Ronald F. Hayden, MD Ann E. McDonald, MN John F. Rogers, Esq Alex N. Sabo, MD

1. Improving Clinical Effectiveness and Risk Control in Chronic Pain Management:The Berkshire County Experience Ronald F. Hayden, MD Ann E. McDonald, MN John F. Rogers, Esq Alex N. Sabo, MD Berkshire Health Systems, Inc. Pittsfield, Massachusetts

2. Disclosure The content of this presentation does not relate to any product of a commercial interest. Therefore, there are no relevant financial relationships to disclose for: Ronald F. Hayden, MD Ann E. McDonald, MN John F. Rogers, Esq Alex N. Sabo, MD

3. Factors Fueling Berkshire Community Pain Management Program Ann E. McDonald, MN Berkshire Community Pain Management Project Berkshire Health Systems, Inc.

4. Berkshire County—Including Area Hospitals And Cities

5. Berkshire County Surface Tranquility

6. Sub-surface Tremors Schedule II Opioid Poisonings Per100,000 2005 Rates per 100,000 population (quintiles) 0 00.01 - 18.01 18.02 - 41.63 41.64 - 62.73 62.74- 225.51 BMC has > 40 survived overdoses annually, mostly oxycodone and hydrocodone combinations

7. Sub-surface TremorsSchedule II Opioid-related HospitalizationsPer 100,000 – 2005

8. 11.6 10.4 7.6 1.1 4.5 9.8 8.3 6.9 7.6 3.1 6.9 9.9 4.9 12.1 4.0 16.5 11.5 NH9.4 9.5 10.0 16.1 VT 10.0 18.6 8.0 10.8 MA13.0 6.2 7.5 11.0 15.3 RI 15.2 CT 10.0 10.2 14.1 NJ 8.6 12.5 14.2 DE 8.6 19.4 11.0 8.9 MD 12.3 7.7 7.9 DC 16.4 10.7 8.4 15.4 12.5 9.9 6.4 Rate per 100,000 population 1.1-8.4 8.5-11.4 11.5-19.4 Sub-surface Tremors Unintentional overdose death rates by state, 2006 – over 16,000 deaths annually MA – 2006 – 13 2005 – 10.6 2002 – 9.2 Len Paulozzi, MD, MPH, Centers for Disease Control and Prevention, 2009

9. Sub-surface TremorsRelationship Between Opioid Sales And Drug Poisoning Mortality MA LJ Paulozzi, GW Ryan , American Journal of Preventive Medicine, 2006

10. Sub-surface Tremors • Increasing reliance on pain specialists for chronic pain medication management instead of PCPs • Pharma industry information suggesting +2 million Schedule II doses in 2005 in Berkshire County • Schools and law enforcement reporting increased discovery of diverted pain medication prescribed by local providers • DA concern about pain medication abuse and opioids as gateway to heroin use • Anecdotal evidence of “doctor shopping” • Addiction specialists seeing greater use of analgesics

11. Doses of Schedule II Opioids Dispensed inBerkshire County: 1996-2008 1996-2005 an increase of 18% annually 2006-2008 inc 4% yr

12. Estimated ratio of Schedule II to Schedule III and IV opioids is 1:4.4 3,168,950 Schedule II opioid pills in 2008 Total 13,943,380 opioid pills prescribed 103.3 tabs per each of 135,000 residents Magnitude of Local Pain Management Risk Control Issue MDPH Prescription Monitoring Program, 2009

13. Schedule II Opioid Prescriptions in Berkshire County 1996-2008 60,000 50,000 40,000 Prescription Numbers 30,000 20,000 10,000 0 FY 1996-2008

14. Schedule II Prescriptions per Individual in Berkshire County:1996-2008 4.00 3.50 3.00 2.50 Estimated prescriptions /individual 2.00 1.50 1.00 0.50 0.00 Fiscal Years 1996-2008

15. Questionable Opioid Activity in Berkshire County: 1996-2008 160 140 120 100 # of Individuals with Questionable Activity 80 60 40 20 0 Fiscal Years 1996-2008

17. Linear Relationship Between Opioids Dispensedand. . . • Deaths – tripled in the US between 1999 and 2007, now more than 1000 deaths each month in US • Overdoses – major culprit is oxycodone, most are unintentional and occur in relatively young individuals • Hospitalizations – secondary to rescue and treatment of addiction, risk of addiction after treatment for several months or longer is 35% (BMJ, 2011) • Impaired Lifestyle – isolation, loss of function, motivation • Worse Outcomes - most commonly studied in LBP, leading to high rates of long term disability

18. Prescriber Role in Both Proper Control and Misuse Alex N. Sabo, MD BMC Department of Psychiatry and Behavioral Sciences Berkshire Health Systems, Inc

