PMID- 21384463 OWN - NLM STAT- MEDLINE DCOM- 20111013 LR - 20131121 IS - 1099-1557 (Electronic) IS - 1053-8569 (Linking) VI - 20 IP - 6 DP - 2011 Jun TI - Adverse drug reactions in Germany: direct costs of internal medicine hospitalizations. PG - 626-34 LID - 10.1002/pds.2118 [doi] AB - PURPOSE: German hospital reimbursement modalities changed as a result of the introduction of Diagnosis Related Groups (DRG) in 2004. Therefore, no data on the direct costs of adverse drug reactions (ADRs) resulting in admissions to departments of internal medicine are available. The objective was to quantify the ADR-related economic burden (direct costs) of hospitalizations in internal medicine wards in Germany. METHODS: Record-based study analyzing the patient records of about 57,000 hospitalizations between 2006 and 2007 of the Net of Regional Pharmacovigilance Centers (Germany). All ADRs were evaluated by a team of experts in pharmacovigilance for severity, causality, and preventability. The calculation of accurate person-related costs for ADRs relied on the German DRG system (G-DRG 2009). Descriptive and bootstrap statistical methods were applied for data analysis. RESULTS: The incidence of hospitalization due to at least 'possible' serious outpatient ADRs was estimated to be approximately 3.25%. Mean age of the 1834 patients was 71.0 years (SD 14.7). Most frequent ADRs were gastrointestinal hemorrhage (n = 336) and drug-induced hypoglycemia (n = 270). Average inpatient length-of-stay was 9.3 days (SD 7.1). Average treatment costs of a single ADR were estimated to be approximately euro2250. The total costs sum to euro434 million per year for Germany. Considering the proportion of preventable cases (20.1%), this equals a saving potential of euro87 million per year. CONCLUSIONS: Preventing ADRs is advisable in order to realize significant nationwide savings potential. Our cost estimates provide a reliable benchmark as they were calculated based on an intensified ADR surveillance and an accurate person-related cost application. CI - Copyright (c) 2011 John Wiley & Sons, Ltd. FAU - Rottenkolber, Dominik AU - Rottenkolber D AD - Ludwig-Maximilians-Universitat Munchen, Institute of Health Economics and Health Care Management and Munich Center of Health Sciences, Munich, Germany. rottenkolber@bwl.lmu.de FAU - Schmiedl, Sven AU - Schmiedl S FAU - Rottenkolber, Marietta AU - Rottenkolber M FAU - Farker, Katrin AU - Farker K FAU - Salje, Karen AU - Salje K FAU - Mueller, Silke AU - Mueller S FAU - Hippius, Marion AU - Hippius M FAU - Thuermann, Petra A AU - Thuermann PA FAU - Hasford, Joerg AU - Hasford J CN - Net of Regional Pharmacovigilance Centers LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20110308 PL - England TA - Pharmacoepidemiol Drug Saf JT - Pharmacoepidemiology and drug safety JID - 9208369 SB - IM MH - Adolescent MH - Adult MH - Adverse Drug Reaction Reporting Systems/*statistics & numerical data MH - Aged MH - Aged, 80 and over MH - Costs and Cost Analysis MH - Data Interpretation, Statistical MH - Drug-Related Side Effects and Adverse Reactions/*economics MH - Female MH - Germany MH - Hospital Departments/economics MH - Hospitalization/*economics MH - Humans MH - Male MH - Middle Aged MH - Severity of Illness Index MH - Young Adult EDAT- 2011/03/09 06:00 MHDA- 2011/10/14 06:00 CRDT- 2011/03/09 06:00 PHST- 2010/06/25 00:00 [received] PHST- 2010/10/13 00:00 [revised] PHST- 2011/01/13 00:00 [accepted] PHST- 2011/03/09 06:00 [entrez] PHST- 2011/03/09 06:00 [pubmed] PHST- 2011/10/14 06:00 [medline] AID - 10.1002/pds.2118 [doi] PST - ppublish SO - Pharmacoepidemiol Drug Saf. 2011 Jun;20(6):626-34. doi: 10.1002/pds.2118. Epub 2011 Mar 8.