Motola Domenico, Melis Mauro, Lo Bianco Salvatore, Buccellato Elena, Biagi Chiara, Vaccheri Alberto
University of Bologna, Department of Medical and Surgical Sciences, Unit of Pharmacology , Via Irnerio 48, 40126 Bologna , Italy +39 0512091779 ; +39 0512091780 ;
Expert Opin Drug Saf. 2014 Jul;13(7):867-73. doi: 10.1517/14740338.2014.916687. Epub 2014 May 8.
To describe the evolution of adverse drug reactions (ADRs) spontaneously reporting in the Emilia-Romagna region (ERR) in the period 2001 - 2010 through qualitative and quantitative indicators following local educational and editorial initiatives.
Data of regional spontaneous reporting from 1 January 2001 to 31 December 2010 were obtained from the Pharmacovigilance National Network of the Italian Medicines Agency. Drugs were classified according to the Anatomical Therapeutic Chemical classification. ADRs were coded using the Medical Dictionary for Regulatory Activities Terminology.
The overall contribution of the ERR was 9.7% of the total national number of reports (9631 out of 99,319) with a rate of 8 reports per 100 physicians and 230 per million inhabitants. Reports concerned more females and more patients aged 0 - 2 and 60 - 80 years. Differences between the individual local health authorities were identified in rate of ADR reporting. Hospital doctors were the main source of reports followed by general physicians. Out of 2555 serious reports, 124 cases were lethal (4.9% of serious ADRs and 1.3% of all regional reports).
The results represent a useful trend analysis of the post-marketing surveillance and suggest that, although the pharmacovigilance system has succeeded in reaching a stable and lasting flow of information in ERR, there is considerable place for improvement.
通过定性和定量指标，描述2001 - 2010年期间艾米利亚 - 罗马涅地区（ERR）在当地教育和编辑举措之后自发报告的药物不良反应（ADR）的演变情况。
从意大利药品管理局的国家药物警戒网络获取2001年1月1日至2010年12月31日的地区自发报告数据。药物根据解剖治疗化学分类进行分类。ADR使用《监管活动医学词典术语》进行编码。
ERR的报告总数占全国报告总数的9.7%（99319份报告中的9631份），报告率为每100名医生8份报告，每百万居民230份报告。报告涉及更多女性以及更多0 - 2岁和60 - 80岁的患者。在ADR报告率方面发现了各个地方卫生当局之间的差异。医院医生是报告的主要来源，其次是全科医生。在2555份严重报告中，有124例是致命的（占严重ADR的4.9%，占所有地区报告的1.3%）。
这些结果代表了对上市后监测的有用趋势分析，并表明，尽管药物警戒系统已成功在ERR实现稳定且持续的信息流，但仍有很大的改进空间。
