Managing Difficult Issues Regarding Patient Prescription Drug Abuse: An Educational Program for Emergency Physicians

1. "Managing Difficult Issues Regarding Patient Prescription Drug Abuse: An Educational Program for Emergency Physicians" Maine ACEP Chapter Grant Project Coordinator Michael Gibbs and Tamas Peredy, MD

2. Program Description Maine ACEP proposes to hold five three-hour educational programs for Maine�s emergency physicians on the issue of patient diversion of drugs for street use over the course of the 18-month grant period in 2009/2010 at various rural locations across the state. Objectives 1. Increase clinician awareness of the issues surrounding opioid misuse including risk of oligoanalgesia, factors that may identify high risk patients and rights and responsibilities of law enforcement reporting. 2. Increase enrollment in the Maine�s Electronic Web-based Prescription Monitoring Program. 3. Share evidence-based Pain Management Policies and Protocols.

3. Conference Speakers Maine ACEP Michael Gibbs, MD, FACEP Tamas Peredy, MD, FACEP Maine Medical Association Gordon Smith, ESQ, Andrew MacLean, ESQ Maine OSA/Prescription Monitoring Program Daniel Eccher, MPH, Stacey Chandler, Anne Rogers, M Ed, Maine DEA Officers Chris Gardner, James Pease, Lowell Woodman, Kevin Cashman, Gerry Baril

4. Special Thanks to Anna Bragdon Chapter Executive, MACEP Maine Medical Center Hannaford Center for Safety, Innovation and Simulation Marcella Sorg, PhD Margaret Chase Smith Policy Center University of Maine Scott Kemmerer, MD Immediate Past President MACEP

5. Conference Sites Pilot Programs: Portland 10/16/2008 Bangor 3/12/2009 Augusta/Waterville 3/31/2011 Orono 4/12/2011 Lewiston/Auburn 4/21/2011 Topsham 4/27/2011 Biddeford 4/28/2011

6. Hannaford Center for Safety, Innovation and Simulation Department of Medical Education 4 Case scenarios 1) Ankle Fx in chronic pain pt, 2) Forged script with back pain pt, 3) Migraine HA in drug seeker and 4) Dental pain with and without brief assessment Appeared in Scenarios Tamas Peredy, MD Michael Gibbs, MD Shelly Chipman, Todd Dadaleares and Susie Lane

7. Challenge Increased dispensation of opioids coupled with changing societal attitudes towards prescription opioids has contributed to our current pandemic of non-medical pain reliever misuse.

8. Response To develop a balanced approach to the proper distribution of pain medication to those in need while developing safeguards that reduce the amount of diversion.

9. General Articles McLellan AT, Turner B, Prescription Opioids, Overdose Deaths and Physician Responsibility, JAMA, 300(22): 2672-2673. MacCarberg BH, Balancing Patient Needs and Provider Responsibilities in the use of Opioids, P&T Digest, 32-38, 2006. Woodcock J, A Difficult Balance � Pain Management, Drug Safety and the FDA, NEJM, 361(22): 2105-2107.

10. Societies American College of Emergency Physicians American Society of Interventional Pain Physicians International Association for the Study of Pain American Pain Society American Academy of Pain Medicine SAMHSA 1. National Survey on Drug Use and Health (NSDUH) annual since 1990 formerly NHSDA 2. Drug and Alcohol Services Information Sys (DASIS) 3. Drug Abuse Warning Network (DAWN), SAMHSA NIH, NIDA Monitoring the Future Study (MTF) National Institute Alcohol Abuse and Alcoholism (NIAAA), CDC National Epidemiologic Survey Alcohol Related Conditions (NESARC) Youth Risk Behavior Survey Automation of Reports and Consolidated Orders System ARCOS http://www.deadiversion.usdoj.gov/index.html The National Center on Addiction and Substance Abuse at Columbia University (CASA) http://www.casacolumbia.org/absolutenm/templates/Home.aspx SAMHSA 1. National Survey on Drug Use and Health (NSDUH) annual since 1990 formerly NHSDA 2. Drug and Alcohol Services Information Sys (DASIS) 3. Drug Abuse Warning Network (DAWN), SAMHSA NIH, NIDA Monitoring the Future Study (MTF) National Institute Alcohol Abuse and Alcoholism (NIAAA), CDC National Epidemiologic Survey Alcohol Related Conditions (NESARC) Youth Risk Behavior Survey Automation of Reports and Consolidated Orders System ARCOS http://www.deadiversion.usdoj.gov/index.html The National Center on Addiction and Substance Abuse at Columbia University (CASA) http://www.casacolumbia.org/absolutenm/templates/Home.aspx

