The Antimicrobial Resistance Regulatory Strategy

Master's Thesis from the year 2017 in the subject Medicine - Pharmacology, grade: 70, University of Hertfordshire, language: English, abstract: Some years after the first use of penicillin, resistant bacteria emerged. The phenomenon of resistance has continued to show up similarly for almost every marketed antibiotic product, endangering the safety of humans, animals and the environment. This major threat has been proven to have a worldwide impact. In response, national action plans must be implemented following "anti-resistance" guidance: WHO’s Global Action Plan on Antimicrobial Resistance (GAP-AMR) in collaboration with FAO and OIE. These plans are to be adopted by 2017, aiding the protection of antibiotic medicines adhering to the approach of One Health. The aim of the current study was to review the process of such adoptions in the EU and US, understand its practicality, challenges and any out of scope issues.With the use of a phenomenological approach, this qualitative study found that thanks to the general population’s increment in knowledge and awareness, collaboration and engagement grew stronger, especially among policy makers and pharmaceutical companies, but also healthcare leaders and providers, physicians and veterinarians, and patients. When trying to discover new antibiotic drugs, serendipity is not an option, therefore, companies must be incentivised to increase their antibiotic pipelines. During the analysis of the inclusion of the plans, a paradox appeared: due to the reduced use of antibiotics, it is difficult to motivate drug developers to increase research in new medicines and alternative forms of treatment. The research concluded, that legislation must be focused on supporting changes that will ease entry of antibiotics to the market (i.e. with a congruent regulatory pathway and/or with financial support of governments) to allow a practical inclusion of the national plans.

The resistance topic is timely given current events. The emergence of mysterious new diseases, such as SARS, and the looming threat of bioterrorist attacks remind us of how vulnerable we can be to infectious agents. With advances in medical technologies, we have tamed many former microbial foes, yet with few new antimicrobial agents and vaccines in the pipeline, and rapidly increasing drug resistance among infectious microbes, we teeter on the brink of loosing the upperhand in our ongoing struggle against these foes, old and new. The Resistance Phenomenon in Microbes and Infectious Disease Vectors examines our understanding of the relationships among microbes, disease vectors, and human hosts, and explores possible new strategies for meeting the challenge of resistance.

This Open Access volume provides in-depth analysis of the wide range of ethical issues associated with drug-resistant infectious diseases. Antimicrobial resistance (AMR) is widely recognized to be one of the greatest threats to global public health in coming decades; and it has thus become a major topic of discussion among leading bioethicists and scholars from related disciplines including economics, epidemiology, law, and political theory. Topics covered in this volume include responsible use of antimicrobials; control of multi-resistant hospital-acquired infections; privacy and data collection; antibiotic use in childhood and at the end of life; agricultural and veterinary sources of resistance; resistant HIV, tuberculosis, and malaria; mandatory treatment; and trade-offs between current and future generations. As the first book focused on ethical issues associated with drug resistance, it makes a timely contribution to debates regarding practice and policy that are of crucial importance to global public health in the 21st century.

Avoiding infection has always been expensive. Some human populations escaped tropical infections by migrating into cold climates but then had to procure fuel, warm clothing, durable housing, and crops from a short growing season. Waterborne infections were averted by owning your own well or supporting a community reservoir. Everyone got vaccines in rich countries, while people in others got them later if at all. Antimicrobial agents seemed at first to be an exception. They did not need to be delivered through a cold chain and to everyone, as vaccines did. They had to be given only to infected patients and often then as relatively cheap injectables or pills off a shelf for only a few days to get astonishing cures. Antimicrobials not only were better than most other innovations but also reached more of the world’s people sooner. The problem appeared later. After each new antimicrobial became widely used, genes expressing resistance to it began to emerge and spread through bacterial populations. Patients infected with bacteria expressing such resistance genes then failed treatment and remained infected or died. Growing resistance to antimicrobial agents began to take away more and more of the cures that the agents had brought.

Tackling the realities of the antimicrobial resistance (AMR) situation today is no longer uncommon. Many battles have been fought in the past since the discovery of antibiotics between man and microbes. In the tussle of new antibiotic modifications, the transmission of resistant genes, both vertically and horizontally unveils yet another resistant attribute for the microbe, for it only to be faced with a more powerful, wide spectrum antibiotic; the cycle continues-and the winner is yet to be known. This book aims to provide some insight into various molecular mechanisms, agricultural mitigation methods, and the One Health applications to maybe, just maybe, tip the scales towards us.

"In May 2015, the Sixty-eighth World Health Assembly adopted the Global action plan on antimicrobial resistance, which reflects the global consensus that AMR poses a profound threat to human health. One of the five strategic objectives of the Global action plan is to strengthen the evidence base through enhanced global surveillance and research. The Global Antimicrobial Resistance Surveillance System (GLASS) has been developed to facilitate and encourage a standardized approach to AMR surveillance globally and in turn support the implementation of the Global action plan on antimicrobial resistance. This manual addresses the early phase of implementation of GLASS, focussing on surveillance of resistance in common human bacterial pathogens. The intended readership of this publication is public health professionals and health authorities responsible for national AMR surveillance. It outlines the GLASS standards and describes the road map for implementation of the system between 2015 and 2019. Further development of GLASS will be based on the lessons learnt during this period"--Publisher's description.

When Antibiotics Fail examines the current impacts of AMR on our healthcare system, projects the future impact on Canada’s GDP, and looks at how widespread resistance will influence the day-to-day lives of Canadians. The report examines these issues through a One Health lens, recognizing the interconnected nature of AMR, from healthcare settings to the environment to the agriculture sector. It is the most comprehensive report to date on the economic impact of AMR in Canada.

Globalization of the food supply has created conditions favorable for the emergence, reemergence, and spread of food-borne pathogens-compounding the challenge of anticipating, detecting, and effectively responding to food-borne threats to health. In the United States, food-borne agents affect 1 out of 6 individuals and cause approximately 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths each year. This figure likely represents just the tip of the iceberg, because it fails to account for the broad array of food-borne illnesses or for their wide-ranging repercussions for consumers, government, and the food industry-both domestically and internationally. A One Health approach to food safety may hold the promise of harnessing and integrating the expertise and resources from across the spectrum of multiple health domains including the human and veterinary medical and plant pathology communities with those of the wildlife and aquatic health and ecology communities. The IOM's Forum on Microbial Threats hosted a public workshop on December 13 and 14, 2011 that examined issues critical to the protection of the nation's food supply. The workshop explored existing knowledge and unanswered questions on the nature and extent of food-borne threats to health. Participants discussed the globalization of the U.S. food supply and the burden of illness associated with foodborne threats to health; considered the spectrum of food-borne threats as well as illustrative case studies; reviewed existing research, policies, and practices to prevent and mitigate foodborne threats; and, identified opportunities to reduce future threats to the nation's food supply through the use of a "One Health" approach to food safety. Improving Food Safety Through a One Health Approach: Workshop Summary covers the events of the workshop and explains the recommendations for future related workshops.