text: Background Designating Federal Programs as High Risk Since the early 1990s, our high-risk program has focused attention on government operations with greater vulnerabilities to fraud, waste, abuse, and mismanagement, or that are in need of transformation to address economy, efficiency, or effectiveness challenges. To determine which federal government programs and functions should be designated high risk, we use our guidance document, Determining Performance and Accountability Challenges and High Risks. We consider qualitative factors, such as whether the risk (1) involves public health or safety, service delivery, national security, national defense, economic growth, or privacy or citizens’ rights; or (2) could result in significantly impaired service, program failure, injury or loss of life, or significantly reduced economy, efficiency, or effectiveness. We also consider the exposure to loss in monetary or other quantitative terms. At a minimum, $1 billion must be at risk, in areas such as the value of major assets being impaired; revenue sources not being realized; major agency assets being lost, stolen, damaged, wasted, or underutilized; potential for, or evidence of improper payments; and presence of contingencies or potential liabilities. Before making a high-risk designation, we also consider corrective measures that are planned or under way to resolve a material control weakness and the status and effectiveness of these actions. We release a High-Risk Series report every two years at the start of each new Congress. Our biennial reports detail progress made on previously designated high-risk issues. We designate any new issue areas we identify as high risk, based on the above criteria, in these reports or in separate products outside of the two-year cycle. We make out-of-cycle designations—as has been the case for seven other high-risk designations we have made—to highlight urgent issues, help ensure focused attention, and maximize the opportunity for the federal government to take action. National Drug Control Program Agencies The Office of National Drug Control Policy (ONDCP) was established by the Anti-Drug Abuse Act of 1988 as a component of the Executive Office of the President, and its Director is to assist the President in the establishment of the policies, goals, objectives, and priorities for the National Drug Control Program. In October 2018, the SUPPORT Act, among other things, reauthorized ONDCP and amended its authorities. ONDCP is responsible for (1) leading the national drug control effort, (2) coordinating and overseeing the implementation of national drug control policy, (3) assessing and certifying the adequacy of National Drug Control Programs and the budget for those programs, and (4) evaluating the effectiveness of national drug control policy efforts. As part of these efforts, ONDCP is to coordinate with more than a dozen federal agencies—known as National Drug Control Program agencies— that have responsibilities for activities including education and prevention, treatment, and law enforcement and drug interdiction (see fig. 1). Within these agencies, there may be components or offices that handle specific aspects of drug control. Some examples include SAMHSA and CDC within HHS, and the Drug Enforcement Administration (DEA) within the Department of Justice. Rates of Drug Misuse and Drug Overdose Deaths Have Generally Increased in the United States Rates of drug misuse and drug overdose deaths have generally increased in the United States. Nationally representative data show that this increase in the estimated rate of drug misuse has occurred across several demographic categories such as sex and education levels. Nationally, the rate of drug overdose deaths decreased in 2018 after increasing almost every year since 2002. Drug overdose death rates vary by region and by different types of drugs. Drug Misuse Has Increased in the United States and Affected People across a Range of Demographics Drug misuse—the use of illicit drugs and the misuse of prescription drugs—has generally increased in the United States since 2002. According to SAMHSA, estimates of self-reported drug misuse among people aged 12 or older increased from 14.9 percent in 2002 to 16.7 percent in 2014, and then further increased from 17.8 percent in 2015 to 19.4 percent in 2018 (see fig. 2). The increase in estimated drug misuse from 2015 to 2018 by people aged 12 or older is evident in people across a broad range of demographic groups, including sex, race or ethnicity, military veterans, income and education levels, employment status, and geographic categories, with few exceptions (see figures 3 through 5). Additionally, the estimated percentage of drug misuse within certain demographic groups increased for some years and decreased for others, in every year more than 10 percent of the people in every demographic group reported misusing drugs. The National Rate of Drug Overdose Deaths Increased between 2002 and 2018 The rate of drug overdose deaths in the United States increased between 2002 and 2018 (see fig. 6). For context, in 2002, there were 23,518 drug overdose deaths, and in 2018, there were 67,367 drug overdose deaths, according to CDC data. Furthermore, the rate of drug overdose deaths increased more rapidly in recent years; the rate increased on average by 2 percent per year from 2006 through 2013, and by 14 percent per year from 2013 through 2016; however, the rate decreased by 4.6 percent between 2017 and 2018. Regional Rates of Drug Overdose Deaths Varied Across the Nation Rates of drug overdose deaths varied in counties across the nation in 2003 and 2017, the most recent year that county-level data were available (see fig. 7). In 2017, there were some areas of the country with high rates of drug overdose deaths. For example, in 2017, 1,354 counties (43.2 percent of counties) had estimates of more than 20 drug overdose deaths per 100,000 people, including 448 counties with rates that were significantly higher than this amount. Rates of Overdose Deaths Increased for Multiple Drug Types between 2002 and 2018 The rate of overdose deaths for different types of drugs increased between 2002 and 2018. Rates of drug overdose deaths involving synthetic opioids, natural and semi-synthetic opioids, methadone, heroin, cocaine, benzodiazepines, psychostimulants, and antidepressants generally increased between 2002 and 2018 (see fig. 8). It is important to note that drug overdose deaths may involve more than one drug, and the drugs most frequently involved in overdose deaths were often found in combination with each other. The most common drugs involved in overdose deaths vary in different parts of the United States, according to data for each of the 10 HHS public health regions (see fig. 9). Generally, in eastern regions, fentanyl was the most common drug involved in overdose deaths in 2017, the most recent year that data were available, whereas methamphetamine was the most common drug involved in overdose deaths in western regions. As previously discussed, many drug overdose deaths involve more than one drug. Negative Effects of Drug Misuse Are Widespread and Cost Billions Past GAO work, as well as other selected government and academic studies, have found that drug misuse results in high costs for society and the economy. Such costs vary and include