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¹Box A-4 in Appendix A lists the current grantees of the OD Treatment Access program.

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² SAMHSA originally awarded funding to 28 grantees in the FY2018 cohort; one of the original grantees rescinded, and 27 remain funded. See Public Access File (PAF), Item 58. This source will be referred to in the chapter as “SAMHSA Responses: OD Treatment Access” or “SAMHSA Responses: FR-CARA.” PAF available by request via the National Academies. See https://www.nationalacademies.org/our-work/review-of-specific-programs-in-the-comprehensive-addiction-and-recovery-act (accessed March 10, 2021).

³ For the full list of FR-CARA grantees, see Box A-5 in Appendix A.

^a See the toolkit at https://store.samhsa.gov/product/Opioid-Overdose-Prevention-Toolkit/SMA18-4742 (accessed March 13, 2020).

^b The committee prefers the term “survivors”; however, “victims” will be used when directly quoting SAMHSA.

^c SAMHSA initially awarded funding to 28 grantees in this year. One of the original grantees rescinded (see section “FR-CARA Program Description”).

SOURCES: The information in this table is pulled directly from the funding opportunity announcements for OD Treatment Access (SAMHSA, 2017d) and FR-CARA (SAMHSA, 2017c). The information in the Awards and Projects column comes from the Individual Grant Awards pages for OD Treatment Access (SAMHSA, 2017f, 2018e) and FR-CARA (SAMHSA, 2017e, 2018d).

Summary Report from the CSAP Division of State Programs Management Reporting Tool (DSP-MRT)

The first source document is a report that presents SAMHSA’s summary of the information grantees submitted using the CSAP DSP-MRT reporting tool.⁴ Grantees for both programs included in this chapter (OD Treatment Access and FR-CARA) were required to use this reporting tool, which is used by a variety of SAMHSA grant programs. The questions in the tool prompt grantees to report about their work plans and implementation progress through a series of drop-down menu questions and free text responses. SAMHSA used the grantees’ responses

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⁴ For additional detail on the reporting tool, please refer to Box A-6 in Appendix A.

to generate two summary reports—one for each grant program—that were then shared with the committee. The reporting period covered by the report for the FR-CARA grantees was FY2019; the reporting period for OD Treatment Access grantees is unclear, and will be discussed in the limitations section.

The two CSAP DSP-MRT summary reports were received in May 2020.⁵ Following an initial review of the documents, the committee contacted SAMHSA with a list of questions about the information provided. SAMHSA responded with two documents, one for each program (clarifications for the information in the OD Treatment Access reporting form were provided alongside clarifications from that program’s CSAP DSP-MRT summary report); some of the agency’s responses informed the creation of this report as well.⁶ The committee notes that, at times, SAMHSA’s responses to its questions did not provide additional clarifications. All of these documents can be found in full in the Public Access File; in the results section, all of these documents will be referenced parenthetically by report name.⁷

Limitations

There are several important limitations to the CSAP DSP-MRT summary reports that SAMHSA shared with the committee. First, of six OD Treatment Access grantees, only four submitted information to SAMHSA that is reflected in the summary report. The four reporting grantees represent both the FY2017 and FY2018 cohorts of the program, and SAMHSA did not provide an explanation for why the remaining two grantees did not report (SAMHSA Responses: OD Treatment Access). Similarly, SAMHSA only provided information submitted by the FY2018 cohort of the FR-CARA program. When the committee inquired as to whether it would receive data from any of the 21 grantees in the FY2017 cohort, SAMHSA responded that the FY2018 cohort is the only one required to submit an annual progress report to SAMHSA. Of the 27 grantees from the FY2018 cohort, only 21 submitted reports; SAMHSA did not provide an explanation for why the other grantees did not report (SAMHSA Responses: FR-CARA). As such, the committee’s report cannot comment on any progress that might have been made by the non-reporting grantees.

Additionally, the reporting period covered by the CSAP DSP-MRT summary report for the OD Treatment Access grantees was not clearly stated, either in the initial report or in SAMHSA’s responses to the National Academies’ clarifying questions. As such, it is unclear to the committee when the activities covered in the reports were undertaken—that is, in one particular fiscal year, or the entirety of the grant period so far—or whether the reporting periods varied by grantee (as was the case for the treatment programs). Within the text of grantees’ responses, there were occasional mentions of dates and years, and the committee knows that the FR-CARA DSP-MRT summary report covered FY2019. These two pieces of context led the committee to tentatively presume that the DSP-MRT summary report for the OD Treatment Access program covers program activities undertaken during the reporting periods of FY2018 and FY2019. The summarized nature of the material in the DSP-MRT summary reports presented additional limitations. First, the summaries were created by the funder, rather than an independent evaluator. It is unclear to the committee what criteria SAMHSA used to determine which information from grantee submissions would be included or excluded in the summary, and difficult to confirm SAMHSA’s interpretation of the data. Furthermore, it was at times not possible for the committee to surmise how many grantees had reported a given experience or achievement. Because the committee could not attribute activities to specific grantees, it is unclear whether the program progress reported reflects on the whole group or is disproportionately carried by particular grantees. Similarly, when it came to quantitative data, SAMHSA’s decision to present aggregated data prevented quantitative analysis by the committee (e.g., to determine variation or to associate data with program or community features).

