To provides references for drug intensive monitoring. Through analyzing the situation and the main problems of archival filing work relating to drug intensive monitoring in Jiangsu since August 2015, when the Jiangsu Archival Filing Procedure of Drug Intensive Monitoring was issued, corresponding mea-sures are offered. Drug manufacturers are willing to carry out drug intensive monitoring, but have doubts about its purpose and role; the game of practice and science runs through the whole process of drug in-tensive monitoring; there is no consensus on ethics review and informed consent. Coordination and explana-tion of policies should be done; the guidelines of drug intensive monitoring should be issued and technical standards should be made clear; and ethical review should be performed to enhance the scientific and eth-ical levels of drug intensive monitoring.%为推进药品重点监测提供参考.分析2015年8月我省印发《江苏省药品重点监测报备工作程序的通知(试行)》后,对药品重点监测方案报备情况及主要问题,提出相应的改进措施.企业有意愿开展重点监测,但对重点监测目的和作用存在疑虑;可操作性与科学性的博弈贯穿重点监测全过程;方案伦理审查与患者知情同意是否执行,尚待形成共识.应做好政策间的衔接及说明工作;出台重点监测指南,明确技术标准;确定开展伦理审查,提高重点监测的科学性和伦理性.
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