Faculty Bibliography

BACKGROUND AND AIMS:Opioid overdose is a public health emergency in the United States. In an attempt to reduce potentially inappropriate opioid prescribing, many US states have adopted legal restrictions on the ability of medical professionals to prescribe or dispense opioids for pain. This review describes the major elements of relevant US state laws and the ways in which they have changed over time. METHODS:Systematic legal review in which two trained legal researchers collected and reviewed all US state laws that limit the amount or duration of opioids that medical professionals may prescribe or dispense for pain. These laws were then coded on a set of pre-selected measures, including when the law was enacted, dosage and duration limits imposed, circumstances in which the restrictions do not apply and whether additional requirements or restrictions apply to prescriptions issued to minors. RESULTS:The number of US states with opioid limitation laws increased from 10 in 2016 to 39 by the end of 2019. The provisions of these laws vary between states and have shifted within states over time. At the end of 2019 the modal duration limit was 7 days, with a range of 3 to 31. Fourteen states imposed limits on the dosage of opioids that can be prescribed, ranging from 30 morphine milligram equivalents (MME) to a 120 MME daily maximum. In 16 states, different limits apply to prescriptions issued to minors. CONCLUSIONS:The number of US states with opioid limitation laws nearly quadrupled between 2016 and 2019, with a great amount of heterogeneity between state restrictions and changes over time.

BACKGROUND:As of July 2018, 45 United States (US) states and the District of Columbia have enacted an overdose Good Samaritan law (GSL). These laws, which provide limited criminal immunity to individuals who request assistance during an overdose, may be of importance in the current wave of the overdose epidemic, which is driven primarily by illicit opioids including heroin and fentanyl. There are substantial differences in the structures of states' GSL laws which may impact their effectiveness. This study compared GSLs which have legal provisions protecting from arrest and laws which have more limited protections. METHODS:Using national county-level overdose mortality data from 3109 US counties, we examined the association of enactment of GSLs with protection from arrest and GSLs with more limited protections with subsequent overdose mortality between 2013 and 2018. Since GSLs are often enacted in conjunction with Naloxone Access Laws (NAL), we examined the effect of GSLs separately and in conjunction with NAL. We conducted these analyses using hierarchical Bayesian spatiotemporal Poisson models. RESULTS:GSLs with protections against arrest enactment in conjunction with a NAL were associated with 7% lower rates of all overdose deaths (rate ratio (RR): 0.93% Credible Interval (CI): 0.89-0.97), 10% lower rates in opioid overdose deaths (RR: 0.90; CI: 0.85-0.95) and 11% lower rates of heroin/synthetic overdose mortality (RR: 0.89; CI: 0.82-0.96) two years after enactment, compared to rates in states without these laws. Significant reductions in overdose mortality were not seen for GSLs with protections for charge or prosecution. CONCLUSION/CONCLUSIONS:GSLs with more expansive legal protections combined with a NAL, were associated with lower rates of overdose deaths, although these risk reductions take time to manifest. Policy makers should consider enacting and implementing more expansive GSLs with arrest protections to increase the likelihood people will contact emergency services in the event of an overdose.

The United States continues to face a public health emergency of opioid-related harm, the effects of which could be dramatically reduced through increased access to the opioid antagonist naloxone. Unfortunately, naloxone is too often unavailable when and where it is most needed, partly due to its continued status as a prescription medication. Although states and the federal Food and Drug Administration (FDA) have acted to increase access to naloxone, these changes are insufficient to address this unprecedented crisis. In this Commentary, we argue that FDA can and should immediately reclassify naloxone from prescription-only to over-the-counter status, a change that could save hundreds if not thousands of lives in the United States every year.

: The United States is currently in the midst of 2 public health emergencies: COVID-19 and the ongoing opioid crisis. In an attempt to reduce preventable harm to individuals with opioid use disorder (OUD), federal, state, and local governments have temporarily modified law and policy to increase access to OUD treatment and divert some individuals at high risk away from the correctional system. In this Commentary, we briefly describe how people with OUD are at increased risk for COVID-19, discuss existing policy barriers to evidence-based prevention and treatment for individuals with OUD, explain the temporary rollbacks of those barriers, and argue that these changes should be made permanent. We also suggest several additional steps that federal and state governments can urgently take to reduce barriers to care for individuals with OUD, both during the current crisis and beyond.

PURPOSE:Buprenorphine is an opioid partial agonist used to treat opioid use disorder. While several policy changes have attempted to increase buprenorphine availability, access remains well below optimal levels. This study characterized how buprenorphine utilization in the United States has changed over time and whether there are regional disparities in distribution of the medication. METHODS:The amount of buprenorphine distributed from 2007 to 2017 was obtained from the Drug Enforcement Administration's Automated Reports and Consolidated Ordering System. Data were expressed as the percent change and milligrams per person in each state. The formulations and cost for prescriptions covered by Medicaid (2008 to 2018) were also examined. RESULTS:Buprenorphine distributed to pharmacies increased about 7-fold (476.8 to 3179.9 kg) while the quantities distributed to hospitals grew 5-fold (18.6 to 97.6 kg) nationally from 2007 to 2017. Buprenorphine distribution per person was almost 20-fold higher in Vermont (40.4 mg/person) relative to South Dakota (2.1 mg/person). There was a strong association between the number of physicians authorized to prescribe buprenorphine and distribution per state (r[49] = +0.94, P < .0005). The buprenorphine/naloxone sublingual film (Suboxone) was the predominant formulation (92.6% of 0.31 million Medicaid prescriptions) in 2008 but accounted for less than three-fifth (57.3% of 6.56 million prescriptions) in 2018. CONCLUSIONS:Although buprenorphine availability has substantially increased over the last decade, distribution was very nonhomogeneous across the United States.