Anatomy Department, Facultad de Medicina, Universidad Nacional Autónoma de México (UNAM), Mexico City, Mexico.
Clinical Pharmacology Laboratory, UMIEZ, Facultad de Estudios Superiores Zaragoza, Universidad Nacional Autónoma de México (UNAM), Batalla 5 de Mayo s/n Esquina Fuerte de Loreto, Col. Ejército de Oriente, Iztapalapa, Mexico City, C.P. 09230, Mexico.
Daru. 2024 Jun;32(1):421-434. doi: 10.1007/s40199-024-00508-z. Epub 2024 Mar 1.
Underreporting of adverse drug reactions (ADRs) limits and delays the detection of signs. The aim of this systematic review with meta-analyses was to synthesize the evidence of educational interventions (EIs) efficacy in health professionals to increase ADR reporting, attitudes, and knowledge of pharmacovigilance.
A systematic literature review was carried out to identify randomized clinical trials evaluating the efficacy of EI in pharmacovigilance in health professionals to improve ADR reports, knowledge, and attitude toward pharmacovigilance. ADR reports were pooled by calculating Odds Ratio (OR) with a 95% confidence interval (95%CI), while pharmacovigilance knowledge and attitude were pooled by calculating a mean difference (MD) with 95%CI. In addition, the subanalysis was performed by EI type. Meta-analysis was performed with RevMan 5.4 software. PROSPERO registry CRD42021254270.
Eight hundred seventy-five articles were identified as potentially relevant, and 11 were included in the systematic review. Metanalysis showed that EI increased ADR reporting in comparison with control group (OR = 4.74, [95%CI, 2.46 to 9.12], I = 93%, 5 studies). In subgroup analysis, the workshops (OR = 6.26, [95%CI, 4.03 to 9.73], I = 57%, 3 studies) increased ADR reporting more than telephone-based interventions (OR = 2.59, [95%CI, 0.77 to 8.73], I = 29%, 2 studies) or combined interventions (OR = 5.14, [95%CI, 0.97 to 27.26], I = 93%, 3 studies). No difference was observed in pharmacovigilance knowledge. However, the subanalysis revealed that workshops increase pharmacovigilance knowledge (SMD = 1.85 [95%CI, 1.44 to 2.27], 1 study). Only one study evaluated ADR reporting attitude among participants and showed a positive effect after the intervention.
EI improves ADR reports and increases pharmacovigilance knowledge. Workshops are the most effective EI to increase ADR reporting.
药物不良反应（ADR）报告的漏报限制并延迟了信号的检测。本系统评价和荟萃分析的目的是综合评估教育干预（EI）对提高卫生专业人员 ADR 报告、态度和药物警戒知识的有效性的证据。
进行了系统的文献综述，以确定评估 EI 在提高卫生专业人员药物警戒中的 ADR 报告、知识和对药物警戒态度的疗效的随机临床试验。通过计算优势比（OR）和 95%置信区间（95%CI）来汇总 ADR 报告，而通过计算均数差（MD）和 95%CI 来汇总药物警戒知识和态度。此外，还按 EI 类型进行了亚分析。使用 RevMan 5.4 软件进行荟萃分析。PROSPERO 注册 CRD42021254270。
确定了 875 篇可能相关的文章，其中 11 篇被纳入系统评价。荟萃分析表明，与对照组相比，EI 增加了 ADR 报告（OR=4.74，[95%CI，2.46 至 9.12]，I=93%，5 项研究）。在亚组分析中，与电话干预（OR=2.59，[95%CI，0.77 至 8.73]，I=29%，2 项研究）或联合干预（OR=5.14，[95%CI，0.97 至 27.26]，I=93%，3 项研究）相比，工作坊（OR=6.26，[95%CI，4.03 至 9.73]，I=57%，3 项研究）增加了 ADR 报告。药物警戒知识没有差异。然而，亚分析显示工作坊增加了药物警戒知识（SMD=1.85，[95%CI，1.44 至 2.27]，1 项研究）。只有一项研究评估了参与者的 ADR 报告态度，结果表明干预后有积极影响。
EI 提高了 ADR 报告，并增加了药物警戒知识。工作坊是提高 ADR 报告最有效的 EI。
