消费者、医疗保健专业人员和制药公司自发报告的药品不良反应完整性比较:对两个高收入国家数据库的评估
Comparison of the Completeness of Spontaneously Reported Adverse Drug Reactions by Consumers, Healthcare Professionals, and Pharmaceutical Companies: An Evaluation of Databases From Two High-Income Countries.
作者信息
Dedefo Mohammed Gebre, Kassie Gizat M, Gebreyohannes Eyob Alemayehu, Lim Renly, Roughead Elizabeth, Kalisch Ellett Lisa
机构信息
Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, Australia.
South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
出版信息
Pharmacol Res Perspect. 2025 Aug;13(4):e70164. doi: 10.1002/prp2.70164.
This study assessed whether the completeness of spontaneously reported adverse drug reaction (ADR) reports differs between consumers and healthcare professionals when submitted directly to regulators, and how this compares to reports from pharmaceutical companies. ADR reports (2014-2023) were obtained from public databases in Canada and the United Kingdom (UK), focusing on the medicine classes sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, and dipeptidyl peptidase-4 inhibitors. ADR report completeness was assessed using vigiGrade tool variables. Descriptive statistics and chi-square tests were used for analysis. A total of 17 897 reports were analyzed-13 613 from the UK Yellow Card Scheme and 4284 from Canada. Most Canadian reports were submitted by pharmaceutical companies (55%), while in the UK, healthcare professionals submitted the majority (69%). Few reports were submitted directly by consumers in either Canada (4%) or the UK (7%). In Canada, the average completeness was 82% for consumer and healthcare professional reports and 57% for pharmaceutical companies. In the UK, completeness was 80% (consumers), 82% (healthcare professionals), and 69% (pharmaceutical companies). Canadian pharmaceutical company reports were significantly less complete for age, sex, outcome, dose, indication, and route of administration (all p < 0.001). In the UK, they were less complete for age, sex, and route of administration (all p < 0.001). In conclusion, reports submitted directly to regulators by consumers and healthcare professionals were more complete than those from pharmaceutical companies. The low consumer reporting rate, yet high completeness rate, highlights the need to encourage direct reporting to regulators to improve medicine safety monitoring.
本研究评估了消费者和医疗保健专业人员直接向监管机构提交的自发报告的药品不良反应(ADR)报告的完整性是否存在差异,以及与制药公司提交的报告相比情况如何。从加拿大和英国的公共数据库获取了2014年至2023年的ADR报告,重点关注钠-葡萄糖协同转运蛋白2抑制剂、胰高血糖素样肽1受体激动剂和二肽基肽酶-4抑制剂这几类药物。使用vigiGrade工具变量评估ADR报告的完整性。采用描述性统计和卡方检验进行分析。共分析了17897份报告,其中13613份来自英国黄卡计划,4284份来自加拿大。加拿大的大多数报告由制药公司提交(55%),而在英国,医疗保健专业人员提交的报告占多数(69%)。在加拿大和英国,直接由消费者提交的报告都很少(分别为4%和7%)。在加拿大,消费者和医疗保健专业人员报告的平均完整性为82%,制药公司报告的平均完整性为57%。在英国,消费者报告的完整性为80%,医疗保健专业人员报告的完整性为82%,制药公司报告的完整性为69%。加拿大制药公司报告在年龄、性别、结果、剂量、适应症和给药途径方面的完整性明显较低(所有p<0.001)。在英国,这些报告在年龄、性别和给药途径方面的完整性较低(所有p<0.001)。总之,消费者和医疗保健专业人员直接向监管机构提交的报告比制药公司提交的报告更完整。消费者报告率低但完整性率高,凸显了鼓励直接向监管机构报告以改善药品安全监测的必要性。
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