health care costs, criminal justice costs, workplace productivity costs, education costs, human services costs, and mortality costs. Figure 10 below includes examples of costs and other effects of drug misuse in these areas. These costs are born by federal, state, and local governments; private businesses and nonprofit organizations; employers; families, and individuals who misuse drugs. While selected studies we reviewed provided estimates for some of the costs of drug misuse, one study also indicated it is difficult to precisely quantify these costs. For example, concepts such as the quality of life or the pain and suffering of family members are difficult to fully capture or quantify. Challenges Impede National Efforts to Prevent, Respond to, and Recover from the Drug Crisis Our recent work on the topic of drug misuse and its effects has highlighted challenges the federal government faces that impede national efforts to address the drug crisis. We categorized these challenges as related to sustained leadership and strengthened coordination; capacity to address the crisis; and measurement, evaluation, and demonstration of progress. In the course of our work on the topic of drug misuse, we have identified many actions that if taken could help to address challenges in each of these areas, and have made specific recommendations to federal agencies about these actions. While over 25 of these recommendations have been implemented by National Drug Control Program agencies since fiscal year 2015, over 60 of our recommendations to at least 10 federal agencies—including recommendations that have received our highest priority designation— have not yet been implemented as of February 2020. The information below describes our findings and how agencies’ inaction on our recommendations has contributed to the federal government’s lack of progress in addressing the drug crisis. Sustained leadership and strengthened coordination. Making progress in high-risk areas requires demonstrated, strong, and sustained commitment and coordination, which we have found to be a challenge facing the federal government’s drug control efforts. Our work has identified the need for ONDCP to improve its efforts to lead and coordinate the national effort to address drug misuse and for agency leaders to engage in more effective coordination across the government and with stakeholders. ONDCP has a responsibility to coordinate and oversee the implementation of the national drug control policy across the federal government, and the National Drug Control Program agencies also have important roles and responsibilities that involve reducing drug misuse and mitigating its effects. ONDCP’s responsibility to develop the National Drug Control Strategy offers the office an important opportunity to help prioritize, coordinate, and measure key efforts to address the drug crisis. Our work has shown that ONDCP can improve its efforts to develop a National Drug Control Strategy that meets statutory requirements and effectively coordinates national efforts to address drug misuse. In 2017 and 2018, ONDCP lacked a statutorily required National Drug Control Strategy, and we recently reported that the 2019 National Drug Control Strategy did not fully comply with the law. In December 2019, we recommended that ONDCP develop and document key planning elements to help ONDCP structure its ongoing efforts and to better position the agency to meet these requirements for future iterations of the National Drug Control Strategy. ONDCP subsequently issued the 2020 National Drug Control Strategy on February 3, 2020. We reviewed this Strategy and found that it made progress in addressing several statutory requirements. For example: The 2020 National Drug Control Strategy includes 17 annual quantifiable and measurable objectives and specific targets, such as reducing overdose deaths by 15 percent by 2022, whereas we found that the 2019 National Drug Control Strategy did not contain such annual targets. The 2020 Strategy also includes a description of how each of the Strategy’s long-range goals was determined, including required consultations and data used to inform the determination, and a list of anticipated challenges to achieving the Strategy’s goals, such as limitations in existing data systems that provide little insight into emerging patterns of drug misuse, and planned actions to address them. However, the 2020 Strategy fell short in meeting other requirements. For example, the 2020 Strategy does not include a list of each National Drug Control Program agencies’ activities and the role of each activity in achieving the Strategy’s long-range goals, as required by law. The federal government invests billions of dollars each year in programs spanning over a dozen agencies, and therefore the development and implementation of a comprehensive Strategy is critical to guiding and ensuring the effectiveness of federal activities to address drug misuse. In December 2019, we recommended that ONDCP routinely implement an approach to meet the requirements for future Strategy iterations, and ONDCP agreed. ONDCP is uniquely situated to promote coordination across federal agencies. For example, the National Drug Control Strategy is required to include a description of how each of the Strategy’s long-range goals will be achieved, including a list of each existing or new coordinating mechanism to achieve each goal and a description of ONDCP’s role in facilitating achievement of each goal. The 2020 Strategy partially addressed these required elements. By including these descriptions in future iterations of the Strategy and effectively implementing them, ONDCP has the potential to strengthen coordination and provide sustained leadership. ONDCP has previously used its unique position to help implement some of our recommendations aimed at improving coordination across federal agencies in their efforts to prevent and respond to drug misuse. For example, ONDCP implemented our recommendation to assess the extent of overlap and potential for duplication across federal programs engaged in drug abuse prevention and treatment activities and to identify opportunities for increased coordination as well as developed performance metrics and reporting data regarding field-based coordination to prevent drug trafficking. We have also reported on the lack of available treatment programs for pregnant women and newborns with neonatal abstinence syndrome as well as gaps in research related to the treatment of prenatal opioid use. As of February 2020, ONDCP implemented our recommendation to document the process the agency uses to identify gaps and action items to track federal activities related to prenatal opioid use and neonatal abstinence syndrome. Sustaining and building on these coordination efforts will help maximize opportunities, leverage resources, and better position ONDCP to identify opportunities for increased efficiencies in preventing and treating drug misuse. National Drug Control Program agencies also have a responsibility to coordinate their efforts, and we have reported that gaps in agency coordination have hindered national drug control efforts. For example, the Department of Homeland Security (DHS), the U.S. Postal Service (USPS), and U.S. Customs and Border Protection (CBP) each have important roles in enforcing certain data-sharing and