New York, NY/USA - 08.31.2018: Overdose Awareness March.

Advancing a Public Health-Promoting National Opioid Policy

Register to attend “Addressing the Overdose Epidemic: Substance Use Policy for the Biden Administration” on March 24th.

By Jennifer D. Oliva & Kelly K. Dineen

“America’s drug regime is a monstrous, incoherent mess.”
– Dr. Carl L. Hart, Drug Use for Grown-Ups: Chasing Liberty in the Land of Fear (2021)

By any measure, American drug policy is an ineffective and costly failure.

The U.S. drug policy regime’s defining quality is its persistent adherence to the same approaches in the face of overwhelming evidence that they are unsuccessful, including supply-side tactics, fear mongering, and misinformation dissemination. These policies are racist by design and their myriad, negative impacts are disproportionately borne by marginalized and stigmatized communities.

The “war on drugs” and its repeated loop of lost battles have earned the nation the highest incarceration rate in the world, fomented a number of serious health issues related to drug use, and fueled a drug overdose and suicide crisis. Our shape-shifting overdose crisis recently claimed the highest number of overdose deaths ever recorded during a twelve-month period in American history.

As author Dominic Milton Trott explains, “People are dying because of ignorance . . . because unremitting propaganda is denying them essential safety information, and . . . because legislators and the media are censoring the science, and are ruthlessly pushing an ideological agenda instead. They are dying because the first casualty of war is truth, and the war on drugs is no different.”

According to the Centers for Disease Control and Prevention (CDC), the fight against prescription opioids costs Americans approximately $78.5 billion dollars each year. In return for that investment, the policy actions of the last fifteen years appear to have harmed more people than they have helped for a number of reasons, including the willful blindness of drug policymakers and enforcers to the entirely predictable shift in use to riskier drugs.

Despite the widespread display of prescription pill images in the media, the use of prescription opioids by people with opioid use disorder is a distant memory in this country. Heroin-related overdoses eclipsed prescription opioid-involved deaths nearly a decade ago and nearly two-thirds of those deaths today are attributable to illicit fentanyl and polysubstance drug use. In 2019, prescription opioids were only present in 17% of drug overdose deaths — and often in combination with other substances. One study that examined Massachusetts overdose deaths from 2013-2015 determined that “[o]nly 1.3% [of all] decedents had an active prescription for [a prescription] opioid detected in toxicology reports on the date of death.”

Policymakers have met each wave of the evolving overdose crisis with a prohibitionist, “get tough on drugs” approach. The prescription opioids crackdown appears to have exacerbated the suffering and deaths of individuals with persistent pain conditions, opioid use disorder, or both.

The federal Department of Justice (DOJ), for example, funded and facilitated the creation of controlled substance surveillance tools in the form of state prescription drug monitoring programs (PDMPs). PDMPs are “smart” databases that collect voluminous prescribing information. These surveillance platforms use proprietary, black-box algorithms to generate scores that estimate patient risk for opioid misuse. Not only have PDMP platforms never been subject to external validation, the proxies that they use to score risk are questionable at best and likely disparately impact already marginalized and stigmatized patients, including women and racial and ethnic minorities with complex, co-morbid conditions. Worse yet, there is scant evidence that PDMP surveillance leads to improved health outcomes. In fact, studies associate PDMPs with increased illicit drug overdose mortality.

The CDC issued prescribing guidelines in 2016 that were misinterpreted as mandating opioid deprescribing, states have enacted a number of similar laws and regulations, and third party payers have adopted restrictive opioid policies that induce harms. Taken together, the rapid deployment of such blunt force instruments has brought about a precipitous decline in opioid prescribing over the last decade, including the rapid tapering of pain patients without their consent. The serious risks attendant to the nonconsensual, aggressive tapering of a patient taking opioids long-term include excruciating pain, depression, suicidal ideation, and death.

Meanwhile, the Drug Enforcement Administration (DEA) concedes that overdose deaths primarily driven by dangerous, illicit drugs continue to escalate and that the war on the prescription opioid supply has motivated drug cartels to target individuals with untreated pain with counterfeit fentanyl pills. As DEA noted in its 2020 National Drug Threat Assessment, “[t]he increasing number of counterfeit pills resembling prescription medications and users who may be pivoting to abusing illicit substances with waning [prescription opioid] availability may prove to be a significant threat into 2021.”

