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医薬品添付文書の重大な副作用の追記に影響を及ぼす要因の解析
https://gifu-pu.repo.nii.ac.jp/records/13162
https://gifu-pu.repo.nii.ac.jp/records/13162c3eba048-441f-4003-946f-3b132eb9701a
| Item type | 研究室原著論文(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2018-06-14 | |||||
| タイトル | ||||||
| タイトル | 医薬品添付文書の重大な副作用の追記に影響を及ぼす要因の解析 | |||||
| タイトル | ||||||
| タイトル | Evaluation of Factors Influencing Addition of Clinically Significant Adverse Reactions Section in Drug Package Inserts | |||||
| 言語 | en | |||||
| 言語 | ||||||
| 言語 | jpn | |||||
| キーワード | ||||||
| 言語 | en | |||||
| 主題Scheme | Other | |||||
| 主題 | post-marketing safety-related regulatory action | |||||
| キーワード | ||||||
| 言語 | en | |||||
| 主題Scheme | Other | |||||
| 主題 | clinically significant adverse reaction | |||||
| キーワード | ||||||
| 言語 | en | |||||
| 主題Scheme | Other | |||||
| 主題 | package insert | |||||
| 資源タイプ | ||||||
| 資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
| 資源タイプ | journal article | |||||
| アクセス権 | ||||||
| アクセス権 | metadata only access | |||||
| アクセス権URI | http://purl.org/coar/access_right/c_14cb | |||||
| 抄録 | ||||||
| 値 | Objective: The aim of this study was to analyze the factors influencing the addition of clinically significant adverse reactions (CSDR) section in drug package inserts in Japan. Methods: The summaries of investigation results from August 2011 to July 2014 were evaluated. The revisions were classified into revisions based only on case reports from Japan ([Revision Y]) and revisions based on other information and/or case reports from Japan ([Revision X]). The revisions were classified into MedDRA system organ class (SOC). As index of amount of information from domestic case reports, the number of accumulated cases ([Case A]), cases for which a causal relationship to the product could not be ruled out ([Case B]), and fatal cases ([Case C]) were used. In each SOC, as index of causal relationship to the product, [Index B/A] ([Case B]/[Case A]) was calculated. Relationship of [Index B/A] to [Revision X]/all revisions, or to the number of [Case A] in [Revision Y] were evaluated. Deference of drug lag between [Revision X] and [Revision Y] was evaluated. Results: Three hundreds twenty-three revisions with respect to the addition of CSDR section were identified. [Revision Y] was 203 revisions (63%). The number of [Case A], ([Case B], and ([Case C]) that were required for [Revision X] (120 revisions) were significantly lower than that were required for [Revision Y] (p<0.0001 for all comparisons). [Index B/A] tended to inversely correlate with [Revision X]/all revisions (r=−0.52, p=0.066), and the number of [Case A] in [Revision Y] (r=−0.61, p=0.025). Drug lag of [Revision X] was significantly longer than that of [Revision Y] (p<0.001). Conclusions: In future, it would especially needed to pay attention to adverse reactions with a low [Index B/A] of which revisions relatively depend on other information. |
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| 書誌情報 |
医薬品情報学 en : Iyakuhin Johogaku 巻 19, p. 17-13, 発行日 2017 |
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| DOI | ||||||
| 値 | 10.11256/jjdi.19.17 | |||||
