Prescription Drug Overdose Prevention FY 2014 Background Document Preventing Prescription Drug Overdoses Saves Lives Drug overdose death rates in the United States have more than tripled since 1990. Three quarters of drug overdose deaths involve prescription drugs in the US today. Nearly three out of four prescription drug overdoses are caused by prescription painkillers. The public health consequences of prescription-drug use have led the Centers for Disease Control and Prevention (CDC) to classify prescription drug overdose as an epidemic. CDC’s National Center for Injury Prevention and Control (Injury Center) provides leadership in conducting surveillance, identifying and evaluating prevention strategies and work with clinical providers to reduce prescription drug overdoses in the United States. Prescription drug overdoses can be prevented and lives can be saved. Public Health Problem Prescription painkillers work by binding to receptors in the brain to decrease the perception of pain. These powerful drugs can create a feeling of euphoria, cause physical dependence, and can lead to addiction in some people. They can also cause sedation and slow down breathing. A person who is abusing prescription painkillers might take larger doses or inject the drug to achieve a euphoric effect. Used in this way, prescription painkillers can cause breathing to slow down so much that it stops, resulting in a fatal overdose. Drug overdoses are now the leading cause of injury death in the United States. Over 38,329 people died from drug overdoses in the United States in 2010, and more than 16,650 of these deaths involved an opioid pain reliever. More than 125,000 people in the United States have died from overdoses involving opioid pain relievers in the last decade. Opioid pain relievers are now involved in more overdose deaths than cocaine and heroin combined. This unprecedented rise in overdose parallels dramatic increases in the prescribing of opioid pain relievers (drugs derived from the opium poppy or semi-synthetic or synthetic versions of it like oxycodone, hydrocodone, methadone, or fentanyl). Millions of Americans now use opioids for chronic pain, and millions more use opioids nonmedically (for reasons not associated with pain). Enough opioid pain relievers were prescribed in 2010 to medicate every American adult aroundthe-clock for one month. Although most of these pills were prescribed for a medical purpose, many ended up in the hands of people who misused or abused them. 1 Additionally, prescription drug abuse can lead to other public health problems including unintentional injuries, such as falls and fractures among the elderly or motor vehicle crashes. and intentional injuries including drugrelated self harm and drug-crime-related interpersonal violence; infections from intravenous use including HIV and Hepatitis C, and; reproductive health problems including birth defects related to opioid exposure during pregnancy, newborn withdrawal syndrome and infertility from chronic heavy use. In addition to the negative health and social consequences, this epidemic exacts a significant economic toll on the United States, with nonmedical use of opioids costing more than $72 billion annually. Promising Strategies Several promising strategies have been identified to address this problem, but additional research is needed to understand the impact of these interventions on prescription drug overdose deaths. States play a central role in protecting the public health and regulating health care and the practice of the health professions. As such, states are a powerful ally in reversing the prescription drug overdose epidemic. Promising strategies include: Prescription Drug Monitoring Programs (PDMPs) PDMPs are state-run electronic databases used to track the prescribing and dispensing of controlled prescription drugs to patients. Forty-three states have operational PDMPs. They are designed to monitor this information for suspected abuse or diversion—the channeling of the drug into an illegal use—and can give a prescriber or pharmacist critical information regarding a patient’s controlled substance prescription history. CDC’s Injury Center recommends PDMPs focus on: Patients at highest risk in terms of prescription painkiller dosage, numbers of controlled substance prescriptions, and numbers of prescribers; and 2 Prescribers who clearly deviate from accepted medical practice in terms of prescription painkiller dosage, numbers of prescriptions for controlled substances, and proportion of doctor shoppers among their patients. CDC’s Injury Center also recommends PDMPs link to electronic health records systems so PDMP information is better integrated into health care providers’ day-to-day practices. Patient Review and Restriction Programs (PRRs) State benefits programs and workers’ compensation programs can monitor prescription claims and PDMP data for inappropriate use of controlled drugs. For patients whose use of multiple providers and multiple controlled drugs cannot be justified on medical grounds, reimbursement of claims for these drugs are limited to a single designated physician and a single designated pharmacy. These PRR programs can improve the coordination of care and use of medical services. Preventing Prescription Drug Abuse and Diversion States can enact and enforce laws to prevent doctor shopping, the operation of rogue pain clinics or “pill mills,” and other laws to reduce opioid painkiller diversion and abuse while safeguarding legitimate access to pain management services. These