Sharma Pramod Kumar, Misra Arup Kumar, Gupta Neeraj, Khera Daisy, Gupta Ajay, Khera Pushpinder
Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Department of Pediatrics, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Indian J Pharmacol. 2017 Sep-Oct;49(5):390-395. doi: 10.4103/ijp.IJP_256_17.
The objective of this study is to determine the nature and severity of adverse drug reactions (ADRs) in pediatric patients.
In this retrospective cohort study, we extracted the data from all the available pediatric ADR forms submitted to ADR monitoring center (AMC) from May 2014 to December 2016. The data including nature, frequency, causality (World Health Organization [WHO] causality scale), and the severity (Hartwig and Siegel scale for severity) of ADR were extracted. We also assessed the preventability of the event on modified Schumock and Thornton scale of ADR preventability.
There were a total of 20 pediatric ADRs reported during this period. Nearly two-thirds of the ADRs occurred in patients who were receiving multiple drugs (polytherapy). Antimicrobial agents were the most commonly implicated drugs. The most common ADRs were skin rash (maculopapular, erythematous, and urticaria, itching, etc.). The severity and preventability scales indicated that most reactions (18/20) were moderate in nature and all were preventable. Four reactions were "certainly" and ten ADRs were "probably" related to the suspected drug as determined by the WHO causality assessment.
Frequency of ADR increased with number of medications patient was receiving. Health-care providers (HCPs) involved in the care of children must be aware of this fact and should use additional drugs when absolutely necessary. They should be involved in pharmacovigilance program by exchanging and updating each other through sharing constructive information, communication, and education concerning the appropriate use of drugs in children. Pediatric pharmacovigilance is the need of the hour and should be given utmost importance for monitoring the safety of drugs in children. Motivating HCPs for voluntary reporting of ADRs for preventing the morbidity and mortality in this vulnerable population could be of immense importance.
本研究的目的是确定儿科患者药物不良反应（ADR）的性质和严重程度。
在这项回顾性队列研究中，我们从2014年5月至2016年12月提交给药品不良反应监测中心（AMC）的所有可用儿科ADR表格中提取数据。提取的数据包括ADR的性质、频率、因果关系（世界卫生组织[WHO]因果关系量表）和严重程度（Hartwig和Siegel严重程度量表）。我们还根据改良的Schumock和Thornton ADR可预防性量表评估了事件的可预防性。
在此期间共报告了20例儿科ADR。近三分之二的ADR发生在接受多种药物治疗（多药疗法）的患者中。抗菌药物是最常涉及的药物。最常见的ADR是皮疹（斑丘疹、红斑和荨麻疹、瘙痒等）。严重程度和可预防性量表表明，大多数反应（18/20）性质为中度，且所有反应均可预防。根据WHO因果关系评估，有4例反应“肯定”与可疑药物有关，10例ADR“可能”与可疑药物有关。
ADR的发生率随患者接受的药物数量增加而增加。参与儿童护理的医疗保健提供者（HCP）必须意识到这一事实，并且在绝对必要时才应使用额外的药物。他们应通过就儿童合理用药交流和更新建设性信息、进行沟通和教育，参与药物警戒计划。儿科药物警戒是当务之急，对于监测儿童用药安全应给予 utmost 重视。激励HCP自愿报告ADR以预防这一脆弱人群的发病和死亡可能极为重要。
