Who is Behind the Opioid Epidemic?

Safe and Effective Management of Pain and Addiction CARL CHRISTENSEN, MD PHD MEDICAL DIRECTOR, DAWN FARM CLINICAL ASSOCIATE PROFESSOR, WSU SCHOOL OF MEDICINE WWW.CHRISTENSENRECOVERY.COM Tonight s Talk: my part The Opioid Epidemic-Who s Behind It? The Answer to the Prescription Pill epidemic: Board of Medicine, the HPRP and the DEA The Answer to the Prescription Pill epidemic: the CDC guidelines The Answer to the Prescription Pill epidemic: the new Michigan Opioid Laws Why Quit? The Answer to the Heroin/ Fentanyl epidemic: Opioid Rescue Rates of Opioid Sales, OD Deaths, and Treatment, 1999 2010 8 Opioid Sales KG/10,000 Opioid Deaths/100,000 Who is Behind the Opioid Epidemic? 7 6 5 4 3 Rate sales deaths 2 treatment 1 0 1999 CDC. MMWR 2000 2011 2001 2002 2003 2004Year2005 2006 2007 2008 2009 2010 3 Pushback on CDC guidelines The real problem? 6 7 Carl Christensen MD 1

Michigan is 10 th in the US: 107 prescriptions/100 people. WHY do doctors over prescribe? The Four D s: Dated Dishonest Duped Disabled 8 9 The Four D s: The Four D s: Dishonest? Dated Disabled Duped Dishonest? Dated Disabled Duped 10 11 Dishonest? Dated Disabled Duped The Four D s: Dishonest? Dated Disabled Duped The Four D s: 12 13 Carl Christensen MD 2

Pressure on Doctors? Dishonest Dated Disabled Duped The 5 th D: defamation The Four D s: 15 Career Builder? Worst Doctor I ve Ever Seen 17 Carl Christensen MD Solution: DEA intervention He is a complete asshole. He is a controlling, son of a ****, who bases his decisions without completely listening to you. Carl Christensen MD 3

Chronic Pain? ADDICTION AND PREGNANCY 20 21 Woof! Solution: Physician/Prescriber Monitoring Programs ADDICTION AND PREGNANCY 22 Solution: Board of Medicine Who Can You Call? If you see one of us SELLING pills in the parking lot, please call: 517-241-700 Licensing and Regulatory Affairs complaint line If you see one of us TAKING pills in the parking lot, please call: 800 453 3784 HPRP hotline Carl Christensen MD 4

Solution: The CDC The hardest part is taking off. CO*RE 2014 27 CO*RE 2013..and landing The CDC Guidelines for Opioids MOST RECOMMENDATIONS ARE TYPE 4 (LOWEST QUALITY). NO RECOMMENDATIONS ARE TYPE 1 OR TYPE 2. ALL RECOMMENDATIONS EXCEPT #10 (DRUG TESTING) ARE CATEGORY A (APPLY TO ALL PATIENTS OUTSIDE OF CANCER, PALLIATIVE CARE, AND END-OF LIFE CARE) CO*RE 2014 28 CO*RE 2013 CDC Guidelines: Three Sections Determining when to initiate or continue opioids for chronic pain Opioid selection, dosage, duration, follow up and discontinuation Assessing risk and addressing harms of opioid use. Determining when to initiate or continue opioids for chronic pain: Guideline 1= Don t use opioids first 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 nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate. Carl Christensen MD 5

Determining when to initiate or continue opioids for chronic pain: Guideline 2= Risk vs. Benefits of opioids 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 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. Determining when to initiate or continue opioids for chronic pain : Guideline 3 = Ditto Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioids therapy and patient and clinician responsibilities for managing therapy. Carl Christensen MD 6