enforcement requirements of the Synthetics Trafficking and Overdose Prevention Act of 2018 (STOP Act). The STOP Act requires DHS to promulgate regulations detailing additional USPS responsibilities—beyond those included in the Act—related to sharing advance electronic data with CBP that can be used to identify shipments at high risk of transporting illegal drugs by October 24, 2019. However, as of November 2019, DHS had not drafted these regulations, and therefore USPS’s and CBP’s responsibilities for sharing advance electronic data—a key tool that could help stop the flow of illicit drugs into the United States—remain unclear. As we reported in December 2019, DHS does not have a plan for drafting these regulations, and therefore we recommended that DHS develop a timeline to do so; DHS agreed with this recommendation. It is also important for the federal government to coordinate among different levels of government and across issue areas, including with state, local, and tribal agencies, as well as with community groups and organizations in the private sector working to address the drug crisis. Our prior work has also found ways in which coordination between federal efforts to address drug misuse and those of local governments and other stakeholders could be more effective. In January 2018, we reported that states cited the need for additional guidance, training, and technical assistance from HHS to address the needs of infants born with prenatal drug exposure. HHS disagreed with our recommendation to provide such guidance regarding the safe care for substance-affected infants, and has not implemented the recommendation. HHS stated that it had already clarified guidance in this area and believed that states needed flexibility to meet the program requirements in the context of each state’s program. We found that states continued to report issues with the guidance, and that the clarifications did not address an ongoing challenge regarding the program requirements. We continue to believe our recommendation is warranted. As of February 2020, HHS continues to disagree with us and with the states. Without adequate supports and services to ensure their safety, these vulnerable infants may be at risk for child abuse and neglect. We have also recently recommended in January 2020 that DEA should, in consultation with industry stakeholders—such as drug distributors— identify solutions to address the limitations of the ARCOS Enhanced Lookup Buyer Statistic Tool, to ensure industry stakeholders have the most useful information possible to assist them in identifying and reporting suspicious opioid orders to DEA. DEA agreed with our recommendation, and is starting to assess how to address this recommendation. These limitations, including a lack of appropriately detailed data, may limit the usefulness of the tool in assisting distributors in determining whether an order is suspicious. In addition, we have previously reported in 2019 that coordination across private health plans, health-care prescribers, pharmacists, and at-risk beneficiaries could contribute to the success of Medicare drug monitoring programs, which are designed to identify beneficiaries at risk of opioid misuse. We also have ongoing work on how federal departments and agencies coordinate their drug prevention efforts in schools as well as on how effectively federal agencies coordinated their counter-drug activities with Mexico. Capacity to address the crisis. We have identified ongoing challenges related to the nation’s capacity to address the drug crisis. Sufficient capacity and efficient use of that capacity are key components for making progress in high-risk areas; they are necessary for federal, state, and local agencies to achieve strategic goals in addressing drug misuse, such as implementing the National Drug Control Strategy. In our work designating high-risk government programs and functions, we define capacity as having the people and resources sufficient to address the risk. Our prior work has found that the nation faces insufficient capacity to successfully address persistent, troubling trends in drug misuse, including the lack of treatment options. In addition, the nation’s existing capacity may be plagued by inefficiencies and gaps in information about what resources are most effective in addressing drug misuse. These capacity challenges permeate every level of government and affect the nation’s key social services and health care programs. As a result, effectively addressing the drug crisis requires harnessing capacity across agencies within the federal government as well as coordinating with state and local governments and community-based nongovernment organizations. The availability of treatment for substance use disorders has not kept pace with needs, and the federal government has faced barriers to increasing treatment capacity. For example, we have reported on barriers to increasing access to evidence-based treatment for opioid use disorder, and federal efforts to address these barriers. Such barriers to treatment include a lack of Medicaid coverage for treatment medications in some states, delays that can be caused by the need for prior authorizations for some treatment medications, and the unwillingness of some health care providers to obtain the federal waiver required to prescribe some treatment medications. We have also reported that, according to officials at the Veterans Health Administration (VHA), many veterans lack access to residential substance use treatment programs because of high demand relative to capacity. Developing and maintaining sufficient capacity to address the drug crisis also requires that federal agencies use existing resources—such as data—effectively. For example, we have recently reported in January 2020 that DEA should be more proactive in using the data it already collects from DEA registrants to identify problematic drug transaction patterns. According to DEA officials, one analysis that they conduct on a quarterly basis involves using a computer algorithm when comparing large volumes of drugs purchased in a given geographic area to the area’s population data. However, DEA did not report conducting active and recurring monitoring of transactions using algorithms to detect and flag transactions that indicate potential diversion, either on a real-time or near real-time basis, to help identify questionable patterns in the data or unusual patterns of drug distribution on a more routine basis. Such analyses could be used to proactively support or generate leads for investigations of potential drug diversion. Registrants already report data on controlled-substance transactions to the DEA. DEA could use these data to identify trends in distribution or purchases of drugs in a given geographic area. DEA could also look for and compare unusual patterns in drug order activity in different locations to identify potential issues that warrant further investigation. Further, DEA has not established a way to manage all of the data it collects and maintains. DEA agreed with three of our four recommendations to better manage and use the data it collects. DEA neither agreed nor disagreed with the fourth recommendation. However, DEA has not yet implemented any of the recommendations. By implementing these recommendations, DEA could ensure that important data assets are