Use of Naloxone for the Prevention of Opioid Overdose Deaths

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Background

Drug-related overdose is the leading cause of accidental death in the US. According to the Centers for Disease Control and Prevention (CDC), there were 70,630 drug-related overdose deaths in 2019. Deaths from opioid overdose accounted for 70.6% of those fatalities.¹ Provisional estimates indicate that more than 93,000 drug overdose deaths occurred in the United States in the 12-months ending in December 2020, with synthetic opioids as the primary driver for the increase over the period.^2,3

Naloxone is a mu-opioid antagonist with well-established safety and efficacy that can reverse opioid-related respiratory arrest and prevent fatalities. Naloxone treatment of opioid overdose has been in use in hospital settings for decades. Over the last several years and in response to the overdose epidemic in the US, training and distribution of naloxone has been expanded to include emergency medical technicians, police officers, firefighters, correctional officers, and others who might experience or witness opioid overdose such as individuals who use opioids and their families.⁴ The Substance Abuse and Mental Health Services Administration (SAMHSA) supports the use of naloxone for the treatment of opioid overdose by bystanders in their Opioid Overdose Prevention Toolkit.⁵

Naloxone is a remarkably effective, inexpensive and safe medication. It acts quickly, has no addictive potential, may be dispensed by injection (preferably intramuscular) or intranasally, and has mild side effects (other than precipitating opioid withdrawal) when used at the lowest effective dosage for reversal.

Until relatively recently, only physicians and certain emergency medical personnel were authorized to administer naloxone to resuscitate opioid overdose victims. Nearly every state has now provided legislative authority for others (e.g. lay persons, emergency medical technicians and police officers) to administer naloxone in such cases. Prompt action by a someone who observes an individual experiencing early stages of opioid overdose and who administers naloxone before professional first responders are on the scene, greatly increases the probability of survival.

Training in the use of naloxone is simple, due to the absence of complicated administration requirements or serious reactions, although referral for subsequent medical attention is recommended. There are three populations that would benefit most from being provided naloxone: individuals who use opioids who are not in treatment; individuals diagnosed with opioid use disorder and in treatment; and individuals prescribed opioid medication for pain control. In addition, family and friends who come into regular contact with individuals in these populations should be provided naloxone. Since 2014 the Food and Drug Administration (FDA) has as approved two new delivery devices for naloxone that can be used by laypersons with virtually no training. FDA has also taken the unprecedented step of developing model Drug Facts Labels for both intranasal and auto-injector naloxone to spur the development of over-the-counter (OTC) naloxone products.⁶

In response to the impact of the devastating opioid overdose epidemic, as of 2017, all 50 states and the District of Columbia had passed legislation designed to improve naloxone access.⁷;These access laws include measures that provide civil, criminal, and disciplinary immunity for medical professionals who prescribe or dispense naloxone, as well as laypeople who administer it, but their provisions vary by state and some provide immunity only in limited circumstances. They may also allow organizations that are not otherwise permitted to dispense naloxone, such as non-profits, to distribute it, and allow laypeople to possess naloxone without a prescription. Finally, naloxone access laws may permit naloxone to be prescribed to third parties (i.e., to a person other than the person at risk of overdose) and/or permit it to be prescribed via a standing order. As of 2019, 35 states had some mechanism in place for the statewide distribution of naloxone without a patient-specific prescription.⁸ Most state directives permit anyone, including minors, who may be in a position to assist in reversal of an overdose to access naloxone under their provisions. Some states and jurisdictions are expanding naloxone access through innovative distribution methods such as vending machines, naloxone kits placed in or near automated external defibrillator (AED) cabinets, and online access.⁹ Studies have found that increasing access to naloxone among people who use drugs is associated with decreases in overdose deaths and that there is no associated increase in opioid use.¹⁰

Additionally, as of May 2020, 47 states and the District of Columbia, have enacted some form of a Good Samaritan or 911 immunity law that provides some protection from arrest or prosecution for persons who call for emergency medical assistance for an opioid overdose victim.¹¹ These laws may protect persons who report an overdose from arrest, charge and prosecution for controlled substances and/or drug paraphernalia possession. They may also provide protection from protective or restraining orders, probation or parole violations, and other crimes. Finally, they may provide that reporting an overdose can be a mitigating factor in sentencing for crimes for which immunity is not provided.

