U.S. Trends in Registration for Medical Cannabis and Reasons for Use From 2016 to 2020 : An Observational Study.

BACKGROUND: Cannabis policy liberalization has increased cannabis availability for medical or recreational purposes. Up-to-date trends in medical cannabis licensure can inform clinical policy and care. OBJECTIVE: To describe recent trends in medical cannabis licensure in the United States. DESIGN: Ecological study with repeated measures. SETTING: State registry data via state reports and data requests on medical cannabis licensure from 2016 to 2020. PARTICIPANTS: Medical cannabis patients (persons with medical cannabis licenses) in the United States. MEASUREMENTS: Total patient volume, patients per 10 000 of total population, and patient-reported qualifying conditions (that is, symptoms or conditions qualifying patients for licensure)-including whether these symptoms align with current therapeutic evidence of cannabis-cannabinoid efficacy. RESULTS: In 2020, 26 states and Washington, DC reported patient numbers, and 19 states reported patient-reported qualifying conditions. Total enrolled patients increased approximately 4.5-fold from 678 408 in 2016 to 2 974 433 in 2020. Patients per 10 000 total population generally increased from 2016 to 2020, most dramatically in Oklahoma (927.1 patients per 10 000 population). However, enrollment increased in states without recreational legalization (that is, medical-only states), whereas enrollment decreased in 5 of 7 with recreational legalization (that is, recreational states). In 2020, 68.2% of patient-reported qualifying conditions had substantial or conclusive evidence of therapeutic value versus 84.6% in 2016. Chronic pain was the most common patient-reported qualifying condition in 2020 (60.6%), followed by posttraumatic stress disorder (10.6%). LIMITATION: Missing state data; lack of rationale for discontinuing medical cannabis licensure. CONCLUSION: Enrollment in medical cannabis programs approximately increased 4.5-fold from 2016 to 2020, although enrollment decreased in recreational states. Use for conditions or symptoms without a strong evidence basis increased from 15.4% (2016) to 31.8% (2020). Thoughtful regulatory and clinical strategies are needed to effectively manage this rapidly changing landscape. PRIMARY FUNDING SOURCE: National Institute on Drug Abuse of the National Institutes of Health.

Common themes in early state policy responses to substance use disorder treatment during COVID-19.

Background: Limited research has examined how states have changed policies for treatment of substance use disorder (SUD) during the COVID-19 pandemic.Objectives: We aimed to identify themes in state policy responses to the pandemic in the context of SUD treatment. Identifying themes in policy responses provides a framework for subsequent evaluations of the relationship between state policies and health service utilization.Methods: Between May and June 2020, we searched all Single State Agencies for Substance Abuse Services (SSA) websites for statements of SUD treatment policy responses to the pandemic. We conducted Iterative Categorization of policies for outpatient programs, opioid treatment programs, and other treatment settings to identify themes in policy responses.Results: We collected 220 documents from SSA websites from 45 states and Washington D.C. Eight specific themes emerged from our content analysis: delivery of pharmacological and non-pharmacological services, obtaining informed consent and documentation for remote services, conducting health assessments, facility operating procedures and staffing requirements, and permissible telehealth technology and billing protocols. Policy changes often mirrored federal guidance, for instance, by expanding methadone take-home options for opioid treatment programs. The extent and nature of policy changes varied across jurisdictions, including telehealth technology requirements and staffing flexibility.Conclusion: States have made significant policy changes to SUD treatment policies during COVID-19, particularly regarding telehealth and facilitation of remote care. Understanding these changes could help policymakers prioritize guidance during the pandemic and for future health crises. Impacts of policies on disparate treatment populations, including those with limited technological access, should be considered.

The Association of State Opioid Misuse Prevention Policies With Patient- and Provider-Related Outcomes: A Scoping Review.

