马来酸麦角新碱注射液临床使用可及性与处方管理探讨

Discussion on clinical accessibility and prescription management of ergometrine maleate injection

目的 以妇产科马来酸麦角新碱注射液为例,探讨如何合理促进易制毒药品的临床可及性及处方管理问题。方法 通过文献分析梳理马来酸麦角新碱注射液的可及性相关问题,同时选取国内东、中、西部具有代表性的8家省级三甲医院,采用深度访谈法分析马来酸麦角新碱注射液为代表的易制毒类药品临床应用可及性风险和处方管理方式。结果 妇产科使用的麦角新碱药品因其原料药易制毒属性曾经停产,导致该药物有近十几年时间在国内不可及,重新上市后该药品同样因为其原料药易制毒属性面临可及性风险。在政策法规层面,国内没有明确的处方管理细则,导致受访医院普遍对马来酸麦角新碱注射液的临床使用和处方管理存在疑虑,医疗机构只能依靠主观判断来确定是否严格处方管理,很有可能增加药品临床获取难度,最终导致药品不可及,损害患者的健康权益。结论 建议考虑临床需求和专业意见,出台明确区分易制毒药品风险类别的临床处方管理细则,严格马来酸麦角新碱注射液的院内药房管理,避免药品流失的同时降低临床取用难度,减少对药品临床可及性的影响。

Objective To discuss clinical access and prescription management issues of drug precursors using ergometrine maleate injection in obstetrics and gynecology as an example. Methods We performed literature review to summarize and analyze the accessibility of ergometrine maleate injection and its related issues. We also selected 8 provincial-level tertiary hospitals in eastern, central, and western parts of China as representatives and conducted in-depth interviews with their healthcare professionals. We used ergometrine maleate injection as a representative example to understand the risk on clinical access of drug precursors and its prescription management methods. Results Ergonovine classes drug for obstetric and gynecologic uses experienced challenges on production and clinical access due to its precursor properties, even after its reapproval for marketing. At the policy level, there are no clear prescription management guidelines, which raised confusion on the clinical use and prescription management of ergonovine drugs at hospitals we visited. Medical institutions can only rely on their own subjective judgment to determine whether a strict prescription management is necessary, which can increase the difficulty of clinical access to drugs, making the drug unavailable and damage the health rights and interests of patients. Conclusion Based on clinical requirements and feedback from healthcare professionals, there is a critical need for government departments to create a clinical prescription management guideline with more specific instruction on the categorization of different precursor drugs based on their risks. Hospital pharmacies should also strengthen their management on ergometrine maleate injection to avoid the loss of drug, decrease the difficulty of clinical access, and reduce the influence of drug inaccessibility.