NATIONAL PRESCRIPTION DRUG ABUSE PREVENTION STRATEGY

Transcription

1 NATIONAL PRESCRIPTION DRUG ABUSE PREVENTION STRATEGY 2015 UPDATE Addressing the Evolution of the Epidemic

2 About CLAAD The not-for-profit Center for Lawful Access and Abuse Deterrence (CLAAD) coordinates a comprehensive national effort to prevent prescription drug fraud, diversion, misuse, and abuse while advancing consumer access to high-quality health care. CLAAD enables health professionals, law enforcement, businesses, government officials, and others to share resources and work together to improve public health and safety. We foster collaboration among the multiple sectors of society that had previously been working concurrently, yet not in unison, to address the growing national concern for prescription drug abuse. CLAAD gathers information and research on prescription drug abuse, misuse, and diversion. We also coordinate grassroots activities among interested organizations and makes policy recommendations on prescription drug abuse with the goal of improving the public health. CLAAD s policy positions are established through a consensus process, in which at least 80 percent of the participants must represent not-for-profit organizations. This rule of governance ensures that the public interest drives CLAAD s priorities, as opposed to the interests of individual stakeholders. CLAAD is a 501(c)(3) organization. The Generation Rx Initiative and Higher Education Center for Alcohol and Drug Misuse Prevention and Recovery at the Ohio State University support and endorse the Center for Lawful Access and Abuse Deterrence s latest update on the national prescription drug abuse epidemic. CLAAD s annual National Prescription Drug Abuse Prevention Policy Consensus Meeting has engaged national thought leaders to address this issue for seven years. Their work is helping to advance prevention and recovery efforts, and this latest report provides a thorough and insightful perspective on prevention, intervention, treatment, and recovery needs, so that individuals may get the help they need to lead healthful lives. KENNETH M. HALE, R.PH., PH.D. CO-DIRECTOR, THE GENERATION RX INITIATIVE As the Director of Allies in Recovery, a center dedicated to training families of those struggling from substance abuse, I endorse CLAAD s important and well-balanced 2015 update of its National Prescription Drug Abuse Prevention Strategy. The plan calls for continuing access to legally prescribed and properly used opiate drugs, while focusing on the need for deterrence and treatment for those who abuse them. DOMINIQUE SIMON-LEVINE, PH.D., MPH DIRECTOR, ALLIES IN RECOVERY

3 The National Prescription Drug Abuse Prevention Strategy i s p r e s e n t e d b y a n d e n d o r s e d b y t h e f o l l o w i n g o r g a n i z a t i o n s :

4 International Scientific and Medical Forum ON DRUG ABUSE PROFESSIONALS FOR RATIONAL OPIOID MONITORING & PHARMACOTHERAPY Foundation

5 The principal writers of this report were Michael C. Barnes, Esq.; Stacey L. Worthy, Esq.; and Kyle Simon, M.Sc. The Center for Lawful Access and Abuse Deterrence gratefully acknowledges the expert input of Andrea G. Barthwell, M.D., and Amy B. Goldstein, M.SW.

6 Table of Contents Introduction Substance Use Disorders and Substances of Abuse 7 Policy Update: Preliminary Signs of Progress 8 Security and Safety Protocols for Opioids 8 Regulatory Clarity to Advance New Technologies 8 Data Collection and Analysis Professional Education.. 10 Safe Storage and Responsible Disposal. 11 Presciption Monitoring Programs 11 Additional State Efforts...13 Community Coalitions Public Awareness..14 Decrease in Rates of Abuse. 14 Evolution of the Epidemic 15 Substances of Abuse.. 15 Tactics of Dirty Docs and Other Bad Actors 16 Consequences of Ill-Advised Approaches Reducing Both Supply and Demand 18 Interventions 19 SBIRT and HCP Education Intervention in the Workplace 19 Responding to Nonfatal Overdoses 20 Treatment 22 Psychosocial Treatment. 22 Medication-Assisted Treatment...22 Verification and Vigilance 23 Testing for Substance Use Material Substance Use and Neonatal Abstinence Syndrome 23 Drug Courts.. 24 Prisons 25 Remove Roadblocks to Treatment DATA Lack of Practicing Physicians.. 27 The Equity Act, The ACA, and Insurance Coverage 27 Outreach 30 Recovery Community Organizations. 30 Collegiate Recovery Communities and Recovery High Schools 30 Conclusion 31 Appendix 32 Footnotes 32

