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Source: https://www.cidrap.umn.edu/news-pers...ial-resistance
Report calls for broader US effort against antimicrobial resistance
Filed Under:
Antimicrobial Stewardship
Chris Dall | News Reporter | CIDRAP News
| Oct 21, 2021
Addressing the challenge of antimicrobial resistance (AMR) and ensuring the continued effectiveness of the drugs that underpin modern medicine is going to require a broad effort that cuts across scientific disciplines, medical specialties, and government agencies, according to new report from the National Academies of Science, Engineering and Medicine (NASEM).
The congressionally mandated reported, produced by a committee of experts from across the human, animal, and environmental health sectors, concludes that AMR is a "complex web of related problems" that will require a One Health response that addresses misuse and overuse of antibiotics in human medicine and veterinary medicine and the little-understood role that the environment plays.
While ensuring a strong pipeline of new antibiotics is a key element of the effort to combat AMR, a multisectoral effort to preserve the effectiveness of current antibiotics through antibiotic stewardship, surveillance, diagnostic innovation, and infection prevention should be a cornerstone, the report says. And the US role in addressing AMR will have to extend beyond its borders.
"The evolutionary basis of antimicrobial resistance dictates that there will be no magic bullets or simple solutions," committee chair Guy Palmer, DVM, PhD, a professor of pathology and infectious diseases at Washington State University, wrote in the preface to the report. "Ensuring that modern medicine can continue to rely on effective antibiotics will require continual innovation and process improvement."
Stewardship and surveillance
The committee, which was tasked by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH) with studying the progress made against the 2014 National Strategy for Combating Antibiotic-Resistant Bacteria, uses the 333-page report to lay out the scope of the AMR problem. It also makes 14 recommendations for actions that government agencies can take to address the problem.
On the stewardship side, the committee notes that, while nearly 90% of US hospitals have comprehensive antibiotic stewardship programs, antibiotics are commonly overused in nursing homes, dialysis centers, and long-term acute care facilities, among other settings. To rectify this, the report recommends that the Centers for Medicare and Medicaid Services (CMS) require these settings to have stewardship programs, or at minimum have a process for regular review of all antibiotic prescriptions.
To promote better stewardship in veterinary medicine, which accounts for roughly two thirds of all medically important antibiotic use in the United States, the report calls on the Food and Drug Administration's (FDA's) Center for Veterinary Medicine to facilitate better tracking of antibiotic consumption in animals.
This has long been an issue; while the FDA currently tracks sales of antibiotics for use in animals, it doesn't have a way of tracking how those antibiotics are used.
One way to collect such data, the committee suggests, would be to promote the use of electronic prescriptions and encourage veterinarians to share prescribing data with the FDA. "This information would support the design and implementation of stewardship programs," the committee wrote.
To improve surveillance or resistant pathogens in humans and animals, the committee recommends that the National Library of Medicine (NLM) establish an open-source unified AMR database that would take in resistance data from hospitals, laboratories, and surveillance networks. The experts also call on the Environmental Protection Agency to provide funding for states to conduct testing for resistance genes at wastewater treatment plants, with the hope that such data would be fed into the NLM database.
Funding for new antibiotics, diagnostics
Addressing the need for new antibiotics and the economic challenges that have led most pharmaceutical companies to abandon antibiotic development, the committee explains why continued government investment, through a combination of push and pull incentives, will be needed to help fill the funding gap.
But the report notes that the package of financial incentives that are currently in place, including the 2012 Generating Antibiotic Incentives Now (GAIN) Act, have not produced the type of innovative antibiotics that are needed. For example, few of the 20 antibiotics approved by the FDA from 2014 through 2019 are meaningfully different from existing medicines, and only 6 of the 50 antibacterials in the development pipeline meet even one of the criteria for being innovative.