The questions in the DSP-MRT at times elicited different types of answers from grantees, suggesting that the prompts were not entirely clear. At other times, the questions overlapped with one another, leading to repetition in

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⁵ See PAF, Item 45.

⁶ The documents with SAMHSA’s responses can be found in PAF, Item 58.

⁷ The DSP-MRT summary reports will be cited as “DSP-MRT”; the summary report generated from the OD Treatment Access reporting form will be cited as “OD Tx ARF”; the agency’s clarifications will be cited as “SAMHSA Responses: OD Treatment Access” and “SAMHSA Responses: FR-CARA,” respectively.

the answers.⁸ Additionally, not all grantees responded to each question in the CSAP DSP-MRT. SAMHSA did not offer explanations for these omissions, which created ambiguity for interpretation. It is unclear whether a lack of response suggested, for example, that a grantee had undertaken no relevant activities to date, that they were still in a planning phase but did not yet have reportable data, or that they simply failed to report an activity.

Report from the OD Treatment Access Reporting Form

The second source type was another summary report that pertained only to the OD Treatment Access grantees. In addition to the more general CSAP DSP-MRT, SAMHSA created a reporting tool specifically for the OD Treatment Access grant program, called the OD Treatment Access reporting form (OD Tx ARF). This tool consists of eight questions, five of which prompted open-ended narrative responses, and three of which requested quantitative data. SAMHSA generated a report from these responses that included largely full, narrative responses from grantees (which were de-identified), and some information that had been aggregated across grantees. The reporting period covered by the OD Treatment Access reporting form report is unclear, and will be addressed in the limitations section.

The report was sent to the committee by SAMHSA in May 2020.⁹ As previously discussed, the committee contacted SAMHSA with a list of questions about the information provided on the OD Treatment Access program in the two reports. The agency responded in September 2020.¹⁰ In the results section of this chapter, these documents will be referred to in parentheses.

Limitations

SAMHSA’s report on the OD Treatment Access reporting form reflects the answers of only four of six grantees, and the other two did not submit responses. The reporting period for this document is also unclear. The title of the document says “FY2018 and FY2019 grantee survey responses” (OD Tx ARF), so the committee has assumed that the summary represents grantee activities from both FY2018 and FY2019. However, it is unclear whether the reporting periods are consistent across grantees, or whether the reports cover the entirety of both of the two fiscal years. SAMHSA did not clarify this when asked (SAMHSA Responses: OD Treatment Access). As with the DSP-MRT, the prompts to which grantees must respond do not precisely align with the required and allowable activities of the OD Treatment Access program.

The OD Treatment Access form report, in contrast to the CSAP DSP-MRT summary report, consisted in large part of verbatim responses from grantees. For five of the eight questions asked to grantees, the narrative responses of each grantee are presented separately and completely, with grantee names redacted. Though these responses varied in detail and length, the fact that grantee responses were separated out (rather than summarized) in some instances provided clarity that the CSAP DSP-MRT summary report lacked. However, for the remaining three questions, SAMHSA generated a summary report that included results from all four responding grantees, similar to the CSAP DSP-MRT summary report. For the information presented in these questions, the same limitations previously discussed apply: there were unclear inclusion criteria for the information presented, it was unclear how many grantees reported a given activity, and aggregated data presented challenges for analysis.

There were a few instances in which the committee identified seemingly conflicting data between the OD Treatment Access form report and the CSAP DSP-MRT summary report for the OD Treatment Access grantees (e.g., data on trainings provided, data on naloxone kits distributed). It is possible that these discrepancies could be the result of differences in the reporting periods covered by the two documents; however, because the time frame is also unclear, the committee cannot determine whether that is the case. It is also possible that one or the other report includes erroneous data. In either case, without further explanation, the committee cannot interpret these data.

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⁸ For a complete list of the prompts included in this reporting tool, please refer to Box A-7 in Appendix A.

⁹ See PAF, Item 45.

¹⁰ See PAF, Item 58.

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¹¹ See PAF, Item 2.

The grantees described many lessons learned and best practices (formulated with the assistance of their partners) for prescribing and co-prescribing. It should be noted that the following reflections come from the grantee leader perspective, and do not include feedback or best practices as reported by, for example, program participants or clients. Grantees reported the advantages of enlisting champions at each health care site, the utility of a 24/7 hotline to assist those actively treating patients, and the need to get buy-in from leadership. They also suggested that participation in community events and advertising the availability of opioid reversal treatments (even within a facility) could be useful. One grantee underscored the importance of using evidence-based models such as trauma-informed care and stages of changes, and stated that they were incorporated into their protocols and toolkits; this grantee and one other both emphasized the harm reduction model. Use of local networks, incorporation of assessment and treatment recommendations in electronic health record (EHR) systems, and paying close attention to workflow were also important lessons learned. One grantee pointed out that interventions should be made sustainable by incorporating changes into normal workflows and changing policies. One group developed an interdisciplinary Chronic Pain Management Work Group to both serve as a resource and monitor opioid prescribing trends (OD Tx ARF). The need to educate pharmacists and enlist the aid of pharmacies was also mentioned (OD Tx ARF, DSP-MRT). The extent to which these best practices were directly implemented by grantees or their partners was not always clear in the summary reports.

