{"id":256,"date":"2020-10-16T10:34:58","date_gmt":"2020-10-16T10:34:58","guid":{"rendered":"https:\/\/www.enago.cn\/academychina\/?p=256"},"modified":"2020-10-19T08:56:28","modified_gmt":"2020-10-19T08:56:28","slug":"pharmacovigilance-post-covid-19-opportunities-and-challenges","status":"publish","type":"post","link":"https:\/\/www.enago.cn\/academychina\/pharmacovigilance-post-covid-19-opportunities-and-challenges\/","title":{"rendered":"\u540e\u75ab\u60c5\u65f6\u4ee3\u7684\u836f\u7269\u8b66\u6212\uff1a\u673a\u4f1a\u4e0e\u6311\u6218"},"content":{"rendered":"<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div><p>\u6839\u636e\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\uff08WHO\uff09\u7684\u5b9a\u4e49\uff0c\u836f\u7269\u8b66\u6212\uff08Pharmacovigilance\uff09\u662f\u6307\u4e3a\u300c\u4fa6\u6d4b\u3001\u8bc4\u4f30\u3001\u4e86\u89e3\u4ee5\u53ca\u9884\u9632\u836f\u7269\u4e0d\u826f\u53cd\u5e94\u4ee5\u53ca\u4efb\u4f55\u5176\u4ed6\u4e0e\u836f\u7269\u6709\u5173\u95ee\u9898\u7684\u6d3b\u52a8\u53ca\u79d1\u5b66\u3002\u300d\u836f\u7269\u8b66\u6212\u662f WHO \u5728 1961\u5e74Thalidomide (\u6c99\u5229\u5ea6\u80fa) \u9020\u6210\u5927\u91cf\u7578\u5f62\u5a74\u513f\u7684\u60b2\u5267\u540e\u63a8\u52a8\u4ea7\u751f\uff0c\u65e8\u5728\u63d0\u5347\u75c5\u4eba\u5b89\u5168\u53ca\u7167\u62a4\uff0c\u5e76\u63d0\u4f9b\u516c\u5171\u536b\u751f\u7cfb\u7edf\u5e73\u8861\u3001\u53ef\u9760\u7684\u4fe1\u606f\uff0c\u4ece\u800c\u66f4\u5b8c\u5584\u5730\u8bc4\u4f30\u836f\u7269\u98ce\u9669\u4e0e\u76ca\u5904\u3002<\/p>\n<h2>\u65b0\u51a0\u75c5\u6bd2\u75ab\u60c5\u4e0b\u836f\u7269\u8b66\u6212\u7684\u8c03\u6574<\/h2>\n<p><a href=\"https:\/\/regulis.com\/pv\/covid-19-impact-on-pharmacovigilance\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u4e34\u5e8a\u8bd5\u9a8c\u6267\u884c<\/a>\uff1a\u7531\u4e8e\u65b0\u51a0\u75c5\u6bd2\u75ab\u60c5\u9020\u6210\u7684\u65c5\u884c\u9650\u5236\u3001\u4eba\u5458\u9694\u79bb\u3001\u533b\u5b66\u7814\u7a76\u4e2d\u65ad\u3001\u533b\u7597\u4eba\u5458\u611f\u67d3\u7b49\u95ee\u9898\uff0c\u82f1\u56fd (MHRA)\u3001\u6b27\u6d32 (EMA)\u3001\u6cd5\u56fd (ANSM) \u548c\u7f8e\u56fd\u7684\u836f\u76d1\u5c40\u5173 (FDA) \u5df2\u5bf9\u4e34\u5e8a\u8bd5\u9a8c\u7684\u836f\u7269\u8b66\u6212\u63d0\u51fa\u65b0\u7684\u6307\u5bfc\u65b9\u9488\uff0c\u5982\u5fc5\u987b\u4f18\u5148\u5448\u62a5\u672a\u9884\u671f\u4e25\u91cd\u836f\u54c1\u4e0d\u826f\u53cd\u5e94 (SUSARs)\uff0c\u65e0\u6cd5\u4e0e\u75c5\u4eba\u9762\u5bf9\u9762\u95ee\u8bca\u65f6\u5e94\u91c7\u7528\u7535\u8bdd\u8054\u7edc\uff0c\u5e76\u4e14\u589e\u52a0\u5176\u4ed6\u836f\u7269\u8b66\u6212\u62a5\u544a\u7684\u65f6\u95f4\u5f39\u6027\u3002<\/p>\n<p><a href=\"https:\/\/www.gmp-compliance.org\/gmp-news\/pharmacovigilance-audits-and-inspections-during-cov19\" target=\"_blank\" rel=\"noopener noreferrer\">\u4e34\u5e8a\u8bd5\u9a8c\u7a3d\u6838<\/a>\uff1a\u6b27\u6d32 EMA \u4e5f\u6307\u793a\u4e34\u5e8a\u8bd5\u9a8c\u7a3d\u6838\u7684\u89c4\u5212\u4e0e\u6267\u884c\u5fc5\u987b\u8003\u8651\u98ce\u9669\uff0c\u4e14\u4f18\u5148\u6267\u884c\u6709\u56e0\u6027 (For cause) \u7a3d\u6838\uff0c\u4e5f\u5fc5\u987b\u8861\u91cf\u8fdc\u7a0b\u7a3d\u6838\u662f\u5426\u53ef\u884c\uff0c\u5982\u91c7\u7528\u7535\u8bdd\u3001\u89c6\u9891\u548c\u7535\u5b50\u6587\u4ef6\u7a3d\u6838\u3002<\/p>\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/public-health-threats\/coronavirus-disease-covid-19\/guidance-medicine-developers-other-stakeholders-covid-19\" target=\"_blank\" rel=\"noopener noreferrer\">\u836f\u7269\u4e0a\u5e02<\/a>\uff1a\u4e3a\u4e86\u5c3d\u5feb\u4fc3\u8fdb\u65b0\u51a0\u75c5\u6bd2\u836f\u7269\u53ca\u75ab\u82d7\u4e0a\u5e02\uff0c\u6b27\u6d32 EMA \u5df2\u7ecf\u52a0\u901f\u7528\u4e8e\u6cbb\u7597\u65b0\u51a0\u75c5\u6bd2\u7684\u65b0\u836f\u4ee5\u53ca\u8001\u836f\u65b0\u7528 (Drug repurposing) \u7684\u5ba1\u6838\u901f\u5ea6\u4e0e\u5f39\u6027\uff0c\u5e76\u63d0\u4f9b\u514d\u8d39\u4e14\u66f4\u5b9e\u65f6\u7684\u4e13\u5bb6\u54a8\u8be2\u3002<\/p>\n<h2>\u836f\u7269\u8b66\u6212\u5728\u540e\u75ab\u60c5\u65f6\u4ee3\u7684\u8d21\u732e<\/h2>\n<p>\u76ee\u524d\u6570\u79cd\u9488\u5bf9\u65b0\u51a0\u75c5\u6bd2\u7684\u75ab\u82d7\u3001\u65b0\u836f\u548c\u5c1d\u8bd5\u65b0\u7528\u7684\u8001\u836f\u7684\u4e34\u5e8a\u8bd5\u9a8c\u90fd<a href=\"https:\/\/link.springer.com\/article\/10.1007\/s40264-020-00965-w\" target=\"_blank\" rel=\"noopener noreferrer\">\u5982\u706b\u5982\u837c\u5730\u8fdb\u884c<\/a>\uff0c\u4e14\u6709\u7684\u5df2\u7ecf\u8fdb\u5c55\u5230\u7b2c\u4e09\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002\u5168\u7403\u6700\u5927\u4e14\u4e0e WHO \u5408\u4f5c\u7684\u836f\u7269\u8b66\u6212\u6570\u636e\u5e93 VigiBase \u4e5f<a