Fentanyl and Opioids

From the Executive Summary: "The 2017 National Drug Threat Assessment is a comprehensive strategic assessment of the threat posed to the United States by domestic and international drug trafficking and the abuse of illicit drugs. The report combines federal, state, local and tribal law enforcement reporting; public health data; open source reporting; and intelligence from other government agencies to determine which substances and criminal organizations represent the greatest threat to the United States. Over the past 10 years, the drug landscape in the United States has shifted, with the opioid threat (controlled prescription drugs, synthetic opioids, and heroin) reaching epidemic levels, impacting significant portions of the United States. While the current opioid crisis has deservedly garnered significant attention, the methamphetamine threat has remained prevalent; the cocaine threat appears to be rebounding; new psychoactive substances (NPS) continue to be a challenge; and the focus of marijuana enforcement efforts continues to evolve. Drug poisoning deaths are the leading cause of injury death in the United States; they are currently at their highest ever recorded level and, every year since 2011, have outnumbered deaths by firearms, motor vehicle crashes, suicide and homicide. In 2015, approximately 140 people died every day from drug poisoning."

This is the March 14, 2022 hearing on "Addressing the Evolving Threat of Illegal Drug Trafficking to Our Communities," held before the U.S. Senate Subcommittee on Emerging Threats and Spending Oversight of the Committee on Homeland Security and Governmental Affairs. From the opening statement of Maggie Hassan: "Our hearing will address the ongoing threat of heroin, fentanyl, and opioid trafficking, and will also address the rising threat that methamphetamine poses to our communities. Methamphetamine has contributed to increasing incidents of violent crime and dangerous encounters with community members and law enforcement, in addition to overdose deaths." Statements, letters, and materials submitted for the record include those of the following: Matthew Millhollin, Michael P. Manning, Jon DeLena, Ellen M. Arcieri, and Joseph M. Ebert.

From the Executive Summary: "Many Medicare and Medicaid beneficiaries and their families have experienced opioid use disorder, commonly referred to as addiction. Given the growing body of evidence on the risks of misuse, highlighted by the recently published guidance from the Centers for Disease Control (CDC), and the Administration's commitment to combatting the opioid epidemic, CMS [Centers for Medicare & Medicaid Services] is outlining our agency's strategy and the array of actions underway to address the national opioid misuse epidemic. Strategies outlined in this paper do not include CMS's vision for the treatment of cancer and hospice patients. Treatment of patients in these situations requires careful medical supervision based on therapeutic goals, ethical considerations, and the balance of risks and benefits of opioid therapy. Opioid drugs can treat both acute and chronic pain. While these types of drugs, including fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, oxycodone, and oxymorphone, can have benefits for many patients with serious pain-related conditions, these drugs cause serious and substantial harm when used improperly. Even when used as directed, they contribute to overdose or lead to development of substance use disorder in some individuals. The high potential for misuse of opioids have led to alarming trends across the United States, including record numbers of people developing opioid use disorders, overdosing on opioids, and dying from overdoses. Opioid misuse places Americans at an elevated risk for heroin use, overdose, and death. Use by injection places them at risk for exposure to blood borne diseases, including HIV and Hepatitis C."

This is the December 10, 2020 hearing on "Combatting the Opioid Crisis: Oversight of the Implementation of the STOP [Synthetics Trafficking and Overdose Prevention] Act," held before the U.S. Senate Permanent Subcommittee on Investigations of the Committee on Homeland Security and Governmental Affairs. From the opening statement of Rob Portman: "Today's hearing is the continuation of our work in this Subcommittee on the Federal Government's efforts to crack down on the fentanyl coming into our country and more broadly to deal with the fentanyl and opioid crisis that has seized our entire country and every State represented in this chamber. We started with a hearing in May 2017 examining how illicit fentanyl, a synthetic opioid 50 times more powerful than heroin, is being shipped into the United States through the U.S. mail. We found out that, unbelievably, almost all this was coming through the mail system into our communities from China, and it was the number one killer and remains the number one killer." Statements, letters, and materials submitted for the record include those of the following: Eric Green, Robert Cintron, and Thomas F. Overacker.

