{"created":"2023-06-19T07:25:23.360842+00:00","id":13162,"links":{},"metadata":{"_buckets":{"deposit":"cfea35c9-8e3b-458f-8792-618f0126676b"},"_deposit":{"created_by":23,"id":"13162","owners":[23],"pid":{"revision_id":0,"type":"depid","value":"13162"},"status":"published"},"_oai":{"id":"oai:gifu-pu.repo.nii.ac.jp:00013162","sets":["212:261:309"]},"author_link":["18225","18744","18743","18257"],"item_3_biblio_info_3":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2017","bibliographicIssueDateType":"Issued"},"bibliographicPageEnd":"13","bibliographicPageStart":"17","bibliographicVolumeNumber":"19","bibliographic_titles":[{"bibliographic_title":"医薬品情報学"},{"bibliographic_title":"Iyakuhin Johogaku","bibliographic_titleLang":"en"}]}]},"item_3_text_4":{"attribute_name":"DOI","attribute_value_mlt":[{"subitem_text_value":"10.11256/jjdi.19.17"}]},"item_3_textarea_2":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_textarea_value":"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.\nMethods: 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.\nResults: 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).\nConclusions: 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."}]},"item_access_right":{"attribute_name":"アクセス権","attribute_value_mlt":[{"subitem_access_right":"metadata only access","subitem_access_right_uri":"http://purl.org/coar/access_right/c_14cb"}]},"item_keyword":{"attribute_name":"キーワード","attribute_value_mlt":[{"subitem_subject":"post-marketing safety-related regulatory action","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"clinically significant adverse reaction","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"package insert","subitem_subject_language":"en","subitem_subject_scheme":"Other"}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"jpn"}]},"item_resource_type":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"resourcetype":"journal article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_title":"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","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"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"},{"subitem_title":"Evaluation of Factors Influencing Addition of Clinically Significant Adverse Reactions Section in Drug Package Inserts","subitem_title_language":"en"}]},"item_type_id":"3","owner":"23","path":["309"],"pubdate":{"attribute_name":"公開日","attribute_value":"2018-06-14"},"publish_date":"2018-06-14","publish_status":"0","recid":"13162","relation_version_is_last":true,"title":["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"],"weko_creator_id":"23","weko_shared_id":-1},"updated":"2023-06-19T08:57:41.591140+00:00"}