And the Oscar for Best Actor Goes to…Hydrocodone? Prescription Drug Abuse in Modern American Film: Lessons for Treatment, Prevention, and Public Health Robert Valuck, PhD, RPh Professor of Pharmacy, Epidemiology, and Family Medicine Coordinating Center Director, Colorado Consortium for Prescription Drug Abuse Prevention May 18, 2014 Office of the Governor Objectives • Using a sample (real, but identity protected) patient and clips from modern American films as examples… – Describe the scope of the prescription drug abuse problem in the United States and Colorado – Discuss some of the factors contributing to the growth in prescription drug abuse – Highlight policy initiatives and programs at the federal and state levels (including Colorado) to address the problem – Offer examples of actions that physicians can take to promote safe use, safe storage, and safe disposal of prescription drugs Office of the Governor Prologue So, what’s the big deal? Office of the Governor Drug Overdose Mortality • In 2010, 38,329 people died from a drug overdose in the U.S. – One every 14 minutes – Nearly 60% of those deaths involved prescription drugs – Painkillers (opioids) were involved in 75% of those deaths • In Colorado, drug overdose deaths range from 250-500/year • Since 2003, more overdose deaths have involved opioids than heroin and cocaine combined • Rates of misuse and overdose death are highest among men, persons aged 20-64, non-Hispanic whites, and poor and rural • Two main at-risk populations: long term medical users (>10 million) and nonmedical users in past month (>6 million) CDC/MMWR Jan 13, 2012; 61(01):10-13. Colorado Rx Abuse Task Force data SAMSHA/NSDUH 2009 survey . Office of the Governor Drug Overdose Mortality in the U.S. (2010) CDC/NCHS National Vital Statistics System, CDC Wonder. Updated 2010.. Office of the Governor Drug Overdose Mortality Trends (1979-2010) CDC/NCHS National Vital Statistics System, CDC Wonder. Updated 2010.. Office of the Governor Drug Overdose Death Rates in the US Motor Vehicle Traffic Drug Poisoning (Overdose) 25 Deaths per 100,000 population 20 15 10 5 0 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 Year Office of the Governor NCHS Data Brief, December, 2011, Updated with 2009 and 2010 mortality data Opioid and Benzodiazepine Trends Different than Heroin and Cocaine in the US (1999-2010) Opioids Heroin Cocaine Benzodiazepines 18,000 16,000 Number of Deaths 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Year CDC/NCHS National Vital Statistics System, CDC Wonder. Updated 2010.. Office of the Governor 8 Prescription Drugs: primary driver of Overdose Deaths in US (2010) 18,000 16,000 Number of Deaths 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 Drug or Drug Class Jones et al. JAMA 2013; and CDC/NCHS 2010. Office of the Governor 9 Opioids more likely to be involved in single drug class deaths (US, 2010) 35 30 29.4 25 Percent 20 15 10.5 9.1 10 8.3 6.4 6.2 3.7 5 0 Opioid Analgesics (n=16651) Antiepileptic and Antiparkinsonism Drugs (n=1717) Benzodiazepines (n=6497) Barbiturates (n=296) Antidepressants (n=3889) Antipsychotic and Neuroleptic Drugs (n=1351) Other Psychotropic Drugs (n=24) Psychotherapeutic Pharmaceuticals Jones et al. JAMA 2013 Office of the Governor 10 Deaths are the Tip of the Iceberg… For every opioid overdose death in 2011 SAMHSA NSDUH, DAWN, TEDS data sets Coalition Against Insurance Fraud. Prescription for Peril. http://www.insurancefraud.org/downloads/drugDiversion.pdf 2007 . Office of the Governor 11 Cost of Prescription Drug Abuse on the U.S. Economy (2006) Hansen et al. Clin J Pain 2011; 27(3): 194-202. Office of the Governor How did we get into this mess? • An enormous amount of opioids moves through U.S. channels – 1997: 96mg “morphine