Prescription Opioid Policies (22 March 2016)

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Prescription Opioid Policies (22 March 2016) Prescription opioid misuse and abuse has become problematic in the United States and internationally in economically developed countries. Increased use of opioids for control of chronic non-cancer pain has increased population access to opioid analgesics, enhanced their nonmedical use, and is associated with increases in diagnoses of opioid dependence and elevated rates of opioid overdose. 1. Centers for Disease Control and Prevention Documents from the Center for Disease Control and Prevention (CDC) published in the Morbidity and Mortality Weekly Report (MMWR) monitor and describe the epidemiology of opioid use and opioid overdose. Opioid prescribing guidelines were released in March 2016. CDC Guideline for Prescribing Opioids for Chronic Pain United States, 2016. MMWR, 2016, 65 (1); 1 50. http://www.cdc.gov/mmwr/volumes/65/rr/pdfs/rr6501e1.pdfhttp://www.cdc.gov/mmwr/vol umes/65/rr/pdfs/rr6501e1.pdf Centers for Disease Control and Prevention. Increases in Drug and opioid overdose deaths United States, 2000 2014. MMWR, 2016, 64 (50); 1378 1382. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6450a3.htm?s_cid=mm6450a3_w Demographic and Substance Use Trends Among Heroin Users United States, 2002 2013. MMWR 2015; 64(26);719-725. Centers for Disease Control and Prevention. Decrease in Rate of Opioid Analgesic Overdose Deaths Staten Island, New York City, 2011 2013. MMWR 2015; 64(18);491-494. Centers for Disease Control and Prevention. Increases in Heroin Overdose Deaths 28 States, 2010 to 2012. MMWR 2014; 63: 849-854. Centers for Disease Control and Prevention. Decline in drug overdose deaths after state policy changes Florida, 2010-2012. MMWR 2014; 63(26):569-574. Centers for Disease Control and Prevention. Alcohol Involvement in Opioid Pain Reliever and Benzodiazepine Drug Abuse Related Emergency Department Visits and Drug-Related Deaths United States, 2010. MMWR 2014; 63: 881-885. Centers for Disease Control and Prevention. Vital Signs: Variation Among States in Prescribing of Opioid Pain Relievers and Benzodiazepines United States, 2012. MMWR 2014; 63(26);563-568. Centers for Disease Control and Prevention. Decline in Drug Overdose Deaths After State Policy Changes Florida, 2010 2012. MMWR 2014; 63(26);569-574. Centers for Disease Control and Prevention. Vital Signs: Overdoses of Prescription Opioid Pain Relievers and Other Drugs Among Women United States, 1999 2010. MMWR 2013; 62(26);537-542. Centers for Disease Control and Prevention. Vital Signs: Risk for Overdose from Methadone Used for Pain Relief United States, 1999 2010. MMWR 2012; 61(26): 493-497. Centers for Disease Control and Prevention. CDC Grand Rounds: Prescription Drug Overdoses a U.S. Epidemic. MMWR 2012; 61(01):10-13. Centers for Disease Control and Prevention. Vital Signs: Overdoses of Prescription Opioid Pain Relievers---United States, 1999 2008.MMWR 2011; 60(43):1487-1492. Centers for Disease Control and Prevention. Drug Overdose Deaths --- Florida, 2003--2009. MMWR 2011;60(26);869-872.