Required Activity 2: Train and Provide Resources for Health Care Providers and Pharmacists on the Prescribing of Such Drugs or Devices

Trainings Provided

All four reporting grantees created curricula and delivered trainings on the prescribing of overdose drugs and devices. In aggregate, across grantees, their trainings reached a variety of audiences. As the required activity specifies, two of their key audiences were health care providers and pharmacists. Additionally, though not specified in the activity, grantees also provided trainings to individuals who use drugs and other community members. In order to reach these varied audiences, the grantees drew on existing partnerships and formed new ones; they provided sessions with health care providers and pharmacies, as well as with higher education programs, church congregations, local businesses, and substance use services including clinics that provide medications for OUD (MOUD) and syringe exchange programs (OD Tx ARF, DSP-MRT).

Both sources of grantee reporting material (the OD Treatment Access reporting form and the CSAP DSP-MRT) include quantitative data about the trainings delivered by grantees. In both cases, these numbers were aggregated by SAMHSA across all grantees. According to the data provided through the OD Treatment Access reporting form

summary report, grantees held training sessions in 92 locations, reaching a total of 2,398 individuals. Those trained included physicians (n = 97), physician assistants (n = 1), nurse practitioners (n = 57), pharmacists (n = 42), and “others” (n = 2,201). Notably, one grantee appeared to have recently posted training material on a website that is capable of tracking “future receipt of the program,” and it is unclear whether data on the number and/or type of individuals accessing the site are included in these counts (OD Tx ARF). The committee notes that the majority of individuals trained fall into the “other” category; because there was no further specificity in this category, the committee cannot assess whether health care workers and pharmacists, the audiences specified in this required activity, were the focus of these trainings.

These data were inconsistent with the data provided by the DSP-MRT summary report, with the latter reflecting significantly lower numbers. According to the data provided by the DSP-MRT summary report, grantees held “up to 96 trainings”¹² in 9 different locations, reaching 1,870 participants (DSP-MRT). These data do not provide a breakdown of participants by type as seen in the data from the OD Treatment Access reporting form. It is possible that the discrepancies in the data provided by the two reports may be partially explained by a difference in the reporting periods they cover. However, as described in the methodology section, the reporting periods for both are unclear. With the discrepancies unexplained, it is difficult to interpret either of these sets of data about the trainings provided. Furthermore, due to the aggregation of the data across grantees, it is not possible to determine whether a few grantees may have been responsible for a disproportionate number of training sessions. In any case, it is evident that grantees have made progress in conducting trainings.

The committee found little information regarding outcomes of these trainings (e.g., increased knowledge, changes in practices). The OD Treatment Access reporting form did not require that grantees submit information on training outcomes,¹³ but one grantee self-reported that of 144 providers they surveyed, “98 percent indicated that they were more prepared in responding to a suspected overdose after participating in training” (OD Tx ARF). The DSP-MRT summary report noted that “throughout all trainings enrollment forms, pre and post tests were gathered which allowed grantees to gather demographic information and measure change in knowledge, behaviors, and attitudes regarding the opioid epidemic” (DSP-MRT). This would seem to suggest that at least more than one grantee used pre–post tests, but due to the summary nature of this report, it is unclear which or how many. The committee did not receive copies of these tests or information regarding their results.

Several of the programming best practices identified by grantees in their reports pertained specifically to these trainings. They reported the benefits of “drop-in” training sessions as a strategy for reaching new audiences. One grantee recommended participating in community events in order to advertise the trainings. They recommended that training be individualized and tailored to the audience, and emphasized considerations of cultural competency and non-judgment. They also suggested avoiding lectures that appear authoritative in order to not put off attendees (OD Tx ARF). For the sake of sustainability and ease, one grantee recommended incorporating changes into existing trainings (OD Tx ARF, DSP-MRT). The committee would like to highlight that one grantee adapted their in-person training curriculum to an online format, an innovation that could potentially increase the reach or accessibility of the training (OD Tx ARF).

One grantee also identified challenges encountered in the delivery of trainings, particularly when it came to audiences of health care providers. They expressed that they found low demand for their trainings among FQHCs and hospitals because, they felt, providers considered themselves already knowledgeable about the administration of naloxone. This grantee expressed that they felt there was in fact a large gap among providers in practical considerations, such as understanding of the laws around naloxone access and administration and insurance coverage. In order to address the barrier of low interest among providers, they incorporated MOUD training into their curriculum, for which they found there was greater demand among providers (OD Tx ARF).

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¹² It is unclear in the source whether grantees held 96 trainings in aggregate, or whether grantees provided different numbers of training, with a maximum of 96 trainings having been provided by one individual grantee.

¹³ See PAF, Item 2.

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¹⁴ See PAF, Item 2.

3 in Box 3-2). As the other two grantees did not provide greater specificity on this point, the committee cannot determine whether their protocols resulted in clients being referred to appropriate, evidence-based practices.

General Processes for Connection to Treatment

In addition to the protocols previously presented, several grantees described processes aimed at connecting all individuals with OUD to treatment services; the following are examples that grantees presented as approaches that benefit all clients living with OUD, including survivors of overdoses.