equivalents” dispensed per person (in the U.S.) – 2007: 700mg per person (in the US) – an increase of >600% – That 700mg per person is enough for every person in the U.S. to take a typical 5mg dose of Vicodin every 4 hours for 3 weeks – While accounting for about 5 percent of the world’s population, the U.S. now consumes 99 percent of the world’s Vicodin and 84 percent of its Oxycontin • Causes of the increase? There are many, including… – – – – – – Increased recognition of pain, undertreatment of pain Pain as the “fifth vital sign”, JCAHO quality measure, etc. Drug company advertising and promotion Practitioners are not well trained in opioid pharmacology, addiction Drugs are very powerful, highly addictive if not used properly Scamming, doctor/pharmacy shopping, black market for opioids CDC/MMWR Jan 13, 2012; 61(01):10-13. SAMHSA/NSDUH 2009 CDC/MMWR Jan 13,survey 2012; 61(01):10-13. . SAMHSA/NSDUH 2009 survey . Office of the Governor Sales of Opioid Pain Relievers and Nonmedical Opioid Use (2010-11) #37 in U.S. Office of the Governor Sales of Opioid Pain Relievers and Nonmedical Opioid Use (2010-11) #2 in U.S. (Oregon = 6.4) Office of the Governor Scene #1 Nonmedical Use: The Beginnings Office of the Governor A Typical Patient: Aaron • Aaron is a 22 year old male, who started using prescription opioids when he was in high school • He was a typical high school student, from an upper middle class family, played sports, was looked up to by siblings and friends • Aaron started experimenting with prescription drugs at a “pharming” party, where students raid their (parents’) medicine cabinets, bring any Rx drugs they can find to the party, dump them all into a bowl, stir them around, and “pick one or two and chase them with a beer” • This led to further nonmedical use: trying one or two of his parents’ Vicodin, then one or two more; getting more from friends; and gradually falling into the spiral of increased use, leading to tolerance, leading to increased use, leading to dependence, and ultimately addiction Office of the Governor Other Paths to Nonmedical Use From 1967…Valley of the Dolls http://youtu.be/t054GSzRywg Office of the Governor Other Paths to Nonmedical Use From 2014…in your own home https://www.youtube.com/watch?v=0bZOgj5HEAE Office of the Governor Sources of Opioids among Nonmedical Users CDC/MMWR Jan 13, 2012; 61(01):10-13. SAMHSA/NSDUH 2009 survey . Office of the Governor Scene #2 Getting Worse: Scamming and Stealing Office of the Governor Aaron: Spiraling Downward • As his addiction became stronger, Aaron started to scam doctors for opioid medications (later described it as easy: “Google ‘how to get opioids from a doctor’ and you’ll get lots of ideas”) • He estimated that he visited between 40 and 50 doctors over an 18 month period, and went to about an equal number of pharmacies, to “spread myself around and stay beneath the radar” • Most of the doctors gave him at least an initial Rx for Vicodin (his drug of choice due to the ability to request and get refills from doctors, their weekend colleagues covering for them, etc.) • He finally started running into difficulty when the Vicodin “didn’t do it for me”, and he progressed to OxyContin (oxycodone) Office of the Governor Majority of opioids consumed by small percentage of patients (Arkansas Medicaid, 2005) 70 62.9 Percent of total opioids consumed 60 50 40 30 20 16.4 8.9 10 0.1 0.3 0.6 1 1.6 2.9 <17 17-22 23-27 28-31 32-38 39-45 5 0 46-56 57-75 76-99 100+ Deciles of Daily Dosage in Morphine Equivalents Edlund et al. J Pain Symp Manage 2010;40:279-289 Office of the Governor 23 Top 8.1% of providers prescribe 79% of CII-CIV drugs (Oregon PDMP, 2011-12) Remaining 45,330 Providers 21% Top 2,000 Providers 2,001-4,000 Providers 19% 60% Oregon PDMP