11. Oligoanalgesia in the Emergency Department Developed by Michael Gibbs, MD

13. Barriers to Adequate Analgesia Lack of Medical Provider Education Non-existence of Pain Treatment Quality Management Programs Lack of ED Pain Treatment Efficacy Studies (including pediatric, geriatric�) Clinician�s attitudes about addiction, drug-seeking Opiophobia � safety concerns relative to other modalities Unappreciated cultural and gender differences in pain reporting Racial and ethnic stereotyping

17. Oligoanalgesia Articles Todd KH, Samaroo N, Hoffman JR, Ethnicity as a Risk Factor for Inadequate Emergency Department, JAMA, 269: 1537-1539, 1993. Todd KH, Deaton Cm D�Adamo AP et al, Ethnicity and Analgesic Practice, Ann Emerg Med, 35(1): 11-16, 2000. Pletcher MJ, Kertesz SG, Kohn MA et al, Trends in opioid prescribing by race/ethnicity for patients seeking care in US emergency departments. JAMA. 299:70-78, 2009. Jones JS, Johnson K, McNinch M, Age as a Risk Factor for Inadequate Analgesia in the Emergency Department, Am J Emerg Med, 14:157-160, 1996. Brown JC, Klein EJ, Lewis CW, Emergency Department Analgesia for Fracture Pain, Ann Emerg Med, 42(2): 197-205, 2003. Rupp T, Delaney KA, Inadequate Analgesia in Emergency Medicine, Ann Emerg Med 43(4): 494-503, 2004. Alexander J, Manno M, Underuse of Analgesia in Very Young Pediatric Patients with Isolated Painful Injuries Ann Emerg Med, 41(5):617-622, 2003. Goldman RD, Crum D, Bromberg R et al, Analgesia Administration for Acute Abdominal Pain in the Pediatric Emergency Department, Pedi Emerg Care, 22(1):18-21, 2006. Pines JM, Hollander JE, Emergency Department Crowding is Associated with Poor Care for Patients with Severe Pain, Ann Emerg Med 51(1): 1-5, 2008. Decosterd I, Hugli O, Tamches E et al, Oligoanalgesia in the Emergency Department, Ann Emerg Med, 50(4): 462-471, 2007. Duignan M, Dunn V, Barriers to Pain Management in Emergency Departments, Emerg Nurse, 15(9): 30-34, 2008. Chan L, Winegard B, Attitudes and Behaviors Associated with Opioid Seeking in the Emergency Department, J Opioid Manage, 3(5): 244-248, 2007.

18. Pandemic of Prescription Misuse Excerpts from Presentation #2

19. Opioid Prescriptions Overall opioids 1997 50.7 M grams 2006 115.3 M grams 1997-2006 Methadone ?1117% Oxycodone ?732% Hydrocodone ?244% Supply US #1 world opioid consumption 2006 33,532 daily doses/M x 300M = 10M doses 20% received script for opioids per annum Demand 10-20% of ED patients have chemical dependency Isaacson JH, Case Western 5.1% used opioids non-medically (age >11) 11.3M (higher than other psychotherapeutics, heroin, cocaine, inhalants, hallucinogens�) Supply US #1 world opioid consumption 2006 33,532 daily doses/M x 300M = 10M doses 20% received script for opioids per annum Demand 10-20% of ED patients have chemical dependency Isaacson JH, Case Western 5.1% used opioids non-medically (age >11) 11.3M (higher than other psychotherapeutics, heroin, cocaine, inhalants, hallucinogens�)

