医疗机构应对带量采购药品供应链中断的采购策略

目的探索带量采购模式下医疗机构药品集采策略行为,提升药品供应链在面临供应中断风险下的运营效率。方法依据供应链风险管理理论,结合我国医疗机构的公益性,建立基于期望成本函数的药品采购模型,分析药品供应中断概率、订单分配比例等因素对药品集采策略的影响,并运用Matlab 2018b进行模拟仿真。结果通过模型分析和数值仿真发现:当供应中断风险较低时,现有带量采购模式有效降低药品集采成本,而双源采购或完全可靠供应商采购可在中断风险高时避免更大的损失;此外,期望成本函数与后备供应商订单比例并非总是正相关。结论在药品集中采购制度持续深化改革的宏观背景下,药品采购策略不应仅关注药价本身的高低,更应注重药品持续供应的稳定性。基于此,提出应优化现有药品带量采购模式,增加中标企业审核机制等建议。

Analysis of Drug Purchase and Pricing Decision under the Mode of Procurement with Target Quantity

Objective To study the reasonable pricing strategy to effectively reduce the risk of drug supply disruption.This paper studies the vertical competition between drug purchasers and pharmaceutical enterprises,and the horizontal competition between different pharmaceutical enterprises.Based on the wholesale price of drugs made by pharmaceutical enterprises,drug purchasers adopt different procurement strategies.Methods A multi-stage game model was used to analyze the collusion and competition between two drug procurement parties.Results and Conclusion(1)Enterprise B can choose the optimal game strategies according to the stability of enterprise A;(2)Two procurement parties should choose collusion when the risk of supply interruption is low;(3)Emergency dual sourcing strategy is better than single sourcing strategy;(4)The optimal procurement quantity is irrelevant to the monotonicity of the stability of enterprise A in Cournot game.Through numerical analysis,the optimal decisions of pharmaceutical enterprises and drug purchasers are obtained respectively.

亚硝胺类DNA反应性杂质可接受摄入量的监管科学研究

DNA反应性杂质在上市药品中屡见不鲜,引起国内外药品监管机构的高度重视。基于不同国家和地区发布的相关指导原则或草案,2017年ICH M7(R1)采用决策树法对DNA反应性杂质提出了较为明确的分类及控制策略。本文就ICH M7(R1)的底层设计科学逻辑和亚硝胺类杂质的可接受摄入量的确定方法展开论述,结合杂质限度、杂质风险预测和毒性数据库创建三个维度,探讨符合中国国情的DNA反应性杂质监管工作。