Centers for Disease Control and Prevention. Drug-induced deaths United States 2003 2007. MMWR 2011;60(supp):60-61. Centers for Disease Control and Prevention. Emergency department visits involving nonmedical use of selected prescription drugs United States, 2004 2008. MMWR 2010;59:705-709. Centers for Disease Control and Prevention. Ecstasy overdoses as a New Year s Eve rave Los Angeles, California, 2010. MMWR 2010; 59:671-681. Centers for Disease Control and Prevention. Overdose deaths involving prescription opioids among Medicaid enrollees Washington, 2004-2007. MMWR 2009;58:1171-1175. Centers for Disease Control and Prevention. QuickStats: Percentage change in death rates for the leading causes of unintentional injury, by mechanism of injury --- United States, 1999 2005. MMWR 2008;57:701. Centers for Disease Control and Prevention. Unintentional poisoning deaths United States, 1999-2004. MMWR 2007;56:93-96. Centers for Disease Control and Prevention. Nonfatal, unintentional medication exposures among young children United States, 2001-2003. MMWR 2006;55:1-5. Centers for Disease Control and Prevention. Unintentional and undetermined poisoning deaths 11 states, 1990-2001. MMWR 2004;53:233-8. CDC guidelines for prescribing opioids for chronic pain. http://www.cdc.gov/mmwr/volumes/65/rr/pdfs/rr6501e1.pdf See related papers in Journal of the American Medical Association and the New England Journal of Medicine. Dowell, Haegerich & Chou, JAMA, March 15, 2016 (condensed version of guidelines): http://jama.jamanetwork.com/article.aspx?articleid=2503508 Olsen, JAMA, March 15, 2016: http://jama.jamanetwork.com/article.aspx?articleid=2503503 Frieden & Houry, NEJM, March 15, 2016 (comments from CDC Director): http://www.nejm.org/doi/full/10.1056/nejmp1515917 Califf, Woodcock & Ostroff, NEJM, February 4, 2016 (FDA comments on prescription opioid abuse): http://www.nejm.org/doi/full/10.1056/nejmsr1601307?query=psychiatry 2. Office of National Drug Control Policy: Prescription drug strategy Epidemic: Responding to America s Prescription Drug Abuse Crisis, 2011 https://www.whitehouse.gov/sites/default/files/ondcp/policy-andresearch/rx_abuse_plan.pdf The Office of National Drug Control Policy, the Department of Health and Human Services, and the US Surgeon General have developed strategies and plans for addressing the opioid epidemic and communities and states have initiated action to reduce harms related to opioid abuse and misuse. The 2011 Prescription Drug Abuse Prevention Plan expands upon the Obama Administration's National Drug Control Strategy and includes action in four major areas to reduce prescription drug abuse: Education. A crucial first step in tackling the problem of prescription drug abuse is to educate parents, youth, and patients about the dangers of abusing prescription drugs, while requiring prescribers to receive education on the appropriate and safe use, and proper storage and disposal of prescription drugs.

Monitoring. Implement prescription drug monitoring programs (PDMPs) in every state to reduce doctor shopping and diversion, and enhance PDMPs to make sure they can share data across states and are used by healthcare providers. Proper Medication Disposal. Develop convenient and environmentally responsible prescription drug disposal programs to help decrease the supply of unused prescription drugs in the home. Enforcement. Provide law enforcement with the tools necessary to eliminate improper prescribing practices and stop pill mills. In its FFY 2017 budget request, the Whitehouse requests $1.1 Billion to address prescription opioid abuse and heroin use epidemic: https://www.whitehouse.gov/the-press-office/2016/02/02/president-obama-proposes-11- billion-new-funding-address-prescription 3. Department of Health and Human Services (DHHS) Scientists from the DHHS collaborated on a New England Journal of Medicine review article assessing the relationships between prescription opioid use and the use of heroin. The paper is open access and available at http://www.nejm.org/doi/full/10.1056/nejmra1508490 See the DHHS opioid webpage for general information on prescription opioids and the prescription opioid epidemic: http://www.hhs.gov/opioids/ The website provides public education and guidance on a) the prescription opioid epidemic scope, b) history of opioid use in the United States, c) drugs and pain medication, d) prevention and disposal guidance e) treatment and recovery resources, and f) overdose prevention and rescue. There are also resources for professionals involved in health care and in criminal justice. 