Construction of an infrastructure for an adverse drug reaction monitoring support system that utilizes real world data
| Project/Area Number |
18K14995
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| Research Category |
Grant-in-Aid for Early-Career Scientists
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| Allocation Type | Multi-year Fund |
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| Review Section |
Basic Section 47060:Clinical pharmacy-related
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| Research Institution | Osaka Medical and Pharmaceutical University (2021-2022)
Osaka University of Pharmaceutical Sciences (2018-2020) |
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Principal Investigator |
KADOYAMA Kaori 大阪医科薬科大学, 薬学部, 専門教授 (10571391)
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| Project Period (FY) |
2018-04-01 – 2023-03-31
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| Project Status |
Completed (Fiscal Year 2022)
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| Budget Amount *help |
¥3,770,000 (Direct Cost: ¥2,900,000、Indirect Cost: ¥870,000)
Fiscal Year 2020: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2019: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2018: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
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| Keywords | 副作用モニタリング / JADER / 医薬品副作用データベース / 自発報告 / 有害事象 / 発現時期 / 薬歴 / テキストマイニング / 抗精神病薬 / 関節リウマチ / 生物学的製剤 / リアルワールドデータ / 有害事象自発報告システム / プッシュ型通知 / 情報提供 |
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| Outline of Final Research Achievements |
We proceeded with the analysis using the database of adverse drug reactions (JADER) to clarify the characteristics of adverse events of antipsychotic drugs and biological agents that are frequently used in clinical practice, including the types and timing of their occurrence. To compensate for the shortcomings of JADER, which has deficiencies in the starting date of administration of the suspect drugs and the onset date of adverse events, we focused on the drug history data of insurance pharmacies as another information source and analyzed the timing of adverse drug reactions by combining the dispensing history and patient complaints in the medication instruction records. Focusing on hypertension and psychiatric disorders, which have a large number of patients, we were able to clarify the onset timing of cough caused by antipsychotic drugs in 2021, and the onset timing of cough caused by antihypertensive drugs and acne caused by antipsychotic drugs in the final year of the study.
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| Academic Significance and Societal Importance of the Research Achievements |
本研究の社会的意義として、臨床で繁用される降圧薬、抗精神病薬、生物学的製剤などに焦点をあて、これら医薬品の有害事象の種類や発現時期等の特徴を明らかにし、副作用の早期発見・重篤化回避につながる情報を提供できたこと、また、得られた結果は、副作用モニタリングシステムに搭載できるようにIT開発ベンダーと調整を始めており、現実社会での利活用につなげようとしていることが挙げられる。また、薬局の薬歴データを用いて、調剤歴と服薬指導記録の内容を組合わせることで、これまで気づきにくかった副作用とその発現時期を明らかにできた。これにより今以上にきめ細かなモニタリングが可能となるため、本研究の学術的意義は大きい。
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Report
(6 results)
Research Products
(8 results)
