Analysis of safety‐related regulatory actions by Japan's pharmaceutical regulatory agency

Ishiguro, Chieko; Misu, Takashi; Iwasa, Eiko; Izawa, Tadashi

doi:10.1002/pds.4252

Cited by 18 publications

(10 citation statements)

References 7 publications

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“…Of the 108 target active product ingredients (APIs), "cardiovascular agents" were the most common, followed by "miscellaneous metabolism agents" and "central nervous system agents" ( Table 1). Median of the year after generic marketed was 11 ± 0.8 (6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18) (median ± SE (interquartile range)) years that included 55 APIs for ≧ 11 years, 28 APIs for < 11 years and ≧ 6 years, and 25 APIs for < 6 years.…”

Section: Resultsmentioning

confidence: 99%

“…SAERs have been utilized as an important source of information for postmarketing safety measures. [5][6][7] Impacts of growth market share of generic drugs on SAERs in Japan have not been studied, although lower reporting proportion of generic antiepileptic drugs has been reported in the United States. 8 This study shows that the reporting proportion of SAERs is lower for generic drugs than for the original branded drugs marketed in Japan.…”

Section: Discussionmentioning

confidence: 99%

“…For example, safety-related drug label changes were a result of SAERs in > 50% of cases in the United States 5,6 and ~ 83% of cases in Japan. 7 In terms of the regulation on SAERs in Japan, the same requirement is imposed for the marketing authorization holders (MAHs) of original branded and generic drugs.…”

mentioning

confidence: 99%

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Lower Proportion of Spontaneous Adverse Event Reports for Generic Drugs by Comparison With Original Branded Drugs at the Postmarket Stage in Japan

Takami

Hirata

Ishiguro

et al. 2019

Clin Pharma and Therapeutics

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We investigated impacts of increased generic drug use on spontaneous adverse event reports (SAERs), because SAERs have been a major source of data for drug safety assessment at the postmarket stage. Reporting proportion of SAERs for the generic drugs was consistently and significantly lower than that for the original branded drugs. The reporting proportion targeting for 55 active product ingredients, which had the longest follow-up period after generic drug marketed, gradually decreased for the original branded drugs and increased for the generic drugs. However, these transitions did not parallel the changes in market share over the same period. These results suggest that the reporting proportion of SAERs for generic drugs may not keep pace with growth in market share. When generic drugs account for the majority of market share, utilization of multiple sources of information and data, in addition to SAERs, may be a key to assuring drug safety at the postmarket stage.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Lower Proportion of Spontaneous Adverse Event Reports for Generic Drugs by Comparison With Original Branded Drugs at the Postmarket Stage in Japan

Takami

Hirata

Ishiguro

et al. 2019

Clin Pharma and Therapeutics

Self Cite

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“…severe liver injury with telithromycin or suicidal behaviour with varenicline) and longer when ADRs were absent [23]. Other accounts report that it may take 2-12 years for drug-induced harms to be communicated to healthcare workers after marketing authorization of a medicinal product [24][25][26][27]. These studies have computed the difference between dates of communication of signals and launch dates to measure the time-to-signal, while databases of reports of ADRs, such as VigiBase, could estimate this interval and account for unpublished records.…”