href=\"https:\/\/www.uppsalareports.org\/articles\/pharmacovigilance-in-the-age-of-covid-19\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u5f00\u59cb\u6536\u5230\u4e0d\u540c\u7a0b\u5ea6\u7684\u4e0d\u826f\u53cd\u5e94<\/a>\u3002\u4e34\u5e8a\u8bd5\u9a8c\u6210\u529f\u7684\u836f\u7269\u4e0e\u75ab\u82d7\u5c06\u88ab<a href=\"https:\/\/acuvate.com\/blog\/pharmacovigilance-analytics\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u5927\u91cf\u7528\u4e8e\u5168\u7403\u4eba\u53e3<\/a>\uff0c\u56e0\u6b64\u51c6\u786e\u3001\u8be6\u5c3d\u7684\u7684\u836f\u7269\u8b66\u6212\u6570\u636e\u66f4\u663e\u91cd\u8981\u3002<\/p>\n<h2>\u65b0\u51a0\u75c5\u6bd2\u75ab\u60c5\u540e\u836f\u7269\u8b66\u6212\u7684\u8f6c\u578b<\/h2>\n<p>\u56e0\u4e3a\u65b0\u51a0\u75c5\u6bd2\u75ab\u60c5\u8ba9\u836f\u7269\u8b66\u6212\u5bf9\u5168\u4eba\u7c7b\u7684\u91cd\u8981\u6027\u5267\u589e\uff0c\u5404\u673a\u5173\u4e5f\u66f4\u79ef\u6781\u63a8\u5e7f\u5e76\u5347\u7ea7\u836f\u7269\u8b66\u6212\uff0c\u4f8b\u5982\u82f1\u56fd MHRA \u6210\u7acb\u4e86\u6536\u96c6\u6240\u6709\u65b0\u51a0\u75c5\u6bd2\u6cbb\u7597\u7684\u526f\u4f5c\u7528\u6570\u636e\u5e93 <a href=\"http:\/\/www.pharmafile.com\/news\/548013\/mhra-launches-new-pharmacovigilance-reporting-platform-covid-19-treatments\" target=\"_blank\" rel=\"noopener noreferrer\">Yellow Card<\/a>\uff0c\u8ba9\u75c5\u4eba\u4e0e\u533b\u7597\u4eba\u5458\u80fd\u66f4\u65b9\u4fbf\u5730\u63d0\u4f9b\u836f\u7269\u8b66\u6212\u4fe1\u606f\u3002WHO \u4e5f\u8ddf\u5317\u6b27\u3001\u975e\u6d32\u3001\u8377\u5170\u7b49\u6570\u4e2a<a href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/safety_efficacy\/pharmvigi\/en\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u836f\u7269\u76d1\u6d4b\u4e2d\u5fc3\u3001\u516c\u5171\u536b\u751f\u4e2d\u5fc3\u5408\u4f5c<\/a>\uff0c\u901a\u8fc7\u8bad\u7ec3\u4e0e\u6559\u80b2\u5404\u56fd\u4e3b\u7ba1\u673a\u5173\u3001\u533b\u7597\u4eba\u5458\u3001\u4ee5\u53ca\u51fa\u7248\u5b66\u672f\u8457\u4f5c\u548c\u6587\u7ae0\u63d0\u5347\u4e16\u754c\u5404\u56fd\u836f\u7269\u8b66\u6212\u3002<\/p>\n<p>\u968f\u7740\u75ab\u60c5\u7684\u53d1\u5c55\uff0c\u8fd1\u671f\u5168\u7403\u7684\u533b\u7597\u4ea7\u4e1a\u8d8b\u52bf (\u5982\u836f\u7269\u4e0d\u826f\u53cd\u5e94\u968f\u75be\u75c5\u590d\u6742\u5ea6\u589e\u52a0\u3001\u516c\u53f8\u7f29\u51cf\u5f00\u652f\u7684\u538b\u529b\u3001\u5168\u7403\u6cd5\u89c4\u65e5\u8d8b\u590d\u6742\u3001\u7a7f\u6234\u88c5\u7f6e\u4e0e\u793e\u4ea4\u5a92\u4f53\u8ba9\u5b9e\u65f6\u6570\u636e\u53ef\u5f97\u6027\u589e\u52a0\u7b49\u7b49) \u4e5f\u63a8\u52a8\u8fd1\u4ee3\u836f\u7269\u8b66\u6212\u8f6c\u578b\u3002\u4f20\u7edf\u836f\u7269\u8b66\u6212\u53ea\u662f\u5c06\u6570\u636e\u5448\u62a5\u7ed9\u4e3b\u7ba1\u673a\u5173\uff0c\u6d41\u7a0b\u4e0d\u4ec5\u8017\u65f6\u590d\u6742\uff0c<a