7 Introduction A ccording to the Centers for Disease Control and Prevention (CDC), prescription drug abuse 1 is a national epidemic. 2 The Substance Abuse and Mental Health Services Administration (SAMHSA) has estimated that 6.5 million people 12 years of age or older reported using prescription medications for nonmedical reasons in 2013 alone. 3 Although the general public perceives prescription medications as inherently safer than illicit substances, 4 22,810 overdose deaths involved prescription medications as compared with 18,530 overdose deaths involving illicit drugs in The not-for-profit Center for Lawful Access and Abuse Deterrence (CLAAD) and its partner organizations 6 have worked together since 2008 to reduce prescription drug fraud, diversion, misuse, and abuse. For the past seven years, CLAAD has convened the National Prescription Drug Abuse Prevention Policy Consensus Meeting to consult with experts and leaders of professional associations and public health and safety organizations from across the country. The goal of each meeting was to generate consensus on proactive policy strategies that address the U.S. prescription drug abuse epidemic. The National Prescription Drug Abuse Prevention Strategy ( National Strategy ), set forth in manuscripts dated 2009, 2010, and , documented the policy priorities established in the annual consensus meetings and laid an early foundation for coordinated, multi-sector efforts to reduce prescription drug abuse. By 2011, the federal government s National Prescription Drug Abuse Prevention Plan adopted some 95 percent of the consensus-based policy recommendations in the National Strategy. 7 As of 2011, the Office of National Drug Control Policy (ONDCP), which coordinates the federal government s substance abuse prevention policy efforts, had effectively expressed support for all of the National Strategy s proposals. 8 The Congressional Research Services and executive and legislative officials in at least 14 states have looked to the National Strategy in researching and formulating policy to reduce prescription drug abuse. 9 Numerous commercial entities have also heeded the National Strategy s call for private-sector leadership to reduce prescription drug abuse in areas such as research and development, product safety, and public awareness. 10 While efforts to prevent prescription drug abuse have begun to yield positive results, now more than ever, wide-ranging intervention and treatment policies and programs are essential to reducing prescription drug abuse. 11 This 2015 National Prescription Abuse Prevention Strategy is intended to update and expand upon the recommendations set forth in the prior versions of the National Strategy and has been developed using the same broad-based consensus process. This document is presented within the context of, and aims to address, the prescription drug abuse epidemic. It is constructed on the premise that prescription drug abuse often occurs with 12 and can progress to 13 other substance use. National Prescription Drug Abuse Prevention Strategy: 2015 Update 6

8 SUBSTANCE USE DISORDERS AND SUBSTANCES OF ABUSE Substance use is a preventable behavior, and a substance use disorder (SUD) is a fundamental, yet treatable, disease of the brain. 14 According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), an SUD is diagnosed based on a pathological pattern of behaviors related to use of particular substances. 15 SUDs range from mild to severe, based on the number of symptom criteria identified in the individual. 16 Millions of people suffer from SUDs each year, and an estimated 89.6 percent of them go untreated. 17 One manifestation of this disorder is prescription drug abuse, a problem that has consistently worsened over the past decade. 18 Certain controlled substances, when used appropriately, have helpful and lifesaving functions. 19 Yet, several classes of controlled substances are prone to abuse including central nervous system (CNS) depressants, such as anesthetics, barbiturates, and benzodiazepines, which are sedatives that slow brain activity. 20 Another class of often abused medications is stimulants, which includes methylphenidate, dextroamphetamine, and pemoline. Individuals tend to abuse stimulants to seek euphoric effects similar to those induced by cocaine. 21 Stimulant abuse can lead to cardiovascular complications, aggressive behavior, suicidal or homicidal tendencies, and overdose-related deaths, among other consequences. 22 A third and most commonly abused class of prescription medications is opioid pain relievers, such as hydrocodone, oxycodone, morphine, hydromorphone, and meperidine. 23 Physicians prescribe opioids because they can effectively change the way a person experiences pain, making the pain more tolerable. 24 However, opioids may also result in a heightened sense of pleasure, making such medication prone to abuse. 25 Since 2003, more overdose deaths have involved opioid analgesics than heroin and cocaine combined. 26 Many of these opioid-related overdose deaths result from mixing opioids with alcohol or with other pharmaceuticals, such as benzodiazepines. 27 National Prescription Drug Abuse Prevention Strategy: 2015 Update 7

9 Policy Update: Preliminary Signs of Progress The National Strategy Update s action agenda included data collection and analysis, new technologies, medical education, safe storage and responsible disposal of controlled substances, and prescription monitoring programs. 28 Since 2011, the U.S. has made substantial progress in each of these areas, although there is more work to be done. SECURITY AND SAFETY PROTOCOLS FOR OPIOIDS In recent years, the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), Department of Health and Human Services (HHS) have commenced important efforts to improve awareness and understanding of the prescription drug abuse epidemic among health care professionals, patients, and the public. For example, in 2012, the FDA approved a subclasswide Risk Evaluation and Mitigation Strategy (REMS), a strategy to manage known or potential serious risks associated with a medication, for extended-release and long-acting (ER/LA) opioids. 29 Additionally, in 2013, the FDA implemented new safety labeling and post-marketing study requirements for ER/LA opioids. 30 In August 2014, the DEA, in cooperation with the HHS and the FDA, issued a final rule to reschedule hydrocodone combination products (HCPs) to Schedule II of the Controlled Substances Act (CSA), 31 increasing the restrictions on prescribing and dispensing hydrocodone, including security protocols, labeling and packaging, inventory, and recordkeeping and reporting requirements. 32 REGULATORY CLARITY TO ADVANCE NEW TECHNOLOGIES The National Strategy Update recommended that the federal government encourage the development of new technologies to prevent prescription drug abuse, including abusedeterrent formulations ( ADFs ). 33 ADFs are reformulations of medications with the intent to reduce the drug-liking qualities of a controlled substance by hindering the extraction of active ingredients, limiting their bioavailability, preventing administration through alternative routes, or making abuse of the manipulated product less attractive or rewarding. 34 These medications allow for treatment of medical conditions while reducing the likelihood of diversion, misuse, and abuse, and related adverse outcomes. 35 In 2013, the FDA issued draft guidance for abuse-deterrent opioids, which includes ADF categories, recommended studies to demonstrate abuse-deterrent properties, and an explanation of how studies are evaluated and what labeling claims may be approved. 36 National Prescription Drug Abuse Prevention Strategy: 2015 Update 8

