薬剤の副作用に関する医師の報告を改善するための教育的介入:クラスターランダム化制御試験

Adolfo Figueiras¹, Maria T Herdeiro, Jorge Polónia

¹Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Spain, Portugal. adolfo.figueiras@usc.es

JAMA

|September 7, 2006

まとめ

教育的なアウトリーチは,薬剤の副作用 (ADRs) の医師の報告を大幅に改善しました. この標的型の介入により,ADR報告の質と量は向上し,販売後の薬物安全性監視において決定的な役割を果たしました.

科学分野:

医薬品監視と医薬品の安全性について
医療サービス研究医療サービス
医療教育医療教育について

背景:

新規販売薬の副作用に関するデータは限られている.
医療従事者が自発的な報告システムを十分に活用していないことが,販売後の監視を妨げています.
薬剤不良反応 (ADR) の報告を改善するために,効果的な戦略が必要である.

研究の目的:

医師によるADR報告の強化における教育的なアウトリーチ訪問の有効性を評価する.
報告されたADRの質に対する標的型教育の影響を評価する.

主な方法:

ポルトガル北部で6451人の医師を対象としたクラスターランダム化対照試験.
介入グループは,1時間の教育的なアウトリーチ訪問を受けた.
一般化された線形混合モデルを使用して,ADR報告率の変化を分析しました.

主要な成果:

介入グループは,ADR報告率の全体的な有意な増加を示しました (RR, 10.23).
重篤な,高因果関係,予期せぬ,および新薬に関連したADRの報告において,著しい改善が観察されました.
報告率に対するポジティブな影響は,介入後少なくとも12ヶ月間続いた.

結論:

ターゲットを絞った教育的なアウトリーチプログラムは,医師によるADR報告の質と量を効果的に改善することができます.
このような介入は,販売後の薬物安全性監視システムの強化に価値があります.

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