The Prescription Drug Abuse Crisis: 2016 Update Scott Hambleton, M.D. Medical Director Mississippi Physician Health Program 2 nd Annual Symposium on Addiction Opioid addiction: The Highs, The Highways, The Hope Lombard. IL September 23, 2016
No Disclosures Todays speaker has no disclosure of real or apparent conflict related to the content of this presentation.
Objectives: 1) To describe the epidemiology of prescription drug abuse. 2) To identify factors which have contributed to prescription drug abuse in America. 3) To summarize risks of prescribing controlled substances for chronic, nonlife threatening conditions.
Acknowledgement Much of the content of this presentation was made possible by Andrew Kolodny, MD and his work with the Physicians for Responsible Opioid Prescribing www.supportprop.org
Classes of * Prescription Drugs Opioids CNS Depressants Stimulants Other Substances
Opioids Prescribed to alleviate pain Examples include : Hydromorphone (, (Dilaudid ) Hydrocodone (Vicodin Lortab ) oxycodone (OxyContin )
US Consumption of Global Supply of Opioids: 2010 55% of all morphine 56% of all hydromorphone 80% of all oxycodone 99% of all hydrocodone Americans represent 5.2% of the earth s population (International Narcotics Control Board 2011 Report)
111 Tons Dispensed in 2010 69 tons of pure oxycodone 42 tons of pure hydrocodone 222,000 pounds (CDC, 2012)
Opioid Prescriptions Dispensed per Year (Oxycodone and Hydrocodone)
The Eye of the Perfect Storm The use of opioids for chronic noncancer pain
Introduction of OxyContin: 1996 Active ingredient: oxycodone Manufactured by Purdue Pharma $48 million in sales in 1996 (Van Zee, 2009)
Industry Marketing Purdue aggressively promoted the use of opioids for use in the non-malignant pain market. Targeted primary care Risk of addiction much less than 1%. $200 million spent in marketing in 2001 (Van Zee, 2009)
Dollars Spent Marketing OxyContin (1996-2001) (www.supportprop.org)
OxyContin Sales 2010 $3.1 billion in sales in 2010 Over $17 billion in sales 2000-2010 (IMS Health, National Prescription Audit, Dec 2010)
Chronic Opioid Therapy (COT) Myths MYTH: Opioid use for chronic non-cancer pain is supported by strong evidence. FACT: Evidence for long-term use in chronic noncancer pain is limited and of low quality. (Murray, 2013; Reuben, 2015)
Chronic Opioid Therapy (COT) Myths MYTH: Tolerance an physical dependence only happens with high doses over long periods of time. FACT: With daily use, physical dependence and tolerance can develop in weeks or days. (Volkow & McLellan, 2016)
Chronic Opioid Therapy (COT) Myths MYTH: Patients who develop physical dependence on opioids can easily be tapered off. FACT: Successfully tapering chronic pain patients from opioids can be difficult even for those who are highly motivated to discontinue the opioids. (CDC Guidelines for Prescribing Opioids for Chronic Pain 2016)
Chronic Opioid Therapy (COT) Myths MYTH: Addiction is rare in patients receiving medically prescribed COT. FACT: Rates of misuse, and aberrant drug-seeking behaviors between 15-26%. (Volkow & McLellan, 2016)
MYTH: Dose-related risk of overdose associated with COT can be avoided by slow upward titration. FACT: Chronic Opioid Therapy (COT) Myths The risk for ANY opioid related overdose event is dose dependent. CDC Guidelines recommend that clinicians should avoid increasing dosage to >90MME/day. (CDC Guidelines for Prescribing Opioids for Chronic Pain 2016)
Chronic Opioid Therapy (COT) Myths MYTH: Addiction is the main reason to be concerned when prescribing opioids. FACT: Other significant risks include respiratory depression and unintentional overdose, serious fractures from falls, increased pain sensitivity and sleep-disorder breathing. (National Safety Council WHITE PAPER, 2014)
Chronic Opioid Therapy (COT) Myths MYTH: Long acting/extended release opioid medications have less risk of overdose than short-acting opioid medication. FACT: Patients initiating therapy long-acting opioids twice as likely to overdose compared to patients initiating therapy with short-acting opioids. (Miller M, et al., 2015)
Non-heroin opioid admissions, by gender, age, race/ethnicity: 2011 30
. Source: CDC, Unintentional Drug Poisoning in the United States
. Heroin Epidemic 1970s Source: CDC, Unintentional Drug Poisoning in the United States
. Cocaine Epidemic 1986-1992. Source: CDC, Unintentional Drug Poisoning in the United States
. OxyContin 1996 Source: CDC, Unintentional Drug Poisoning in the United States
. 5 th Vital Sign Implemented 2001 Source: CDC, Unintentional Drug Poisoning in the United States
. 26,389 Deaths in 2006 Source: CDC, Unintentional Drug Poisoning in the United States (2010)