10 To date, the FDA has approved ADF labeling for four ER/LA opioid analgesics: two reformulations of oxycodone ER, one oxycodonehydrochloride/naloxone-hydrochloride ER, and one hydrocodone ER. 37 Additionally, upon granting abuse-deterrent labeling for the ER/LA oxycodone ER product, the FDA announced that it would not consider for approval any generics based on the original oxycodone formulation because the risks of the original product outweighed the benefits and because the original was withdrawn from sale for reasons of safety or effectiveness. 38 More federal action is necessary to foster a broad transition to ADFs. When a medication is granted abuse-deterrent labeling, the FDA should initiate procedures to eventually withdraw non-abuse-deterrent versions already on the market unless there are unique patient needs or public health reasons not to do so. Any new generic drug referencing a branded ADF in its application for FDA approval must not have abuse-deterrent properties inferior to those of the branded ADF drug. Similarly, if a branded drug becomes a drug with an ADF, then any FDA-approved generic drug that references the branded drug s prior, non-adf should ultimately no longer be considered bioequivalent to, or to have the same therapeutic effects as, the reformulated ADF drug unless the generic drug demonstrates that it does not have abuse-deterrent properties inferior to those of the branded ADF drug. This transition will require adequate time to allow the market to adjust and ensure patients have adequate access to affordable, effective treatments. The federal government should require manufacturers of all Schedule II controlled substances (and other controlled substances at the discretion of the FDA) without abuse-deterrent technologies to convert their products to ADFs by a specific date. Federally funded prescription drug benefit plans should be required to cover ADFs to ensure their accessibility to consumers. To do otherwise would undermine the eventual widespread adoption of ADFs. In order for manufacturers to understand and effectively meet these requirements, the FDA must finalize and periodically update guidance for pharmaceutical manufacturers on ADF development and labeling for branded and generic opioids and all schedule II controlled substances. The Prescription Drug Abuse Deterrence Incentive Act (PDADI Act) is a proposed bill that would accomplish the recommendations outlined above. PDADI will likely be passed into law in the 114th Congress. National Prescription Drug Abuse Prevention Strategy: 2015 Update 9

11 DATA COLLECTION AND ANALYSIS The National Strategy Update recommended that deaths.47 The 2014 update to ICD codes includes three opioid Medicaid, Medicare, and private insurance companies analyze analgesics categories: T40.2 for natural and semi-synthetic opioid data to identify patients who use multiple providers to obtain analgesics,48 T40.3 for methadone, and T40.4 for synthetic opioid quantities of medications beyond that which could be analgesics other than methadone.49 These codes become therapeutically necessary ( doctor shopping ).39 In 2011, the U.S. effective on October 1, Government Accountability Office (GAO) issued a report on doctor shopping among Medicare participants in five states, and found that roughly 170,000 beneficiaries obtained prescriptions from five or more medical practitioners for 12 classes of commonly abused controlled substances.40 In response, Medicare Part D plans began to implement program integrity measures, such as withholding reimbursement, if doctor shopping is suspected.41 PROFESSIONAL EDUCATION The National Strategy Update suggested amending the CSA to require continuing education in safe prescribing of controlled substances.51 Given strong resistance from professional associations, a federal education mandate is politically unfeasible. Instead, states have taken their own initiatives. Currently, 24 states have enacted statutes and As of December 2013, 28 states had Medicaid lock-in programs that required beneficiaries suspected of abusing controlled substances to use a single prescriber and pharmacy.42 As a result, doctor shopping has decreased (although this is not the only reason for the decrease in doctor shopping; many physicians have stopped treating patients seeking controlled substances for fear of prosecution, creating an access problem for legitimate patients, as discussed below).43 In 2013, a study found that less than one percent of all patients (not just Medicare patients) who purchased opioids were classified as doctor shoppers,44 and North Carolina s lock-in program has been credited with saving $5.2 million in one year based on a reduction in doctor shopping.45 Private insurers have also implemented data analysis and professional consultation programs to detect and address regulations that address prescriber education, and about 73 percent of those states require education focused on pain management, prescribing controlled substances, and addiction and treatment.52 In New Mexico, a change in state law in 2012 resulted in the formation of a coalition consisting of an academic medical center, the state department of health, the medical and pharmacy licensing boards, a university-based health care organization, and the state legislature, which united to develop a five-hour continuing medication education requirement on pain management.53 A 2014 assessment of the 1,090 clinicians who participated in the CME course found there to be a significant positive change in knowledge, self-efficacy, and attitudes. 54 Since the CME requirement went into effect, the number and morphine milligram equivalence of opioids and benzodiazepines potentially problematic behaviors.46 prescribed and dispensed in New Mexico have declined55 The National Strategy Update called for adoption of states. 56 without the restriction of physician autonomy seen in other updated International Classification of Diseases (ICD) codes, specifically to improve collection of data on drug-related National Prescription Drug Abuse Prevention Strategy: 2015 Update 10

