2014 MA ACP Annual Scientific Meeting 1

Transcription

1 Safe & Effective Management of Chronic : A Primary Care Core Competency November 8, 2014 Christopher W. Shanahan, MD, MPH, FACP Assistant Professor of Medicine Boston University School of Medicine Boston Medical Center Certified: Internal Medicine (ABIM) & Addiction Medicine (ASAM ) No Conflict of Interest 1 Learning objectives Understand the scope, etiology, & consequences of the U.S. prescription opioid epidemic. Understand rationale for & methods to: Risk assess patients prior to treating pain with opioid medications. Monitor benefit & risk associated with pain management using opioid medications. Refer or discontinue opioid medications. 2 The Problem Under-treatment of pain MA ACP Annual Scientific Meeting 1

2 Opiophobia Addiction / Diversion Quality of Care Safety / Liability 4 Opioid sales, opioid-related deaths & opioid treatment admissions Warner et al Drug overdose deaths by major type in U.S., National Vital Statistics System MA ACP Annual Scientific Meeting 2

3 Where Med Rx s were obtained Source for Most Recent Nonmedical use (Past year users > 11 yo) SAMHSA, OAS, NSDUH data, Where are all these meds coming from? Legitimate Provider Prescriptions: common source misused/diverted opioids Doctor shopping: ~ 0.7% of pts on opioids. a/w mortality. Drug dealers also obtain Rx s from physicians. ED & Day surgery opioid prescriptions a significant source of misused opioids Cicero TJ, et.al. J Drug Issues. 2011; Rigg KK,, et.al. Drugs McDonald DC,, et.al. PLoS One. 2013; Jena AB,, et.al. BMJ Peirce GL,, et.al. Med Care. 2012; Chapman CR, Korean J Factors leading to risk of overdose death 1/1/07-12/31/11 (5 years) 30% Tennessee population filled opioid Rx each year. Gwira Baumblatt, JAMA 2014 risk of opioid-related OD death a/w: Risk Factor Adjusted Odds Ratio 95% CI 4 or more prescribers pharmacies more than 100 MMEs Persons w/ 1+ risk factor comprise 55% of all OD deaths MA ACP Annual Scientific Meeting 3

4 Chronic and the Unexpected 66 yo here for follow-up Primary Care. Hx: Longstanding T2DM, HTN, OSA and Severe diabetic neuropathy confirmed by Neurology. Ibuprofen & Acetaminophen tried with no or limited effect. Pt still requesting treatment for lower extremity pain. New meds prescribed: Oxycodone (5 mg) / APAP (325 mg). 1 tab po qid X 28 days; Disp: #112. Gabapentin 300 tid (tapered start). FU visit in 1 month. 12 days later patient calls: Out of pain medication & requesting oxycodone refill. Took more pills than Rx d b/o inadequate pain relief. is 12/10. Not taking gabapentin because Doesn t do anything. 10 Goals Goal 1: Avoid / Mitigate this situation. Set expectations - Informed consent Assess for risk. Goal 2: Maximize Benefit (Safety & Quality of Care). management plan, Goal 3: Minimize risk. Prepare for the unexpected. Establish monitoring plan. 11 Setting expectations - Informed consent Set Expectations: free is not a realist expectation. Treatment as a Trial Reserving the right to stop the medications if response is inadequate or unsafe. Patient Responsibilities: Communication if unacceptable levels of post-operative pain, Medication Disposal, No sharing. Discuss Benefits & Risks Opioids (Focus: Safety) Benefits relief, Increased function, Quality of Life. Risks Side effects: physical dependence; sedation. Misuse, abuse, addiction, overdose, death. Drug interactions. Paterick et al. Mayo Clinic Proc MA ACP Annual Scientific Meeting 4

