The U.S. Drug Enforcement Agency (DEA) is pushing to have the popular anesthetic propofol classified as a schedule IV drug to more tightly control its distribution with the goal of preventing abuse.
If that happens, veterinarians will be left with no injectible drug options in terms of anesthetic agents that do not require the paperwork and oversight demanded by the DEA for controlled substances.
Veterinarians such as Dr. Richard Headley, a practitioner in East Mishawaka, Ind., characterize the potential change as a nuisance. If approved, veterinarians using propofol will need to maintain a DEA license and record how they use the anesthetic via controlled drug inventory and log forms.
“It's just one more piece of paper we'll fill out,” he says. “We're already tracking ketamine and butorphanol. The hardest thing will be calculating the waste because a vial of propofol is only good for a day. A 20-cc vial will take care of two big dogs. If you open a bottle, you’d better have several cats.”
Notice of the DEA’s proposed rule appeared in the Oct. 27 Federal Register, the official daily journal that contains the public notices of U.S. government agencies.
The Federal Register reports that the proposal was initiated by the U.S. Department of Health and Human Services, which 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.
In June 2009, propofol made headlines when music superstar Michael Jackson died following an overdose of the anesthetic. His personal physician faces charges of involuntary manslaughter in Jackson’s death.
What impact that incident had on the push to schedule propofol is unclear. Background information published by the Federal Register indicates that the drug is being abused by medical professionals who can access it in facilities that perform anesthesia.
Propofol has been around since 1989, and board-certified anesthesiologist Dr. Meghan Richey rejects the notion that its abuse is a major problem, at least among veterinarians. She believes that elevating its status will only attract the attention of drug abusers, much like what happened when the DEA classified ketamine as a schedule III narcotic.
Drug seekers are known to break into veterinary practices in search for ketamine, also known by the street name Special K.
“I don't think people break into veterinary practices to get propofol,” says Richey, who works in private practice and consults on the Veterinary Information Network (VIN), an online community for the profession and parent of the VIN News Service. “Now this will give it more attention. Once ketamine was controlled, everybody wanted it. They figure if the DEA has scheduled, there must be something wicked-cool about it.”
Richey plans to submit a letter of objection to the DEA’s proposal before the public comment period closes on Dec. 26, which likely will express her belief that the level of documented propofol abuse-related deaths does not warrant reclassification. The DEA did not respond to a request to characterize the number of drug abuse cases among DVMs.
“Sterile water can kill you. Heck, look at the chemotherapy agents,” Richey reasons. “There are tons of people who don’t keep butorphanol because of the pain in the butt associated with keeping controlled drugs. This is ridiculous."
Like Richey, the American Veterinary Medical Association (AVMA) plans to weigh in. The national association's Council on Biologic and Therapeutic Agents as well as the Clinical Practitioners Advisory Committee have formed a working group to discuss formulating a response to the proposal.
It is not yet known what position the AVMA will take; the association's focus on propofol comes at a time when veterinarians’ access to the drug has been unreliable. Discussions on VIN reveal that many veterinarians have experienced supply shortages, though some report having no trouble acquiring propofol for use in their practices. In August, the VIN News Service linked the reported dry spell to disruptions to the drug’s production by the two companies that manufacture it: APP Pharmaceuticals, a subsidiary of Germany-based Fresenius Kabi AG, and Hospira Inc., of Lake Forest, Ill.
A third company, Israel-based Teva Pharmaceutical Industries Ltd., was a major supplier of propofol to the U.S. market until recently. Bacterial contamination forced several recalls of the company’s propofol starting in July 2009. Last May, Teva announced it would no longer make the drug, characterizing it as unprofitable and difficult to manufacture.
The result: PropoFlo and Rapinovet — the two name-brand propofol products — were not manufactured for much of this year. To shore up supply on the human side, the U.S. Food and Drug Administration temporarily allowed APP Pharmaceuticals to import unapproved propofol, though the company reports that it’s still having trouble keeping up with demand.
Dr. John Daugherty, owner of a small animal practice in Poland, Ohio, says that he’s had no trouble stocking the drug lately and uses it several times a week. He’s also not worried about plans to classify propofol as a controlled substance.
He already treats it as one.
“We already log it and put it in a lock box,” he says. “We logged ketamine two years before it went to schedule. I lock anything where there’s a potential for human abuse.”
Want to be heard?
Written comments in reference to the DEA's proposal to elevate propofol to a schedule IV status must be postmarked on or before Dec. 27. Those filed electronically must be sent before midnight EST, Dec. 27.
All written and electronic correspondence should reference “Docket No. DEA-327.” Comments sent via standard or express mail should be sent to the DEA, attention:
DEA Federal Register Representative
ODL, 8701 Morrissette Drive
Springfield, VA 22152
E-mailed comments can be sent to the DEA at dea.diversion.policy@usdoj.gov or via the electronic comment form found here: http://www.regulations.gov. The DEA only accepts electronic comments written in the following formats: Microsoft Word, WordPerfect, Adobe PDF or Excel file.
All comments received are considered public record and will appear on the DEA’s website and in the DEA's public docket. Those who want aspects of their comments unavailable for public consumption must include phrases such as “personal identifying information” or “confidential business information” in the document’s initial paragraph, though the Freedom of Information Act applies to all comment received.