12 SAFE STORAGE AND RESPONSIBLE DISPOSAL The National Strategy Update called for safe storage and expanded secure consumer disposal programs in pharmacies and law enforcement offices. 57 Campaigns like Lock Your Meds have helped spread the word on the need for safe storage and preventing diversion. In 2011, the National Association of Drug Diversion Investigators (NADDI) launched Project Drug Drop Box to reduce the diversion of controlled substances through proper disposal practices and community awareness education. 58 NADDI has provided grants to cities and counties throughout the U.S. to purchase drop boxes and has seen numerous successes. For instance, in six months, Floyd County, Georgia, collected 246 pounds of prescription medications. 59 In September 2014, the DEA issued a final rule on the secure disposal of controlled substances, implementing the Secure and Responsible Drug Disposal Act of 2010 to 60 expand the options available to consumers for drug disposal, including drug takeback events, mail-back programs, and collection receptacles for controlled substances at pharmacies. 61 Prior to the enactment of the new rule, the CSA only permitted users to dispose of controlled substances by destroying them or surrendering them to law enforcement. 62 The new rule is intended to reduce the accumulation of controlled substances in household medicine cabinets that were available for abuse, misuse, and diversion. 63 PRESCRIPTION MONITORING PROGRAMS PMPs can be effective health care delivery tools, especially in determining appropriate treatment plans for patients with pain or SUDs. As such, the National Strategy Update urged the adoption and optimization of PMPs in all 50 states, 64 and currently, every state except Missouri has enacted laws that authorize PMPs. 65 Forty-seven states have the authority to require prescribers or pharmacists to report to the PMP and to monitor schedule II, III, and IV substances using PMP data. 66 Forty-five states and the District of Columbia share PMP data either with other states, authorized users in other states, or both. 67 Optimization strategies include mandatory PMP training for all controlled substance prescribers, mandatory checking of PMP data prior to prescribing a controlled substance to new patients and periodically thereafter, and verification and recording of recipient identity into the PMP. As of June 2014, 10 states require prescribers and dispensers to obtain PMP training, 68 and 19 states require prescribers or dispensers to access PMP information, with requirements for Ohio and Virginia to be effective in After implementing the PMP requirement in New York, between August 2013 and February 2014, more than 66,000 health care professionals ran more than seven million individual prescription checks on an estimated three million unique patients, thereby decreasing the chances of doctor shopping. 70 By comparison, the National Prescription Drug Abuse Prevention Strategy: 2015 Update 11

13 PMP was only utilized by approximately 5,000 practitioners who checked less than 500,000 patients over a three-and-a-half year period prior to August Advocacy groups have also focused on developing best practice that ensure practitioners properly use PMPs to provide optimal health care treatment. For instance, the State Pain Policy Advocacy Network (SPPAN), has created an ad hoc group that meets monthly to address improving the efficacy of PMPs as health care delivery tools. 72 Real-time PMP data access is also essential. In June 2012, SAMHSA launched the Prescription Drug Monitoring Integration and Interoperability Expansion Grant program to enable states to integrate PMPs into electronic health records (EHR) and other health information technology. 73 The purpose of the program was to improve real-time access to PMP data by integrating PMPs into existing technologies, such as EHRs. 74 States have taken reactive and proactive approaches when accessing PMP data. 75 States that take a reactive approach generate reports in response to a specific request or inquiry by an authorized user. 76 States that take a proactive approach generate reports based on patterns of behavior that raise red flags and provide this unsolicited data to authorized individuals or agencies, such as medical boards for further investigation or action. 77 Licensing boards should review PMP information and refer it to the appropriate law enforcement agency when criminal activity is apparent. 78 In 31 states and the District of Columbia, law enforcement officials may access PMP data pursuant to active investigations, but restrictions on access by law enforcement officials vary by state. 79 In 17 states, law enforcement officials may access PMP data with probable cause, a search warrant, subpoena, or other judicial process. 80 In one state (Pennsylvania), law enforcement officials may access PMP data upon request, 81 while Vermont law enforcement officials may only receive information from professional licensing boards. 82 In extreme instances, inadequate privacy protections have resulted in law enforcement going on fishing expeditions for wrongdoing in states requiring only that an active investigation be underway to access PMP data,. 83 In Oregon, PMP administrators objected to an attempt by DEA agents to use an administrative subpoena, rather than a search warrant, to access PMP data. 84 Subsequently, the U.S. District Court for the District of Oregon ruled that a lack of search warrant for prescription records violated the Fourth Amendment as an unreasonable search and seizure of information for which patients and prescribers both have a reasonable expectation of privacy. 85 When PMPs are fully optimized under a public health model that requires prescriber training, periodic data checks, and red flag reports, information on suspected criminal activity flows from health officials and licensing boards to law enforcement, making law enforcement access to PMPs without a public health referral or a search warrant unnecessary. National Prescription Drug Abuse Prevention Strategy: 2015 Update 12

