Center for Drug Evaluation of Henan, Zhengzhou, Henan, China.
Tianjin University of Traditional Chinese Medicine, Tianjin, China.
BMJ Open. 2024 Oct 7;14(10):e087701. doi: 10.1136/bmjopen-2024-087701.
Adverse drug reaction (ADR) reporting systems are critical for monitoring and managing drug safety. However, various factors influence the willingness to use these systems. This study aimed to investigate the willingness to use ADR reporting systems through an integrated model of the Technology Acceptance Model (TAM) and Task-Technology Fit (TTF) theory, conducting a multicentre qualitative study from the user's perspective.
This study used qualitative research methods, including in-depth interviews with clinicians, nurses, pharmacists and administrators who reported ADRs through the National Adverse Drug Reaction Monitoring System (NADRMS) and the China Hospital Pharmacovigilance System (CHPS). The interviews were audio-recorded, transcribed verbatim and analysed using QDA Miner software for data management and thematic analysis.
Eighteen healthcare workers from five healthcare organisations participated in the study. They found the ease of use and usefulness of the current NADRMS and CHPS to be acceptable. The essential technical requirements identified included accuracy, standardisation, timeliness and confidentiality. However, challenges such as inaccurate information capture, unstable interfacing with medical record systems, low reporting efficiency and lack of data sharing were highlighted. Overall, front-line healthcare workers exhibited a generally negative attitude towards using NADRMS and CHPS, driven more by necessity than preference. Factors influencing their willingness to use these systems included ease of use, practicality, risk perception and social impact, with varying attitudes and requirements observed between user groups.
This study provides practical recommendations that can be readily implemented to enhance the effectiveness and sustainability of ADR reporting systems. While front-line users in China acknowledged the systems' ease of use and usefulness, they also noted significant gaps in technological adaptation. They expressed the need for improvements in data openness and sharing, accessibility and system intelligence.
药物不良反应(ADR)报告系统对于监测和管理药物安全至关重要。然而,各种因素影响着人们使用这些系统的意愿。本研究旨在通过整合技术接受模型(TAM)和任务-技术适配(TTF)理论,从用户的角度出发,采用多中心定性研究方法,调查使用 ADR 报告系统的意愿。
本研究采用定性研究方法,对通过国家药品不良反应监测系统(NADRMS)和中国医院药物警戒系统(CHPS)报告 ADR 的临床医生、护士、药师和管理人员进行了深入访谈。访谈进行了录音,并逐字转录,使用 QDA Miner 软件进行数据管理和主题分析。
来自五个医疗机构的 18 名医护人员参与了这项研究。他们发现当前 NADRMS 和 CHPS 的易用性和有用性是可以接受的。确定的基本技术要求包括准确性、标准化、及时性和保密性。然而,也强调了一些挑战,如信息采集不准确、与病历系统接口不稳定、报告效率低以及缺乏数据共享。总体而言,一线医护人员对使用 NADRMS 和 CHPS 的态度普遍较为消极,更多的是出于必要性而非偏好。影响他们使用这些系统的意愿的因素包括易用性、实用性、风险感知和社会影响,不同用户群体之间存在不同的态度和要求。
本研究提供了切实可行的建议,可以迅速实施,以提高 ADR 报告系统的有效性和可持续性。尽管中国的一线用户承认这些系统的易用性和有用性,但他们也指出了在技术适应方面存在显著差距。他们表示需要改进数据开放性和共享性、可及性和系统智能。