Antibiotic Resistance:

Data Gaps Will Remain Despite HHS Taking Steps to Improve Monitoring

GAO-11-406: Published: Jun 1, 2011. Publicly Released: Jul 1, 2011.

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Infections that were once treatable have become more difficult to treat because of antibiotic resistance. Resistance occurs naturally but is accelerated by inappropriate antibiotic use in people, among other things. Questions have been raised about whether agencies such as the Department of Health and Human Services (HHS) have adequately assessed the effects of antibiotic use and disposal on resistance in humans. GAO was asked to (1) describe federal efforts to quantify the amount of antibiotics produced, (2) evaluate HHS's monitoring of antibiotic use and efforts to promote appropriate use, (3) examine HHS's monitoring of antibiotic-resistant infections, and (4) describe federal efforts to monitor antibiotic disposal and antibiotics in the environment, and describe research on antibiotics in the development of resistance in the environment. GAO reviewed documents and interviewed officials, conducted a literature review, and analyzed antibiotic sales data.

Federal agencies do not routinely quantify the amount of antibiotics that are produced in the United States for human use. However, sales data can be used as an estimate of production, and these show that over 7 million pounds of antibiotics were sold for human use in 2009. Most of the antibiotics that were sold have common characteristics, such as belonging to the same five antibiotic classes. The class of penicillins was the largest group of antibiotics sold for human use in 2009, representing about 45 percent of antibiotics sold. HHS performs limited monitoring of antibiotic use in humans and has implemented efforts to promote their appropriate use, but gaps in data on use will remain despite efforts to improve monitoring. Although HHS's Centers for Disease Control and Prevention (CDC) monitors use in outpatient healthcare settings, there are gaps in data on inpatient antibiotic use and geographic patterns of use. CDC is taking steps to improve its monitoring, but gaps such as information about overall antibiotic use will remain. Because use contributes to resistance, more complete information could help policymakers determine what portion of antibiotic resistance is attributed to human antibiotic use, and set priorities for action to control the spread of resistance. CDC's Get Smart program promotes appropriate antibiotic use; CDC has observed declines in inappropriate prescribing, but it is unclear to what extent the declines were due to the program or to other factors. CDC's program has been complemented by efforts by the National Institutes of Health and the Food and Drug Administration, such as supporting studies to develop tests to quickly diagnose bacterial infections. Gaps in CDC's monitoring of antibiotic-resistant infections limit the agency's ability to assess the overall problem of antibiotic resistance. There are data gaps in monitoring of such infections that occur in healthcare facilities; CDC does not collect data on all types of resistant infections to make facilitywide estimates and the agency's information is not nationally representative. CDC can provide accurate national estimates for certain resistant infections that develop in the community, including tuberculosis. Although CDC is taking steps to improve its monitoring, these efforts will not allow CDC to accurately assess the overall problem of antibiotic resistance because they do not fill gaps in information. Without more comprehensive data, CDC's ability to assess the overall scope of the public health problem and plan and implement preventive activities will be impeded. Federal agencies do not monitor the disposal of most antibiotics intended for human use, but they have detected them, as well as antibiotics for animal use, in the environment, which results partly from their disposal. EPA and DOI's United States Geological Survey have examined the presence of certain antibiotics in environmental settings such as streams. Studies conducted by scientists have found that antibiotics present in the environment at certain concentrations can increase the population of resistant bacteria. To better control the spread of resistance, GAO recommends that CDC develop and implement strategies to improve its monitoring of (1) antibiotic use and (2) antibiotic-resistant infections. HHS generally agreed with our recommendations. HHS, the Environmental Protection Agency (EPA) and the Department of the Interior (DOI) provided technical comments, which we incorporated as appropriate.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    Recommendation: To better prevent and control the spread of antibiotic resistance, the Director of CDC should develop and implement a strategy to improve CDC's monitoring of antibiotic use in humans, for example, by identifying available sources of antibiotic use information.

    Agency Affected: Department of Health and Human Services: Public Health Service: Centers for Disease Control

    Status: Closed - Implemented

    Comments: Since our report was issued CDC has improved its monitoring of antibiotic use in humans by obtaining additional data on the use of antibiotics in both inpatient and outpatient settings through its existing surveillance systems as well as other sources. In 2011 CDC conducted a new prevalence survey in 10 states through its existing Emerging Infections Program to gather data on the use of antibiotics in hospitals and stated in its 2013 report entitled Antibiotic Resistance Threats in the United States that the agency plans to repeat the prevalence survey. In 2012 CDC started collecting antibiotic use data from hospitals already participating in its National Healthcare Safety Network and is supporting efforts to extend the use of its electronic data collection tool. CDC has acquired eight years of pharmacy data on the prescribing of antibiotics in outpatient settings and is using the data to better characterize patterns in outpatient prescribing and develop targeted interventions to address high prescribing. CDC has partnered with federal agencies, state and local health departments and others to support these activities and has completed and published several analyses on antibiotic use including state-level prescribing rates, the conditions for which antibiotics were prescribed, and the appropriateness of their use.

    Recommendation: To better prevent and control the spread of antibiotic resistance, the Director of CDC should develop and implement a strategy to improve CDC's monitoring of antibiotic-resistant infections in inpatient healthcare facilities to more accurately estimate the national occurrence of such infections.

    Agency Affected: Department of Health and Human Services: Public Health Service: Centers for Disease Control

    Status: Closed - Implemented

    Comments: Since our report was issued CDC has used its existing surveillance systems to improve its monitoring of antibiotic-resistant infections in inpatient healthcare settings and has prioritized individual antibiotic-resistant infections requiring additional monitoring because of their increased threat to human health. In 2011 CDC conducted a new prevalence survey in 10 states through its Emerging Infections Program to gather data about the national frequency of infections that occur as a result of medical treatment in a hospital, including those infections that are resistant to antibiotics. In 2013 CDC issued a report called Antibiotic Resistance Threats in the United States that provided the first national summary of the burden and threats posed by antibiotic-resistant infections having the most impact on human health. In the report CDC identified the tracking of data on antibiotic-resistant infections as a core action to prevent and control the spread of antibiotic resistance. CDC also stated in its 2013 report that the agency plans to repeat the prevalence survey on the occurrence of infections in inpatient healthcare settings. CDC has partnered with federal agencies, state and local health departments and others to support these and other related activities and has completed and published several of its analyses on the occurrence and impact of antibiotic-resistant infections.

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