Non-equivalence of antibiotic generic drugs and risk for intensive care patients

  • Background: The underlying axiom in applying generic drugs is the equivalence of their active ingredient with the (usually more expensive) innovator product, an all-embracing statement with the insidious result that physicians assume that the generic products have been subjected to the same rigorous testing regimens as the brand-name products. The present paper presents novel experimental data on an investigator-blinded comparison between the innovator imipenem antibiotic, and a number of its generics. Methods: Particulate matter contamination of each group was visualized by means of a membrane filter method. Functional studies in an animal model–the dorsal skinfold chamber technique in mice-designed to simulate the state of microcirculatory dysfunction in intensive care patients was performed, in order to assess the influence of the particulate matter of each group on the functional capillary density of the striated skin muscle, after their intravenous injection. Results: The results showed massive particulate contamination of the generics, in a size range relevant for impacting the microcirculation. The particulate contamination contributed in some generic groups to a significant shutdown of tissue perfusion. Conclusion: The presented data underscore the need to raise the regulatory barriers for the entry of generics to the market, well beyond the simplistic proof of “bioequivalence”, which in no measure deals with the essential questions of quality and patient safety. If generics are used, they should be tested by a filter technique and optical microscopy, to ensure the absence especially of small particulate contaminants and their purity.
Author:Charles James Kirkpatrick, Ramzan Rangoonwala, Mykhaylo Reshetnykov, Mike Barbeck, Shahram GhanaatiORCiDGND
Parent Title (English):Pharmaceutical Regulatory Affairs
Publisher:OMICS Publishing Group
Place of publication:Sunnyvale, Calif.
Document Type:Article
Date of Publication (online):2013/05/20
Date of first Publication:2013/05/20
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2013/10/01
Tag:Antibiotic generic drugs; Generic drugs
Issue:1 1000109
Page Number:7
First Page:1
Last Page:7
Copyright: © 2013 Kirkpatrick CJ, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Licence (German):License LogoCreative Commons - Namensnennung 3.0