Tramadol post-marketing surveillance in health care professionals.
Tramadol has been marketed in the US since 1995. The US Food and Drug Administration agreed to release tramadol as a non-scheduled drug if proactive post-marketing surveillance studies would be conducted. This study was one of two phase IV protocols that were part of the overall surveillance program. It focused on impaired health professionals who are a high risk/high access population for drug abuse. All active participants in four state monitoring programs between November 1, 1995 and August 15, 1998 (n = 1,601) were recruited for the study. With the exceptions of implementing a standardized intake interview and urine testing for tramadol metabolites, all states operated their programs in the usual fashion. The programs were alerted to persistent non-prescribed tramadol use so that appropriate interventions could be employed. Despite availability of tramadol and the conditions that might lead to its abuse, the incidence rate for tramadol use in the study population was only 69 per thousand persons per year and the incidence rate for tramadol abuse or dependence was 6.9 per thousand persons per year.
Knisely
Janet S
JS
Department of Psychiatry, Virginia Commonwealth University, P.O. Box 980109, Richmond, VA 23298-0109, USA. knisely@hsc.vcu.edu
Campbell
Eleanor D
ED
Dawson
Kathryn S
KS
Schnoll
Sidney H
SH
D000328:Adult; D000701:Analgesics, Opioid; D005260:Female; D006282:Health Personnel; D006801:Humans; D008297:Male; D008875:Middle Aged; D010820:Physicians; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D019966:Substance-Related Disorders / Q000453:epidemiology*; D014147:Tramadol; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
D000701:Analgesics, Opioid; D014147:Tramadol