4. DHHS, Office of the Assistant Secretary for Planning and Evaluation Opioid Abuse in the U.S. and HHS Actions to Address Opioid-Drug Related Overdoses and Deaths, 2015: http://aspe.hhs.gov/sp/reports/2015/opioidinitiative/ib_opioidinitiative.pdf The Secretary s initiative supports ONDCP s Prescription Drug Strategy and targets three priority areas to combat opioid abuse: Opioid prescribing practices to reduce opioid use disorders and overdose Expanded use and distribution of naloxone Expansion of Medication-assisted Treatment (MAT) to reduce opioid use disorders and overdose In March 2016 the Office released a National Pain Strategy: A Comprehensive Population Health-Level Strategy for Pain. http://iprcc.nih.gov/docs/hhsnational_pain_strategy.pdf See also the National Institutes of Health webpages for The Interagency Pain Research Coordinating Committee and its Federal Pain Research Strategy, notes from its meetings, and an analysis of the NIH research related to pain and pain treatment: http://iprcc.nih.gov/index.htm 5. DHHS, Behavioral Health Coordinating Committee Addressing Prescription Drug Abuse in the United States: Current Activities and Future Opportunities

http://www.cdc.gov/drugoverdose/pdf/hhs_prescription_drug_abuse_report_09.2013.pdf This report focuses on opioid analgesics due to the significant role these drugs play in abuse and overdose. Current HHS prescription drug abuse activities fall within eight domains: 1) surveillance, 2) drug abuse prevention, 3) patient and public education, 4) provider education, 5) clinical practice tools, 6) regulatory and oversight activities, 7) drug abuse treatment, and 8) overdose prevention. Fifteen opportunities may enhance current activities: Strengthen surveillance systems and capacity Build the evidence-base for prescription drug abuse prevention programs Enhance coordination of patient, public, and provider education programs among federal agencies Further develop targeted patient, public, and provider education programs Support efforts to increase provider use of prescription drug monitoring programs (PDMPs) Leverage health information technology to improve clinical care and reduce abuse Synthesize pain management guideline recommendations and incorporate into clinical decision support tools Collaborate with insurers and pharmacy benefit managers to implement robust claims review programs Collaborate with insurers, and pharmacy benefit managers to identify and implement programs that improve oversight of high-risk prescribing. Improve analytic tools for regulatory and oversight purposes Continue efforts to integrate drug abuse treatment and primary care Expand efforts to increase access to medication-assisted treatment Expand Screening, Brief Intervention, and Referral to Treatment services Prevent opioid overdose through new formulations of naloxone 6. DHHS, U.S. Surgeon General National Prevention Strategy: Preventing Drug Abuse and Excessive Alcohol Use http://www.surgeongeneral.gov/priorities/prevention/strategy/preventing-abuse.pdf RECOMMENDATIONS 1. Support State, tribal, local and Territorial implementation and enforcement of alcohol control policies. 2. Create environments that empower young people not to drink or use other drugs. 3. Identify alcohol and other drug abuse disorders early and provide brief intervention, referral, and treatment. 4. Reduce inappropriate access to and use of prescription drugs. State and community programs are addressing prescription opioid misuse and abuse at the local level. 7. Community Interventions Project Lazarus http://www.projectlazarus.org/about-lazarus/project-lazarus-model Project Lazarus public health model asserts that drug overdose and drug overdose deaths can be prevented through five community activities: 1. Activation and coalition building, 2. Monitoring and epidemiological surveillance, 3. Overdose prevention through medical and community education, 4. Use of rescue medication to reverse overdoses, and

5. Evaluation of project components. The community interventions are cyclical and community advisory boards develop and design each facet of the interventions. 