A mortality index for postmarketing surveillance of new medications

The rate of introduction of new pharmaceuticals is growing as a result of a dvances in molecular pharmacology and targeted drug development, The Fatal Toxicity Index (FTI) has been proposed as a means far monitoring drug toxic ity through post-marketing surveillance, The FTI requires data regarding th e general availability of a particular agent in the community which, in the US, is proprietary, The authors propose a Mortality Index as an alternativ e method for calculating relative lethality that does not rely on proprieta ry information for postmarketing surveillance. Using data from the Toxic Ex posure Surveillance System (TESS) a Mortality Index was calculated from the proportion of deaths occurring among all patients who present to a health care facility with an overdose on the same agent or class of agents. The av erage Mortality index for various drugs or drug classes for the years 1989 to 1997 is reported, Because the Mortality Index for desipramine appeared m uch greater than that for the other tricyclics, a chi-squared analysis was performed. The authors conclude, based on this analysis, that desipramine i s significantly more likely to lead to death after overdosage than any othe r tricyclic antidepressant in the study. Also, the Mortality index appeared to identify the impact of pediatric formulations on overdose lethality We conclude that the Mortality Index may be a useful tool for determining the safety of agents during the postmarketing surveillance phase, (Am J Emerg M ed 2000;18:176-179. Copyright (C) 2000 by W.B. Saunders Company).