14 ADDITIONAL STATE EFFORTS In addition to setting education requirements and enhancing PMPs, states have made progress in prescription drug abuse prevention policy. For example, states, such as Florida, Indiana, and Kentucky, have implemented mandatory safer prescribing standards. 86 In response to a 220 percent increase in drug overdoses between 1999 and 2012, Tennessee lawmakers introduced a seven-step plan in June 2014 to prevent and treat substance use disorders, including expanding access to and improving the quality of early intervention, treatment, and recovery services. 87 Kentucky lawmakers announced in January 2014 that $32 million in funds obtained from settlements with pharmaceutical manufacturers would be allocated toward strengthening Kentucky s drug addiction treatment program. 88 Kentucky s Substance Abuse Treatment Advisory Committee will use the funds to construct a recovery center, provide over 800 scholarships to the center, create 14 drug-free homes, and institute a grant program for new juvenile treatment programs, among other uses. 89 States have also enacted new laws to improve drug overdose care. For example, 20 states and the District of Columbia have enacted 911 Good Samaritan Laws, which provide limited immunity from arrest or prosecution for minor drug offenses to individuals who report overdoses. 90 Several states have laws that permit and train first responders or loved ones to fill prescriptions for naloxone in order to prevent opioid overdoses. 91 States have also increased enforcement efforts against bad actors. For example, prosecutors in Florida and California are now charging doctors who improperly prescribe controlled substances with first- and second-degree murder when patients die of overdoses. 92 COMMUNITY COALITIONS In response to concerns about prescription drug abuse and other substance use, more than 2,000 communities nationwide have mobilized local citizens. 93 These initiatives, often referred to as community coalitions, are alliances among representatives of different sectors, organizations, or constituencies for the common purpose of reducing substance use. 94 By bringing together representatives from local government, law enforcement, education, media, parent groups, health agencies, and businesses, coalitions can provide a community forum for identifying, planning, and adopting localized prevention programs and treatment that would not otherwise be possible through the efforts of a single agency. 95 Local coalitions that are data-driven, multi-sectored, and use local knowledge are highly effective; independent evaluations of community coalitions have shown that, on average, these coalitions have been able to reduce youth substance use rates faster and more substantially than communities without such coalitions over the same time period. 96 Successful behavior change strategies used by these coalitions include providing information and enhancing skills activities; changing policies and practices; community education; media campaigns; compliance checks and training; recognition programs for businesses that comply with local ordinances; and participating in prescription drug disposal programs. Carter County Drug Task Force, located in Grayson, Kentucky, provides an example of how these strategies used by community coalitions have achieved real-world success. This coalition used a combination of the aforementioned strategies to reduce past 30- day non-medical use of prescription drugs among 10th graders from 9% in 2004 to 1% in 2012 (a decrease at a rate of 88.9%) and, among 12th graders, from 12% in 2004 to 2% in 2012 (a decrease at a rate of 83.3%). Community coalitions are essential to any comprehensive effort to reduce prescription drug abuse, as their on-the-ground knowledge, multi-sectored membership, and local data-driven strategies have proven successful. Enhancing the capacity and ability of these coalitions to achieve population level outcomes in preventing and reducing substance use is recommended. National Prescription Drug Abuse Prevention Strategy: 2015 Update 13

15 PUBLIC AWARENESS The National Strategy Update recommended making federal funds for public awareness campaigns available to non-profit organizations.97 The federal government has collaborated with the Partnership for Drug-Free Kids (Partnership) to98 lead the ONDCP s Above the Influence Campaign, a drug and alcohol prevention campaign targeted at reducing teen substance abuse.99 Studies indicate that the program has had a positive impact in reducing teen substance abuse and,100 in 2012, the program received an Effie Award as one of the nation s most effective marketing communications programs.101 DECREASE IN RATES OF ABUSE These prescription drug abuse prevention strategies are beginning to yield positive results. Federal data released in October of 2014 shows that deaths from opioids dropped 5 percent, while deaths from all categories of prescription drugs dropped 3 percent.102 In 2011, prescription drug abuse among adults ages 18 to 25 nationwide fell by 14 percent to 1.7 million, which SAMHSA attributed to successful public health and law enforcement efforts to curb prescription drug abuse; however, there is still a long way to go given that the same survey found that 6.1 million people of all ages abuse prescription medications.103 States that have taken aggressive action to deter prescription drug abuse, such as Florida and Kentucky, have seen a reduction in prescription drug-related crimes and overdose deaths.104 For instance, after Florida enacted laws to prevent the overprescribing of controlled substances, the state saw a decline in rates of drug diversion and a 52 percent decline in oxycodone overdose-related deaths.105 National Prescription Drug Abuse Prevention Strategy: 2015 Update 14