Opioid selection, dosage duration, follow up and discontinuation : Guideline 4 When starting opioid therapy for chronic pain, clinicians should prescribe immediate releases opioids instead of extendedrelease/long-acting (ER/LA) opioids. = Don t start with Oxycontin Opioid selection, dosage duration, follow up and discontinuation : Guideline 5 = opioid deaths are dose related 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 increasing doses to morphine milligram equivalents dose (M.E.D.) per day, and should avoid increasing dosage to 90 M.E.D. per day or carefully justify a decision to titrate dosage to 90 M.E.D.. Dose and Risk of Death Opioid selection, dosage duration, follow up and discontinuation : Guideline 6 =acute pain leads to long term opioid use. Long term opioid use often begins with treatment acute pain. When opioid are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release (IR) opioid and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioid. Three days or less will often be sufficient; more than seven days will rarely be needed. Maybe 4 days? BUT.. 1. If you take an opioid prescription for 1 week, there is a 5 to 10% chance you WON T STOP. 2. If you take an opioid prescription for 1 MONTH, there is a 15 to 25% chance you WON T STOP. 3. The type of surgery DOESN T MATTER. 4. 6% of patients never stop taking opioids after their surgery! Carl Christensen MD 7

Opioid selection, dosage duration, follow up and discontinuation : Guideline 7 = if they don t work, don t keep prescribing. 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. Rapid Opioid Detox? Assessing risk and addressing harms of opioid use : Guideline 8 = keep monitoring / offer Naloxone (Narcan) 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 opioids overdose, such as history of higher opioids, history of overdose, history of substance use disorder (SUD), dosages ( 50 M.E.D./day), or concurrent benzodiazepine use, are present. Assessing risk and addressing harms of opioid use : Guideline 9 = do a MAPS Clinicians should review the patient s history of controlled Substance (CS) prescriptions using prescription drug monitoring program (Michigan Automated Prescription System, MAPS) 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 MAPS data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months. I don t take pain meds Assessing risk and addressing harms of opioid use : Guideline 10 = do a urine drug screen When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and and consider urine drug screens (testing) at least annually to asses for prescribed medications as well as other CS and illicit drugs. Carl Christensen MD 8

Prescribed Norco, positive for heroin and Fentanyl Prescribed buprenorphine, positive for heroin 50 51 Assessing risk and addressing harms of opioid use : Guideline 11 Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible. Benzodiazepines and opioids: Guideline 11 Benzo Use TRIPLES the risk of Opioids! This ALSO applies to.. Carl Christensen MD 9

Assessing risk and addressing harms of opioid use : Guideline 12 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. Treatment Includes. Intermission. Why Detox off Pain Meds? Safety (focus of the CDC recommendations) Development of addiction/abuse (ditto) Tolerance (treated also with rotation) Opioid Induced Hyperalgesia (OIH) Cold Pressor Test ADDICTION AND PREGNANCY 61 Carl Christensen MD 10

NO PAIN MEDS: lasted 138 seconds (average) Patients on opioids: lasted 60 to 62 seconds (average) 62 63 Detoxing off Pain Meds: Improvement in Pain Scores-all modalities (Baron 2006) Pain Scores on opioids Detoxing off Pain Meds: Improvement in Pain Scores-all modalities (Baron 2006) Pain Scores OFF opioids How To Get Off Pain Meds? Slower Taper (10% per week etc, see FDA Guidelines) Sudden Discontinuation (ditto) Buprenorphine Induction Naltrexone (Dr. Morrone) Buprenorphine for Chronic Pain Malinoff 2005: Saw 50% reduction in pain scores for > 80% of patients. Berland, Malinoff & Weiner: approx 65% success (buprenorphine or no opioids after detox); 2/3 reported improvement. Carl Christensen MD 11