With antibiotic development advocates suggesting that government-funded market entry rewards of $500 million to $2 billion will be needed to spur development of innovative antibiotics, the committee says the federal government has to be able to determine that taxpayer money is funding truly innovative candidates that will have a clinical impact and address unmet needs. To that end, they suggest the Department of Health and Human Services (HHS) establish well-targeted, objective criteria to identify such novel antibiotics and support the trials that will establish the additional clinical benefit and optimal use of these drugs.
To ensure that new antibiotics are being used appropriately, the committee suggests that Congress make automated antibiotic susceptibility test makers eligible for tax incentives so they can bring new tests to market. They also call on the FDA to reduce the regulatory hurdles for such tests. And they recommend that HHS, the FDA, CMS, and the Centers for Disease Control and Prevention (CDC) work together to support outcomes research in diagnostic testing.
Beyond new antibiotics and diagnostics, the committee sees a potential role for vaccines and other therapeutics. It recommends that NIH and CDC provide additional funding to determine whether vaccination could be a tool to reduce antibiotic use and mitigate AMR. The committee also recommends development of a public-private partnership similar to ACTIV (Accelerating COVID-19 Therapeutics and Vaccines) to create a balanced and diversified portfolio of tools to address the AMR threat.
Global engagement
While the report focuses mainly on what actions US government agencies can take on a national level, it also acknowledges that, with antibiotic consumption and AMR rising most dramatically in low- and middle countries, the United States will have to expand its global engagement and coordinate with other countries to address the problem.
That could be achieved, the committee says, by bolstering international surveillance, antibiotic stewardship, and infection prevention and control efforts.
But the United States could play an even bigger role in addressing the global AMR threat, the report suggests. The committee envisions a program similar to The President's Emergency Plan for AIDS Relief (PEPFAR), which was established by President George W. Bush in 2003 to address the global HIV/AIDS epidemic.
"The ambitious global program envisioned in this recommendation will require coordination with an increasingly large group of stakeholders both in the United States and abroad," the committee wrote. "By supporting a truly systemic, One Health response, the recommended program may be able to drive progress on a range of health indicators, including, but not limited to, the burden of resistant infections."
Report calls for broader US effort against antimicrobial resistance
Filed Under:
Antimicrobial Stewardship
Chris Dall | News Reporter | CIDRAP News
| Oct 21, 2021
Addressing the challenge of antimicrobial resistance (AMR) and ensuring the continued effectiveness of the drugs that underpin modern medicine is going to require a broad effort that cuts across scientific disciplines, medical specialties, and government agencies, according to new report from the National Academies of Science, Engineering and Medicine (NASEM).
The congressionally mandated reported, produced by a committee of experts from across the human, animal, and environmental health sectors, concludes that AMR is a "complex web of related problems" that will require a One Health response that addresses misuse and overuse of antibiotics in human medicine and veterinary medicine and the little-understood role that the environment plays.
While ensuring a strong pipeline of new antibiotics is a key element of the effort to combat AMR, a multisectoral effort to preserve the effectiveness of current antibiotics through antibiotic stewardship, surveillance, diagnostic innovation, and infection prevention should be a cornerstone, the report says. And the US role in addressing AMR will have to extend beyond its borders.
"The evolutionary basis of antimicrobial resistance dictates that there will be no magic bullets or simple solutions," committee chair Guy Palmer, DVM, PhD, a professor of pathology and infectious diseases at Washington State University, wrote in the preface to the report. "Ensuring that modern medicine can continue to rely on effective antibiotics will require continual innovation and process improvement."
Stewardship and surveillance
The committee, which was tasked by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH) with studying the progress made against the 2014 National Strategy for Combating Antibiotic-Resistant Bacteria, uses the 333-page report to lay out the scope of the AMR problem. It also makes 14 recommendations for actions that government agencies can take to address the problem.
On the stewardship side, the committee notes that, while nearly 90% of US hospitals have comprehensive antibiotic stewardship programs, antibiotics are commonly overused in nursing homes, dialysis centers, and long-term acute care facilities, among other settings. To rectify this, the report recommends that the Centers for Medicare and Medicaid Services (CMS) require these settings to have stewardship programs, or at minimum have a process for regular review of all antibiotic prescriptions.