16 Evolution of the Epidemic SUBSTANCES OF ABUSE Although there are signs of progress, the prescription drug abuse epidemic is evolving. Trends include increased abuse of stimulants, benzodiazepines, buprenorphine, and heroin. 106 A recent study reported that 20 percent of college students misused or abused prescription stimulants to improve their studies or academic performance, stay awake, or improve work performance. 107 This trend has led to a drastic increase in the number of emergency room visits related to stimulant use among people ages 18 to 34 from 5,600 in 2005 to 23,000 in 2011 a 292 percent increase. 108 An estimated 1.7 million Americans have taken tranquilizers, such as benzodiazepines, without a prescription. 109 The number of emergency room visits between 2005 and 2010 involving abuse of alprazolam, a type of benzodiazepine, more than doubled from 57,419 to 124,902 visits. 110 In 2011, alprazolam, a type of benzodiazepine, was the medication most commonly involved in overdose-related deaths in the state of Georgia 111 and contributed to 35 percent of overdose-related deaths in Kentucky. 112 The success of efforts to reduce the supply of opioids available for abuse has paralleled an increase in heroin use and the diversion and misuse of buprenorphine, medication used to treat opioid addiction. 113 Heroin use among people aged 12 and older increased by 55 percent between 2007 (373,000) and 2013 (681,000). 114 A recent study found that heroin incidence rates was 19 times higher among those who reported prior abuse of opioids than among those who did not, and 79 percent of recent heroin initiates had previously abused opioids whereas only one percent of those who began abusing opioids had prior use of heroin. 115 Likewise, SAMHSA reported a sharp rise in buprenorphine-related emergency visits from 3,161 visits in 2005 to 30,135 visits in 2010, in which 52 percent (15,778) involved non-medical use. 116 Studies have shown that the majority of patients who use diverted buprenorphine do so to treat opioid withdrawal symptoms, to stop using other opioids, or because they could not access drug treatment. 117 Other substances of abuse include sleep medications and marijuana. For instance, the number of emergency room visits involving the overmedication (taking more than the prescribed dose) of zolpidem, the active ingredient in prescription sleep aids, doubled from 21,824 visits in 2005 to 42,274 visits in As of October 2014, medical marijuana laws have been enacted in 23 states and the District of Columbia, and Colorado and Washington have legalized the commercialization and consumption of the substance. 119 Yet, according to the National Institute on Drug Abuse, marijuana dependence and addiction are similar to other SUDs, although the long-term clinical outcomes may be less severe. 120 National Prescription Drug Abuse Prevention Strategy: 2015 Update 15

17 TACTICS OF DIRTY DOCS AND OTHER BAD ACTORS As states enact strong pill mill regulations and prosecutors crack down on the physicians who operate them, 121 rogue prescribers have begun implementing new schemes, such as profiteering from black-market drugs. 122 For example, bad actors purchase deeply discounted, diverted medications intended for sale in foreign countries and resell them in the U.S. market at a much higher cost. 123 The quality of black market medications is uncertain: they may be expired, diluted, contaminated, or tainted due to improper storage conditions, or relabeled with the wrong information. 124 This is especially problematic because, unlike opioid abuse, consumers of medications purchased on the black market are often unwitting participants. Many health care professionals are inadequately informed about the risks of black-market medications and may recommend or administer them to lower costs for their patients. Although bad actors exist throughout the entire chain of distribution diligent physicians and pharmacists can prevent dangerous black-market medications from reaching patients. 125 Although the federal government has prosecuted black-market participants under various legal theories, 126 states must also take action, not only to enact and enforce policies requiring professional education but also to rehabilitate or sanction negligent licensees. 127 Once properly educated, the physicians and pharmacists with good intentions will know better than to purchase or dispense blackmarket medications, and intentional wrongdoers will be subject to vigorous prosecution. 128 Other unscrupulous practitioners have profited through substance use testing kickback schemes. As a best practice, practitioners commonly perform substance use testing on patients who are prescribed controlled substances. However, some have taken advantage of this practice by entering into arrangements with laboratories in which the practitioner accepts payments for referring patients to the laboratories, and the laboratories bill third-party payers to cover such costs. 129 Not only are these arrangements illegal under many federal and state laws, 130 but kickbacks can lead to overutilization, increased program costs, and corruption of medical decision-making. 131 National Prescription Drug Abuse Prevention Strategy: 2015 Update 16