20. Non-medical Use of Prescription Drugs NSDUH 2006 20.4 M (8.3% population) current illicit drug users 14.8 M (6%) THC 7 M (2.8%) Prescription Drugs 5.2 M pain relievers 2.4 M cocaine, 1 M hallucinogens Psychotherapeutic nonmedical use up 162% in 10 years (THC up 33%, cocaine up 61%Psychotherapeutic nonmedical use up 162% in 10 years (THC up 33%, cocaine up 61%

21. Drug Diversion Doctor shopping Wrote fake prescription Internet pharmacy $4B Stolen from doctor�s office/pharmacy Illicit script from Prescriber

22. 1. Reported Methods of Obtaining �Its nice to share� Figure 1. (left) Percentages of Reported Method** of Obtaining Prescription Pain Relievers for Their Most Recent Nonmedical Use in the Past Year among Persons Aged 18 to 25: 2005 NSDUH Figure 2. (right) Percentages of Reported Method*** of Obtaining Prescription Pain Relievers for Their Most Recent Nonmedical Use among Persons Aged 18 to 25 Who Were Dependent on or Abused Prescription Pain Relievers in the Past Year: 2005 NSDUH Figure 1. (left) Percentages of Reported Method** of Obtaining Prescription Pain Relievers for Their Most Recent Nonmedical Use in the Past Year among Persons Aged 18 to 25: 2005 NSDUH Figure 2. (right) Percentages of Reported Method*** of Obtaining Prescription Pain Relievers for Their Most Recent Nonmedical Use among Persons Aged 18 to 25 Who Were Dependent on or Abused Prescription Pain Relievers in the Past Year: 2005 NSDUH

23. Emergency Department Visits Drug Abuse Warning Network (DAWN) 2005 1.3 M visits drug use/misuse 196,000 visits opioids (?24% since 2004) >2/3rds multiple drugs

25. U.S. Crude Death Rate: Unintentional Drug Overdose Second only to motor vehicle crashes Nearly all �poisonings� attributable to drug abuse (pharmaceutical & illicit) Has been increasing since 1980s 1999-2004 increased 63% nationally Source: MMWR (2007) 56:93-96Second only to motor vehicle crashes Nearly all �poisonings� attributable to drug abuse (pharmaceutical & illicit) Has been increasing since 1980s 1999-2004 increased 63% nationally Source: MMWR (2007) 56:93-96

26. Unintentional Poisoning Deaths by Specific Drug TypeUS1999-2005 Unintentional drug poisoning mortality rates increased on average 5.3% per year from 1979 to 1990 and 18.1% per year from 1990 to 2002. The rapid increase during the 1990s reflects the rising number of deaths attributed to narcotics and unspecified drugs. Between 1999 and 2002, the number of opioid analgesic poisonings on death certificates increased 91.2%, while heroin and cocaine poisonings increased 12.4% and 22.8%, respectively. By 2002, opioid analgesic poisoning was listed in 5528 deaths-more than either heroin or cocaine. The increase in deaths generally matched the increase in sales for each type of opioid. The increase in deaths involving methadone tracked the increase in methadone used as an analgesic rather than methadone used in narcotics treatment programs. CONCLUSIONS: A national epidemic of drug poisoning deaths began in the 1990s. Prescriptions for opioid analgesics also increased in this time frame and may have inadvertently contributed to the increases in drug poisoning deaths.Unintentional drug poisoning mortality rates increased on average 5.3% per year from 1979 to 1990 and 18.1% per year from 1990 to 2002. The rapid increase during the 1990s reflects the rising number of deaths attributed to narcotics and unspecified drugs. Between 1999 and 2002, the number of opioid analgesic poisonings on death certificates increased 91.2%, while heroin and cocaine poisonings increased 12.4% and 22.8%, respectively. By 2002, opioid analgesic poisoning was listed in 5528 deaths-more than either heroin or cocaine. The increase in deaths generally matched the increase in sales for each type of opioid. The increase in deaths involving methadone tracked the increase in methadone used as an analgesic rather than methadone used in narcotics treatment programs. CONCLUSIONS: A national epidemic of drug poisoning deaths began in the 1990s. Prescriptions for opioid analgesics also increased in this time frame and may have inadvertently contributed to the increases in drug poisoning deaths.

