Hydrocodone-combination drugs, such as Vicodin (hydrocodone/acetaminophen, Abbott) and Lortab (hydrocodone/acetaminophen, UCB Pharma) could be moving from Schedule III to the more restrictive Schedule II category, based on the recommendation of an FDA advisory panel. If this change happens, it could block many ODs from prescribing these drugs.
On January 25, the FDA Drug Safety and Risk Management Advisory Committee voted 19 to 10 in favor of the reclassification—over the objections of the American Optometric Association and national groups representing dentists, nurse practitioners, physician assistants and others.
Several experts advocated for the scheduling change, arguing that hydrocodone drugs are too frequently abused and misused. Sharon Walsh, PhD, from the Center on Drug and Alcohol Research, University of Kentucky, presented evidence from human studies that hydrocodone has similar potential for dependency and abuse as Schedule II controlled substances, such as morphine and oxycodone.
But Jimmy Bartlett, OD, who testified on behalf of AOA, warned that simply moving hydrocodone-combination drugs into Schedule II would have harmful health consequences for patients and would limit proven treatment options for providers. Dr. Bartlett suggested maintaining hydrocodone drugs as Schedule III, but with safety restrictions equal to Schedule II drugs.
The advisory committee’s recommendations will now be delivered to FDA leaders, who will in turn make a recommendation to US Department of Health and Human Services. HHS will then make its official medical and scientific evaluation on this issue to the US Drug Enforcement Administration, which has the ultimate authority on the scheduling of controlled substances.
The AOA has begun urging the federal officials who will review this decision to discuss the modifications needed to safeguard optometry patients. If you are interested in working with Dr. Bartlett and the AOA Advocacy Group, contact Matt Willette of the AOA Washington, DC office at