Public Health Solutions to Combat Fentanyl Poisoning in the United States

Americans are united in their concerns about illicit fentanyl—more than nine out of 10 voters (92%) believe it is a serious problem in the U.S. today (RMG Research, Inc., 2023). The latest provisional data from the Centers for Disease Control and Prevention (CDC) reports more than 70,000 deaths from synthetic opioids, such as illicit fentanyl, over a 12-month period ending in January 2023 (Ahmad, 2023). This is equivalent to losing one commercial 737 aircraft worth of passengers each day. The epidemic is indiscriminate, impacting Americans of all backgrounds. According to an advocacy group analysis of CDC data, fentanyl poisoning is the leading cause of death for Americans ages 18-45 (Families Against Fentanyl, 2021).

This paper will explore data on how illicit fentanyl is impacting the opioid crisis and contributing to fentanyl poisonings, including in adolescents, children, and infants. The presence of deadly fentanyl is increasing, on its own and in many other drugs, such as cocaine, marijuana, and street drugs. Record amounts of illicitly manufactured fentanyl are being seized by law enforcement. Victims who encounter illicit fentanyl may take it unknowingly, believing it is something completely different—either another illicit substance or a legitimate prescription drug. Such accidental poisonings are an emerging new facet of the opioid crisis, along with opioid dependence and abuse, creating a need for targeted policy solutions to reduce the growing number of senseless deaths from accidental fentanyl ingestion.   

Unless otherwise noted, policy solutions in this paper are intended to target illicitly manufactured fentanyl, not prescription fentanyl. Illicitly manufactured fentanyl is fentanyl created and sold outside of the legal pharmaceutical drug prescription and distribution process in the U.S. Public health solutions for the illicit fentanyl crisis must occur in tandem with a broader set of solutions, including stopping the flow from China and the U.S.-Mexico border and implementing public safety measures.

UNDERSTANDING THE PROBLEM

The Growing Presence of Illicit Fentanyl

The amount of illicit fentanyl detected by law enforcement has grown significantly in recent years. Lab testing on all the seized fentanyl-laced counterfeit pills in the U.S. analyzed in 2022 found that six out of 10 pills contained a potentially lethal dose of fentanyl (U.S. DEA, n.d.a.). Last year, more than 250 pounds of fentanyl powder and 160,000 fake pills containing fentanyl were seized by the Washington division (covers the District of Columbia, Maryland, and Virginia) of the Drug Enforcement Agency (DEA) alone (U.S. DEA, 2023). A DEA press release noted that this was enough to potentially kill more than 8.3 million people, or about half of the combined populations of the District of Columbia, Maryland, and Virginia (U.S. DEA, 2023). It is widely known that fentanyl is being manufactured by Mexican drug cartels using chemicals from China and that it is subsequently smuggled across the border and distributed throughout our country in the form of powder, liquids, or pills that look like candy or that are virtually indistinguishable from legitimate prescription drugs. (Law et al., 2022; U.S. DEA, 2022; U.S. DEA, n.d.c)

Recognizing Deaths from Accidental Fentanyl Poisonings in Non-Chronic Drug Users 

Illicitly manufactured fentanyl is recognized by the CDC as a major contributing factor to the third “wave” in the ongoing opioid crisis, which began decades ago (NCIPC, 2022b). However, the sheer volume of fentanyl being seized and the largely unsuspecting manner in which people sometimes are exposed to it has revealed a new facet of the opioid epidemic—accidental poisoning. Indeed, the evidence suggests that non-chronic drug users are frequent victims.

The following subsections outline drug overdose deaths in adolescents, children, and infants. While all findings are tragic, the data for infants and children represents perhaps the most compelling evidence that the opioid crisis has broadened far beyond chronic drug users and those who use illicit substances to one of significant risk for the general population. Although these deaths are officially classified as overdoses from exposure to a deadly amount of a chemical substance, a more appropriate way to describe them would be as a category of deaths from accidental fentanyl poisonings. 

