Adverse Event Reporting and Standardized Medical Terminologies: Strengths and Limitations
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0092-8615/2002 Copyright 0 2002 Drug Information Association Inc.
ADVERSE EVENT REPORTING AND STANDARDIZED MEDICAL TERMINOLOGIES: STRENGTHS AND LIMITATIONS STEPHEN A. GOLDMAN,MD Stephen A. Goldman Consulting Services, L.L.C., Morns Plains, New Jersey
The International Conference on Harmonization (ICH) is a unique multinational effort involving globalization of the pharmaceutical industry. In response to a need perceived by both industry and regulatory authorities for a common medical terminology designed for regulatory purposes, the Medical Dictionary for Regulatory Activities (MedDRA@) was developed under ICH auspices. As a dynamic terminology, MedDRA has undergone review and refinements by its associated Expert Working Group to facilitate analysis and presentation of data. The MedDRA Maintenance and Suppon Services Organization is responsible for maintaining and updating the terminology, utilizing user experience and feedback. While not the first coding terminology designed for adverse reaction reporting, MedDRA reportedly offers advantages over previous terminologies. Further, a common terminology provides for greater ease of analysis and data transmission both within and between countries, Howevel; no medical terminology is without limitations, particularly with respect to coding issues and specific clinical entities. These limitations must be recognized and considered in the performance of phannacovigilance and phannacoepidemiology, if the terminology’s utility as a safety tool is to be maximized. Key Words: Adverse; Reporting; MedDRA@;Pharmacovigilance; Pharmacoepidemiology
INTRODUCTION THE ICH, INITIATED IN 1990, is a unique multinational (United States, European Union, and Japan) effort involving globalization of the pharmaceutical industry through such initiatives as standardization of regulatory requirements (1). ICH has already had an important impact on the area of product safety,
Presented at the DIA 37th Annual Meeting, July 8-12, 2001, Denver, Colorado. Reprint address: Stephen A. Goldman, MD. Stephen A. Goldman Consulting Services, L.L.C., 34 Arlington Avenue, M o m s Plains, NJ 07950.
including the development of a global medical terminology called [email protected] was done in response to a need perceived by both industry and regulatory authorities for a common medical terminology designed for regulatory purposes (1,2). In 1994, the Multidisciplinary Communication Initiative (Ml) to establish such an international medical terminology was introduced, with a draft (alpha) version of M1 terminology released for review and evaluation later that year. Since 1995, the Expert Working Group has performed review and made refinements to facilitate analysis and presentation of data. The MedDRA Mainte-
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nance and Support Services Organization is responsible for maintaining and updating the terminology (1,2). As MedDRA implementation and experience progresses, it is hoped that use of such an accepted medical terminology will facilitate analysis and data transmission both within and between cou
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