Over the past two years, the AVMA has been closely monitoring a federal situation that has the potential to impact practitioner access to human-labeled drugs, particularly certain opioids. The federal government’s concern is regarding abuse of prescription drugs in people (especially youth). The federal plan is to increase education of healthcare providers, patients, parents, and youth about the dangers of prescription drug abuse; to increase drug tracking, monitoring, and enforcement; and to increase proper drug disposal.
In February 2009, the Food and Drug Administration (FDA) proposed to implement a “Risk Evaluation and Mitigation Strategy” (REMS – strategies the FDA can implement to ensure a drug’s benefits outweigh the risks) for extended-release opioids. During the FDA’s first proposed REMS program for extended-release opioids, AVMA presented both verbal and written comments to FDA personnel, and to two of FDA’s advisory committees. (View previous actions including the AVMA’s correspondence with FDA, AVMA’s verbal comments to two of FDA’s advisory committees, and our AVMA Advocate article on this topic.) Our basic assertions were that veterinarians need continued access to extended-release opioids for relieving animal pain and suffering, and we believe veterinarians should be exempted from any opioid REMS, or, any REMS required for veterinarians should be tailored for veterinary needs so access is not barred. Two advisory committees voted against the FDA’s proposed REMS in July 2010. In short, the advisory committees felt this REMS did not go far enough to prevent misuse of opioids.
The federal government has reformulated its overall plan on opioid diversion, with the FDA’s REMS being just one component of the entire plan. The federal government’s new plan to curtail drug abuse is Epidemic: Responding to America’s Prescription Drug Abuse Crisis. There are many components to the plan, but the main components that are probably most pertinent to the profession are:
1) The Administration’s desire for Congress to pass legislation to require practitioners to take training on responsible opioid prescribing, use, storage, and disposal before being able to procure DEA registration, 2) plans for federal rulemaking on proper medication disposal, 3) requirement for opioid manufacturers to develop training for prescribers (FDA’s REMS), 4) plans to engage stakeholders on the publicizing of need for the public to use, store and dispose of opioids safely, 5) plans to work with states to implement prescription-monitoring programs in all states and to require prescriber training on program use, and 6) encouragement of federal agencies to increase “take-back” programs.
AVMA’s Governmental Relations Division and Scientific Activities staff continue working in coordination with our lead governance groups on this topic (Council on Biologic and Therapeutic Agents and Clinical Practitioners Advisory Committee), and we will continue to monitor the situation carefully.