摘要
目的:探讨药品说明书对医疗机构可能增加、激化的各种风险,以推动药品说明书归档管理。方法:调查2010年11月-2011年1月我院第一门诊经营的药品说明书现状,分析其可能导致的风险,并提出药品说明书的归档建议。结果与结论:我院药品说明书存在修改频繁、不同厂家同品种药品的药品说明书差异明显、高风险品种药品的药品说明书不够详细的现象,可分别导致法律风险、治疗风险和经济风险。建议可通过保存所有经营品种的药品说明书、重点监视使用量与销售量大的药品的药品说明书、相关部门及时提供其供应药品的药品说明书的修改情报等方面来健全药品说明书归档管理。
OBJECTIVE： To investigate the intensifying risks of medical institutions,which is resulted from package insert,and to promote the pigeonholing and management of package inserts.METHODS： The status quo of package inserts in the first outpatient department of our hospital during Nov.2010-Jan.2011 were investigated to analyze the drug risk and put forward the suggestions on pigeonholing of package inserts.RESULTS CONCLUSIONS： There are problems existing,such as frequent revision,significant differences in package inserts of same category from different manufacturers,high risk varieties but short on detailed specification.They can bring about legal,treatment and economic risks to the medical institutions to some extent.It is suggested to perfect package inserts archive establishment management by conserving package inserts of all category,monitoring package inserts of drugs with great consumption,providing related revision information timely by relevant department,etc.
出处
《中国药房》
CAS
CSCD
2012年第17期1619-1621,共3页
China Pharmacy
关键词
药品说明书
风险
建档
分析
Package insert
Risk
Archive establishment
Analysis
