news release from the society.

Contrast that stance with this comment provided to Addiction Professional from the National Community Pharmacists Association (NCPA) in response to our questions about its point of view on the scheduling issue: “With hydrocodone in combination being one of the last non-Schedule II drugs available to treat moderate to severe pain, the proposed change would create an inordinate amount of hurdles such as preventing prescribers from phoning in prescriptions to pharmacies, stopping prescription refills, limiting who can prescribe, and in some instances, prohibiting electronic prescribing.”

Training gap

While they acknowledge hydrocodone combination products’ effectiveness for relieving serious pain in patients, ASAM physicians see a widespread lack of proper training for many prescribers of the drugs.

“The problems begin when doctors and patients don’t know how or when to taper these medications,” West Virginia physician and ASAM member Brad Hall, MD, said in the society’s news release. “A little education about pain management and addiction risk evaluation could go a long way toward stemming the opioid epidemic and overdose rates I see at home.”

The NCPA has expressed concern about the proposed rescheduling’s potential for increasing patient visits for already overworked doctors in underserved communities such as rural areas. At an FDA advisory hearing last January, the pharmacists group offered its concerns as well as suggestions for alternative strategies that to a degree are already in place to stem prescription drug misuse, such as state prescription drug monitoring programs and medication take-back initiatives. The NCPA would like to see the removal of any obstacles to seeing these other approaches reach their full potential.

In the same week that the FDA made its intentions known on the rescheduling issue, it approved the first single-entity extended-release formulation of hydrocodone; it will be sold as Zohydro ER. While some physicians expressed surprise at the timing of introducing another narcotic at a time that the scheduling issue for hydrocodone combination products is being vetted, the federal agency said Zohydro ER is intended to manage pain so severe that it requires round-the-clock monitoring.

A Nov. 1 Medscape article quoted the FDA in announcing the approval as stating, “Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA (long-acting) opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.”