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AVMA Comments on DEA’s Proposed Controls for Propofol

Posted: December 21, 2010, 6:45 p.m., EDT

AVMA Comments on DEA’s Proposed Controls for PropofolThe American Veterinary Medical Association reported today that it sent a letter to the Drug Enforcement Agency offering guidance on the DEA’s proposal of designating propofol as a Schedule IV drug under the Controlled Substances Act.

The DEA issued the proposal in late October based on reports it received concerning the increased abuse of propofol and that the abuse potential is comparable to other Schedule IV substances. Propofol abuse also has a high mortality rate, the DEA noted.

If finalized, the rule would impose the regulatory controls and criminal sanctions of Schedule IV on those who handle propofol and products containing propofol.

The AVMA is concerned that the new rule could discourage veterinarians from using the “useful and effective induction agent.”

“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,” Ron DeHaven, DVM, CEO of the AVMA, said in the letter.

He goes on to explain that propofol has a very short shelf life, meaning that it becomes unusable within hours of opening. Given this, some unusable product often remains in the vial after veterinary use.Currently, veterinarians dispose of any unused propofol into an absorbent substance, like kitty litter, for incineration or disposal as solid waste.

This method follows AVMA’s Best Management Practice for Pharmaceutical Disposal, which was instituted to help stop pharmaceutical waste from entering waterways.

If the proposed rule goes into effect, veterinarians may no longer be able to dispose unused propofol in this manner. Instead, veterinary practices would need to contract with a registered company to pick up any unused product or go through the process of contacting the local DEA field office to gain approval to destroy the product in the clinic, according to Lynn White-Shim, DVM, assistant director of AVMA’s Scientific Activities Division.

Contracting with a company could be costly while contacting local DEA offices may be time consuming and, in the end, ineffective, she said.

The hope is that, if the rule passes, the DEA will develop a nationwide process that would allow vets to destroy any unused product in their clinic on an ongoing basis, Dr. White-Shim said.

Dr. DeHaven echoed the sentiment in the letter. “If propofol becomes a Schedule IV controlled substance, the AVMA believes that it is important for the DEA to have a pre-defined process set in place that would allow for convenient disposal of wasted propofol on an ongoing basis.”

According to the DEA, the current abuse profiles of propofol indicate that it is abused by medical professionals since they have access to the drug in medical facilities which perform anesthesia.

The motivation for abuse of propofol is generally for its sedative and relaxing properties and induction of euphoric effects, according the DEA.

The DEA is accepting comments on the proposed designation until Monday, Dec. 27, on this website under Docket No. DEA-338.

The proposed rule can be found here.

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