While policymakers myopically focused on the prescription opioid supply, they also neglected countless opportunities to improve access to — and quality of care for — people with substance use disorders and persistent pain. They left in place or made worse health-harming laws that restrict access to therapeutic prescription opioids, including medications for opioid use disorder like methadone and buprenorphine, the gold standard treatment. Today, most people with opioid use disorder do not receive treatment. Among those that do, less than a third received the gold standard medications for opioid use disorder. Individuals with opioid use disorder in treatment also continue to face discrimination across a range of settings, including in health care. In addition, prescription opioid reduction policies and the failure to incentivize the development of effective alternative treatment have left a subset of the more than 50 million Americans with persistent pain conditions abandoned by providers and the health care delivery system.

Punitive and facile “solutions” to problems with varied, complex, and structurally determined root causes exacerbate existing harms and create new ones. Here, failure begets failure when the complexity of the overdose crisis is ignored. As it turns out, the war metaphor is fitting: our ongoing drug battles have cost money, lives, health, and a significant degree of our humanity. The crisis demands complex, structural care and support solutions that well-exceed the scope of this commentary and its recommendations.

The good news for the Biden administration is that the current drug regulatory regime is so flawed that it presents countless opportunities to meaningfully mitigate the health-harming consequences of the ongoing war on opioids. An American public health and safety-promoting drug policy agenda grounded in sound science is long overdue. At minimum, the new administration can enhance patient access to affordable, evidence-based prescription opioid treatment by adopting the following reforms:

  • Revise the CDC guidelines to eliminate arbitrary dose caps and to account for the evolved evidence of increased deaths from involuntary tapers and discontinuations, suffering from inadequate and non-individualized pain treatment, and the failure to treat patients for substance use disorders;
  • Revise the CDC guidelines to acknowledge the misappropriation and misapplication of clinical recommendations in narrow circumstances by regulators and institutions for widespread non-clinical purposes;
  • Enjoin the federal DEA and DOJ from conducting dragnet sweeps of PDMP data to target and punish prescribers, dispensers, and patients unless and until the Food and Drug Administration validates those algorithm-fueled diagnostic platforms as safe and effective under its Software as a Medical Device authority;
  • Incentivize hospitals and health systems to require both addiction and pain medicine consult services;
  • Incentivize health care provider training programs in addiction and pain medicine;
  • Enforce anti-discrimination laws for people with pain and substance use disorder (SUD), including against health care providers and institutions that refuse medically appropriate care;
  • Eliminate prescribing restrictions on methadone, including in-person initiation requirements;
  • Eliminate mandatory random drug testing at opioid treatment programs (OTPs) for patients who are in compliance with program rules;
  • Repeal the prerequisite that individuals must suffer opioid use disorder for at least a year in order to be eligible for treatment at an OTP;
  • Repeal the requirement that OTP patients participate in counseling in order to receive treatment;
  • Authorize mobile, community-based SUD therapeutic treatment for individuals with SUD that do not have ready access to a treatment provider;
  • Eliminate prior authorization requirements and reimbursement restrictions that apply to buprenorphine and methadone;
  • Repeal the Drug Addiction Treatment Act of 2000 buprenorphine waiver requirements;
  • Reclassify naloxone from a prescription to an over-the-counter medication;
  • Extend enhanced telehealth equipment and reimbursements to SUD and pain medicine providers;
  • Provide adequate telehealth equipment and data plans to SUD and pain patients;
  • Ensure that SUD and pain medicine providers are equipped with adequate personal protective equipment;
  • Fund and expand syringe exchange programs; and
  • Legalize overdose prevention sites.

Jennifer D. Oliva is an Associate Professor and Director of the Center for Health & Pharmaceutical Law at Seton Hall Law where she specializes in health law and policy, FDA law, drug policy, evidence, and complex litigation.

Kelly K. Dineen is the director of the health law program at Creighton University School of Law and an Associate Professor of Law. 

The Petrie-Flom Center Staff

The Petrie-Flom Center staff often posts updates, announcements, and guests posts on behalf of others.

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