1. ResponsiblePrescribing Practices April 10-12, 2012 Walt Disney World Swan Resort
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. 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.
7. Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
8. Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
9. Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
10. Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
11. Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
12. Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
13. Characteristics of opioid-addicted, treatment-seeking patients
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. 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. 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. 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. Dollars Spent Marketing OxyContin (1996-2001)Source: United States General Accounting Office: Dec. 2003, OxyContin Abuse and Diversion andEfforts to Address the Problem.
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. Photo taken at the The 7th International Conference on Pain and Chemical Dependency, June 2007
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. The Emperor s New Paradigm:Patient Selection, Risk Stratification & Monitoring
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. 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. 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. 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. 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. 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. 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. Develop and Implement a Standard of Care Opioid Prescribing in 2012-The Wild West
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. 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. 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.