Federal Agencies Do Not Routinely Quantify Amount of Antibiotics Produced for Human Use, but Sales Data Show Over 7 Million Pounds of Antibiotics Were Sold in 2009

Federal agencies do not routinely quantify the amount of antibiotics that  are produced in the United States for human use, but sales data, which can  be used to estimate the quantity of antibiotic production, show that over   7 million pounds of antibiotics were sold in 2009 for human use in the  United States. These data indicate that most of the antibiotics sold have  common characteristics, such as belonging to five antibiotic classes. The class of  penicillins was the largest group of antibiotics sold in 2009. Penicillins, such as amoxicillin, are used to  treat bacterial infections that include pneumonia and urinary tract  infections. Data Gaps Remain Despite CDC’s Efforts to Expand Its Limited Monitoring of Antibiotic Use; CDC, NIH, and FDA Have Implemented Efforts to Promote Appropriate Use

Although CDC annually collects certain national data on antibiotic  prescriptions to monitor the use of antibiotics, these data have limitations  and do not allow for important analyses. Information about overall  antibiotic use in humans is also needed to routinely assess the  contribution that human antibiotic use makes to the overall problem of  antibiotic resistance in humans, relative to other contributing factors. For  example, monitoring what portion of antibiotic use is attributed to humans  versus animals is important to understanding antibiotic resistance. CDC Has Observed Declines in Inappropriate Antibiotic Prescribing, but It Is Unclear to What Extent Its Program to Promote Appropriate Antibiotic Use Contributed to Recent Trends

CDC has observed declines in inappropriate antibiotic prescribing in  outpatient settings since its Get Smart program began in 1995, but it is  unclear to what extent this program contributed to these trends. Without an accurate national estimate of  antibiotic-resistant HAIs, CDC cannot assess the magnitude and types of  such infections that occur in all patient populations (i.e., facilitywide)  within healthcare settings. CDC Is Taking Steps to Improve Its Monitoring of Antibiotic-Resistant Infections in Healthcare Facilities, but These Steps Will Not Improve CDC’s Ability to Assess the Overall Problem of Antibiotic Resistance

CDC is taking steps to improve its monitoring of antibiotic-resistant  infections in healthcare facilities, but CDC’s ability to assess the overall  problem of antibiotic resistance will not be improved. Federal Agencies Do Not Monitor Antibiotic Disposal, but Have Examined the Presence of Antibiotics in the Environment, and Studies Find that Such Antibiotics Can Increase the Population of Resistant Bacteria

Federal agencies do not collect data regarding the disposal of most  antibiotics intended for human use, but EPA and USGS have measured the  presence of certain antibiotics in the environment due, in part, to their  disposal. Studies conducted by scientists have found that antibiotics that  are present in the environment at certain concentration levels can increase  the population of resistant bacteria due to selective pressure. EPA and USGS have conducted several studies to measure the presence of  antibiotics in the environment, which results partly from their disposal. Such information could help  policymakers set priorities for actions to control the spread of antibiotic  resistance. Without more comprehensive information about the occurrence of cases  of antibiotic-resistant infections and the use of antibiotics, the agency’s  ability to understand the overall scope of the public health problem, detect  emerging trends, and plan and implement prevention activities is impeded. Recommendations

To better prevent and control the spread of antibiotic resistance, we  recommend that the Director of CDC take the following two actions:    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; and   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. HHS  provided written comments, which are reproduced in appendix V. HHS,  EPA, and DOI provided technical comments, which we incorporated as  appropriate. In its written comments, HHS generally agreed with the actions we  recommend it take to improve its monitoring of antibiotic use and  resistance. At that time, we will send copies to the Secretaries of the  Department of Health and Human Services and the Department of the  Interior, the Administrator of the Environmental Protection Agency, and  other interested parties.
Why GAO Did This Study

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.

What GAO Found

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.

What GAO Recommends

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.