formally managed and fully utilized to inform investigations and prevent diversion of prescription opioids to be sold illegally. Overall, federal efforts to address the drug crisis could make better use of available data to assist in identifying emerging patterns of misuse, allowing the government to respond more quickly to evolving trends. Beyond specific capacity challenges that we have identified, in December 2019 we reported on challenges federal agencies face in assessing the resources they will need to achieve the goals of the National Drug Control Strategy. ONDCP is required to issue drug control funding guidance to the heads of departments and agencies with responsibilities under the National Drug Control Program by July 1 of each year, and such funding guidance must address funding priorities developed in the National Drug Control Strategy. Since ONDCP did not issue a Strategy in 2017 or 2018, ONDCP could neither provide funding guidance to National Drug Control Program agencies based on the Strategy, nor could it review and certify budget requests of these agencies to determine if they are adequate to meet the goals of the Strategy, in accordance with and as required by law. Without a National Drug Control Strategy in 2017 or 2018, ONDCP used other sources—such as policy priorities identified in the President’s Budget from fiscal year 2018—to identify drug policy priorities and develop funding guidance. ONDCP issued a National Drug Control Strategy in 2019 and 2020, but neither Strategy included a 5-year projection for program and budget priorities, as required by law. In December 2019, we recommended that ONDCP develop and document key planning elements to help ONDCP structure its ongoing efforts and to better position the agency to meet these requirements for future iterations of the National Drug Control Strategy. We also found that the 2020 National Drug Control Strategy does not include estimates of federal funding or other resources needed to achieve each of ONDCP’s long-range goals. The 2020 Strategy includes a plan to expand treatment of substance use disorders that identifies unmet needs for substance use disorder treatment and a strategy for closing the gap between available and needed treatment. The plan also describes the roles and responsibilities of relevant National Drug Control Program agencies for implementing the plan. However, the plan does not identify resources required to enable National Drug Control Program agencies to implement the plan or resources required to eliminate the treatment gap, as required by law. The National Drug Control Strategy is important for assessing the nation’s capacity to address drug misuse through both the development of federal funding estimates and the certification of agency budget requests that aim to meet the goals of the Strategy. Additionally, we have ongoing work on the federal government’s capacity to address the drug crisis. For example, we are studying gaps in the capacity of the health care system to treat substance use disorders, and examining how grantees use funding from selected SAMHSA grant programs to increase access to substance use disorder treatment. We are also studying school-based drug prevention programs and the effects of drug misuse on the workforce. This work will examine challenges that states and local educational entities face in serving the needs of communities affected by the drug crisis. We also have planned work examining the effectiveness of federal funding to combat the ongoing opioid crisis. Measurement, evaluation, and demonstration of progress. The federal government faces challenges related to measuring, evaluating, and demonstrating progress towards addressing the crisis. We have reported that key data needed to measure and evaluate progress towards strategic goals are not reliable or are not collected and reported. We have also found that some agencies lack plans or metrics to measure the effectiveness of specific programs to address the drug crisis and to demonstrate that these programs are making progress towards stated national goals, including reducing drug overdose deaths and expanding access to addiction treatment. Successfully addressing drug misuse requires ongoing measurement and evaluation of efforts towards stated goals and the ability to share and use performance information to make midcourse changes and corrections where needed. Regarding challenges related to data, we have identified gaps in the availability and reliability of data for measuring progress. ONDCP and other federal, state, and local government officials have identified challenges with the timeliness, accuracy, and accessibility of data from law enforcement and public health sources related to both fatal and non- fatal overdose cases. In March 2018, we recommended that ONDCP lead a review on ways to improve overdose data; ONDCP did not indicate whether it agreed with our recommendation. Additionally, in December 2019, we found that ONDCP’s Drug Control Data Dashboard did not include all of the data required by the SUPPORT Act, such as data sufficient to show the extent of the unmet need for substance use disorder treatment. We recommended that ONDCP establish the planning elements to ensure that these data were included in the Data Dashboard, and ONDCP disagreed with our recommendation. Having accessible and reliable data, including data on drug overdoses will help ONDCP and other agencies better measure the scope and nature of the drug crisis. We also found in 2019 that the State Department cannot ensure the reliability of its program monitoring data for its Caribbean Basin Security Initiative, which seeks to reduce illicit drug trafficking. The State Department agreed with the recommendation to ensure the development and implementation of a data management system for centrally collecting reliable program monitoring data for all Caribbean Basin Security Initiative activities, but has not yet implemented it. Without this action, there may be discrepancies in how Caribbean Basin Security Initiative program performance data is defined and collected, and the State Department cannot report comprehensively or accurately on the Initiative’s activities to reduce illicit drug trafficking or track data trends across countries. While ONDCP is responsible for evaluating the effectiveness of national drug control policy efforts across the government, we found that ONDCP has not developed performance evaluation plans for the goals in the 2020 National Drug Control Strategy. Some of the long-range goals listed in the 2020 Strategy include expanding access to evidence-based treatment, reducing the availability of illicit drugs in the United States, and decreasing the over-prescribing of opioid medications. However, the 2020 National Drug Control Strategy does not include performance evaluation plans to measure progress against each of the Strategy’s long-range goals, as required by law. These performance evaluation plans are required by statute to include (1) specific performance measures for each National Drug Control Program agency, (2) annual and—to the extent practicable—quarterly objectives and targets for each measure, and (3) an estimate of federal funding and other resources necessary to achieve each performance objective and target. Without effective long-term plans that clearly