Descriptive study of adverse drug reactions in a tertiary care pediatric hospital in México from 2014 to 2017

IntroductionIn Pediatrics, adverse drug reactions (ADRs) affect morbidity and mortality. In Mexico, the characteristics of ADRs and suspect drugs have not been described in hospitalized children.ObjectiveTo estimate the frequency of ADRs and describe them, as well as suspect drugs, in a tertiary care pediatric hospital in Mexico.MethodsA total of 1,649 Hospital Infantil de Mexico Federico Gómez ADR reports were analyzed. Completeness of the information was assessed, and ADRs severity and seriousness were assigned based on NOM-220-SSA1-2012, with causality being established according to the Naranjo algorithm. ADRs were classified with WHO Adverse Drug Reaction Terminology (WHO-ART). The drugs involved in ADRs were categorized according to the Anatomical Therapeutic Chemical (ATC) classification. Descriptive analysis was performed using the SPSS 20 statistical package.ResultsOf all the reports, 5.8% lacked sufficient information for the analysis (grade 0). ADRs frequency ranged from 2.12% to 8.07%. ADRs occurred most commonly in children (56.9%), in the female gender (52%), in subjects with normal BMI Z-score (46.6%) and malnutrition (35.3%), diagnosed with neoplasms (72.2%) and in the Emergency Department (70.0%). ADRs were severe in 14.4% of cases, in 81.0% they were serious and 2.1% were classified as definite. Most common serious ADR was febrile neutropenia (44.5%). The 0.7% of patients recovering with sequelae; 1.1% died (with the medication being associated) and 70.3% were admitted to the hospital as a result of an ADR. Antineoplastic and immunomodulating agents were more commonly associated with serious ADRs.ConclusionADRs affected morbidity and mortality, which is why strengthening pharmacovigilance programs in Mexican pediatric hospitals is necessary.引言 在儿科领域，药品不良反应（Adverse Drug Reactions, ADRs）会对发病率与死亡率产生影响。在墨西哥，目前尚未有针对住院儿童的药品不良反应及其可疑涉药特征的相关描述。 研究目的 本研究旨在评估墨西哥某三级儿科医院的药品不良反应发生频率，并对其特征及可疑涉药情况进行描述。 研究方法 共分析了1649份墨西哥费德里科·戈麦斯儿童医院（Hospital Infantil de Mexico Federico Gómez）的药品不良反应报告。对报告信息的完整性进行评估，并依据NOM-220-SSA1-2012标准对药品不良反应的严重程度与严重性进行分级，同时采用Naranjo算法判定因果关联性。采用世界卫生组织药品不良反应术语集（WHO Adverse Drug Reaction Terminology, WHO-ART）对药品不良反应进行分类，并根据解剖学治疗学及化学分类系统（Anatomical Therapeutic Chemical, ATC）对涉药进行分类。使用SPSS 20统计软件包开展描述性分析。 研究结果 在所有报告中，5.8%的报告信息不足以进行分析（等级0）。药品不良反应的发生频率介于2.12%至8.07%之间。药品不良反应最常发生于56.9%的儿童群体、52%的女性患儿、46.6%的BMI Z评分正常患儿及35.3%的营养不良患儿中；72.2%的患儿被诊断为肿瘤，且70.0%的不良反应事件发生于急诊科。14.4%的病例为重度药品不良反应，81.0%为严重性药品不良反应，2.1%被判定为肯定因果关联。最常见的严重性药品不良反应为发热性中性粒细胞减少症（44.5%）。0.7%的患者康复后遗留后遗症，1.1%的患者死亡（与所用药物相关），且70.3%的患者因药品不良反应入院。抗肿瘤及免疫调节药物与严重性药品不良反应的关联性更高。 结论 药品不良反应会影响发病率与死亡率，因此有必要加强墨西哥儿科医院的药物警戒体系建设。