EXPLORING NALOXONE UPTAKE AND USE PUBLIC MEETING July 01 02, 2015 Fred Wells Brason II

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1 EXPLORING NALOXONE UPTAKE AND USE PUBLIC MEETING July 01 02, 2015 Fred Wells Brason II

2 Disclosures Project Lazarus Zogenix Charitable Contribution 2015 Kaléo Charitable Contribution 2015 Ameritox Charitable Contribution 2014 Purdue Pharma L.P. Unrestricted Educational Grant 2014 Indivior Consultant 2015

3 Prescription Medication/Heroin Crisis Project Lazarus Prevention Intervention - Treatment Preventing opioid/opiate poisonings Presenting responsible pain management Promoting Substance Use Treatment and Support services

4 Naloxone I. Populations necessary to be reached II. Naloxone Community Integration III. Provider Education IV. Co-Prescribing venues V. Co-Prescribing Obstacles

5 Prescription Medication Misuse Overdose Who, What, When, Where, Why, How? The WHO: Patient misuse respiratory depression Family/Friends sharing to self medicate Accidental ingestion Recreational User Substance Use Disorder/Treatment/Recovery

6 Risks of Opioid-Induced Respiratory Depression Persons are at risk of overdose if there is a combination of prescription opioids with any of the following: Smoking, COPD, emphysema, asthma, sleep apnea, or other respiratory issue Renal dysfunction or hepatic disease. Known or suspected concurrent alcohol use. Concurrent benzodiazepine prescription. Concurrent SSRI or TCA anti-depressant prescription. Recent emergency medical situation for opioid poisoning and/or intoxication. Suspected history of illicit or non-medical opioid use. Prescription for a high dose opioid Methadone prescription (specifically, opioid naïve patients). Recent release from incarceration. Recent release from an opioid detox or mandatory abstinence program. Enrolled in a methadone or buprenorphine detox and/or maintenance program for addiction or pain. Voluntary request from patient or family member. Difficulty accessing EMS due to distance, remoteness, etc.

7 Project Lazarus Model The Wheel Addiction Treatment Community Education Public Awareness Provider Education Harm Reduction Pain Patient Support Coalition Action Data & Evaluation Diversion Control Hospital ED Policies The Project Lazarus model can be conceptualized as a wheel, with three core components (The Hub) that must always be present, and seven components (The Wheel) which can be initiated based on specific needs of a community.

8 Project Lazarus Model naloxone integration Addiction Treatment Community Education Provider Education Harm Reduction Pain Patient Support NALOXONE Diversion Control Hospital ED Policies The Project Lazarus model can be conceptualized as a wheel, with three core components (The Hub) that must always be present, and seven components (The Wheel) which can be initiated based on specific needs of a community.

9 Prescriber Education Chronic Pain Initiative CPI PURPOSE Reduce risk of patient overdose Reduce risk of patient medication diversion Treatment of chronic pain Exploring options instead/ in addition to medications OUTREACH Reached via trainings with Continuing Medical Education Units (CME), lunch and learn, Grand Rounds, webinars Use of the Prescribers Toolkit Overdose/Respiratory Depression Risks Prescribing naloxone Use of Prescription Drug Monitoring Program

10 Most continuing medical education on pain management is didactic. Most effective method for implementation Source: 2011 Project Lazarus Health Director Survey

11 Summary When prescribing medications with potential for misuse/abuse, it is necessary to balance the need for help with potential risk with each unique clinical situation. Risk of abuse can be minimized by using appropriate screening, rational prescribing (abuse deterrent formulations) and appropriate monitoring. Biological/Cultural/Environmental Factors Do no harm! When in doubt, do prescribe naloxone

12 Pain Management Chronic Opioid Risk Stratification LOW: ORT < 4 AND < 3 Minor Risk Factor AND No abnormal urine screens MODERATE: ORT > 4 OR > 2 Minor Risk Factor OR > 1 abnormal urine screen OR Takes over 100mg Oral DME Hx substance abuse Suboptimal MGMT of psychiatric Dx Weigh Risks and Benefits of Opioid Therapy HIGH: ORT > 4 OR > 2 Minor Risk Factor OR 1 or more Major Risk Factor OR > 1 abnormal urine screen OR Documented overdose OR Suboptimal MGMT of psychiatric Dx If: Urine screen: 2x/year Visit Interval: Up to 3 months Review PMP Every 6 months Urine screen: 4x/year Visit Interval: Up to 2 months Review PMP Every 2 months Substance Use Evaluation as soon as new risk level identified Urine screen: 6x/year Visit Interval: Up to 1 month Review PMP monthly Identify and engage patient support system emphasize risk/benefits of medication educate and dispense naloxone consider home health safety evaluation Risk> Benefit STOP Opioid THERAPY Referral Army 15 of 400 to 1

13 NALOXONE Co-Prescribing Venues Provider Education Behavioral health and substance use assessments Overdose Prevention Toolkit Patient/Family with Education Third Party prescribing Opioid Risk Stratification Hospital ED Policies Patient/Family Education Naloxone provided/prescribed

14 NALOXONE Co-Prescribing cont. Person with Pain Support Patient/Family/Caregiver information and education Pharmacy (reimbursement for training required) Addiction Treatment Narcotic Treatment Programs Buprenorphine, methadone Recovery based programs Drug Courts, Probation Inmate Release

15 Project Lazarus - naloxone 5200 Naloxone as of August 2013 Healthcare Networks Medicaid 38% Law Enforcement/First Responders 16% Pharmacy 12% Public Health Clinics 12% Addiction Treatment 10.5% Physicians 4% Hospital/Pharmacy 4% Health Department >1% Pain Management Clinics >1% Individuals >1% Managed Care Behavioral Health >1% Psych & Mental Health >1% Known Rescues in Each Category

16 Obstacles to routine co-prescribing Medical School not in curriculums, nor is addiction Lack of awareness, knowledge and understanding with current practitioner s, lack of integration into practice Discussing the subject respiratory depression/opioid emergency Informed consent (freely discuss OIC opioid induced constipation) Incorporate as part of REMS/Labeling Accessibility with Medicaid, Medicare and Insurance Coverage eliminates cost factor (19 states current FDA approved auto-injector) 3 rd party prescribing Reimbursement for pharmacist OD training Myths of Addiction not in my practice! ( If doing everything right with opioid prescription no need for naloxone!

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