1/25/17 PISA & THMEP January 28, 2017 Kenneth B. Gossler M.D. PISA Physicians Kenneth B. Gossler M.D. Education University of Arizona Med School 1992. THMEP Intern 1993 Anesthesiology Residency at Financial Disclosures: None University of Arizona 1996 Pain Management Fellowship Mayo Clinic 1997 Board Certified Anesthesiology and Pain Medicine Practicing Pain Management in Tucson since 1997 U of A Assoc. Professor Objectives When to Refer 1. Understand when to refer to pain management. To Pain Management To Spine Surgeon $$ 2. Opioid review including abuse deterrence. Pain that interferes with function. Before Long term opioids Before Surgical referral Chronic LBP Acute Radiculopathy Patients who don t want surgery. Cervical Stenosis with myelomalacia Cauda Equina Syndrome Severe Weakness Persistent radiculopathy despite conservative care Ultra-Severe Lumbar Spinal Stenosis 3. Become familiar with Opioid Prescribing Guidelines. 4. Review Urine Drug Screening. 1
Refer for Medical Management When to Refer to Pain Not responding /Outside comfort zone Diagnostic help Interventional Pain Help with adjuvants Weaning Endorsing therapy Detox How to refer to Pain Provide notes, MRI, and reason for referral Have at least 2 week supply of medications Provide risk information Impolite to refer patients with interventions done elsewhere. Interventional Pain Epidural Steroids: Cervical, Thoracic, Lumbar Radiofrequency Facet Rhizotomy Major Joint and Trigger Point Injections Sacroiliac RF Lateral Branch Rhizotomy Sympathetic Blocks Peripheral Nerve Blocks Trigger Point Injections Kyphoplasty Spinal Cord Stimulation Primary Care Assessment after Intervention Pain is very subjective Must identify for the patient what pain is being treated. Pain does not move. Ask for % relief or improvement of function Try to get validation from family members Patients have very poor memory reporting pain. We call patients 1 week after. Chronic Opioid Therapy (COT) Evidence for Chronic Narcotic Therapy Review of Opioids & Abuse Deterrence Opioid Treatment Guidelines Opioid Contracts Urine Drug Screens Dismissing Patients Chronic Pain Prevalence of Chronic Pain: 9-20% of the population has moderate to severe chronic pain. More than 20% of patients in an average primary care practice have chronic pain Cost to treat chronic pain exceeds the combined cost of treating patients with coronary artery disease, cancer and AIDS. Medical School and Residency Programs spend very little time teaching how to treat Chronic Pain. Evidence Supporting Chronic Opioids Opioids moderately effective for pain relief Slightly effective for functional outcomes Pain relief is in the 30% range Very little evidence supporting use beyond 12 weeks Half of patients discontinue opioids There is very little evidence supporting doses higher than 200mg/day morphine equivalents 2
National Institutes of Health 2015 The role of opioids in the treatment of chronic pain: Evidence is insufficient for every clinical decision that a provider needs to make about the use of opioids for chronic pain, leaving the provider to rely on his or her clinical experience. Sustained Release Opioids Morphine: (200 mg/day=200 MED/day) Oxycodone: (130 mg/day) Hydromorphone: (50mg/day) Transdermal Fentanyl: (75ug/day) Oxymorphone:(70mg/day) Methadone: (25 mg/day)? Tramadol (1000 mg/ day) Buprenorphine : Transdermal and Buccal Film Tapentadol: (560mg/day) Buprenorphine Transdermal and Buccal Patch Schedule III 5, 7.5, 10,15 and 20 ug/hr 7 day patch 75-900 microgram Buccal Patch Partial agonist at mu, Antagonist at Kappa and Delta Seems more effective than equianalgesic Do not use if MME> 160mg Tapentadol First new opioid molecule in decades ER and IR Opioid receptor activity and SNRI Activity Better G.I. Side effect profile Better for neuropathic pain (PHN) Abuse Deterrent Opioid Studies Category 1: Laboratory Manipulation and Extraction Studies. Category 2: Pharmacokinetic Studies Category 3: Clinical Abuse Potential Studies Category 4: Postmarket Studies Abuse Deterrent Opioids Strategy Physical/Chemical Barriers Agonist/Antagonist Combinations Aversion Implants/Depot formulations New Molecular Entities CDER, US FDA, US HHS, Guidance for Industry: Abuse Deterrent Opioids-Evaluation and Labeling 20152 3
