论文部分内容阅读
目的:调查国内外处方集新药的遴选过程及影响因素。方法:通过阅读国内外文献对所报道的药事管理与药物治疗学委员会的组成和职能以及处方集新药的遴选过程和影响因素等内容进行分析。结果:处方集新药的遴选主要由药事管理与药物治疗学委员会负责组织进行,药师负责对申请新药进行评估并交由药事会讨论。药品的有效性和安全性是首要考虑因素,经济学因素和操作性方面的因素次之。结论:新药上会前的药品评估过程是药品遴选的关键环节,药品的安全性和有效性是影响药品能否过会的关键因素。
Objective: To investigate the selection process and influential factors of new drug prescriptions at home and abroad. Methods: By reading the literature both at home and abroad, we analyzed the composition and function of the committee and the selection process and influencing factors of prescription drugs. Results: The selection of new prescription drugs was mainly organized by the Board of Pharmacy Administration and Drug Therapeutics. The pharmacists were responsible for evaluating the applications for new drugs and submitting them to the Board of Pharmacy for discussion. The effectiveness and safety of medicines are the primary consideration, followed by the economic and operational factors. Conclusion: The drug evaluation process before the new drug is a key link in drug selection. The safety and effectiveness of the drug are the key factors that affect whether the drug can be passed or not.