ResponsiblePrescribing Practices         April 10-12, 2012  Walt Disney World Swan Resort
Learning Objectives:1. Describe how cautious, evidence-basedprescribing practices can lower opioid-relatedoverdose deaths ...
Disclosure Statement•  All presenters for this session, Dr. Rollin   M. Gallagher, Dr. Andrew Kolodny, and   Robert Sproul...
The Opium Poppy Papaver Somniferum
Crude Opium Latex on Poppy Head
Opioids•    Morphine•    Codeine•    Heroin•    Hydrocodone (Vicodin, Lortab)•    Methadone•    Oxycodone (Percodan, Oxyco...
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)
Characteristics of opioid-addicted, treatment-seeking patients
Rates of ED visits for nonmedical use of selected             opioid analgesics increased significantly in the US         ...
Number of of drug-induced deaths compared with Number drug-induced deaths compared with other types               of death...
Unintentional Drug Overdose Deaths                    United States, 1970–2007                                 36,450 drug...
Unintentional overdose deaths involving opioid  analgesics parallel per capita sales of opioidanalgesics in morphine equiv...
Dollars Spent Marketing OxyContin (1996-2001)Source: United States General Accounting Office: Dec. 2003, OxyContin Abuse a...
Industry-influenced Education on Opioidsfor Chronic Non-Cancer Pain Emphasizes:•  Opioid addiction is rare in pain patient...
Photo taken at the The 7th International Conference  on Pain and Chemical Dependency, June 2007
Federation of State Medical Boards     of the United States, IncModel Policy for the Use of Controlled Substances for the ...
The Emperor s New Paradigm:Patient Selection, Risk Stratification & Monitoring
?           Chronic Opioid Therapy Guidelines                                     Trial of Opioid Therapy                 ...
Stratify Risk            Low Risk                       Moderate Risk          High Risk       •  No past/current         ...
Clozapine vs Opioids         Comparison of methods for preventing serious adverse events                                 C...
Prevalence of Misuse, Abuse,               and Addiction          Misuse 40%         Abuse: 20%                           ...
Monitoring Aberrant Drug-taking           Behaviors•  Probably more                              •  Probably less   predic...
Urine Tox Results in Chronic Pain Patients on Opioid Therapy Source: Couto JE, Goldfarb NI, Leider HL, Romney MC, Sharma S...
Controlling the epidemic:         A Three-pronged Approach•  Primary Prevention- prevent new cases of   opioid addiction• ...
Develop and Implement a Standard of Care       Opioid Prescribing in 2012-The Wild West
Opioid Prescribing Rules• Require urine toxicology for all patients receiving long-term opioid therapy• Require a physical...
Limit Pharma Influence•  Prohibit drug rep detailing for opioids•  Consider legal action against opioid   manufacturers•  ...
Summary•  The United States is facing a public health crisis   fueled by overprescribing of opioids.•  Prescribers and the...
Questions?
Andrew Kolodny
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Andrew Kolodny
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Andrew Kolodny
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Andrew Kolodny

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Responsible Prescribing Practices
National Rx Drug Abuse Summit 4-11-12

