The Opioid Safety Initiative in the Department of Veterans Affairs

1. The Opioid Safety Initiative in the Department of Veterans Affairs Candy Still, Pharm D., BCPS VISN 16 Academic Detailing Service

2. Objectives • Discuss the background and statistics surrounding the opioid epidemic in the United States. • Identify steps taken by the Department of Veterans Affairs to combat the opioid epidemic. • Explain the Opioid Safety Initiative and various components within the VA. • Review actions taken by VISN 16 in executing the Opioid Safety Initiative. • Describe how the VA is bridging the gap between Opioid Safety Initiative and the Psychotropic Drug Safety Initiative.

3. Background • In 2016, the number of overdose deaths involving opioids (including prescription opioids and illegal opioids like heroin and illicitly manufactured fentanyl) was 5 times higher than in 1999. • On average, 115 Americans die every day from an opioid overdose.

4. Opioid Statistics • Arkansas has the second highest opioid prescribing rate – not in the top 5 for high-dosage prescribing rate (> 90 MEDD). • In 2016, a total • 42,249 persons in the United States died from drug overdoses involving opioids • 37,814 were unintentional drug overdoses • In 2016, a total of 17,087 persons in the United States died from drug overdoses involving prescription opioids (natural and semi-synthetic opioids [e.g., oxycodone and hydrocodone] and methadone) • The rate of drug overdose deaths involving any opioid of all intents increased from 2.9 per 100,000 in 1999 to 13.3 in 2016 (p<0.05). • Unintentional drug overdose death rates involving any opioid increased from 2.1 per 100,000 in 1999 to 11.9 per 100,000 in 2016 (p<0.05).

5. Opioid Statistics • The rate increased on average by 18% per year for drug overdose deaths of all intents (p<0.05), and 20% per year for unintentional drug overdose deaths (p<0.05) between 2014 and 2016. • The rate increased on average by 19% per year for drug overdose deaths involving any opioid of all intents (p<0.05), and 20% for unintentional drug overdoses involving any opioid (p<0.05) between 2013 and 2016.

6. Opioid Epidemic

7. Opioid Abuse It is not just prescription opioids; heroin use is on the rise. Three out of four new heroin users report abusing prescription opioids before using heroin. • Why are more people using heroin? • Low cost • Easily available • Increased purity • Increased potency

8. 3 Waves of Opioid Overdose Deaths

9. CDC Guidelines for Prescribing Opioids for Chronic Pain: Determining when to initiate or continue opioids for chronic pain • Non-pharmacologic therapy and non-opioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with non-pharmacologic therapy and non-opioid pharmacologic therapy, as appropriate. • Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how opioid therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety. • Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy.

10. CDC Guidelines for Prescribing Opioids for Chronic Pain: Opioid selection, dosage, duration, follow-up, and discontinuation • When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids. • When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day. • Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.

11. CDC Guidelines for Prescribing Opioids for Chronic Pain: Opioid selection, dosage, duration, follow-up, and discontinuation 7. Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids.

12. CDC Guidelines for Prescribing Opioids for Chronic Pain: Assessing risk and addressing harms of opioid use • Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (≥50 MME/day), or concurrent benzodiazepine use, are present. • Clinicians should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.

13. CDC Guidelines for Prescribing Opioids for Chronic Pain: Assessing risk and addressing harms of opioid use • When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs. • Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible. • Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

14. AR State Medical Board Legislative Changes to Opioid Prescribing – Regulation 2 The Arkansas Medical Practices Act authorizes the State Medical Board to revoke or suspend the license issued by the Board to practice medicine if the holder thereof has been found guilty of grossly negligent or ignorant malpractice. It shall include, among other things, but not limited to: 4. The prescribing of excessive amounts of controlled substances to a patient including the writing of an excessive number of prescriptions for an addicting or potentially harmful drug to a patient. “Excessive” is defined as the writing of any prescription in any amount without a detailed justification for the prescription documented in the patient record.

