Comment period closes Dec. 27
The American Veterinary Medical
Association (AVMA) wants the U.S. Drug Enforcement Agency (DEA) to consider the
impact that plans to
raise propofol to a schedule IV drug might have on those who use the
popular anesthetic on a regular basis.
In a letter to the agency
, AVMA Chief Executive Officer Dr. Ron DeHaven warns that veterinarians might turn away from what the association deems to be a useful and effective induction agent.
Elevating propofol to a scheduled status calls for veterinarians to employ special drug inventory logs, secured storage and other requirements deemed burdensome by some. Veterinarians using scheduled drugs must maintain a DEA license. But the AVMA also is concerned about new disposal regulations that might be tied to propofol’s elevated status as a controlled substance.
"While we understand the importance of controlling the use of any drug with high abuse potential, we also have concerns that adding propofol as a schedule IV controlled substance may result in decreased use of this important anesthetic by some veterinarians because of the burdens associated with registration, record keeping and, especially, waste disposal in accordance with DEA rules,” DeHaven wrote in the letter. "... Due to a very short time interval before propofol becomes unusable and the partial amount of drug typically used in a veterinary setting, some unusable product often remains in the vial after veterinary use."
Veterinarians might no longer be able to dispose of unused propofol “into an absorbent substance for incineration or disposal as solid waste,” the letter states. In that case, the AVMA wants the DEA to have a pre-defined process put in place that would allow for convenient disposal of leftover propofol.
The DEA is pushing to have propofol classified as a schedule IV drug
to more tightly control its distribution with the goal of preventing abuse. The DEA’s proposed new rule was posted in the Oct. 27 Federal Register
The U.S. Department of Health and Human Services initially petitioned the DEA in 2008 to classify propofol as a schedule III substance. (Control measures for schedule III and schedule IV drugs are similar; the lower number indicates a higher potential for abuse.) The department cited a steady uptick in documented abuse cases involving the intravenous anesthetic during the past decade, with more than 33 percent of those cases resulting in death.
published by the Federal Register
indicates that the drug is being abused by medical professionals who can access it in facilities that perform anesthesia.
"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," the AVMA letter states.
The DEA is accepting comments to its proposal until Dec. 27. Two AVMA internal groups — the Council on Biologic and Therapeutic Agents as well as the Clinical Practitioners Advisory Committee — reportedly
are authoring comments in addition to the letter signed by DeHaven.
Comments to the proposed rule can be viewed on a federal website
designed to publicly share such documents. Those who might like to submit comments to the DEA can e-mail them to firstname.lastname@example.org or mail them, attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. Comments should refer to Docket No. DEA–327.