\u3086\u3046\u304c\u3044\u3058\u3057\u3087\u3046<\/p>\n\n\n\n
Adverse event<\/p>\n\n\n\n
\u5b9a\u7fa9
(1) \u60a3\u8005\u306b\u56de\u907f\u53ef\u80fd\u306a\u5bb3\u3092\u3082\u305f\u3089\u3057\u305f\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\uff08WHO, 2020\uff09
(2) \u533b\u85ac\u54c1\u304c\u6295\u4e0e\u3055\u308c\u305f\u969b\u306b\u8d77\u3053\u308b\uff0c\u3042\u3089\u3086\u308b\u597d\u307e\u3057\u304f\u306a\u3044\uff0c\u3042\u308b\u3044\u306f\u610f\u56f3\u3057\u306a\u3044\u5fb4\u4faf\uff08\u81e8\u5e8a\u691c\u67fb\u5024\u306e
\u7570\u5e38\u3092\u542b\u3080\uff09\uff0c\u75c7\u72b6\uff0c\u307e\u305f\u306f\u75c5\u6c17\u306e\u3053\u3068\u3067\u3042\u308a\uff0c\u5f53\u8a72\u533b\u85ac\u54c1\u3068\u306e\u56e0\u679c\u95a2\u4fc2\u306e\u6709\u7121\u306f\u554f\u308f\u306a\u3044
(3) \u5b9f\u65bd\u3055\u308c\u305f\u7814\u7a76\u3068\u306e\u56e0\u679c\u95a2\u4fc2\u306e\u6709\u7121\u3092\u554f\u308f\u305a, \u7814\u7a76\u5bfe\u8c61\u8005\u306b\u751f\u3058\u305f\u5168\u3066\u306e\u597d\u307e\u3057\u304f\u306a\u3044\u53c8\u306f\u610f\u56f3\u3057\u306a
\u3044\u50b7\u75c5\u82e5\u3057\u304f\u306f\u305d\u306e\u5fb4\u5019\uff08\u81e8\u5e8a\u691c\u67fb\u5024\u306e\u7570\u5e38\u3092\u542b\u3080\uff09
\u89e3\u8aac
(1) 2005 \u5e74\u306b\u516c\u8868\u3055\u308c\u305f\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\u304a\u3088\u3073\u5b66\u7fd2\u30b7\u30b9\u30c6\u30e0\u306b\u95a2\u3059\u308b WHO \u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u8349\u6848 1)<\/sup>\u3067\u306f\uff0c\u75be
\u60a3\u306e\u5408\u4f75\u75c7\u3068\u306f\u5bfe\u7167\u7684\u306b\uff0c\u533b\u5b66\u7684\u7ba1\u7406\u306b\u95a2\u9023\u3059\u308b\u640d\u50b7\u3060\u3068\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u308b. \u533b\u7642\u7ba1\u7406\u306b\u306f\uff0c\u8a3a\u65ad\u3068\u6cbb
\u7642\uff0c\u8a3a\u65ad\u307e\u305f\u306f\u6cbb\u7642\u306e\u5931\u6557\uff0c\u304a\u3088\u3073\u533b\u7642\u3092\u63d0\u4f9b\u3059\u308b\u305f\u3081\u306e\u30b7\u30b9\u30c6\u30e0\u3068\u6a5f\u5668\u3068\u3044\u3063\u305f\u533b\u7642\u306b\u95a2\u3059\u308b\u5168\u3066\u306e
\u3053\u3068\u304c\u542b\u307e\u308c\uff0c\u6709\u5bb3\u4e8b\u8c61\u306b\u306f\u56de\u907f\u53ef\u80fd\u306a\u3082\u306e\u3068\u56de\u907f\u4e0d\u53ef\u80fd\u306a\u3082\u306e\u304c\u3042\u308b\u3068\u8aac\u660e\u3055\u308c\u305f\uff0e2009 \u5e74\u306b\u767a\u8868\u3055
\u308c\u305f\u60a3\u8005\u5b89\u5168\u306e\u56fd\u969b\u5206\u985e\u306e\u6982\u5ff5\u7684\u67a0\u7d44\u307f\uff08Conceptual framework for the International Classification for Patient Safety\uff09\u3067\u3082\uff0cadverse event \u3068 harmful incident \u306f\u540c\u7fa9\u3068\u3055\u308c\u305f(WHO, 2009)\uff0e\u3057\u304b\u3057\uff0c
2011 \u5e74\u306b\u767a\u884c\u3055\u308c\u305f\u60a3\u8005\u5b89\u5168\u30ab\u30ea\u30ad\u30e5\u30e9\u30e0\u30ac\u30a4\u30c9\u591a\u8077\u7a2e\u7248\u306e\u91cd\u8981\u306a\u6982\u5ff5\u8a9e\u306e\u5b9a\u7fa9\u96c6\u3067\u306f\uff0c\u6709\u5bb3\u53cd\u5fdc