19. Project Thesis Health care entities and clinicians uniquely situated to lead effort among community-based stakeholders to: Improve quality/availability of care for patients with chronic pain through provider and patient education with adoption of strategies to improve safety in prescribing Improve individual and public health and safety by reducing misuse and diversion of prescription pain medication Reduce expense of care, productivity loss and other societal costs of dependence and addiction through prevention and early identification

20. Twin Project Goals Assuring safe and effective treatment of those suffering from acute and chronic pain in Berkshire County whilepreventing individual and community harm from misuse and diversion of prescribed pain medication

21. Participating Community Organizations Community Treatment Providers: Physicians and other clinicians Dentists Pharmacies Criminal Justice: MA Probation Services BC Sheriff’s Office BC District Attorney Police Departments BC Drug Task Force • Community Stakeholders: • Public and private schools • Three community coalitions • Massachusetts Dept of Public Health: • Drug Control Program • Prescription Monitoring Program • Academic Affiliations: • Brandeis University • Tufts University

22. First Barrier to Safe Prescribing: Lack of Effective Communication

23. Goal: An Integrated Community Program Optimize treatment planning and EMR communication

25. Pain Care Resource Manual Tools Universal Precautions Clarify expectations Improve patient care and patient safety Reduce stigma Contain risk Diagnosis and Treatment Algorithms Reinforce evidence-based medicine in pain management Opioid Medication & Risk Information Treatment Agreements Medication benefits and risk informed consent document Treatment goals and expectations set One prescriber/one pharmacy Appropriate communication among all co-managers of care

26. Pain Care Resource Manual Tools Urine Drug Screening Advice and Forms – 3x annually Liquid chromatograph/mass spectrometry technology added in 3Q 2008 Improves patient safety by identifying non-compliance Aids prescriber risk assessment Opioid Risk Screening Tools: SOAPP & COMM Multidisciplinary Assessment Program Description Regulatory Information Community Resources, including substance abuse services

27. Key Project Components Provider Education Pain Care Resource Manual Encouragement of BioPsychoSocial Model for Addressing Persistent Pain County-wide Medical Conferences: 2005, 2006, 2009-10 Introduction of Content into Residency Program Training Education of entire care team, including MAs and practice administrators, through biannual meetings on implementation

28. Key Project Components Integration of Care Information Technology: Optimizing EMR Monthly Multidisciplinary Treatment Planning Conferences Integrated Pain Treatment Pilot Program – CBT and Yoga Psychologist Added to the Pain Treatment Program Wrap-around Buprenorphine Treatment Residency QI program to measure and improve use of quality of care tools Community Assistance and Awareness Safe Medication Disposal Initiatives Partnerships with MA DPH and Research Institutions

29. Information Technology Tools Flag Electronic Medical Records Co-management issues with opioid medication Existence of chronic pain and medication contracts are noted in Patient Summary Screen Substance Use Alerts on Aberrant Behavior are noted in Patient Summary Screen; history/risk of abuse Automatic system for maintaining currency of contract notation Create Pain Management Plan note to allow more effective co-management of care Identify “doctor shoppers” through multiple prescribers/visits Study e-Prescribing of Controlled Substances in ambulatory setting Track individual cases and assemble aggregate outcomes

30. Monthly Multidisciplinary Treatment Conference Goal: Efficiently communicate coordinated treatment plan for challenging patients across provider network Plan identified in EHR problem list as “Pt Specific Treatment Plan (See MTP 01/01/11)” Participants include: Interventional Pain Physicians ED Chair Psychiatrist with addiction specialty Psychologist Ideally – PCPs, neurologists, rheumatologists and mental health providers already involved in care

31. Community Assistance and Awareness: Parent Education: 1/5

32. Community Assistance and Awareness: Partnership with Criminal Justice System Collaboration with District Attorney’s Office Measure local opioid poisonings and deaths, Annual “State of the Streets” report 3 Drug Take Back Programs Facilitation of Pre- and Post-trial Substance Abuse treatment Berkshire Partnership in Care Program Pilot program with Probation Services in central and southern county to better manage care of probationers at risk for prescription medication abuse

33. The “Oxy” Free ED:An New Approach to Prescribing Controlled Substances in the BHS Emergency Departments Ronald F Hayden, MD, FACEP BMC Department of Emergency Medicine Berkshire Health Systems, Inc.