Policy Points This scoping review reveals a growing literature on the effects of certain state opioid misuse prevention policies, but persistent gaps in evidence on other prevalent state policies remain. Policymakers interested in reducing the volume and dosage of opioids prescribed and dispensed can consider adopting robust prescription drug monitoring programs with mandatory access provisions and drug supply management policies, such as prior authorization policies for high-risk prescription opioids. Further research should concentrate on potential unintended consequences of opioid misuse prevention policies, differential policy effects across populations, interventions that have not received sufficient evaluation (eg, Good Samaritan laws, naloxone access laws), and patient-related outcomes. CONTEXT: In the midst of an opioid crisis in the United States, an influx of state opioid misuse prevention policies has provided new opportunities to generate evidence of policy effectiveness that can inform policy decisions. We conducted a scoping review to synthesize the available evidence on the effectiveness of US state interventions to improve patient and provider outcomes related to opioid misuse and addiction. METHODS: We searched six online databases to identify evaluations of state opioid policies. Eligible studies examined legislative and administrative policy interventions that evaluated (a) prescribing and dispensing, (b) patient behavior, or (c) patient health. FINDINGS: Seventy-one articles met our inclusion criteria, including 41 studies published between 2016 and 2018. These articles evaluated nine types of state policies targeting opioid misuse. While prescription drug monitoring programs (PDMPs) have received considerable attention in the literature, far fewer studies addressed other types of state policy. Overall, evidence quality is very low for the majority of policies due to a small number of evaluations. Of interventions that have been the subject of considerable research, promising means of reducing the volume and dosages of opioids prescribed and dispensed include drug supply management policies and robust PDMPs. Due to low study number and quality, evidence is insufficient to draw conclusions regarding interventions targeting patient behavior and health outcomes, including naloxone access laws and Good Samaritan laws. CONCLUSIONS: Recent research has improved the evidence base on several state interventions targeting opioid misuse. Specifically, moderate evidence suggests that drug supply management policies and robust PDMPs reduce opioid prescribing. Despite the increase in rigorous evaluations, evidence remains limited for the majority of policies, particularly those targeting patient health-related outcomes.

Opioid Prescribing After Opioid-related Inpatient Hospitalizations by Diagnosis: A Cohort Study.

BACKGROUND: Any opioid-related hospitalization is an indicator of opioid-related harm and should ideally trigger carefully monitored decreases in opioid prescribing after inpatient stays in many, if not most, cases. However, past studies on opioid prescribing after hospitalizations have largely been limited to overdose related visits. It is unclear whether prescribing is different for other opioid-related indications such as opioid dependence and abuse and how that may compare with hospitalizations for overdose. OBJECTIVE: To examine opioid-prescribing patterns before and after opioid-related hospitalizations for all opioid-related indications, not limited to overdose. RESEARCH DESIGN: Retrospective cohort analysis of Veterans Health Administration (VHA) administrative claims from 2011 to 2014. SUBJECTS: VHA patients who were hospitalized between fiscal years 2011 and 2014 and had at least 1 prescription opioid medication filled through the VHA pharmacy before their hospitalization. MEASURES: Opioid dispensing trajectories after hospitalization by opioid-related indication (ie, opioid dependence and/or abuse vs. overdose) compared with prescribing patterns for non-opioid-related hospitalizations. RESULTS: Overall, opioid dosage dropped significantly (66% for dependence/abuse, 42% for overdose, and 3% for nonopioid diagnoses; P<0.001) across all 3 categories when comparing dose 57-63 days after admission to 57-63 days before hospitalization. However, 47% of the patients remained on the same dose or increased their opioid dose at 60 days after an opioid-related hospitalization. After adjusting for covariates, patients with a primary diagnosis of dependence/abuse had higher odds of having their dose discontinued compared with those with overdose: odds ratio (OR) 2.17 (1.19-3.96). Patients with admissions for opioid dependence and/or abuse had a statistically significant higher prevalence of depression, posttraumatic stress disorder, anxiety, and substance use disorders compared with those with an opioid overdose hospitalization. CONCLUSIONS: Opioid prescribing and patient risk factors before and after opioid-related hospitalizations vary by indication for hospitalization. To reduce costs and morbidity associated with opioid-related hospitalizations, opioid deintensification efforts need to be tailored to indication for hospitalization.

Association of Federal Mental Health Parity Legislation With Health Care Use and Spending Among High Utilizers of Services.

