Overview of the Opioid Analgesic Epidemic

Overview of the Opioid Analgesic Epidemic Putnam County, MD September 14th, 2012, Andrew Kolodny, M.D. Chair, Department of Psychiatry Maimonides Medical Center Brooklyn, New York

Presentation Outline I. Past opioid epidemics II. Current epidemic III. Reasons for the current epidemic IV. The chronic pain controversy V. Strategies to control the epidemic

The Opium Poppy Papaver Somniferum

The Opium Poppy Papaver Somniferum

Crude Opium Latex on Poppy Head

Opioids Morphine Codeine Heroin Hydrocodone (Vicodin, Lortab) Methadone Oxycodone (Percodan, Oxycontin) Hydromorphone (Dilaudid) Meperidine (Demerol)

In 1804, Frederich Serturner isolated an alkaloid base from opium which he called Morphium (after the Greek god of sleep and dreams, Morpheus).

Winslow's Soothing Syrup for infants Active Ingredient: Morphine

1889 Opinion Survey of 180 Druggists in Massachusetts regarding economic/social status of opioid-addicted customers Opioid-addicted customers are from All classes 22% The upper class 22% The middle class 3% The lower class 6% The Sale and Use of Opium in Massachusetts, 1889 Annual Report of the Massachusetts Board of Health, as reported in The American Disease by DF Musto, 1973

THE HYPODERMIC SYRINGE

Heroin Discovered in 1878 Synthesized by mixing morphine with acetic anhydride (an acid) and heating up the mixture Bayer s name heroin believed to derive from the German word heroisch Thought to be a non-addictive alternative to morphine

Mulberry Street in New York City 1900

Harrison Act of 1914 Required all persons who dealt in or prescribed opium or opium derivatives to register with the IRS, pay special taxes and keep records of their transactions Treasury Department (Bureau of Internal Revenue) interpretation was that it was unlawful for a physician to prescribe an opioid to treat addiction

Charlie Parker 1920-1955

Source: The New York Times Magazine, June 5, 1977

Source: New York Magazine, August 14th 2000

Prior Opioid Abuse Epidemics 1. Late 1800s: Morphine Mainly middle class Female > Male 2. Early 1900s: Heroin (pharmaceutical grade) First generation Italians, Jews, Irish Male > Female 3. 1960s-1970s- Heroin (illicit) African American/Latinos > White Male > Female

Past Year Initiates among Persons Aged 12 or Older: 2007 Source: SAMHSA Office of Applied Studies (2007)

Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)

Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)

Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)

Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)

Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)

Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)

80000 Opioid Analgesic Treatment Admissions: U.S. 70000 60000 50000 40000 30000 20000 10000 0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 Substance Abuse and Mental Health Services Administration, Office of Applied Studies. Treatment Episode Data Set (TEDS) Highlights - - 2007 National Admissions to Substance Abuse Treatment Services. OAS Series #S-45, HHS Publication No. (SMA) 09-4360, Rockville, MD, 2009.

Characteristics of opioid-addicted, treatment-seeking patients

Rates of ED visits for nonmedical use of selected opioid analgesics increased significantly in the US 40 35 2004 2005 2006 2007 2008 ED visits per 100,000 population 30 25 20 15 10 * * * * * * 5 0 * * * * Fentanyl Hydrocodone Hydromorphone Methadone Morphine Oxycodone * Indicates a rate that was significantly less than the rate in 2008. Note: Drug types include combination products, e.g, combinations of oxycodone and aspirin.

Number of of drug-induced deaths deaths compared compared with other with types of deaths, US, 1999-2006 other types of deaths, US, 1999-2006

Motor vehicle traffic, poisoning, and drug poisoning death rates of all intents, U.S., 1980-2009 Source: NCHS Data Brief, December, 2011, updated with 2009 mortality data. Some overdose deaths were not included in the total for 2009 because of delayed reporting of the final cause of death. The reported 2009 numbers are underestimates. 39

Overdose deaths of all intents by major drug type, U.S., 1999-2009 Number of deaths 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 Opioid analgesic Cocaine Heroin 99 00 01 02 03 04 05 06 07 08 09 Source: National Vital Statistics System 40

Unintentional overdose deaths involving opioid analgesics parallel per capita sales of opioid analgesics in morphine equivalents by year, U.S., 1997-2007 14000 12000 10000 8000 6000 4000 2000 0 Number of Deaths '97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07 * Opioid sales (mg/person) 800 700 600 500 400 300 200 100 0 Source: National Vital Statistics System, multiple cause of death dataset, and DEA ARCOS * 2007 opioid sales figure is preliminary.

