深圳市部分药品行业从业人员对药品不良反应损害补偿的认知、态度与行为的调查分析

Investigation and Analysis of Cognition,Attitude and Behavior of Part of Drug Practitioners in Shenzhenon Compensation of Adverse Drug Reaction Injury

目的:调查深圳市部分药品行业从业人员对药品不良反应(ADR)损害补偿的认知、态度与行为,为建立该市ADR损害补偿制度提供依据。方法:以2018年深圳市召开的相关会议中的药品上市许可持有人(MAH)、二级及以上医疗机构与药品监管部门工作人员为调查对象,采用"问卷星"小程序现场匿名调查的方式,收集并分析上述人员对ADR损害补偿的认知、态度(包括对ADR损害赔偿的态度和对ADR损害补偿制度的态度)与行为等,并提出相关建议。结果与结论:共收集填写完整调查问卷172份(均为有效问卷)。认知方面,调查对象对于ADR的认知普遍较高(ADR概念正确认知占比为82.0%)。对ADR损害赔偿态度方面,100名(58.1%)调查对象认为用药后发生了ADR应该获得赔偿,147名(85.5%)调查对象认为应对严重(含死亡)的ADR进行补偿;对ADR损害补偿制度态度方面,对于ADR损害补偿经费,选择应该由MAH承担的有131例次(76.2%);对于推行ADR损害补偿存在的困难,多数被调查者认为ADR跟药物相关性的评价困难导致推行ADR损害补偿存在困难(143例次,83.1%);大部分调查对象认为推行ADR补偿制度首先要推行法规制度(145例次,84.3%)。行为方面,104名(60.5%)调查对象处理过因ADR而产生的治疗费用,多数选择自行解决(85名,81.7%);112名(65.1%)选择直接向医护人员或药店报告。建议深圳市相关部门应通过建立面向公众的ADR科普宣传平台和机制(成立相关科室、监督新闻媒体的公益宣传行为、将公益宣传拓展至社区)、探索建立ADR损害补偿机制(建立ADR损害条例专项立法试点、成立ADR损害鉴定委员会)、加大对ADR监测工作的投入(充分利用"互联网+"大数据手段、拨付专项经费)等措施,探索构建适应深圳市情的ADR损害补偿机制。

OBJECTIVE:To investigate the cognition,attitude and behavior of part of drug practitioners in Shenzhen on compensation of adverse drug reaction(ADR)injury,and to provide relevant reference for the establishment of ADR injury compensation system.METHODS:Taking marketing authorization holder(MAH),staff of medical institutions at the second level or above and drug regulatory authorities in the relevant meeting held in Shenzhen in 2018 as objects,on-the-spot anonymous investigation of“questionnaire star”was used to collect and analyze the cognition,attitude(including attitude towards ADR compensation and ADR compensation system)and behavior of the above-mentioned personnel to ADR compensation.The relevant suggestion was put forward.RESULTS&CONCLUSIONS:A total of 172 questionnaires were collected(all being valid).In term of cognition,the respondents generally had high awareness of ADR(response rate of ADR concept was 82.0%).In term of attitude to ADR injury compensation,100 respondents(58.1%)believed that ADR after medication should be compensated,and 147 respondents(85.5%)believed that compensation should be made for serious and fatal adverse reactions.In term of attitude to ADR injury compensation system,respondents thought that ADR damage compensation funds be undertaken by MAH for 131 case times(76.2%).As for the difficulties in the implementation of ADR compensation,it was considered that the evaluation of the correlation between adverse reactions and drugs led to the difficulties in the implementation of ADR compensation(143 case times,83.1%);most respondents thought that the first thing to do in the implementation of ADR compensation system was to implement laws and regulations(145 case times,84.3%).In term of behavior,104 respondents(60.5%)had processed costs due to ADR,most of whom chose self-resolved(85 cases,81.7%);112 respondents(65.1%)chose to inform medical personnels or pharmacies directly.It is suggested that the relevant departments in Shenzhen should explore and establish ADR injury compensation mechanism in Shenzhen by establishing a public oriented platform and mechanism for ADR science popularization(setting up relevant departments,supervising the public propaganda of news media,expanding the public propaganda to the community),exploring and establishing ADR injury compensation mechanism(setting up a special legislativepilot of ADR injury regulations,setting up ADR injury appraisal committee),and increasing the investment in ADR testing(fullyusing of“Internet+”Big Data,allocating special funds).