The opioid epidemic has been recognized as a national emergency (Gostin et al., 2017; Trump, 2019). Deaths from prescription and synthetic opioids and heroin increased over the past 10 years, with a notable increase in death from illicitly manufactured fentanyl and analogs as well as use of opioids with other drugs, such as benzodiazepines, stimulants, or alcohol (CDC, 2018, 2019, 2020). Factors leading to mortality increases include accidental overdose with high-potency drugs, suicidality, limited availability and use of treatment (NASEM, 2020; Oquendo and Volkow, 2018), stigma, low treatment retention, and over-prescribing (NASEM, 2017). Not all individuals with opioid use disorder (OUD) are able to obtain treatment, and treatment access and uptake varies widely (NASEM, 2020). The opioid crisis has both biological and societal causes, with social determinants of health playing a key role (Dasgupta et al., 2018; Volkow and Blanco, 2020). These data reinforce the need for comprehensive approaches to prevent overdose, provide access to evidence-based treatment, and ensure retention in treatment and recovery protocols.
To prevent overdose deaths, naloxone distribution among a broad range of actors is recommended (Bach and Hartung, 2019; Davis et al., 2014; Naumann et al., 2019). Community pharmacists may dispense naloxone without prescription in many states, though pharmacy dispensing may not be enough to meet the overall need (Guy et al., 2019). Syringe services programs can reduce high-risk injection behaviors and consequences, such as increases in infectious diseases, and promote treatment
referrals (NASEM, 2020). Distribution of rapid fentanyl test strips in syringe services programs may lead to changes in injecting behavior and lower overdose risk (Krieger et al., 2018a,b; Peiper et al., 2019).
Treatment access for substance use disorder (SUD) and OUD in particular is limited in rural areas and urban areas and in regions with large percentages of minority populations (NASEM, 2017). Buprenorphine has become increasingly available in medical practice, with an increase in waivered physicians and policy changes on dispensing (Andrilla et al., 2019). Still, availability is limited relative to the overall need, and not all patients are retained in treatment (Williams et al., 2019). Other contributing factors to the epidemic are limited use of prevention programs (school and community based) for long-term reduction in drug use and overdoses, limited prescribing of naloxone and/or harm-reduction strategies (NASEM, 2020), and high-dose and long-term prescriptions (NASEM, 2017).
Data suggest a negative correlation between overdose death and increased treatment access, reduced prevalence and comorbidities, and better prescribing practices (with some important consequences, such as increased pain for pain patients) (Seth et al., 2018). Use of medication for OUD (MOUD)1 reduces overdose and increases quality of life, and is particularly beneficial for populations at high risk of overdose, such as incarcerated populations (NASEM, 2020). While detoxification may be necessary to start treatment, detoxification without initiation of and engagement in treatment can lead to increased risk of overdose (SAMHSA, 2016). Current practice guidelines reinforce approved MOUD over detoxification alone (NASEM, 2017). Barriers to MOUD include limited availability of waivered providers, insurance coverage limits, and stigma (NASEM, 2020). Peer support programs may also decrease substance use and provide linkages to medical care (Ashford et al., 2018; Englander et al., 2019).
COMPREHENSIVE ADDICTION AND RECOVERY ACT
To help address overdose deaths and lack of access to treatment, the Comprehensive Addiction and Recovery Act (CARA) (P.L. 114-198) was signed into law on July 22, 2016.2 CARA is extensive legislation intended to address the opioid epidemic, including prevention, treatment, recovery,
1 As mentioned in the preface, the committee has elected to use MOUD rather than medication-assisted treatment, as the latter gives the false impression that medications alone are not helpful in treating OUD (NASEM, 2019, 2020).
2 See https://www.congress.gov/bill/114th-congress/senate-bill/524/text (accessed March 13, 2020).
law enforcement, criminal justice reform, and overdose reversal. CARA authorizes more than $181 million each year in new funding to fight the opioid epidemic and requires programs and services to be implemented across the United States to address addiction recovery.3 While OUD is a significant cause of harm in the United States, it is important to note that many individuals do not have only one SUD; rather, SUDs tend to co-occur (NIDA, 2020; Seth et al., 2018). The CARA program grants presented in this report, while focused on opioids, also occasionally address treatment and recovery services for other SUDs.
Following the passage of CARA, the Departments of Labor, Health and Human Services (HHS), and Education, and Related Agencies Appropriations Act, 2018 included appropriations specific to a study of the Substance Abuse and Mental Health Services Administration (SAMHSA) components in CARA to be conducted by the National Academies of Sciences, Engineering, and Medicine (the National Academies).4 Specifically, it stated that
within the total for administration, technical assistance, and evaluation, provided to SAMHSA for the State Opioid Response Grants, the agreement includes … a [National Academies] review [to] identify outcomes that are to be achieved by activities authorized in the Comprehensive Addiction and Recovery Act (P.L. 114-198) and the metrics by which the achievement of such outcomes shall be determined, as required by section 701 of such Act. The [National Academies] study should report on the effectiveness of the programs in achieving their respective goals for preventing, treating, and supporting recovery from SUDs. The [National Academies] study will result in the public availability of program-level data and recommendations to Congress concerning the appropriate allocation of resources to such programs to ensure cost-effectiveness in the Federal government’s response to the opioid addiction epidemic. It is expected that an interim report will be completed within three years after enactment of this Act, and a final report will be completed within five years after enactment of this Act.