15. AR State Medical Board Legislative Changes to Opioid Prescribing – Regulation 2: Chronic Pain If there is documented medical justification, “excessive” is defined pursuant to the Centers for Disease Control (CDC) guideline for prescribing opioids for chronic pain, as prescribing opioids at a level that exceeds ≥ 50 Morphine Milligram Equivalents (MME) per day, unless the physician / physician assistant documents each of the following: a. Objective findings, which include, but are not limited to, image studies, lab testing and results, nerve conduction testing, biopsy, and any other test that would establish pain generating pathology. b. Specific reasons for the need to prescribe ≥ 50 MME per day. c. Documented alternative treatment plans as well as alternative therapies trialed and failed prior to considering chronic opioid therapy. d. Documented risk factor assessment detailing that the patient was informed of the risk and the addictive nature of the prescribed drug. e. Documented assessment of the potential of abuse and / or diversion of the prescribed drug.

16. AR State Medical Board Legislative Changes to Opioid Prescribing – Regulation 2: Chronic Pain f. That the Prescription Drug Monitoring Program had been checked prior to issuing the prescription. g. A detailed clinical rationale for the prescribing and the patient must be seen in an in-person examination every three (3) months or every 90 days. h. The definition of “excessive” as contained in this Regulation shall not apply to prescriptions written for a patient in hospice care, in active cancer treatment, palliative care, end-of-life care, nursing home, assisted living or a patient while an inpatient setting or in an emergency situation. i. Regular urine drug screens should be performed on patients to insure the patient is taking the prescribed medications and is not participating in or suspected in participating in diversion or abuse of non-prescribed medications. The treatment of chronic pain shall be consistent with the CDC guidelines as they relate to baseline drug testing, and at least annual follow up testing as warranted for treatment.

17. AR State Medical Board Legislative Changes to Opioid Prescribing – Regulation 2: Chronic Pain j. A pain treatment agreement must be signed and reviewed by the patient when initiating chronic opioid therapy. This agreement should discuss the following: - informed risk and addictive nature of prescribed medications - outline the specific expectations between patient and physician - informed consent for periodic urine drug screens and random pill counts with urine screening - provisions for termination of opioid therapy

18. AR State Medical Board Legislative Changes to Opioid Prescribing – Regulation 2: Acute Pain and Careful Consideration For treatment of acute pain, “excessive” is further defined as an initial prescription written for more than seven (7) days, without detailed, documented medical justification in the medical record. If the patient requires further prescriptions, they must be evaluated in regular increments with documented medical justification for continued treatment in the medical record. When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to > 50 MME/day, and should avoid increasing dosage > 90 MME/day or carefully justify a decision to titrate dosage > 90 MME/day.

19. Risk of Opioids in Acute Pain

20. Arkansas Prescription Monitoring Program • Arkansas’s Electronic Prescription Monitoring Program (PMP) was authorized in 2011 by Arkansas State Legislature Act 304. • The Arkansas Department of Health (ADH) oversees the operation of the PMP. • Arkansas law requires that each dispenser shall submit, by electronic means, information regarding each prescription dispensed for a controlled substance.  • Act 820 of 2017 mandates that a prescriber access the Arkansas Prescription Monitoring Program in the following circumstances: • 1. Each time a CII opioid is prescribed. • 2. Each time a CIII opioid is prescribed. • 3. The first time a benzodiazepine is prescribed. • There are exemptions to this mandate that pertain to surgery, oncology, palliative and hospice care. • Pharmacies are required to upload dispensing data on a daily basis.

21. Joint Commission Standards • Pain Management - Patient and Family Education - PC.01.02.07 EP 8 • It is the responsibility of each organization to determine who is qualified and responsible to educate the patient and family at discharge regarding the pain management plan, side effects of treatment, impact on activities of daily living, safe use, storage, and disposal of opioids when prescribed. PC.01.02.07 EP 8 requires written documentation that the patient and family were educated on these requirements. Each organization determines where this information will be documented in the medical record. • Pain Management - Screening versus Assessment - PC.01.02.07 EP 1 What’s the difference? • Organizations are responsible for ensuring that appropriate screening and assessment tools are readily available and used appropriately. The tools required to adequately assess pain may differ depending on a patient’s age, condition, and ability to understand, and whether pain is acute or chronic.

