Escola Nacional de Saúde Pública, Universidade NOVA de Lisboa, Av Padre Cruz, 1600-560, Lisbon, Portugal.
AMGEN Biofarmaceutica, Lisbon, Portugal.
BMC Pharmacol Toxicol. 2017 May 10;18(1):34. doi: 10.1186/s40360-017-0140-y.
The aim of this study is to identify the distribution by municipalities of adverse drug events (ADE) in Portugal, including adverse drug reactions (ADR) and accidental poisoning by drugs (AP), on municipality/years ADE rate clustering. Also we identify areas with different trends in time.
We used a national dataset of public hospital discharges in Continental Portugal from 2004 to 2013. Events were identified based on codes: from E930 to E949.9 (ADR) and from E850 to E858.9 (AP). Space-time clustering and spatial variation in temporal trends methods were applied in three different time-periods: globally, by year and grouped in 2 classes (periods of 5 years).
A total of 9,320,076 patients were discharged within this period, with 133,688 patients (1.46%) having at least one ADE, 4% of them related with AP. Critical space-time identified clusters (p < 0.001) were the municipalities from Lisbon metropolitan area and Centro region area. The global rate increased at a 7.8% mean annual percentage change, with high space-time heterogeneity and variation in time trends clusters (p < 0.001). For whole period, 2004-2013, all clusters presented increasing trends. However when analyzed by period of 5 years we identified two clusters with decreasing trends in time in 2004-2008.
The impact of ADE is huge, with widely variations within country and in time, and represents an increasing challenge. Future research using individual and contextual risk factors are urgently needed to understand this spatiotemporal variability in order to promote local tailored and updated actions of prevention.
本研究旨在通过市镇分布，确定葡萄牙的药物不良事件（ADE），包括药物不良反应（ADR）和药物意外中毒（AP），并对 ADE 发生率聚类进行分析。同时，我们还确定了具有不同时间趋势的区域。
我们使用了 2004 年至 2013 年葡萄牙大陆公立医院出院患者的全国性数据集。根据以下代码识别事件：E930 至 E949.9（ADR）和 E850 至 E858.9（AP）。采用时空聚类和时间趋势空间变化方法，在三个不同时期进行分析：总体、按年份以及分为两个类（5 年时期）。
在此期间共出院 932 万患者，其中 133688 例（1.46%）至少发生过一次 ADE，其中 4%与 AP 相关。具有重要时空意义的聚类（p<0.001）是里斯本大都市区和中心地区的市镇。全球发生率以每年 7.8%的平均百分比变化率增加，具有高度的时空异质性和时间趋势聚类变化（p<0.001）。在整个研究期间（2004-2013 年），所有聚类均呈现出上升趋势。然而，当按 5 年时期进行分析时，我们发现有两个聚类在 2004-2008 年间呈下降趋势。
ADE 的影响巨大，在国内和时间上存在广泛差异，是一个日益严峻的挑战。未来需要使用个体和环境风险因素进行研究，以了解这种时空变异性，从而促进针对当地情况制定和更新的预防措施。