BACKGROUND: Decades-long efforts to require parity between behavioral and physical health insurance coverage culminated in the comprehensive federal Mental Health Parity and Addiction Equity Act. OBJECTIVES: To determine the association between federal parity and changes in mental health care utilization and spending, particularly among high utilizers. RESEARCH DESIGN: Difference-in-differences analyses compared changes before and after exposure to federal parity versus a comparison group. SUBJECTS: Commercially insured enrollees aged 18-64 with a mental health disorder drawn from 24 states where self-insured employers were newly subject to federal parity in 2010 (exposure group), but small employers were exempt before-and-after parity (comparison group). A total of 11,226 exposure group members were propensity score matched (1:1) to comparison group members, all of whom were continuously enrolled from 1 year prepolicy to 1-2 years postpolicy. MEASURES: Mental health outpatient visits, out-of-pocket spending for these visits, emergency department visits, and hospitalizations. RESULTS: Relative to comparison group members, mean out-of-pocket spending per outpatient mental health visit declined among exposure enrollees by $0.74 (1.40, 0.07) and $2.03 (3.17, 0.89) in years 1 and 2 after the policy, respectively. Corresponding annual mental health visits increased by 0.31 (0.12, 0.51) and 0.59 (0.37, 0.81) per enrollee. Difference-in-difference changes were larger for the highest baseline quartile mental health care utilizers [year 2: 0.76 visits per enrollee (0.14, 1.38); relative increase 10.07%] and spenders [year 2: $-2.28 (-3.76, -0.79); relative reduction 5.91%]. There were no significant difference-in-differences changes in emergency department visits or hospitalizations. CONCLUSIONS: In 24 states, commercially insured high utilizers of mental health services experienced modest increases in outpatient mental health visits 2 years postparity.

Legal review of state emergency medical services policies and protocols for naloxone administration.

BACKGROUND: Given the continued rise in opioid-related overdoses, many states have expanded access to the opioid antagonist naloxone. We sought to provide comprehensive data on one such strategy: the authority of providers at different emergency medical services (EMS) licensure levels to administer naloxone. METHODS: We conducted a systematic legal review of state laws and protocols governing the authority of different EMS licensure levels to administer naloxone. We used Westlaw, state government websites and scope of practice protocols. We coded relevant policies regarding which, if any, administration routes and dosages of naloxone are permitted for each licensure level: emergency medical responder (EMR), emergency medical technician (EMT), advanced emergency medical technician (AEMT), and paramedic. RESULTS: As of July 2020, all states with relevant laws or protocols authorize paramedics, AEMTs, and EMTs to administer naloxone. Thirty-nine states with an EMR licensure level and statewide protocol authorize naloxone administration by EMRs, up from only two in 2013. Permissible routes of administration have increased across all EMS provider levels, providing advanced life support providers (i.e., paramedics and AEMTs) with expanded discretion; however, authorization for intravenous and intramuscular administration remains relatively uncommon for basic life support (BLS) providers. When specified, maximum doses authorized ranged widely, from 2.0 to 12.0 milligrams. CONCLUSIONS: Naloxone administration authority is now widely granted to EMS providers. Most states allow all licensed EMS provider levels to administer naloxone, a substantial increase for EMRs and EMTs since 2013. Paramedics and AEMTs have the greatest authority to select the dosage and route of administration.

Did prescribing laws disproportionately affect opioid dispensing to Black patients?

OBJECTIVE: To evaluate whether pain management clinic laws and prescription drug monitoring program (PDMP) prescriber check mandates, two state opioid policies with relatively rapid adoption across states, reduced opioid dispensing more or less in Black versus White patients. DATA SOURCES: Pharmacy claims data, US sample of commercially insured adults, 2007-2018. STUDY DESIGN: Stratifying by race, we used generalized estimating equations with an event-study specification to estimate time-varying effects of each policy on opioid dispensing, comparing to the four pre-policy quarters and states without the policy. Outcomes included high-dosage opioids, overlapping opioid prescriptions, concurrent opioid/benzodiazepines, opioids from >3 prescribers, opioids from >3 pharmacies. DATA EXTRACTION METHODS: We identified all prescription opioid dispensing to Black and White adults aged 18-64 without a palliative care or cancer diagnosis code. PRINCIPAL FINDINGS: Exactly 7,096,592 White and 1,167,310 Black individuals met inclusion criteria. Pain management clinic laws were associated with reductions in two outcomes; their association with high-dosage receipt was larger among White patients. In contrast, reductions due to PDMP mandates appeared limited to, or larger in, Black patients compared with White patients in four of five outcomes. For example, PDMP mandates reduced high-dosage receipt in Black patients by 0.7 percentage points (95% CI: 0.36-1.08 ppt.) over 4 years: an 8.4% decrease from baseline; there was no apparent effect in White patients. Similarly, while there was limited evidence that mandates reduced overlapping opioid receipt in White patients, they appeared to reduce overlapping opioid receipt in Black patients by 1.3 ppt. (95% CI: -1.66--1.01 ppt.) across post-policy years-a 14.4% decrease from baseline. CONCLUSIONS: PDMP prescriber check mandates but not pain management clinic laws appeared to reduce opioid dispensing more in Black patients than White patients. Future research should discern the mechanisms underlying these disparities and their consequences for pain management.

