Tramadol HCI, marketed as Ultram in the USA, was introduced as a non-scheduled drug in April 1995 based on the assumption that the risk of abuse was sufficiently low to warrant a non-scheduled status. However, approval was contingent upon the development of an innovative proactive surveillance program, to be overseen by an independent steering committee (ISC), which would detect unexpectedly high level of abuse. The ICS developed a two-tiered approach to detect whether tramadol had unexpectedly high abuse potential. The first tier consisted of a comprehensive, proactive surveillance program devised to detect any signal that abuse of tramadol might be emerging, particularly in populations at risk for abuse. The second tier consisted of two analytical post-marketing studies focusing on the potential abuse of tramadol in pain patients and impaired health care professionals. The program developed to meet these goals and the abuse profile of tramadol in the 3 years since its introduction will be discussed as a model program for a post-marketing surveillance program. The overwhelming majority of abuse cases (97%) have been found to occur among individuals with a history of substance abuse and the abuse has been confined to isolated pockets around the country – notably none of which have significant populations of street drug abusers. Thus, the data support the decision not be schedule tramadol and, furthermore, suggest that a proactive post-marketing surveillance program can be successfully developed to effectively monitor abuse of new medications.
Learning Objectives: Illustrate innovative methods for post-marketing surveillance programs for medications with potential for abuse
Keywords: Surveillance, Data Collection
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.