Salmerón-García Antonio, Cabeza Barrera José, Vergara Pavón Maria José, Román Márquez Eva, Cortés de Miguel Sol, Vallejo-Rodríguez Inmaculada, Raya García Susana, Casado Fernández Emilia
Department of Pharmacy, San Cecilio University Hospital, Granada, Spain.
Pharm World Sci. 2010 Jun;32(3):322-8. doi: 10.1007/s11096-010-9372-2. Epub 2010 Mar 6.
To analyze adverse drug reaction (ADR) detection using the Minimum Basic Data Set (MBDS) at hospital discharge and to compare the ADR reporting rate to the Pharmacovigilance Referral Centre with other similar hospitals that do not use this reporting system. Setting 650-bed University Hospital serving a population of 294,000 inhabitants in Spain.
A retrospective descriptive study was conducted between January 2006 and December 2007. All reports of ADRs gathered in MBDS (a tool that encodes all administrative and clinical information generated for each patient during a hospitalization episode) with International Classification Disease codes between E930 and E949.9 were analyzed to assess the appropriateness of their referral to the pharmacovigilance centre. Finally, we compared our reporting rate with other hospitals that do not use this system for ADR identification.
The incidence of ADRs detected in hospitalized patients and the reporting rate (per thousand inhabitants) to the referral pharmacovigilance centre using the Yellow Card system.
Out of 43,282 hospital discharges, 386 ADR were recorded (0.89% of hospitalized patients). The mean (+/-SD) age of patients with reported ADR was 61.9 years (+/-19.2), median age was 65 years, and 55.2% were female. The Department of Pharmacy reported 276 (71.5%) of ADR using the Yellow Card system. The most frequently reported drugs were anti-cancer agents (42.5%) and cardiovascular drugs (23.8%), with a high frequency of digitalis glycosides (18.4%). ADR were most frequently recorded by the Departments of Oncology (41.7%) and Internal Medicine (17.9%).
The MBDS is a useful and accessible instrument to determine the incidence of ADR in a hospital, resulting in the notification of severe events that might otherwise not be reported. Its use also improves identification of the main drugs responsible for ADR and of the patient populations at greatest risk, facilitating the implementation of alert systems and the development of prevention and detection strategies.
分析使用出院时最小基本数据集（MBDS）进行药品不良反应（ADR）检测的情况，并将向药物警戒转诊中心的ADR报告率与其他未使用该报告系统的类似医院进行比较。研究地点为西班牙一家拥有650张床位、服务于29.4万居民的大学医院。
于2006年1月至2007年12月进行一项回顾性描述性研究。分析MBDS（一种对住院期间为每位患者生成的所有行政和临床信息进行编码的工具）中收集的所有国际疾病分类代码在E930至E949.9之间的ADR报告，以评估其转诊至药物警戒中心的适宜性。最后，我们将我们的报告率与其他未使用该系统进行ADR识别的医院进行了比较。
住院患者中检测到的ADR发生率以及使用黄卡系统向转诊药物警戒中心的报告率（每千居民）。
在43282例出院病例中，记录了386例ADR（占住院患者的0.89%）。报告ADR的患者平均（±标准差）年龄为61.9岁（±19.2），中位年龄为65岁，女性占55.2%。药剂科使用黄卡系统报告了276例（71.5%）ADR。报告频率最高的药物是抗癌药（42.5%）和心血管药物（23.8%），洋地黄苷的频率较高（18.4%）。ADR最常由肿瘤科（41.7%）和内科（17.9%）记录。
MBDS是确定医院中ADR发生率的一种有用且可获取的工具，能够通报那些可能未被报告的严重事件。其使用还能改进对导致ADR的主要药物以及风险最高的患者群体的识别，有助于实施警报系统以及制定预防和检测策略。
