摘要
目的:完善医院新药准入决策体系,为医院新药准入决策提供参考。方法:采用规范主义分析方法,从价值判断的角度,探究医院应当建立怎样的新药准入价值判断标准;并从医院新药准入决策指标体系的建立、实施主体的组织构成以及决策流程3个方面来论述如何贯彻实施价值判断标准。结果与结论:医院实施新药准入决策,应当建立以患者利益最大化为核心的价值判断体系;医院新药准入决策指标体系可完整表达价值判断内涵,包括药品实质因素、药品符号因素等6个一级指标和药品安全性、有效性等22个二级指标;医院新药准入实施主体药事管理委员会负责指标信息的传递,应由医院管理者、药学部专家、临床医药专家、药学信息人员、医保人员和财务管理者、患者代表等构成;同时应构建医院新药准入决策流程,确保合适的专家利用合适的规则正确传达决策信息。
OBJECTIVE: To improve new drug access decision-making system and provide reference for hospital new drug access decision-making. METHODS : The value judgment criteria that hospitals should set up for new drug assess was explored by patternalism analysis from the perspective of value judgment; and the implementation of value judgment criteria was discussed from three aspects: the establishment of the indicator system for hospital new drug access decision-making, subject of implementation and decision-making process. RESULTS & CONCLUSIONS: Hospital new drug access decision-making should be based on a val- ue judgment system that maximizes patients' benefits. The indicator system of hospital new drug access decision-making can fully express the implication of value judgment, including 6 major factors as drug texture factor and symbol factor, and 22 secondary index as drug safety and effectiveness; subject of implementation--pharmaceutical management committee, including hospital manager, pharmacy and clinical medical experts, pharmacy information personnel, medical insurance personnel and financial manager, patient representatives, are responsible for delivering information; and the decision-making process of new drug access should be established to ensure that appropriate experts convey correct decision information with appropriate rules.
出处
《中国药房》
CAS
CSCD
2014年第45期4229-4231,共3页
China Pharmacy
关键词
医院
新药准入
决策
价值判断
Hospital
New drug access
Decision-making
Value judgment