| Creating knowledge about adverse drug reactions: a critical analysis of the Danish reporting system from 1968 to 2005. | |
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MedLine Citation:
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PMID: 17566621 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Data on adverse drug reactions (ADRs) have been collected in Denmark since 1968 and the process is ongoing. This article explores knowledge created by the system, including how the collected data have been used to monitor the safety of licensed drugs. Nonaka's theory of knowledge creation was used to discriminate between tacit and explicit knowledge. A total of 56,802 ADR case reports were received from 1968 to 2005. The analysis shows a rather stable number of ADR cases from 1980, with about 2000 reports per year. The distribution of cases into serious and non-serious ADRs has been one to four throughout the period under study, but with large variations. Analysis of selected ADR cases shows that the system lacked the potential to capture available knowledge. Consequently the ADR reports have had limited value and significance in the process of creating scientific knowledge. Thus, the analysis questions the way available data can become explicit as a basis for regulatory decisions and whether all data can become knowledge, including who decides what knowledge is. |
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Authors:
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Lise Aagaard; Birthe Soendergaard; Elin Andersen; Jens Peter Kampmann; Ebba Holme Hansen |
Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't Date: 2007-06-12 |
Journal Detail:
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Title: Social science & medicine (1982) Volume: 65 ISSN: 0277-9536 ISO Abbreviation: Soc Sci Med Publication Date: 2007 Sep |
Date Detail:
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Created Date: 2007-08-20 Completed Date: 2007-12-06 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8303205 Medline TA: Soc Sci Med Country: England |
Other Details:
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Languages: eng Pagination: 1296-309 Citation Subset: IM |
Affiliation:
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Section of Social Pharmacy, Department of Pharmacology and Pharmacotherapy, Faculty of Pharmaceutical Sciences (Research Center for Quality in Medicine Use), The Danish Medicines Agency, Denmark. lia@dkma.dk |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adverse Drug Reaction Reporting Systems
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organization & administration,
trends* Denmark Drug Monitoring Humans Knowledge* |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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