laws should also be rigorously evaluated for their effectiveness. Reassess the Prescription of Methadone for Pain Methadone prescribed for pain is disproportionately involved in this epidemic, contributing to nearly one (1) in three (3) opioid pain reliever overdose deaths in 2009. Methadone persists in the body long after its painkilling effect wears off, so it can accumulate over time if taken too frequently and lead to a greater risk for overdose. Policies and practices promoting the use of methadone for pain such as naming methadone as a preferred drug on insurance formularies should be evaluated critically. Unique Role of the CDC Injury Center and Federal Partnerships The CDC Injury Center’s primary focus for reversing the prescription drug overdose epidemic is to conduct surveillance on prescription drug abuse and overdose trends, evaluate and identify effective interventions for reducing overdoses, and improve clinical practice to reduce prescription drug diversion and abuse. CDC’s Injury Center works closely with federal partners such as the White House Office of National Drug Control Policy (ONDCP), Substance Abuse and Mental Health Services Administration (SAMHSA), Food and Drug Administration (FDA), National Institute on Drug Abuse (NIDA) and the Department of Justice (DOJ) to address the problem of prescription drug overdose through surveillance, research, and policy-related activities. As an example, CDC’s Injury Center is a key player in the ONDCP National Drug Control Strategy and collaborates with DOJ’s Bureau of Justice Assistance to better understand how PDMPs can be effectively used to curb abuse and overdose deaths. Prescription Drug Overdose Prevention in Action Understanding the Epidemic The greatest challenges facing states and other policy makers in mitigating drug overdose deaths have been a lack of knowledge regarding the scope and nature of this public health problem as well as identification and implementation of effective intervention strategies. CDC’s Injury Center leads the way in enhancing data sources for surveillance and evaluation purposes to sharpen the understanding of this epidemic. 3 Research CDC’s Injury Center research was instrumental in connecting the increased prescribing of opioid pain relievers with the rise in overdose deaths. Research done by the CDC Injury Center in this area has been presented to Congress, NIDA, FDA, the Safe States Alliance, the Association of State and Territorial Health Officials (ASTHO), and the Council of State and Territorial Epidemiologists (CSTE) and is widely cited in the press. Data and Trend Analysis CDC’s Injury Center is conducting a number of studies to better understand the nature of this public health problem. Additional analyses are also underway identifying trends in prescribing rates and daily dosage; studying state variations in drug distributions to physicians who are both prescribers and dispensers (such physicians have been associated with ‘pill mills’); and using insurance claims data to identify patterns of inappropriate prescribing and use of opioid pain relievers. Improving Surveillance CDC’s Injury Center is also working to improve surveillance of prescription drug misuse and abuse. It is working to better characterize drug use using survey data, working to expand the use of prescription drug monitoring programs as a surveillance and evaluation tool, and exploring publicly available data sources that can inform surveillance activities. The CDC Injury Center is also partnering with FDA and DOJ’s Bureau of Justice Assistance to develop the Prescription Behavior Surveillance System, a surveillance and evaluation tool incorporating PDMP data from multiple states. This system will leverage PDMP data to track drug use and misuse more accurately and rapidly and provide a means of measuring and evaluating the impact of national and selected state interventions. Identifying and Evaluating Policy Solutions Effective policies and practices are needed to reduce prescription drug overdoses while ensuring legitimate patients have access to appropriate treatment. The CDC Injury Center works to identify, evaluate, and recommend promising local, state, and federal policies to reduce prescription drug abuse and overdose. PRR Evaluation CDC’s Injury Center is evaluating PRR programs used by Medicaid and private insurers. Past evaluations indicate such programs reduce costs by improving the coordination of care and reducing inappropriate utilization of medical and pharmacy services. For example, total savings of the Washington state PRR through 2012 are estimated at $120 million, with the calculated return on investment of at least $12 for every $1 invested in the program. Other states have also reported substantial savings with their PRR program. Evaluation is needed to examine PRRs’ impact on patient drug use and abuse. Proactive PDMP Evaluation CDC’s Injury Center is funding a randomized controlled trial in Nevada, which will test whether a PDMP’s proactive reporting to health care providers of patients going to multiple providers and pharmacies to obtain controlled prescription drugs affects their subsequent use of such drugs. State Law Inventory CDC’s Injury Center and Public Health Law Program maintain an environmental scan of state laws related to prescription drugs. State laws regarding prescription drugs differ considerably, and the CDC Injury Center created this inventory of laws to better understand how states are approaching the epidemic and to inform evaluation efforts. 