Opioids Do Not Prevent End Organ Damage Chronic pain releases excitatory neurotransmitters which causes localized cortical volume loss Effects Prefrontal Cortex, and connections More common in neuropathic pain. Changes reversed with SCS, Injections and Surgery. New Pharmacologic targets to treat chronic pain. Adjuvants NSAIDS, Acetaminophen Pregabalin (Lyrica) Gabapentin Sustained release gabapentin TCAs, Duloxetine Muscle Relaxants (Short Term) Avoid Carisoprodal, Benzodiazepines and Marijuana in combination with opioids. Complex Decision RISKS Abuse, Addiction, Overdose Toler ance Accidents injuries Hypogonadism Sleep Apnea Hyperalgesia Diversion Risk to Medical License BENEFITS Quality of Life Mood Social Role Physical Activity Work Pain Relief Decade of Pain Control and Research 2000-2010 Opioid sales have quadrupled 1999-2010 Oxycodone usage increased 866% in 10 yrs 2% of Americans abuse prescription pain relievers Abuse rates of C.O.T. 5-40% 14,000 people died in the US (2010) from overdose related to opioid pain relievers. 4 times the number in 1999. 4
2009 American Geriatric Society Guidelines NSAIDS: may be considered rarely and with extreme care in highly selected individuals. Opioids: All patients with moderate to severe pain, pain related functional impairment or diminished quality of life due to pain should be considered for opioid therapy. State Guidelines Opioid Guidelines Federation of State Medical Boards CDC Guidelines Medical Society Guidelines Arizona Opioid Prescribing Guidelines 2014 Standard of Care? Opioid Overdose Washington State Guidelines 2007: Reduced High Dose (120 MED/day) opioids by 35% deaths dropped 50%. 1 Risk of Overdose Odds Ratio 2 1-20 MED 20-49 MED 50-99 MED 100+ MED 1. 0 1.4 4.0 9.o 1. American Journal of Ind Med 21012;55:325-331 2. Ann Inter Med 2010;152(2):85-92 Governor Doug Ducey Executive Order October 2016 401 people in Arizona Died of Prescription Drug Overdose Initial fill of any opioid prescription limited to a 7 day supply. Minors can only get a 7 day supply for initial and subsequent opioid prescriptions, EXCEPT in the case of cancer, other chronic disease or traumatic injury. Intended to decrease diversion. Arizona Opioid Prescribing Guidelines 2014 Twelve steps to prescribe opioids. BEST PRACTICE not Standard of Care Follows Federation of State Medical Board guidelines but updated. www.azdhs.gov/clinicians/cli nica l- gui del ines -recomme nda ti ons 5
Arizona Opioid Prescribing Guidelines 2014 1. Comprehensive medical and pain related evaluation that includes assessing for substance use, psychiatric comorbidities and functional status should be performed before initiating opioid treatment for chronic pain. We u tilize the Opioid Risk Tool and the Prolo Functional and Economic Scale #2 Goal Directed COT Trial #2 Goal directed trial of opioid therapy is considered appropriate when pain is severe enough to interfere with quality of life and function and the patient has failed to adequately respond to indicated non-opioid and non-drug therapeutic interventions. Potential benefits should be determined to outweigh risks. The patient should agree to participate in other aspects of pain care such as physical therapy and cognitive behavioral therapy when these therapies are recommended and available. Chronic opioid therapy should be a last resort. #3 Assess Risk of Misuse Substance use history: Alcohol, tobacco, illicit drug use. Family history, legal problems, psychiatric illnesses age,45 y.o. Risk of Adverse Events: Age>65, sleep disordered breathing, use of sedative medications, cognitive impairment. Aberrant Drug Related Behaviors: Decreased function, non-compliance Risk Stratify : Low Medium, High Low