From the Executive Summary: "The abuse of opioid drugs has become a national health crisis. Sixty percent of the record 47,000 drug overdose deaths in 2014 were attributable to prescription opioids or heroin. Approximately 19,000 of those deaths were due to prescription opioids. Combatting this public health emergency requires a collaborative effort by treatment centers, the health care community, and law enforcement. Those integrated efforts have been the subject of many congressional hearings. The Subcommittee has focused on the significant role that the Centers for Medicare and Medicaid Services (CMS) and private health insurers play in detecting, reporting, and addressing opioid abuse. Specifically, the Subcommittee examined the efforts undertaken by CMS and its main program integrity contractor, the Medicare Drug Integrity Contractor (MEDIC), to address opioid-related fraud and abuse in Medicare Part D-the federal prescription drug coverage program serving nearly 35 million senior citizens and 7 million Social Security disability benefit recipients. In addition, the Subcommittee examined the anti-opioid abuse efforts of six of the nation's largest health insurance companies-both in their commercial insurance business and in their role as Medicare Part D plan sponsors."

From the Document: "The United States is experiencing an unprecedented epidemic of opioid use disorder and overdose. In 2015, more than 33,000 Americans died of an overdose involving a prescription or illicit opioid, and more than 2 million individuals had an opioid use disorder. In partnership with state and local governments, healthcare professionals, and other key stakeholders, HHS [U.S. Department of Health and Human Services] launched its Opioid Initiative in March 2015 and has taken significant steps to: 1) improve opioid prescribing practices; 2) increase the use of naloxone to reverse opioid overdoses; and 3) expand access to and the provision of medication-assisted treatment with methadone, buprenorphine, or naltrexone - in combination with appropriate psychosocial services. The Department has also continued to prioritize reducing stigma and advancing prevention, treatment, and parity for people needing care for mental health and substance use disorders."

From the Highlights: "Drug misuse--the use of illicit drugs and the misuse of prescription drugs--has been a persistent and long-standing public health challenge in the U.S. resulting in significant loss of life and a negative effect on society and the economy. These costs are borne by individuals who misuse drugs, as well as their families and employers, private businesses and nonprofit organizations, and federal, state, and local governments. GAO [Government Accountability Office] has a body of work on drug policy and ongoing work on ONDCP [Office of National Drug Control Policy]'s efforts, including issuance of the National Drug Control Strategy. This statement includes preliminary GAO observations on the 2022 National Drug Control Strategy and related findings from selected GAO reports on federal drug control-related efforts."

From the "Policy" section: "It shall be the policy of the executive branch to combat the scourge of drug abuse, addiction, and overdose (drug addiction), including opioid abuse, addiction, and overdose (opioid crisis). This public health crisis was responsible for more than 50,000 deaths in 2015 alone, most of which involved an opioid, and has caused families and communities across America to endure significant pain, suffering, and financial harm."

From the Document: "In 2015, over 27 million people in the United States reported current use of illicit drugs or misuse of prescription drugs, and over 66 million people (nearly a quarter of the adult and adolescent population) reported binge drinking in the past month. Alcohol and drug misuse and related disorders are major public health challenges that are taking an enormous toll on individuals, families, and society. Neighborhoods and communities as a whole are also suffering as a result of alcohol- and drug-related crime and violence, abuse and neglect of children, and the increased costs of health care associated with substance misuse. It is estimated that the yearly economic impact of substance misuse is $249 billion for alcohol misuse and $193 billion for illicit drug use. Despite the social and economic costs, this is a time of great opportunity. Ongoing health care and criminal justice reform efforts, as well as advances in clinical, research, and information technologies are creating new opportunities for increased access to effective prevention and treatment services. This Report reflects our commitment to leverage these opportunities to drive improvements in individual and public health related to substance misuse, use disorder, and related health consequences."

From the Introduction: "Nonmedical prescription opioid misuse is a fast growing public health problem and primary cause of unintentional deaths nationwide, particularly in many rural areas of the country. According to the Centers for Disease Control and Prevention (CDC), everyday 44 people die of a prescription drug related overdose. The opioid crisis is multifaceted and affects communities nationwide. When the costs are calculated they exceed $55 billion annually."