Several of the grantees themselves provide treatment services to individuals with OUD. A few grantees highlighted the centrality of a harm reduction framework in their protocols. One grantee described theirs as an “individualized,” patient-centered approach that takes into account a patient’s “readiness,” “history of use,” and “concurrent treatment services.” The same grantee is one of the largest providers of buprenorphine in the community, and states that almost all of their eligible providers hold Drug Addiction Treatment Act of 2000 waivers (OD Tx ARF).

The grantees who provided treatment services themselves described a number of strategies they use to garner referrals to their own services, ultimately facilitating connections for clients. Several of these were outlined in Box 3-2, as they apply directly to overdose survivors, but also facilitate connection for other individuals with OUD (e.g., one grantee updated their electronic medical record [EMR] system updates to facilitate referrals from hospitals and the county jail; disseminating of bed availability to community partners). Additionally, one grantee emphasized the importance of their outreach staff in facilitating connection to treatment. One grantee reformulated its policy on buprenorphine with the aim of helping providers “reduce barriers which may delay the initiation of MOUD and support a harm-reduction stepped-approach to prescribing.” Specifics of this new policy were not provided (OD Tx ARF). Because some of the questions in the report were summarized across grantees, it is unclear whether some of these activities may have come from the same grantee.

Grantees also described developing protocols and strategies to refer individuals to external treatment services. One grantee provides transportation to other services and assists clients in completing online application processes for other residential services (OD Tx ARF). Another reported connecting syringe exchange clients to “detoxification units” (DSP-MRT).

Though it was not explicitly requested in this required activity, all four grantees emphasized the importance of connection to case management and social services as a key facilitator for clients’ engagement in treatment. As such, all grantees included social service activities or referrals when describing their efforts to connect clients to treatment. Several grantees directly provide case management to help link clients to needed social services and benefits enrollment. One provides social work services onsite, and another developed a protocol to connect City Fire patients to their social workers (OD Tx ARF). One grantee reported collaborating with community partners to maintain a database of social and medical services related to substance use, in order to help facilitate connections to such resources (DSP-MRT).

Quantitative Data on Connections to Treatment

The OD Treatment Access form report provided quantitative data on the number of overdose survivors who were connected to and initiated various types of treatment during the reporting period. All four reporting grantees submitted these data to SAMHSA and they were aggregated across grantees. Ultimately, grantees reported that a total of 139 overdose survivors were connected to treatment, including MOUD (n = 86), counseling (n = 83), behavioral therapies (n = 71), and other types of treatment (n = 122). The application of “other” was left to the discretion of grantees; SAMHSA speculates that it is most likely applied to mental health and substance abuse treatment services (SAMHSA Responses: FR-CARA). The grantees in aggregate reported that 76 overdose survivors initiated treatment, including MOUD (n = 51), counseling (n = 53), behavioral therapies (n = 41), and

other types of treatment (n = 63; OD Tx ARF).¹⁵ However, without more specificity about the types of behavioral therapies, counseling, or “other” treatments included in these numbers, the committee cannot determine whether those treatment services to which grantees connected patients are evidence-based.

There are a number of confounds that make it difficult to interpret these quantitative data. First, the data provided in the summary report did not include a clear denominator representing the number of overdose survivors, in total, who were in contact with the grantees (SAMHSA Responses: OD Treatment Access).¹⁶ Additionally, because there are no baseline data with which to compare, it is not possible to determine whether the OD Treatment Access program has increased the rate at which grantees have connected overdose survivors to treatment. Grantees also did not establish goals at the beginning of the grant cycle for how many overdose survivors would be referred to treatment services (SAMHSA Responses: FR-CARA), so results also cannot be measured against expectations. SAMHSA explained that it does not require grantees to set goals for referrals because the number of overdose events cannot be predicted at the outset of the fiscal year, and therefore neither can the number of survivors who might need connection to treatment (SAMHSA Responses: FR-CARA). However, the committee notes that SAMHSA could have set a goal for grantees using percentage targets (e.g., that 100 percent of overdose survivors in contact with the program should receive evidence-based treatment).

While the committee notes that the figures for referrals to treatment seem low, it acknowledges that there may be significant barriers to receiving treatment following an overdose.

Connection to Treatment for Those at High Risk of Overdose

In addition to connecting overdose survivors to treatment, SAMHSA reported that all grantees had focused efforts on identifying and connecting to treatment those individuals who are at high risk for overdose. One grantee wrote about calling on the city to “identify individuals and communities at the greatest risk for opioid overdose;” another noted that their prescribing toolkit included a “detailed description identifying potential risk factors” for overdose (OD Tx ARF). SAMHSA reported that grantees created plans to more effectively reach high-risk and high-need individuals and to connect them to treatment services, though it is unclear how many grantees undertook each activity (DSP-MRT). Some examples highlighted by the two summary reports included building partnerships; conducting outreach to those utilizing syringe services or housing services, low-income individuals, and those facing barriers to accessing quality health care; alerting providers within the EMR system when a patient’s history may put them at higher risk of overdose; and introducing an MOUD program into the county jail, coupled with a continuity of care plan (OD Tx ARF, DSP-MRT). One strategy highlighted repeatedly was the training of culturally competent staff (OD Tx ARF, DSP-MRT). One grantee reported that they provided treatment to more than 1,500 individuals with “histories of opioid misuse,” and upon discharge, had successfully trained and provided naloxone to 500 of those patients (DSP-MRT).