(adverse reaction)\u3068\u3044\u3046\u7528\u8a9e\u304c\u65b0\u305f\u306b\u5b9a\u7fa9\u3055\u308c\uff0c\u6b63\u3057\u3044\u30d7\u30ed\u30bb\u30b9\u306b\u5f93\u3063\u3066\u9069\u5207\u306a\u884c\u52d5\u306b\u3088\u3063\u3066\u5b9f\u65bd\u3055\u308c
\u305f\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u60a3\u8005\u306b\u767a\u751f\u3057\u305f\u4e88\u671f\u305b\u306c\u5bb3\u3068\u3057\u3066\uff0cadverse event \u3068\u533a\u5225\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u305f\u304c
(WHO, 2011)\uff0c\u4e00\u65b9\u3067\uff0c\u60a3\u8005\u5b89\u5168\u30ab\u30ea\u30ad\u30e5\u30e9\u30e0\u30ac\u30a4\u30c9\u591a\u8077\u7a2e\u7248\u306e\u672c\u6587\u3067\u306f\uff0charmful incident \u3068
adverse event \u304c\u7f6e\u304d\u63db\u3048\u53ef\u80fd\u306a\u5f62\u3067\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u7b87\u6240\u3082\u3042\u3063\u305f 2)<\/sup>\uff0e2020 \u5e74\u306b\u767a\u884c\u3055\u308c\u305f WHO \u306e\u6587
\u66f8\u3067\u306f\uff0c\u4e21\u8005\u3092\u533a\u5225\u3057\u305f\u5206\u985e\u304c\u660e\u8a18\u3055\u308c\u305f(WHO, 2020)\uff0e\u3053\u306e\u3088\u3046\u306b WHO \u306e\u60a3\u8005\u5b89\u5168\u306e\u6982\u5ff5\u306b\u3082\u5909\u5316
\u304c\u307f\u3089\u308c\u308b\u304c\uff0c\u672c\u7528\u8a9e\u96c6\u306f\uff0cWHO \u306e\u6700\u65b0\u306e\u5b9a\u7fa9\u3092\u63a1\u7528\u3059\u308b\u3053\u3068\u3068\u3057\u305f\uff0e\u56de\u907f\u53ef\u80fd\u306a\u5bb3\u306f\uff0c\u30d7\u30ed\u30bb\u30b9\u306b
\u30a8\u30e9\u30fc\u3084\u6a19\u6e96\u7684\u306a\u533b\u7642\u304b\u3089\u306e\u9038\u8131\u3068\u3044\u3063\u305f\u554f\u984c\u304c\u3042\u3063\u305f\u3082\u306e\u3092\u6307\u3059\u304c\uff0c\u5bb3\u306b\u81f3\u308b\u6a5f\u5e8f\u306f\u8907\u96d1\u3067\u3042\u308a\u60a3\u8005
\u5074\u306e\u8981\u56e0\u306e\u95a2\u4e0e\u3082\u3042\u308b\uff0e\u307e\u305f\uff0c\u5225\u306e\u65b9\u6cd5\u3092\u3068\u3063\u3066\u3044\u308c\u3070\uff0c\u5bb3\u3092\u8efd\u6e1b\u3067\u304d\u305f\u306e\u3067\u306f\u306a\u3044\u304b\u3068\u8003\u3048\u3089\u308c\u308b\u3082
\u306e\u3082\u3042\u308a\uff0c\u3053\u308c\u3092 ameliorable adverse event \u3068\u3044\u3046\u7528\u8a9e\u3067\u5b9a\u7fa9\u3059\u308b\u8003\u3048\u3082\u3042\u308b 3)<\/sup> \uff0e\u660e\u3089\u304b\u306a\u30a8\u30e9\u30fc\u304c
\u3042\u3063\u305f\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u3060\u3051\u3092\u533b\u7642\u5b89\u5168\/\u60a3\u8005\u5b89\u5168\u306e\u6d3b\u52d5\u306e\u5bfe\u8c61\u306b\u3059\u308b\u306e\u3067\u306f\u306a\u304f\uff0c\u3088\u308a\u8cea\u306e\u9ad8\u3044\u533b\u7642\u3092\u63d0\u4f9b
\u3059\u308b\u3053\u3068\u306b\u3088\u3063\u3066\uff0c\u60a3\u8005\u306e\u30a2\u30a6\u30c8\u30ab\u30e0\u3092\u6539\u5584\u3059\u308b\u3068\u3044\u3046\u8003\u3048\u3082\u3042\u308b\uff0e\u3088\u308a\u7dca\u6025\u6027\u306e\u3042\u308b\u6d3b\u52d5\u306f\uff0c\u30b7\u30b9\u30c6
\u30e0\u306e\u6539\u5584\u306b\u3088\u3063\u3066\u30a8\u30e9\u30fc\u3084\u6a19\u6e96\u304b\u3089\u306e\u9038\u8131\u306b\u3088\u308b\u5bb3\u3092\u7121\u304f\u3059\u3082\u306e\u3060\u3068\u8a00\u3048\u308b\u304c\uff0c\u533b\u7642\u306e\u8cea\u6539\u5584\u3068\u60a3\u8005\u5b89