Recommendations

1. ASAM supports the increased use of naloxone in cases of opioid overdose to prevent or reverse respiratory arrest. Naloxone can be administered quickly and effectively by trained professionals and by lay individuals who observe the initial signs of an opioid overdose and are trained in the proper administration of naloxone.
2. ASAM supports broadened accessibility to naloxone for people who use drugs and other individuals in a position to initiate early response to evidence of opioid overdose. These individuals would include:
   1. People who use or are prescribed opioids, or may have unintended exposure to opioids through other substance use;
   2. Family members, significant others, companions of people who use or are prescribed opioids;
   3. People re-entering the community from correctional settings and their family members;
   4. Early responders to calls for emergency medical assistance (EMTs and paramedics);
   5. Clinicians and others who provide services to individuals with substance use disorders in office-based, clinic or residential settings;
   6. Corrections staff;
   7. Law enforcement officers; and
   8. Staff of state and community-based public and private organizations serving populations at high risk for opioid overdose.
3. ASAM encourages the co-prescribing of naloxone for people at risk of overdose, which includes those receiving opioid treatment for pain and those being treated for opioid use disorder. The prescription ideally would be complemented by appropriate patient and/or family education about the risks of opioid overdose, the signs/symptoms of overdose, the proper use of naloxone for revival of accidental overdose victims, and instructions for referral to emergency care, addiction treatment, and the need for follow-up.
4. All persons provided with naloxone supplies for use in the event of opioid overdose should be offered training and education in the prevention, detection, and appropriate response to an overdose, including the recognition of opioid overdose symptoms, proper technique for administration of the opioid antagonist, either by intramuscular injection or by the nasal mucosa, and essential follow-up procedures, including referral to emergency medical services. This includes people provided with naloxone supplies under a public health program of harm reduction and those offered prescriptions for naloxone at medical visits.
5. Federal and state health departments should be encouraged to develop and maintain data tracking systems that capture both fatal and non-fatal overdoses and reversals, as well as instances when naloxone is administered.
6. States with legislative barriers or resistance to broadened distribution of naloxone for opioid overdose reversal should be encouraged by their state medical societies and health department officials, addiction treatment providers, and the public to support legislation to eliminate such barriers.
7. All jurisdictions should adopt laws that provide overdose victims and persons assisting with the emergency immunity from prosecution and civil liability should they come in contact with emergency responders. This immunity should apply as well to overdose victims and persons assisting with the emergency who are supervised as part of probation or parole agreements.
8. All jurisdictions should provide adequate funding for the implementation of naloxone distribution and/or co-prescription programs and consider innovative ways to increase clinical and public access to this life-saving medication. Access to naloxone should not be inhibited by a lack of funding from the respective jurisdiction.
9. Regulations should be amended to permit access to naloxone at pharmacies either by a standing prescription for eligible individuals or by designating naloxone as an over-the-counter medication. Pharmacists should be encouraged to recommend naloxone when indicated. Insurance regulations should be amended to allow individuals to make use of medication benefits when naloxone is obtained at pharmacies regardless of whether it is obtained by standing prescription or as an over-the-counter medication.
10. Opioid overdose reversal programs should be regarded as a potential gateway to ongoing medical care and opioid addiction treatment if indicated.
11. All addiction treatment agencies, including outpatient and residential facilities, and recovery houses should have on-site supplies of naloxone for “rescue” dosing in cases of opioid overdose that may appear among patients of the agency or others on the agency’s grounds. ASAM encourages state regulatory agencies to fund and require the on-site presence of naloxone supplies and methods of medication delivery as a condition of facility licensure for addiction treatment facilities. In addition, addiction treatment agencies and office-based providers should encourage patients with opioid use disorder and significant others of people at risk for overdose to receive naloxone training.
12. Follow-up services, including addiction treatment and harm reduction services, should be available and offered to overdose survivors.
13. ASAM supports research into other interventions for the prevention and reversal of opioid overdose and death.