Tramadol Becomes Schedule IV Drug

Abstract

The Drug Enforcement Administration (DEA) has placed tramadol into schedule IV of the Controlled Substances Act. Tramadol (Ultram) is a synthetic opioid analgesic used in the treatment of pain. As a schedule IV drug, tramadol will be under greater regulatory control; anyone who violates these controls, including manufacturers, prescribers, dispensers, and researchers may face administrative, civil, or criminal sanctions. This will make the prescribing of tramadol in the post-acute/long-term care setting more time consuming, with either a written prescription or direct contact between prescriber and pharmacist required as with other schedule III-V medications, such as benzodiazepines and codeine combinations. Schedule IV medications can be refilled up to five times for up to 6 months. Tramadol was approved in Europe in the mid-1970s and was approved by the Food and Drug Administration in 1995. Preliminary studies in the United States demonstrated a low potential for abuse, and the drug initially was not categorized as a controlled substance. However, 3 years after its approval, signs of patient abuse surfaced, as did subsequent findings of abuse complications. In the following years, several states classified tramadol as a schedule IV substance. The DEA's reclassification of tramadol comes amid mounting concerns about abuse and misuse of opioid analgesics. The final rule is available online at www.regulations.gov.