论文部分内容阅读
目的:分析含苯酚医院制剂的风险因素,探索有效的预防措施进行风险控制。方法:统计《医疗单位制剂规程》、《中国医院制剂规范》中含苯酚医院制剂的所有品种,检索和查阅相关文献、法律法规、标签和说明书,分析存在的问题,探讨可能造成此类制剂风险的原因。结果:含苯酚医院制剂风险环节主要为处方合理性有待商榷、原辅料管理欠规范、职业暴露、质量标准和检验手段落后及疗效和安全性评价不足。结论:采取有效的风险管理措施,严格实施GPP建设,加强原辅料的质量控制、完善质量标准和检验手段、监测不良反应和用药错误,最大程度降低风险危害。
OBJECTIVE: To analyze the risk factors of phenol-containing hospital preparations and explore effective preventive measures for risk control. Methods: Statistics of “preparation regulations of medical units” and “specifications of Chinese hospital preparations” included all varieties of phenolic hospital preparations, searched and consulted relevant documents, laws and regulations, labels and manuals, analyzed the existing problems and explored possible risk of such preparations s reason. Results: The main risk factors of phenol-containing hospital preparations were to discuss the rationality of the prescriptions, the management of raw materials was under-regulated, the occupational exposure, the quality standard and the testing methods lagged behind, and the evaluation of curative effect and safety was insufficient. Conclusion: Effective risk management measures should be taken to strictly implement GPP construction, quality control of raw materials and accessories should be strengthened, quality standards and testing methods should be improved, adverse reactions and medication errors should be monitored, and risks and risks should be minimized.