Department of Pharmacology, College of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
Saudi Pharm J. 2013 Jul;21(3):261-6. doi: 10.1016/j.jsps.2012.09.004. Epub 2012 Oct 6.
Children are more vulnerable to ADRs, and this susceptibility is compounded due to hospitalization. There is a lack of local data regarding the potential risk of ADRs in hospitalized pediatric patients. Therefore, this study is designed to identify the frequent nature, severity of adverse drug reactions, drugs implicated and factors influencing ADRs.
Intensive monitoring study of ADRs was done in hospitalized pediatric patients of King Abdulaziz University Hospital, Jeddah from January to December 2011, with an analogous retrospective study for the preceding year to determine incidence rate, demographic aspects, causality appraisal, polypharmacy, body organs/systems involved and drugs implicated in ADR. Comparison of the two data was done to determine the impact of pharmacovigilance.
Incidence rate of ADRs in retrospective study was (4.50%) and (8.2%) in prospective study. ADR was more in patients who received 5-6 drugs, which was (15.5%) in retrospective study and (22.1%) in prospective study. Regarding age, it was the highest in patients of 0-1 year of age which was (40.7%) in retrospective study and (38.8%) in prospective study. Anti-infective agents were the most frequently involved in ADR (40.8%) in prospective study and (48.2%) and retrospective study. This study also demonstrated that, there was high susceptibility of the skin to the ADR which was (37%) in retrospective study and (42.9%) in prospective study. None of the ADRs proved to be fatal.
Well premeditated intensive monitoring approach in pharmacovigilance amplifies the ADR detection, which can persuade healthcare providers into more drug safety.
儿童更容易受到药物不良反应的影响，而住院会使其易感性进一步增加。关于住院儿科患者发生药物不良反应的潜在风险，本地缺乏相关数据。因此，本研究旨在确定药物不良反应的常见性质、严重程度、涉及的药物以及影响药物不良反应的因素。
2011 年 1 月至 12 月，对吉达阿卜杜勒阿齐兹国王大学医院的住院儿科患者进行了药物不良反应的强化监测研究，并对前一年进行了类似的回顾性研究，以确定发生率、人口统计学方面、因果关系评估、多药治疗、涉及的身体器官/系统以及药物不良反应涉及的药物。对这两个数据进行了比较，以确定药物警戒的影响。
回顾性研究中药物不良反应的发生率为（4.50%），前瞻性研究中为（8.2%）。接受 5-6 种药物治疗的患者中药物不良反应更多，回顾性研究中为（15.5%），前瞻性研究中为（22.1%）。就年龄而言，0-1 岁的患者最高，回顾性研究中为（40.7%），前瞻性研究中为（38.8%）。抗感染药物是最常涉及药物不良反应的药物（前瞻性研究中为 40.8%，回顾性研究中为 48.2%）。本研究还表明，皮肤对药物不良反应的敏感性很高，回顾性研究中为（37%），前瞻性研究中为（42.9%）。没有药物不良反应被证明是致命的。
在药物警戒中进行精心策划的强化监测方法可以提高药物不良反应的检测率，从而促使医疗保健提供者更加关注药物安全性。