BUT BUT. Many patients have increased function on pain meds. Many patients try to taper/detox off them without benefit. Buprenorphine is not effective for all patients. Patient autonomy must be considered. The 2018 Michigan Opioid Laws The 2018 Michigan Opioid Laws: Minors = detailed informed consent must be used with minors PRESCRIBING OPIOIDS TO A MINOR - REQUIREMENT FOR INFORMED CONSENT (House Bill 4408, Public Act 246 2017) Effective June 1, 2018, before issuing an initial prescription for an opioid in a single course of treatment to a minor, a prescriber must discuss all of the following with the minor and the minor s parent or guardian: The risks of addiction and overdose The increased risks of addition for patients with underlying mental health or existing substance use disorders The danger of taking an opioid along with a benzodiazepine, alcohol or other central nervous system depressant Any other information in the patient counseling information section of the label for the controlled substance that is required under federal law (21 CFR 201.57(c) (18)) The 2018 Michigan Opioid Laws: Informed Consent = adults too! PATIENT INFORMATION ON OPIOID RISKS - REQUIREMENT FOR INFORMED CONSENT (House Bill 4408, Public Act 246 2017) Effective June 1, 2018, before an opioid is prescribed to a patient by a physician (and/or any other prescribers licensed with the state), the physician will be required to obtain the patient's informed consent on a form prescribed by the Michigan Department of Health and Human Services that they have received from the physician, the following information: The danger of opioid addiction How to properly dispose of an expired, unused or unwanted controlled substance That the delivery of a controlled substance is a felony under Michigan law If the patient is pregnant or is a female of reproductive age, the short- and long-term effects of exposing a fetus to a controlled substance, including neonatal abstinence syndrome ENFORCEMENT Failure to comply with this section could result in disciplinary action by the Michigan Board of Medicine. The 2018 Michigan Opioid Laws: MAPS MANDATORY MICHIGAN AUTOMATED PRESCRIPTION SYSTEM (MAPS) CHECKS (Senate Bills 166 & 167, Public Act (PA) 248 of 2017, and PA 249 of 2017) Effective June 1, 2018, all licensed prescribers in Michigan will be required to query the Michigan Automated Prescription System (MAPS) when prescribing controlled substances to any patient. Exceptions include the following: Prescriptions written for quantities less than a 3-day supply. If dispensing occurs in hospital or surgical freestanding outpatient facility and is administered in the facility. If the patient is an animal and the controlled substance is administered in a veterinary hospital or clinic. If the controlled substance is prescribed by a veterinarian and dispensed by a pharmacist. All licensed prescribers in Michigan will be required to register with MAPS by June 1, 2018. Carl Christensen MD 12

The 2018 Michigan Opioid Laws: 7 Day Limit LIMITATION ON OPIOID PRESCRIBING: 7-DAYS FOR ACUTE PAIN (Senate Bill 274, Public Act 251 of 2017) Beginning July 1, 2018 if a licensed prescriber is treating a patient for acute pain, the prescriber shall not prescribe the patient more than a 7-day supply of an opioid within a 7-day period. "Acute pain" is defined as pain that is the normal, predicted physiological response to a noxious chemical or thermal or mechanical stimulus and is typically associated with invasive procedures, trauma, and disease and usually lasts for a limited amount of time. ENFORCEMENT Non-compliance could result in disciplinary action by the Michigan Board of Medicine. The 2018 Michigan Opioid Laws: Bona Fide Patient- Prescriber Relationship = no pill mills BONA FIDE PRESCRIBER-PATIENT RELATIONSHIP (Senate Bill 270, Public Act 247) Beginning March 31, 2018, a licensed prescriber shall not prescribe a controlled substance listed in schedules 2 to 5 unless the prescriber is in a "bona fide prescriber-patient relationship." If a licensed prescriber prescribes a controlled substance, he or she must provide follow-up care to the patient to monitor the efficacy of the use of the controlled substance. The prescriber shall refer the patient to the patient s primary care provider for follow-up care unless the patient does not have a primary care provider, the physician must refer the patient to another geographically accessible primary care provider. Bona fide prescriber-patient relationship" is defined as treatment or counseling relationship between a prescriber and a patient in which both of the following are present: The prescriber has reviewed the patient s relevant medical or clinical records and completed a full assessment of the patient s medical history and current medical conditions, including a relevant medical evaluation of the patient conducted in person or via telehealth The prescriber has created and maintained records of the patient s condition in accordance with medically accepted standards Intermission. The Opioid Epidemic & Naloxone (Narcan ) Rescue DEVELOPED FOR FAMILIES AGAINST NARCOTICS HTTP://WWW.FAMILIESAGAINSTNARCOTICS.ORG/ Naltrexone vs. Naloxone NALTREXONE NALOXONE Oral (Rivea ) or IM (Vivitrol ) IV, IM, SC or IN (Narcan, Evzio ) Slow onset Rapid Onset Long acting (hours to weeks) Short acting (minutes) Tightest binding to brain Less tightly bound Used for PREVENTION of overdose (FDA) Used for TREATMENT of overdose (FDA) What Does Narcan NOT Do? It will not reverse an overdose from alcohol, sedatives (Benzodiazepines such as Xanax, Valium and Klonopin), muscle relaxants, or stimulants like Cocaine or Amphetamines. If there is more than one drug involved (usually Benzodiazepines and Opioids), it may partially revive the patient until EMS arrives. 78 Carl Christensen MD 13

