Torelló Iserte J, Castillo Ferrando J R, Laínez M M, García Morillas M, Arias González A
Centro Andaluz de Farmacovigilancia.
Aten Primaria. 1994 Apr 15;13(6):307-11.
To discover the sort of adverse reactions to medication (ARM) notified by Primary Care doctors and identify the under-notification of those cases having special clinical-epidemiological interest.
Retrospective study in which 2,597 ARM corresponding to 1,467 Yellow Cards (YC) were analysed. These were notified by Primary Care doctors to the Centro Andaluz de Farmacovigilancia (Andalusian Drug-watch centre) during the period from 1/6/90 to 31/12/92. To assess the seriousness of the ARM, their terminological classification and imputability, the criteria used in the WHO's international "Yellow Card" programme of spontaneous notification were followed.
77.2% of all notifications were from Primary Care, of which 7.4% were of special interest due to their serious or novel character. However an undernotification of serious and well-known ARM was detected, such as digestive haemorrhages (1.07/10(6) inhibitants per year), anaphylactic shock (0.34/10(6) inhab/year), agranulocytosis (0.23/10(6) inhab/year) and aplastic anaemia (0.05/10(6) inhab/year), among others.
Most of the main under-notified ARM are generated in the community but treated in hospital Casualty departments. Therefore it would be useful to develop specific Drug-watch programmes in the hospitals themselves.
了解基层医疗医生上报的药物不良反应（ARM）类型，并确定那些具有特殊临床流行病学意义的病例上报不足的情况。
回顾性研究，分析了与1467张黄卡相对应的2597例ARM。这些是基层医疗医生在1990年6月1日至1992年12月31日期间向安达卢西亚药物警戒中心（安达卢西亚药品监测中心）上报的。为评估ARM的严重性、术语分类和可归因性，遵循了世界卫生组织国际自发上报“黄卡”计划中使用的标准。
所有上报病例中77.2%来自基层医疗，其中7.4%因其严重或新颖的特征而具有特殊意义。然而，发现存在严重且常见的ARM上报不足的情况，如消化道出血（每年每10⁶居民中有1.07例）、过敏性休克（每年每10⁶居民中有0.34例）、粒细胞缺乏症（每年每10⁶居民中有0.23例）和再生障碍性贫血（每年每10⁶居民中有0.05例）等。
大多数上报不足的主要ARM发生在社区，但在医院急诊部门治疗。因此，在医院自身开展特定的药品监测计划会很有用。