8. Community Interventions Oregon s Prescription Opioid Strategy http://www.sciencedirect.com/science/article/pii/s0740547214001494 (This paper is open access) Former Oregon Governor John Kitzhaber appointed a Prescription Drug Taskforce to address Oregon's opioid epidemic. This case study reviews the Taskforce's participation in the National Governors Association State Policy Academy on Reducing Prescription Drug Abuse. To address the challenge of the misuse and abuse of prescription opioids, the Taskforce developed a strategy for practice change, community education and enhanced access to safe opioid disposal using stakeholder meetings, consensus development, and five action steps: (1) fewer pills in circulation, (2) educate prescribers and the public on the risks of opioid use, (3) foster safe disposal of unused medication, (4) provide treatment for opioid dependence, and (5) continued leadership from the Governor, health plans and health professionals. There are lessons for leadership in other states and for public health and medical practitioners throughout the country. The initiative continues as the Oregon Coalition for Responsible Use of Medication (OCRM): http://orcrm.org/ 9. Community Interventions Rhode Island; Governor s Overdose Prevention and Intervention Taskforce -- http://www.strategicplanri.org/ Rhode Island has a four point plan to reduce opioid overdose deaths by one-third in three years. Treatment Strategy Every door is the right one. Provide access to agonist and antagonist pharmacotherapy through medical services (e.g., emergency departments), criminal justice systems, drug treatment programs, and community services. Rescue Strategy Naloxone as a standard of care. Make overdose rescue medication available through a) co-prescriptions of naloxone and provision of naloxone education when opioids are prescribed, b) creation of designated fund to support naloxone purchase, c) aggressive outreach to high risk populations. Prevention Strategy Safer prescribing and dispensing. Enhance opioid safety by enhancing the prescription drug monitoring program to alert prescribers to the patients with prescriptions of benzodiazepines and opioids. Encourage standardized urine testing for the combination of benzodiazepines and opioids coupled with prescriber outreach and education. Recovery Strategy Expand recovery supports. Add peer recovery coaches to every emergency department and health care system in the states. Use peer recovery coaches in the criminal justice system to support the use of agonist therapy. Support peer recovery coaches in street outreach and build a pipeline of peer recovery coaches. 10. Community Interventions Massachusetts Department of Public Health Opioid Taskforce Recommendations http://www.mass.gov/eohhs/docs/dph/substance-abuse/opioid/report-of-the-opioid-taskforce-6-10-14.pdf

The report summarizes the findings of the Task Force and provides recommendations for strengthening the Commonwealth s ability to respond to the opioid crisis with a focus on prevention, intervention, treatment and recovery. These recommendations include expansion of treatment beds; the formation of a centralized navigation system for patients, families, and first responders to locate treatment services; a public-facing dashboard that facilitates consumer choice of services; additional opioid prevention coalitions for support and education; more stringent safeguards for those opioids which are most frequently abused and misused; a meeting of New England governors to develop a regional response to the opioid epidemic; and the expansion of the use of injectable naltrexone for persons reentering the community from correctional facilities. See link for updated information: http://www.mass.gov/eohhs/feature-story/end-opioid-abuse-in-mass.html 11. Community Interventions Johns Hopkins Bloomberg School of Public Health -- http://www.jhsph.edu/research/centers-and-institutes/center-for-drug-safety-andeffectiveness/opioid-epidemic-town-hall-2015/2015-prescription-opioid-epidemic-report.pdf Public health experts make seven recommendations for action: 1) enhance prescribing guidelines, 2) mandate use of prescription drug monitoring programs, 3) strengthen pharmacy benefit management, 4) engineer safer packaging and products, 5) naloxone distribution and overdose education, 6) expand access to agonist and antagonist therapies, and 7) community-based prevention approaches. 12. Recent research Links to Pub Med for recent research papers: JAMA. 2015 Oct 13;314(14):1468-78. doi: 10.1001/jama.2015.11859. Nonmedical Prescription Opioid Use and Use Disorders Among Adults Aged 18 Through 64 Years in the United States, 2003-2013. Han B 1, Compton WM 2, Jones CM 3, Cai R 1. http://www.ncbi.nlm.nih.gov/pubmed/26461997 J Intern Med. 2015 Jul;278(1):92-4. doi: 10.1111/joim.12345. Epub 2015 Feb 2. Reflections on the role of opioids in the treatment of chronic pain: a shared solution for prescription opioid abuse and pain. Thomas D 1, Frascella J 1, Hall T 1, Smith W 2, Compton W 3, Koroshetz W 4, Briggs J 5, Grady P 6, Somerman M 7, Volkow N 3. http://www.ncbi.nlm.nih.gov/pubmed/25556772 N Engl J Med. 2014 May 29;370(22):2063-6. doi: 10.1056/NEJMp1402780. Medication-assisted therapies--tackling the opioid-overdose epidemic. Volkow ND 1, Frieden TR, Hyde PS, Cha SS. http://www.ncbi.nlm.nih.gov/pubmed/24758595