Publication

The out-of-focus bias in drug surveillance

Journal Paper/Review - Aug 16, 2012

Units
PubMed
Doi

Citation
Gnädinger M, Mellinghoff H. The out-of-focus bias in drug surveillance. Eur J Clin Pharmacol 2012; 69:357-9.
Type
Journal Paper/Review (English)
Journal
Eur J Clin Pharmacol 2012; 69
Publication Date
Aug 16, 2012
Issn Electronic
1432-1041
Pages
357-9
Brief description/objective

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.