越南医护人员自发报告药物不良反应的影响因素。

Factors associated with spontaneous adverse drug reaction reporting among healthcare professionals in Vietnam.

机构信息

Department of Pharmaceutical Management and PharmacoEconomics, Hanoi University of Pharmacy, Hanoi, Vietnam.

The National Centre for Drug Information and Adverse Drug Reactions Monitoring, Hanoi University of Pharmacy, Hanoi, Vietnam.

出版信息

J Clin Pharm Ther. 2020 Feb;45(1):122-127. doi: 10.1111/jcpt.13037. Epub 2019 Sep 5.

DOI:10.1111/jcpt.13037

PMID:31486525

Abstract

WHAT IS KNOWN AND OBJECTIVE

Under-reporting is a major drawback of a voluntary adverse drug reaction reporting system in pharmacovigilance. However, little is known about facilitators and barriers to ADR reporting by healthcare professionals (HCPs) in developing countries. To investigate factors associated with adverse drug reaction (ADR) reporting among HCPs in Vietnam.

METHODS

A cross-sectional survey of 2091 HCPs was conducted in 2015 at 10 hospitals throughout Vietnam. The binary outcome was ever reporting ADRs. Healthcare professionals knowledge, attitude and practice about ADR reporting were measured. Multiple logistic regression analyses examined factors significantly associated with ever ADR reporting.

RESULTS

Overall, 29.3%, 2.2% and 68.4% of the sample were doctors, pharmacists and nurses, respectively. More than half (59.3%) had ever reported any ADR. Facilitators for ADR reporting were educational training (OR = 1.77, 95%CI = 1.42-2.22) and having better knowledge, such as awareness of ADR reporting regulation (OR = 1.63, 95%CI = 1.19-2.21), of reporting time (OR = 1.76, 95%CI = 1.35-2.29) and of necessary information in reporting form (OR = 1.94, 95%CI = 1.53-2.45).Conversely, barriers to non-reporting were unknown of reporting procedure (OR = 0.27, 95%CI = 0.22-0.35), unavailability of reporting form (OR = 0.54, 95%CI = 0.42-0.68) and lack of time (OR = 0.59, 95%CI = 0.46-0.74).

WHAT IS NEW AND CONCLUSION

Given the low ADR reporting rate among HCPs, educational interventions to improve their knowledge and attitude should be prioritized in Vietnam. Additional interventions addressing obstacles (i.e. availability and complexity of reporting form, lack of time) should be considered to improve both the quantity and quality of ADR reporting.

摘要

已知和目的

在药物警戒中，自愿不良反应报告系统的主要缺点是报告不足。然而，在发展中国家，关于医疗保健专业人员（HCP）报告不良反应的促进因素和障碍知之甚少。本研究旨在调查越南 HCP 报告不良反应的相关因素。

方法

2015 年，在越南的 10 家医院对 2091 名 HCP 进行了横断面调查。二项结局是 HCP 是否报告过不良反应。测量了 HCP 对不良反应报告的知识、态度和实践。多因素逻辑回归分析检查了与 HCP 曾报告不良反应显著相关的因素。

结果

总体而言，样本中医生、药剂师和护士分别占 29.3%、2.2%和 68.4%。超过一半（59.3%）的人曾报告过任何不良反应。促进不良反应报告的因素包括教育培训（OR=1.77，95%CI=1.42-2.22）和更好的知识，例如不良反应报告法规的认识（OR=1.63，95%CI=1.19-2.21）、报告时间（OR=1.76，95%CI=1.35-2.29）和报告表中必要信息的认识（OR=1.94，95%CI=1.53-2.45）。相反，不报告的障碍包括报告程序未知（OR=0.27，95%CI=0.22-0.35）、报告表不可用（OR=0.54，95%CI=0.42-0.68）和缺乏时间（OR=0.59，95%CI=0.46-0.74）。