Report 2012: http://www.orpdmp.com/orpdmpfiles/PDF_Files/ Reports/Statewide_10.01.11_to_03.31.12.pdf Office of the Governor 24 Top 20% of prescribers account for 63% of Overdose Deaths (Ontario Public Drug Program, 2006) Pct of total patients 70 Pct of total deaths 62.7 60 Percent 50 40 30 20 17.3 21.9 20.4 18.9 18.6 21.4 12.7 10 4.0 2.0 0 1 2 3 4 5 Quintiles of Prescribers from lowest to highest prescribing rate Dhalla et al. Can Fam Physician 2011;57:e92-e96. Office of the Governor 25 Overdose risk highest among small percentage of patients at high dosage (Group Health, 1997-2005) 8.87 100 9 90 8 80 7 70 6 60 5 50 3.73 4 40 3 30 2 1 1.44 % Patient Years Risk (Odds Ratio) 10 20 1 10 0 0 1-19 20-49 50-99 100+ Opioid dosage (MME/d) Dunn et al, Ann Int Med 2010;152:85-92. Office of the Governor 26 More patients on opioids = more doctor shoppers Odds ratio of having doctor shoppers as patients 700 620.1 600 500 400 300 200 100 0 100% of patients are doctor shoppers 171.1 60.1 1.0 4.1 7.1 14.5 1-17 18-35 36-65 66-149 29.8 0.0 150-227 228-457 458-915 916-1831 1,832-2936 Number of patients on opioid analgesics per prescriber Cepeda et al. J Opioid Manag. 2013. Office of the Governor 27 Stealing Can Turn to Robbery…and Worse From 1989…Drugstore Cowboy http://youtu.be/puXEHhZgXaY Office of the Governor Scene #3 Rock Bottom: Heroin and Overdose Office of the Governor Aaron: Spiraling Downward • AD eventually started using OxyContin at very high doses, mixed it with Xanax and often alcohol, and overdosed at age 21 • AD had a difficult stay in the ICU, and while there had two myocardial infarctions, seizures, a staph infection and pneumonia, and underwent extreme withdrawal symptoms • Doctors were preparing AD’s parents for his death, which appeared imminent and very likely • Surprisingly, AD regained consciousness, and eventually recovered well enough to be discharged home with his parents • The disposition of AD’s case will be shown at the end of the talk; his is certainly not the only example of the downward spiral… Office of the Governor Frequent Nonmedical Users of Opioids more likely to Engage in Risky Use Behaviors (US, 2008-2010) 1-29 Days of PYNMU of Opioid Pain Relievers 30-99 Days of PYNMU of Opioid Pain Relievers 100-365 Days of PYNMU of Opioid Pain Relievers aOR (95% CI) aOR (95% CI) aOR (95% CI) Past Year Heroin Use referent 2.8 (1.7-4.5) 6.4 (3.7-11.1) Ever Inject Heroin referent 1.6 (0.9-2.9) 4.3 (2.5-7.3) Ever Inject Opioid Pain Relievers referent 3.8 (1.9-7.8) 13.3 (7.7-23.0) Past Year Heroin Abuse or Dependence referent 3.2 (1.7-6.1) 7.8 (4.7-12.8) Past Year Opioid Pain Reliever Abuse or Dependence referent 2.9 (2.3-3.8) 8.9 (7.1-11.3) Heroin Fairly or Very Easy to Obtain referent 1.4 (1.1-1.7) 2.1 (1.8-2.6) Characteristic Abbreviations: PYNMU, past year nonmedical use; aOR, adjusted Odds Ratio; 95% CI, 95% Confidence Interval 1Odds ratio adjusted for sex, age, race/ethnicity, total family income, and county type Jones, CM. Drug Alcohol Depend 2013. Office of the Governor 31 Majority of Heroin users in past year reported Nonmedical use of Opioids before heroin initiation (US, 2002-2004 and 2008-2010) Age first use OPR same as heroin Age first use heroin before OPR Age first use OPR before heroin 100 90 80 Percent 70 65.1 69.1 60 64.1 74.7 66.8 76.4 77.4 82.6 50 40 30 20 2.1 18.4 32.8 10 15.2 12.4 10.1 2008-2010 2002-2004 6.7 16.4 25.4 9.7 6.2 16.9 10.5 11.2 2002-2004 2008-2010 16.8 12.9 2002-2004 2008-2010 0 2002-2004 1-29 Days PYNMU 2008-2010 30-99 Days PYNMU 100-365 Days PYNMU Any PYNMU Frequency of Past Year Nonmedical Use Jones, C.M. Drug Alcohol Depend 2013. Office of the Governor 32 The Heroin Lifestyle From 1996…Trainspotting http://www.youtube.com/watc h?v=Naf_WiEb9Qs&list=PLBA06 