Division of Occupational and Environmental Medicine, Epidemiology, Biostatistics and Prevention Institute, University of Zurich and University Hospital Zurich, Zurich, Switzerland.
Center for Primary and Community Care, University of Lucerne, Lucerne, Switzerland.
Drug Saf. 2023 Aug;46(8):753-763. doi: 10.1007/s40264-023-01319-y. Epub 2023 Jun 19.
Adverse drug reactions (ADRs) contribute to morbidity, and serious ADRs may cause hospitalisation and death. This study characterises and quantifies ADR-related hospitalisations and subsequent in-hospital deaths, and estimates the spontaneous reporting rate to regulatory authorities in Switzerland, where healthcare professionals are legally obliged to report ADRs.
This retrospective cohort study from 2012 to 2019 analysed nationwide data from the Federal Statistical Office. ICD-10 coding rules identified ADR-related hospitalisations. To estimate the reporting rate, individual case safety reports (ICSRs) collected in the Swiss spontaneous reporting system during the same period were considered.
Among 11,240,562 inpatients, 256,550 (2.3%) were admitted for ADRs, 132,320 (51.6%) were female, 120,405 (46.9%) were aged ≥ 65 (median of three comorbidities, interquartile range [IQR] 2-4), and 16,754 (6.5%) were children/teenagers (0 comorbidities, IQR 0-1). Frequent comorbidities were hypertension (89,938 [35.1%]), fluid/electrolyte disorders (54,447 [21.2%]), renal failure (45,866 [17.9%]), cardiac arrhythmias (37,906 [14.8%]), and depression (35,759 [13.9%]). Physicians initiated 113,028 (44.1%) of hospital referrals, and patients/relatives 73,494 (28.6%). Frequently ADR-affected were the digestive system (48,219 [18.8%], e.g. noninfective gastroenteritis and colitis), the genitourinary system (39,727 [15.5%], e.g. acute renal failure), and the mental/behavioural state (39,578 [15.4%], e.g. opioid dependence). In-hospital mortality was 2.2% (5669). Since ICSRs indicated 14,109 hospitalisations and 700 in-hospital deaths, estimated reporting rates were 5% and 12%, respectively.
This 8-year observation in Switzerland revealed that 2.3%, or roughly 32,000 admissions per year, were caused by ADRs. The majority of ADR-related admissions were not reported to the regulatory authorities, despite legal obligations.
药物不良反应（ADR）可导致发病，严重的 ADR 可能导致住院和死亡。本研究旨在对 ADR 相关住院和随后的院内死亡进行描述和量化，并估计瑞士监管机构收到的自发报告率，在瑞士，医疗保健专业人员有法律义务报告 ADR。
这是一项 2012 年至 2019 年的全国性回顾性队列研究，数据来自联邦统计局。ICD-10 编码规则确定了与 ADR 相关的住院治疗。为了估计报告率，考虑了同期在瑞士自发报告系统中收集的个别病例安全报告（ICSR）。
在 11240562 名住院患者中，256550 人（2.3%）因 ADR 住院，其中 132320 人（51.6%）为女性，120405 人（46.9%）年龄≥65 岁（中位数合并症 3 种，四分位距[IQR]2-4），16754 人（6.5%）为儿童/青少年（0 种合并症，IQR 0-1）。常见合并症为高血压（89938 例[35.1%]）、液体/电解质紊乱（54447 例[21.2%]）、肾衰竭（45866 例[17.9%]）、心律失常（37906 例[14.8%]）和抑郁（35759 例[13.9%]）。医生发起了 113028 次（44.1%）住院转诊，患者/亲属发起了 73494 次（28.6%）。消化系统（48219 例[18.8%]，如非传染性肠胃炎和结肠炎）、泌尿系统（39727 例[15.5%]，如急性肾衰竭）和精神/行为状态（39578 例[15.4%]，如阿片类药物依赖）受 ADR 影响最常见。院内死亡率为 2.2%（5669 例）。由于 ICSR 表明有 14109 例住院和 700 例院内死亡，估计报告率分别为 5%和 12%。
这项在瑞士进行的为期 8 年的观察发现，每年约有 2.3%，或 32000 例住院治疗是由 ADR 引起的。尽管有法律义务，但大多数与 ADR 相关的住院治疗并未向监管机构报告。