27. Epidemiology Articles Paulozzi LJ, Ryan GW, Opioid Analgesics ad Rates of Fatal Drug Poisoning in the US, Am J Prev Med, 31(6): 506-511, 2006. Bailey JE, Campagna E, Dart RC et al, The Under recognized Toll of Prescription Opioid Abuse on Young Children, Ann Emerg Med, 2008. Hall AJ, Logan JE, Toblin RL et al, Patterns of Abuse Among Unintentional Pharmaceutical Overdose Fatalities, JAMA, 300(22): 2613-2620, 2008. McCabe SE, Cranford JA, Boyd CJ et al, Motives, Diversion and Routes of Administration Associated with Non-Medical Use of Prescription Opioids, Addict Behav, 32: 562-575, 2007.

28. Opioid Addiction TherapyHistory Harrison Narcotic Act 1914 Webb vs. United States 1919 Physicians could not prescribe narcotics for addiction Methadone Treatment for Opioid began 1964 (NYC) Narcotic Addict Treatment Act 1974 Federal Regulation SAMHSA CSAT ~15% addicts in a program, 150,000 participants Drug Addiction Treatment Act Oct 2000 Schedule II, III, IV medications for the detoxification or maintenance of opioid dependency FDA approval buprenorphine (+/- naloxone) Oct 2002 Schedule III drug for detoxification or maintenance of opioid dependency Office-based Opioid Treatment (OBOT)

30. Methadone Pharmacology Mu agonist, NMDA agonist Usual dosing 60-120 mg/ once per day High dose protocols (Strain, Shinderman) Analgesic action 4-8 hrs Elimination half-life 8-59 hrs Major metabolite EDDP metabolite QT prolongation (Black Box Warning) Krantz Ann Inter Med 2002 In one month in 2007, an estimated 5.2 million people 12 years of age or older used prescription pain relievers nonmedically.3 In 2006, there were approximately 57,000 emergency department visits for nonmedical use of hydrocodone or hydrocodone combinations, 65,000 for nonmedical use of oxycodone or oxycodone combinations, and 45,000 for nonmedical use of methadone An analysis of poison-control data from 2003 through 2006 identified 9179 children who were inadvertently exposed to prescription opioids. The median age of the children was 2 years, and 92% of the poisonings occurred in the child's home In one month in 2007, an estimated 5.2 million people 12 years of age or older used prescription pain relievers nonmedically.3 In 2006, there were approximately 57,000 emergency department visits for nonmedical use of hydrocodone or hydrocodone combinations, 65,000 for nonmedical use of oxycodone or oxycodone combinations, and 45,000 for nonmedical use of methadone An analysis of poison-control data from 2003 through 2006 identified 9179 children who were inadvertently exposed to prescription opioids. The median age of the children was 2 years, and 92% of the poisonings occurred in the child's home

31. Methadone Unintended Deaths Nationally (FDA warning 2006) # scripts ?700% 1998-2006 Deaths 790 in 1999 ? 3849 in 2004 (?468%) 82% unintentional (most polydrug e.g. benzos) Increase not related to MMTP Locally Vermont 17?79 2001-2006 Shapiro 2007 Maine 23?67 2001-2006 Sorg 2007 Compared with all opioid death increase of 66% Consumption ?9-22%/yr to 5200g/100K (2000-2007) Methadone deaths 1999-2004 ?390% Compared with all opioid death increase of 66% Consumption ?9-22%/yr to 5200g/100K (2000-2007) Methadone deaths 1999-2004 ?390%

32. Buprenorphine Pharmacology Partial mu agonist May induce withdrawal in dependent patients High mu affinity Elimination half-life 4-5 hours Analgesic ceiling ~32 mg/day Usual dosing 4-16 mg/day BID

33. Acute Pain Management in Chronic Pain Patients Re-emphasize non-pharmaceutical and non-opioid treatments Do not vary long-acting opioid dosing methadone or fentanyl patch dose Buprenorphine frequency or dose may be increased to q6 or up to 32 mg/day Titrate a short-acting opioid Rapid referral or re-check to reduce quantity dispensed Re-emphasize non-pharmaceutical and non-opioid treatments Do not vary long-acting opioid dosing methadone or fentanyl patch dose Buprenorphine frequency may be increased to q6 Titrate short-acting opioid Rapid referral or re-check to reduce quantity dispensed Re-emphasize non-pharmaceutical and non-opioid treatments Do not vary long-acting opioid dosing methadone or fentanyl patch dose Buprenorphine frequency may be increased to q6 Titrate short-acting opioid Rapid referral or re-check to reduce quantity dispensed

