Fundació Institut Català de Farmacologia, Passeig Vall d'Hebron 119-129, Barcelona 08035, Spain.
Eur J Clin Pharmacol. 2010 Sep;66(9):937-45. doi: 10.1007/s00228-010-0856-8. Epub 2010 Jun 16.
A continuous intervention based on healthcare management agreements was associated in our hospital with an increase in the absolute number of spontaneous reporting of adverse drug reactions (ADRs), and also with an increase in the number of reports of serious or unexpected ADRs and ADRs associated with new drugs. The objective was to analyse the effect of this intervention on the features of ADRs spontaneously reported in a hospital, the drugs involved and the number of signals identified.
A longitudinal study with two periods, the 1st period without intervention from 1998 to 2002 and the 2nd period with intervention from 2003 to 2005, was carried out in a tertiary teaching hospital. Changes between the two periods with regard to the following variables were analysed: the patients' characteristics, such as gender and age; the reported ADRs, and the medical assistance required; the suspected drugs involved in the ADRs; the main signals identified.
Gender and age distribution of patients described in the spontaneous reports were no different in the two periods. During the second period, spontaneously reported cases requiring hospital admission and those occurring in hospital increased (236 from 2 in the first period and 277 from 99 in the first period respectively) and cases from outpatient hospital consultations began to be reported (13.9% of reports). The spontaneous reporting on all kinds of ADRs and drugs increased during the second period. Cutaneous reactions were the most frequently spontaneously reported ADRs in both periods followed by cardiovascular and neurological reactions in the first period, and haematological and gastrointestinal reactions in the second one. However, during the second period the higher increase was for endocrinological, urinary and hepatic reactions. Systemic antibiotics, anti-thrombotics and cardiac therapy drugs were the most common therapeutic subgroups reported to be suspected drugs in both periods, but in the second period the proportion of immunostimulants, beta blocking agents, immunosuppressants and psychoanaleptics increased. No signals were recognised during the first period; however, two signals and one additional safety concern were identified during the second.
An intervention based on healthcare management agreements, was associated with an important increase in spontaneous reporting of ADRs by hospital physicians and also with a change in terms of the type of ADRs identified affecting different organs or systems, and the therapeutic groups of drugs involved. Future studies should analyse the effect of different types of intervention on the spontaneous reporting of ADRs in hospitals.
在我院，基于医疗保健管理协议的连续干预措施与不良反应（ADR）自发报告的绝对数量增加有关，并且还与严重或意外 ADR 以及与新药相关的 ADR 报告数量的增加有关。目的是分析这种干预措施对医院内自发报告的 ADR 特征、涉及的药物以及识别的信号数量的影响。
在一家三级教学医院进行了一项具有两个时期的纵向研究，第一时期为 1998 年至 2002 年，无干预措施，第二时期为 2003 年至 2005 年，干预措施。分析了两个时期之间的以下变量变化：患者的特征，如性别和年龄；报告的 ADR 以及所需的医疗援助；涉及的可疑药物；主要识别出的信号。
两个时期报告的患者性别和年龄分布没有差异。在第二时期，需要住院治疗和在医院发生的自发报告病例增加（第二期为 2 例，第一期为 277 例），并且开始报告门诊医院咨询的病例（占报告的 13.9％）。第二期报告的所有类型的 ADR 和药物均增加。在两个时期，皮肤反应都是最常自发报告的 ADR，其次是心血管和神经反应，其次是血液学和胃肠道反应。但是，在第二期，内分泌，泌尿和肝脏反应的增幅更高。系统抗生素，抗血栓药和心脏治疗药物是两个时期报告的最常见治疗亚组可疑药物，但在第二期，免疫刺激剂，β阻断剂，免疫抑制剂和精神兴奋剂的比例增加。在第一期没有识别出信号，但是在第二期识别出了两个信号和一个额外的安全问题。
基于医疗保健管理协议的干预措施与医院医生自发报告 ADR 的重要增加有关，并且与所识别的 ADR 类型的变化有关，这会影响到不同的器官或系统以及涉及的药物治疗组。未来的研究应分析不同类型的干预措施对医院自发报告 ADR 的影响。