18 CONSEQUENCES OF ILL-ADVISED APPROACHES Law enforcement officials are aggressively pursuing bad actors in the health care industry, including rogue prescribers who operate pill mills or accept kickbacks at the expense of their patients health and safety. 132 Such intentionally bad actors must continue to be identified and prosecuted to prevent further diversion, misuse, and abuse. 133 Lawmakers and regulatory agencies must ensure that aggressive law enforcers are consistent in their treatment of blatant bad actors. The regulations governing the Drug Enforcement Administration (DEA) investigations are broad, and research shows the agency has interpreted them liberally and inconsistently. 134 The DEA has authority to revoke or suspend the registration of a practitioner, distributor, or pharmacist for a variety of reasons, including if the registrant has committed such acts as would render his registration... inconsistent with the public interest. 135 Generally, before suspending or revoking a registration, the DEA must issue an order to show cause containing its basis for the proceedings and provide an administrative hearing within 30 days. 136 However, in cases where the DEA has reason to believe that a registrant's continued operation would pose an imminent danger to the public health or safety, the DEA can suspend that party s registration immediately, prior to an administrative hearing, by issuing an immediate suspension order (ISO). Over the past few years, the DEA has aggressively exercised its administrative inspection authority to scrutinize health care practitioners, 137 pharmacists, and distributors, and it has loosely interpreted the requirements to issue an ISO, often basing its decision to issue an ISO on the quantity of prescriptions written rather than on evidence of bad acts. For instance, in Holiday CVS, LLC v. Holder, pursuant to an investigation, DEA agents discovered that a pharmacy distributor sold over 12.8 million dosages units of oxycodone to its top four pharmacy customers, two of which were CVS pharmacies. 138 The DEA raided the pharmacies, and the plaintiffs took a number of remedial steps in response to the agency s concerns. 139 As a result, dispensing volumes for oxycodone at the two CVS pharmacies decreased by 86 percent. 140 Nevertheless, the DEA ignored the pharmacies action plan and issued an ISO two months later on the two CVS pharmacies because, prior to taking corrective measures, they had purchased quantities of oxycodone that considerably surpassed the amount of oxycodone ordinarily purchased by a retail pharmacy. 141 The DEA asserted that the pharmacies had dispensed controlled substances to customers under circumstances indicating that the drugs were illegally diverted. 142 In suspending the pharmacies registrations, the DEA argued that CVS s conduct violated the CSA and continued registration posed an imminent danger to the public health and safety. 143 State and federal law enforcement and prosecutors must continue to hold such practitioners liable for unlawful schemes; however, when practitioners make legitimate, good faith attempts to correct their behaviors, their action plans should be taken into consideration. Given the lack of published regulations specifying the DEA s expectations, the health care industry has responded by restricting access to medication for fear of raids and prosecution. Pharmacists are increasingly refusing to fill legitimate prescripttions for controlled substances for individuals with pain. 144 The American Medical Association and the American Academy of Pain Management reported receiving a flood of complaints from patients and physicians regarding pharmacies refusing to fill prescriptions for opioid pain medications. 145 These policies are applied inconsistently and place patient safety at risk by delaying or preventing dispensation of medication while pharmacies gather information above and beyond requirements set forth by state and federal regulations. 146 Some physicians have become reluctant to write prescriptions for opioids out of fear of facing criminal or civil liability for patient overdoses. 147 In certain areas of the country, patients with chronic pain are unable to find physicians to treat them. 148 In some cases, legitimate prescribers under investigation have been forced to abandon their patients medical needs and have faced loss of reputation, even when the investigation reveals no wrongdoing. 149 To address these concerns, in July 2014, the U.S. House of Representatives passed H.R. 4709: Ensuring Patient Access and Effective Drug Enforcement Act, which would require the DEA to promulgate regulations that would set expectations for members of the health care industry. 150 The bill requires the DEA to provide registrants with notice and an opportunity to submit a corrective action plan, and allow the corrective plan time to yield results before revoking or suspending a registration. 151 The companion bill, S. 2862: Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act, was referred to committee in September National Prescription Drug Abuse Prevention Strategy: 2015 Update 17

19 Reducing Both Supply and Demand Reductions in the supply of medications available for abuse must be matched by corresponding decreases in demand. Health and safety policy makers and professionals must facilitate early interventions, effective treatment, and sustainable recovery. Many prescription drug overdose deaths can be avoided through proper SUD treatment. SUDs are comparable to other chronic medical conditions, such as hypertension and asthma, in their heritability, etiology, pathophysiology, and response to treatment. 153 Effective treatments are available that can lead to substantial benefits, such as reduction in substance use, improved psychiatric status, greater social adjustment, increase in functional state and quality of life, and a decrease in hospital and emergency room visits. 154 Despite the benefits of treatment, 89 percent of the estimated 22.7 million people aged 12 or older who have a diagnosable SUD went untreated. 155 Recognizing the imperative to prevent prescription drug-related overdoses, the Obama Administration has called for expanding access to addiction treatment, including medication-assisted treatment (MAT), a therapy for persons with opioid use disorders that combines FDA-approved medications with psychosocial treatments. 156 National Prescription Drug Abuse Prevention Strategy: 2015 Update 18

20 Interventions Intervention is a powerful tool in reducing substance abuse. Given the progressive nature of SUDs, early intervention can effectively diminish the duration, prevalence, and resultant problems of substance use. 157 SBIRT AND HCP EDUCATION INTERVENTION IN THE WORKPLACE Screening, Briefing Intervention, and Referral to Treatment Employers can reduce prescription drug abuse and other (SBIRT) is an early intervention approach that targets individuals substance use by implementing effective prevention and with nondependent substance use to intervene prior to the need intervention programs. Employee assistant programs (EAPs) are for more extensive or specialized treatment. 158 The patient is work-based programs supplemental to the employer s health clinically screened 159 so the physician can determine whether insurance plan that address a broad and complex range of brief intervention, brief treatment, or referral to substance use mental health issues, including SUDs. 164 EAP services typically treatment are necessary, depending on the patient s level of include initial assessments, short-term counseling, referral, and risk. 160 Practitioners should universally and routinely screen all follow-up services. 165 Employees may enroll in EAPs either patients to address the spectrum of behavioral health voluntarily or by mandate from a supervisor. 166 problems. 161 By providing treatment rather than terminating employment, SBIRT has numerous benefits, including reducing health care employers can lower their own costs, while simultaneously costs, the severity of drug and alcohol use, and risks of trauma. 162 reducing the overall impact of substance use. 167 Savings result Yet, few physicians currently practice SBIRT due to a lack of from decreased absenteeism; fewer accidents; less employee training. 163 SBIRT training and practice should be integrated into theft; reduced recruitment, hiring costs, and training; higher nearly every practice area, including pain, addiction, psychiatry, morale; greater job efficiency; and significantly reduced medical obstetrics, peri-operative, emergency, and primary care, as part costs arising from early identification and treatment of substance of medical licensure and continuing medical education. use. 168 National Prescription Drug Abuse Prevention Strategy: 2015 Update 19