This testimony compilation is from the April 5, 2017 hearing on "Federal Response to the Opioid Abuse Crisis" before the U.S. House of Representatives Subcommittee on Labor, Health and Human Services, Education, and Related Agencies of the Committee on Appropriations. The purpose of this hearing was to discuss the programs funded by the Committee on Appropriations to help end the opioid epidemic, as well as steps in progress to help resolve the opioid abuse crisis. Statements, letters, and materials submitted for the record include those of the following: Barbara Cimaglio, Bill Guy, Nancy Hale, and Rosalie Liccardo Pacula.

"In February 2017, the Commission published a staff report titled 'Fentanyl: China's Deadly Export to the United States', which detailed how illicit flows of fentanyl and other new psychoactive substances (NPS) from China are fueling an opioid crisis in the United States. The 2017 report's conclusions remain accurate[.]" This document provides updates to the 2017 report.

From the Summary and Key Findings: "The Fentanyl Profiling Program (FPP) performs in-depth chemical analyses on fentanyl and fentanyl-related samples obtained from seizures made throughout the United States. Analytical methodologies developed at the Special Testing and Research Laboratory (SFL1) allow in-depth reporting on samples. The Fentanyl Profiling Program Report summarizes the results and conclusions derived from these analyses on a bi-annual basis. FPP data is not intended to reflect U.S. market share, but is rather a snapshot of samples submitted to this laboratory from the eight DEA [Drug Enforcement Administration] regional and sub-regional chemistry laboratories."

From the Executive Summary: "Fentanyl is the most prevalent and the most significant synthetic opioid a threat to the United States and will very likely remain the most prevalent synthetic opioid threat in the near term. The fentanyl threat remains most severe in the white powder heroin user market in the Midwest and Northeast United States, and fentanyl availability continues to be primarily by itself or with heroin. Fentanyl mixtures with non-opioid substances are a cause for public health concern due to the high potential for large numbers of fatal overdoses in short periods of time; however, there is no evidence that transnational criminal organizations (TCO) are trafficking strategic quantities of fentanyl already mixed with non-opioid drugs. Fentanyl's popularity is unlikely to be challenged in the near term, but traffickers will likely continue to produce new fentanyl-related substances and other novel opioids."

"The status and trends of the illicit drug trade, which includes Fentanyl, Fentanyl analogues and other potent synthetic opioids and analgesics in Canada are ever evolving. The intention of this site is to provide first responders with accurate safety information related to situations where opioids may be involved."

From the Executive Summary: "Opioids, both illegal (e.g., heroin, illicitly manufactured synthetic opioids) and legal (e.g., oxycodone, hydrocodone) are drugs that reduce the body's perception of pain. The 'Diagnostic and Statistical Manual of Mental Disorders' (5th ed., 'DSM-5') defines opioid use disorder as a problematic pattern of opioid use leading to significant impairment or distress. Opioid use disorder is increasing at alarming rates for both men and women in the United States. While the epidemic is being addressed at many different levels, much still needs to be done. The prevalence of prescription opioid and heroin use among women is substantial. Between 1999 and 2015, the rate of deaths from prescription opioid overdoses increased 471 percent among women, compared to an increase of 218 percent among men, and heroin deaths among women increased at more than twice the rate than among men. Most alarmingly, there has been a startling increase in the rates of synthetic opioid-related deaths; these deaths increased 850 percent in women between 1999 and 2015. At the same time, the differences between how opioid misuse and use disorder impact women and men are often not well understood. Even in areas where differences between the sexes are apparent, such as women appearing to progress more quickly to addiction than men, very little is understood about why those differences occur. This Report highlights the key background and findings from the white paper, provides a summary of the September 2016 national meeting, and concludes with a section focused on findings and takeaways from both the national and regional meetings."

"During the height of the prescription opioid crisis in the United States, Insys Therapeutics, Inc., adopted and intensified sales and marketing techniques Purdue Pharma pioneered in the 1990s for OxyContin and applied them to Insys' powerful fentanyl drug Subsys. Like Purdue, Insys aggressively used speakers programs--in which the company paid physicians to discuss Subsys with colleagues--and compensation programs for sales representatives to boost sales for Subsys [...] This report also highlights the examples of Heather Alfonso, a nurse practitioner from Connecticut, and Dr. Steven Simon, a physician practicing near Kansas City, Missouri--two practitioners separated by geography but united in their high Subsys prescribing and receipt of substantial payments from Insys. These case studies demonstrate exactly how company executives motivated sales representatives to 'own' physicians through promises of compensation for both sides--and how these efforts in turn significantly affected patient treatment."

