The US Opioid Crisis: Current Federal and State Legal Issues

Abstract

The United States is in the midst of a devastating opioid misuse epidemic leading to over 33,000 deaths per year from both prescription and illegal opioids. Roughly half of these deaths are attributable to prescription opioids. Federal and state governments have only recently begun to grasp the magnitude of this public health crisis. In 2016, the Centers for Disease Control and Prevention released their Guidelines for Prescribing Opioids for Chronic Pain. While not comprehensive in scope, these guidelines attempt to control and regulate opioid prescribing. Other federal agencies involved with the federal regulatory effort include the Food and Drug Administration (FDA), the Drug Enforcement Agency (DEA), and the Department of Justice. Each federal agency has a unique role in helping to stem the burgeoning opioid misuse epidemic. The DEA, working with the Department of Justice, has enforcement power to prosecute pill mills and physicians for illegal prescribing. The DEA could also implement use of prescription drug monitoring programs (PDMPs), currently administered at the state level, and use of electronic prescribing for schedule II and III medications. The FDA has authority to approve new and safer formulations of immediate- and long-acting opioid medications. More importantly, the FDA can also ask pharmaceutical companies to cease manufacturing a drug. Additionally, state agencies play a critical role in reducing overdose deaths, protecting the public safety, and promoting the medically appropriate treatment of pain. One of the states' primary roles is the regulation of practice of medicine and the insurance industry within their borders. Utilizing this authority, states can both educate physicians about the dangers of opioids and make physician licensure dependent on registering and using PDMPs when prescribing controlled substances. Almost every state has implemented a PDMP to some degree; however, in addition to mandating their use, increased interstate sharing of prescription information would greatly improve PDMPs' effectiveness. Further, states have the flexibility to promote innovative interventions to reduce harm such as legislation allowing naloxone access without a prescription. While relatively new, these types of laws have allowed first responders, patients, and families access to a lifesaving drug. Finally, states are at the forefront of litigation against pharmaceutical manufacturers. This approach is described as analogous to the initial steps in fighting tobacco companies. In addition to fighting for dollars to support drug treatment programs and education efforts, states are pursuing these lawsuits as a means of holding pharmaceutical companies accountable for misleading marketing of a dangerous product.

Opioid prescribing patterns among medical providers in the United States, 2003-17: retrospective, observational study

“…Inappropriate opioid prescribing can lead to diversion of, addiction to, and overdose from prescription opioids,56789 contributing to an epidemic of opioid related deaths in recent years 10. Promoting cautious, scientifically justified, opioid prescribing has become a leading goal of policy makers in both government and healthcare 11121314…”

A systematic review of strategies to improve appropriate use of opioids and to reduce opioid use disorder and deaths from prescription opioids

“…Strategies and interventions to address the sweeping opioid crisis have been the subject of several narrative reviews, [98][99][100][101] providing a broad overview of existing strategies, as well as drawing attention to more novel interventions. Narrative syntheses, however, lack comprehensive and systematic literature search strategies and, thus are prone to publication bias.…”

Mechanisms for therapeutic effect of bulleyaconitine A on chronic pain

“…The tolerance together with the addiction of opioid leads to over 33,000 deaths per year in the United States, the situation called opioid crisis. 47 Fortunately, an animal study shows that BLA has synergistic effect with morphine and can completely abolish morphine tolerance. 32 Further studies are needed to verify the antitolerance effect in human patients and to elucidate the underlying mechanisms.…”