5 Pre-prescribing opioid risk assessment 1. Screen for Risk Substance Use Single Item Drug & Alcohol 2.CheckMassachusetts Prescription Medication Program (PMP) 3.UseOpioid Risk Tool (ORT) 13 Single item drug & alcohol risk screening Drug How many times in the past year have you used an illegal drug or used a prescription medication for non-medical reasons? If asked to clarify meaning of non-medical reasons, add "for instance because of the experience or feeling it caused" = Response >0 100% sens., 74% spec. for Drug Use Disorder 93% sens. & 94% spec. for Past-year Drug Use Smith PC, et.al Alcohol (NIAAA): Do you sometimes drink beer wine or other alcoholic beverages? How many times in the past year have you had 5 (4 for women) or more drinks in a day? = Response >0 82% sens., 79% spec. for Alcohol Use Disorder NIAAA. Clinicians Guide to Helping Patients Who Drink Too Much, Massachusetts Prescription Medication Program (PMP) A secure website supporting safeprescribing & dispensing. A licensed prescriber or pharmacist may obtain authorization, to view the prescription history of a patient for the past year. MA Online PMP assists state & federal agencies address prescription drug diversion supports ongoing, specific controlled substances-related investigations MA ACP Annual Scientific Meeting 5

6 Before Prescribing: The Opioid Risk Tool (ORT) Family History of Substance Abuse Alcohol 3 1 IllegalDrugs 3 2 Prescription Drugs 4 4 Personal History of Substance Abuse Alcohol 3 3 IllegalDrugs 4 4 Prescription Drugs 5 5 Age (Mark box if 16 45) 1 1 h/o Preadolescent Sexual Abuse If present 0 3 Psychological Disease h/o ADD, OCD, Bipolar, Schizophrenia 2 2 Depression 1 1 Total LR Webster, management planning Non-opioid pain medications Adjunct Medications to Opioids. Acetaminophen / NSAIDS (Naprosyn). Tylenol with Codeine. Adjunct analgesics: Gabapentin, Amitriptyline. Local measures (heat/ cold / massage, etc.). Non-medication based Therapies. Physical Therapy / Counseling / Optimize transportation & housing. Plan for unexpected outcomes Develop & implement policies. Discuss policy pre-operatively with patient when consenting. Instruct patient when, how, & who to contact. Establish specific strategies for: Treatment escalation. Dealing w/ aberrant medication taking behaviors. J Barden J, et.al. Cochrane Reviews 2004 CJ Derry et.al. Cochrane Reviews Ran out meds early is a symptom. 1. With patient Review treatment agreement & Policies. Reset expectations. 2. What is going on? What is the diagnosis? Unfounded patient expectations? Inadequate pain-management? Progression of disease? New disease process? Misuse? Addiction? Diversion? MA ACP Annual Scientific Meeting 6

7 4 yrs later: Managing chronic pain Pt (70 yo) stable on MS Contin 60 mg bid. (~3.5 ys.). Today: Monthly Follow-up visit for refills. Patient reports: manageable. (PEG = 5 5). Feeling more anxious (PEG = 3 7). Less active. (PEG= 4 9). Increasingly forgetful. Recently fell & hit head. Despite repeated attempts, unable to taper opioid - Pt states is the onlypain med that works. 19 Risk - Benefit Framework Unintended consequences Not all meds taken Increased risk for Diversion Misuse, abuse, addiction, overdose, death 20 Assessing benefit PEG(, Enjoyment, General activity) scale (0-10) 1. What number best describes your on averagein the past week? (No pain (0) as bad as you can imagine (10)) 2. What number best describes how, during the past week, pain has interfered with your Enjoyment of life? (Does not interfere(0) completely interferes (10)) 3. What number best describes how, during the past week, pain has interfered with your General activity? (Does not interfere(0) Completely interferes (10)) Krebs EE, et al. J Gen Intern Med MA ACP Annual Scientific Meeting 7