href=\"https:\/\/acuvate.com\/blog\/pharmacovigilance-analytics\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u4e14\u96be\u4ee5\u5206\u6790\u975e\u7cfb\u7edf\u5316\u4fe1\u606f<\/a>\u3002\u8fd1\u671f\u7684<a href=\"https:\/\/www2.deloitte.com\/content\/dam\/Deloitte\/us\/Documents\/life-sciences-health-care\/us-lshc-transforming-pharmacovigilance.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">\u836f\u7269\u8b66\u6212\u516c\u53f8\u5f00\u59cb\u5f15\u8fdb\u5927\u6570\u636e\u5206\u6790<\/a>\uff0c\u8fd0\u7528\u81ea\u52a8\u5316\u7cbe\u5bc6\u5206\u6790\u4e0e\u8ba4\u77e5\u6280\u672f\u6574\u5408\u4e0d\u540c\u836f\u7269\u8b66\u6212\u6570\u636e\u5e93\uff0c\u4ee5\u53ca\u975e\u7cfb\u7edf\u5316\u4fe1\u606f\u3002\u5982\u6cd5\u89c4\u3001\u533b\u7597\u7ecf\u6d4e\u3001\u793e\u4ea4\u5a92\u4f53\u3001\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\uff0c\u8ba9\u4e0b\u4e00\u4ee3\u836f\u7269\u8b66\u6212\u4e0d\u53ea\u505c\u7559\u5728\u5448\u62a5\u4e0e\u8ffd\u8e2a\uff0c\u800c\u4e14\u80fd\u591f\u8fdb\u5316\u6210\u80fd\u9884\u6d4b\u3001\u9884\u9632\uff0c\u4e14\u52a0\u901f\u6700\u4f73\u836f\u7269\u7b5b\u9009\u7684\u6d41\u7a0b\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u6839\u636e\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\uff08WHO\uff09\u7684\u5b9a\u4e49\uff0c\u836f\u7269\u8b66\u6212\uff08Pharmacovigilance\uff09\u662f\u6307\u4e3a\u300c\u4fa6\u6d4b\u3001\u8bc4\u4f30\u3001\u4e86\u89e3\u4ee5\u53ca\u9884\u9632\u836f\u7269\u4e0d\u826f\u53cd\u5e94\u4ee5\u53ca\u4efb\u4f55\u5176\u4ed6\u4e0e\u836f\u7269\u6709\u5173\u95ee\u9898\u7684\u6d3b\u52a8\u53ca\u79d1\u5b66\u3002\u300d\u836f\u7269\u8b66\u6212\u662f WHO \u5728 1961\u5e74Thalidomide (\u6c99\u5229\u5ea6\u80fa) \u9020\u6210\u5927\u91cf\u7578\u5f62\u5a74\u513f\u7684\u60b2\u5267\u540e\u63a8\u52a8\u4ea7\u751f\uff0c\u65e8\u5728\u63d0\u5347\u75c5\u4eba\u5b89\u5168\u53ca\u7167\u62a4\uff0c\u5e76\u63d0\u4f9b\u516c\u5171\u536b\u751f\u7cfb\u7edf\u5e73\u8861\u3001\u53ef\u9760\u7684\u4fe1\u606f\uff0c\u4ece\u800c\u66f4\u5b8c\u5584\u5730\u8bc4\u4f30\u836f\u7269\u98ce\u9669\u4e0e\u76ca\u5904\u3002 \u65b0\u51a0\u75c5\u6bd2\u75ab\u60c5\u4e0b\u836f\u7269\u8b66\u6212\u7684\u8c03\u6574 \u4e34\u5e8a\u8bd5\u9a8c\u6267\u884c\uff1a\u7531\u4e8e\u65b0\u51a0\u75c5\u6bd2\u75ab\u60c5\u9020\u6210\u7684\u65c5\u884c\u9650\u5236\u3001\u4eba\u5458\u9694\u79bb\u3001\u533b\u5b66\u7814\u7a76\u4e2d\u65ad\u3001\u533b\u7597\u4eba\u5458\u611f\u67d3\u7b49\u95ee\u9898\uff0c\u82f1\u56fd (MHRA)\u3001\u6b27\u6d32 (EMA)\u3001\u6cd5\u56fd (ANSM) \u548c\u7f8e\u56fd\u7684\u836f\u76d1\u5c40\u5173 (FDA) \u5df2\u5bf9\u4e34\u5e8a\u8bd5\u9a8c\u7684\u836f\u7269\u8b66\u6212\u63d0\u51fa\u65b0\u7684\u6307\u5bfc\u65b9\u9488\uff0c\u5982\u5fc5\u987b\u4f18\u5148\u5448\u62a5\u672a\u9884\u671f\u4e25\u91cd\u836f\u54c1\u4e0d\u826f\u53cd\u5e94 (SUSARs)\uff0c\u65e0\u6cd5\u4e0e\u75c5\u4eba\u9762\u5bf9\u9762\u95ee\u8bca\u65f6\u5e94\u91c7\u7528\u7535\u8bdd\u8054\u7edc\uff0c\u5e76\u4e14\u589e\u52a0\u5176\u4ed6\u836f\u7269\u8b66\u6212\u62a5\u544a\u7684\u65f6\u95f4\u5f39\u6027\u3002 \u4e34\u5e8a\u8bd5\u9a8c\u7a3d\u6838\uff1a\u6b27\u6d32 EMA \u4e5f\u6307\u793a\u4e34\u5e8a\u8bd5\u9a8c\u7a3d\u6838\u7684\u89c4\u5212\u4e0e\u6267\u884c\u5fc5\u987b\u8003\u8651\u98ce\u9669\uff0c\u4e14\u4f18\u5148\u6267\u884c\u6709\u56e0\u6027 (For cause) \u7a3d\u6838\uff0c\u4e5f\u5fc5\u987b\u8861\u91cf\u8fdc\u7a0b\u7a3d\u6838\u662f\u5426\u53ef\u884c\uff0c\u5982\u91c7\u7528\u7535\u8bdd\u3001\u89c6\u9891\u548c\u7535\u5b50\u6587\u4ef6\u7a3d\u6838\u3002 \u836f\u7269\u4e0a\u5e02\uff1a\u4e3a\u4e86\u5c3d\u5feb\u4fc3\u8fdb\u65b0\u51a0\u75c5\u6bd2\u836f\u7269\u53ca\u75ab\u82d7\u4e0a\u5e02\uff0c\u6b27\u6d32 EMA \u5df2\u7ecf\u52a0\u901f\u7528\u4e8e\u6cbb\u7597\u65b0\u51a0\u75c5\u6bd2\u7684\u65b0\u836f\u4ee5\u53ca\u8001\u836f\u65b0\u7528 (Drug repurposing) \u7684\u5ba1\u6838\u901f\u5ea6\u4e0e\u5f39\u6027\uff0c\u5e76\u63d0\u4f9b\u514d\u8d39\u4e14\u66f4\u5b9e\u65f6\u7684\u4e13\u5bb6\u54a8\u8be2\u3002 \u836f\u7269\u8b66\u6212\u5728\u540e\u75ab\u60c5\u65f6\u4ee3\u7684\u8d21\u732e \u76ee\u524d\u6570\u79cd\u9488\u5bf9\u65b0\u51a0\u75c5\u6bd2\u7684\u75ab\u82d7\u3001\u65b0\u836f\u548c\u5c1d\u8bd5\u65b0\u7528\u7684\u8001\u836f\u7684\u4e34\u5e8a\u8bd5\u9a8c\u90fd\u5982\u706b\u5982\u837c\u5730\u8fdb\u884c\uff0c\u4e14\u6709\u7684\u5df2\u7ecf\u8fdb\u5c55\u5230\u7b2c\u4e09\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002\u5168\u7403\u6700\u5927\u4e14\u4e0e WHO \u5408\u4f5c\u7684\u836f\u7269\u8b66\u6212\u6570\u636e\u5e93 VigiBase 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