articulate goals and objectives and without specific measures to track performance, federal agencies cannot fully assess whether taxpayer dollars are invested in ways that will achieve desired outcomes such as reducing access to illicit drugs and expanding treatment for substance use disorders. Additionally, National Drug Control Program agencies are responsible for evaluating their progress toward achieving the goals of the National Drug Control Strategy, and in some cases have improved how to measure this progress. For example, although the federal government continues to face barriers to increasing access to treatment for substance use disorders, HHS has recently implemented our recommendation to establish performance measures with targets to expand access to medication-assisted treatment (MAT) for opioid use disorders. As of March 2020, HHS has established such performance measures with targets to increase the number of prescriptions for MAT medications and to increase treatment capacity, as measured by the number of providers authorized to treat patients using MAT. Monitoring progress against these targets will help HHS determine whether its efforts to expand treatment are successful or whether new approaches are needed. We have also identified challenges regarding how federal agencies demonstrate the progress of specific programs toward addressing the drug crisis. We reported in 2018 on DEA’s 360 Strategy—which aims to coordinate DEA enforcement, diversion control, and demand reduction efforts—as well as on ONDCP’s Heroin Response Strategy under its High Intensity Drug Trafficking Areas program. We found that neither DEA’s 360 Strategy nor ONDCP’s Heroin Response Strategy included outcome- oriented performance measures for its activities and goals, respectively. DEA disagreed with and has not yet implemented our recommendation to establish these types of performance measures for its activities. ONDCP neither agreed nor disagreed with our recommendation to establish outcome-oriented performance measures for the goals of the Heroin Response Strategy, and has not yet implemented the recommendation. Without these measures, it is unclear the extent to which DEA or ONDCP can accurately and fully gauge their efforts and their overall effectiveness in combatting heroin and opioid use and reducing overdose deaths. Additionally, we have found that DEA does not have outcome-oriented goals and performance targets for its use of data in opioid diversion activities, making DEA likely not able to adequately assess whether its investments and efforts are helping to limit the availability of and better respond to the opioid prescription diversion threat. DEA neither agreed nor disagreed with our recommendation to establish these outcome- oriented goals and related performance targets for its opioid diversion activities, and has not implemented this recommendation. We have also reported that the Department of State has not established performance indicators for its Caribbean Basin Security Initiative to facilitate performance evaluation across agencies, countries, and activities, inhibiting the assessment of the program’s progress to reduce illicit drug trafficking. The State Department agreed with our recommendation to develop and implement a data management system for centrally collecting reliable program monitoring data. The State Department has not yet implemented this recommendation. Without robust assessments of how specific programs help to achieve the goals of the National Drug Control Strategy, federal agencies may be unable to demonstrate progress in addressing the drug crisis, and may be unable to make any needed adjustments to their strategies. Concluding Observations Illicit drug use and misuse of prescription drugs is a long-standing national problem that will continue to evolve. The terrible effects of drug misuse on families and communities have persisted over decades, despite ongoing federal, state, and local efforts. Federal agencies and Congress can and must work to ensure that available resources are coordinated effectively to mitigate and respond to the drug misuse crisis. Maintaining sustained attention on preventing, responding to, and recovering from drug misuse will be challenging in the coming months as many of the federal agencies responsible for addressing drug misuse are currently focused on addressing the COVID-19 pandemic. However, the severe public health and economic effects of the pandemic could fuel some of the contributing factors of drug misuse, such as unemployment— highlighting the need to sustain drug misuse prevention, response, and recovery efforts. Addressing these challenges will require sustained leadership and strengthened coordination; the necessary capacity to address the crisis; and the systems to measure, evaluate, and demonstrate progress. The more than 60 related GAO recommendations that have yet to be implemented are an indication of how federal agencies may begin addressing these challenges. For example: ONDCP should ensure future iterations of the National Drug Control Strategy include all statutorily required elements. Examples of statutorily required elements include a 5-year projection for the National Drug Control Program and budget priorities; a description of how each of the Strategy’s long-range goals will be achieved, including a list of each National Drug Control Program agency’s activities, and the role of each activity in achieving these goals, and estimates of federal funding or other resources needed to achieve these goals; performance evaluation plans for each year covered by the Strategy for each long-range goal for each National Drug Control Program agency; and resources required to enable National Drug Control Program agencies to implement the plan to expand treatment of substance use disorders and eliminate the treatment gap; ONDCP should take steps to ensure effective, sustained implementation of the 2020 National Drug Control Strategy and future strategies; HHS should provide guidance to states for the safe care for infants born with prenatal drug exposure, who may be at risk for child abuse and neglect; DEA should take steps to better analyze and use drug transaction data to identify suspicious opioid orders and prevent diversion of prescription opioids to be sold illegally; and the State Department should develop and implement a data management system for all Caribbean Basin Security Initiative activities to reduce illicit drug trafficking or track data trends across countries. Through our ongoing and planned work, we will continue to review the effects of drug misuse, the federal response, and opportunities for improvement. Agency Comments and Our Evaluation We provided draft report excerpts regarding our analysis of the 2020 National Drug Control Strategy to the Office of National Drug Control Policy for review and comment. ONDCP officials stated that they plan to address the statutory requirements that we identified as missing in additional documents, including the Fiscal Year 2021 Budget and Performance Summary. We will review and assess any additional materials that ONDCP publishes in response to the requirements for the 2020 National Drug Control Strategy. Findings regarding other programs and activities are drawn from past GAO work and our follow-up work on our recommendations; the