Analyzation and suggestion of irregular usage of drug prescriptions in clinic
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摘要: 目的 为规范医院超说明书用药管理提供建议。 方法 分析超说明书用药这一现象存在的客观原因及其可能为临床用药带来的隐患;查找国际已有的药事管理经验并进行描述性分析。 结果 药品说明书存在自身漏洞和不全面性,其内容更新明显滞后,导致了超说明书用药的客观存在。但超说明书用药可能增加患者的用药风险和医师的执业风险,从而应由国家干预管理。国际已有的管理经验包括:规定超说明书用药应有的循证依据,鼓励企业及时更新说明书,设立药品信息的独立机构等。 结论 超说明书用药具有合理性和必要性。国家应尽快立法明确超说明书用药的合法性并规范责任范围;临床上超说明书用药时应遵循相应原则;各相关部门应提供积极和及时的信息支持;加强宣传和教育。Abstract: Objective To offer suggestions for how to administrate irregular usage of drug prescriptions in clinic. Methods The objective reasons and the hidden danger of irregular usage of drug prescriptions were analyzed. The existing international administration experience was searched and descriptive analysis was conducted. Results The existence of off-label use was rational because the drug instruction had its loophole, and the information usually was lagged updated. However, off-label use could increase risks for both patients and doctors, which should be administrated by the government. International experience includes: set up clinical evidence references, encourage drug companies to update instructions in time;establish independent drug information organization. Conclusion Irregular usage of drug prescriptions had its rationality and necessity. Relative regulations should be formulated in China as soon as possible. Irregular usage of drug prescriptions should follow certain principles. Active information support should be offered from related organization. Media administration and public education should be focused.
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