Prescription Medication Abuse : The Silent Epidemic

1. Prescription Medication Abuse :The Silent Epidemic Sanford M. Silverman, MD CEO, Comprehensive Pain Medicine Pompano Beach, Florida

2. Disclaimer Sanford Silverman,MD Medical Director, Comprehensive Pain Medicine, Pompano Beach, FL Member: ASIPP, AAPM, FAPM, FSIPP, ASAM, FSAM, FMA, BCMA Officer/ Board Position: Vice president FSIPP, member at large FAPM, Broward County Commission on Substance Abuse, Board of Directors BCMA Publications: Articles in Anesthesiology, Canadian Journal of Anesthesia, Pain Physician No outside funding, No Grants, No Industrial support. Speaker Reckitt Benckiser

3. Objectives • Discuss Pain and Addiction and as co-morbid disease states • Discuss Epidemiology of Prescription Drug Abuse • Discuss guidelines for prescribing opioids, Prescription Drug Monitoring Plans

4. Pain and Addiction as Disease States

5. Pain DEFINITION: an unpleasant sensory & emotional experience associated with actual tissue damage or described in terms of such damage. IASP task force on pain

6. Analgesia and the Pain Pathway Opioids 2 agonists Centrally acting analgesics COX-2–specific inhibitors Traditional NSAIDs Pain Ascending signals input Descending modulation Local anesthetics Opioids 2 agonists Dorsal horn Dorsal root ganglion Adapted from Gottschalk A, Smith DS. Am Fam Physician. 2001;63:1979-84. Spinothalamic tract Local anesthetics AEDs Local anesthetics Corticosteroids Traditional NSAIDs Cox-2–specific inhibitors Substance P inhibitors Opioids Baclofen Clonidine Peripheral nociceptors Peripheral nerve Trauma

7. Addiction … a primary, chronic, neurobiological disease, with genetic, psychosocial, and environmental factors influencing the development and manifestations. It is characterized by behaviors that include one or more of the following: • Impaired control over drug use • Compulsive use • Continued use despite harm • Craving (ASAM, 2001)

9. Pain and Addiction • Problem • Pain and Addiction CAN coexist • SO DOES Pain and Depression (reduced hedonic tone) • Addiction in General Population (6-15%) • Varies with the drug, gender, economic status, race • Addiction in Chronic Pain Population • Probably increased (at least 15%) • We use the same terms, with different meaning • Lack of precision in definitions around • abuse/dependency/addiction

10. The Nexus Of Pain And Addiction Is A Major Contributor To Current Epidemic • High risk • costs • Prescription abuse • Morbidity & Mortality

11. Epidemiology: Pain , Prescription Opioid Abuse

12. PAIN FACTS • Pain costs $150 billion annually • 65 Million Americans suffer painful disability • 90% of all diseases noticed due to pain • Untreated pain results in unemployment • Untreated pain associated with alcohol and medication abuse • 90% of patients in US pain clinics are taking opioid analgesics

13. Factors Responsible For Increased Demand In Managing Chronic Pain • Pharmaceutical companies marketing • Numerous organizations providing guidelines • Patient advocacy groups • Enactment of Patient’s bill of rights in many states • Unproven regulations by JCAHO misunderstood by media and public • Perceived patient’s right to pain relief • Increased availability to internet • “Pill Mills” • High street value of prescription drugs • Perceived legitimacy and safety prescription drugs (pharm parties)

14. Prescription Opioid Abuse • Has always existed • Recent explosive increase parallels that of demand for pain management • Paradigm shift in 1990’s to aggressively treat pain • Pain is the 5th vital sign • Epidemic is the byproduct of compassion and fundamental lack of understanding of complex nature of pain and nexus of chemical dependency

15. Drug Diversion • Doctor Shopping • Internet Sales • Drug Theft • Improper prescribing • Sharing amongst family and friends • Diversion and abuse of Methadone

16. Criminal Justice17% $1.4 billion $4.6 billion $2.6 billion Workplace53% Health Care30% Prescription Opioid Abuse Is a Significant and Costly Public Health Problem Total cost of prescription opioid abuse in the United States was $8.6 billion in 2001 and continues to grow. Birnbaum HG et al. Clin J Pain. 2006;22:667-676.