related content was previously provided to the respective agencies for review as part of the original work. We are sending copies of this report to the appropriate congressional committees, the Director of the Office of National Drug Control Policy, and other interested parties. In addition, the report is available at no charge on the GAO website at http://www.gao.gov. If you or your staff have any questions about this report, please contact Triana McNeil at (202) 512-8777 or McNeilT@gao.gov, Mary Denigan- Macauley at (202) 512-7114 or DeniganMacauleyM@gao.gov, or Jacqueline M. Nowicki at (617) 788-0580 or NowickiJ@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix II. Appendix I: List of Selected Related GAO Reports Fiscal Year 2020 Reports International Mail: Stakeholders' Views on Possible Changes to Inbound Mail Regarding Customs Fees and Opioid Detection Efforts. GAO-20- 340R. Washington, D.C.: February 27, 2020. Medicaid: States' Changes to Payment Rates for Substance Use Disorder Services. GAO-20-260. Washington, D.C.: January 30, 2020. Drug Control: Actions Needed to Ensure Usefulness of Data on Suspicious Opioid Orders. GAO-20-118. Washington, D.C.: January 29, 2020. Opioid Use Disorder: Barriers to Medicaid Beneficiaries’ Access to Treatment Medications. GAO-20-233. Washington, D.C.: January 24, 2020. Social Security Disability: Action Needed to Help Agency Staff Understand and Follow Policies Related to Prescription Opioid Misuse. GAO-20-120. Washington, D.C.: January 9, 2020. Countering Illicit Finance and Trade: U.S. Efforts to Combat Trade-Based Money Laundering. GAO-20-314R. Washington, D.C.: December 30, 2019. Drug Control: The Office of National Drug Control Policy Should Develop Key Planning Elements to Meet Statutory Requirements. GAO-20-124. Washington, D.C.: December 18, 2019. International Mail: Progress Made in Using Electronic Data to Detect Illegal Opioid Shipments, but Additional Steps Remain. GAO-20-229R. Washington, D.C.: December 18, 2019. Counternarcotics: Treasury Reports Some Results from Designating Drug Kingpins, but Should Improve Information on Agencies’ Expenditures. GAO-20-112. Washington, D.C.: December 16, 2019. Mental Health and Substance Use: State and Federal Oversight of Compliance with Parity Requirements Varies. GAO-20-150. Washington, D.C.: December 13, 2019. Veterans Health Care: Services for Substance Use Disorders, and Efforts to Address Access Issues in Rural Areas. GAO-20-35. Washington, D.C.: December 2, 2019. Coast Guard: Assessing Deployable Specialized Forces' Workforce Needs Could Improve Efficiency and Reduce Potential Overlap or Gaps in Capabilities. GAO-20-33. Washington, D.C.: November 21, 2019. Substance Use Disorder: Prevalence of Recovery Homes, and Selected States’ Investigations and Oversight. GAO-20-214T. Washington, D.C.: October 24, 2019. Medicaid: Opioid Use Disorder Services for Pregnant and Postpartum Women, and Children. GAO-20-40. Washington, D.C.: October 24, 2019. Fiscal Year 2019 Reports U.S. Assistance to Central America: Department of State Should Establish a Comprehensive Plan to Assess Progress Toward Prosperity, Governance, and Security. GAO-19-590. Washington, D.C.: September 26, 2019. Science & Tech Spotlight: Opioid Vaccines. GAO-19-706SP. Washington, D.C.: September 16, 2019. U.S. Assistance to Mexico: State and USAID Allocated over $700 Million to Support Criminal Justice, Border Security, and Related Efforts from Fiscal Year 2014 through 2018. GAO-19-647. Washington, D.C.: September 10, 2019. Prescription Opioids: Patient Options for Safe and Effective Disposal of Unused Opioids. GAO-19-650. Washington, D.C.: September 3, 2019. Land Ports of Entry: CBP Should Update Policies and Enhance Analysis of Inspections. GAO-19-658. Washington, D.C.: August 6, 2019. Drug Control: Certain DOD and DHS Joint Task Forces Should Enhance Their Performance Measures to Better Assess Counterdrug Activities. GAO-19-441. Washington, D.C.: July 9, 2019. VA Mental Health: VHA Improved Certain Prescribing Practices, but Needs to Strengthen Treatment Plan Oversight. GAO-19-465. Washington, D.C.: June 17, 2019. Health Centers: Trends in Revenue and Grants Supported by the Community Health Center Fund. GAO-19-496. Washington, D.C.: May 30, 2019. Prescription Opioids: Voluntary Medicare Drug Management Programs to Control Misuse. GAO-19-446. Washington, D.C.: May 20, 2019. Drug Policy: Assessing Treatment Expansion Efforts and Drug Control Strategies and Programs. GAO-19-535T. Washington, D.C.: May 9, 2019. Drug Policy: Preliminary Observations on the 2019 National Drug Control Strategy. GAO-19-370T. Washington, D.C.: March 7, 2019. Behavioral Health: Research on Health Care Costs of Untreated Conditions is Limited. GAO-19-274. Washington, D.C.: February 28, 2019. Security Assistance: U.S. Agencies Should Establish a Mechanism to Assess Caribbean Basin Security Initiative Progress. GAO-19-201. Washington, D.C.: February 27, 2019. Drug Control: DOD Should Improve Its Oversight of the National Guard Counterdrug Program.GAO-19-27. Washington, D.C.: January 17, 2019. Colombia: U.S. Counternarcotics Assistance Achieved Some Positive Results but State Needs to Review the Overall U.S. Approach. GAO-19-106. Washington, D.C.: December 12, 2018. Illegal Marijuana: Opportunities Exist to Improve Oversight of State and Local Eradication Efforts. GAO-19-9. Washington, D.C.: November 14, 2018. Fiscal Year 2018 Reports Opioid Crisis: Status of Public Health Emergency Authorities. GAO-18-685R. Washington, D.C.: September 26, 2018. Adolescent and Young Adult Substance Use: Federal Grants for Prevention, Treatment, and Recovery Services and for Research. GAO-18-606. Washington, D.C.: September 4, 2018. Foster Care: Additional Actions Could Help HHS Better Support States’ Use of Private Providers to Recruit and Retain Foster Families. GAO-18-376. Washington, D.C.: May 30, 2018. VA Health Care: Progress Made Towards Improving Opioid Safety, but Further Efforts to Assess Progress and Reduce Risk Are Needed. GAO-18-380. Washington, D.C.: May 29, 2018. Prescription Opioids: Medicare Needs Better Information to Reduce the Risk of Harm to Beneficiaries. GAO-18-585T. Washington, D.C.: May 29, 2018. Illicit Opioids: Office of National Drug Control Policy and Other Agencies Need to Better Assess Strategic Efforts. GAO-18-569T. Washington, D.C.: May 17, 2018. Substance Use Disorder: Information on Recovery Housing Prevalence, Selected States’ Oversight, and Funding. GAO-18-315. Washington, D.C.: March 22, 2018. Illicit Opioids: While Greater Attention Given to Combating Synthetic Opioids, Agencies Need to Better Assess their Efforts. GAO-18-205. Washington, D.C.: March 29, 2018. Substance-Affected Infants: Additional Guidance Would Help States Better Implement Protections for Children. GAO-18-196. Washington, D.C.: January 19, 2018. Prescription Opioids: Medicare Should Expand Oversight Efforts to Reduce the Risk of Harm. GAO-18-336T. Washington, D.C.: January 17, 2018. Preventing Drug Abuse: Low Participation by Pharmacies and Other Entities as Voluntary Collectors of Unused Prescription Drugs. GAO-18-25. Washington, D.C.: October 12, 2017. Border Patrol: Issues Related to Agent Deployment Strategy and Immigration Checkpoints. GAO-18-50. Washington, D.C.: November 8, 2017. Prescription Opioids: Medicare Needs to Expand