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¹⁵ Two grantees added caveats to the data that they reported for these questions. One grantee clarified that they had 41 patients initiate treatment for OUD during the reporting period, but only two were immediately following admission to the emergency room for an overdose event (OD Tx ARF); only those two are included in the aggregated numbers included here. Another grantee stated that 566 patients received MOUD during the reporting period, “many” of whom have a history of drug overdose occurring before the reporting period; it appears that the grantee did not include them in the aggregated numbers (OD Tx ARF). It is unclear to the committee whether the other two grantees used similar rules in deciding what numbers to report.

¹⁶ According to the OD Treatment Access FOA, one of the goals of grantee data collection is to “understand” the impact of grant program activities on overdose rates overall. The CSAP DSP-MRT summary report provided by SAMHSA included several tables with data submitted by grantees reflecting overdose rates from year to year in their jurisdiction, tribal area, or entire state, and within identified “high-risk communities.” The committee has determined that these overdose rates data are contextual, and cannot be used to evaluate whether grantees’ program activities have impacted overall rates in their locality. Due to a number of confounds and limitations that could lead readers to misinterpret their significance, these tables are not included in this report. They can be found in the Public Access File within the respective DSP-MRT Summary Reports for the program.

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¹⁷ PAF, Item 2.

¹⁸ PAF, Item 2.

referrals to services, and naloxone distribution and collected pre–post tests for trainings (DSP-MRT, OD Tx ARF). One grantee reported using “unique communication tools, OpiRescue and Live Stories,” to track and illustrate data in their state (OD Tx ARF). Such systems can help focus and direct future efforts, and the collection of data on efforts or needs identification could potentially help secure future funding. One grantee explicitly stated that they planned to increase their focus on data collection in the coming year because, in their view, doing so will “support program evaluation and community impact” (OD Tx ARF).

Required Activity 5: Use SAMHSA’s Opioid Overdose Prevention Toolkit¹⁹ as a Guide to Develop and Implement a Comprehensive Prevention Program to Reduce the Number of Opioid Overdose-Related Deaths and Adverse Events

The OD Treatment Access reporting form asks grantees to describe “in what ways is your training curriculum informed by or consistent with” SAMHSA’s Opioid Overdose Prevention Toolkit.²⁰ However, neither this tool nor the DSP-MRT reporting tool asked that grantees comment on how the toolkit influenced other components of their “comprehensive prevention programs” (e.g., establishing prescribing programs, connecting survivors to treatment). One grantee noted that they used the toolkit in the creation of prescribing practice guidelines (DSP-MRT). No other grantees mentioned having used the toolkit in these contexts. As such, the committee will comment specifically on the use of the toolkit to develop the training curriculums.

All four of the reporting grantees stated that they used the SAMHSA toolkit in developing their training curriculums. Several added supplementary components and one stated that they used a “condensed” version of the toolkit. In their reports, grantees provided great detail about the specific sections from the toolkit that they incorporated into their training; while responses were varied, many highlighted incorporation of the Centers for Disease Control and Prevention (CDC) Opioid Prescribing guidelines, information for prescribers, strategies to prevent overdose, and legal considerations (OD Tx ARF).

Additionally, all of the grantees highlighted that they also incorporated into their training important local or internal considerations. Several included relevant local resources, such as pharmacies known to carry naloxone and OUD and SUD services agencies, local data on overdose rates, and information on local Good Samaritan and naloxone access legislation. One grantee included internal policies for their organization (OD Tx ARF).

Allowable Activity 1: Collaborate with Health Care Providers and Pharmacists to Educate Them on Overdose Dangers, and to Recommend That They Consider Providing Standing Orders for FDA-Approved Overdose Reversal Drugs to Patients and Individuals Who Support Persons at High Risk for Overdose

As described under Activity 2, over the course of the reporting period, the grantees collaborated with health care providers and pharmacists to provide them with training on prescribing overdose treatment drugs or devices. Much of this training included information about overdose dangers and the scope of the health issue. In aggregate across grantees, they provided training to 97 physicians, 1 physician assistant, 57 nurse practitioners, and 42 pharmacists (OD Tx ARF).

The two reports provide very little information that would indicate whether grantees were recommending to health care providers and pharmacists that they consider providing standing orders. In fact, standing orders are not mentioned at all in the DSP-MRT summary report. The OD-Tx Access reporting form mentions standing orders three times, but none of them give a clear statement about this activity having occurred. One grantee noted that, prior to the reporting period, the city health department had issued a standing order for naloxone from “participating pharmacies” (OD Tx ARF). It is unclear whether the pharmacies with which the grantee later partnered were already participating pharmacies, or, if they were not, whether the grantee attempted to encourage the pharmacies with which it partnered to become participating pharmacies. One grantee described having discussed “the standing

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¹⁹ See https://store.samhsa.gov/product/Opioid-Overdose-Prevention-Toolkit/SMA18-4742 (accessed March 12, 2020).