To promote better stewardship in veterinary medicine, which accounts for roughly two thirds of all medically important antibiotic use in the United States, the report calls on the Food and Drug Administration's (FDA's) Center for Veterinary Medicine to facilitate better tracking of antibiotic consumption in animals.
This has long been an issue; while the FDA currently tracks sales of antibiotics for use in animals, it doesn't have a way of tracking how those antibiotics are used.
One way to collect such data, the committee suggests, would be to promote the use of electronic prescriptions and encourage veterinarians to share prescribing data with the FDA. "This information would support the design and implementation of stewardship programs," the committee wrote.
To improve surveillance or resistant pathogens in humans and animals, the committee recommends that the National Library of Medicine (NLM) establish an open-source unified AMR database that would take in resistance data from hospitals, laboratories, and surveillance networks. The experts also call on the Environmental Protection Agency to provide funding for states to conduct testing for resistance genes at wastewater treatment plants, with the hope that such data would be fed into the NLM database.
Funding for new antibiotics, diagnostics
Addressing the need for new antibiotics and the economic challenges that have led most pharmaceutical companies to abandon antibiotic development, the committee explains why continued government investment, through a combination of push and pull incentives, will be needed to help fill the funding gap.
But the report notes that the package of financial incentives that are currently in place, including the 2012 Generating Antibiotic Incentives Now (GAIN) Act, have not produced the type of innovative antibiotics that are needed. For example, few of the 20 antibiotics approved by the FDA from 2014 through 2019 are meaningfully different from existing medicines, and only 6 of the 50 antibacterials in the development pipeline meet even one of the criteria for being innovative.
With antibiotic development advocates suggesting that government-funded market entry rewards of $500 million to $2 billion will be needed to spur development of innovative antibiotics, the committee says the federal government has to be able to determine that taxpayer money is funding truly innovative candidates that will have a clinical impact and address unmet needs. To that end, they suggest the Department of Health and Human Services (HHS) establish well-targeted, objective criteria to identify such novel antibiotics and support the trials that will establish the additional clinical benefit and optimal use of these drugs.
To ensure that new antibiotics are being used appropriately, the committee suggests that Congress make automated antibiotic susceptibility test makers eligible for tax incentives so they can bring new tests to market. They also call on the FDA to reduce the regulatory hurdles for such tests. And they recommend that HHS, the FDA, CMS, and the Centers for Disease Control and Prevention (CDC) work together to support outcomes research in diagnostic testing.
Beyond new antibiotics and diagnostics, the committee sees a potential role for vaccines and other therapeutics. It recommends that NIH and CDC provide additional funding to determine whether vaccination could be a tool to reduce antibiotic use and mitigate AMR. The committee also recommends development of a public-private partnership similar to ACTIV (Accelerating COVID-19 Therapeutics and Vaccines) to create a balanced and diversified portfolio of tools to address the AMR threat.
Global engagement
While the report focuses mainly on what actions US government agencies can take on a national level, it also acknowledges that, with antibiotic consumption and AMR rising most dramatically in low- and middle countries, the United States will have to expand its global engagement and coordinate with other countries to address the problem.
That could be achieved, the committee says, by bolstering international surveillance, antibiotic stewardship, and infection prevention and control efforts.
But the United States could play an even bigger role in addressing the global AMR threat, the report suggests. The committee envisions a program similar to The President's Emergency Plan for AIDS Relief (PEPFAR), which was established by President George W. Bush in 2003 to address the global HIV/AIDS epidemic.
"The ambitious global program envisioned in this recommendation will require coordination with an increasingly large group of stakeholders both in the United States and abroad," the committee wrote. "By supporting a truly systemic, One Health response, the recommended program may be able to drive progress on a range of health indicators, including, but not limited to, the burden of resistant infections."