Emergency Legal Authority and the Opioid Crisis

Authors: Lainie Rutkow, J.D., Ph.D., M.P.H., and Jon S. Vernick, J.D., M.P.H.

N Engl J Med 2017; 377:2512-2514 December 28, 2017

Opioid-overdose deaths in the United States have steadily increased for the past 15 years, with more than 33,000 such deaths reported in 2015. The epidemic is unfolding on two fronts: use of prescription opioid pain relievers (OPRs) accounts for approximately half of opioid-overdose deaths, and deaths from heroin and synthetic opioids such as fentanyl, obtained illicitly, have increased dramatically during the past 5 years.

In the face of this public health crisis, various policies have been enacted — particularly at the state level — often to address OPR prescribing and limit opportunities for OPR diversion. For example, all 50 states have established prescription drug monitoring programs (PDMPs) that collect information about individuals’ prescription-drug history in an electronic database. Eleven states have laws regulating pain-management clinics, and several states have enacted laws to limit the dosage or duration of OPR prescriptions.

Recently, six states have taken the unusual step of using their legal authority to declare their opioid-overdose situation an emergency. When a government issues an emergency declaration, it can temporarily act to mitigate the emergency using powers and resources that might not otherwise be available to it. Typically, emergency declarations pertain to natural disasters or infectious disease outbreaks. The severity of the opioid-overdose crisis has led to some of the first emergency declarations for a noncommunicable health condition, though their impact remains unclear.

In July 2017, the President’s Commission on Combating Drug Addiction and the Opioid Crisis called for a national declaration of emergency. In its preliminary report, the commission stated that issuing such a declaration was its “first and most urgent recommendation,” since doing so would potentially provide the impetus for the federal government’s executive and legislative branches to respond to the crisis with additional resources and policies. On October 26, 2017, President Donald Trump directed the acting secretary of health and human services to declare the opioid crisis a national public health emergency under the federal Public Health Services Act. The President has declined to declare a separate national emergency under a different federal law, the Robert T. Stafford Disaster Relief and Emergency Assistance Act.

As the federal government determines the specific actions that will follow its declaration, and more individual states consider issuing their own emergency declarations, policymakers, health care providers, and emergency managers can learn from aspects of the state emergency declarations that have already been issued. Though the scope of these declarations has been limited, they could suggest helpful, additional responses to multiple facets of the crisis (e.g., problematic OPR prescribing and opioid use disorders), especially if emergency powers are used in new and innovative ways.

Every state has the legal authority to declare an emergency, disaster, or public health emergency, which are functionally similar. State laws specify how these legal declarations are made, most often through an executive order issued by the governor, though some states use other mechanisms (e.g., a statement from the health commissioner). Many local governments have analogous systems in place.

Once an emergency declaration has been issued, a state government can take actions that are available only for the duration of the emergency. These declarations and their accompanying powers give states flexibility to respond to exigent circumstances, including by reallocating state funds, managing property, and mandating collaboration among public health and law-enforcement agencies. Emergency declarations often facilitate coordination with other jurisdictions — including the federal government and other state governments — allowing the affected state to draw on human, financial, or other resources. Of course, any use of emergency powers must be balanced by respect for individuals’ civil liberties and implemented with appropriate safeguards, including application of due process for anyone affected by the exercise of these powers.

In 2014, shortly after the Food and Drug Administration approved Zohydro, an extended-release opioid, Massachusetts declared the first opioid-related emergency. Virginia followed in 2016. In 2017, Alaska, Arizona, Florida, and Maryland issued emergency declarations, with Alaska and Maryland explicitly citing concerns about synthetic opioids such as fentanyl.

Five of the six declarations seek to improve access to the opioid antagonist naloxone, either through education and training (e.g., teaching law-enforcement officers to administer it) or through a standing order to allow pharmacists to dispense it without an individual prescription. The Arizona and Massachusetts declarations explicitly address opioid-prescribing practices, through the development of prescribing guidelines, regulations, or requirements for PDMP use.

Although the effects of these declarations are difficult to measure, it appears that their primary effect has been to communicate the severity of the opioid crisis to the public and improve naloxone access or awareness. These outcomes are important, but emergency declarations should be only a first step in facilitating other responses to mitigate the emergency. States can capitalize on the opportunity provided by these declarations to undertake innovative legal responses.

Perhaps the most immediate effect of an emergency declaration is to raise the public profile of an issue. By declaring that opioid-related morbidity and mortality constitute an emergency, government leaders can inform the public about the nature of the crisis. For example, emergency declarations provide an opportunity to frame the opioid crisis as a public health problem that affects communities and thus requires population-level solutions.

But beyond communicating, emergency declarations should facilitate measured, pragmatic actions to mitigate the emergency. State governments could use an emergency declaration to take concrete steps to address opioid use disorders. For example, using emergency legal powers, states could expand access to evidence-based medication-assisted treatment (MAT), such as buprenorphine therapy, through their Medicaid program. States vary in the extent to which they support MAT through Medicaid, and access could be improved by minimizing prior-authorization requirements or removing lifetime limits for MAT.

For expanded MAT access to be meaningful, providers must be trained in it. As part of an emergency declaration, states could enhance training opportunities for providers in conjunction with their state medical licensing board or through continuing medical education. In addition, emergency powers could be used to temporarily waive state-specific licensure requirements for certain types of health care providers, allowing addiction medicine specialists to deploy to areas in greatest need of immediate MAT services.

Continued efforts to ease access to naloxone are critical, as demonstrated by the near-universal focus on naloxone in the extant opioid-related state emergency declarations. In particular, naloxone access and training for laypeople should be prioritized. By issuing a standing order in conjunction with an emergency declaration, states can allow pharmacists to dispense naloxone to people who have not previously obtained a prescription for it. With an emergency declaration, states can also allocate funds for community-based training in naloxone administration for laypeople or for the purchase of naloxone for distribution to schools or other state facilities.

Although opioid-related morbidity and mortality present a public health challenge different from those in previously declared emergencies, the same underlying principles apply, including the need for due process, ongoing review, and other legal safeguards for vulnerable groups. The recent federal emergency declaration will supplement, not replace, state declarations. Federal emergency powers have the potential to cover different actions, such as deployment of providers from the Public Health Service or steps to reduce the price of key medications, including naloxone. For now, however, the front line of emergency response to the opioid epidemic remains the states. Emergency declarations are one tool that states can use as part of a multifaceted prevention and mitigation effort.

 

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