889EA057B4C0&feature=share Office of the Governor Scene #4 The Way Out: Treatment and Recovery Office of the Governor Rates of opioid overdose deaths, sales and treatment admissions increased in parallel (US, 1999-2010) Opioid Sales KG/10,000 Opioid Deaths/100,000 Opioid Treatment Admissions/10,000 8 7 6 Rate 5 4 3 2 1 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Year CDC/National Vital Statistics System DEA ARCOS System SAMHSA’s TEDS System Office of the Governor 35 Substance Abuse Treatment Gap (2011) SAMHSA/NSDUH 2011 survey Office of the Governor Physicians Authorized to Treat Addiction (Buprenorphine/Methadone) SAMHSA. National Expenditures for MH Services and Substance Abuse Treatment, 1986-2009. Pub SMA-13-4740. Office of the Governor Scene #5 The Way Forward: Coordinated Responses Office of the Governor Office of the Governor 39 Federal Initiatives (alphabet soup warning) • FDA: REMS programs, stricter regulation on DTC advertising, support of rescheduling certain drugs (hydrocodone) to C-II • CDC: Increased surveillance, grant funding, elevate topic in national discussion • DEA: Takeback events (2X/year), new rules on returning unused controlled substances (pending), rescheduling • ONDCP: Federal strategic plan, elevate topic in national discussion • DOJ: Promote PDMP programs, interstate data sharing • CMS: Pharmacy/provider restrictions, quantity restrictions • NIH: Research funding (basic science, clinical science, policy, collaborative mechanisms/center grants) Office of the Governor Other States and Policy Examples • • • • • • • • Tougher Pill Mill Laws, Doctor Shopping Laws Physical Exam Requirements Tamper Resistant Form Requirements Prescription Limits Patient ID Requirements Immunity from Prosecution Naloxone Laws Prospective Reports from PDMP programs (and other enhancements) Office of the Governor Pill Mill Laws CDC PHLP 2013 Brandeis TTAC Best Practices Report 2013. Trust for America’s Health Report 2013. . Office of the Governor 42 Doctor Shopping Laws CDC PHLP 2013 Brandeis TTAC Best Practices Report 2013. Trust for America’s Health Report 2013. . Office of the Governor 43 Physical Exam Requirements CDC PHLP 2013 Brandeis TTAC Best Practices Report 2013. Trust for America’s Health Report 2013. . Office of the Governor 44 Tamper Resistant Forms CDC PHLP 2013 Brandeis TTAC Best Practices Report 2013. Trust for America’s Health Report 2013. . Office of the Governor 45 Prescription Limits CDC PHLP 2013 Brandeis TTAC Best Practices Report 2013. Trust for America’s Health Report 2013. . Office of the Governor 46 Patient ID Requirements CDC PHLP 2013 Brandeis TTAC Best Practices Report 2013. Trust for America’s Health Report 2013. . Office of the Governor 47 Immunity from Prosecution CDC PHLP 2013 Brandeis TTAC Best Practices Report 2013. Trust for America’s Health Report 2013. . Office of the Governor 48 PDMP Proactive Reporting Brandeis TTAC Best Practices Report 2013. Trust for America’s Health Report 2013. . Office of the Governor 49 Here in Colorado… Office of the Governor In 2010… Office of the Governor Office of the Governor Office of the Governor Recommendations to Reduce Prescription Drug Misuse and Abuse in Colorado Colorado Consortium for Prescription Drug Abuse Prevention Provider & Prescriber Education • The Colorado Consortium for Prescription Drug Abuse Prevention, housed at the CU School of Pharmacy, will serve as the operational lead for the CO Plan to Reduce Rx Abuse with participation from the Governor’s Policy Office, a variety of state agencies, and community partners. The Consortium will help to facilitate and implement Workgroup Recommendations mentioned below. • Change state board policies (or rules) for all DORA-licensed prescribers to include pain management guidelines. • Enlist