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Andrew Kolodny

  1. 1. ResponsiblePrescribing Practices April 10-12, 2012 Walt Disney World Swan Resort
  2. 2. Learning Objectives:1. Describe how cautious, evidence-basedprescribing practices can lower opioid-relatedoverdose deaths while maintaining appropriateaccess for medically needed treatment of chronicpain.2. Identify “best practice” strategies that can beused by clinicians for pain management treatment.3. Explain evidence-based practice and policies forprovider education and patient educationprograms being utilized across the US.
  3. 3. Disclosure Statement•  All presenters for this session, Dr. Rollin M. Gallagher, Dr. Andrew Kolodny, and Robert Sproul, have disclosed no relevant, real or apparent personal or professional financial relationships.
  4. 4. The Opium Poppy Papaver Somniferum
  5. 5. Crude Opium Latex on Poppy Head
  6. 6. Opioids•  Morphine•  Codeine•  Heroin•  Hydrocodone (Vicodin, Lortab)•  Methadone•  Oxycodone (Percodan, Oxycontin)•  Hydromorphone (Dilaudid)•  Meperidine (Demerol)
  7. 7. Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
  8. 8. Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
  9. 9. Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
  10. 10. Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
  11. 11. Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
  12. 12. Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
  13. 13. Characteristics of opioid-addicted, treatment-seeking patients
  14. 14. Rates of ED visits for nonmedical use of selected opioid analgesics increased significantly in the US 40 35 2004 2005 2006 2007 2008ED 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.
  15. 15. Number of of drug-induced deaths compared with Number drug-induced deaths compared with other types of deaths, US, 1999-2006other types of deaths, US, 1999-2006
  16. 16. Unintentional Drug Overdose Deaths United States, 1970–2007 36,450 drug overdose deaths in 2008 Cocaine Heroin Year National Vital Statistics System, http://wonder.cdc.gov25
  17. 17. Unintentional overdose deaths involving opioid analgesics parallel per capita sales of opioidanalgesics in morphine equivalents by year, U.S., 1997-2007 * Number of Opioid sales (mg/ Deaths person)Source: National Vital Statistics System, multiple cause of death dataset, and DEA ARCOS* 2007 opioid sales figure is preliminary.
  18. 18. Dollars Spent Marketing OxyContin (1996-2001)Source: United States General Accounting Office: Dec. 2003, OxyContin Abuse and Diversion andEfforts to Address the Problem.
  19. 19. Industry-influenced Education on Opioidsfor 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.
  20. 20. Photo taken at the The 7th International Conference on Pain and Chemical Dependency, June 2007
  21. 21. Federation of State Medical Boards of the United States, IncModel Policy for the Use of Controlled Substances for the Treatment of Pain Federation of State Medical Boards House of Delegates, May 2004. http://fsmb.org. Accessed March 2010.
  22. 22. The Emperor s New Paradigm:Patient Selection, Risk Stratification & Monitoring
  23. 23. ? Chronic Opioid Therapy Guidelines Trial of Opioid Therapy Patient Reassessment Continue Opioid Implement Exit Strategy TherapyChou R, et al. J Pain. 2009;10:113-130.*Clinician accepting primary responsibility for a patient s overall medical care.
  24. 24. Stratify Risk Low Risk Moderate Risk High Risk •  No past/current •  History of treated •  Active substance history of substance abuse abuse substance abuse •  Significant family •  Active addiction •  Noncontributory history of •  Major untreated family history of substance abuse psychological substance abuse •  Past/comorbid disorder •  No major or psychological •  Significant risk disorder untreated to self and psychological practitioner disorderWebster LR, Webster RM. Pain Med. 2005;6:432-442.
  25. 25. Clozapine vs Opioids Comparison of methods for preventing serious adverse events Clozapine for Opioids for Schizophrenia Chronic PainEvidence-Based Treatment Yes NoAdverse Event (AE) Agranulocytosis AddictionRisk(%) 1% 25%Routine lab monitoring Weekly WBCs Urine ToxicologyMonitoring can prevent AE Yes NoPatient Registry Yes No
  26. 26. Prevalence of Misuse, Abuse, and Addiction Misuse 40% Abuse: 20% Total Pain Addiction: 2% to 5% PopulationWebster LR, Webster RM. Pain Med. 2005;6(6):432-442.
  27. 27. Monitoring Aberrant Drug-taking Behaviors•  Probably more •  Probably less predictive predictive –  Selling prescription drugs –  Aggressive complaining about need for higher doses –  Prescription forgery –  Drug hoarding during periods of –  Stealing or borrowing another reduced symptoms patient s drugs –  Requesting specific drugs –  Injecting oral formulation –  Acquisition of similar drugs from –  Obtaining prescription drugs from other medical sources non-medical sources –  Unsanctioned dose escalation –  Concurrent abuse of related illicit 1–2 times drugs –  Unapproved use of the drug to –  Multiple unsanctioned dose treat another symptom escalations –  Reporting psychic effects not –  Recurrent prescription losses intended by the clinician Portenoy 1998Passik and Portenoy, 1998.
  28. 28. 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.
  29. 29. 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 over- prescribing and black-market availability
  30. 30. Develop and Implement a Standard of Care Opioid Prescribing in 2012-The Wild West
  31. 31. Opioid Prescribing Rules• Require urine toxicology for all patients receiving long-term opioid therapy• Require a physical exam and documentation thatalternative treatments have failed• Set dosing limits to prevent high dose prescribing• Require screening for addiction before & duringtreatment• Require screening for depression before initiatingtherapy• Mandate training in pain and addiction
  32. 32. Limit Pharma Influence•  Prohibit drug rep detailing for opioids•  Consider legal action against opioid manufacturers•  Advocacy with FDA: –  to limit approval of new opioids –  Up-schedule hydrocodone combos (Vicodin) –  Label changes for all opioids
  33. 33. 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.
  34. 34. Questions?
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