Oversight Efforts to Reduce the Risk of Harm. GAO-18-15. Washington, D.C.: October 6, 2017. Opioid Use Disorders: HHS Needs Measures to Assess the Effectiveness of Efforts to Expand Access to Medication-Assisted Treatment. GAO-18-44. Washington, D.C.: October 31, 2017. Counternarcotics: Overview of U.S. Efforts in the Western Hemisphere. GAO-18-10. Washington, D.C.: October 13, 2017. Newborn Health: Federal Action Needed to Address Neonatal Abstinence Syndrome. GAO-18-32. Washington, D.C.: October 4, 2017. Fiscal Year 2017 Reports Anti-Money Laundering: U.S. Efforts to Combat Narcotics-Related Money Laundering in the Western Hemisphere. GAO-17-684. Washington, D.C.: August 22, 2017. Nonviolent Drug Convictions: Stakeholders’ Views on Potential Actions to Address Collateral Consequences. GAO-17-691. Washington, D.C.: September 7, 2017. Medicaid: States Fund Services for Adults in Institutions for Mental Disease Using a Variety of Strategies. GAO-17-652. Washington, D.C.: August 9, 2017. International Mail Security: Costs and Benefits of Using Electronic Data to Screen Mail Need to Be Assessed. GAO-17-606. Washington, D.C.: August 2, 2017. Drug Control Policy: Information on Status of Federal Efforts and Key Issues for Preventing Illicit Drug Use. GAO-17-766T. Washington, D.C.: July 26, 2017. Medicaid Expansion: Behavioral Health Treatment Use in Selected States in 2014. GAO-17-529. Washington, D.C.: June 22, 2017. Border Security: Additional Actions Could Strengthen DHS Efforts to Address Subterranean, Aerial, and Maritime Smuggling. GAO-17-474. Washington, D.C.: May 1, 2017. VA Health Care: Actions Needed to Ensure Medical Facilities’ Controlled Substance Programs Meet Requirements. GAO-17-442T. Washington, D.C.: February 27, 2017. VA Health Care: Actions Needed to Ensure Medical Facility Controlled Substance Inspection Programs Meet Agency Requirements. GAO-17-242. Washington, D.C.: February 15, 2017. Drug Free Communities Support Program: Agencies Have Strengthened Collaboration but Could Enhance Grantee Compliance and Performance Monitoring. GAO-17-120. Washington, D.C.: February 7, 2017. Highlights of a Forum: Preventing Illicit Drug Use. GAO-17-146SP. Washington, D.C.: November 14, 2016. Fiscal Year 2016 Reports Opioid Addiction: Laws, Regulations, and Other Factors Can Affect Medication-Assisted Treatment Access. GAO-16-833. Washington, D.C.: September 27, 2016. Drug Enforcement Administration: Additional Actions Needed to Address Prior GAO Recommendations. GAO-16-737T. Washington, D.C.: June 22, 2016. Controlled Substances: DEA Should Take Additional Actions to Reduce Risks in Monitoring the Continued Eligibility of Its Registrants. GAO-16-310. Washington, D.C.: May 26, 2016. Office of National Drug Control Policy: Progress toward Some National Drug Control Strategy Goals, but None Have Been Fully Achieved. GAO-16-660T. Washington, D.C.: May 17, 2016. Veterans Justice Outreach Program: VA Could Improve Management by Establishing Performance Measures and Fully Assessing Risks. GAO-16-393. Washington, D.C.: April 28, 2016. State Marijuana Legalization: DOJ Should Document Its Approach to Monitoring the Effects of Legalization. GAO-16-419T. Washington, D.C.: April 5, 2016. DOD and VA Health Care: Actions Needed to Help Ensure Appropriate Medication Continuation and Prescribing Practices. GAO-16-158. Washington, D.C.: January 5, 2016. State Marijuana Legalization: DOJ Should Document Its Approach to Monitoring the Effects of Legalization. GAO-16-1. Washington, D.C.: December 30, 2015. Office of National Drug Control Policy: Lack of Progress on Achieving National Strategy Goals. GAO-16-257T. Washington, D.C.: December 2, 2015. Drug Control: Additional Performance Information Is Needed to Oversee the National Guard’s State Counterdrug Program. GAO-16-133. Washington, D.C.: October 21, 2015. Fiscal Year 2015 Reports Medicaid: Additional Reporting May Help CMS Oversee Prescription-Drug Fraud Controls. GAO-15-390. Washington, D.C.: July 8, 2015. Prescription Drugs: More DEA Information about Registrants’ Controlled Substances Roles Could Improve Their Understanding and Help Ensure Access. GAO-15-471. Washington, D.C.: June 25, 2015. Behavioral Health: Options for Low-Income Adults to Receive Treatment in Selected States. GAO-15-449. Washington, D.C.: June 19, 2015. Drug-Impaired Driving: Additional Support Needed for Public Awareness Initiatives. GAO-15-293. Washington, D.C.: February 24, 2015. Prenatal Drug Use and Newborn Health: Federal Efforts Need Better Planning and Coordination. GAO-15-203. Washington, D.C.: February 10, 2015. Medicare Program Integrity: CMS Pursues Many Practices to Address Prescription Drug Fraud, Waste, and Abuse. GAO-15-66. Washington, D.C.: October 24, 2014. Reports from Fiscal Years 1972-2014 Office of National Drug Control Policy: Office Could Better Identify Opportunities to Increase Program Coordination. GAO-13-333. Washington, D.C.: March 26, 2013. Drug Control: Initial Review of the National Strategy and Drug Abuse Prevention and Treatment Programs. GAO-12-744R. Washington, D.C.: July 6, 2012. Prescription Pain Reliever Abuse: Agencies Have Begun Coordinating Education Efforts, but Need to Assess Effectiveness. GAO-12-115. Washington, D.C.: December 22, 2011. Adult Drug Courts: Studies Show Courts Reduce Recidivism, but DOJ Could Enhance Future Performance Measure Revision Efforts. GAO-12-53. Washington, D.C.: December 9, 2011. Drug Control: U.S. Assistance Has Helped Mexican Counternarcotics Efforts, but Tons of Illicit Drugs Continue to Flow into the United States. GAO-07-1018. Washington, D.C.: August 17, 2007. Adult Drug Courts: Evidence Indicates Recidivism Reductions and Mixed Results for Other Outcomes. GAO-05-219. Washington, D.C.: February 28, 2005. Prescription Drugs: OxyContin Abuse and Diversion and Efforts to Address the Problem. GAO-04-110. Washington, D.C.: December 19, 2003. Drug Courts: Better DOJ Data Collection and Evaluation Efforts Needed to Measure Impact of Drug Court Programs. GAO-02-434. Washington, D.C.: April 18, 2002. Drug Abuse: Efforts under Way to Determine Treatment Outcomes. T-HEHS-00-60. Washington, D.C.: February 17, 2000. Emerging Drug Problems: Despite Changes in Detection and Response Capability, Concerns Remain. HEHS-98-130. Washington, D.C.: July 20, 1998. Drug Courts: Overview of Growth, Characteristics, and Results. GGD-97- 106. Washington, D.C.: July 31, 1997. Drug Control: Reauthorization of the Office of National Drug Control Policy. T-GGD-97-97. Washington, D.C.: May 1, 1997. Confronting the Drug Problem: Debate Persists on Enforcement and Alternative Approaches. GGD-93-82. Washington, D.C.: July 1, 1993. War on Drugs: Federal Assistance to State and Local Drug Enforcement. GGD-93-86. Washington, D.C.: April 29, 1993. Drug Control: Coordination of Intelligence Activities.GGD-93-83BR. Washington, D.C.: April 2, 1993. Drug Abuse Prevention: Federal Efforts to Identify Exemplary Programs Need Stronger Design. PEMD-91-15. Washington, D.C.: August 22, 1991. VA Health Care: Inadequate Controls over Addictive Drugs. HRD-91-101. Washington, D.C.: June 6, 1991. The War on Drugs: Arrests Burdening Local Criminal Justice Systems. GGD-91-40. Washington, D.C.: April 3, 1991. Drug Treatment: Targeting Aid to States Using Urban Population as Indicator of Drug Use. HRD-91-17. Washington, D.C.: