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In the U.S., the sheer number of antibiotics prescribed indicates that a lot of work must be done to reduce the use of these medications.12 An analysis of the IMS Health Midas database, which estimates antibiotic consumption based on the volume of antibiotics sold in retail and hospital pharmacies, indicated that in 2010, 22.0 standard units (a unit equaling one dose, i.e., one pill, capsule, or ampoule) of antibiotics were prescribed per person in the U.S.17 The number of antibiotic prescriptions varies by state, with the most written in states running from the Great Lakes down to the Gulf Coast, whereas the West Coast has the lowest use (Figure 2).5,12 In some states, the number of prescribed courses of treatment with antibiotics per year exceed the population, amounting to more than one treatment per person per year.12
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The frequency with which doctors prescribe antibiotics varies greatly from state to state. The reasons for this variation are being studied and might suggest areas where improvements in antibiotic prescribing (fewer unnecessary prescriptions) would be most helpful.
The antibiotics used in livestock are ingested by humans when they consume food.1 The transfer of resistant bacteria to humans by farm animals was first noted more than 35 years ago, when high rates of antibiotic resistance were found in the intestinal flora of both farm animals and farmers.14 More recently, molecular detection methods have demonstrated that resistant bacteria in farm animals reach consumers through meat products.14 This occurs through the following sequence of events: 1) antibiotic use in food-producing animals kills or suppresses susceptible bacteria, allowing antibiotic-resistant bacteria to thrive; 2) resistant bacteria are transmitted to humans through the food supply; 3) these bacteria can cause infections in humans that may lead to adverse health consequences.5
The agricultural use of antibiotics also affects the environmental microbiome.5,14 Up to 90% of the antibiotics given to livestock are excreted in urine and stool, then widely dispersed through fertilizer, groundwater, and surface runoff.5,14 In addition, tetracyclines and streptomycin are sprayed on fruit trees to act as pesticides in the western and southern U.S.1 While this application accounts for a much smaller proportion of overall antibiotic use, the resultant geographical spread can be considerable.1 This practice also contributes to the exposure of microorganisms in the environment to growth-inhibiting agents, altering the environmental ecology by increasing the proportion of resistant versus susceptible microorganisms.1
The number of new antibiotics developed and approved has decreased steadily over the past three decades (although four new drugs were approved in 2014), leaving fewer options to treat resistant bacteria.
Another factor that causes antibiotic development to lack economic appeal is the relatively low cost of antibiotics. Newer antibiotics are generally priced at a maximum of $1,000 to $3,000 per course compared with cancer chemotherapy that costs tens of thousands of dollars.2,3,13,14 The availability, ease of use, and generally low cost of antibiotics has also led to a perception of low value among payers and the public.13
Changes in standards for clinical trial design made by the U.S. Food and Drug Administration (FDA) during the past two decades have made antibiotic clinical trials particularly challenging.3 Studies comparing antibiotics with placebo are considered to be unethical; therefore, trials are designed to demonstrate noninferiority of new agents compared to existing drugs, within a varying statistical margin.3 This requires a large sample population and consequently high costs, making the development of antibiotics uneconomical and unattractive.3,13 While small companies have stepped in to fill the gap in antibiotic discovery and development formerly occupied by large pharmaceutical companies, the complexity and high cost of phase 3 clinical trials can exceed the financial means of these companies.13 However, in December 2014, Merck acquired the small antibiotic research company Cubist Pharmaceuticals, which is expected to accelerate the study and regulatory approval of new antibiotic agents in the future.19
\nThe list highlights in particular the threat of gram-negative bacteria that are resistant to multiple antibiotics. These bacteria have built-in abilities to find new ways to resist treatment and can pass along genetic material that allows other bacteria to become drug-resistant as well.