From the Executive Summary: "Prescription opioid misuse and opioid use disorder (OUD) are significant and growing public health problems in the United States (U.S.) that impact stakeholders across the healthcare sector, including private, employer-sponsored, and public health plans.(1-4)[1] Healthcare payers (herein, payers), employer organizations, and law enforcement all have strong motivations to combat the inappropriate prescribing of opioids to improve patient health and reduce expenditures for medically unnecessary services and therapies. These are largescale problems for which payers play a critical role in reducing fraud, waste, and abuse while ensuring access to medically necessary therapies. Payers can help to combat the opioid crisis by identifying and sharing strategies, such as reimbursement and coverage policies, conditions for provider plan participation, and dissemination of information to a variety of audiences, to address the large-ranging issues that lead to fraud, waste, and abuse in the healthcare system. Such interventions are particularly suited to payers due to their relationships with providers of healthcare services, pharmacies, insured patients, employers, and law enforcement (in cases where potential fraud is identified). Payers collect and administer a large amount of healthcare information that can be used to identify and intervene on behalf of patients at risk of opioid-related harm, as well as to target fraud, waste, and abuse in opioid prescribing."

From the Summary: "Over the past several years, the nation has seen an uptick in the use and abuse of opioids--both prescription substances and non-prescription substances such as heroin. The estimated number of individuals who had used heroin was 914,000 in 2014. Further, about 586,000 individuals (0.2% of the 12 and older population) had a heroin use disorder in 2014. In addition to an increase in heroin use over the past several years, there has been a simultaneous increase in its availability in the United States. This has been fueled by a number of factors, including increased production and trafficking of heroin--principally by Mexican criminal networks. […] Going forward, there are a number of issues policymakers may consider as they address the issue of heroin trafficking. For instance, what is known about drug trafficking is contingent on data surrounding poppy cultivation, heroin production, and product inflows into the United States. Given that these are often based on snapshots of knowledge from disparate sources, Congress may question the collection and adequacy of these data. In addition, Congress may examine current law enforcement efforts to maximize the dismantling and prosecution of heroin trafficking networks. Policymakers may also look at existing federal strategies on drug control, transnational crime, and Southwest border crime to evaluate whether they are able to target the current heroin trafficking threat."

"Fentanyl, heroin, and some prescription painkillers (such as morphine and oxycodone) belong to the class of drugs known as opioids, which act on receptors in the brain important in regulating pain and emotion. Opioids have susceptibility for abuse and potential for overdose. In 2016, more than 42,000 of the nearly 64,000 drug overdose deaths in the United States involved opioids. Led by fentanyl, a synthetic opioid 50-100 times more potent than morphine, synthetic opioids emerged as the leading cause of opioid-related overdose deaths in 2016. The steep increase in deaths involving fentanyl is seen as a 'new chapter' in the opioid epidemic."

From the Document: "I am pleased to transmit the 2022 'National Drug Control Strategy'. This inaugural 'Strategy' proposes bold, targeted, and consequential actions to bend the curve on overdose deaths in the immediate term and reduce drug use and its damaging consequences over the longer term. These actions are based on the best science, evidence, and data available. Through them, we strive to usher in a new era of drug policy centered on individuals and communities. [...] Saving lives is our North Star, and the 2022 'National Drug Control Strategy' calls for immediate actions that will save lives in the short term and outlines long-term solutions to reduce drug use and its associated harms, including overdose."

From the Highlights: "Opioid misuse has been a persistent problem in the U.S. In 2017, the Department of Health and Human Services (HHS) declared the opioid crisis a public health emergency. The Department of Labor (DOL) awarded grants to help address this crisis. While some research sheds light on the relationship between opioid misuse and workforce participation among workers of all ages, questions remain about the employment experiences of older workers affected by opioid misuse, as well as the experiences of workers during the COVID-19 [coronavirus disease 2019] pandemic. GAO [Government Accountability Office] was asked to explore recent trends among older adults and opioid misuse. This report examines (1) how individual characteristics and employment experiences differ between older workers who do and do not misuse opioids and (2) challenges that selected local workforce agencies identified in helping workers--including older workers--affected by opioid misuse during the COVID-19 pandemic."

