Harry M, Lebel D, Comtois A, Bussières J-F
Département de pharmacie et unité de recherche en pratique pharmaceutique, centre hospitalier universitaire Sainte-Justine, 3175, chemin de la Côte-Sainte-Catherine, H3T 1C5, Montréal, Québec, Canada.
Service des archives médicales, centre hospitalier universitaire Sainte-Justine, Montréal, Québec, Canada.
Arch Pediatr. 2017 Dec;24(12):1179-1187. doi: 10.1016/j.arcped.2017.09.026. Epub 2017 Nov 21.
In view of the underdeclaration of adverse drug reactions (ADRs), there is a need for optimizing their reporting. To improve our declaration, a pharmacovigilance program was started in 2006 at our center and measures were progressively started (weekly patient rounds, monthly report, etc.). The objectives of the study were to describe and compare the annual average incidence of the ADRs coded by the medical archivists from 1 April 1989 to 31 March 2010 (period 1) and from 1 April 2010 to 31 March 2015 (period 2), to determine the therapeutic classes of drugs associated with ADRs according to age and determine the percentage of ADRs that are declared to Health Canada.
This was a nonexperimental, descriptive, and retrospective study in a mother-child university hospital. All the ADRs that arose with patients less than 18 years old during period 2 were included. The results of a previous study, conducted during period 1 were used. A Student t-test was used to compare the mean annual incidence and the average number of ADRs per year between the two periods.
The average number of ADRs per year was 225.7±65.1 ADRs during period 1 versus 429.6±52.1 ADRs during period 2 (P<0.01). The mean annual incidence of the ADRs was 1.64%±0.41% during period 1 versus 3.17%±0.43% during period 2 (P<0.01). Throughout the study period, the mean annual gravity and mortality index were stable. The ADRs caused by antibiotics/antifungals, anticancer agents, opiates, and corticoids accounted for more than 50% of the total ADRs from 1989-1990 to 2014-2015. Only 37% of the ADRs were declared to Health Canada during period 1 versus 41% during period 2.
This study highlighted a progressive increase in the codification of the ADRs in the pediatric population from 1989-1990 to 2014-2015. No causal effect could be obtained between the measures that we implemented in 2006 and the improvement seen with the ADR codification, but we can reasonably suspect a positive impact.
鉴于药物不良反应（ADR）报告不足，有必要优化其报告方式。为改进我们的报告工作，2006年我们中心启动了药物警戒计划，并逐步采取了一些措施（每周查房、每月报告等）。本研究的目的是描述和比较1989年4月1日至2010年3月31日（时期1）以及2010年4月1日至2015年3月31日（时期2）医学档案管理员编码的ADR的年平均发生率，根据年龄确定与ADR相关的药物治疗类别，并确定向加拿大卫生部报告的ADR的百分比。
这是一项在母婴大学医院进行的非实验性、描述性回顾性研究。纳入了时期2内18岁以下患者出现的所有ADR。使用了在时期1进行的一项先前研究的结果。采用学生t检验比较两个时期的年平均发生率和每年ADR的平均数。
时期1每年ADR的平均数为225.7±65.1例，而时期2为429.6±52.1例（P<0.01）。时期1 ADR的年平均发生率为1.64%±0.41%，而时期2为3.17%±0.43%（P<0.01）。在整个研究期间，年平均严重程度和死亡率指数保持稳定。1989 - 1990年至2014 - 2015年，抗生素/抗真菌药、抗癌药、阿片类药物和皮质类固醇引起的ADR占ADR总数的50%以上。时期1只有37%的ADR向加拿大卫生部报告，而时期2为41%。
本研究强调了1989 - 1990年至2014 - 2015年儿科人群中ADR编码呈逐步增加趋势。我们在2006年实施的措施与ADR编码方面的改善之间未发现因果关系，但我们可以合理怀疑存在积极影响。