²⁰ PAF, Item 2.

order regarding naloxone access without a prescription” in their conversations with “various stakeholder” partners, which included pharmacies and health care providers (OD Tx ARF). It is unclear whether the grantee was recommending that they create standing orders, or simply informing them of the existence of standing orders in their locality. Another grantee noted that one of the most frequently asked questions during their training with providers was about “statewide legislation regarding access and distribution (e.g., a statewide standing order)” (OD Tx ARF).

Allowable Activity 2: Collaborate with Pharmacies to Distribute Overdose Reversal Drugs or Devices, If Permitted by State Law

The OD Treatment Access form report highlighted two instances in which grantees collaborated with pharmacies for the distribution of such drugs and devices. One grantee developed a system through which they could alert the local pharmacy prior to ordering a naloxone prescription, in order to “ensure it is properly stocked” (DSP-MRT). Additionally, one grantee’s state Board of Pharmacy requires that pharmacies undergo training in order to furnish these drugs and devices; the grantee provided educational resources and information to 24 pharmacies in the area about the required training in order to facilitate distribution (OD Tx ARF). It is unclear in the source whether these two activities were undertaken by the same or different grantees. Grantees also collaborated with pharmacies for training on prescribing overdose reversal drugs or devices. As highlighted in the section for Required Activity 2, pharmacists were one of the key audiences for the trainings that grantees conducted. In one case, a grantee had partnered with a pharmacist in the development of their training on prescribing practice guidelines, and a general naloxone training curriculum, which they then delivered to a number of other organizations (OD Tx ARF).

In this first stretch of the grant period, grantees reported undertaking outreach efforts through which they were beginning to develop partnerships. In reflecting on best practices and lessons learned about prescribing programs, many grantees observed the important role of pharmacies. Though it is unclear whether all grantees have already collaborated with pharmacies, these observations and identification of potential partnerships may still constitute a step toward this allowable activity. The grantees documented some of what they observed:

Although it is unclear whether these observations were directly linked to action, observations such as these could be an important outcome of outreach and partnership building.

The grantee who provided training to 24 pharmacies underscored the importance of collaborating with pharmacies and felt that, at the time of writing, there was a gap in understanding the importance of naloxone on the part of many pharmacies. Only 6 of the 24 pharmacies with which they ultimately partnered had been furnishing naloxone prior to their collaboration. During their outreach, they found that “most pharmacists stated they do not furnish naloxone because their clients do not ask for it.” This grantee expressed their opinion that directly collaborating with and partnering with pharmacies would improve access (OD Tx ARF).

Allowable Activity 3: Provide Public Education on Any State “Good Samaritan” Laws Related to Drug Overdose

Although no grantees reported having conducted additional educational programming specifically focused on Good Samaritan laws (see Box 3-4 for more information on Good Samaritan laws), one grantee highlighted that discussion of the subject is included in their other programming. This grantee reported that their training curriculum (for Required Activity 2) includes a section on “Legal and liability considerations, including the Good Samaritan law.” They also created a document on “Naloxone Prescribing Practice Guidelines,” posted to their website and available to the public, that includes a section on Good Samaritan laws (OD Tx ARF).

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²¹ Refer to Box 3-1 for definitions of these two actors.

unknown dosage (DSP-MRT). As SAMHSA noted to the committee, each kit administered does not necessarily suggest a unique overdose event; especially in cases of fentanyl use, multiple kits may be needed to reverse an overdose (SAMHSA Responses: FR-CARA; Schumann et al., 2008; Somerville et al., 2017). These naloxone administrations took place in private residences (n = 1,781), public outdoor spaces (n = 471), and public indoor spaces (n = 326). Of the reported administrations, 1,954 did not have location data. Of note, SAMHSA reported that at least one grantee is working on developing a system to map overdoses (and recovery services activities) more granularly, using geographic information systems (DSP-MRT).

In analyzing the significance of the administration data, there are a few important limitations to consider. First, several grantees informed SAMHSA that Health Insurance Portability and Accountability Act rules and other confidentiality issues (perhaps including legal concerns in the absence of Good Samaritan laws) presented obstacles to data collection about administrations (SAMHSA Responses: FR-CARA). Furthermore, the reporting system for administrations (namely, who reports these data and to whom) varies by grantee. It is possible that the actual number of administrations was higher than reported, as additional kits may have been administered but simply not reported back to the grantees (SAMHSA Responses: FR-CARA). In order to consider whether a lack of Good Samaritan laws in select jurisdictions may have contributed to lower administration rates for some grantees, it would be necessary to review administration rates by specific grantee.

Of the administrations reported by grantees, 1,815 were reported to have resulted in overdose reversals, and 107 in deaths (DSP-MRT).²² As previously noted, a one-to-one ratio of kits used to overdose events should not be

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²² Due to a number of confounds and limitations that could lead the reader to misinterpret their significance, the committee chose not to present the contextual overdose data tables included in the DSP-MRT. See footnote 17 of this chapter for a more detailed explanation. The tables can be found in PAF, Item 45.

expected, because multiple kits may be necessary for an effective reversal. However, the outcomes reported would add up to only 1,922 overdose events, which is well under 50 percent of the number of reported administrations (DSP-MRT). It is possible that there were instances where a kit was administered and no outcome was reported.

