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目的剖析美国儿童用药数据保护制度的安全监控效应并对提高我国儿童用药安全提供建议。方法在制度理论分析基础上,以芬太尼透皮贴剂Duragesic为案例开展实证研究。结果美国儿童用药数据保护制度有效提高药品安全监控效应。结论建议我国借鉴美国制度设立儿童用药数据保护机制,强化全生命周期风险管理及企业主体责任意识,提高儿童用药安全性。
Objective To analyze the safety monitoring effect of the drug protection system for children in the United States and to provide suggestions for improving the drug safety for children in our country. Methods Based on the institutional theory analysis, an empirical study was conducted with Duragesic as the transdermal patch of fentanyl. Results American children drug data protection system effectively improve drug safety monitoring effect. Conclusions It is suggested that our country draw lessons from the American system to set up a data protection mechanism for children’s medication, strengthen life-cycle risk management and awareness of corporate responsibility, and improve the safety of children’s medication.