Perceptions of buprenorphine barriers and efficacy among nurse practitioners and physician assistants.

BACKGROUND: Medications for opioid use disorder (MOUDs), including methadone, buprenorphine, and naltrexone, decrease mortality and morbidity for people with opioid use disorder (OUD). Buprenorphine and methadone have the strongest evidence base among MOUDs. Unlike methadone, buprenorphine may be prescribed in office-based settings in the U.S., including by nurse practitioners (NPs) and physician assistants (PAs) who have a federal waiver and adhere to federal patient limits. Buprenorphine is underutilized nationally, particularly in rural areas, and NPs/PAs could help address this gap. Therefore, we sought to identify perceptions of buprenorphine efficacy and perceptions of prescribing barriers among NPs/PAs. We also sought to compare perceived buprenorphine efficacy and perceived prescribing barriers between waivered and non-waivered NPs/PAs, as well as to compare perceived buprenorphine efficacy to perceived naltrexone and methadone efficacy. METHODS: We disseminated an online survey to a random national sample of NPs/PAs. We used Mann-Whitney U tests to compare between waivered and non-waivered respondents. We used non-parametric Friedman tests and post-hoc Wilcoxon signed-rank tests to compare perceptions of medication types. RESULTS: 240 respondents participated (6.5% response rate). Most respondents agreed buprenorphine is efficacious and believed counseling and peer support should complement buprenorphine. Buprenorphine was generally perceived as more efficacious than both naltrexone and methadone. Perceived buprenorphine efficacy and prescribing barriers differed by waiver status. Non-waivered practitioners were more likely than waivered practitioners to have concerns about buprenorphine affecting patient mix. Among waivered NPs/PAs, key buprenorphine prescribing barriers were insurance prior authorization and detoxification access. CONCLUSIONS: Our results suggest that different policies should target perceived barriers affecting waivered versus non-waivered NPs/PAs. Concerns about patient mix suggest stigmatization of patients with OUD. NP/PA education is needed about comparative medication efficaciousness, particularly regarding methadone. Even though many buprenorphine treatment patients benefits from counseling and/or peer support groups, NPs/PAs should be informed that such psychosocial treatment methods are not necessary for all buprenorphine patients.

Has Declining Opioid Dispensing to Cancer Patients Been Tailored to Risk of Opioid Harms?

CONTEXT: Opioid prescribing to cancer patients is declining, but it is unknown whether reductions have been tailored to those at highest risk of opioid-related harms. OBJECTIVES: Examine whether declines in opioid dispensing to patients receiving active cancer treatment are sharper in patients with substance use disorder (SUD) or mental health diagnoses. METHODS: We used 2008-2018 national, commercial healthcare claims data to examine adjusted and unadjusted trends in opioid dispensing (receipt of ≥1 fill; average daily dosage; receipt of high-dose opioids; receipt of concurrent opioids and benzodiazepines) to patients ages ≥18 receiving treatment for one of four cancer types (breast; colorectal; head and neck; sarcoma; N = 324,789 patients). To compare declines across subgroups with varying risk of opioid-related harms, we stratified by SUD and mental health diagnosis. To address potential confounding, we estimated subgroup-specific trends using generalized estimating equations, adjusting for covariates. RESULTS: Across groups, rate of ≥1 opioid fill per quarter fell 32.5% (95% CI: 31.8%-33.2%) from 2008 to 2018; daily dose among those receiving opioids fell 37.6% (95% CI: 36.7%-38.6%). In most cases, these declines were not sharper in subgroups at greater risk of opioid-related harms. For example, patients with opioid use disorder experienced the smallest declines in dispensing frequency, and there was no evidence that declines were sharper in patients with mental health diagnoses. CONCLUSION: Sharp declines in opioid prescribing during the drug overdose crisis have affected a wide range of patients undergoing cancer treatment and may not have been sufficiently tailored to patient characteristics. Research on implications for opioid-related harms and pain management is needed.

CDC Guideline For Opioid Prescribing Associated With Reduced Dispensing To Certain Patients With Chronic Pain.