21 RESPONDING TO NONFATAL OVERDOSES Ideally, if SBIRT were universally employed, substance use would be detected early on and addressed before the individual developed a chronic SUD. However, currently, many individuals with severe SUDs do not obtain the treatment they need and require emergency care. Such occurrences are prime opportunities to intervene and refer a patient to substance use treatment. NALOXONE: Given that overdose is a frequent incident among opioid abusers, 169 first responders, including emergency medical technicians, state and local law enforcement, and firefighters must have all the tools and training necessary to save the lives of individuals who have overdosed. Naloxone is a prescription medication used in opioid overdoses to counteract life-threatening depression of the central nervous system and respiratory system, allowing a person experiencing an overdose to breathe normally. 170 Many states have passed laws to expand access to naloxone to first responders. 171 For instance, in Ohio, more than 53,000 individuals have been trained by Ohio s naloxone distribution programs, resulting in more than 10,000 overdose reversals using naloxone since All first responders should be trained on naloxone and carry it with them at all times when on duty. In April 2014, the FDA approved a naloxone auto-injector, intended for use by caregivers, family members, and other people present in the event of an opioid overdose. 173 As of June 2014, 14 states allow third parties (family member, friend, or other person in a position to assist the at-risk person in the event of an opioid-related overdose) to obtain prescriptions for naloxone for use if an at risk individual overdoses. 174 States allowing such a practice should require counseling on proper naloxone use and substance use intervention strategies and resources in order to obtain the prescription. INVOLUNTARY TREATMENT: Patients who seek treatment often do so because of external, coercive influences. 175 Given that individuals with SUDs often do not seek treatment voluntarily, it may be necessary for loved ones to intervene by pursuing involuntary treatment on the individual s behalf in certain, limited circumstances, such as when the patient may cause himself severe harm. However, to ensure individual civil liberties are protected, involuntary treatment should only be authorized as a last resort. Involuntary treatment is court-mandated substance use treatment. 176 Currently, 38 states have involuntary treatment laws that can require inpatient or outpatient care. 177 The circumstances under which an individual may be required to undergo involuntary assessment and treatment vary widely from state to state and may include dangerousness to self or others, grave disability, lack of decisional capacity, incapacitation, failure to manage personal affairs, and addiction or loss of control. 178 For instance, Florida s Substance Abuse Impairment Act, commonly known as the Marchman Act, outlines the following criteria and procedures for involuntary substance use assessment and treatment: 1. A good faith belief that the person is substance abuse impaired ; and 2. His or her impairment has caused a loss of self-control that either a. Has inflicted or is likely to inflict physical harm on himself or another; or b. Is in need of substance abuse services and the individual s impairment renders him or her incapable of making a rational decision to seek substance abuse treatment. 179 The process generally requires a spouse, relative, or eligible care provider to file a petition with the court and initiate a hearing on whether the person should undergo assessment or treatment involuntarily. 180 If the judge issues an order, the individual is typically committed for five days to 60 days depending on diagnosis. 181 In comparison, Massachusetts s involuntary substance use treatment laws require current substance abuse and a likelihood of serious harm as a result of the person s... substance abuse. 182 In making a determination of the seriousness of a person s substance use, a National Prescription Drug Abuse Prevention Strategy: 2015 Update 20

22 practitioner must examine the individual s incapacitation, inability to manage personal affairs, and his ability to exert self-control over the addiction. The conduct does not warrant involuntary commitment until the individual poses a threshold level of serious harm,183 and if a judge orders involuntary commitment, an individual may be sent to a treatment facility for up to 90 days.184 Despite the best attempts to convince individuals with SUDs of their need for treatment, they may not heed such advice. Nevertheless, as the National Institute on Drug Abuse (NIDA) has determined, treatment does not have to be voluntary to be effective. 185 Therefore, all states should adopt involuntary treatment laws. MANDATORY NOTIFICATION AND INFORMATION ON INVOLUNTARY TREATMENT: Of 5.1 million drug-related emergency department visits in 2011, percent were attributed to drug misuse or abuse.187 Studies have shown that individuals who visit the emergency room for nonfatal overdoses present a high likelihood of future hospitalization and fatal or near-fatal events.188 When a patient receives emergency care for a non-fatal, substance-related overdose, the physician should assess whether SUD treatment is appropriate and, if so, refer the patient to such treatment. Pennsylvania s Warm Hand-off workgroup recommends just this.189 The workgroup, established as part of the Pennsylvania Department of Drug and Alcohol Programs Overdose Rapid Response Task Force, supports a policy to require survivors of overdoses to receive immediate hand-offs to appropriate SUD services once they are medically stabilized.190 Alternatively, states should implement the Overdose Death Prevention Act (ODPA), which requires the following: Emergency care practitioners must perform an SBIRT diagnosis on the patient and refer the patient to treatment; Prior to discharging the patient, the attending physician must make reasonable efforts to contact the patient s primary care physician, any practitioner who prescribed the patient controlled substances, or addiction specialist, if the patient has one, within the past month and notify the physician or prescriber of the non-fatal overdose; Notify the patient s emergency contact or next of kin of the overdose; and Provide the emergency contact or next of kin with information on addiction treatment.191 In states that choose not to implement the ODPA, hospitals should adopt these requirements as mandatory policy. National Prescription Drug Abuse Prevention Strategy: 2015 Update 21