粘膜経由の即時放出フェンタニル製品に対するFDAのリスク評価と緩和戦略の評価
Jeffrey Eric Rollman1, James Heyward1, Lily Olson1
1Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
JAMA
|February 20, 2019
まとめ
TIRFの適切な使用に関する高い知識にもかかわらず,ラベルの外での重要な処方が行われました. FDAはリスク評価と緩和戦略 (REMS) プログラムに実質的な変更を義務付けませんでした.
科学分野:
- 薬理学について
- 薬物安全性
- 規制科学
背景:
- トランスムコザの即時放出フェンタニル (TIRF) は,オピオイド耐性患者における突破性がんの痛みに対してのみ投与されます.
- 米国食品医薬品局 (FDA) のリスク評価および緩和戦略 (REMS) は,不適切なTIRFの処方防止のために実施されました.
研究 の 目的:
- TIRFの適切な使用に関する薬剤師,処方者,患者の知識評価を評価する.
- REMSプログラムが目標を達成したかどうかを,クレームデータを用いて評価する.
- REMS評価に対するFDAの反応を特徴づけるため
主な方法:
- FDA文書の4877ページ (2012年−2017年) の定性分析
- REMSの評価報告書,FDAの評価,FDAのスポンサーの通信が含まれています.
- 情報提供の自由法 (FOIA) の要求を活用した.
主要な成果:
- TIRFの不適切な使用率は,クレームデータと調査によって確認された.
- 処方医と患者はしばしば適切なTIRFの指示を誤って理解したり,誤って報告したりした.
- 特定された問題にもかかわらず,REMSプログラムに実質的な変更はほとんど行われませんでした.
結論:
- 調査によると,TIRFの適切な処方に関する知識は一般的に高い.
- 請求に基づいた分析は,TIRFの不適切な使用率を明らかにした.
- FDAはTIRF REMSプログラムに重大な変更を要求しなかった.
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