Opioids

From the executive summary: "The 2016 National Drug Threat Assessment is a comprehensive strategic assessment of the threat posed to the United States by the trafficking and abuse of illicit and prescription drugs. This report combines federal, state, and local law enforcement reporting; public health data; news reports; and intelligence from other government agencies to provide a coordinated and balanced approach to determining which substances represent the greatest drug threat to the United States. Over the past 10 years, the drug landscape in the United States has shifted, with the tripartite opioid threat (controlled prescription drugs, fentanyl, and heroin) having risen to 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 was in a state of steady decline, but appears to be rebounding; and due in part to the national discussion surrounding legalization efforts, the focus of marijuana enforcement efforts continues to evolve. Drug poisoning is the leading cause of injury death in the United States. Drug poisoning deaths are currently at their highest ever recorded level and, every year since 2009, drug poisoning deaths have outnumbered deaths by firearms, motor vehicle crashes, suicide, and homicide. In 2014, approximately 129 people died every day as a result of drug poisoning."

"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."

"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."

"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 "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."

"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."

"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.

"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."

"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."

"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."

"Throughout much of the last century, our understanding of drug use was influenced by powerful myths and misconceptions about the nature of addiction. People who used illicit drugs and had substance use disorders were thought to be morally flawed or lacking in willpower. These views shaped our responses to drug policy, resulting in punitive rather than therapeutic approaches to reduce drug use. Today, the Nation's response to addressing substance use disorders and our views about those who suffer from the disease of addiction have begun to change. Groundbreaking discoveries about the brain have revolutionized our understanding, therefore enabling us to develop evidence-based and humane interventions to reduce drug use and its consequences. Substance use disrupts our families, schools, and communities and limits the hopes and dreams of young people across the country. Illicit drug use is associated with addiction, disease, and lower academic performance among our young people, and contributes to crime, injury, lost productivity and serious dangers on our Nation's roadways. Successfully addressing these complex issues requires a range of approaches. The Obama Administration is committed to restoring balance to U.S. drug-control efforts by coordinating an unprecedented government-wide public health and public safety approach."

"The threat posed by heroin in the United States is serious and has increased since 2007. Heroin is available in larger quantities, used by a larger number of people, and is causing an increasing number of overdose deaths. In 2014, 10,574 Americans died from heroin-related overdoses, more than triple the number in 2010. Increased demand for, and use of, heroin is being driven by both increasing availability of heroin in the U.S. market and by some controlled prescription drug (CPD) abusers using heroin. CPD abusers who begin using heroin do so chiefly because of price differences."

"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."

"Over this past decade, Congress has responded to the growing threat of bioterrorism and risks to US national security with increased funding for biosecurity and public health preparedness. This has included investment in domestic vaccine manufacturing capacity by the United States government. As a result, a policy of vaccine production self-sufficiency has emerged that should cause policy makers to pause and ask: 'what is the next step?' In the near future, this policy may create a surge of efficient vaccine production that current emergency distribution models are ill equipped to manage. This article presents the results of a research project aimed at developing a model that could serve as a strategy for pandemic vaccine distribution. It argues that as the nation readied for its first pandemic in forty years, it benefited from investments in preparedness but still found itself unprepared for the 2009 H1N1 Pandemic vaccination campaign."

"Between 2005 and 2014 there was a dramatic increase nationally in hospitalizations involving opioids: the rate of opioid-related inpatient stays increased 64 percent, and the rate of opioid-related emergency department (ED) visits nearly doubled. In a series of Statistical Briefs, the Agency for Healthcare Research and Quality (AHRQ) is providing descriptive information on opioid-related hospitalizations nationally and at the State level, based on data from the Healthcare Cost and Utilization Project (HCUP) Fast Stats online tool. In a previous Statistical Brief, AHRQ reported that across States in 2014 the rate of opioid-related inpatient stays varied more than five-fold and the rate of opioid-related ED visits varied more than ten-fold. Rates were reported for each State at the overall State level."

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."

"Increased illicit use of opioids, including synthetic opioids such as fentanyl and its analogue carfentanil, is a source of increased risk to responders. Most routine encounters between patients or detainees and EMS [emergency medical services] or law enforcement do not present a significant threat of toxic exposure. While there are anecdotal reports of public safety personnel being exposed to opioids during operations, they are largely unconfirmed. To proactively address the potential risks, this document establishes guidance for personal protective equipment selection and use, decontamination, detection, and medical countermeasures for first responders who may be exposed to opioids in the course of their occupational activities. Throughout the remainder of this document, the term synthetic opioids will be used to include fentanyl, fentanyl analogues, morphine analogues, the U-series opioids, and others."

