Pagotto Caroline, Varallo Fabiana, Mastroianni Patrícia
Drugs and Medicines, School of Pharmaceutical Sciences of the Universidade Estadual Paulista Júlio de Mesquita Filho-Unesp.
Int J Technol Assess Health Care. 2013 Oct;29(4):410-7. doi: 10.1017/S0266462313000457.
Spontaneous adverse drug events (ADE) reporting is the main source of data for assessing the risk/benefit of drugs available in the pharmaceutical market. However, its major limitation is underreporting, which hinders and delays the signal detection by Pharmacovigilance (PhV).
To identify the techniques of educational intervention (EI) for promotion of PhV by health professionals and to assess their impact.
A systematic review was performed in the PUBMED, PAHO, LILACS and EMBASE databases, from November/2011 to January/2012, updated in March/2013. The strategy search included the use of health descriptors and a manual search in the references cited by selected papers.
101 articles were identified, of which 16 met the inclusion criteria. Most of these studies (10) were conducted in European hospitals and physicians were the health professionals subjected to most EI (12), these studies lasted from one month to two years. EI with multifaceted techniques raised the absolute number, the rate of reporting related to adverse drug reactions (ADR), technical defects of health technologies, and also promoted an improvement in the quality of reports, since there was increased reporting of ADR classified as serious, unexpected, related to new drugs and with high degree of causality.
Multifaceted educational interventions for multidisciplinary health teams working at all healthcare levels, with sufficient duration to reach all professionals who act in the institution, including issues related to medication errors and therapeutic ineffectiveness, must be validated, with the aim of standardizing the Good Practice of PhV and improve drug safety indicators.
自发报告药物不良事件（ADE）是评估药品市场上现有药物风险/效益的主要数据来源。然而，其主要局限性在于报告不足，这阻碍并延迟了药物警戒（PhV）的信号检测。
确定促进卫生专业人员开展药物警戒的教育干预（EI）技术，并评估其影响。
于2011年11月至2012年1月在PUBMED、泛美卫生组织、拉丁美洲和加勒比卫生科学数据库（LILACS）以及EMBASE数据库中进行了系统评价，并于2013年3月更新。检索策略包括使用健康描述符以及对所选论文引用的参考文献进行手工检索。
共识别出101篇文章，其中16篇符合纳入标准。这些研究大多（10项）在欧洲医院开展，卫生专业人员中接受最多EI的是医生（12项），这些研究持续时间从1个月到2年不等。采用多方面技术的EI提高了与药物不良反应（ADR）相关的报告绝对数量、报告率、卫生技术的技术缺陷，还促进了报告质量的提高，因为被归类为严重、意外、与新药相关且因果关系程度高的ADR报告有所增加。
必须对在各级医疗保健机构工作的多学科卫生团队进行多方面的教育干预，并给予足够的持续时间以覆盖机构内所有从业人员，包括与用药错误和治疗无效相关的问题，目的是规范药物警戒的良好实践并改善药物安全指标。