\u5168\u306f\u76f8\u4e92\u306b\u95a2\u9023\u3057\uff0c\u533a\u5225\u305b\u305a\u306b\u5b9f\u88c5\u3055\u305b\u3066\u3044\u304f\u3068\u3044\u3046\u8003\u3048\u3082\u3042\u308a\uff0cadverse event \u3092\u3088\u308a\u5e83\u304f\u5b9a\u7fa9\u3059\u308b
\u3053\u3068\u306f\u5341\u5206\u5408\u7406\u7684\u306a\u8003\u3048\u65b9\u3067\u3042\u308b\uff0e
(2)(3) \u6cbb\u9a13\u4e2d\u306b\u5f97\u3089\u308c\u308b\u5b89\u5168\u6027\u60c5\u5831\u306b\u3064\u3044\u3066\u306f\uff0c\u65e5\u30fb\u7c73\u30fbEU \u4e09\u6975\u533b\u85ac\u54c1\u627f\u8a8d\u5be9\u67fb\u30cf\u30fc\u30e2\u30ca\u30a4\u30bc\u30fc\u30b7\u30e7
\u30f3\u56fd\u969b\u4f1a\u8b70\uff08ICH\uff09\u306e\u5408\u610f\u4e8b\u9805\u306b\u57fa\u3065\u3044\u3066\uff0c\u6709\u5bb3\u4e8b\u8c61\u3084\u6709\u5bb3\u53cd\u5fdc\u306e\u5b9a\u7fa9\u304c\u5b9a\u3081\u3089\u308c\u3066\u3044\u308b 4,5)<\/sup>\uff0e\u4eba\u3092\u5bfe\u8c61
\u3068\u3059\u308b\u81e8\u5e8a\u7814\u7a76\u306b\u304a\u3044\u3066\u3082\uff0c\u56fd\u5916\u3068\u65e5\u672c\u3067\u540c\u69d8\u306e\u6709\u5bb3\u4e8b\u8c61\u306e\u57fa\u6e96\u304c\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u308b 6,7)<\/sup>\uff0e
\u53c2\u8003\u6587\u732e
1) World Health Organization. WHO Draft Guidelines for Adverse Event Reporting and Learning
Systems From information to action. (2005)
2) World Health Organization.\u60a3\u8005\u5b89\u5168\u30ab\u30ea\u30ad\u30e5\u30e9\u30e0\u30ac\u30a4\u30c9 \u591a\u8077\u7a2e\u7248. (2011)
https:\/\/www.who.int\/docs\/default-source\/patient-safety\/9789241501958-
jpn.pdf?isAllowed=y&sequence=3<\/a>[\u30a2\u30af\u30bb\u30b9\u65e5 2023.05.07]
3) Adverse Events, Near Misses, and Errors (2019). https:\/\/psnet.ahrq.gov\/primer\/adverseevents-near-misses-and-errors[\u30a2\u30af\u30bb\u30b9\u65e5 2023.05.07]
4) Guideline for good clinical practice E6(R2). (2016)
https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/ich-guideline-good-clinicalpractice-e6r2-step-5_en.pdf<\/a>[\u30a2\u30af\u30bb\u30b9\u65e5 2023.05.07]
5) \u6cbb\u9a13\u4e2d\u306b\u5f97\u3089\u308c\u308b\u5b89\u5168\u6027\u60c5\u5831\u306e\u53d6\u308a\u6271\u3044\u306b\u3064\u3044\u3066\uff0e\u5e73\u6210 7 \u5e74 3 \u6708 20 \u65e5 \u85ac\u5be9\u7b2c 227 \u53f7\uff08\u5404\u90fd\u9053\u5e9c\u770c
\u885b\u751f\u4e3b\u7ba1\u90e8\uff08\u5c40\uff09\u9577\u3042\u3066 \u539a\u751f\u7701\u85ac\u52d9\u5c40\u5be9\u67fb\u8ab2\u9577\u901a\u77e5\uff09\uff0e(1995)
https:\/\/www.pmda.go.jp\/files\/000156127.pdf<\/a>[\u30a2\u30af\u30bb\u30b9\u65e5 2023.05.07]
6) National Library of Medicine. Glossary of Common Site Terms.
https:\/\/clinicaltrials.gov\/ct2\/about-studies\/glossary<\/a>[\u30a2\u30af\u30bb\u30b9\u65e5 2023.05.07]
7) \u4eba\u3092\u5bfe\u8c61\u3068\u3059\u308b\u751f\u547d\u79d1\u5b66\u30fb\u533b\u5b66\u7cfb\u7814\u7a76\u306b\u95a2\u3059\u308b\u502b\u7406\u6307\u91dd\u30ac\u30a4\u30c0\u30f3\u30b9.(2022)
https:\/\/www.mhlw.go.jp\/content\/000909926.pdf<\/a> [\u30a2\u30af\u30bb\u30b9\u65e5 2023.05.07]<\/p>\n\n\n\n