Since Aug. 18, 2014, tramadol (trade names: Ultram® and Ultracet®) has been classified as a schedule IV controlled substance.
The U.S. Drug Enforcement Administration and Health and Human Services evaluated tramadol using an eight-factor analysis and concluded that:
- Tramadol’s potential for abuse is low compared to schedule III substances. Further, its abuse potential is comparable to propoxyphene, a schedule IV controlled substance.
- Use of tramadol for medical treatment of moderate to moderately severe pain is currently acceptable in the U.S.
- Abuse of tramadol may result in physical or psychological dependence comparable to substances classified as schedule IV drugs.
Classifying tramadol as a scheduled controlled substance changes how it can be handled.*
For instance, DEA and Controlled Substance Regulation (CSR) numbers are required to dispense or prescribe controlled substances. Prescriptions must be written on tamper-resistant prescription pads, and limits are applied on lengths of the prescriptions and number of refills.
Impact on other health professionals
The classification of tramadol also affects other licensees. Advance practice nurses and licensed physician assistants may only prescribe consistent with their collaborative/supervisory agreement, respectively.
Physician assistants must also remain within the scope of practice of their licensed supervising physician and can only prescribe a controlled substance in an aggregate amount that does not exceed a 30-day supply. Any subsequent prescriptions beyond that limit must be authorized by the supervising physician and recorded in the medical record.
As a reminder, physicians may not delegate their authority to make medical determinations on whether or not to prescribe. All prescriptions must be issued for a legitimate medical purpose in a reasonable quantity and in the usual course of professional practice by either a practitioner who has conducted at least one in-person medical evaluation of the patient or a covering practitioner.
Further, prescribers must personally date and sign all prescriptions the day when issued. Physicians may not delegate signature authority.
For specific information, consult these additional resources:
*This article is intended to be general in nature and not intended to be legal advice
NOTE: Tramadol became a Schedule IV controlled substance in Indiana as of 04/23/15 (HB 1184). The law has been updated for physician assistants since this article was published.