Artikel
Preventability of adverse drug reactions leading to hospital admission – assessment of inter-rater variability within the Network of Regional Pharmacovigilance Centers
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Autoren
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S. Schmiedl
- Pharmacovigilance Center Wuppertal, Philipp-Klee Institute of Clinical Pharmacology, HELIOS Clinic Wuppertal, University Witten/Herdecke, Germany
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J. Szymanski
- Pharmacovigilance Center Wuppertal, Philipp-Klee Institute of Clinical Pharmacology, HELIOS Clinic Wuppertal, University Witten/Herdecke, Germany
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M. Rottenkolber
- Pharmacovigilancecenter for Methodology Research and Datamanagement, Institute of Medical Informatics, Biometry and Epidemiology, Ludwig-Maximilians-University Muenchen, Munich, Germany
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B. Drewelow
- Regional Pharmacovigilance Center Rostock, Institute of Clinical Pharmacology, University of Rostock, Germany
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K. May
- Regional Pharmacovigilance Center Greifswald, Institute of Clinical Pharmacology, University of Greifswald, Germany
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M. Hippius
- Regional Pharmacovigilance Center Jena, Institute of Pharmacology and Toxicology, Department of Clinical Pharmacology, University of Jena, Germany
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K. Farker
- Regional Pharmacovigilance Center Weimar, Institute of Pharmacology and Toxicology, Department of Clinical Pharmacology, University of Jena, Germany
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J. Hasford
- Pharmacovigilancecenter for Methodology Research and Datamanagement, Institute of Medical Informatics, Biometry and Epidemiology, Ludwig-Maximilians-University Muenchen, Munich, Germany
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P. A. Thürmann
- Pharmacovigilance Center Wuppertal, Philipp-Klee Institute of Clinical Pharmacology, HELIOS Clinic Wuppertal, University Witten/Herdecke, Germany
| Veröffentlicht: | 5. November 2009 |
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Gliederung
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Background and aim: Preventability of adverse drug reactions (ADRs) is a matter of public concern and usually evaluated using pre-defined questions and algorithms. Assessment of preventability of ADRs is characterised by a significant inter-rater variability (IRV). Within the German Network of Regional Pharmacovigilance Centers (NRPC), ADRs leading to hospitalisation are collected in 4 hospitals (i.e. regional centers [RC]) and quality assurance (QA) is performed independently [Schneeweiss et al., 2002]. Preventability of ADRs is assessed by RC and QA using a questionnaire containing 8 items. In this pilot study we aimed to quantify IRV between RC’s and QA’s preventability assessments.
Material and method: Out of all cases documented in 2008 and 2009, 100 ADRs were randomly chosen. Concordance and IRV were analysed for ADRs assessed as ‘probable’ or ‘definite’ by the QA. Since there are 3 potential answers (‘yes’, ’no’, ‘not known’) for each statement, a 3x3 table was used for evaluating IRV. The degree of agreement was analysed using the chance-corrected index delta taking into account the unbalance of the two marginal totals [Martin Andres et al., 2005].
Results: Out of 100 ADRs, 80 cases were assessed as at least ‘probable’ ADRs and included in the final analysis. Best agreement (95.0%, delta=0.86) was observed for the item „contraindications, warnings and precautions considered concerning over the counter drugs“. Lowest agreements were found for „consideration of required dose adjustments“ (68.8%, delta=0.49) and „prevention strategies“ (71.3%, delta=0.03). In 36 cases (45%), all items were assessed in complete concordance by either RC and QA.
Conclusions: In a sample of ADRs leading to hospitalisation, we observed good consensus in assessing preventability by the NRPC. Based on further analyses, we will develop an algorithm for assessing the overall preventability taking into account the complex benefit-risk-ratio of pharmacotherapy particularly in multimorbid elderly patients with increased ADR risk.
Acknowledgements: (supported by BfArM Project No.: Fo 2.1-68502-201).
