Health Policy Brief on Antibiotic Resistance

June 23, 2015
Antibiotic ResistanceRead the full brief at HealthAffairs.org

"According to the Centers for Disease Control and Prevention (CDC), at least two million illnesses and 23,000 deaths are caused by antibiotic-resistant bacteria in the United States alone. In 2013 there were about 480,000 new global cases of multidrug-resistant tuberculosis. According to the World Health Organization (WHO), gonorrhea may soon become untreatable as more than ten countries have reported strains that are resistant to all currently available forms of antibiotic treatment, and no new drugs have been approved. If trends persist and resistance continues to rise, some reports estimate that by 2050 there will be ten million antimicrobial resistance-related deaths worldwide, costing the world up to US$100 trillion.

To some degree, antibiotic resistance is unavoidable. The development of resistance is an evolutionary inevitability, even where antimicrobials are used properly and sparingly. All microbes have the potential to mutate and render drugs ineffective. Once a few have mutated, they spread when antibiotics wipe out the susceptible bacteria, leaving a niche for the resistant ones to occupy.

Antibiotic-resistant infections typically occur in health care-related settings, such as hospitals and nursing homes, where infections can spread quickly between patients with compromised immune systems. Patients who use certain medical devices, such as ventilators and catheters, are at a higher risk for infection, according to the CDC.

Overuse and Misuse

The more antibiotics are used, the more opportunities bacteria have to evolve to defeat them. The overuse of antibiotics--the CDC estimates that up to 50 percent of antibiotics are unnecessary or inappropriate as prescribed--in medicine and agriculture has led to a slew of so-called superbugs.

The potential impact of widespread antibiotic resistance is far reaching within the health care system. When first-line and then second-line antibiotic treatment options are limited by resistance or are unavailable, health care providers are forced to use antibiotics that may be less effective and more toxic and that may require resources such as longer hospital stays--driving up both morbidity rates and health care costs.

Without new therapies to treat or prevent infections, lifesaving procedures such as organ transplants, chemotherapy, dialysis, and caesarian sections will become more dangerous; and non-lifesaving surgeries, such as hip operations, that allow people to live active lives for longer and may enable them to stay in the workforce could theoretically become too risky to undertake at all.

One issue that makes antibiotic resistance difficult to combat is that drug-resistant microbes are everywhere. According to the WHO, in all regions of the world there are high proportions of antibiotic resistance in bacteria that cause common infections in the urinary tract, lungs, and bloodstream; and a high percentage of hospital-acquired infections are caused by highly resistant or multidrug-resistant bacteria. In fact, most deaths related to antibiotic resistance are attributable to infections acquired in health care settings such as hospitals and nursing homes.

Another frequently cited factor in the emergence of multidrug-resistant strains of bacteria is the misuse of antibiotics. For example when patients fail to complete their drug regimens at home, they may allow some bacteria to survive the treatment and develop resistance in the process. In other circumstances, antibiotics may be prescribed when they are not medically necessary. This can allow otherwise harmless bacteria to develop resistance, which may then be transferred to other more dangerous bacteria.

Agricultural Use

While these practices may contribute to the spread of resistant microbes, human consumption only makes up about 20 percent of antibiotic sales in the United States. The vast majority of antibiotics is used agriculturally in beef, poultry, pork, and fish farms to prevent infection and promote growth among the animals.

While it is unclear whether the larger volume of antibiotics used in agriculture compared to hospitals translates to a greater contribution to the emergence of multidrug-resistant strains of bacteria, the use of the drugs in food production has garnered a significant amount of attention in media and policy spheres.

According to an investigative report by the news outlet Reuters, antibiotics are given as standard practice during most of the life of chickens, not just when the birds are sick. In every instance of antibiotic use identified, the doses were at the low levels that scientists say are especially conducive to the development of drug-resistant strains.

Many of the antibiotics used agriculturally belong to categories considered medically important to humans (such as penicillin and tetracyclines). Despite this evidence, the United States (in sharp contrast to Europe, which has a long history of restricting antibiotic use in animals) has been slow to pass any binding legislation limiting the agricultural use of critical antibiotics.