From the Document: "Beginning in the late 1990s, the United States experienced a significant increase in opioid-related drug overdose deaths, which rose from 8,050 in 1999 to 49,860 in 2019. To address the rising rates of opioid use and overdose deaths, Congress created new opioid-specific block grant programs that provide funding to increase access to substance use disorder (SUD) treatment such as medication-assisted treatment (MAT) for opioid-use disorder."

From the Summary: "Over the last several years, there has been growing concern among the public and lawmakers in the United States about rising drug overdose deaths, which more than tripled from 1999 to 2014. In 2015, more than 52,000 people died from drug overdoses, and approximately 63% of those deaths involved an opioid. Many federal agencies are involved in efforts to combat opioid abuse. The primary federal agency involved in drug enforcement, including diversion control efforts for prescription opioids, is the Drug Enforcement Administration (DEA). The primary agency supporting drug treatment and prevention is the Substance Abuse and Mental Health Services Administration (SAMHSA). The federal government also has several programs that may be used, or are specifically designed, to address opioid abuse. These range from law enforcement assistance in combatting drug trafficking to assistance for states in developing a coordinated response to address opioid abuse. These programs span across several departments, including (but not limited to) the Department of Justice (DOJ), the Department of Health and Human Services (HHS), and the Office of National Drug Control Policy (ONDCP). Federal and state lawmakers have addressed opioid abuse as a public health concern in enacting legislation that focuses heavily on prevention and treatment. [...] This report answers common questions that have arisen as drug overdose deaths in the United States continue to increase. It does not provide a comprehensive overview of opioid abuse as a public health or criminal justice issue."

From the Document: "The Office of Inspector General (OIG) has been tracking opioid use in Part D since 2016. From 2016 to 2019, Medicare Part D saw a steady decline in opioid use, along with an increased use of drugs for treatment of opioid use disorder. With the onset of COVID-19 [coronavirus disease 2019] and the new dangers it poses for beneficiaries taking opioids, it is imperative that the Department of Health and Human Services (HHS) closely monitor opioid use during this unprecedented time. This data snapshot describes opioid use in Part D during the onset of COVID-19, focusing on the first 8 months of 2020. For context, this snapshot also provides data on the first 8 months of 2019."

From the Introduction: "COVID-19 [coronavirus disease 2019] has intensified the nation's troubling long-term trends for alcohol, drug, and suicide deaths. [...] Five years ago, Trust for America's Health and Well Being Trust started the Pain in the Nation report series to examine the alcohol, drug, and suicide crises in the United States and called for a comprehensive National Resilience Strategy. [...] The first Pain in the Nation report projected that, if mortality trends held steady, drug-induced deaths would reach 28.4 deaths per 100,000 people in 2025. In reality, that projection was low and was reached by 2020--within half the time expected. Despite the various federal and state programs and policies implemented, they have not slowed the trends, and likely were insufficient--especially considering that the worldwide pandemic further exacerbated existing problems. The latest provisional data show fatal overdoses exceeding 100,000 Americans annually, driven by a significant rise in synthetic opioid and psychostimulant overdoses. Policymakers, health officials, and all Americans must recognize the shortcomings of existing policy efforts to address the ever-changing and escalating drug overdose crisis and also consider how to make progress in the years ahead. This brief includes three sections: (1) a look back at the past two decades of the drug overdose crisis and a reconsideration of policy priorities; (2) a review of the latest mortality trends from alcohol, drugs, and suicide; and (3) an outline of key policy solutions and recommendations to stem and reverse these trends."

