By Jennifer D. Oliva, Taleed El-Sabawi, and Shelly Weizman
The tragedy of the ever-worsening drug poisoning and overdose crisis in the United States is compounded by a simple fact: We know how to prevent overdose deaths, and yet, the overwhelming majority of individuals with opioid use disorder (OUD) lack access to the lifesaving, standard of care treatment.
Research demonstrates that the opioid agonist medications methadone and buprenorphine are the safest and most effective treatments for OUD. As the National Academy of Sciences explained in a 2019 report, these two medications reduce risk of death by up to 50 percent and are associated with numerous other benefits, including improved quality of life, reduced rates of use of other opioids, and reduced risk of contracting illnesses including HIV and hepatitis C.
However, during the worst drug poisoning crisis in U.S. history, which is now killing more than 100,000 people a year, the country’s outdated and restrictive federal regulatory schemes that pertain to methadone and buprenorphine present a pernicious and persistent barrier to accessing OUD medications.
Federal drug laws that date back to the early 1970s War on Drugs create significant barriers for individuals seeking OUD medications. Under the current rules, methadone administration is limited to highly regulated Opioid Treatment Programs (OTPs). OTPs, in turn, are generally mandated by law to limit methadone treatment eligibility to individuals who have satisfied specific diagnostic criteria for OUD for at least a year and who show up in-person, on a daily basis for medication administration.
Unlike methadone, federal law permits buprenorphine to be prescribed in most outpatient settings and to be dispensed by pharmacists to treat OUD. It does, however, restrict buprenorphine prescribing authority to qualified practitioners who have completed a training course and obtained a Drug Enforcement Administration (DEA) waiver. Federal law also limits the number of patients that a waivered prescriber can treat at any given time and mandates an in-person patient examination prior to medication initiation. As experts have argued, this latter “requirement, while well intentioned, can create a potentially insurmountable barrier for individuals who would benefit from buprenorphine treatment but are unable to meet with a waivered provider in person, and disproportionately impacts individuals with OUD in rural areas, those without reliable transportation, and individuals with disabilities.” In practice, these rules are arbitrary and often too restrictive to be tailored to individual patient needs. This has cost our society trillions of wasted dollars over the last half-century.
The good news is the federal government has waived several of these unwarranted legal barriers during the COVID-19 pandemic. A subset of these COVID-related waivers are set to expire when the COVID emergency declaration is terminated, while others will continue in force post-pandemic. The bad news is that, even assuming the federal government loosens access to OUD medication treatment by permanently waiving all the regulations, patients will continue to face significant obstacles to OUD medication treatment for several reasons.
First, the country lacks an adequate supply of OUD medication prescribers. As has been well-chronicled in the literature, OUD is a complex and highly stigmatized condition about which most general practitioners have little training and expertise and, therefore, little desire to treat. Only 5% of American doctors are eligible to prescribe buprenorphine, and most of those physicians treat far fewer patients with OUD than they are permitted to under the patient limitation rules. In addition, in many rural counties with high OUD incidence rates, individuals with OUD lack access to even a single buprenorphine prescriber.
Second, individuals with OUD often lack access to critical pharmacy services. Non-hospital pharmacies are precluded by law from dispensing methadone and are often unwilling to stock and dispense buprenorphine. A recent study demonstrates that 20% of American pharmacies entirely refuse to dispense buprenorphine and even those that do dispense the drug set caps on its stock. In addition, federal and state actors — ranging from state medical and pharmacy boards, to local law enforcement, to the DEA — have significantly enhanced surveillance of both opioid prescribers and dispensers as the national drug poisoning crisis has intensified. Among other things, regulatory authorities and law enforcement routinely utilize prescription drug monitoring programs (PDMPs) — which are state-operated “smart” databases that collect voluminous prescription drug information — to identify and investigate purportedly problematic opioid prescribers and dispensers.
Finally, we lack the sense of urgency required to implement bold reforms that will decrease drug poisoning deaths. It is time for a new, evidence-based approach to American drug policy. There are several things that the United States ought to do immediately to meaningfully address the ongoing overdose crisis. At the minimum, the federal government should:
- entirely revamp the methadone administration system with the input of people who currently are or have been treated for OUD with methadone, or who are seeking treatment for OUD;
- eliminate sweeping buprenorphine prescriber training mandates in favor of widely available and more specialized training;
- increase insurance reimbursement for the evidence-based treatment of OUD, including in Medicaid;
- include robust addiction treatment training, including on the use of buprenorphine, in medical and nursing schools and in ongoing provider education;
- eliminate patient treatment restrictions and institute quality measures and incentives to ensure compliance with the standard of care;
- tether the new federal money earmarked to address the current crisis to immediate access to care from every provider at every level;
- fund and establish centralized prescriber access that is available 24/7; and
- place mandates on pharmacies that require them to adequately stock and dispense buprenorphine in exchange for maintenance of their controlled substance registration.
The United States has spent five decades enacting and enforcing laws and policies that limit access to methadone and buprenorphine. As our horrifying drug poisoning crisis makes clear, it is beyond time to change course. We urge policymakers to take up these recommendations to ensure easy and widespread access to life saving OUD medications.
Jennifer D. Oliva is the Associate Dean for Faculty Research & Development and Director of the Center for Health & Pharmaceutical Law at Seton Hall Law.
Taleed El-Sabawi is an Assistant Professor of Law at Elon University and a Scholar with the Addiction and Public Policy Initiative at the O’Neill Institute.
Shelly Weizman is the associate director of the Addiction and Public Policy Initiative at the O’Neill Institute and an adjunct professor of law at Georgetown University Law Center.