National Drug Information and Adverse Drug Reaction Monitoring Centre, Hanoi University of Pharmacy, Hanoi, Vietnam.
PharmacoEpidemiology and Drug Safety Research Group, Department of Pharmacy, and, PharmaTox Strategic Research Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway.
Ther Innov Regul Sci. 2023 Sep;57(5):1104-1112. doi: 10.1007/s43441-023-00552-y. Epub 2023 Jun 30.
Antibiotics are commonly used in both outpatient and inpatient settings and are responsible for the majority of adverse drug reaction (ADR) reports. We aimed to characterize spontaneously reported ADRs associated with antibiotics and assessing the preventability of these ADRs in a Vietnamese setting.
We conducted a retrospective descriptive study based on ADRs related to antibiotics spontaneously reported by healthcare workers to the National Pharmacovigilance Database of Vietnam (NPDV) between June 2018 and May 2019. The characteristics of included reports were descriptively analyzed. The preventability of reported ADRs was assessed using a standardized preventability scale. We identified the leading causes and described the characteristics associated with preventable ADRs (pADRs).
We included 6385 antibiotic-related reports from a total of 12,056 reports submitted to the NPDV during the study period. Beta-lactam antibiotics, mostly broad-spectrum with parenteral route, were suspected in the majority cases. The most commonly reported pADRs were allergic reactions, mostly classified under skin and subcutaneous tissue disorders. Of all included cases, 537 cases (8.4%) were deemed as associated with pADRs. Major causes of pADRs include potentially inappropriate prescribing (352/537, 65.5%) and re-administration of antibiotics causing prior allergy/allergies (99/537, 18.4%). The majority of pADRs involved the use of beta-lactam antibiotics with inappropriate indications.
ADRs related to antibiotic use represent more than half of ADRs spontaneously reported in Vietnam. Approximately one in every ten reported cases is associated with pADRs. The majority pADRs can be prevented through simple improvement in antibiotic prescribing practices.
抗生素在门诊和住院环境中都被广泛使用，也是导致大多数药物不良反应（ADR）报告的主要原因。本研究旨在描述越南自行报告的抗生素相关 ADR 特征，并评估这些 ADR 的可预防程度。
我们对 2018 年 6 月至 2019 年 5 月期间，越南国家药物警戒数据库（NPDV）中卫生保健工作者自行报告的抗生素相关 ADR 进行了一项回顾性描述性研究。对纳入报告的特征进行了描述性分析。采用标准化预防量表评估报告 ADR 的可预防程度。我们确定了主要原因，并描述了与可预防 ADR（pADR）相关的特征。
在研究期间，共向 NPDV 提交了 12056 份报告，其中 6385 份与抗生素相关。在大多数情况下，β-内酰胺类抗生素（大多为广谱抗生素，通过注射途径给药）被怀疑是导致 ADR 的原因。最常报告的 pADR 是过敏反应，主要归类于皮肤和皮下组织疾病。在所纳入的病例中，537 例（8.4%）被认为与 pADR 有关。pADR 的主要原因包括潜在不合理的处方（352/537，65.5%）和重新使用导致先前过敏/过敏的抗生素（99/537，18.4%）。大多数 pADR 涉及不合理使用β-内酰胺类抗生素。
与抗生素使用相关的 ADR 占越南自行报告的 ADR 的一半以上。大约每十个报告的病例中就有一个与 pADR 有关。通过简单改善抗生素处方实践，大多数 pADR 是可以预防的。