Section: Introductionmentioning

confidence: 99%

Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature

2020

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Background: Signals of adverse drug reactions (ADRs) form the basis of some regulatory risk-minimization actions in pharmacovigilance. Reviews of limited scope have highlighted that such signals are mostly supported by reports of ADRs or multiple types of evidence. The time that elapses between a report of a suspected ADR and the communication of a signal has not been systematically characterized. Neither has the features of reports of suspected ADRs that authors used to support putative causal relationships, although difficulties with establishing causal relationships between medicinal products and adverse events have been highlighted. The objectives of this study will be to describe the evidence underpinning signals in pharmacovigilance, the features of reports of ADRs supporting signals, and the time that it takes to communicate a signal. Methods: We shall retrieve records from PubMed, EMBASE, Web of Science, and PsycINFO (from inception onwards), without language/design restrictions, and apply backward citation screening. We shall hand-search the websites of 35 regulatory agencies/authorities, restricted publications from the Uppsala Monitoring Centre, and drug bulletins. Signals will be requested from the competent stakeholder, if absent from websites. We shall use VigiBase, the World Health Organization's Global Individual Case Safety Report database, to determine the dates on which ADRs were reported. We shall manage records using EndNote (v. 8.2); one reviewer will screen titles/ abstracts and full texts, a second will cross-validate the findings, and a third will arbitrate disagreements. Data will be charted via the Systematic Reviews Data Repository, following the same procedures as for data retrieval. Evidence will be categorized according to the Oxford Centre for Evidence-Based Medicine Levels of Evidence. Features of reports of ADRs will be coded. Tables will display frequencies of types of evidence and features of reports of ADRs. We shall use plots or pictograms (if appropriate) to represent the time from the first report of a suspected ADR to a signal. Discussion: We expect the findings from this review will allow a better understanding of global patterns of similarities or differences in terms of supporting evidence and timing of communications and identify relevant research questions for future systematic reviews.

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“…severe liver injury with telithromycin or suicidal behaviour with varenicline), but longer when ADRs were absent [22]. Other accounts report that it may take 2-12 years for drug-induced harms to be communicated to healthcare workers after marketing authorization of a medicinal product [23][24][25][26]. These studies have computed the difference between dates of communication of signals and launch dates to measure the time-to-signal, while databases of reports of ADRs, such as VigiBase, the World Health Organization's (WHO's) global individual case safety reports database, could estimate this interval and account for unpublished records.…”

mentioning

confidence: 99%

Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature

Sartori

Aronson

Onakpoya

2020

Preprint

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Background: Signals of adverse drug reactions (ADRs) form the basis of some regulatory risk-minimization actions in pharmacovigilance. Reviews of limited scope have highlighted that such signals are mostly supported by reports of ADRs or multiple types of evidence. . The time that elapses between a report of a suspected ADR and the communication of a signal has not been systematically characterized. Neither have the features of reports of suspected ADRs that authors used to support putative causal relationships, although difficulties with establishing causal relationships between medicinal products and adverse events have been highlighted. The objectives of this study will be to describe the evidence underpinning signals in pharmacovigilance, the features of reports of ADRs supporting signals, and the time that it takes to communicate a signal.Methods: . We shall retrieve records from PubMed, EMBASE, Web of Science, PsycINFO (from inception onwards), without language/design restrictions and apply backward citation screening . We shall hand-search the websites of 35 regulatory agencies/authorities, restricted publications from the Uppsala Monitoring Centre, and drug bulletins. Signals will be requested from the competent stakeholder, if absent from websites. We shall use VigiBase, the World Health Organization’s Global Individual Case Safety Report database, to determine the dates on which ADRs were reported . We shall manage records using EndNote (v. 8.2); one reviewer will screen titles/abstracts and full texts, a second will cross-validate the findings, and a third will arbitrate disagreements. Data will be charted via the Systematic Reviews Data Repository, following the same procedures as for data retrieval. Evidence will be categorized according to the Oxford Centre for Evidence-Based Medicine Levels of Evidence. Features of reports of ADRs will be coded. Tables will display frequencies of types of evidence and features of reports of ADRs. We shall use plots or pictograms (if appropriate) to represent the time from the first report of a suspected ADR to a signal.Discussion: We expect the findings from this review will allow better understanding of global patterns of similarities or differences in terms of supporting evidence and timing of communications, and identify relevant research questions for future systematic reviews.Scoping review registration: osf.io/jtv38

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Analysis of safety‐related regulatory actions by Japan's pharmaceutical regulatory agency

Cited by 18 publications

References 7 publications

Lower Proportion of Spontaneous Adverse Event Reports for Generic Drugs by Comparison With Original Branded Drugs at the Postmarket Stage in Japan

Lower Proportion of Spontaneous Adverse Event Reports for Generic Drugs by Comparison With Original Branded Drugs at the Postmarket Stage in Japan

Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature

Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature

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