E-DRUG: Medicine production can contribute to AMR
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Medicine production can directly contribute to the development of antimicrobial resistance (AMR)
Dear E-druggers,
Since how many years are we discussing rational uses of medicines (RUM) and AMR?
We all know the key elements causing AMR: Overconsumption of antibiotics in human and veterinary use / lacking of effective hygiene in health facilities, households and wherever / irrational prescribing and improper use (e.g., underdosing or not ending the full course of treatment) / weak or ineffective diagnostic management together with a lack of advanced technologies/ substandard production quality of antibiotics / lacking of KNOWLEDGE and, yes, not seldom no WILLINGNESS to change the situation (because the sale of medicines increases the profit of pharmaceutical companies and other stakeholders why is there a need to change?).
WHO launched an AMR strategy 2016/2017, the upcoming WHA will discuss the results next week.
But these days another reason causing AMR has to be added: The production of antibiotics in countries such as India or China itself!!! A scientific study proved a very serious situation caused by improper wastewater management of pharmaceutical companies in Hyderabad/ India: Multi-resistant pathogens producing carbapenemases where found especially at places in the environment with high concentration of antibiotics and antifungal agents. Laws exist (like everywhere) but not well controlled (like at many places). Systems to clean and handle wastewater are in place, but they are often inadequate or not effective because of using old and dysfunctional technology.
Families living around these places are in danger; and people traveling may contribute to carry these extreme dangerous pathogens around the world.
This situation might be similar in other places of pharmaceutical production in Asia and emerging countries on other continents.
Its easy now to blame the company managers or the weak and intransparent control systems in India, African countries, probably China. But from my point of view this would be not the full picture. Lots of medicines used in Europe are produced in India or Asia, almost all APIs are from these regions, and quite some of the big Multi-Pharma-Companies are partnering with Asian companies in R&D issues. And we know that most of the medicine used in African countries are from Asia, almost all GFTAM and PEPFAR funded ARVs used in the ACT projects are from India etc. etc.
Therefore two questions:
1) How many teams of experts are auditing these companies regularly and do focus on production halls, laboratories and the quality of finished tablets only?
Here definitely the question of waste-water-management needs to be added to the audit forms immediately (and dont ask for reports, look around the company, take water samples like you take tabs for own quality analyses
).
2) One might argue that effective environmental standards would increase the price of the product.
Two answers from my side:
a) Environmental standards are not questionable and should NEVER be part of any negotiation because this is affecting health and life of human beings and the nature itself.
b) I would argue that one will not be able to identify a pharmaceutical company that would suffer because of the investment needed for safe basic environmental standards all these branches are still in the highest rates of revenue, up to 20%.
And I assume that World Bank or other sources could be asked for support.
Regards,
Albert Petersen
Head of Department of Pharmaceutical Development Cooperation
DIFAM - German Institute for Medical Mission
Mohlstraße 26
D-72074 Tuebingen
P.O.Box 1307, 72003 Tuebingen, Germany
Tel: +49/7071 704 90 13
Fax +49/7071 704 90 37
E-Mail: petersen.amh@difaem.de
www.difaem.de
www.facebook.de/difaem
www.twitter.com/difaemtuebingen
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Environmental pollution with antimicrobial agents from bulk drug manufacturing industries in Hyderabad, South India, is associated with dissemination of extended-spectrum beta-lactamase and carbapenemase-producing pathogens
Abstract
Purpose
High antibiotic and antifungal concentrations in wastewater from anti-infective drug production may exert selection pressure for multidrug-resistant (MDR) pathogens. We investigated the environmental presence of active pharmaceutical ingredients and their association with MDR Gram-negative bacteria in Hyderabad, South India, a major production area for the global bulk drug market.
Methods
From Nov 19 to 28, 2016, water samples were collected from the direct environment of bulk drug manufacturing facilities, the vicinity of two sewage treatment plants, the Musi River, and habitats in Hyderabad and nearby villages. Samples were analysed for 25 anti-infective pharmaceuticals with liquid chromatographytandem mass spectrometry and for MDR Gram-negative bacteria using chromogenic culture media. In addition, specimens were screened with PCR for blaVIM, blaKPC, blaNDM, blaIMP-1, and blaOXA-48 resistance genes.
Results
All environmental specimens from 28 different sampling sites were contaminated with antimicrobials. High concentrations of moxifloxacin, voriconazole, and fluconazole (up to 694.1, 2500, and 236,950 µg/L, respectively) as well as increased concentrations of eight other antibiotics were found in sewers in the PatancheruBollaram industrial area. Corresponding microbiological analyses revealed an extensive presence of extended-spectrum beta-lactamase and carbapenemase-producing Enterobacteriaceae and non-fermenters (carrying mainly blaOXA-48, blaNDM, and blaKPC) in more than 95% of the samples.
Conclusions
Insufficient wastewater management by bulk drug manufacturing facilities leads to unprecedented contamination of water resources with antimicrobial pharmaceuticals, which seems to be associated with the selection and dissemination of carbapenemase-producing pathogens. The development and global spread of antimicrobial resistance present a major challenge for pharmaceutical producers and regulatory agencies.
Link to the full study (for 6 months accessible free of charge):
Link to the documentation presented by the German Television 8th of Mai (in German language with subtitles in English):
http://www.ardmediathek.de/tv/Reportage-Dokumentation/The-invisible-enemy-deadly-superbugs-f/Das-Erste/Video?bcastId=799280&documentId=42690832
Link to The Times article released 6th of May 2017:
For further information you may contact Dr Lübbert:
Christoph Lübbert, M.D., Ph.D., D.T.M.&H.
Division of Infectious Diseases and Tropical Medicine & Interdisciplinary Center for Infectious Diseases
Department of Gastroenterology and Rheumatology,
Leipzig University Hospital
Liebigstr. 20
D-04103 Leipzig, Germany