Risk Diagnosis makes sense Active coping strategies Risk Stratification Well motivated, compliant Attempting to function UDT and CSMP appropriate No ADRB: Lost prescriptions Moderate Risk Multiple areas of Pain Moderate psychological issue History of substance abuse Only one UDT or CSMP violation Moderate activity and coping strategies High Risk Widespread pain without objective signs and symptoms Unstable or untreated substance abuse, psychiatric disorder, suicide risk History of current or troublesome ADRB Unwilling to participate in multimodal therapy, not functioning Multiple CSPMP issues, or UDT inconsistent #4 Trial of Opioids Initiating opioids should be short term therapy to facilitate treatment. PT, Interventions, Surgery COT: A trial of 30-90 days. Then document a risk benefit decision. Consider consulting a pain specialist Discontinue if there is not an improvement in quality of life, improved function, and improved analgesia 6
#5 Patient Involvement Opioid Pain Agreement Treatment Goals Informed Consent Multimodal treatment, PT, Cognitive Behavioral, Interventions Patient Monitoring Monitor progress on treatment plan Regular face to face encounters. No longer than 3 months 6 A s: Analgesia, Activity, ADRB, Adverse Effects, Affect, and Adjuncts Periodic UDT: Low risk (yearly), Moderate (6 months), High (3 months) Re-evaluate Use the lowest possible dose to improve function Doses > 100 MEDD should trigger a re-evaluation Consider: Switching opioids, taper, referral to specialist Primary care setting > 50-100 MEDD consider referral to specialist If functioning well and on >50-100 MEDD consider Taper Reasons for Taper/Discontinuation Unmanageable side effects Illegal or unsafe behaviors Misuse suggestive of addiction Lack of effectiveness Successful treatment of pain Poor function, high degree of disability Consider referral to addiction specialist/ Inpatient Detox Other Issues Do not prescribe with Benzodiazepines and Carisoprodol Do not use Methadone. Don t exceed 30 mg/day in primary care. Marijuana? Chronic Pain Patients Sir William Osler It is much more important to know what sort of a patient has a disease than what sort of disease a patient has. 7
Urine Drug Screen Prescreen to look for drugs of abuse, and compliance with current therapy Continued Random Drug Screen: Used to encourage compliance and detect illicit drug use. Quantitative Urine Drug Screens used to measure compliance and detect possible diversion. Urine Drug Screen dipstick In Office Point of Care Testing Test for Drugs of Abuse plus usual chronic Must get confirmatory testing for all positives before making clinical decisions. High Rate of False positives and moderately high rate of false negatives Immunoassay $ Urine Drug Testing Much lower Cut-offs Very Low false negatives Still Significant false positives Used as a screen to reduce the # of tests for GC/MS Gas Chromatography Mass Spec $$ Confirmatory testing of the Immunoassay Very accurate with cutoffs in the 100ng/ml. Interpreting UDS Codeine Metabolized to Morphine Morphine can be metabolized to Hydromorphone Hydrocodone Metabolized to Hydromorphone Oxycodone metabolized to oxymorphone Methamphetamines false positives with cold medications Will dismiss patients for illicit drug use Management of Opioid Withdrawal If patient is unsafe, consider inpatient Detox. Clonidine 0.1 mg tid x 1 week Nausea: Ondansetron, Promethazine, Prochlorperazine Sleep: Trazodone, Hydroxyzine, Diphenylhydramine Diarrhea: Bismuth, Loperamide. Follow up in 1 week. Dismissing Patients Must give 30 days continued care. Not obligated to prescribe opioids if unsafe Can prescribe a tapering dose Medications to ameliorate withdrawal symptoms Some patients will go through withdrawal. Provide a list of other providers Referral for Detox 8
Future Directions New opioids and medications directed towards neuroinflammation. Biologics: PRP, Stem Cell, Amniotic Fluid Treatment for Addiction Cognitive Behavioral Therapy Discogenic LBP 9