Comparing reporting rates of adverse events between drugs with adjustment for year of marketing and secular trends in total reporting*
- 1 January 1995
- journal article
- research article
- Published by Taylor & Francis in Journal of Biopharmaceutical Statistics
- Vol. 5 (1) , 95-114
- https://doi.org/10.1080/10543409508835100
Abstract
The Food and Drug Administration has collected spontaneous reports on adverse events (AE) from manufacturers and individuals. These data provide useful information on the safety of marketed drugs. Due to many unique characteristics of this reporting system, the information is difficult to evaluate. Incidence rates for specific adverse events and drug combinations cannot be estimated. However, reporting rates (number oi reports per market share) based on prescriptions can be computed. These reporting rates provide signals of serious adverse experience that may deserve mention. when the ratio of reporting rates is used for the comparison of two drugsKeywords
This publication has 8 references indexed in Scilit:
- False alarm rates of statistical methods used in determining increased frequency of reports on adverse drug reactionJournal of Biopharmaceutical Statistics, 1992
- A Rapidly Converging Algorithm for Exact Binomial Confidence Intervals About the Relative Risk in Follow-up Studies with Stratified Incidence-Density DataEpidemiology, 1990
- Adverse Drug Reactions and the Food and Drug AdministrationJournal of Pharmacy Practice, 1989
- A statistical methodology for postmarketing surveillance of adverse drug reaction reportsStatistics in Medicine, 1988
- Differences in Manufacturer Reporting of Adverse Drug Reactions to the FDA in 1984Drug Information Journal, 1987
- Ulcerogenicity of piroxicam: an analysis of spontaneously reported data.BMJ, 1987
- Adverse-Drug-Reaction MonitoringNew England Journal of Medicine, 1986
- Management of ADR Reports at the FDADrug Information Journal, 1985