Farcas Andreea, Bucsa Camelia, Sinpetrean Aura, Leucuta Daniel, Mogosan Cristina, Dumitrascu Dan, Achimas Andrei Cadariu, Bojita Marius
Drug Information Research Center, School of Pharmacy, "Iuliu Hatieganu" University of Medicine and Pharmacy, Pasteur 6, 400349, Cluj-Napoca, Romania,
Intern Emerg Med. 2014 Mar;9(2):187-93. doi: 10.1007/s11739-012-0843-4. Epub 2012 Aug 21.
In order to improve patient safety, systematic analysis of common and repetitive patterns of preventable adverse drug reactions (pADRs) in the clinical setting should be performed regularly in order to propose adequate prevention strategies. Our aim is to evaluate the preventability of all ADRs collected in a drug information research center database, by spontaneous reporting and clinical surveillance in two internal medicine departments. One reviewer systematically reevaluated all the cases stored in the database. ADRs were deemed preventable if they were due to: a contraindication, an inadequate dose, a drug interaction, an inappropriate prescribing decision for the patient's condition, inadequate monitoring, self-medication, or non-adherence to therapy. Out of 251 ADRs evaluated, 103 (41 %) were considered preventable. Out of the total pADRs, 86.4 % were serious. The most frequent adverse outcomes affected the gastrointestinal system (21.4 %), followed by the renal (11.6 %), metabolic (10.7 %), vascular (10.7 %) and hepatic (6.8 %) systems. Acenocoumarol (28 %), diclofenac (12.6 %), digoxin and furosemide accounted for more than 50 % of all preventable reports. One of up to three factors was involved in the preventability of the analyzed reports. Drug-drug interactions were the cause of 49.5 % of the pADRs. Inappropriate dose accounted for 17.5 % reports out of the total pADRs, inappropriate monitoring for 9.7 % reports, history of allergy to drug or drug class for 5.8 % reports and administration of a contraindicated drug for 4.8 % reports. Identifying prevalent pADRs in this study indicates a clear target for prevention strategies: drug prescription, with a special emphasis on drug interactions.
为提高患者安全，应定期对临床环境中可预防的药物不良反应（pADR）的常见和重复模式进行系统分析，以提出适当的预防策略。我们的目的是通过在两个内科部门进行自发报告和临床监测，评估药物信息研究中心数据库中收集的所有药物不良反应的可预防性。一名审查员系统地重新评估了数据库中存储的所有病例。如果药物不良反应是由以下原因引起的，则被认为是可预防的：禁忌症、剂量不足、药物相互作用、针对患者病情的不适当处方决定、监测不足、自我用药或不坚持治疗。在评估的251例药物不良反应中，103例（41%）被认为是可预防的。在所有可预防的药物不良反应中，86.4%是严重的。最常见的不良后果影响胃肠道系统（21.4%），其次是肾脏（11.6%）、代谢（10.7%）、血管（10.7%）和肝脏（6.8%）系统。醋硝香豆素（28%）、双氯芬酸（12.6%）、地高辛和呋塞米占所有可预防报告的50%以上。在分析报告的可预防性中，涉及一至三个因素。药物相互作用是49.5%的可预防药物不良反应的原因。剂量不当占所有可预防药物不良反应报告的17.5%，监测不当占9.7%的报告，对药物或药物类别过敏史占5.8%的报告，使用禁忌药物占4.8%的报告。本研究中确定常见的可预防药物不良反应为预防策略指明了明确目标：药物处方，特别强调药物相互作用。
