Abstract
THE Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act requires the US Office of National Drug Control Policy (ONDCP) to closely monitor evolving and emerging drug threats and to take action at the onset of a trend to prevent such threats from reaching levels seen during the opioid crisis. 1 Although ONDCP and its partners in the federal government that work on drug-related matters have long tracked and sought to monitor and respond to changes in drug markets, the SUPPORT Act formalized this process in 2018. As part of this effort, the law requires ONDCP to create standards for designating an evolving or emerging drug threat, as well as criteria to terminate such a designation.
The formal designation as an evolving or emerging drug threat triggers several required actions by the federal government, with strict timelines for completing these actions. Designating a substance as an emerging threat requires a robust national response in order to protect the lives of Americans.
The SUPPORT Act requires ONDCP to establish an Evolving and Emerging Threats Committee, which consists of representatives from local and state governments, representatives from federal national drug control agencies, and additional members appointed by the director of ONDCP. 1 The committee provides input to ONDCP on the criteria to be used to identify potential candidates for designation as an evolving or emerging drug threat. These criteria can include not just a particular substance but a class of substances, a pattern of use, a route of administration, or a concerning trendline in a particular cohort of Americans. The committee also advises the ONDCP director on the decision to issue a formal designation. Careful monitoring of data related to illicit drug use through a wide variety of information sources is crucial to this process. Further, ONDCP is required to disseminate highlights of this information to federal, state, and local partners so they may take appropriate action within their jurisdictions.
ONDCP and the Evolving and Emerging Threats Committee review several sources of information before making recommendations to the director of ONDCP about the designation of a drug as an emerging threat.
As required by the SUPPORT Act, in January 2023 ONDCP published formal criteria for designating evolving and emerging drug threats. 2 These new criteria focus on threats arising in at least 3 of 4 census regions in the United States, and for which a key public health metric (especially fatal and nonfatal drug poisonings) has increased 15% or more for the past unit of time (usually 1 year). Other key public health metrics that may be considered include morbidity, frequency of use, new patterns of use in specific groups of individuals, prevalence of emergency department visits, hospitalization and treatment related to substance use disorders, and other related data that document the rising risk of public harm related to drug use. Designations are ultimately determined by the ONDCP director. Further, if after designation as an emerging threat the metrics for a particular substance decrease over time, the ONDCP director may designate that a substance is no longer considered an emerging threat.
The decision to declare a substance an emerging threat is not a simple dichotomous choice. For instance, some new threats that may not meet the criteria for designation as an emerging threat still deserve careful monitoring, increased awareness, consideration for support for basic science and clinical research, and possible public health action. Additionally, drug use and its threat to health can quickly change over time. Therefore, it is important to monitor illicit drug use on a regular basis and disseminate available data to interested parties, so that proper public health actions can be made in a timely manner.
In addition to the formal emerging threats criteria, ONDCP adapted a framework originally used in the infectious diseases arena to guide day-to-day thinking about emerging drug threats. The US Department of Health and Human Services (HHS) established the SARS-CoV-2 Interagency Group to assist HHS in monitoring and characterizing emerging COVID-19 variants and the risks they might pose to public health. 3 The group developed a 4-part framework that includes COVID-19 variants that are (1) being monitored, (2) of interest, (3) of concern, and (4) of high consequence. Based on this work, ONDCP developed a similar framework for ongoing monitoring of evolving and emerging threats related to illicit drug use.
The Framework
The ONDCP framework includes the use of 4 categories of an evolving and emerging illicit drug: (1) drug being monitored, (2) drug of interest, (3) drug of concern, and (4) drug of high consequence. While the term “drug” is used, in this context this term can include a new chemical entity, a known chemical entity, a new combination of drugs, or a new method of drug(s) use.
Drug Being Monitored
A monitored drug is a drug or method of use that has a potential or documented risk for harm. Limited data may be available to determine the impact of use. In addition, reported illicit use may be limited in scope or be known to impact a small proportion of the population. Such drugs may warrant more intense monitoring to further define the risks associated with use and to determine if risk of harm is increasing over time. These drugs are often reclassified as additional data become available.
Drug of Interest
A drug of interest is a drug associated with illicit use that may impact risk for overdose or death or the effect of the ingested drug(s). This category can include a new chemical, known chemical, new combination of drugs, or new method of use, with a rising level of information suggesting the establishment of a drug or method of use of concern in some communities or populations.
A drug of interest might require initial public health actions including increased monitoring, basic science or clinical research related to the pharmacology, mechanism of action, pharmacological effects, and safety of the drug.
Drug of Concern
A drug of concern is a drug for which there is evidence of an increase in prevalence of use or in the risk of harm associated with use, and which is observed in a specific subset of the population or a growing portion of the population.
A drug of concern might require additional public health actions including systematic monitoring of use and risk of harm, development of enhanced detection methods, additional interdiction efforts, advocacy for research into diagnosis and treatment of substance use disorders, or support of efforts to increase public awareness and prevention. A drug of concern may be formally designated as an evolving or emerging drug threat by the director of ONDCP, especially if the emerging threats criteria are met.
Drug of High Consequence
A drug of high consequence has a major impact on fatal overdoses, nonfatal overdoses, and quality of life. An emergent example of this category might be methamphetamine use, and a longer standing example is fentanyl. Such drugs require intensive, urgent national programming and policymaking. As with drugs of concern, drugs of high consequence may ultimately be formally designated as an evolving or emerging drug threat by the ONDCP director.
Evolving or Emerging Drug Threat Illustration
In addition to the ONDCP director's authority for designation, Congress may issue such a designation through legislation, as was recently done for methamphetamine. 4 President Biden signed this designation into law on March 14, 2022. As the designation of methamphetamine illustrates, a substance does not have to be new to be formally designated as an emerging threat. The SUPPORT Act legislation is written in such a way that the ONDCP director, with the advice of the Evolving and Emerging Threats Committee, can designate any substance or pattern of use posing an urgent threat to the country, even if illicit use of the substance has been present for decades. In the case of methamphetamine, the dramatic increase of methamphetamine fatal overdoses over the first 2 decades of the 21st century made clear that the United States was facing a rapidly evolving and lethal drug threat from illicit methamphetamine use.5,6 However, we believe that the 4-part framework described here, combined with the recently approved emerging threats criteria, likely would have drawn earlier attention to evolving illicit methamphetamine use. Identifying these changes in the illicit methamphetamine use earlier could have rapidly moved methamphetamine from a drug being monitored (based on early reports of methamphetamine use in the literature in the late 1990s) 7 to a drug of interest (with intensive examinations of methamphetamine use reported by the early 2000s), 7 and the criteria of 15% increase in drug overdose deaths and emergence in 3 of 4 census regions would have been easily met by the early- to mid-2010s, if not before. 8 For instance, between 2015 and 2016, psychostimulants with abuse potential (largely methamphetamines)-associated deaths increased from 5,890 in 2015 to 7,771 in 2016, 6 a 32% increase, and methamphetamine-associated deaths were seen in most regions of the United States. Earlier recognition could have led to increased data collection and rapid development and implementation of a public health response at the local, state, and federal levels.
Conclusion
This 4-part framework is intended to enhance monitoring of the constantly changing landscape of illicit drug use in the United States. The framework enables federal policymakers to make evidence-based decisions related to allocating public health resources to protect lives and improve the health of Americans. The framework recognizes that illicit drug use evolves rapidly over time, and that data on new trends in illicit drug use may be limited. It is our hope that early recognition of evolving and emerging threats, before any formal designation of a specific drug as an emerging threat, enables earlier public health intervention that leads to saved lives.