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運用資訊系統促進醫師主動通報藥物不良反應

The Use of Information System to Enhance Voluntary Physician Reporting of Adverse Drug Reactions

摘要


藥品研發階段之臨床試驗因規模有限,恐無法代表正式上市後廣大病人群的所有反應,為有效掌握所有藥品上市後不良反應資訊,確保上市藥品之安全性,對於藥品使用所產生的不良反應通報至為重要。而醫師診治病人,對於病人的病情、生理狀況及對藥品療效的反應或導致之任何藥品不良反應最為清楚。因此,若能鼓勵醫師主動通報,對於通報作業與品質及對病人用藥安全的維護都能大幅提升。

並列摘要


During the development of a new drug, the number of patients enrolled in clinical trials is often limited. The results can not represent all the adverse reactions from different patient populations after marketing. The reporting of adverse drug reactions is important in order to continuously survey and complete information on marketed drugs, and to ensure drug safety. Physicians play an important role in reporting such events, since they are more familiar with the patients' medical conditions, physiological status and the effectiveness of drugs prescribed. If the primary physicians can be encouraged to actively report adverse drug reactions, it will not only improve the quality of reporting, but also ensure the drug safety for patients.

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