针对国内医疗机构普遍采用的纸质ADR(Adverse Drug Reaction)报告逐级上报的方式存在时效性差、收集及监管效率低下、报告质量不高等诸多问题,本文通过分析北京医院药品安全性监管的工作流程,设计了适合大型医疗机构的药品安全性监测管...针对国内医疗机构普遍采用的纸质ADR(Adverse Drug Reaction)报告逐级上报的方式存在时效性差、收集及监管效率低下、报告质量不高等诸多问题,本文通过分析北京医院药品安全性监管的工作流程,设计了适合大型医疗机构的药品安全性监测管理系统,重点讨论了该系统的架构设计、功能设计以及设计的重点和难点,并通过与医院HIS(Hospital Information System)的对接,提高ADR报告的及时性、准确性,形成系统性的监测工作模式,建立了由基层医务人员与医院监测中心组成的两级药品安全性网络监管平台。该系统的设计可以为其他大型三甲医院开展药品安全性监测工作提供借鉴参考,具有现实意义和实际应用前景。展开更多
Purpose: The aim of this study was to examine if package inserts (PIs) supplied with prescribed medications in the Emirate of Abu Dhabi contain all relevant information to the safe and appropriate use of these medicat...Purpose: The aim of this study was to examine if package inserts (PIs) supplied with prescribed medications in the Emirate of Abu Dhabi contain all relevant information to the safe and appropriate use of these medications. Methods: Sixty seven PIs for prescription—only medications were evaluated against a set of safety criteria published from the Ministry of Health. Results: Analyzed PIs showed many deficiencies with regard to the Ministry of Health (MOH) Investigation New Drug Application (INDA) requirements. Particularly of concern were side effects, warnings, use in pregnancy, lactation, and the storage conditions for the product. Conclusions: This study indicated that information relevant to the safe and appropriate use of medications was not uniformly mentioned in the PIs analyzed. To avoid medication errors due to deficits in the current PIs, we recommend regulatory oversight and regulator audits from pharmaceutical company, followed by enhancement of regulations requiring companies to also create patient information leaflets.展开更多
文摘针对国内医疗机构普遍采用的纸质ADR(Adverse Drug Reaction)报告逐级上报的方式存在时效性差、收集及监管效率低下、报告质量不高等诸多问题,本文通过分析北京医院药品安全性监管的工作流程,设计了适合大型医疗机构的药品安全性监测管理系统,重点讨论了该系统的架构设计、功能设计以及设计的重点和难点,并通过与医院HIS(Hospital Information System)的对接,提高ADR报告的及时性、准确性,形成系统性的监测工作模式,建立了由基层医务人员与医院监测中心组成的两级药品安全性网络监管平台。该系统的设计可以为其他大型三甲医院开展药品安全性监测工作提供借鉴参考,具有现实意义和实际应用前景。
文摘Purpose: The aim of this study was to examine if package inserts (PIs) supplied with prescribed medications in the Emirate of Abu Dhabi contain all relevant information to the safe and appropriate use of these medications. Methods: Sixty seven PIs for prescription—only medications were evaluated against a set of safety criteria published from the Ministry of Health. Results: Analyzed PIs showed many deficiencies with regard to the Ministry of Health (MOH) Investigation New Drug Application (INDA) requirements. Particularly of concern were side effects, warnings, use in pregnancy, lactation, and the storage conditions for the product. Conclusions: This study indicated that information relevant to the safe and appropriate use of medications was not uniformly mentioned in the PIs analyzed. To avoid medication errors due to deficits in the current PIs, we recommend regulatory oversight and regulator audits from pharmaceutical company, followed by enhancement of regulations requiring companies to also create patient information leaflets.