. 38,329 Deaths in 2010.. (CDC, 2012) 2010
. 47,055 Deaths. (All O.D. Deaths) (CDC, 2014 Mortality Data) 2014
Adverse Selection Patients with mental health and substance abuse co-morbidities are more likely to receive chronic opioid therapy than patients who lack these risk factors. (Edlund, et al., 2007)
How Many Americans Have Moderate to Severe Chronic Pain? moderate to severe chronic pain that limits activities and diminishes quality of life. 25 million Americans (Annals of Internal Medicine. POSITION PAPER. 2015)
Opioids for Treatment of Back Pain? Patients initially treated with opioids (for lumbar disc herniation) had a higher rate of surgery and a greater chance of being on opioids four years later but no significant change in overall outcome. (Radcliff, et al., 2013)
Opioids for Dental Pain After Wisdom Tooth Extraction? 2013 quantitative systematic review in the Journal of the American Dental Association 325 mg of acetaminophen (APAP) taken with 200 mg of ibuprofen provides better pain relief than oral opioids. (Moore, et al., 2013)
Number Needed to Treat (NNT) 5 4.5 4 4.6 NNT to get 50% pain reduction 3.5 3 2.5 2 1.5 1 0.5 2.7 2.7 1.6 0 Oxycodone 15 Oxycodone 10 + Acetaminophen 650 Naproxen 500 Ibuprofen 200+Acetaminophen 500 (National Safety Council: Evidence for the Efficacy of Pain Medication, 2014)
Prescription Drug Abuse Crisis Boundary Failure Minimization of addictive potential of opioids Lack of sufficient education about addiction
What is a Boundary? A line in the sand that represents the edge of appropriate, professional conduct. (Gutheil & Gabbard, 1993)
7 TH International Conference on Pain and Chemical Dependency June 2007
Heroin Sold over the counter by German drug company Bayer in 1895 to cure morphine addiction a non-addictive morphine substitute and cough suppressant Heroin rapidly metabolizes into morphine.
Purdue Pharma Pays $634.5 Million US Senate investigation resulted in guilty plea on May 10, 2007 Misled regulators, doctors and patients about the enormous addiction and abuse potential of OxyContin (United States DOJ, 2008)
January 2009 $1.4 Billion
September 2009 $2.3 Billion
May 2012 $1.5 Billion
July 2012 $3 Billion
November 2013 $2.2 Billion
R & D Costs for New Drugs Drug companies spend 19 times more on marketing than Research & Development. (Light & Lexchin, BMJ, 2012)
Current Illicit Prescription Drug Use 3 2.5 2 1.5 1.9% 2.7% 7 Million 2.5% (6.5 Million) 1 0.5 0 2002 2012 2013 02 12 13 (NSDUH, 2013)
Past Year Heroin Use 1,000,001 900,001 800,001 700,001 914,000 600,001 500,001 400,001 681,000 300,001 200,001 100,001 1 314,000 2003 2013 2014 (NSDUH, 2014)
Past Year Heroin Use 75% of heroin users report previous abuse of opioid pain medication (SAMHSA, 2014 NSDUH )
CDC Guideline for Prescribing Opioids for Chronic Pain - 2016 No evidence shows a long-term benefit of opioids in pain and function versus no opioids for chronic pain with outcomes examined at least 1 year later (with most placebo controlled randomized trials 6 weeks in duration) http://www.cdc.gov/drugoverdose/pres cribing/resources.html
CDC Guideline for Prescribing Opioids for Chronic Pain - 2016 Extensive evidence shows the possible harms of opioids (including opioid use disorder, overdose, and motor vehicle injury) http://www.cdc.gov/drugoverdose/pres cribing/resources.html
CDC Guideline for Prescribing Opioids for Chronic Pain - 2016 Extensive evidence suggests some benefits of nonpharmacologic and nonopioid pharmacologic treatments compared with long-term opioid therapy, with less harm http://www.cdc.gov/drugoverdose/pres cribing/resources.html
CDC Guideline: 12 Recommendations in Three Areas Determining when to initiate or continue opioids for chronic pain. Opioid selection, dosage, duration, follow-up, and discontinuation. Assessing risk and addressing harms of opioid use. http://www.cdc.gov/drugoverdose/prescri bing/resources.html
Thank You!
REFERENCES: Acknowledgements: Andrew Kolodney, MD et al. Physicians for Responsible Opioid Prescribing. http://www.supportprop.org/about/index.html. Centers for Disease Control and Prevention. National Center for Health Statistics 2014 Mortality Data. http://www.cdc.gov/nchs/deaths.htm. Accessed September 16, 2016. CDC Guidelines for Prescribing Opioids for Chronic Pain United States 2016. http://www.cdc.gov/drugoverdose/prescribing/resources.html. Accessed September 13, 2016. Centers for Disease Control and Prevention. CDC Grand Rounds: Prescription Drug Overdoses a U.S. Epidemic. Morbidity and Mortality Weekly Report. 2012; 61(01); 10-13. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6101a3.htm. Accessed September 12, 2016.
