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Increasing the reporting of adverse drug reaction‐related hospitalizations using an ICD‐10‐based identification workflow: A multicentre study from Switzerland

作者:Georgia Anita Weber, Sophie‐Charlotte Bartel, Michael Boch, Christoph Rosen, Michael Bodmer, Balthasar L. Hug, Thomas Stammschulte, Patrick E. Beeler · 发表于:British Journal of Clinical Pharmacology · 年份:2026 · DOI:10.1002/bcp.70564 · 被引用次数:1 · 研究领域:Pharmacovigilance and Adverse Drug Reactions、Pharmaceutical Practices and Patient Outcomes、Patient Safety and Medication Errors

BACKGROUND: Reporting adverse drug reactions (ADRs) is essential for drug safety. In Switzerland, healthcare professionals are legally required to report serious and unlabelled ADRs, yet under-reporting remains widespread. We tested a novel method to increase reporting of ADR-related hospitalizations. METHODS: This retrospective observational study used ADR-indicative ICD-10 codes to screen admissions to four Swiss hospitals, identify suspected drugs and send individual case safety reports (ICSRs) of confirmed cases to Swissmedic. RESULTS: Participating hospitals previously reported ~18 ICSRs annually. During the study period (7/2023-12/2023), 200 ADR-related hospitalizations were reported following a review of 814 pre-filtered admissions. Most ICSR data were available in structured format: Median age of patients was 59 (interquartile range [IQR] 42-75); 87 (44%) males; median of two comorbidities (IQR 1-3); the three most frequent ADRs were 'K52.1 Toxic gastroenteritis and colitis' (11 [6%]), 'T42.4 Poisoning by benzodiazepines' (10 [5%]) and 'R11 Nausea and vomiting' (10 [5%]). Discharge reports contained free-text information on suspected drugs: More than half of ADR-related hospitalizations were caused by antineoplastics (45 [23%]), psycholeptics (38 [19%]), opioids and other analgesics (34 [17%]). The median time to screen a case was 1 min, 8 min to collect, compile and send data of confirmed cases. CONCLUSION: The approach successfully increased reporting of serious ADR...