There are four sections in CARA specific to SAMHSA.
Title I Prevention and Education, Section 107: Improving Access to Overdose Treatment Program (OD Treatment Access) allows HHS to award grants to eligible entities to expand access to opioid overdose reversal drugs or devices. Examples of other programs in this section
3 See https://www.cadca.org/comprehensive-addiction-and-recovery-act-cara (accessed March 13, 2020).
4 See https://docs.house.gov/billsthisweek/20180319/DIV%20H%20LABORHHS%20SOM%20FY18%20OMNI.OCR.pdf (accessed March 13, 2020).
include an interagency task force on pain management, awareness campaigns about prescription drug use risk/association between opioid and heroin/fentanyl danger, and the National Institutes of Health opioid research into pain treatment alternatives/chronic pain therapies.
Title II Law Enforcement and Treatment, Section 202: First Responder Training (FR-CARA) authorizes HHS to make grants to state, local, and tribal law enforcement agencies for training in the use of naloxone (or other Food and Drug Administration–approved devices) and naloxone purchases. This section also authorizes the expansion of prescription drug take-back programs in state, local, and tribal law enforcement and pharmacies and a grant program in the Department of Justice for treatment alternatives to incarceration, combating illegal distribution of opioids, and comprehensive opioid use response programs at the state, local, and tribal government levels.
Title 5 Addiction and Treatment Services for Women, Families, and Veterans, Section 501: State Pilot Grant Program for Treatment for Pregnant and Postpartum Women (PPW-PLT) reauthorizes a grant program for nonresidential opioid addiction treatment of pregnant and postpartum women and their children and creates a pilot program for state substance abuse agencies to address identified gaps in the continuum of care. Other sections include expansion of veterans’ treatment courts and substance use treatment programs, information about best practices for safe care of infants born with SUD or experiencing withdrawal symptoms, and the Government Accountability Organization report on neonatal abstinence syndrome.
Title 3 Treatment and Recovery Section 302: Building Communities of Recovery (BCOR) authorizes HHS to award grants for the development and expansion of recovery services. It also includes a program that expands MOUD and other evidence-based treatment/interventions in areas with high rates of OUD and raises the number of patients that a prescriber can have for buprenorphine from 30 to 100 per year.
Table 1-1 summarizes the four programs and offers a brief description of each. Based on the reporting tools, evaluation questions, and program purposes, data from the BCOR and PPW-PLT programs will be clinical, while the FR-CARA and OD Treatment Access program data will be qualitative and based on environmental factors, such as barriers and facilitators to treatment uptake (e.g., cultural and linguistic differences, transportation access issues, number of rural providers).
STATEMENT OF TASK AND COMMITTEE APPROACH
The committee’s Statement of Task is in Box 1-1; the committee will produce three reports in 5 years. This first report recommends to
SAMHSA outcomes and metrics that the four grant programs should require grantees to collect and report to SAMHSA. The committee’s second report, expected in 2021, will consider grantees’ reported outcomes and metrics in evaluating grantees’ progress toward achieving the specific goals of each grant program. The final report will assess each program’s effectiveness in accomplishing its purpose, as measured by the metrics identified in the first report. This final report will also recommend to Congress the appropriate distribution of resources for these and similar grant programs to ensure a cost-effective federal response to the opioid epidemic. Reports two and three are considered “Reports to Congress,” as directed in the legislation.
To address its charge, the committee met with SAMHSA representatives to introduce the committee’s task and provide an overview of the four programs. SAMHSA provided copies of the mandatory reporting tools for each of the four programs, discussed in more detail in Chapters 2 and 3 and available as supplementary material to this report. The committee requested information on work plans, evaluation plans, and progress reports from the principal investigator of each grant,5 at which
5 Public access file available via the National Academies at https://www.nationalacademies.org/our-work/review-of-specific-programs-in-the-comprehensive-addiction-and-recoveryact (accessed March 13, 2020).
time, the National Academies sent a request to each grantee for information about its specific program activities. Varying amounts of information were received from 35 grantees, typically including their grant proposals, implementation plans, and evaluation plans.
The committee approached the task as a practical assessment of four discrete programs funded by SAMHSA. The goals of these programs are service delivery and not research. As a result, the committee viewed its responsibility as assessing these four programs rather than SAMHSA’s approach to OUD in general. However, the programs under review here are similar to other SAMHSA programs, several of the reporting tools grantees use are identical or similar to reporting tools that other programs use, and SAMHSA guidance to and resources for grantees are those relevant to other programs. Thus, the committee understands that its conclusions and recommendations, while focused on the four programs in CARA, could be useful for SAMHSA more broadly.
