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The out-of-focus bias in drug surveillance


Gnädinger, Markus; Mellinghoff, Hans-Ulrich (2013). The out-of-focus bias in drug surveillance. European Journal of Clinical Pharmacology, 69(3):357-359.

Abstract

PURPOSE: Existing drug safety systems with phase II and III studies and post-marketing surveillance by principle do not allow for the recognition of an important class of adverse drug reactions (ADRs). ADRs that are resistant to being detected reliably may a) appear as if they are age-related chronic diseases, which also manifest themselves in a high degree without drug treatment, b) arise in "old" drugs, c) arise during long-term application, and d) arise with the administration to frail and aged populations. CONCLUSIONS: "Silent" and multi-factorial health problems evolving from long-term drug treatment must therefore be addressed with a systematic search strategy, as a third track along with the phase II and III studies and spontaneous reporting systems which still exist.

Abstract

PURPOSE: Existing drug safety systems with phase II and III studies and post-marketing surveillance by principle do not allow for the recognition of an important class of adverse drug reactions (ADRs). ADRs that are resistant to being detected reliably may a) appear as if they are age-related chronic diseases, which also manifest themselves in a high degree without drug treatment, b) arise in "old" drugs, c) arise during long-term application, and d) arise with the administration to frail and aged populations. CONCLUSIONS: "Silent" and multi-factorial health problems evolving from long-term drug treatment must therefore be addressed with a systematic search strategy, as a third track along with the phase II and III studies and spontaneous reporting systems which still exist.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Institute of General Practice
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2013
Deposited On:25 Mar 2013 09:50
Last Modified:09 Dec 2017 11:58
Publisher:Springer
ISSN:0031-6970
Additional Information:The original publication is available at www.springerlink.com
Publisher DOI:https://doi.org/10.1007/s00228-012-1371-x
PubMed ID:22895799

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