Adolescent drug overdoses increase as drug use declines

A large national survey conducted yearly on substance use among adolescents shows that prevalence remained stable in 2022 after declining in 2021 (NIH, 2022). The survey found that the trend for the percentage of 12th graders reporting use of narcotics other than heroin in the last 12 months was 1.7% in 2022—down from 2.7% in 2019 and from 2.1% in 2020 but up slightly from 1% in 2021 (Miech, 2023). Notably, the peak for this metric was 9.5% in 2004, and it decreased to 4.2% in 2017, the year that the opioid crisis was declared a public health emergency (Figure 1) (Miech, 2023).

Figure 1[1].

Despite these findings, the number of overdose deaths increased by 94% from 2019 (n=492) to 2020 (n=953) and by 20% from 2020 to 2021 (n=1146) among 14- to 18-year-olds (Friedman et al., 2022, p. 1399). Of the overdose deaths in 2021, 77% (n=884) involved fentanyl (Figure 2) (Friedman et al., 2022, p. 1399). To account for increasing adolescent overdose deaths in the context of decreasing adolescent drug use rates, researchers acknowledged the growing availability of illicit fentanyl and recognized the indiscernible contribution of factors from the COVID-19 pandemic, such as social isolation, mental illness, suicidal ideation, and changes to the illicit drug market. Overall, the results support that illicit fentanyl, taken either knowingly or unknowingly, is becoming more deadly.

Figure 2.

Equally concerning, deaths from fentanyl poisonings are being reported in adolescents with no history of drug use. This means fatalities could be occurring in first-time opioid users or those obtaining non-opioid pills (such as anti-depressants like Xanax or stimulants like Adderall) from a source other than a prescription pharmacy or medical clinic (U.S. DEA, n.d.c). According to an article published by the CDC, 83.9% of adolescent (ages 10-19) overdose deaths from July 2019 through December 2021 involved illicitly manufactured fentanyl, yet only 35% of adolescents in the study had a documented history of opioid use (Tanz et al., 2022, p.1576). The article further delineates that counterfeit pill evidence was present in one-quarter (24.5%) of adolescent overdose deaths, and four in 10 (40.9%) decedents had evidence of mental health conditions or history of treatment (Tanz et al., 2022, p.1576). These data points illustrate that the majority of adolescent fentanyl overdose deaths are in young people who have no record of previous opioid use and those with no history of treatment or evidence of poor mental health. The findings also reveal the continued need for treatment and support resources for the minority of adolescents with a history of opioid use and those living with mental health conditions.

Increases in infant and child illicit fentanyl poisonings

Deaths from fentanyl poisonings are also occurring in infants and young children. A recent research report from Yale School of Medicine evaluated pediatric deaths from fentanyl from 1999-2021(Gaither, 2023). In 1999, fentanyl was involved in 5% of pediatric opioid deaths, but in 2021, it was involved in 94% of pediatric opioid deaths (Gaither, 2023; Tomassl, 2023). Of the 1,557 fentanyl-involved pediatric opioid deaths in 2021, 133 were in children under age 5—40 infants and 93 children ages 1 to 4 (Gaither, 2023; McPhillips, 2023). This marked a nearly sixfold increase among children younger than 5 years since 2018 (Gaither, 2023; Reinberg, 2023).

These findings necessitate new policy solutions to accompany the current ones being used to combat the ongoing opioid crisis. Therefore, lawmakers should prioritize policies that reduce the supply of illicit opioids and that increase access to life-saving measures for someone experiencing an overdose due to fentanyl poisoning.

THE SOLUTIONS

Permanently Scheduling Fentanyl-Related Substances Is a Necessary First Step

Policymakers must take immediate action to reduce the number of citizens dying from fentanyl poisonings. The first step toward combating this scourge is to permanently classify all fentanyl analogues, such as carfentanil, acetylfentanyl, furanylfentanyl, and others, as Schedule I substances under the Controlled Substances Act. As discussed in a previous paper, Schedule I drugs have no currently accepted medical use, a high potential for abuse, and a lack of accepted safety for use of the drug (Law et al., 2022; U.S. DEA, n.d.b). While permanently scheduling fentanyl analogues in a class-based approach (not including fentanyl formulations approved for medical use, such as surgery and pain management) would likely have no effect on deterring the buying or selling of illicit fentanyl, evidence suggests it would remove the incentive for manufacturers to stay ahead of the DEA’s one-by-one scheduling approach by developing new fentanyl analogues using slightly modified chemical structures (Westlake Congressional Testimony, 2023; U.S. Sentencing Commission, 2021). Reports from the National Forensic Lab Information System showed that overdoses due to newly created fentanyl-related substances “have essentially ceased” since fentanyl analogues were temporarily scheduled by the DEA in 2018 (Westlake Congressional Testimony, 2023). Additionally, a 2021 report from the U.S. Government Accountability Office (GAO) explains that DEA officials said the decision to temporarily schedule fentanyl-related substances as a class has been the primary cause of the lower number of new fentanyl analogues found in the country (GAO, 2021). This has helped law enforcement more easily recognize fentanyl analogues for tracking and testing purposes.