34. Chronic Pain Articles Savage SS, Kirsch KL, Passik SD, Challenges in Using Opioids to Treat Pain in Persons with Substance Use Disorders, Addict Sci Clin Pract, 4-25, 2008 Martin TC, Rocque M, Accidental and Non-Accidental Ingestion of Methadone and Buprenorphine in Childhood, Curr Drug Safe, 6(1): 1-5, 2011. Toombs JD, Kral LA, Methadone Treatment for Pain States, Am Fam Phys, 71(7): 1353-8, 2005. Wolff K, Characterization of Methadone Overdose, Therapeu Drug Monitor, 24(4): 457-470, 2002. Fudala PJ, Bridge TP, Herbert S et al, Office-Based Treatment of Opioid Addiction with SL Buprenorphine and Naloxone, NEJM, 349(10): 949-958, 2003. Berg ML, Idrees U, Ding R et al, Evaluation of the Use of Buprenorphine for Opioid Withdrawal in an Emergency Department, Drug Alco Depend, 2006. Bell JR, Butler B, Lawrence A et al, Comparing Overdose Mortality Associated with Methadone and Buprenorphine Treatment, Drug Alco Depend, 104: 73-77, 2009. Sporer KA, Buprenorphine: A Primer for Emergency Physicians, Ann Emerg Med, 43(5): 580-584, 2004.

35. Maine Prescription Monitoring Program

36. Top Five Rx Drugs of Abuse The top five �PD�s of abuse� (i.e., commonly diverted). Maine population 1.3 M peopleThe top five �PD�s of abuse� (i.e., commonly diverted). Maine population 1.3 M people

37. How to register as a Requester Go to: http://www.maine.gov/pmp Click on �RxSentry Data Requester Forms� link. Download appropriate Registration Form. Fill it out, sign it in front of a Notary Public, have them notarize it, and mail it to OSA at the address on the form. Questions: (207) 287-2595 Hand out PMP Data Requester Registration Forms (if you haven�t already done so). Everyone, even those already registered, must submit one of these forms, notarized, by Sept. 30, 2011. Hand out PMP Data Requester Registration Forms (if you haven�t already done so). Everyone, even those already registered, must submit one of these forms, notarized, by Sept. 30, 2011.

38. Sub-account User Registration Go to www.maine.gov/pmp. Click on �RxSentry Data Requester Forms� link. Download �Sub-account User Form.� Fill it out; prescriber signs middle; sub-account user-to-be signs in front of a Notary Public; then, send original form to OSA at address on form.

39. Registration Statistics Dentists 147 828 18% Medical Doctors 1076 3411 32% Nurse Prescribers 485 1108 44% Osteopathic Doctors 295 583 51% Physician Assistants 283 495 57% Podiatrists 11 87 13% Total Prescribers 2297 6512 35% Pharmacists (ME)254 1186 21%Dentists 147 828 18% Medical Doctors 1076 3411 32% Nurse Prescribers 485 1108 44% Osteopathic Doctors 295 583 51% Physician Assistants 283 495 57% Podiatrists 11 87 13% Total Prescribers 2297 6512 35% Pharmacists (ME)254 1186 21%

40. PMP Articles Fishman SM, Papazian JS, Gonzalez S et al, Regulating Opioid Prescribing Through Prescription Monitoring Programs, Am Acad Pain Med, 5(3): 309-324, 2004. Reisman RM, Shenoy PJ, Atherly AJ et al, Prescription Opioid Usage and Abuse Relationships, Subst Abuse Res Treat, 3: 41-51, 2009. Baehren DF, Marco CA, Droz DE et al, A Statewide Prescription Monitoring Program Affects Emergency Department Prescribing Behaviors, Ann Emerg Med, 56(1): 19-23, 2010. Todd KH, Pain and Prescription Monitoring Program in the Emergency Department, Ann Emerg Med , 56(1): 24-26, 2010.

