Contreras-Salinas Homero, Baiza-Durán Leopoldo Martín, Bautista-Castro Manuel Alejandro, Alonso-Rodríguez Diego Rodrigo, Rodríguez-Herrera Lourdes Yolotzin
Pharmacovigilance Department, Laboratorios Sophia, S.A. de C.V., Zapopan 45010, Jalisco, Mexico.
Healthcare (Basel). 2022 Oct 31;10(11):2182. doi: 10.3390/healthcare10112182.
(1) Aims of the study: calculating the underreporting ratio for two different medications, a fixed combination of 0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide (antiglaucoma) and a fixed combination of sodium hyaluronate 0.1% + chondroitin sulfate 0.18% (artificial tears) for characterizing the features influencing the reporting of adverse drug reactions (ADRs) in spontaneous reporting. (2) Methods: The underreporting ratio was calculated by comparing the adverse drug reactions reported in the spontaneous reporting database for every 10,000 defined daily doses marketed and the adverse drug reactions from an active surveillance study for every 10,000 defined daily doses used for different drugs (antiglaucoma and artificial tears). The factors related to the report in spontaneous reporting through statistical tests were also determined. (3) Results: The underreporting ratio of spontaneous reporting was 0.006029% for antiglaucoma and 0.003552% for artificial tears. Additionally, statistically significant differences were found for severity, unexpected adverse drug reactions, and incidence of adverse drug reactions in females when compared with spontaneous reporting and active surveillance. (4) Conclusions: The underreporting ratio of ADRs related to ophthalmic medications indicates worry since the cornerstone of pharmacovigilance focuses on spontaneous reporting. Additionally, since underreporting seems to b selective, the role of certain aspects, such as gender, seriousness, severity, and unexpected ADRs, must be considered in future research.
(1) 研究目的：计算两种不同药物的漏报率，一种是0.5%噻吗洛尔+0.2%溴莫尼定+2.0%多佐胺的固定复方制剂（抗青光眼药物），另一种是0.1%透明质酸钠+0.18%硫酸软骨素的固定复方制剂（人工泪液），以表征影响自发报告中药物不良反应（ADR）报告的特征。(2) 方法：通过比较自发报告数据库中每10000个已上市规定日剂量报告的药物不良反应与针对不同药物（抗青光眼药物和人工泪液）每10000个使用的规定日剂量的主动监测研究中的药物不良反应来计算漏报率。还通过统计检验确定了与自发报告中的报告相关的因素。(3) 结果：抗青光眼药物自发报告的漏报率为0.006029%，人工泪液的漏报率为0.003552%。此外，与自发报告和主动监测相比，在严重程度、意外药物不良反应以及女性药物不良反应发生率方面发现了统计学上的显著差异。(4) 结论：与眼科药物相关的ADR漏报率令人担忧，因为药物警戒的基石侧重于自发报告。此外，由于漏报似乎具有选择性，在未来的研究中必须考虑某些方面的作用，如性别、严重性、严重程度和意外ADR。