and support DORA to provide education about the existence and utilization of PDMP as part of the licensing processes for prescribers and pharmacists. • Form taskforce with representation from various agencies to examine the use of PDMP as a public health tool. PDMP • Improve usability and appropriate accessibility of the PDMP system through the use of information technology and increased stakeholder access. • Expand take-back program in law enforcement agencies – develop permanent drop-off sites with Law Enforcement. Disposal • Expand take-back program to pharmacies (pending DEA approval). • Establish Colorado guidelines on flushing. • Develop (or utilize existing) social marketing campaign that targets the General Public and overcomes existing obstacles and misperceptions. Public Awareness Data & Analysis • Develop (or utilize existing) social marketing campaign that targets Youth and Young Adults (12-25 year olds) and overcomes existing obstacles and misperceptions. • Map out all sources of data related to prescription drug use, misuse and overdose in the state in order to monitor trends, educate the public and inform decision making by multiple stakeholders. • Identify other efforts that successfully use crosswalks between diverse data sources and successfully standardize their data collection tools across agencies. Office of the Governor Colorado Consortium for Prescription Drug Abuse Prevention A coordinated, statewide, interuniversity/interagency network PDMP Workgroup Treatment Workgroup Agency Co-Chair: Prescriber and Provider Education Workgroup Chris Gassen, DORA Univ Co-Chair: Jason Hoppe, DO Agency Co-Chair: Governor Denise Vincioni, OBH Univ Co-Chair: Paula Riggs, MD Policy Lead Agency Co-Chair: Cathy Traugott, HCPF Univ Co-Chair: Lee Newman, MD Coordinating Center CU School of Pharmacy CO Attorney General Subcommittee +Coordinating Committee Substance Abuse Trend & Response Task Force Safe Disposal Workgroup Agency Co-Chair: Shannon Breitzman, CDPHE Univ Co-Chair: Sunny Linnebur, PharmD Public Awareness Workgroup Data/Analysis Workgroup CO Legislature Agency Co-Chair: Barbara Gabella, CDPHE Agency Co-Chair: Stan Paprocki, OBH LEGEND Univ Co-Chair: = New Ingrid Binswanger, MD Univ Co-Chair: Carol Runyan, PhD Office of the Governor = Existing Epilogue Making an Impact: One Patient at a Time Office of the Governor Aaron: Where is he now? http://www.riseaboveco.org/rx/rx4.html Office of the Governor What can I do for my patients? Office of the Governor Six Things You Can Do 1. Take C.E. courses, get all the additional training you can 2. Find and follow guidelines for safe opioid prescribing 3. Be willing to prescribe less (smaller quantities, other alternatives), and see patients more often 4. Check the PDMP more often (more on this shortly) 5. Educate patients on the importance of safe storage and disposal of unused medications 6. Talk with your colleagues, family, friends and neighbors about this…tell them stories about affected patients Office of the Governor Office of the Governor HB14-1283 (PDMP Enhancement Bill) • Passed this Spring, will be signed into law on Weds 5/21/14 • Several key provisions: – – – – – Mandatory registration for PDMP account (not mandatory use) Delegated access (up to three delegates per provider) Unsolicited reports of potential doctor/pharmacy shoppers CDPHE access to system for public health surveillance Advisory Board (consortium PDMP work group) to guide implementation and future directions Not requiring legislation: daily reporting of dispensing data (Rx’s filled) by pharmacies, system/interface enhancements, batch querying and reporting, fewer clicks and fewer attestations (monthly or quarterly) Office of the Governor Questions? Office of the Governor