Several bills introduced in both chambers of Congress and sponsored by members of both parties contain policies that would permanently schedule fentanyl-related substances as Schedule 1 controlled substances. These bills include The HALT Fentanyl Act, Stopping Overdoses of Fentanyl Analogues Act, and Protecting Americans from Fentanyl Trafficking Act of 2023, among others (HR 467, 2023; SB 600, 2023; SB 614, 2023). The HALT Fentanyl Act passed the House on May 25, 2023, by a wide margin of 289-133 (HR 467, 2023). While permanently scheduling fentanyl-related substances is paramount, that action alone will not solve the problem of illicit fentanyl poisonings. Lawmakers must do more to address the rising toll this drug has taken on communities and families.

Making Naloxone More Readily Available

Naloxone is an opioid antagonist that rapidly reverses an overdose due to opioids and illicit fentanyl (NIDA, n.d.). It can be administered to an individual experiencing an opioid overdose to immediately counteract the effects of the drugs in the body and save that individual’s life. Naloxone has no negative effects if administered to someone who has not taken opioids and is safe for use in children (Emergent, 2020). Naloxone has a shelf life between two and three years and comes branded as Narcan, Kloxxado, and others (Emergent, 2020). It can be administered via injection or inhaled in a nasal spray form (NIDA, 2022). Critics worry that making naloxone more readily available could increase risky behaviors, but the evidence presented above on the shifting nature of the opioid crisis and the prevalence of fentanyl poisonings necessitates increased access to this life-saving medication.

On March 29, 2023, the U.S. Food and Drug Administration (FDA) approved Narcan nasal spray for over-the-counter sale at pharmacies, following an FDA Advisory Panel recommendation (FDA, 2023). This action reduces barriers to obtaining naloxone and makes the potentially life-saving product as easy to purchase as ibuprofen or band-aids. This action is also widely supported by the public, as 84% of voters favor over-the-counter availability of opioid reversal treatments like naloxone (RMG Research, Inc., 2023).

 While it is likely that the over-the-counter availability of Narcan will increase access for those who need it, other factors, such as cost and coverage by health plans, should be considered. As with many prescription drugs, the price of naloxone varies, but a pack of two 4 mg generic naloxone nasal sprays is reported on GoodRX.com to be available for between $73 and $134 in the Washington, D.C. area (GoodRx, n.d.).[2] Similarly, the price listed on that site for branded Narcan is $136 to $145. In a press statement, the maker of Narcan stated that they expect over-the-counter versions to be available on shelves and online by late summer 2023 (Emergent, 2023). The press statement does not specify a price for the over-the-counter product, and other formulations and dosage amounts will remain available by prescription only.

Other naloxone applications exist for over-the-counter distribution but have not been approved yet (Harm Reduction Therapeutics, Inc, 2022). Approval of more over-the-counter naloxone products would ensure price competition on retail shelves, and the FDA should review all applications with expediency.

Additionally, states have acted to improve access to naloxone by allowing pharmacists to dispense it without a prescription. Currently, all 50 states allow pharmacists to dispense naloxone without a prescription to those in need through either a state standing order or a specific state protocol, such as to those who ask for it (LAPPA, 2023; SAFE Project, n.d.).