The Centers for Disease Control and Prevention's 2016 Guideline for Prescribing Opioids for Chronic Pain aimed to reduce unsafe opioid prescribing. It is unknown whether the guideline influenced prescribing in the target population: patients with chronic, noncancer pain, who may be at particular risk for opioid-related harms. To study this question, we used 2014-18 data from a commercial claims database to examine associations between the release of the guideline and opioid dispensing in a national cohort of more than 450,000 patients with four common chronic pain diagnoses. We also examined whether any reductions associated with the guideline were larger for diagnoses for which there existed stronger expert consensus against opioid prescribing. Overall, the guideline was associated with substantial reductions in dispensing opioids, including a reduction in patients' rate of receiving at least one opioid prescription by approximately 20 percentage points by December 2018 compared with the counterfactual, no-guideline scenario. However, the reductions in dispensing did not vary by the strength of expert consensus against opioid prescribing. These findings suggest that although voluntary guidelines can drive changes in prescribing, questions remain about how clinicians are tailoring opioid reductions to best benefit patients.

Trends in Suicidality 1 Year Before and After Birth Among Commercially Insured Childbearing Individuals in the United States, 2006-2017.

Importance: Suicide deaths are a leading cause of maternal mortality in the US, yet the prevalence and trends in suicidality (suicidal ideation and/or intentional self-harm) among childbearing individuals remain poorly described. Objective: To characterize trends in suicidality among childbearing individuals. Design, Setting, and Participants: This serial cross-sectional study analyzed data from a medical claims database for a large commercially insured population in the US from January 2006 to December 2017. There were 2714 diagnoses of suicidality 1 year before or after 698 239 deliveries among 595 237 individuals aged 15 to 44 years who were continuously enrolled in a single commercial health insurance plan. Data were analyzed from October 2019 to September 2020. Main Outcomes and Measures: The primary outcome was diagnosis of suicidality in childbearing individuals 1 year before or after birth based on the identification of relevant International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) and ICD-10-CM diagnosis codes during at least 1 inpatient or 2 outpatient visits. Results: Of 595 237 included childbearing individuals, the mean (SD) age at delivery was 31.9 (6.4) years. A total of 40 568 individuals (6.8%) were Asian, 52 613 (8.6%) were Black, 73 172 (12.1%) were Hispanic, 369 501 (63.1%) were White, and 59 383 (9.5%) had unknown or missing race/ethnicity data. A total of 2683 individuals were diagnosed with suicidality 1 year before or after giving birth for a total of 2714 diagnoses. The prevalence of suicidal ideation increased from 0.1% per 100 individuals in 2006 to 0.5% per 100 individuals in 2017 (difference, 0.4%; SE, 0.03; P < .001). Intentional self-harm prevalence increased from 0.1% per 100 individuals in 2006 to 0.2% per 100 individuals in 2017 (difference, 0.1%; SE, 0.02; P < .001). Suicidality prevalence increased from 0.2% per 100 individuals in 2006 to 0.6% per 100 individuals in 2017 (difference, 0.4%; SE, 0.04; P < .001). Diagnoses of suicidality with comorbid depression or anxiety increased from 1.2% per 100 individuals in 2006 to 2.6% per 100 individuals in 2017 (difference, 1.4%; SE, 0.2; P < .001). Diagnoses of suicidality with comorbid bipolar or psychotic disorders increased from 6.9% per 100 individuals in 2006 to 16.9% per 100 individuals in 2017 (difference, 10.1%; SE, 0.2; P < .001). Non-Hispanic Black individuals, individuals with lower income, and younger individuals experienced larger increases in suicidality over the study period. Conclusions and Relevance: In this cross-sectional study of US childbearing individuals, the prevalence of suicidal ideation and intentional self-harm occurring in the year preceding or following birth increased substantially over a 12-year period. Policy makers, health plans, and clinicians should ensure access to universal suicidality screening and appropriate treatment for pregnant and postpartum individuals and seek health system and policy avenues to mitigate this growing public health crisis, particularly for high-risk groups.

The Public Health Value of Opioid Litigation.

Opioid litigation continues a growing public health litigation trend in which governments seek to hold companies responsible for population harms related to their products. The litigation can serve to address gaps in regulatory and legislative policymaking and in market self-regulation pervasive in the prescription opioid domain. Moreover, prior opioid settlements have satisfied civil tort litigation objectives of obtaining compensation for injured parties, deterring harmful behavior, and holding certain opioid manufacturers, distributors and pharmacies accountable for their actions. In this way, opioid litigation represents progress over prior public health litigation campaigns involving tobacco, lead paint, and asbestos, which had more limited tort litigation effects. Although opioid litigation is not a comprehensive solution to the opioid crisis, it can complement other strategies and infuse much needed money, behavior changes, and public accountability for prescription opioid and related harms.