European Journal of Clinical Pharmacology

, Volume 69, Issue 3, pp 357–359 | Cite as

The out-of-focus bias in drug surveillance

Special Article

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.

Keywords

ADRs Drug surveillance Phase II studies Phase III studies Adverse drug reactions 

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Copyright information

© Springer-Verlag 2012

Authors and Affiliations

  1. 1.Department of General PracticeUniversity Hospital ZurichZurichSwitzerland
  2. 2.Department of EndocrinologyDiabetology and Osteology, Internal MedicineSt. GallenSwitzerland

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