Hospitalisations Related to Adverse Drug Reactions in Switzerland in 2012-2019: Characteristics, In-Hospital Mortality, and Spontaneous Reporting Rate.

ABSTRACT

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.