Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: current status, challenges and the future.
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TLDR
This article provides the various issues to be considered while depending on healthcare professionals’ reporting of adverse effects as a method of post marketing surveillance, and highlights the strengths and weaknesses of spontaneous reporting programs.Abstract:
Background:To highlight the importance of spontaneous reporting programs in post marketing surveillance of medicines. Authors also aimed at providing various dimensions of spontaneous programs, inc...read more
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References
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Journal ArticleDOI
Incidence of Adverse Drug Reactions in Hospitalized Patients: A Meta-analysis of Prospective Studies
TL;DR: The incidence of serious and fatal adverse drug reactions in US hospitals was found to be extremely high, and data suggest that ADRs represent an important clinical issue.
Journal ArticleDOI
Drug-Related Morbidity and Mortality: A Cost-of-Illness Model
TL;DR: The cost of drug-related morbidity and mortality in the ambulatory setting in the United States is considerable and should be considered in health policy decisions with regard to pharmaceutical benefits.
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Quantitative signal detection using spontaneous ADR reporting.
TL;DR: The role of Bayesian shrinkage in screening spontaneous reports, the importance of changes over time in screening the properties of the measures and some suggestions as to where emerging research is likely to lead are given.
Journal ArticleDOI
Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions.
Diane K. Wysowski,Lynette Swartz +1 more
TL;DR: This work analyzed all reports of suspected adverse drug reactions submitted to the Food and Drug Administration from the inception of the Adverse Event Reporting System database in 1969 through December 2002 to encourage physicians, pharmacists, other health care professionals, and patients to continue to report serious suspected and known adversedrug reactions to manufacturers and the food and drug Administration.
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Pharmacovigilance: methods, recent developments and future perspectives.
L. Harmark,A C van Grootheest +1 more
TL;DR: To review and discuss various aspects of pharmacovigilance, including new methodolgical developments, which include transparency and increased patient involvement are two important elements.
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