AVMA counters on DEA proposal to make propofol a Schedule IV veterinary drug

AVMA counters on DEA proposal to make propofol a Schedule IV veterinary drug

Dec 22, 2010
By dvm360.com staff
Schaumburg, Ill. -- The Drug Enforcement Administration's (DEA) proposal to make propofol a Schedule IV drug drew a letter of caution from the American Veterinary Medical Association (AVMA).

In fact, the national association's initial response to agency was to offer "input regarding disposal" of the anesthetic agent.

"The DEA cites research that 28 percent of drug abusers of propofol die as a result of this abuse, so the AVMA understands the DEA's actions to stop diversion of propofol from its intended use," explains Dr. Ron DeHaven, chief executive officer of the AVMA in a prepared statement. "However, propofol is also an effective drug used in veterinary anesthesia, and we want to make sure that the burden of disposing of it under the DEA's rules doesn't discourage veterinarians from utilizing propofol," DeHaven says.

"The AVMA is concerned that under DEA rules, veterinarians may no longer be allowed to dispose of any unused propofol into an absorbent substance for incineration or disposal as solid waste," the association adds.

AVMA, however, did not comment on the new administrative burdens that a Schedule IV substance would require for veterinarians.

DEA's proposal, outlined recently in the Federal Register, would "impose regulatory controls and criminal sanctions of schedule IV on those who handle propofol and products containing propofol."

DEA's action is a result of a 2008 petition citing an increasing number of documented cases of abuse -- a trend also associated with a high mortality rate, DEA reports. In addition, the database of the Adverse Event Reporting System indicates that of all the reported diversion and abuse cases, 96 percent were committed by health-care providers.

If propofol is categorized as a schedule IV substance, veterinarians would need to seek DEA registration, maintain and keep inventory records as required by the Controlled Substances Act and impose security requirements applicable to schedules III and IV substances. Prescriptions for propofol or products containing propofol would be required, DEA says.

"The AVMA is asking the DEA to balance the essential need to protect the public from abuse of propofol while also allowing for convenient disposal of wasted propofol on an ongoing basis," DeHaven says.

At presstime, the American Veterinary Medical Association's Council on Biologic and Therapeutic Agents and its Clinicial Practitioners Advisory Committee were crafting written responses to the proposed rules.