The U.S. Drug Enforcement Administration began labeling tramadol, an opioid pain medication, as a Schedule IV controlled substance on Monday, according to a final rule published in the Federal Register.
Tramadol, which is sold under the names Ultram and Ultracet, is used to manage moderate to moderately severe pain, according to the DEA.
Schedule IV drugs have less potential for abuse than the substances in Schedules III, II and I, and may be refilled up to five times within six months after the date prescribed, according to the DEA.
Tramadol was not previously considered a controlled substance, but now that it is, drug monitoring programs will begin collecting data on usage, according to comments posted online by DEA from medical groups that supported controlling the opioid.
The DEA published a final rule in the Federal Register in July that said it would begin labeling tramadol as a controlled substance this month.
In support of the rule, one prescription drug abuse task force called tramadol a “ 'loop hole drug which is addictive, abused, and diverted,' but which is not yet realized as such by many patients and prescribers,” according to the DEA.
As of 2012, 3.2 million people in the United States age 12 or older had used tramadol during their lifetime for nonmedical purposes, according to the National Survey on Drug Use and Health, which is conducted by the U.S. Public Health Service. Workers compensation experts say the opioid is commonly prescribed to comp claimants.
Other Schedule IV controlled substances include benzodiazepenes, such as Xanax and Valium.
The federal Controlled Substances Act includes a total of five schedules or drug classifications which regulate the use and distribution of controlled substances. Prior to Tramadol being named a Schedule IV controlled substance, 10 states controlled it as such under state law, “with requirements that meet or exceed the DEA's requirements for schedule IV controlled substances” and therefore those “states are not economically impacted by this rule,” according to the DEA.