2015
DOI: 10.1371/journal.pone.0126413
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Bias in Spontaneous Reporting of Adverse Drug Reactions in Japan

Abstract: BackgroundAttitudes of healthcare professionals regarding spontaneous reporting of adverse drug reactions (ADRs) in Japan are not well known, and Japan’s unique system of surveillance, called early post-marketing phase vigilance (EPPV), may affect these reporting attitudes. Our objectives were to describe potential effects of EPPV and to test whether ADR seriousness, prominence, and frequency are related to changes in reporting over time.MethodsA manufacturer’s database of spontaneous ADR reports was used to e… Show more

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Cited by 40 publications
(33 citation statements)
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“…SJS and TEN are rare but severe adverse drug reactions that require hospitalization for urgent treatment. Thus, reporting bias is possible because these are reported more frequently than mild or well-known AEs 49. Another limitation is that causal relationships between drugs and AEs in the JADER database are only verified by the PMDA for fatalities, with other outcomes only estimated by the reporter; consequently, we cannot be certain that all AEs were caused by the medications listed.…”
Section: Discussionmentioning
confidence: 99%
“…SJS and TEN are rare but severe adverse drug reactions that require hospitalization for urgent treatment. Thus, reporting bias is possible because these are reported more frequently than mild or well-known AEs 49. Another limitation is that causal relationships between drugs and AEs in the JADER database are only verified by the PMDA for fatalities, with other outcomes only estimated by the reporter; consequently, we cannot be certain that all AEs were caused by the medications listed.…”
Section: Discussionmentioning
confidence: 99%
“…This suggested a need for continued vigilance and efficient strategies for dissemination of information about ADRs associated with cancer drugs . Healthcare professionals may be more likely to report serious than nonserious adverse drug reactions . One reason a drug may be used for years before risks become evident may be that there is no active drug surveillance system .…”
Section: Discussionmentioning
confidence: 99%
“…20 Healthcare professionals may be more likely to report serious than nonserious adverse drug reactions. 21 One reason a drug may be used for years before risks become evident may be that there is no active drug surveillance system. 22 An automated reporting system is needed to obtain data for a database with an aim for reducing cost and labor.…”
Section: All-case Surveillance Of Oncology Drugs In Japanmentioning
confidence: 99%
“…Typically, the number of reports of the target adverse reaction could be temporarily increased after the regulatory action, in which even the events occurred in the pre-period might be included in response to the regulatory action. 21,22) In this study, to avoid the influence of transient reporting bias as much as possible, the analysis was based on the date of the adverse event and not the report. We also analyzed not only the short-term but also the long-term trend from 1 to 2 years after the measure was instituted.…”
Section: Discussionmentioning
confidence: 99%