Naloxone (Narcan) Saves Lives, But Legal Barriers Prevent Its Use

As a result of the opioid epidemic, drug overdose is now the leading cause of injury death in the U.S. Naloxone, however, is a medication that has been approved by the Food & Drug Administration since 1971 and has the ability to reverse opioid overdoses and, therefore, save lives.

 WHAT PROBLEM DOES THIS STUDY ADDRESS?

Aside from its ability to save lives, naloxone has no potential for misuse, is cost-effective, and its availability does not lead to risky behavior such as opioid users increasing their opioid use.

Despite these benefits of naloxone, legal barriers make it difficult for people who use opioids, and their friends and families who may be present at the scene of an overdose, to obtain a prescription. In this study, Davis and Carr describe recent changes in state policies and regulations that have increased access to naloxone and identify areas that still need to be addressed.

HOW WAS THIS STUDY CONDUCTED?

The authors searched a legal database for all statutes and regulations (i.e., laws) related to layperson access to naloxone in the 50 states and the District of Columbia.

The authors then used categories within these domains that represented a characteristic of each state’s law. Finally, the authors checked for the presence or absence of each characteristic for each state.

WHAT DID THIS STUDY FIND?

By 2010, only four states had changed their laws to increase access to naloxone, but by 2015 all but seven (Arizona, Iowa, Kansas, Missouri, Montana, South Dakota, and Wyoming) had made changes.

Another legal change is standing orders for naloxone distribution which allows physicians to permit other personnel such as pharmacists or nurses to dispense naloxone to any person meeting specific criteria. While this is common in the pharmacy setting, these laws may also allow for expansion of naloxone distribution beyond the pharmacy to settings such as drug treatment centers and community organizations which reach a population that otherwise may not access naloxone. Twenty-nine states permit standing orders for naloxone and 12 allow people who otherwise cannot prescribe medication to distribute it.

In 38 states, there is at least one law allowing people under certain circumstances (which vary by law) to come in “off the street” without a prescription and purchase naloxone at a pharmacy. This may be authorized under standing order laws (see above) or laws allowing pharmacists to prescribe naloxone themselves. Some states require individuals without a prescription to receive training before the medication can be dispensed.

There may be concerns about liability in prescribing or dispensing naloxone. As a result, 32 states provide immunity from civil liability (i.e., protection from being sued by another individual for damages for personal injury) to prescribers, 30 to dispensers, and 36 to lay administrators. Some states also provide immunity from criminal liability (i.e., protection from prosecution by the state) to address concerns regarding risk associated with its use. Thirteen states have laws explicitly stating that possessing naloxone without a prescription is not a criminal offense. While people at the scene of an overdose may hesitate to call 911 out of fear that they may be arrested for involvement with illegal drugs, 35 states have Good Samaritan Lawsthat encourage people to call for medical assistance by protecting them and the person experiencing the overdose from prosecution for minor drug possession.

WHY IS THIS STUDY IMPORTANT

Every day in the U.S. 44 people die from a prescription drug overdose. Naloxone provides an opportunity to prevent some of these deaths and offer these individuals a chance at recovery.

While increased access to naloxone is crucial for saving lives, naloxone rescues may provide an opportunity to engage individuals in treatment because some may experience increased motivation for change as a result of this potentially fatal consequence. Thus, efforts should also help link individuals to treatment and recovery support services after a naloxone rescue.

Despite being on the market for decades, people have had difficulty accessing naloxone due to state laws and regulations often fueled by the assumption that providing naloxone will result in increased opioid use, which is not supported by research (see here). As a response and solution to the growing opioid problem becomes more vital, laws are being modified to implement this harm reduction strategy. And despite the uptake of laws supporting access to naloxone, cost is now a major barrier as recent price increases are making it unaffordable for many organizations and individuals whose insurance may not cover it. This will require intervention at the federal level to insure that public insurers like Medicare and Medicaid and private insurers cover naloxone at a level that makes it affordable for the people who need it. Another consideration is naloxone’s status as a prescription medication with some agencies suggesting it may be beneficial to switch it to an over-the-counter medication.

LIMITATIONS

1. This is a descriptive study of laws that support increased access to naloxone so it is unknown how these policy changes may directly impact outcomes of interest including fatal and non-fatal overdose rates.

NEXT STEPS

Research is needed to determine the effect of these policies on fatal opioid overdose rates. It is also important to create a standardized measure for averted overdoses to provide estimates of lives saved by naloxone.

BOTTOM LINE

CITATIONS

Davis, C. S., & Carr, D. (2015). Legal changes to increase access to naloxone for opioid overdose reversal in the United States. Drug Alcohol Depend, 157, 112-120. doi:10.1016/j.drugalcdep.2015.10.013