Drug overdose deaths of all intents by type of opioid involved, US, 1999-2009 Number of deaths 12,000 10,000 8,000 6,000 Hydrocodone, oxycodone, morphine, codeine, hydromorphone, et al. Methadone 4,000 2,000 0 Fentanyl, meperidine, propoxyphene, buprenorphine, et al 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Some overdose deaths were not included in the total for 2009 because of delayed reporting of the final cause of death. The reported 2009 numbers are underestimates.

Unintentional Drug Overdose Deaths United States, 1970 2007 10 9 36,450 drug overdose deaths in 2008 8 Death rate per 100,000 7 6 5 4 3 2 Heroin Cocaine 1 0 '70 '72 '74 '76 '78 '80 '82 '84 '86 '88 '90 '92 '94 '96 '98 '00 '02 '04 '06 Year National Vital Statistics System, http://wonder.cdc.gov 43

Heroin Treatment Admissions: Age & Race, 1999-2009

Dollars Spent Marketing OxyContin (1996-2001) Source: United States General Accounting Office: Dec. 2003, OxyContin Abuse and Diversion and Efforts to Address the Problem.

Total Sales & Prescriptions for OxyContin (1996-2002) Source: United States General Accounting Office: Dec. 2003, OxyContin Abuse and Diversion and Efforts to Address the Problem.

Industry-influenced Education on Opioids for Chronic Non-Cancer Pain Emphasizes: Opioid addiction is rare in pain patients. Physicians are needlessly allowing patients to suffer because of opiophobia. Opioids are safe and effective for chronic pain. Opioid therapy can be easily discontinued.

Only four cases of addiction among 11,882 patients treated with opioids. Porter J, Jick H. Addiction rare in patients treated with narcotics. N Engl J Med. 1980 Jan 10;302(2):123 Cited 693 times (Google Scholar)

N Engl J Med. 1980 Jan 10;302(2):123.

Heroin compared to prescription opioids Peak ratings for I feel high similar for heroin, morphine and oxycodone. Subjects willing to pay $10-15 for highest dose of heroin, morphine and oxycodone. Buprenorphine had highest I feel bad drug effect. Comer et al. Abuse Liability of Prescription Opioids Compared to Heroin in Morphine-Maintained Heroin Abusers. Neuropsychopharmacology (2008) 33, 1179 1191

Photo taken at the The 7th International Conference on Pain and Chemical Dependency, June 2007

Federation of State Medical Boards Model Policy for the Use of Controlled Substances for the Treatment of Pain Distributed by 21 state medical boards to over 150,000 clinicians. The book s sponsors include: Abbott Laboratories Alpharma Pharmaceuticals LLC Cephalon, Inc. Endo Pharmaceuticals King Pharmaceuticals Purdue Pharma L.P. Federation of State Medical Boards House of Delegates, May 2004. http://fsmb.org. Accessed March 2010.

I think that after 20 years of a failed experiment that there are not many people supporting this except for the die-hards and the pharmaceutical industry. Jane C. Ballantyne, MD FRCA Professor, Univ. of Washington Source: New York Times, April 9, 2012. Tightening the Lid on Pain Prescriptions.

The Emperor s New Paradigm: Patient Selection, Risk Stratification & Monitoring

Clozapine vs Opioids Comparison of methods for preventing serious adverse events Clozapine for Schizophrenia Opioids for Chronic Pain Evidence-Based Treatment Yes No Adverse Event (AE) Risk(%) Agranulocytosis 1% Addiction 25% Routine lab monitoring Weekly WBCs Urine Toxicology Monitoring can prevent AE Yes No Patient Registry Yes No

Urine Tox Results in Chronic Pain Patients on Opioid Therapy Source: Couto JE, Goldfarb NI, Leider HL, Romney MC, Sharma S. High rates of inappropriate drug use in the chronic pain population. Popul Health Manag. 2009;12(4):185 190.

Controlling the epidemic: A Three-pronged Approach Primary Prevention- prevent new cases of opioid addiction. Secondary Prevention- provide people who are addicted with effective treatment. Supply control- collaborate with law enforcement, DEA and OPMC to overprescribing and black-market availability.

Develop and Implement a Standard of Care Opioid Prescribing in 2012-The Wild West

Opioid Prescribing Rules Require urine toxicology for all patients receiving longterm opioid therapy. Require a physical exam and documentation that alternative treatments have failed. Set dosing limits to prevent high dose prescribing. Require screening for addiction before & during treatment. Require screening for depression before initiating therapy. Mandate training in pain and addiction.

Opioid manufacturers advertise opioids as safe and effective for chronic pain.

FDA permits drug manufacturers to advertise opioids as safe and effective for chronic pain.

Summary The United States is facing a public health crisis fueled by overprescribing of opioids. Prescribers and the public need to be better informed about risks of opioid use/misuse. Interventions to bring this epidemic under control are within our grasp.

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