22. Joint Commission Standards • Pain Management - Leadership Responsibilities for Educating Staff and Practitioners - LD.04.03.13 EP 3: require organizations to provide staff and licensed independent practitioners (LIP) with educational resources regarding pain management and safe use of opioid medication • Organization determines what educational resources and programs to have readily available to staff and licensed independent practitioners, giving consideration to staff needs, services provided, and patient population served. • Pain Management - Leadership Responsibilities for Monitoring and Performance Improvement Activities - LD.04.03.13 EP 1: states that leadership is responsible for developing and monitoring performance improvement activities specific to pain management. • Organization determines whether an individual 'leader' will be is assigned this responsibility, or if a 'team' model is used. Evaluating the scope of services provided and patient populations served will help determine which model would be most effective.  

23. Joint Commission Standards • Pain Management - Leadership Responsibilities for Monitoring and Performance Improvement Activities - LD.04.03.13 EP 1 Continued • Compliance is determined based on the following actions by leader(s): 1. Leader(s) participate in defining the goals and metrics for performance improvement activities, e.g., on monitoring the use of opioids; 2. Leader(s) allocate resources to conduct performance improvement activities, if needed; 3. Leader(s) review performance improvement data; 4. Leaders(s) promote improvements in practices and accountability across disciplines and services involved in opioid prescribing practices • Pain Management - Leadership Responsibility for Providing Access to Prescription Drug Monitoring Program (PDMP) databases - LD.04.03.13 EP 6 • Leadership required to have implemented systems and processes that support both ease of access and consistent access to the PDMP when required

24. The Opioid Safety Initiative (OSI) in the VA • Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain developed in 2010 and updated in 2017 • The Opioid Safety Initiative launched in 2013 • OSI Dashboard • Quarterly report on facility level OSI data • Urine drug screen (UDS) rate for patients on long-term opioid therapy (LTOT) • Patients taking concomitant benzodiazepines and opioids • Opioid morphine equivalent daily dose (MEDD) • Percent of patients dispensed an opioid

25. The Opioid Safety Initiative (OSI) in the VA • Opioid Safety Initiative Toolkit • Acute Pain Provider Guide – Acute Pain Management Opioid Safety VA Educational Guide • Transforming the Treatment of Chronic Pain Moving Beyond Opioids – VA Clinician Guide • Pain Quick Reference Guide – Transforming the Treatment of Pain • Consent Form for Long-Term Opioid Therapy for Pain • TAKING OPIOIDS RESPONSIBLY – Patient Information Guide on Long-Term Opioid Therapy for Chronic Pain • Opioid Taper Tool – for Clinicians • Effective Treatments for PTSD: Consider CBT as First Line Treatment – Clinician Guide • PTSD – Overview for Patients • Effective Treatments for PTSD: Helping Patients Taper from Benzodiazepines – for Clinicians

26. The Opioid Safety Initiative (OSI) in the VA: Stepped Care Model for Pain Management

27. The Opioid Safety Initiative (OSI) in the VA: Academic Detailing 1. A service-oriented outreach education for health care professionals by health care professionals, leveraging the one-on-one communication approach of the pharmaceutical industry detailers combined with evidence-based, non-commercial aims of academic groups, research and development centers. 2. A quality-oriented approach that helps providers make appropriate clinical decisions, ideally based on the best available safety, efficacy, and cost-effectiveness data. • Provides access to balanced evidence-based information in an effective and impactful way • Through dialogue with providers, academic detailing can improve patient care and health outcomes – aligning the interests of patients, providers, and payers • Many providers appreciate information on more effective, safer, or less expensive treatment options • Proven method of providing evidence-based information in an effective and impactful way

28. The Opioid Safety Initiative (OSI) in the VA: Academic Detailing • In-person educational outreach • Information is provided interactively so the educator can: • Understand the provider • Modify the presentation appropriately • Engage the provider • The visit concludes with specific practice-change recommendations • Over time, the educator and provider develop a trusted and useful relationship

29. Academic Detailing: VA PBM Academic Detailing Public Website http://www.pbm.va.gov/PBM/academicdetailingservicehome.asp

