Update: The World Health Organization will not seek to place ketamine under international control, according to a Dec. 8 statement. The decision reflects a review last month by the WHO Expert Committee on Drug Dependence, which determined that ketamine abuse does not pose a global public health threat, and controlling it could limit access to a medically necessary anesthetic agent.
The World Health Organization’s Expert Committee on Drug Dependence are gathered this week in Geneva to consider ketamine hydrochloride and several other drugs for scheduling under the Convention on Psychotropic Substances, a treaty established in 1971 as an international control system for the manufacture, distribution, transfer and use of drugs.
How the WHO’s scrutiny of ketamine might impact U.S. supplies — if at all — is unknown. In the United States, organized veterinary medicine has been on high alert for months given ketamine’s importance to animal health care.
Ketamine has played a role in veterinary medicine for half a century as an anesthetic and adjunct to pain control, and it remains a critical drug in equine medicine. Regulators are taking a harder look at ketamine because its popularity as a recreational drug has increased worldwide, with China becoming the epicenter of global ketamine consumption and production, as reported by the BBC and other news media.
Right now, the Convention on Psychotropic Substances doesn’t list ketamine because the WHO has considered it to be an essential medicine, leaving its regulation to individual nations. If that changes, the WHO’s recommendation will go to the United Nations, where Secretary General Ban Ki-moon has the final word on Convention amendments.
Owing to widespread recreational abuse in the country, China initially sought to place ketamine under Schedule I of the Convention, putting it in the same class as illicit drugs, before revising its petition to request that the drug be classified under Schedule IV, the least restrictive class for controlled substances in the Convention’s four-scale system.
Designed for substances that present a lower risk of abuse and have high therapeutic value, the Convention’s Schedule IV involves less oversight and restriction than the U.S. Drug Enforcement Agency’s treatment of ketamine, which is a Schedule III drug per the Controlled Substances Act.
In other words, U.S. regulations already are tougher on ketamine than what China proposes. What’s more, domestic laws and regulations trump international international treaty obligations.
Via an email blast to its nearly 90,000 members, the American Veterinary Medical Association initiated a letter-writing campaign to the U.S. Food and Drug Administration, which was asked by the WHO to weigh in on ketamine abuse ahead of this week’s review in Geneva.
In a letter dated Oct. 15, the AVMA sought to remind FDA officials of ketamine’s importance to veterinary medicine:
"We reiterate that ketamine is a key component of veterinary medical anesthetic and pain management protocols worldwide, and any regulatory action that limits its availability to the veterinary profession would gravely impact animal health and welfare."
Not to worry, said FDA spokesman Kristofer Baumgartner. In an answer to questions from the VIN News Service, Baumgartner said by email, "China’s latest proposal, to place ketamine under Schedule IV of the Convention on Psychotropic Substances of 1971 would have no impact in the United States. In the U.S., ketamine is already a Schedule III controlled substance, which has stricter provisions than Schedule IV of the 1971 Convention."
The AVMA isn't convinced. In an Oct. 8 blog post, the association stated: "… We have been given different opinions by FDA and DEA on whether a more stringent international scheduling of ketamine would impact the U.S.’s classification. Hence AVMA’s concern and continued engagement and advocacy on this issue."
Practitioners on the Veterinary Information Network, an online community for the profession, worry that they might lose access to the drug. According to some experts, they have reason to stress.
Mary Debartolo, a lawyer for the O’Neill Institute for National and Global Health Law at Georgetown Law, predicts that international ketamine restrictions could impact U.S. supplies even if they don’t change U.S. laws.
"If a substance is scheduled, parties to the Convention must take a variety of actions depending on which schedule the substance falls into," she said in an online review. "These actions can include licensing, dispensing only by prescription, and adoption of measures regarding export, import and repression of acts contrary to the Convention.
"As a result of such actions," she added, "the availability of a scheduled substance may be reduced and access to the substance may become challenging, even if the substance has significant medicinal value."
A handful of companies sell ketamine in the United States, according to the FDA’s list of suppliers. Hospira, recently acquired by Pfizer, carried ketamine but doesn’t have any in stock. Putney Inc., a veterinary pharmacy company that sells ketamine, did not answer to inquiries about their supply.
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