November 27, 1990. Controlling Drug Abuse: A Status Report. GGD-88-39. Washington, D.C.: March 1, 1988. Drug Abuse Prevention: Further Efforts Needed To Identify Programs That Work. HRD-88-26. Washington, D.C.: December 4, 1987. Comprehensive Approach Needed To Help Control Prescription Drug Abuse. GGD-83-2. Washington, D.C.: October 29, 1982. Action Needed To Improve Management and Effectiveness of Drug Abuse Treatment. HRD-80-32 Washington, D.C.: April 14, 1980. Identifying and Eliminating Sources of Dangerous Drugs: Efforts Being Made, but Not Enough. B-175425. Washington, D.C.: Jun 7, 1974. United States Efforts to Increase International Cooperation in Controlling Narcotics Trafficking. B-176625. Washington, D.C.: October 4, 1972. Efforts to Prevent Dangerous Drugs from Illicitly Reaching the Public. B- 175425. Washington, D.C.: April 17, 1972. Appendix II: GAO Contacts and Staff Acknowledgments GAO Contacts Triana McNeil at (202) 512-8777 or McNeilT@gao.gov; Mary Denigan- Macauley at (202) 512-7114 or DeniganMacauleyM@gao.gov; or Jacqueline M. Nowicki at (617) 788-0580 or NowickiJ@gao.gov. Staff Acknowledgments In addition to the contacts named above, Alana Finley (Assistant Director), Bill Keller (Assistant Director), Will Simerl (Assistant Director), Meghan Squires (Analyst-in-Charge), James Bennett, Ben Bolitzer, Breanne Cave, Billy Commons, Holly Dye, Wendy Dye, Brian Egger, Kaitlin Farquharson, Sally Gilley, Sarah Gilliland, Mara McMillen, Amanda Miller, Sean Miskell, Jan Montgomery, Dae Park, Bill Reinsberg, Emily Wilson Schwark, Herbie Tinsley, and Sirin Yaemsiri made key contributions to this report. Key contributors to the prior work discussed in this report are listed in each respective product.
target: Drug misuse—the use of illicit drugs and the misuse of prescription drugs—has been a persistent and long-standing public health issue in the United States. Ongoing drug control efforts seek to address drug misuse through education and prevention, addiction treatment, and law enforcement and drug interdiction, as well as programs that serve populations affected by drug misuse. These efforts involve federal, state, local, and tribal governments as well as community groups and the private sector. In recent years, the federal government has spent billions of dollars and has enlisted more than a dozen agencies to address drug misuse and its effects. This report provides information on (1) trends in drug misuse (2) costs and other effects of drug misuse on society and the economy, and (3) challenges the nation faces in addressing the drug crisis. GAO analyzed nationally representative federal data on drug misuse and deaths from overdoses for 2002–2018 (the most recent available); reviewed selected empirical studies published from 2014–2019; and compared GAO's High-Risk list criteria to findings and recommendations in over 75 GAO reports issued from fiscal year 2015 through March 2020. Nationally, since 2002, rates of drug misuse have increased, according to GAO's analysis of federal data. In 2018, the Substance Abuse and Mental Health Services Administration reported that an estimated 19 percent of the U.S. population (over 53 million people) misused or abused drugs, an increase from an estimated 14.7 percent in 2003. People across a broad range of demographic groups—including sex, race or ethnicity, education levels, employment status, and geographic categories—reported misusing drugs (see figure below). The rates of drug overdose deaths have also generally increased nationally since the early 2000s. Over 716,000 people have died of a drug overdose since 2002, and in 2018 alone, over 67,000 people died as a result of a drug overdose, according to the Centers for Disease Control and Prevention. Although the number of drug overdose deaths in 2018 decreased compared to 2017, drug misuse in the United States continued to rise. Rates of drug overdose deaths varied in counties across the nation in 2003 and 2017, the most recent year that county-level data were available (see figure below). In 2017, 43.2 percent of counties had estimates of more than 20 drug overdose deaths per 100,000 people, including 448 counties with rates that were significantly higher than this amount. Note: CDC's National Center for Health Statistics used a statistical model to estimate rates of drug overdose deaths to account for counties where data were sparse because of small population size. GAO work and other government and academic studies have found that the negative health and societal effects of drug misuse are widespread and costly—for example, the increased need for health care, human services, and special education; increased crime, childhood trauma, reduced workforce productivity; and loss of life. The federal government is making progress in some areas, but a strategic, coordinated, and effective national response—with key sustained leadership from federal agencies—is needed. This report identifies opportunities to strengthen the federal government's efforts to address this persistent and increasing problem. These opportunities include addressing challenges in providing sustained leadership and strengthened coordination; the necessary capacity to address the crisis; and systems to measure, evaluate, and demonstrate progress. For example: the Office of National Drug Control Policy should ensure future iterations of the National Drug Control Strategy include all statutorily required elements. Examples of statutorily required elements include a 5-year projection for the National Drug Control Program and budget priorities; a description of how each of the Strategy's long-range goals will be achieved, including estimates of needed federal resources; and performance evaluation plans for these goals, among other requirements; the Office of National Drug Control Policy should ensure effective, sustained implementation of the 2020 Strategy and future strategies; the Department of Health and Human Services should provide guidance to states for the safe care for infants born with prenatal drug exposure, who may be at risk for child abuse and neglect; the Drug Enforcement Administration should take steps to better analyze and use drug transaction data to prevent diversion of prescription opioids to be sold illegally; and the State Department should develop and implement a data management system for all Caribbean Basin Security Initiative activities to reduce illicit drug trafficking or track data trends across countries. In GAO's March 2019 High-Risk report, GAO named drug misuse as an emerging issue requiring close attention. Based on 25 GAO products issued since that time and this update, GAO has determined that this issue is high risk. Moreover, the severe public health and economic effects of the Coronavirus Disease 2019 (COVID-19) pandemic could fuel some of the contributing factors of drug misuse, such as unemployment—highlighting the need to sustain and build upon ongoing efforts. However, maintaining sustained attention on preventing, responding to, and recovering from drug misuse will be challenging in the coming months, as many of the federal agencies responsible for addressing drug misuse are focused on addressing the pandemic. Therefore, GAO will include this issue in the 2021 High-Risk Series update and make the high-risk designation effective at that time.