AIMS: An intensified monitoring system was set up to identify drug related hospital admissions and estimate population-based incidences for commonly prescribed medications. METHODS: Pharmacovigilance-centres systematically screened nonelective admissions to emergency rooms or departments of internal medicine for drug related hospitalizations (DRH). Clinical pharmacologists used standardized causality assessment. Service areas of each acute care hospital were defined by 5 digit postal codes that covered 60% of all admissions. Drug dispensing information was available through claims processed by regional pharmacy computing centres. Quarterly incidences were estimated by dividing the number of events by the number of treated patients. RESULTS: 435 DRHs were reported during five quarters. The incidence of ADRs leading to admissions varied for specific drug groups from 1.5/10 000 treated patients to 24/10 000. Quarterly variation of incidences was moderate except for insulin and calcium antagonists. 95% confidence intervals overlap for all quarters within each group. Incidences are sensitive to changes in the definition of the source population. CONCLUSIONS: Our pharmacovigilance monitoring system allows comparisons of population-based incidences of drug-related hospitalizations among drugs and over time. It provides important information for risk management and monitoring outcomes of pharmaceutical quality management programmes.
AIMS: An intensified monitoring system was set up to identify drug related hospital admissions and estimate population-based incidences for commonly prescribed medications. METHODS: Pharmacovigilance-centres systematically screened nonelective admissions to emergency rooms or departments of internal medicine for drug related hospitalizations (DRH). Clinical pharmacologists used standardized causality assessment. Service areas of each acute care hospital were defined by 5 digit postal codes that covered 60% of all admissions. Drug dispensing information was available through claims processed by regional pharmacy computing centres. Quarterly incidences were estimated by dividing the number of events by the number of treated patients. RESULTS: 435 DRHs were reported during five quarters. The incidence of ADRs leading to admissions varied for specific drug groups from 1.5/10 000 treated patients to 24/10 000. Quarterly variation of incidences was moderate except for insulin and calcium antagonists. 95% confidence intervals overlap for all quarters within each group. Incidences are sensitive to changes in the definition of the source population. CONCLUSIONS: Our pharmacovigilance monitoring system allows comparisons of population-based incidences of drug-related hospitalizations among drugs and over time. It provides important information for risk management and monitoring outcomes of pharmaceutical quality management programmes.
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