The committee is also cognizant that focusing on only four specific programs may produce an incomplete view of SAMHSA or HHS’s approach to the opioid epidemic. The committee understands that the CARA programs under review touch on only parts of an opioid care continuum (Williams et al., 2019) that includes diagnosis of an OUD, engagement in care, initiation of MOUD, retention in treatment, and remission of OUD. Thus, any recommendations about outcomes and metrics in this report, and assessment of program effectiveness in subsequent reports, do not address the overall needs of a comprehensive approach to OUD. Where reasonable, however, the committee has made conclusions and recommendations that are focused on the scope of these individual grant programs, providing additional metrics and outcomes that would advance their overall goals.
ORGANIZATION OF THE REPORT
The report contains two other chapters. Chapter 2 addresses the two programs administered by SAMHSA’s Center for Substance Abuse Prevention, the FR-CARA and OD Treatment Access programs. Chapter 3 addresses the two programs administered by SAMHSA’s Center for Substance Abuse Treatment, BCOR and PPW-PLT. Both chapters describe the programs, SAMHSA’s mandatory reporting, and committee conclusions and recommendations for outcomes and measures that SAMHSA should consider using in these, and possibly similar, programs.
TABLE 1-1 Summary of Four CARA Programs Under Review
|Program and Funding Opportunity Announcement No.||Eligible Applicants||Awards and Project Period||Program Purpose|
|Comprehensive Addiction and Recovery Act (CARA): Building Communities of Recovery (BCOR)a||Recovery community organizations (RCOs) that are domestic private nonprofit entities in states, territories, or tribes (must be controlled and managed by members of the addiction recovery community)||2017 Awarded: 8 (up to $200,000 each)b
2018 Awarded: 18 (up to $200,000 each)c
Up to 3 years
The goal of BCOR is to enhance the scope and quality of long-term recovery support from substance use and addiction:
TABLE 1-1 Continued
|Program and Funding Opportunity Announcement No.||Eligible Applicants||Awards and Project Period||Program Purpose|
|State Pilot Grant Program for Treatment for Pregnant and Postpartum Women (PPW-PLT)d||Single State Agencies for Substance Abuse||2017 Awarded: 3 ($1,100,000 each)
2018 Awarded: 3 (up to $1,100,000 each)
The purpose of the program is to enhance flexibility in the use of funds to:
|Up to 3 years||Through this program, the Substance Abuse and Mental Health Services Administration (SAMHSA) seeks to reduce the misuse of alcohol and other drugs, increase engagement in treatment services, increase retention in the appropriate level and duration of services, and increase access to the use of medications approved by the Food and Drug Administration (FDA) in combination with counseling to treat drug addiction.|
|First Responder Training (FR-CARA)e||States; tribes and tribal organizations; local governmental entities||2017 Awarded: 21 (between $250,000 and $800,000 each)
2018 Awarded: 28 (between $250,000 and $800,000 each)
Up to 4 years
The purpose of this program is to:
FRs include firefighters, law enforcement officers, paramedics, emergency medical technicians, or other legally organized and recognized volunteer organizations that respond to adverse opioid-related incidents. SAMHSA will take into consideration whether the project will be implemented in rural or non-rural geographic areas.
|Improving Access to Overdose Treatment Program (OD Treatment Access)f||Federally qualified health centers; opioid treatment programs; practitioners dispensing narcotic drugs||2017 Awarded: 1 (up to $1,000,000 each)g
2018 Awarded: 5 (up to $200,000 each)h
Up to 5 years
The purpose of the program is to expand access to FDA-approved drugs or devices for emergency treatment of known or suspected opioid overdose:
a See https://www.samhsa.gov/grants/grant-announcements/ti-19-003 (accessed March 13, 2020).
b See https://www.samhsa.gov/grants/awards/2017/TI-17-015 (accessed April 21, 2020).
c See https://www.samhsa.gov/grants/awards/2018/TI-17-015 (accessed April 21, 2020).
d See https://www.samhsa.gov/grants/grant-announcements/ti-20-010 (accessed March 13, 2020).
e See https://www.samhsa.gov/grants/grant-announcements/ti-19-004 (accessed March 13, 2020).
f See https://www.samhsa.gov/grants/grant-announcements/sp-18-006 (accessed March 13, 2020).
g See https://www.samhsa.gov/grants/awards/2017/SP-17-006 (accessed April 21, 2020).
h See https://www.samhsa.gov/grants/awards/2018/SP-18-006 (accessed April 21, 2020).
i See https://store.samhsa.gov/product/Opioid-Overdose-Prevention-Toolkit/SMA18-4742 (accessed March 13, 2020).
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