A potential use of the National Death Index for postmarketing drug surveillance
S. A. Edlavitch, M. Feinleib and C. Anello
A particularly difficult problem for both the Food and Drug Administration
and the pharmaceutical manufacturer is evaluation of the importance of
spontaneous reports of suspected drug-associated fatalities. These reports
are rare, and usually no accurate denominator data on drug use exist. This
article proposes that the National Death Index be used to calculate
mortality rates for selected drugs as part of the postmarketing
surveillance efforts of the government and manufacturers. When hypotheses
are generated from spontaneous reports and/or the mortality data,
additional studies can be conducted on the cohorts that were identified for
mortality follow-up.
