Jan
10
2011

Dozens of veterinarians, organizations and companies have weighed in on the U.S. Drug Enforcement Agency’s (DEA) proposal to add the anesthesia induction agent propofol to Schedule IV of the Controlled Substances Act (CSA), and many of those are against the change.

The DEA proposed adding propofol to schedule IV in an announcement in the Federal Register in October. In its proposal, the DEA cites research that suggests propofol has the potential to be abused, along the lines of other Schedule IV drugs like methohexital and midazolam.

"In a survey of academic anesthesiology programs, 18 percent reported diversion or abuse of propofol," the DEA says. "Twenty-eight percent of the reported abusers of propofol had died due to propofol overdose. The individuals who died were affiliated with health care facilities in which there were no pharmacy or security mechanisms to control access to propofol."

Hundreds of comments received

Since the proposal was published, nearly 300 individuals, companies and organizations such as the American Veterinary Medical Association (AVMA) have submitted comments to the agency voicing their opinions about the plan. (The comment period ended Dec. 27) The AVMA and many veterinarians expressed concern over the proposal, and urged the DEA not to schedule propofol.

"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," said AVMA CEO Ron DeHaven in his written comments. "AVMA is also concerned that under DEA rules, veterinarians might no longer be allowed to dispose of any unused propofol into an absorbent substance for incineration or disposal as solid waste."

Some commenters suggested that the DEA proposal was based on the media coverage of pop singer Michael Jackson’s death in 2009 from an apparent overdose of propofol. The main concern among veterinarians seemed to be that the increased regulation of the drug would make it prohibitively inconvenient.

"I sincerely doubt that control of this product would prevent enough deaths to justify the innocent deaths that may occur by locking it up, added cost, effort and regulation required to add it to the schedule IV drug list," said Bridget Holden, DVM. "I propose that propofol, in its uncontrolled state, in many circumstances, has indeed saved numerous lives in my small animal practice. Being able to quickly access a drug like propofol has allowed us to quickly and easily induce short, relatively safe anesthesia to remove tracheal foreign bodies and calm seizing animals when access to our lock-box has been limited for whatever reason."

The current shortage of propofol on the market also came up in some of the comments.

"We are strongly concerned that any new requirements involving labeling, packaging and storage of propofol may cause further shortages of this drug and negatively impact patient care," said Brian M. Meyer, Director of Government Affairs for the American Society of Health-System Pharmacists.

Not everyone was opposed to the proposal. In a letter from the American Society of Anesthesiologists (ASA), the group’s president Mark Warner, MD, said they "strongly support" the proposal. However, despite their support, the ASA also cautioned against scheduling the drug before the shortage is resolved.

"Delaying or staggering the full implementation of scheduling may be necessary to ensure that supplies of propofol, the most commonly used anesthetic in the country, will remain readily available to patients undergoing surgery or other procedures requiring sedation," Warner said.

The DEA will evaluate the comments and other data on the drug and will make a final decision at some point in the future.

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