Naloxone formulations: Who is at Greatest Risk? Abstinence > 2 weeks: treatment; jail; relapse. Discontinuing MAT: methadone; buprenorphine; Vivitrol (naltrexone). (Volkow 2014: 50% decr in OD deaths with MAT) Mixing opioids with sedatives: alcohol, benzodiazepines, muscle relaxers FENTANYL 80 81 OD deaths: heroin and Fentanyl: Washtenaw Co. Fentanyl on Urine Drug Screen Pregnant Patient 28 (heroin) 21 (fentanyl + heroin) 12 (pills) (25%) 49 (total) = 84 How To Do A Naloxone Rescue (youtube.com -> ccmdphd) Make Sure They are Not Breathing (always) Call 911 Do Rescue Breaths (not compressions) Give Naloxone Resume Rescue Breaths Repeat Naloxone every 3 mins Confirm OD Breathing: gurgling/snoring Pale, clammy skin Lim body Blue lips or fingernails Cannot wake with shout May have a pulse! 85 86 Carl Christensen MD 14

Sternal/Nasal RUB Sternal Rub Under the nose Trapezius Squeeze Fingernail Squeeze Changing Level of Consciousness (LOC)-treat as OD Call 911 The most critical step The most easily FORGOTTEN step Leave phone on speaker Lay next to you. 87 88 Start Rescue Breathing Flat on Back Tilt the head back If no mask-pinch nose Give 2 breaths, one second each. Chest wall should move 1 inch Abdomen should NOT move Repeat every 5 seconds Rescue Breathing Mask 90 91 Rescue Breathing Video Give Naloxone IM (intramuscular): Evzio IM: use safety needle IN (intranasal): use atomizer No Naloxone? Use buprenorphine!! Welsh C, Sherman SG, Tobin KE. A case of heroin overdose reversed by sublingually administered buprenorphine/naloxone (Suboxone). Addiction. 2008; 103(7):1226 1228. [PubMed: 18554353] 93 Carl Christensen MD 15

Evzio Intranasal (I.N.): ADAPT (4mg!) 94 98 After EMS arrives.. Watch out for needles! Clean up all blood! You now have a window of opportunity.. Window of Opportunity 100 101 Rescue breathing https://www.youtube.com/watch?v=g8sh9-5n- PA&t=7s&list=PLvLNFKhl1S7hE6wVk2kEPEH9HWA7-NIUx&index=1 Giving Naloxone https://www.youtube.com/watch?v=hgvsao1oxpg&list=plvlnfkhl1s7he6wvk2kepeh9hwa7- NIUx&index=2 Carl Christensen MD 16