This is the April 23, 2015 hearing titled "Combating the Opioid Abuse Epidemic: Professional and Academic Perspectives" before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce. From the opening statement of the Honorable Tim Murphy, "Let me state clearly so as to leave no room for doubt: Our current strategy just isn't working, and I am not going to stop until we start moving in the direction of success, defined not just as getting individuals off of street drugs and onto a Government-approved opioid, but getting them to the point of drug-free living. About 3 weeks ago, on the very same day this committee held our first hearing on this issue, the Department of Health and Human Services released its long-awaited three-part plan to reverse this epidemic.[…] Today we have assembled some of the leading opioid addiction experts. We welcome you to get your thoughts on dealing with this epidemic. And I thank you for your expertise and look forward to hearing your testimony. We are in desperate need of innovations to reverse the current trend and not merely maintain it." Statements, letters, and materials submitted for the record include those of the following: Tim Murphy, Diana DeGette, Marsha Blackburn, Janice D. Schakowsky, and Paul Tonko.

This is the May 1, 2015 hearing "What is the Federal Government Doing to Combat the Opioid Abuse Epidemic?" held before the House Committee on Energy and Commerce. From the opening statement of subcommittee chairman Tim Murphy: "Today, we will hear from Federal agencies charged with providing guidance, direction, and leadership in our Nation's public health response to the opiate epidemic. No Federal agency is more central in this ongoing epidemic than the Department of Health and Human Services or HHS. HHS and its Substance Abuse and Mental Health Services Administration, also known as SAMHSA, are responsible for leading our Nation's public health response to the opiate heroin abuse and addiction crisis. SAMHSA regulates our country's 1,300 opiate treatment programs, and SAMHSA is responsible for certifying the 26,000 physicians who prescribe the most commonlyused [sic] opiate maintenance medication, buprenorphine. According to testimony provided by SAMHSA before this subcommittee in April of last year, there were nearly 1.5 million people treated with these opiate maintenance medications in 2012, which is a fivefold increase in the last 10 years. Has SAMHSA defined the goal of recovery for what these federally subsidized treatment programs are supposed to accomplish? Is SAMHSA collecting and evaluating meaningful data at an individualized level that would hold grant recipients individually accountable for effective results? So far, preliminary examination indicates the answers are no. And when you don't define where you're going, every road you take still leaves you lost. So we're hoping we can get some direction today." Statements, letters, and materials submitted for the record include those of the following: Michael P. Botticelli, Richard G. Frank, Nora D. Volkow, Douglas C. Throckmorton, Debra Houry, Pamela S. Hyde, and Patrick Conway.

This is the May 21, 2015 hearing "What are the State Governments Doing to Combat the Opioid Abuse Epidemic?" held before the House Committee on Energy and Commerce. From the opening statement of subcommittee chairman Tim Murphy: "Overdose prevention remains a key aim of any meaningful State strategy, yet States have adopted different approaches to address it. Some provide liability protection for individuals who act in good faith to provide medical assistance to others in the event of an overdose, or expand access to the lifesaving drug naloxone, or use public education on the proper disposal of prescription drugs that are vulnerable to misuse. States also differ on availability and financing of medication-assisted treatments. Opioid maintenance is a bridge for those with addiction disorders to cross over in the recovery process, and we support that. Full recovery is complete abstinence. Medication-assisted treatment is valuable, but it must be coupled with proven psychosocial therapies and other wraparound services to support the person traversing this difficult road and to help with long-term, sustained recovery. Today we want to hear from the States about best-practice models, problems that they have encountered, and how States have addressed this problem. We also seek absolutely candid and honest input from each of our witnesses. Please tell us where there are problems, and please tell us where there are successes with any Federal programs or policies. We will hear from representatives of Indiana, Massachusetts, Missouri, and Colorado State Governments, a sampling of the 50-plus separate efforts being pursued by U.S. States and territories to counter opioid abuse." Statements, letters, and materials submitted for the record include those of the following: Jerome Adams, Monica Bharel, Larry Wolk, and Mark Stringer.