17. Annual Numbers of New Nonmedical Users of Pain Relievers, by Age at Initiation: 1965-2003, SAMHSA

18. Drug Mortality Rate, Source, and Misuse of Prescription Drugs: Data from the 2002, 2003, and 2004 National Surveys on Drug Use and Health, SAMHSA

19. Increase in New Starts of Prescription Opioid Abuse Among Teenagers 700 600 500 400 300 200 100 0 542%—Incidence of new starts of prescription opioid abuse among teenagers Percent Increase 212%----Number of 12-17 year olds abusing CS 150%—Prescriptions written for controlled substances 81%---Adults abusing controlled substances 14%—US population 1992 2003 Adapted from Manchikanti L. Pain Physician. 2006;9:287-321.

20. Past Year Users of Selected Drugs (Prevalence), Including Nonmedical Users of Prescription Psychotherapeutic Drugs: Annual Averages Based on 2002-2004 SAMHSA

21. Past Year Initiates (Incidence) of Illicit Drug Use, by Drug: Annual Averages Based on 2002-2004 (12 or older, 2002-2004) SAMHSA

22. Annual number of new non-medical users of Oxycontin

23. Oxycodone Hydrocodone 42,810 (26.7%) 51,225 (32%) 15,183 (9.5%) Morphine 9,160 (5.7%) 41,216 (25.7%) Methadone Fentanyl Drug-Related Emergency Department Visits With Nonmedical Use of Opioid Analgesics (DAWN) Total = 598,542 Narcotic analgesics alone = 160,363 Adapted from the Drug Abuse Warning Network. DHHS Publication No. 07-4256, 2007. • 1 out of 3 visits were from nonmedical use of opioid analgesics in 2005. • Of these, oxycodone and hydrocodone account for about 60%.

24. DAWN Comparison2004 V. 2005 Adapted from the Drug Abuse Warning Network. DHHS Publication No. 07-4256, 2007.

25. Role of Physicians in Prescription Drug Abuse The 5 D’s • Dated: doctors who have not kept up with standards of practice • Duped: doctors easily manipulated by addicts, perhaps of difficulty in confronting patients, pride • Disabled: doctors who are impaired by illness or chemical dependency • Dishonest: doctors who willfully prescribe and use their licenses to deal drugs • Denial: doctors who refuse to admit that they are wrong, “I know what I am doing” Principles of Addiction Medicine, 3rd Ed, 2005

26. CASA (The National Center on Addiction and Substance Abuse at Columbia University) 20050f 979 physicians • Lack of Awareness • <20% received any medical school training in identifying prescription drug diversion • <40% received any training in medical school in identifying prescription drug abuse and addiction • Inadequate Risk Management • 43% do not ask about prescription drug abuse as part of patient history • 33% do not request records from previous health care providers for new patients • Inadequate Treatment of Patients • 74% have not prescribed a controlled substance due to concern about patient abuse in the past year

27. OPIOID THERAPY FOR CHRONIC PAIN ?

28. Guidelines and Prescribing Principles for Opioid Therapy

29. PAIN MANAGEMENT ≠ OPIOID DISPENSING

30. Universal Precautions in Pain Medicine 1. Diagnosis with appropriate differential 2. Psychological assessment including risk of addictive disorders 3. Informed consent (verbal v. written/signed) 4. Treatment agreement (verballv.written/signed) 5. Pre/Post Intervention Assessment of Pain Level and Function Heit, Gourlay, Pain Medicine; 6,2005. Universal Precautions in Pain Medicine:A Rational Approach to the Treatment of Chronic Pain

31. Universal Precautions in Pain Medicine (cont’d) 6. Appropriate trial of opioid therapy +/- adjunctive medication 7. Reassessment of pain score and level of function 8. Regularly assess the “Four A’s” of pain medicine : Analgesia, Activity, Adverse reactions, Aberrant behavior 9. Periodically review pain diagnosis and co-morbid conditions, including addictive disorders 10. Documentation

32. Assessment Benefit-Risk: New Paradigms in Chronic Pain Treatment Efficacy • Goal of therapyis pain relief and improved function GOOD PRACTICE Abuse Potential Safety • Long vs short acting • Level of difficulty to alter • delivery system • Street value • Predictable • pharmacokinetics • Evaluate interaction • with alcohol

33. X “High” (Euphoria) Pain Control Establish Treatment Goals • Set realistic patient expectations for analgesia and functionality • Smart goals • Realistic pain control • Improved functionality and productivity • Improved quality of life • Concomitant physical therapy to improve treatment outcomes • Commit the patient to routine evaluation of treatment outcomes • Pain relief • Physical and psychosocial function • Commit the patient to monitoring and routine follow-up Adapted from Trescot AM et al. Pain Physician. 2006;9:1-40.