What's the policy?

Combating antibiotic resistance will require coordination on behalf of a complex web of stakeholders. The National Institutes of Health funds research, including studies that pertain to the development of new antimicrobial products. The Food and Drug Administration (FDA) approves them for marketing and sale. The Department of Agriculture and the FDA have roles overseeing their agricultural use.

The CDC, in addition to its role in surveillance, prevention, and control, tracks diseases and engages in public education campaigns to inform doctors and patients how the drugs should be used in humans. The Biomedical Advanced Research and Development Authority engages the drug development industry in an integrated, systematic approach to developing and procuring drugs in tackling public health emergencies. The Department of Defense (DOD) and the Department of Veterans Affairs (VA) determine appropriate use and monitoring in military patient populations. And the State Department determines the US trade policy on prescription drugs.

In recent years, several global and federal health agencies have attempted to call attention to the issue of antibiotic resistance and, more broadly, antimicrobial resistance. In 2011 the theme of World Health Day was "Antimicrobial resistance: no action today, no cure tomorrow." The initiative resulted in a six-point policy package designed to assist countries with tools to combat antimicrobial resistance. In summary, the points were as follows:

  • To commit to a comprehensive, financed national plan with accountability and civil society engagement;
  • To strengthen surveillance and laboratory capacity;
  • To ensure uninterrupted access to essential medicines of assured quality;
  • To regulate and promote rational use of medicines, including in animal husbandry, and ensure proper patient care;
  • To enhance infection prevention and control; and
  • To foster innovations and research and development for new tools.

In 2012, as part of the Food and Drug Administration Safety and Innovation Act, President Barack Obama signed into law the Generating Antibiotic Incentives Now (GAIN) Act of 2011. These provisions added a five-year extension to the exclusivity period during which antibiotics that treat serious or life-threatening infections could be sold without generic competition. The intention of the act was to increase the potential for profits from new antibiotics--giving drug companies more time to recoup their investment costs and encourage the development of new antibiotics.

In 2014 the WHO published its first global report on surveillance of antimicrobial resistance, with data provided by 114 countries. The WHO has already initiated a collaboration with partners across many sectors to identify strategies and actions to mitigate antimicrobial resistance. Those partners have included the World Organisation for Animal Health and the Food and Agriculture Organization of the United Nations to promote best practices to avoid the emergence and spread of antibacterial resistance, including optimal use of antibiotics in both humans and animals.

In January 2014 President Obama again mentioned antibiotic resistance--this time in his State of the Union address. In March 2014 he announced he would add $30 million to the budget to fund monitoring and research into drug-resistant bacteria. Then in September 2014 he issued an executive order on combating antibiotic-resistant bacteria. In it, he called for the establishment of a "task force for combating antibiotic-resistant bacteria...to be co-chaired by the secretaries of Defense, Agriculture, and [Health and Human Services]" with the mission of creating a five-year National Action Plan that would include goals, milestones, and metrics for measuring progress.

In March 2015 President Obama urged Congress to double the federal funding available for antibiotic resistance surveillance and prevention, bringing the total to more than $1.2 million. The same month, the White House released the National Action Plan for Combating Antibiotic-Resistant Bacteria that had been promised the previous fall. The plan detailed five goals: slowing the emergence of drug-resistant bacteria, strengthening national surveillance efforts, improving rapid diagnostic tests for resistant strains of bacteria, promoting research, and fostering collaboration.

Under each goal, the action plan lays out key milestones for the next one, three, and five years. For example, the plan calls for routine reporting of antibiotic use and resistance data by 95 percent of Medicare-eligible hospitals, as well as by DOD and VA health care facilities, by 2020. Over the same time period, the CDC and the FDA will create the repository and database for resistant bacterial strains and, in conjunction with the DOD, will provide them to diagnostic test manufacturers and research laboratories, as needed. Using these new systems, the task force has called for the reduction of inappropriate antibiotic use over the next five years by 50 percent in outpatient settings and by 20 percent in inpatient settings."

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