REFERENCES, CONT D. Centers for Disease Control and Prevention. Release of issue brief: Unintentional drug poisoning in the United States. Morbidity and Mortality Weekly Report. 2010; 59(10); 300. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5910a5.htm. Accessed September 16, 2016. Edlund MJ, steffick D, Hudson T, Harris KM, Sullivan M. Risk factors for clinically recognized opioid abuse and dependence among veterans using opioids for chronic non-cancer pain. Pain. 2007; 129(3):355-62. doi: 10.1016/j.pain.2007.02.014. Gutheil TG, Gabbard GO. The concept of boundaries in clinical practice: theoretical and risk-management dimensions. Am J Psychiatry. 1993;150(2):188-96. doi: 10.1176/ajp.150.2.188. IMS Health, National Prescription Audit, Dec 2010. http://www.imshealth.com/imshealth/global/content/ims%20institute/ Documents/IHII_UseOfMed_report%20.pdf.Accessed February 19, 2013. International Narcotics Control Board. Report 2011. Estimated world requirements for 2012. http://www.incb.org/documents/narcotic- Drugs/Technical-Publications/2011/Part_FOUR_Complete_English-NAR- Report-2011.pdf. Accessed September 12, 2016.
REFERENCES, CONT D. Light DW, Lexchin JR. Pharmaceutical research and development: what do we get for all that money? BMJ. 2012; 345. e4348. doi: 10.1136/bmj.e4348. Moore PA, Hersh EV. Combining ibuprofen and acetaminophen for acute pain management after third-molar extractions. JADA. 2013; 144(8): 898-908. doi: 10.14219/jada.archive.2013.0207. Miller M, Barber CW, Leatherman S, et al. Prescription opioid duration of action and the risk of unintentional overdose among patients receiving opioid therapy. JAMA Intern Med. 2015; 175(4):608-15. doi: 10.1001/jamainternmed.2014.8071. Murray C. The state of US health, 1990-2010: burden of diseases, injuries, and risk factors. JAMA. 2013; 310(6), 591 608. doi:10.1001/jama.2013.13805
REFERENCES, CONT D. Teater D. National Safety Council. Evidence for the efficacy of pain medications. http://safety.nsc.org/painmedevidence. Published 2014. Accessed September 16, 2016. Substance Abuse and Mental Health Services Administration: Center for Behavioral Health Statistics and Quality. Behavioral health trends in the United States: Results from the 2014 National Survey on Drug Use and Health. http://www.samhsa.gov/data/sites/default/files/nsduh-frr1-2014/nsduh-frr1-2014.pdf. Published September 2015. Accessed September 16, 2016. Radcliff K, Freedman M, Hilibrand A, et al. Does opioid pain medication use affect the outcome of patients with lumbar disc herniation? Spine. 2013; 38(14): 849 860. doi:10.1097/brs.0b013e3182959e4e. Reuben DB, Alvanzo AA, Ashikaga T, et al. National Institutes of Health Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain. Annals of Internal Medicine. 2015; 162:295-300. doi:10.7326/m14-2775.
REFERENCES, CONT D. U.S. General Accounting Office: Prescription Drugs: OxyContin Abuse and Diversion and Efforts to Address the Problem (GA0-04- 110), Washington, DC, U.S. General Accounting Office, 2004. http://www.gao.gov/new.items/d04110.pdf. Accessed September 16, 2016. United States Department of Justice. Office of the Deputy Attorney General. Pharmaceutical Marketing Fraud Under the False Claims Act. https://www.justice.gov/sites/default/files/usao/legacy/2009/0 1/29/usab5701.pdf. November 7, 2008. Accessed September 16, 2016. Volkow ND & McLellan AT. Opioid Abuse in Chronic Pain Misconceptions and Mitigation Strategies. N Engl J Med. 2016; 374:1253-1263. doi: 10.1056/NEJMra1507771 Van Zee A. The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy. Am J Public Health. 2009; 99(2): 221 227. doi: 10.2105/AJPH.2007.131714.
RESOURCES American Society of Addiction Medicine(ASAM): www.asam.org/ Centers for Disease Control and Prevention: www.cdc.gov/ Centers for Disease Control, storage and disposal guidelines: www.cdc.gov/homeandrecreationalsafety/poisoning/pr eventiontip.htm Mississippi Professionals Health Program: www.msphp.com National Institute on Drug Abuse(NIDA): www.nida.nih.gov/infofacts/painmed.html
RESOURCES Office of National Drug Control Policy(ONDCP): ww.whitehousedrugpolicy.gov/drugfact/index.html Physicians for Responsible Opioid Prescribing: http://www.supportprop.org Scott Hambleton, MD; Medical Director, Mississippi Professionals Health Program; 408 West Parkway Place, Ridgeland, MS, 39157. (601)420-0240. shambleton@msphp.com Substance Abuse & Mental Health Services Administration(SAMHSA) www.samhsa.gov/ US Drug Enforcement Agency(DEA): www.usdoj.gov/dea