FDA's Adverse Drug Reaction Drug Dictionary and its Role in Post-Marketing Surveillance

Abstract

The FDA's Center for Drugs and Biologics maintains a variety of drug data files which were developed independently rather than as part of an integrated system. Consequently, there is no standardized classification, terminology or coding across files and no Center-wide “data-retrieval” dictionary capable of linking all files. However, a unique active ingredient number has been established internally to standardize and link four of these files (ASTRO IV, Drug Listing, OTC, and ADR). This article briefly describes the role of dictionaries and their application to some of the Center files focusing primarily on the drug dictionary under development for use with the adverse drug reaction (ADR) relational data base. Intended for use for both data entry and retrieval, the dictionary “describes” only products marketed in the US. Trade and nonproprietary (USAN) names can be grouped in a variety of ways ranging from salt specific ingredients to American Hospital Formulary Service (AHFS) class. Users can also assign optional codes for creation of their own groups, for example, different classification systems. Names have been linked to IMS America marketing data for analysis of ADRs in the context of drug exposure. Although still in the development phase, the ADR drug dictionary is a valuable post-marketing surveillance tool for use in ad hoc studies and in generation of routine surveillance tables.