30. The Opioid Safety Initiative (OSI) in the VA • Opioid Therapy Risk Report (OTRR) • Patient focused, actionable and provider specific report for Primary Care Providers (PCP), Patient Aligned Care Teams (PACT) and Clinical Pharmacists for patients on long-term opioid therapy (LTOT) • Nationwide VA data, updated nightly • Includes high risk comorbidities such as SUD, OSA, PTSD, Depression • Includes last PCP, Pain Clinic and MH visit • Dates and status of IMED Consent, UDS and PDMP query • MEDD, last prescriber, quantity, dispensing location, days supply, strength and active benzodiazepine prescription

31. The Opioid Safety Initiative (OSI) in the VA: Comprehensive Addiction and Recovery Act (CARA) of 2016 Sec. 911. Improvement of opioid safety measures by Department of Veterans Affairs. Sec. 912. Strengthening of joint working group on pain management of the Department of Veterans Affairs and the Department of Defense. Sec. 913. Review, investigation, and report on use of opioids in treatment by Department of Veterans Affairs. Sec. 914. Mandatory disclosure of certain Veteran information to State controlled substance monitoring programs. Sec. 915. Elimination of copayment requirement for Veterans receiving opioid antagonists or education on use of opioid antagonists.

32. The Opioid Safety Initiative (OSI) in the VA: Comprehensive Addiction and Recovery Act of 2016 • Comprehensive Addiction and Recovery Act (CARA) of 2016 : Title IX – Department of Veteran Affairs, Subtitle A – Opioid Therapy and Pain Management • Mandated pain management education and treatment for all employees responsible for prescribing opioids • Use of OTRR before initiating opioid therapy • Provider level OSI data • Interdisciplinary Pain Management Teams / Opioid Risk Review Teams • Medical Provider with Pain Expertise • Medical Provider with Addiction Medicine Expertise to provide evaluation for Opioid Use Disorder (OUD) and access to Medication–Assisted Treatment (MAT) • Medical Provider with expertise in Behavioral Medicine with availability of at least one evidence-based behavioral therapy. • Rehabilitation Medicine discipline

33. The Opioid Safety Initiative (OSI) in the VA: Comprehensive Addiction and Recovery Act of 2016 • Complimentary Integrative Health (CIH) • Mandates CIH modalities that must be made available to Veterans throughout VHA, either in a VA facility or in the community (List I) and maintains a second electronic list (List II) of optional CIH approaches that may be provided

34. The Opioid Safety Initiative (OSI) in the VA • CARA Priority Panels • Quarterly Report, reported to Congress • Opioid Education and Naloxone Distribution (OEND) • Police • AED cabinets • Pharmacists prescribe • Stratification Tool for Opioid Risk Mitigation (STORM) • Stepped Care Model for Opioid Use Disorder Train the Trainer (SCOUTT)

35. Additional VISN 16 Actions • VISN 16 Pain and Opioid Safety Committee • Eliminating Medications Through Patient Ownership of End Results (EMPOWER) • Benzodiazepine Direct to Consumer Mail Out • Encouragement for Dose of Opiate Reduction for Safety and Engagement (ENDORSE) • Opioid Direct to Consumer Mail Out • Veteran Letter Campaign • Change in the Standards of Care for Pain Management • Passport to Health • Bi-annual Patient Education Event • Pain Evaluation Program (PEP) • Assist primary care providers (PCPs) with complex chronic pain cases

36. Opioid Safety Initiative Data FY18 Q4

37. Opioid Safety Initiative Data FY18 Q4

38. OSI Data FY16 – FY18 Q3

39. Opioid + Benzodiazepine FY16 – FY18 Q3

40. Urine Drug Screen in Long-Term Opioid Patients FY16 – FY18 Q3

41. High Dose Opioid FY16 – FY18 Q3

42. Recent progress

43. PDMP

44. iMed Consent FY16 – FY18 Q3

45. CARA Priority Panel Report FY18 Q4

46. Opioid Safety Initiative – “The Next Phase” VHA Notice 2018-08

47. Opioid Safety Initiative

48. Opioid Safety Initiative

49. Opioid Safety Initiative

50. Opioid Safety Initiative