Several grantees reported that they undertook community or organizational changes that facilitated their ability to acquire, distribute, or administer naloxone. Four grantees reported that they collaborated with prescribers to obtain standing orders for naloxone. To enhance availability of the drug for lay people, 6 grantees collaborated with pharmacies for distribution, 15 partnered with community entities who were already experienced in distributing naloxone to lay people, and 18 expanded naloxone distribution to new community partners. Furthermore, 17 grantees partnered with first responder agencies who were experienced in the administration of naloxone. Twelve grantees reported that they “enhanced state local executive agency coordination of naloxone efforts,” though no specifics are provided about these efforts or their results (DSP-MRT). As with the other data, it is possible that these numbers underrepresent how many grantees took such actions, because it is unclear in the summary whether other respondents answered in the negative or simply left these questions blank.

Required Activity 2: Train and Provide Resources for First Responders and Members of Other Key Community Sectors on Carrying and Administering a Drug or Device

All FR-CARA grantees who submitted progress reports confirmed that they facilitated training and technical assistance activities during the grant period. In total, the grantees conducted 624 training sessions during the reporting period (DSP-MRT). SAMHSA also highlights that 382 sessions were “requested” (SAMHSA Responses: FR-CARA). Topics covered in these sessions included behavioral health disparities; collaboration; community development; prevention fundamentals; identifying/selecting/implementing evidence-based programs; overdose outcome measures; risk and protective factors; substance use/abuse violence prevention; and overdose prevention in specific settings (e.g., shelter, correction facility). In some cases, the contractors and consultants to the grantees conducted the sessions (DSP-MRT); however, no information was provided on contractor or consultant expertise or the selection process. No information was provided to the committee regarding the selection of venues for the trainings (SAMHSA Responses: FR-CARA).

The 624 training sessions that grantees conducted reached a number of different key community audiences. A total of 15,581 individuals received training from the grantees—49.4 percent (n = 7,690) were first responders, 42.4 percent (n = 6,605) were “laypersons,” 1.2 percent (n = 186) were medical professionals, and 7.1 percent (n = 1,100) were classified as “other” (DSP-MRT). The targeted audiences for training sessions were left to the discretion of each grantee (SAMHSA Responses: FR-CARA). One grantee reported that they conducted “train the trainer” sessions to build a peer-to-peer network in “priority communities” (DSP-MRT).

During the reporting period, 2,023 individuals (13 percent of all individuals trained) completed a post-training survey. Almost 90 percent of respondents (n = 1,817) reported that they “feel confident to administer naloxone.” Almost 87 percent of respondents (n = 1,757) reported that they “learned new information or skills” (DSP-MRT). The committee did not receive a copy of this post-training survey or the possible responses (SAMHSA Responses: FR-CARA). It is important to note that without a pretest, there is no baseline with which to compare participants’ knowledge at post-survey. This, as well as the small number of respondents, makes it difficult for the committee to comment on the effectiveness of the trainings.

Required Activity 3: Establish Processes, Protocols, and Mechanisms for Referral to Appropriate Treatment and Recovery Communities, Which May Include an Outreach Coordinator or Team to Connect Individuals Receiving Opioid Overdose Reversal Drugs to Follow-Up Services

While the first two required activities outlined in the FR-CARA program focus on effective prevention of and response to overdose events, this required activity requires that grantees also support survivors by establishing processes, protocols, and mechanisms for referral to treatment and recovery communities.

Among the FR-CARA grantees who responded in FY2019, SAMHSA reported that 17 strategies had been developed for referring overdose survivors and families to treatment (DSP-MRT). No details are provided that

elaborate on the nature of these strategies or how many grantees developed them. In a different section of the summary, 15 grantees stated that they had undertaken efforts or services to facilitate access to treatment or recovery (DSP-MRT), although no details were provided. It is unclear whether these figures represent unique events and strategies, or whether the two sections overlap. Additionally, eight grantees noted that they have undertaken system changes for post-overdose or high-risk treatment referrals, although details about these were not provided (DSP-MRT).

SAMHSA reported that, in sum across all grantees, 570 overdose survivors and families were reported to have received information from grantees about treatment options in FY2019. Of those overdose survivors receiving treatment, 12 were receiving MOUD, 7 were receiving counseling, 16 were receiving behavioral therapies, and 53 were receiving “other treatments.”²³ The report stated that 188 overdose survivors were receiving treatment, but the committee is unclear on whether this number is correct, because the subtotals do not add up (DSP-MRT).

The information from SAMHSA did not specify how many grantees responded to these questions (DSP-MRT), so it is possible that not all relevant efforts have been captured by these figures or that a few grantees were responsible for a disproportionate number of the referrals. The committee notes that there is no baseline against which to compare these efforts and developments (SAMHSA Responses: FR-CARA); as such, it remains unclear whether FR-CARA programs have increased the number of survivors receiving treatment compared to the situation before the FR-CARA program began. As with OD Treatment Access grantees, SAMHSA did not ask FR-CARA grantees to create goals for survivors referred to treatment services. SAMHSA explained that it does not require grantees to set goals for referrals because SAMHSA felt the number of overdose events cannot be predicted at the outset of the fiscal year, and therefore neither can the number of survivors who might need connection to treatment (SAMHSA Responses: FR-CARA). However, the committee notes that SAMHSA could have set a goal for grantees using percentage targets (e.g., that 100 percent of overdose survivors in contact with the program should receive evidence-based treatment).

