© 2023 MJH Life Sciences™ and dvm360 | Veterinary News, Veterinarian Insights, Medicine, Pet Care. All rights reserved.
DEA moves to reschedule buprenorphine
Government to impose stricter regulatory controls for drug due to abuse potential
Washington-Based on reports of widespread European abuse, Drug Enforcement Agency (DEA) officials moved to reschedule the pain reliever buprenorphine before the U.S. Food and Drug Administration (FDA) approves a potent tablet version for U.S. use.
This long lasting analgesic approved for off-label use by veterinarianscurrently is available in low doses in an injectable form. Acting on a formalrequest by the Department of Health and Human Services, DEA aims to upgradethe semi-synthetic narcotic from a Schedule V to Schedule III drug.
On the human side, buprenorphine treats heroin and cocaine addiction.
Affecting the veterinarian?
As far as obtaining buprenorphine, its reschedule, at most, might meanmore paperwork for the DEA-licensed DVM.
Government officials note that buprenorphine produces effects similarto other pure mu agonists, including euphoria, drug liking, respiratorydepression, pupillary constriction and sedation.
Although little abuse or theft of buprenorphine is noted in the UnitedStates, significant abuse has been reported in countries where strongerversions are marketed. In France, for example, the drug's overdose has resultedin more than 100 deaths.
On the eve of its more potent introduction into the United States' drugmarket, DEA officials warn that, "Buprenorphine products have beendiverted from legitimate channels through theft, doctor shopping and fraudulentprescriptions."
"The drug doesn't have a wide distribution in the U.S. right now,"says Pat Clarke, spokesperson for the DEA's Center for Drug Evaluation andResearch, "but when the tablet version does get abused, that abuseis sure to run rampant."
Narcotics
Classifications
Schedule V
* The drug has a low potential for abuse relative to drugs inother schedules.
* The drug has currently accepted medical use in treatment inthe United States.
* Abuse of the drug or other substance may lead to limited physicaldependence or psychological dependence relative to drugs in other schedules.
Schedule III
* The drug has a potential for abuse less than drugs or othersubstances in schedules I and II.
* The drug has a currently accepted medical use in treatment inthe United States.
* Abuse of the drug or other substance may lead to moderate orlow physical dependence or high psychological dependence.
Source: DEA
