A Preliminary Assessment of the Impact of Meddra on Adverse Event Reports and Product Labeling
- PDF / 820,816 Bytes
- 16 Pages / 504 x 719.759 pts Page_size
- 16 Downloads / 191 Views
0092-8615/98 Copyright 0 1998 Drug Information Association Inc.
A PRELIMINARY ASSESSMENT OF THE IMPACT OF MEDDRA ON ADVERSE EVENT REPORTS AND PRODUCT LABELING CLAUDIAA. WHITE,MS Senior Manager, Central Safety and Surveillance, R. W. Johnson Pharmaceutical Research Institute, Spring House, Pennsylvania
The Medical Dictionary for Drug Regulatory Affairs (MEDDRA) was adopted by the International Conference on Harmonization (ICH) as the basis of a new international terminology for regulatory purposes. MEDDRA is intended for use by regulatory authorities, pharmaceutical companies, and other organizations which are involved in the capture and the communication of data contained in regulatory submissions throughout the clinical drug development cycle and following market approval. MEDDRA is a much larger dictionary than other currently available dictionaries such as World Health Organizationddverse Reaction Terminolgy (WHO-ART). An example of MEDDRAk richness and specificity can be seen when comparing the number of preferred terms between WHO-ART (version 2, 1995) at 3.486 and MEDDRA (version 1.5) at >8,000. The purpose of this study was to obtain a preliminary assessment of the impact of MEDDRA on the frequency of expedited adverse event reports based on current (nonMEDDRA) labeling, This was done by examining 204 unique verbatim adverse event reports for two di8erent marketed drugs and comparing WHO-ART (current dictionary used) preferred terms and MEDDRA preferred terms in relation to the existing labeling for the respective products. A rating scale was established to quantify the significance of the differences. Because WHO-ART in its entirety is included in MEDDRA, it was not surprising that 132 out of 204 terms (65%) were neither different medically nor with regard to labeling. Twenty-seven terms (13.2%) had some syntactic differences although these were not considered medically significant. Thirty-two terms (15.7%)were rated as medically significantly direrent but did not affect the label. Ten terms (4.9%)were rated as both medically different and resulted in a labeling discrepancy. An additional three terms (1.4%) were categorized as not medically significant but nevertheless resulted in a labeling difference. The 10 terms that were medically different and produced labeling discrepancies, although a small percentage of the total, could have produced additional expeditable reports. The 32 terms that had a “medically significant” difference but did not affect the label had the potential of creating labeling discrepancies given another drug or another product label. The results of this limited analysis indicate that the specificity of MEDDRA, at the preferred term level, could produce more unlabeled and therefore more immediately reportable adverse events. MEDDRA needs continuing evaluation with regard to current regulatory requirements and those anticipated in the future. Guidelines from regulatory authorities would be useful for pharmaceutical companies by establishing standards for
Reprint address: Claudia A. W
Data Loading...
