Division of Allergy and Clinical Immunology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Pharmacovigilance Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
J Korean Med Sci. 2023 Feb 27;38(8):e56. doi: 10.3346/jkms.2023.38.e56.
Adverse drug reactions (ADRs) are escalating, and their socioeconomic burden is increasing. However, large-scale prospective studies investigating ADRs during hospitalization are rare in Korea. We prospectively investigated the incidence, characteristics, and economic burden of ADRs in hospitalized patients based on electronic medical records (EMRs).
Among patients admitted to three hospitals from October 2016 to October 2017, 5,000 patients were randomly selected and prospectively observed during hospitalization. Research nurses monitored and detected patients who had symptoms, signs, or laboratory findings suspicious for ADRs using an EMR-based detection protocol. Next, allergy and ADR specialists reviewed the medical records to determine the relationship between adverse reactions and drugs. Cases in which a causal relationship was certain, probable/likely, or possible were included in the ADR cases. Clinically meaningful ADR cases or those leading to prolonged hospitalization were defined as significant ADRs.
ADRs occurred in 510 (10.2%) patients. The mean length of hospital stay was approximately 5 days longer in patients with ADRs. Opioids accounted for the highest percentage of total ADRs. Significant ADRs were observed in 148 (3.0%) patients. Antibiotics accounted for the highest percentage of significant ADRs. Drug hypersensitivity reactions (DHRs) occurred in 88 (1.8%) patients. Antibiotics accounted for the highest percentage of DHRs. The average medical expenses for one day of hospitalization per patient were highest in significant ADRs, followed by non-significant ADRs, and non-ADRs.
ADRs in hospitalized patients are an important clinical issue, resulting in a substantial socioeconomic burden. EMR-based strategy could be a useful tool for ADR monitoring and early detection.
药物不良反应（ADR）不断增加，其带来的社会经济负担也在加重。然而，在韩国，针对住院患者进行的大规模前瞻性 ADR 研究却很少。我们基于电子病历（EMR）前瞻性地调查了住院患者的 ADR 发生率、特征和经济负担。
在 2016 年 10 月至 2017 年 10 月期间，我们从三家医院中随机选择了 5000 名住院患者进行前瞻性观察。研究护士使用基于 EMR 的检测方案监测和发现具有 ADR 可疑症状、体征或实验室发现的患者。接下来，过敏和 ADR 专家审查病历以确定不良反应与药物之间的关系。将因果关系确定、很可能/可能的病例纳入 ADR 病例。将具有临床意义的 ADR 病例或导致住院时间延长的 ADR 病例定义为显著 ADR。
510 名（10.2%）患者发生了 ADR。有 ADR 的患者的平均住院时间延长了约 5 天。阿片类药物占 ADR 总数的比例最高。在 148 名（3.0%）患者中观察到显著 ADR。抗生素占显著 ADR 的比例最高。88 名（1.8%）患者发生了药物过敏反应（DHR）。抗生素占 DHR 的比例最高。每位患者每天住院的平均医疗费用在显著 ADR 中最高，其次是非显著 ADR 和非 ADR。
住院患者的 ADR 是一个重要的临床问题，会导致巨大的社会经济负担。基于 EMR 的策略可能是监测和早期发现 ADR 的有用工具。
