Adverse drug reactions detected by stimulated spontaneous reporting in an internal medicine department in Romania
Adverse drug reactions detected by stimulated spontaneous reporting in an internal medicine department in Romania
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DOI：
10.1016/j.ejim.2010.05.014
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发表时间：
2010-10-01
影响因子：
8
通讯作者：
Dumitrascu, Dan
中科院分区：
文献类型：
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作者：
Farcas, Andreea;Sinpetrean, Aura;Dumitrascu, Dan
背景：人们普遍认为，药物不良反应(ADR)是卫生系统在早期识别、适当管理和预防方面的主要关切。本研究的目的是确定主治医生认识到的最常见的ADR，研究ADR的性质，并针对这些ADR采取进一步的预防措施。方法：在内科进行一项为期12个月的前瞻性研究，采用刺激自发报告的方法来识别ADR。医生报告的所有ADR都被跟踪到患者出院，并由一个独立的药理学家小组进行评估。结果：在1854例住院患者中，94例患者112例(5.07%)的不良反应得到证实。住院患者严重不良反应发生率为4.7%。根据MedDRA分类，最常见的不良反应影响胃肠系统，其次是代谢和血管系统。最常涉及的药物是心血管药物、抗凝剂和非甾体抗炎药。药物相互作用占不良反应的25.9%。根据选定的可预防性量表，40.18%的不良反应被归类为“潜在可预防”，9.82%被归类为“肯定可预防”。大多数不良反应为A型反应，只要调整剂量或避免药物相互作用就可以避免。结论：严重不良反应在住院患者中是常见的，而且往往是可以预防的。预防策略应针对药物处方。适当的药理学培训和优化药物治疗可能有助于降低ADRs的发病率和死亡率。(C)2010年欧洲内科医学联合会。爱思唯尔出版，版权所有。
Background: It is generally recognized that adverse drug reactions (ADRs) represent a major concern of health systems in terms of early recognition, proper management and prevention. The aims of this study were to identify the most frequent ADRs recognized by the attending physicians, study their nature and target these ADRs in order to take future preventive measures.Methods: A prospective study was conducted over a 12-month period in an internal medicine department using stimulated spontaneous reporting for identifying ADRs. All ADRs reported by physicians were followed up to the patient's discharge and evaluated by an independent group of pharmacologists. Causality, severity and preventability were assessed.Results: Of the 1854 admissions, 112 ADRs in 94 patients (5.07%) were validated from the total of 118 ADRs reported. The overall incidence of serious ADRs in the hospitalized patients was 4.7%. According to the MedDRA classification, the most frequent ADRs affected the gastrointestinal system, followed by metabolic and vascular systems. The drugs most frequently involved were cardiovascular agents, anticoagulants and NSAIDs. Drug interactions were responsible for 25.9% of ADRs. According to the selected preventability scale, 40.18% ADRs were classified as 'potentially preventable' and 9.82% 'definitely preventable'. Most of the ADRs were 'type A' reactions and as such could have been avoided simply by adjusting the doses or by avoiding drug interactions.Conclusions: Serious ADRs in hospitalized patients are common and often preventable. Preventing strategies should target drug prescription. Adequate training regarding pharmacology and optimization of drug therapy might help reduce ADRs' morbidity and mortality. (C) 2010 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.