4 Improving Clinical Practice CDC’s Injury Center is working to evaluate the impact of programs and regulations on clinical practice and to help develop and evaluate guidelines designed to improve the prescribing of controlled substances. This includes efforts to integrate PDMP data into clinical work flow. Emergency Department Guidelines The CDC Injury Center has worked with the American College of Emergency Physicians (ACEP) to develop a clinical policy for prescribing opioid pain relievers in emergency departments (EDs). These guidelines are aimed at helping prevent the overprescribing of opioids while ensuring legitimate patients still receive effective pain treatment. The goal is to have these guidelines serve as the basis for standards of care for opioid prescribing in EDs. Assessment of State Prescriber Guidelines CDC’s Injury Center will assist in the evaluation of the impact of statewide guidelines for use of opioids for chronic non-cancer pain such as those implemented in Utah and Washington State. “Consistent Care” Evaluation CDC’s Injury Center is funding two research teams in Washington and North Carolina to conduct randomized trials of “Consistent Care” programs in emergency departments. Such programs develop care plans for patients frequently visiting EDs with complaints of pain to ensure opioids are being used appropriately. Successes The CDC Injury Center’s work has yielded important advances in the understanding of this epidemic including: Developing clinical policy for the prescribing of opioid pain relievers in emergency departments in collaboration with the American College of Emergency Physicians (ACEP). Funding the National Governor’s Association (NGA) to support a year-long prescription drug abuse initiative co-chaired by the governors of Alabama and Colorado to develop and implement comprehensive and coordinated strategies to address prescription drug overdose in seven (7) states. Supporting the Association of State and Territorial Health Officials (ASTHO) through an initiative for state planning teams, including the state health official, from six states (Kentucky, Ohio, Oklahoma, South Carolina, Tennessee, and West Virginia) to develop state action plans. CDC’s Injury Center is also providing technical assistance to states to evaluate interventions and conduct evaluations of their state action plans and state policies implemented to address prescription drug misuse and drug diversion. Publishing two (2) major Vital Signs reports and a Policy Impact report defining the opioid pain reliever epidemic. These reports were widely distributed and significantly enhanced public understanding of the problem. The Vital Signs reports are regularly cited and used in public health literature, and major partners including SAMHSA and the National Governors Association (NGA), have cited the Policy Impact report. Tracking prescription drug abuse and overdose trends using a variety of data sources (e.g., PDMPs, medical examiner data, drug distribution reports from DEA and IMS Health, medical claims data) to significantly improve scientific understanding of the scope of the epidemic, risk groups, and geographic distribution of overdoses. CDC Injury Center surveillance has been instrumental in understanding the connection between opioid sales in a state and the respective state’s rate of overdose death. 5 Developing and publishing an inventory of state prescription drug laws providing a broad understanding of different state legal and regulatory efforts to reverse the epidemic. Future Goals If the painkiller overdose death rate had remained level since 1999, rather than rising so sharply, more than 60,000 people would still be alive today. If overdose death rates remain at this historic high, thousands more will die unnecessarily, and health and economic consequences will continue to rise. The CDC Injury Center will continue to work to expand the capacity to evaluate and identify evidence-based interventions for reducing prescription drug overdose deaths, which remains a major need for states working to reverse this epidemic. Short-Term Next Steps • • • Work with other Health and Human Services (HHS) agencies to facilitate real-time access to PDMPs by leveraging health information technology. Led by the Office of National Coordinator for Health and Information Technology, CDC’s Injury Center has a lead role in the design, evaluation, and policy implications of the pilot projects. Conduct analyses of prescription and medical claims and other data to identify and quantify indicators of inappropriate prescribing and use of opioid pain relievers and other controlled prescription drugs. These findings are critical to the field and will help inform and tailor intervention strategies. Work with state Medicaid patient review and restriction (PRR) program directors and other stakeholders to identify and disseminate best practices for these programs. Long-Term Goals • • • • Work with insurers and pharmacy benefit managers on claims review programs, formulary development, PRR programs, and other tools to reduce inappropriate use of controlled drugs. Evaluate the impact of selected state laws and regulations designed to prevent drug diversion through field investigations and other study designs and disseminate findings. Provide guidance to states on implementing a comprehensive suite of evidence-based interventions aimed to preventing prescription drug overdoses. Realize a reduction in drug overdose deaths as a result of evidence-based intervention implementation in 25 states. 6