34. Return Periodically and Review Outcomes Review comorbidities and pain diagnosis periodically Success—continue therapy Failure—discontinue therapy • Despite dose escalation or switching • to other opioids • Inadequate analgesia • Inadequate improvement in function • Intolerable side effects • Abuse • Noncompliance • Stable doses • Analgesia: decreased pain level (pain score) • and increased level of function in • postintervention reassessment • No evidence or suspicion of abuse • No unmanageable side effects • Improved activity and quality of life Adapted from Trescot AM et al. Pain Physician. 2006;9:1-40.

35. PAIN MANAGEMENT = RATIONAL POLYPHARMACY Ongoing PT, Psych, interventional mgt.

36. Prescription Drug Monitoring

37. Prescription Drug Monitoring Systems • Database designed to track controlled substances • Available to practitioners, pharmacies and law enforcement • Experience shows diversion can be reduced up to 33% • Reduced hours for law enforcement for prosecutions • States without PDMP show increased diversion and prescription abuse that states without Manchikanti L. Pain Physician. 2006;9:287-321.

38. NASPER • National All Schedule Prescription Electronic Reporting Act was signed into law by President Bush August 11, 2005 • Currently unfunded • Modeled after Kentucky (KASPER) Florida Society of Interventional Pain Physicians

39. Source: Broward County Commission on Substance Abuse, United Way, 2008.

40. Percent of KASPER report requests by type Manchikanti L. Pain Physician. 2006;9:287-321.

41. 100 Monitor : Impact of Adherence Monitoring: A Prospective Evaluation Study I (2003)1 Study II (2006)2 N=500 N=500 17.8 Patients Abusing Controlled Substances (%) 9 Adherence Monitoring No Adherence Monitoring 1. Manchikanti L et al. J Ky Med Assoc. 2003;101:511-517. 2. Manchikanti L et al. Pain Physician. 2006;9:57-60.

42. The Florida Experience • In 2007, average of 9 daily lethal overdoses (11 daily as of end of 2008) • 3317 of prescription overdose deaths were 70% of total drug deaths in 2007 • Over 700,000 Floridians misuse prescription pain meds yearly • Top 25 US dispensing practitioners of oxycodone are all in Florida • Florida is the largest state without a Prescription Drug Monitoring Program (PDMP) • Florida has become a major distribution center for opioids and benzodiazepines Source: Broward County Commission on Substance Abuse, United Way, 2008.

43. Factors Contributing to Opioid Over-Prescribing in Florida • Lack of prescription drug monitoring program in Florida • The infiltration of “pill-mills” • Lack of understanding of comprehensive pain management • Lack of physician education of opioid pharmacology and addiction medicine • Lack of Opioid Risk Management protocols1 Heit, Gourlay, Pain Medicine; 6,2005. Universal Precautions in Pain Medicine:Rational Approach to the Treatment of Chronic Pain

44. Source, Automation of Reports and Consolidated Orders System ( ARCOS) data, Broward County Commission on Substance Abuse, United Way 2008

45. Current Legislation in Florida • SB 462/440 (Fasano) passed health care committee unanimously 3/4/2009 • HB 1015/1017 (Kelly) • HB 937 (Lorente) • HB 143 (Domino) requires biometric scanning • HB 583 (Skidmore)

46. References Manchikanti L. Pain Physician. 2006;9:287-321.Prescription Drug Abuse: What is being done to address this new drug epidemic? Testimony before the subcommittee on Criminal Justice, Drug Policy and Human Resources Broward County Commission on Substance Abuse, United Way, 2008. Heit, Gourlay, Pain Medicine; 6,2005. Universal Precautions in Pain Medicine:A Rational Approach to the Treatment of Chronic Pain Principles of Addiction Medicine, 3rd Ed, 2005 Adapted from the Drug Abuse Warning Network. DHHS Publication No. 07-4256, 2007 Misuse of Prescription Drugs: Data from the 2002, 2003, and 2004National Surveys on Drug Use and Health, SAMHSA Manchikanti et al, Pain Physician. 2006; 9: 123-129. Does Random Urine Drug Testing Reduce Ilicit Drug Use in Chronic Pain patients receiving opioids? Trescot et al. Pain Physician. 2008: Opioids Special Issue: S5-S62. Opioids in the Management of Chronic Non-Cancer Pain: An Update of American Society of the Interventional Pain Physicians’(ASIPP) Guidelines