Adverse drug events in hospitalized patientsA comparison of doctors, nurses and patients as sources of reports |
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Authors: | P. M. L. A. van den Bemt A. C. G. Egberts A. W. Lenderink J. M. Verzijl K. A. Simons W. S. C. J. M. van der Pol H. G. M. Leufkens |
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Affiliation: | (1) Hospital Pharmacy Midden-Brabant, Tilburg, The Netherlands, NL;(2) University of Utrecht, Utrecht Institute for Pharmaceutical Sciences, Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht, The Netherlands, NL;(3) Hospital Pharmacy Diagnostisch Centrum SSDZ, Delft, The Netherlands, NL;(4) Hospital Pharmacy, Medisch Centrum Leeuwarden/Hospital `De Tjongerschans' Heerenveen, Postbus 888, NL-8901 BR Leeuwarden, The Netherlands Tel.:+31-582866605/+31-513644444; Fax:+31-582866606/+31-513644721, NL |
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Abstract: | Objective: This study investigated the relative value of adverse drug events reported by doctors, nurses and patients. Methods: The study was conducted on a total of four wards: the paediatric and internal medicine wards (including geriatric patients) of two peripheral hospitals in the Netherlands. Adverse drug events were collected by spontaneous reporting (doctor and nurse reports) and by daily ward visits, during which the patients were interviewed by a hospital pharmacist (patient reports). Criteria for relative value of the reported adverse drug events were the number of potentially serious reactions, the number of reactions not mentioned in the patient information leaflet and the number of reactions reported to new drugs (5 years or less on the Dutch market). No formal causality assessment was applied. Results: Over a period of 2 months in 1996 (Hospital I) and 2 months in 1997 (Hospital II) a total of 620 patients were included in the study and adverse drug events were reported in 179 (29%) of these cases. Doctors reported a statistically significant larger number of serious (26% of all doctor reports; odds ratio (OR) 3.2; confidence interval (CI) 1.2–8.7) and unknown (39%; OR 2.5; CI 1.0–6.0) adverse drug events than patients themselves during the daily ward visit. Doctors also reported more serious and unknown adverse drug events than nurses. Adverse reactions to new drugs were reported during the daily ward visit only (8% of all daily ward visit reports). Conclusion: This study reconfirms that doctors are the main source for reports of serious and unknown adverse drug events in hospitalized patients. However, patients themselves seem to report more adverse reactions to new drugs (during the daily ward visit). By focusing on patients using new drugs, the daily ward visit might become cost-effective. This needs to be explored in future studies. Received: 10 September 1998 / Accepted in revised form: 30 November 1998 |
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Keywords: | Adverse drug event reporting Hospitalized patients Source/relative value of reports |
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