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目的为进一步规范我国药品说明书提供参考。方法通过对我院使用的药品说明书进行抽查,对照《药品说明书和标签管理规定》及《中华人民共和国药典临床用药须知》等相关规定进行调查分析。结果调查发现我国药品说明书仍存在用法用量不合理、表述重复或自相予盾、适应症不完整等问题。结论建议国家药品监督部门、药品生产企业、药品使用单位三方应密切配合,切实做好药品说明书规范化管理。
Objective To provide reference for further standardizing our drug specification. Methods Through the random inspection of drug manuals used in our hospital, the investigation and analysis were conducted according to the relevant provisions of the Drug Administration, Drug Administration, and Regulations of the People’s Republic of China on the Pharmacopoeia of Clinical Pharmacopoeia. Results of the survey found that there are still illegal usage of drugs in our country manual description of duplicate or self-gratification, indications such as incomplete. Conclusions It is suggested that the tripartite coordination of the State Drug Administration, pharmaceutical manufacturers and drug users should be closely coordinated to effectively standardize the management of drug specifications.