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Moments after the arrival of the ambulance, a patient was rolled in on a stretcher to receive almost instant care by the emergency room staff. The patient was about 24 years old, Caucasian, and unconscious. Cardiac monitor leads were placed on his chest, and oxygen was immediately provided. His pulse was weak and his blood pressure extremely low. Heart rate and respiration rate were also depressed. The neurological exam revealed extreme pinpoint pupils, failure to respond to pain, and no response to verbal instructions. Although he was rather thin, his appearance was otherwise unremarkable except that one rolled-up shirt sleeve exposed needle track marks indicating intravenous (IV) drug use. The triad of coma, pinpoint pupils, and depressed respiration is a strong indicator of opioid poisoning, and physical evidence of IV drug use further confirms the diagnosis. To any bystander, death seemed imminent. Nevertheless, 0.8 mg of IV naloxone (Narcan) was ordered immediately. Within a minute or two, respiratory rate had returned to normal, and soon after, the young man was alert enough to respond to a few questions. Although capable of walking out of the emergency room, the patient was convinced to remain overnight for further observation since the half-life of naloxone is somewhat shorter than that of heroin, and he might need a second naloxone infusion.
Naloxone administration in response to suspected opioid overdose has been the standard care of emergency medical professionals for many years. Based on this well-documented success, the distribution of naloxone to first responders has increased dramatically in much of the country. In addition, in many places family and friends of opioid users have been encouraged to have a source of naloxone available at all times to treat any sudden overdoses. In recent years, access to naloxone has been facilitated in many jurisdictions by allowing retail pharmacies to dispense it without a prescription. It has been so effective in helping opioid abusers that take-home naloxone programs have been expanded in some regions to provide naloxone to all primary care patients who receive chronic opioid treatment for pain.
The number of opiate overdose deaths has jumped dramatically, to nearly 50,000 people in the United States in 2019 (CDC, 2020). Opioid overdose deaths have seen a greater than sixfold increase since 1999 because of the increased prescription of opioids for chronic pain and the upsurge in the use of illicit synthetic fentanyl along with heroin (Figure 1; CDC, 2020). Drug deaths are rising faster than ever, so the problem is extremely acute. The figure shows the number of opioid overdose deaths per 100,000 population according to the type of opioid involved.
Take-home naloxone is one of the few approaches with proven effectiveness in reducing opioid mortality. The rationale is that the use of naloxone in combination with calling 911 can provide enough time for the arrival of medical help to save lives. With a minimum of instructions, nonmedical personnel can easily administer the life-saving drug. The drug can be delivered by intramuscular injection, using a premeasured handheld auto-injector, or intranasally with an atomizer. A training video can be accessed at www.kelley-ross.com/naloxone-program/. Naloxone has no psychoactive effects except to reverse opioid-induced effects, so there is no abuse potential. Naloxone distribution is not intended to be a treatment program but merely a temporary means of harm reduction in response to the epidemic of opiate-related deaths.
Despite its recognized effectiveness, there are multiple barriers to its widespread use beyond distribution by local agencies (Bazazi et al., 2010). There is low social priority to deal with this issue because of the stigma surrounding drug users and drug overdose. Despite expressed fears, there is no evidence that providing a harm-reduction safety net encourages increased drug consumption and riskier behavior.
Figure 1 Opioid overdose deaths from 1999 to 2019 by type of opioid Opioids include drugs such as morphine, oxycodone, hydrocodone, heroin, methadone, fentanyl, and tramadol. Commonly prescribed opioids include morphine, codeine, oxycodone, buprenorphine, and methadone. Other synthetic opioids include fentanyl, as well as illicitly manufactured fentanyl and fentanyl analogs. (Source: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control)
One final obstacle to increased use of naloxone is cost. Although naloxone is a drug old enough to be available as a generic, prices for generic drugs have been rising. Naloxone in 2005 cost about $1 per milliliter vial, while the 2021 price was approximately $20. The cost of naloxone in more convenient new delivery systems can vary from $125 (for a nasal spray two-pack) to as much as $4,100 for two prefilled autoinjectors that provide audible, recorded instructions for its use. High prices may limit accessibility to the drug-using community as well as to local governments providing naloxone to their first responders. The U.S. Congress has made several attempts to address the problem, and the U.S. House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law has held a special hearing on the issue (Tirrell, 2017, provides more details) More recently, in an unprecedented move, the FDA took the initiative to develop a consumer-friendly Drug Facts Label (DFL) for naloxone, which pharmaceutical companies must normally submit for approval before a drug can be available for over-the-counter sales. By taking this step, the FDA intends to lower the costs normally associated with developing a drug for over-the-counter sales, thereby increasing access to this life-saving drug (FDA, 2019).
In addition to naloxone, take-home fentanyl test strips have been made available from organizations such as DanceSafe (https://dancesafe.org) that can be used to test for the presence of fentanyl and its analogs in both drug samples (pre-exposure) and in urine (post-exposure), allowing opioid users to more accurately determine their exposure risk. Additionally, some social media platforms have online communities dedicated to harm reduction for opioid users that alert users to geographic trends in fentanyl overdoses and provide education on best practices for harm reduction.
References
Bazazi, A. R., Zaller, N. D., Fu, J. J., and Rich, J. D. (2010). Preventing opiate overdose deaths: Examining objections to take-home naloxone. J. Health Care Poor Underserved, 21, 1108–1113.
Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services. (2020). Opioid Data Analysis and Resources | Drug Overdose | CDC Injury Center. https://www.cdc.gov/drugoverdose/data/analysis.html.
Food and Drug Administration (FDA), U.S. Department of Health and Human Services. (2019) Statement from FDA Commissioner Scott Gottlieb, M.D., on unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-unprecedented-new-efforts-support-development-over.
Tirrell, M. (2017). As Opioid Epidemic Worsens, the Cost of Waking Up from an Overdose Soars. CNBC, Aired January 4, 2017.