Investigation on medical staff′s awareness of pharmacovigilance and the construction of pharmacovigilance system in medical institutions
10.3760/cma.j.cn114015-20240715-00580
- VernacularTitle:医务人员药物警戒认知情况及医疗机构药物警戒体系建设情况调查
- Author:
Yi'nan ZHANG
1
;
Xinchen LI
;
Weizhong SHI
;
Li ZHANG
;
Guoqing LI
;
Zhigang ZHAO
Author Information
1. 首都医科大学附属北京天坛医院药学部，北京 100070
- Publication Type:Journal Article
- Keywords:
Pharmacovigilance;
Adverse drug reaction reporting systems;
Questionnaires;
Medical staff, hospital
- From:
Adverse Drug Reactions Journal
2025;27(6):348-355
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the awareness of medical staff on pharmacovigilance and the current situation of the construction of pharmacovigilance system in medical institutions.Methods:A self-designed questionnaire was sent to medical institutions in China through Professional Committee on Pharmacovigilance Research, China Society for Drug Regulation in the form of Wechat, and medical staff participated voluntarily. The contents of the questionnaire included 23 questions in 4 dimensions, including the basic information of the respondents, their understanding of the concept and regulations of pharmacovigilance, the management of pharmacovigilance, and the reporting and feedback of adverse drug reactions(ADRs)/events in their medical institutions. The survey time was from August 18, 2023 to October 18, 2023. The data from the questionnaire were analyzed descriptively.Results:The collected questionnaires were from medical institutions in 31 provinces, autonomous regions, and municipalities directly under the central government, with a total of over 100 questionnaires collected in each region. A total of 10 991 medical staff participated in the survey, including 5 504 pharmacists, 2 120 doctors, and 3 367 nurses. Among them, 10 131 (92.18%) respondents had heard of pharmacovigilance, 4 511 (41.04%) had participated in pharmacovigilance-related works, 9 368 respondents (86.41%) answered that the ADRs monitoring and management system had been established in medical institutions where they worked, 8 186 respondents (75.51%) answered that leading group for pharmacovigilance (including ADRs monitoring) had been set up in the medical institutions where they worked, 8 605 respondents (79.37%) answered that the pharmacovigilance works was managed by special personnel in the institutions where they worked, 7 859 (72.49%) answered that there were liaison officers in the clinical departments where they worked, 6 043 (55.74%) answered that the individuals would be rewarded for reporting ADRs, 4 809 (44.36%) answered that pharmacovigilance had been included in the daily works and assessment indicators of the departments, and 5 351 (49.36%) answered that reports of ADRs were reviewed by special personnel. Active reporting by medical staff was the main collection channel of ADRs, 3 391 (31.28%) answered they had actively captured ADRs from the hospital information system, and 7 728 (71.28%) answered they had reported ADRs through the hospital information system, 10 061 (92.81%) answered that the monitoring results of ADRs would be regularly fed back in the hospitals where they worked, and 6 239 (57.55%) answered that regular training on pharmacovigilance for all medical staff would be provided in the institutions where they worked.Conclusions:Medical staff have generally heard of pharmacovigilance and are aware of the national pharmacovigilance system, but they still have insufficient understanding of the concept and regulations of pharmacovigilance. The degree of participating in pharmacovigilance works of medical staff in different regions are different. The monitoring and management of ADRs could be paid attention to in the most medical institutions, but the degree of improvement of pharmacovigilance system in different levels of medical institutions is different.
