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一项横断面研究:比较中东部和中西部地区公众对药品不良反应报告和监测的认知。

A cross-sectional study: comparison of public perceptions of adverse drug reaction reporting and monitoring in eastern and western China.

机构信息

The Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy, Xi'an Jiaotong University, Xi'an, Shannxi, China.

The School of Public Health, Xi'an Jiaotong University, Xi'an, Shannxi, China.

出版信息

BMC Health Serv Res. 2022 Mar 8;22(1):318. doi: 10.1186/s12913-022-07720-0.

Abstract

BACKGROUND

Adverse drug reactions (ADRs) cause a substantial clinical and economic burden. Spontaneous reporting of ADRs by the public is crucial. In some developed countries like the United States, Canada, consumers have been allowed to directly report ADRs, however, convenient channels for direct ADR reporting by the public are lacking in China.

OBJECTIVE

We aimed to compare the knowledge, attitudes, and practice(KAP) regarding monitoring and reporting of adverse drug reaction (ADR) among the general public in eastern and western China.

METHODS

A questionnaire-guided cross-sectional study was administered to participants in Nanjing and Xi'an during April-July 2019. A descriptive statistical analysis was used to describe respondents' demographic information and other results. The t-test and analysis of variance were used to test the differences in knowledge and attitudes among respondents with different demographic characteristics. P < 0.05 was considered statistically significant. Binary logistic regression analysis was used to examine factors associated with knowledge and attitudes.

RESULTS

A total of 1085 questionnaires were distributed in this survey, 869 valid questionnaires were returned, the recovery rate was 80.09%. Respondents showed poor knowledge of the definition of ADRs and reporting criteria, with a significant difference in average knowledge scores according to education level, gender, and age group. Most respondents had positive attitudes toward ADR monitoring and reporting, with no significant differences in knowledge and attitude scores between the two cities. In total, 68.93% of respondents said they would feedback information to health care professionals, most (84.35%) would take the initiative to report ADRs if there were a convenient method. More than half (58.57%) of respondents were more likely to report ADRs by telephone.

CONCLUSION

The findings of our study indicated that health care professionals should encourage patients to actively report ADR. China should also explore ways to facilitate direct public reporting of ADRs by improving relevant laws and regulations.

摘要

背景

药物不良反应(ADR)会给临床和经济带来巨大负担。公众自发报告 ADR 至关重要。在美国、加拿大等一些发达国家,消费者已被允许直接报告 ADR,但中国缺乏公众直接报告 ADR 的便捷渠道。

目的

本研究旨在比较中国东部和西部公众对药物不良反应监测和报告的知识、态度和实践(KAP)。

方法

2019 年 4 月至 7 月,在南京和西安进行了一项基于问卷的横断面研究。采用描述性统计分析方法描述受访者的人口统计学信息和其他结果。采用 t 检验和方差分析比较不同人口统计学特征的受访者在知识和态度方面的差异。P<0.05 被认为具有统计学意义。采用二元逻辑回归分析来检验与知识和态度相关的因素。

结果

本研究共发放 1085 份问卷,回收有效问卷 869 份,回收率为 80.09%。受访者对 ADR 的定义和报告标准知之甚少,知识平均得分根据教育水平、性别和年龄组存在显著差异。大多数受访者对 ADR 监测和报告持积极态度,两个城市的知识和态度得分无显著差异。总的来说,68.93%的受访者表示会将信息反馈给医务人员,如果有方便的方法,大多数(84.35%)会主动报告 ADR。超过一半(58.57%)的受访者更愿意通过电话报告 ADR。

结论

本研究结果表明,医疗保健专业人员应鼓励患者积极报告 ADR。中国还应通过完善相关法律法规,探索促进公众直接报告 ADR 的方法。

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