Medicaid covers at least one formulation of naloxone without the need to obtain prior authorization in most states, often with no required co-pay or with a co-pay under $5 (KFF, 2022a; KFF, 2022b). A March 2023 naloxone economic overview from the Reagan-Udall Foundation found that the cost of naloxone is covered by most insurance policies and that the Department of Veterans Affairs has eliminated copayment for opioid antagonists (Reagan-Udall Foundation, 2023). As naloxone becomes available to purchase over the counter in late summer 2023, it will be important to monitor how the transition from prescription-only access may impact insurance coverage status by specific payors and out-of-pocket cost implications for patients (Reagan-Udall Foundation, 2023). In particular, state Medicaid programs should begin evaluating whether over-the-counter Narcan should be covered for beneficiaries. The principle of reducing deaths due to accidental fentanyl poisonings should guide all cost and coverage discussions by payors, provider, and policymakers.

Beyond monitoring naloxone health plan coverage and affordability as over-the-counter options become available, policymakers should consider further broadening access to opioid overdose-reversal treatments. This includes making them readily available in high-traffic public spaces, such as schools and colleges, public transportation stations and airports, and in larger retail spaces, such as shopping malls and grocery stores. Nearly nine out of 10 voters (89%) agree that keeping naloxone in first aid kits in locations such as these is important (RMG Research, Inc., 2023). The CDC’s State Unintentional Drug Overdose Reporting System (SUDORS) shows that in 2021, two-thirds of all drug overdose deaths had at least one potential opportunity for intervention, including 46% with a potential bystander present (NCIPC, 2022a).

Some states have taken action to prevent fentanyl poisonings by requiring naloxone to be stocked in schools. Last year, Florida enacted a law that allowed school districts to stock naloxone and administer it in case of an emergency (FL SB 544, 2022). In January 2023, New Jersey passed a law requiring colleges to stock naloxone and create a plan for emergency administration (NJ A 4852, 2023). On June 17, 2023, Texas Governor Greg Abbott signed one bill allowing the provision of opioid antagonists at institutions of higher education under the state opioid antagonist program and another bill requiring education on fentanyl abuse prevention and drug poisoning awareness in grades 6-12 in Texas public schools (TX SB 867, 2023; TX HB 3908, 2023).

Additional Actions to Prevent Fentanyl Poisonings

Last year, Texas implemented an innovative “One Pill Kills” education campaign to remind citizens of how deadly fentanyl can be, even if it is unknowingly present in a pill made to look like a legitimate prescription drug (Office of the Texas Governor, 2022). The DEA also launched “One Pill Can Kill” education efforts to educate the public on the dangers of fentanyl (U.S. DEA, n.d.c.). These efforts create opportunities for states and communities to partner with advocacy organizations on effective education programs for specific populations.

Co-prescribing naloxone is another common-sense and educational strategy to prevent accidental fentanyl poisonings. Co-prescribing refers to the practice of a healthcare provider writing a prescription for an opioid along with a prescription for naloxone. An analysis of state laws released last year by the Legislative Analysis and Public Policy Association showed that 20 states had laws on co-prescribing (LAPPA, 2023). The purpose of co-prescribing naloxone is to have an effective antidote in the home of a person with a prescription in case the prescribed opioids are taken in too large an amount, taken accidentally at the incorrect timing intervals, or taken by an unintended person in the home. It also gives the healthcare provider an opportunity to educate patients and families about the best practices for having opioids in the home, including safe storage and disposal and how to reverse an overdose with naloxone.

CONCLUSION

Illicit fentanyl has significantly worsened the opioid crisis in America and created dangerous fentanyl poisoning that puts all Americans at risk, even children and infants. Furthermore, these facts worry Americans; nearly six in 10 people (59%) are concerned that a close friend or family member could accidentally take a fake pill containing fentanyl (RMG Research, Inc., 2023). Lawmakers should act at the federal level to make fentanyl analogues a Schedule 1 substance. This would discourage the creation of new fentanyl analogues. Policymakers should also understand that a portion of fentanyl deaths are occurring in non-chronic drug users, and they should employ measures to curb senseless deaths in cases of emergency accidental poisonings. Such measures could include greater availability of naloxone through more approvals of over-the-counter products and stocking naloxone in locations outside the home where poisonings are likely to occur. Furthermore, public education efforts to warn of the dangers of fentanyl and prevent drug use should be implemented and evaluated for effectiveness. Finally, co-prescribing naloxone with certain opioid prescriptions should be encouraged. Through legislation, education, and regulatory action, we can unite against the deadly force of fentanyl and save tens of thousands of children and adults killed by fentanyl poisonings each year.