\n\"This list is a new tool to ensure R&D responds to urgent public health needs,\" says Dr Marie-Paule Kieny, WHO's Assistant Director-General for Health Systems and Innovation. \"Antibiotic resistance is growing, and we are fast running out of treatment options. If we leave it to market forces alone, the new antibiotics we most urgently need are not going to be developed in time.\"
\nThe list is intended to spur governments to put in place policies that incentivize basic science and advanced R&D by both publicly funded agencies and the private sector investing in new antibiotic discovery. It will provide guidance to new R&D initiatives such as the WHO/Drugs for Neglected Diseases initiative (DNDi) Global Antibiotic R&D Partnership that is engaging in not-for-profit development of new antibiotics.
\nThe list was developed in collaboration with the Division of Infectious Diseases at the University of Tübingen, Germany, using a multi-criteria decision analysis technique vetted by a group of international experts. The criteria for selecting pathogens on the list were: how deadly the infections they cause are; whether their treatment requires long hospital stays; how frequently they are resistant to existing antibiotics when people in communities catch them; how easily they spread between animals, from animals to humans, and from person to person; whether they can be prevented (e.g. through good hygiene and vaccination); how many treatment options remain; and whether new antibiotics to treat them are already in the R&D pipeline.
\n\"New antibiotics targeting this priority list of pathogens will help to reduce deaths due to resistant infections around the world,\" says Prof Evelina Tacconelli, Head of the Division of Infectious Diseases at the University of Tübingen and a major contributor to the development of the list. \"Waiting any longer will cause further public health problems and dramatically impact on patient care.\"
\nWhile more R&D is vital, alone, it cannot solve the problem. To address resistance, there must also be better prevention of infections and appropriate use of existing antibiotics in humans and animals, as well as rational use of any new antibiotics that are developed in future.
The list highlights in particular the threat of gram-negative bacteria that are resistant to multiple antibiotics. These bacteria have built-in abilities to find new ways to resist treatment and can pass along genetic material that allows other bacteria to become drug-resistant as well.
"This list is a new tool to ensure R&D responds to urgent public health needs," says Dr Marie-Paule Kieny, WHO's Assistant Director-General for Health Systems and Innovation. "Antibiotic resistance is growing, and we are fast running out of treatment options. If we leave it to market forces alone, the new antibiotics we most urgently need are not going to be developed in time."
The list is intended to spur governments to put in place policies that incentivize basic science and advanced R&D by both publicly funded agencies and the private sector investing in new antibiotic discovery. It will provide guidance to new R&D initiatives such as the WHO/Drugs for Neglected Diseases initiative (DNDi) Global Antibiotic R&D Partnership that is engaging in not-for-profit development of new antibiotics.
The list was developed in collaboration with the Division of Infectious Diseases at the University of Tübingen, Germany, using a multi-criteria decision analysis technique vetted by a group of international experts. The criteria for selecting pathogens on the list were: how deadly the infections they cause are; whether their treatment requires long hospital stays; how frequently they are resistant to existing antibiotics when people in communities catch them; how easily they spread between animals, from animals to humans, and from person to person; whether they can be prevented (e.g. through good hygiene and vaccination); how many treatment options remain; and whether new antibiotics to treat them are already in the R&D pipeline.
"New antibiotics targeting this priority list of pathogens will help to reduce deaths due to resistant infections around the world," says Prof Evelina Tacconelli, Head of the Division of Infectious Diseases at the University of Tübingen and a major contributor to the development of the list. "Waiting any longer will cause further public health problems and dramatically impact on patient care."
While more R&D is vital, alone, it cannot solve the problem. To address resistance, there must also be better prevention of infections and appropriate use of existing antibiotics in humans and animals, as well as rational use of any new antibiotics that are developed in future.
PublicationGlobal priority list of antibiotic-resistant bacteria to guide research, discovery, and development of new antibiotics
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Infection remains a significant problem for the management of patients in the intensive care unit (ICU). In the United States, more than 26% of nosocomial infections, as well as 20 to 40% of bacteremia and 25% of pneumonia acquired within the hospital occur in ICU patients [1, 2]. Such infections are in part a result of advances in medical technology: invasive diagnostic and therapeutic procedures, alteration of host immune responses, overuse of antimicrobial agents. Appropriate use of antibiotics could reduce the morbidity and mortality in the ICU, as well as the high cost of hospital acquired infections. 041b061a72