From the Conclusion: "The goals of the recommendations included in this report are to promote prevention of all drug use with effective education campaigns and restrictions in supply of illicit and misused drugs. To achieve supply reduction, we recommend shaping prescribing practices by improved medical education, by alternatives to pain management, as appropriate, by enhancing physician awareness of high risk patients though substance use, mental, and medical screenings and interrogation of PDMPs [Prescription Drug Monitoring Program], insurance company oversight, and by interdiction of deadly opioids. Treatment and overdose rescue are both distinct and inextricably linked efforts. Overdose rescue procedures need to be opportunistic and include access to trained personnel, to medications, and to treatment services. [...] Treatment services need to be improved, foremost by developing thoughtful national evidence-based standards of care, record-keeping, and long-term support. In view of the need, expansion of services is imperative and so are surmounting barriers - to medications, limited healthcare workforce, to insurance reimbursement - and ensuring high-quality care and long-term recovery support services. The Commission strongly supports research and development of alternatives to opioids for pain management, treatment and rescue, and of modern medical devices essential to improving our responses. The Commission also strongly recommends real-time data analytics to inform our mission and accomplishments. Above all, each recommendation should have accountability built-in and be subjected to measurable goals, quantitative solutions, and measurable outcomes. The Federal Government now must develop a level of accountability that has not been imposed rigorously in the past."

"The Department of Homeland Security (DHS), Countering Weapons of Mass Destruction, Office of Health Affairs, in collaboration with the Department of Transportation, National Highway Transportation Safety Administration, Office of Emergency Medical Services, sponsored a two-day working meeting on September 6 and 7, 2017, entitled 'Protecting First Responders on the Frontlines of the Fentanyl Epidemic.' These proceedings summarize the key messages of the meeting and provide scientifically derived, evidence-based, and practitioner-informed recommendations. These will serve as a guide to inform strategy, policies and procedures to prevent and mitigate unintended fentanyl exposures across first responder occupations. The proceedings also include information obtained from relevant events that have occurred since the meeting and additional research."

From the Letter: "The DEA [U.S. Drug Enforcement Administration] is seeing a nationwide spike in fentanyl-related mass-overdose events involving three or more overdoses occurring close in time at the same location. In just the past two months, there have been at least 7 confirmed mass overdose events across the United States resulting in 58 overdoses and 29 overdose deaths. Many victims of these mass overdose events thought they were ingesting cocaine and had no idea that they ere in fact ingesting fentanyl. [...] Fentanyl is driving the nationwide overdose epidemic: the CDC [Centers for Disease Control and Prevention] estimates that in the 12-month period ending in October 2021, over 105,000 Americans died of drug overdoses and over 66% of those deaths were related to fentanyl and other synthetic opioids. Last year, the United Stats suffered more fentanyl-related deaths than gun-related and auto-related deaths combined. At DEA, we are working to trace mass-overdose events back to the local drug trafficking organizations and to the international cartels that are responsible for the surging domestic supply of fentanyl."

From the Webpage: "An estimated 1.9 million people in the U.S. have a prescription opioid use disorder, while another 586,000 have a heroin use disorder. This class will help you to understand what addiction and opioids are and where you can find authoritative information to understand this complex epidemic. The National Library of Medicine and National Institutes of Health provide resources for both the general public and health professionals to learn about opioid abuse and overdose prevention and treatment options."

This edition of the United States Attorneys' Bulletin covers Fentanyl and Related Threats. The following articles are included: "Danger in Milligrams and Micrograms: United States Attorneys' Offices Confront Illicit Fentanyls"; "A Primer on Investigating Doctors Who Illegally Prescribe Opioids"; "Investigating and Prosecuting 'Pill Press' Manufacturing Schemes"; "New Amendments to the U.S. Sentencing Guidelines Concerning Fentanyl and Fentanyl Analogues"; "The Medical Examiner's Role in Addressing the Opioid Crisis"; "Fentanyl Trafficking Trends in the United States"; "Homeland Security Investigations, Border Search Authority, and Investigative Approaches to Fentanyl Smuggling"; "Hunting in the Dark: A Prosecutor's Guide to the Dark Net and Cryptocurrencies"; "The Role of Community Outreach in the Opioid Crisis: Maintaining Hope in the Face of Rising Overdose Deaths"; "Prescription Drug Abuse and Illicit Substance Use: A Crisis in Indian Country"; "Public Safety and Public Health Efforts to Combat the Opioid Epidemic"; and the book review of "Dreamland: The True Tale of America's Opiate Epidemic."