41. ED Pain Management Guidelines

42. Chronic Pain Ambulatory Care Guidelines (Universal Precautions) Evaluation Risk Assessment Controlled Substance Prescribing Contract Prescription Monitoring Program Drug Education Addiction (4C�s), Dependency, Tolerance Adherence monitoring Pill counts Urine drug screening 9% American Population moderate to severe non-cancer pain, 2/3rds of these > 5 years9% American Population moderate to severe non-cancer pain, 2/3rds of these > 5 years

43. Fundamental Goals �Fifth vital sign� (0-10 scale) JCAHO 2001 One-dimensional Best used to assess therapeutic success Identify cause or causes Objective testing, if needed Therapy may begin simultaneously Treatment Expedience/Titration Individual benefit versus risks (balance) Background: environmental costs

44. Multidisciplinary Treatment Modalities Physical Heat/ice, immobilization, massage, acupuncture Psychobehavioral Relaxation, biofeedback, sleep management, cognitive restructuring Interventional Blocks, stimulators Medications APAP, NSAIDS, topical therapy, Adjuncts, Opioids

45. ED Pain Metric Inclusion: Age range: all Complaint: pain Acuity: < 1 week Exclusion: Unstable vital signs Clear indications for emergent transfer to: L&D, Cath Lab, Operating Room

46. ED Flow Triage Evaluation of Pain (PQRST) and implementation of non-pharmacological measures within 15 minutes Positioning, ice, immobilization Assess medications, allergies, mental status, respiratory status, circulation and gastrointestinal complaints (nausea, vomiting) Pain VAS 1-3 minor Initiate APAP or NSAID 4-10 major Obtain urine specimen Check PMP Ask if patient can wait 30 minutes for medications to work? Yes, give APAP 1g, NSAID ibuprofen 10 mg/kg plus Oxycodone 0.1 mg/kg Reassess 30 minutes, notify provider No, give fentanyl 1 mg/kg up to 100 mcg IV Reassess 10 minutes, notify provider Provider assessment within 1 hour Secondary intervention or documentation of exclusion criteria Complete pain relief, Disingenuous pain, etc.. Metric %secondary assessment within 30-60 min %achieved pain relief 50% or greater

48. Risk Assessment Tools (screening tools) ABD Addiction Behavior Checklist CAGE-AID COMM Current Opioid Misuse Measure CRAFFT Car, relax, alone, forgetfulness, friend tolf you to quit, trouble with law DIRE Diagnosis, intractability, risk, efficacy SISAP Screening Instrument for Substance Abuse Potential SOAPP CAGE plus mood, legal problems, personal, friend and family Hx substance abuse, psychological problems, treatment and treatment failure ORT (opioid risk tool) Personal and family Hx substance abuse, age, social factors, psychological diseases (Pain EDU.org) (Mass Dept. Public Health) (Pain EDU.org) (Mass Dept. Public Health)

49. Urine Drug Screen Rarely impacts acute medical care Opioids (cutoffs, threshold) Typically detection of codeine, hydrocodone, hydromorphone, morphine, heroin (diacetyl-morphine) Variable cross reactivity with oxycodone Special assays required for Methadone, buprenorphine, oxycodone, fentanyl

50. Minimum Documentation Past visits resulting in opioid scripts (recurrence) Past failures of non-opioid pain relieving treatments History of drug use including alcohol and tobacco Past treatment for drug problems Family situation (including relations with substance abuse) Outpatient resources (primary care doctor)

51. ED Pain Management Articles Wilsey B, Fishman S, Rose JS et al, Pain Management in the ED, Am J Emerg Med, 22(1): 51-57, 2004. McIntosh SE, Leffler S, Pain Management After Discharge From the ED, Am J Emerg Med, 22(2): 98-100, 2004. Tamches E, Buclin T, Hugli O et al, Acue Pain in Adults Admitted to the Emergency Room: Development and Implementation of Abbreviated Guidelines, Swiss Med Weekly, 137: 223-227, 2007. Rasor J, Harris G, Using Opioids for Patients with Moderate to Severe Pain, JAOA, 107(9) S5: ES4-10, 2007.