The committee acknowledges that there may be significant barriers to receiving treatment following an overdose. In response to a committee question about the numbers of survivors receiving treatment, SAMHSA replied that survivors may be involved with the criminal justice system and unable to participate in treatment activities; even upon receiving a referral, survivors may choose not to engage in services; and survivors’ insurance status, access to care, or eligibility may pose additional obstacles (SAMHSA Responses: FR-CARA). The committee has not evaluated the literature that could support SAMHSA’s explanation.

Required Activity 4: Form or Join an Established Advisory Council

Per the FOA, the FR-CARA program requires that grantees either join an advisory council where available, or establish a new one. These advisory councils must include representatives of “the Office of the Governor or Chief Executive Officer, tribal council, or office of the local chief executive, as applicable; and a core group of agencies engaged in efforts to prevent prescription drug/opioid overdose-related deaths” (SAMHSA, 2017c). The advisory council should “provide ongoing advice and guidance to the program and create workgroups to monitor progress and ensure that the goals of the project are being met” (SAMHSA, 2017c).

Of the 21 grantees who submitted progress reports, 3 grantees had no advisory committee members. However, one of these still reported having held meetings and even submitted meeting minutes to SAMHSA. This may indicate an unclear question prompt. The other 18 grantees formed or joined advisory councils with anywhere from 1 to 30 member representatives (DSP-MRT). SAMHSA stated that the variation in the number of committee members should not be interpreted as an absence of progress toward this required activity. They explained that some grantees from larger states had an easier time recruiting larger numbers for their committees, and others simply require more time to recruit qualified individuals to their committees (SAMHSA Responses: FR-CARA). Across the grantees, a sum of 92 advisory council meetings (from 0–28 meetings per grantee) occurred in FY2019. For 75 of these meetings, minutes were sent to SAMHSA (DSP-MRT). The committee did not have access to these meeting minutes.

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²³ SAMHSA explained this most likely applied to mental health and substance abuse treatment services (SAMHSA Responses: FR-CARA).

opioid state targeted response (n = 2). SAMHSA stated that grantees reported limited to no capacity to leverage additional funding for future activities (the number of grantees who reported this challenge was unspecified). It is unclear what provisions may be in place for the continuity of these programs when the grant period for FR-CARA comes to a close (DSP-MRT).

A number of grantees highlighted efforts that they had undertaken to build long-lasting community connections. One grantee reported that it had built a “sustainable system” that “demonstrates cooperation and collaboration between first responders and substance abuse treatment programs.” SAMHSA reported that in some cases (though the number is unspecified), community partners were involved in the development of the implementation plans for program activities (DSP-MRT).

Grantees highlighted a number of other innovations intended to improve the sustainability of their processes. One grantee, with collaboration from other organizations and laypersons, developed an internal protocol that has helped them to sustain their supply of naloxone by determining the “true amount of naloxone needed in response to an overdose.” Another grantee created a connection between a network of trained EMS providers and their jurisdiction’s Bureau of Substance Abuse, so that the latter may use the EMS providers as a resource, should another opioid-related initiative arise in the future. Lastly, at least one grantee classified recovery specialist services as a billable service (DSP-MRT). The summary report did not specify how these recovery specialists would be deployed to overdose prevention efforts.

However, the summary of grantee reports also included barriers and challenges to the sustainability of grantee programs. First, SAMHSA stated that grantees had reported encountering several difficulties in the first year of implementation that may continue into future years, ultimately challenging sustainability. This included staffing challenges and turnover; difficulty identifying and hiring outreach workers; a lack of preexisting prevention infrastructure for substance abuse activities, particularly in rural and underserved communities; difficulty sustaining funding necessary to purchase sufficient naloxone to distribute across the entire network of cross-sector partners in high-need communities; and difficulty sustaining sufficient funding to support the necessary workforce. Additionally, SAMHSA reported that grantees expressed concern about the impact that future policy developments could have on program activities (though the number of grantees who raised this was unclear). They specifically mentioned uncertainty about changing prices of naloxone (DSP-MRT). These continuing barriers and challenges are substantial, but due to the summary nature of the report, the committee does not know how many grantees described them in their reports.

Summary of FR-CARA Program Progress

The information received from SAMHSA about the FR-CARA program indicates that with regard to the primary goal of allowing first responders to administer a drug or device for emergency treatment of known or suspected opioid overdose, grantees distributed 14,509 nasal spray kits and 1,925 other kits. The information from SAMHSA suggests that 21 percent of the naloxone kits distributed were administered and 1,815 overdoses were reversed. Training sessions (n = 624) were conducted, with 15,581 individuals involved in these trainings. SAMHSA reported that, overall, grantees had developed 17 new strategies for referring overdose survivors to treatment and recovery services; at the time of reporting, grantees had distributed information about treatment options to 570 overdose survivors and families, and many reported that overdose survivors were receiving various types of treatment, including MOUD, counseling, and more. Twenty grantees had held meetings with advisory councils that they had joined or that were newly established during the reporting period. Some, but not all, grantees engaged to varying degrees in the allowable activities to collaborate with health care providers and to provide public education on applicable Good Samaritan laws. No information was provided on the effectiveness of these trainings or communication campaigns.

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