Department of Social and Clinical Pharmacy, Faculty of Pharmacy, Charles University, Hradec Kralove, Czech Republic.
Eur J Clin Pharmacol. 2012 Jul;68(7):1057-63. doi: 10.1007/s00228-012-1219-4. Epub 2012 Feb 1.
Spontaneous reporting systems in European countries are crucial for collecting adverse drug reaction (ADR) reports. The aim of this study was to evaluate reporting activity among countries and their strategy to increase the number of reports. We also established the best measure for assessment quantity of reports.
This was a retrospective observational study based on questionnaires and annual reports. The most reliable measure of reporting was determined by Spearman correlation coefficients.
Data collected in spontaneous reporting systems in 26 European countries were analysed. In 2007, 2008 and 2009, the average value of reports per year per million inhabitants based on the safety databases of countries was 208, 236, 286, respectively; in comparison, that of Eudra- Vigilance was 311, 453 and 435, respectively. Twelve countries reached a significant level for signal detection of ADRs in 2009. The population-based reporting ratio (PBRR) was correlated to the total expenditure on health (ρ=0.499, p=0.023, n=21), public expenditure on health (ρ=0.477, p=0.035, n=20), density of physicians (ρ=0.336, p=0.136, n=21) and expenditure on pharmaceuticals (ρ=0.365, p=0.114, n=20). Strategies of regulatory authorities to increase reporting were determined.
The results of this study make several noteworthy contributions regarding national spontaneous reporting systems. The relevance of the PBRR for the measurement reporting activity is clearly supported by the current findings. This study also shows that there is a general trend towards increased reporting activity. This is maintained by regional centres and encouragement of reporting. A further study would be helpful to assess the effectiveness of reporting systems at both the national and European level.
欧洲国家的自发报告系统对于收集药物不良反应（ADR）报告至关重要。本研究的目的是评估各国的报告活动及其增加报告数量的策略。我们还确定了评估报告数量的最佳指标。
这是一项基于问卷调查和年度报告的回顾性观察研究。通过 Spearman 相关系数确定最可靠的报告衡量指标。
分析了 26 个欧洲国家自发报告系统中收集的数据。2007 年、2008 年和 2009 年，根据各国安全数据库，每年每百万居民的报告平均值分别为 208、236 和 286；相比之下，Eudra-Vigilance 的报告平均值分别为 311、453 和 435。2009 年，有 12 个国家在 ADR 信号检测方面达到了显著水平。基于人口的报告率（PBRR）与卫生总支出（ρ=0.499，p=0.023，n=21）、公共卫生支出（ρ=0.477，p=0.035，n=20）、医生密度（ρ=0.336，p=0.136，n=21）和药品支出（ρ=0.365，p=0.114，n=20）呈正相关。确定了监管机构增加报告的策略。
本研究结果对国家自发报告系统做出了几项值得注意的贡献。当前研究结果明确支持 PBRR 对报告活动测量的相关性。本研究还表明，报告活动呈普遍增加趋势。这是通过区域中心和鼓励报告来维持的。进一步的研究将有助于评估国家和欧洲层面报告系统的有效性。