52. Legal and Law Enforcement Issues associated with Opioid Dispensing

53. Maine State Law �1109. Stealing drugs 1.� � A person is guilty of stealing drugs if the person violates chapter 15, section 353, 355 or 356-A knowing or believing that the subject of the theft is a scheduled drug, and it is in fact a scheduled drug, and the theft is from a person authorized to possess or traffick in that scheduled drug. [ 2003, c. 1, �9 (AMD) .] 2.� � Stealing drugs is: A. A Class C crime if the drug is a schedule W, X or Y drug; or [2001, c. 419, �21 (NEW).] B. A Class D crime if the drug is a schedule Z drug. [2001, c. 419, �21 (NEW).]

55. Searching for Balance Practitioners have a legal & ethical duty to effectively diagnose & manage pain Practitioners must be aware of federal & state laws governing the prescription of controlled substances for pain management & must keep them in mind when developing treatment plans Following medically-based, peer reviewed, & nationally-recognized guidelines, documenting good faith prior exams, & outlining the parameters of treatment plans will put you in the best position to defend enforcement actions Following BOLIM Rule Chapter 21 essential

56. State Law Aimed at Preventing Diversion Joint Rule Chapter 21, Use of Controlled Substances for Treatment of Pain MDEA Rule Chapter 1, Requirements of Written Prescriptions of Schedule II Drugs (with printer & waiver lists) Board of Pharmacy Rule Chapter 19, Receipt and Handling of Prescription Drug Orders An Act to Facilitate Communication between Prescribers & Dispensers of Prescription Medication (P.L. 2003, Chapter 483; effective 9/13/03) � Prescription Monitoring Program

57. Health Information Privacy Laws & Diversion 22 M.R.S.A. sec. 1711-C, Confidentiality of health care information (Maine�s privacy statute, effective 2/1/00) 45 C.F.R. Parts 160 & 164, Standards for Privacy of Individually Identifiable Health Information (the HIPAA privacy rule, effective 4/14/03) FAQ: What disclosure to law enforcement officials is permitted under these privacy laws? Is there any recognized privacy interest in criminal activity? Can practitioner disclose facts about patient conduct that suggest diversion without disclosing PHI? L.D. 1425, An Act to Facilitate the Reporting of the Crime of Acquiring Drugs by Deception (P.L. 2007, Chapter 382; effective 9/20/07)

58. Amendment to Crime of Acquiring Drugs by Deception L.D. 1425 amends 17-A M.R.S.A. sec. 1108, Acquiring drugs by deception, as follows: 6. A prescribing health care provider, or a person acting under the direction or supervision of a prescribing health care provider, who knows or has reasonable cause to believe that a person is committing or has committed deception may report that fact to a law enforcement officer. A person participating in good faith in reporting under this subsection, or in participating in a related proceeding, is immune from criminal or civil liability for the act of reporting or participating in the proceeding.

59. Medical Marijuana Maine Medical Marijuana Act: passed by referendum in 1999; repealed & replaced by referendum in 2009; amended by legislature in 2010 Expanded list of �debilitating medical conditions� Role of physician: may, but is not required to, provide �written certification� of eligibility Issues of informed consent Uncertain status under federal law: AG Holder statement Drug regulatory concerns: not FDA-approved; don�t �prescribe� or �dispense� Potential exposure to claims of negligence: unregulated drug; may not know strength or impurities Is this at odds with our concern about Maine�s drug problem?

60. Legal Articles Lawrence LL, Legal Issues in Pain Management: Striking a Balance, Emerg Med Clin N Am, 23: 573-584, 2005. Goldenbaum DM, Christopher M, Gallagher RM et al, Physicians Charged with Opioid Analgesic-Prescribing Offenses, Pain Med, 9(6): 737-747, 2008 Fishbain DA, Lewis JE, Gao J et al, Alleged Breaches of �Standards of Medical Care� in a Patient Overdose Death, Am Acad Pain Med, 10(3): 565-572, 2009. Model Policy for the Use of Controlled Substances for the Treatment of Pain, Federation of State Medical Boards.