July 09, 2014
Area(s) of Interest: Public Health
Effective August 18, 2014, tramadol will be classified as a Schedule IV drug, according to a rule recently published by the U.S. Drug Enforcement Agency (DEA). The drug had been a non-controlled substance under federal law for almost 20 years. According to the DEA, the abuse of tramadol products has increased over the last several years, with it being used as a substitute for other opioids such as hydrocodone.
Tramadol is a centrally acting synthetic opioid analgesic used in the management of moderate to moderately severe pain in adults. Tramadol is a novel analgesic having both opiate agonist activity and monoamine reuptake inhibition that contribute to its analgesic efficacy. Tramadol was first approved by the U.S. Food and Drug Administration (FDA) in 1995 under the trade name ULTRAM. Subsequently, the FDA approved generic, combination and extended release tramadol products. Tramadol is manufactured and distributed in various forms including tablets, capsules and liquid.
The final rule imposes the regulatory controls and administrative, civil and criminal sanctions applicable to schedule IV controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities with, or possess) or propose to handle tramadol.
Physicians should be aware of the following:
- The change becomes effective on Monday, August 18, 2014. After that, all regulatory requirements applicable to schedule IV controlled substances will apply to tramadol. This includes specific rules relating to storage, recordkeeping, inventory, disposal and prescribing.
- Every DEA registrant who possesses any quantity of tramadol on August 18 must take an inventory of all stocks of tramadol on hand.
- In order to prescribe tramadol on or after August 18, 2014, prescribers will have to be registered with the DEA to prescribe Schedule IV substances.
- Any unfilled prescriptions/refills for tramadol after August 18 will have to follow Controlled Substances Act rules governing Schedule IV substances, and some patients may need new prescriptions.
Click here to read the final rule.