34. Characteristics Of All EDs That Create Environment of Opioid Prescribing Risk • Open continuously • Often no existing physician-patient relationship • Fragmented connection to primary prescriber • Patients become aware of variance in prescribing patterns, plan visits • Busy environment, easier to write script than start education on safety

35. Why an Oxy Free ED? • The “Oxy Free ED” –a much needed concept to help EDs manage care effectively but also cope an epidemic of opiate misuse, addiction and death occurring over past 15 to 20 years. • Need to prescribe analgesics in manner consistent with the medical evidence, mindful of individual and social risk. • The statistics speak for themselves . . .

36. Sources of Opioid Analgesics Source: National Center for Health Statistics.  Medication therapy in ambulatory medical care: United States, 2003-04 36

37. For acute pain complaints: apply accepted guidelines to effectively treat pain but avoid medications that pose risk of diversion, abuse and addiction. For chronic pain complaints: clarify the role of the ED at presentation, emphasizing coordinated care, information sharing, drug screening and concern for addiction and other risk issues. Reduce the unnecessary volume of prescription opioids in our community…thereby reduce death, overdose and addiction Goals of Oxy-Free ED

38. Principles of “Oxy” Free ED • Acute pain should be treated promptly and appropriately: • Most often non opioid analgesics or schedule III opioids are sufficient • If opioids prescribed, limit discharge medications • If possible, direct communication with primary doctor, including record of visit • Acute exacerbations of chronic pain: Appropriate for treatment in ED? • When urgent treatment necessary—urine drug screen and contact with primary doctor before any prescriptions (limited) are given. • Chronic pain is multifactorial; opioids only small part of care plan • Opioids often not indicated or appropriate • ED management of one small component of overall treatment regimen often ineffective or dangerous • Writing unnecessary opioid script is easy, addressing issue is harder.

39. BHS Emergency Department Guidelines for the Management of Chronic Pain Complaints We Care: To improve your safety and the quality of your care, the BHS Emergency Departments will follow these guidelines in prescribing medication for the treatment of pain.

40. First Principle Pain is a significant medical condition warranting prompt attention and intervention for its relief in the most effective and safest manner feasible: • The Emergency Departments will promptly and effectively address complaints of acute and chronic pain of all patients and, when drugs are appropriate, provide the right drug in the right dosage and for the right duration.

41. Second Principle To prevent the risks of uncoordinated care, one provider should manage all opioids (narcotics) prescribed for chronic pain: • Opioid medications have risks associated with dosage and interaction with other medications, therefore, it is critical to patient safety that one provider coordinate all prescribing. Any exception will require urine drug screen and direct contact with your regular doctor.

42. Third Principle • To avoid the risks associated with the administration of injectable opioids, we will rarely provide these medications for the treatment of chronic pain: • Pain specialists discourage the use of pain medication shots for the treatment of chronic pain as they lead to increase tolerance to the these medications.

43. Fourth Principle In order to avoid the risks of overmedication and other misuse, we will not provide replacement prescriptions that are lost, destroyed or stolen. • Any necessary replacement prescription must be obtained from the original prescribing doctor.

44. Fifth Principle Long-acting or controlled-release opioids (such as OxyContin, oxycodone, fentanyl patches and methadone) are designed to be part of plan for managing chronic pain. We will not prescribe them for managing a chronic pain complaint. These medications need a primary care or pain specialist supervision. • We can assist in managing acute pain either with non-opioid treatment or a short course of opioid medication in appropriate situations.

45. Sixth Principle In order to better assure safe, effective coordination of care, we will share relevant information with doctors involved in caring for the patient. • We will appropriately share information with your doctors.

46. Seventh Principle Patients with complex pain conditions often require treatment by many specialists. These patients are best managed with a coordinated plan of care. This care plan improves safety and effectiveness. • We may develop a patient treatment plan on your condition and record this in the medical record.

47. Summary and Rationale The Departments will rarely prescribe those medications most associated with abuse or addiction: e.g., Percocet, OxyContin, Dilaudid, MS Contin, Duragesic (fentanyl).

48. The Oxy Free ED • Do the right thing and provide acute pain relief promptly and in proportion to injury using a short course of medications. • Reduce dependence, addiction and overdose risk with less opportunity for diversion and non-medical use. • Reduce the high utilization of the ED for chronic pain complaints and engage primary physicians and pain specialists. • Improve better outcomes for patient, family and the community.

49. Key Legal Issues ∆Early Signs of Berkshire Project Impact John F. Rogers, Esq Vice President and General Counsel Berkshire Health Systems, Inc

50. Key Legal Issues Patient Privacy and HIPAA Basics Most states recognize that duty of confidentiality exception in cases of serious danger to patient or others Narrower exception in psychiatric care (Tarasoff cases) Implied consent in co-management of care HIPAA Privacy Rule OCHA NOPP TOP Crime on Premises Federally funded treatment programs (“Part 2 Facilities”)