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ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
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Research Article

Non-Equivalence of Antibiotic Generic Drugs and Risk for Intensive Care Patients

James Kirkpatrick C1*, Ramzan Rangoonwala1, Michael Reshetnykov1, Mike Barbeck1 and Shahram Ghanaati1,2

1Institute of Pathology, University Medical Center of the Johannes Gutenberg University, Mainz, Germany

2Clinic for Maxillofacial and Plastic Surgery, Johann Wolfgang Goethe University, Frankfurt/Main, Germany

Corresponding Author:
James Kirkpatrick C
Institute of Pathology, University Medical Center of the Johannes Gutenberg University Langenbeckstrasse 1, D-55101 Mainz, Germany
E-mail: [email protected]

Received May 04, 2013; Accepted May 15, 2013; Published May 20, 2013

Citation: James Kirkpatrick C, Rangoonwala R, Reshetnykov M, Barbeck M, Ghanaati S (2013) Non-Equivalence of Antibiotic Generic Drugs and Risk for Intensive Care Patients. Pharmaceut Reg Affairs 2:109. doi: 10.4172/2167-7689.1000109

Copyright: © 2013 James Kirkpatrick C, 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.

Abstract

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.

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