8 Aberrant medication-taking behaviors Spectrum: to Flags o Requests for increase opioid dose. o Requests for specific opioid by name, brand name only. o Non-adherence w/other recommended therapies (e.g., PT). o Running out early (i.e., unsanctioned dose escalation). o Resistance to change therapy despite AE (eg. over-sedation). o Deterioration in function at home and work. o Non-adherence w/monitoring (e.g. pill counts, UDT). o Multiple lost or stolen opioid prescriptions. o Illegal activities forging scripts, selling opioid prescription. 22 Monitoring Aberrant Behaviors The Screener & Opioid Assessment for Patients with (SOAPP) helps determine required monitoring for patients on long-term opioid therapy How often do you have mood swings? 2. How often do you smoke a cigarette within an hour after you wake up? 3. How often have any of your family members, including parents and grandparents, had a problem with alcohol or drugs? 4. How often have any of your close friends had a problem with alcohol or drugs? 5. How often have others suggested that you have a drug or alcohol problem? 6. How often have you attended an AA or NA meeting? 7. How often have you taken medication other than the way that it was prescribed? 8. How often have you been treated for an alcohol or drug problem? 9. How often have your medications been lost or stolen? 10. How often have others expressed concern over your use of medication? 11. How often have you felt a craving for medication? 12. How often have you been asked to give a urine screen for substance abuse? 13. How often have you used illegal drugs (for example, marijuana, cocaine, etc.) in the past five years? 14. How often, in your lifetime, have you had legal problems or been arrested? 0 = Never, 1 = Seldom, 2 = Sometimes, 3 = Often, 4 = Very Often 2009 Inflexxion, Inc. 23 A score of 7 or higher is considered positive. Urine Drug Testing (UDT): Key to opioid prescribing Why to do it: Provides objective information supporting safety (patient & public). Demonstrates med adherence. Is patient using the Rx? Shows substances that patient shouldn t be using? Helps prevent abuse if pts know drug tests will occur. How to Discuss UD Testing with Patients: Some providers feel awkward discussing UDT ing. Frame as a personal & public health safety issue. Remind patients that: Opioid are dangerous & Providers can t tell which pts will develop problems. Its the Standard of care for treatment with these medications. You monitor all your patients: Universal Precautions (No singling out). When to Perform Urine Drug Testing: No clear standard: Regular scheduled basis vs. Random. Implement when concerns arise (e.g. aberrant behavior) MA ACP Annual Scientific Meeting 8

9 When to refer Possible addiction or misuse. Addiction Specialist. Substance Abuse Treatment Program. Assistance with or discomfort with prescribing high levels of chronic opioids. Specialist. Assistance w/ tapering / discontinuing high doses of opioid. Addiction Specialist. Substance Abuse Treatment Program. 25 When to discontinue: Risks > Benefits DO NOT have to prove diversion/addiction to stop opioid therapy. Absolute Indications for Stopping Opioid Therapy. No benefit identified. Harms from treatment. Cannot keep medications safe. Unable / unwilling to comply w/ required monitoring. Active addiction (unstable). Illegal activity / medication diversion. Violent / abusive behaviors practice staff/clinicians. Relative Indication for stopping opioid therapy Clinical judgment required (excl. absolute indication for stopping). Risks of opioid treatment outweigh potential benefits. 26 Online tools Before Starting Opioids Starting Opioids Continuing Opioids Stopping Opioids Live Conferences Online Training (FREE) Videos Patient Ed Resources Practice posters ER/LA Opioid Analgesics Info Patient Prescriber Agreements Assessment & Monitoring Tools Resources / Guidelines / Bibliography MA ACP Annual Scientific Meeting 9

10 Treating Chronic - In a Nutshell Establish an etiology of the pain. Establish realistic Goals of Care. Consider & use all modes of pain management. Use online tools to assess risk of treatment with opioids. Set expectations in the context of Informed Consent. Start Low -Go Slow. Adopt a trial mindset based on outcomes. Monitor: Functional Goals (PEG). Urine Drug Testing & Pill Counts (Scheduled & Random). Refer if outside comfort zone ( or Addiction). Discontinue opioids when Risks > Benefits. Judge the treatment not the patient. 28 Summary Screen and assess Risk for all patients for risk of substance misuse / abuse. Provide Informed Consent & Set Expectations. Perform ongoing monitoring. Make a diagnosis when the unexpected occurs. Discontinue opioids when Risks > Benefits. Access resources a/o ask for help. Judge the treatment not the patient. 29 Thank You MA ACP Annual Scientific Meeting 10

11 DSM-5 - Substance use disorder Presence of at least 2 of 11 criteria clustered in four groups: Impaired control: 1. taking more or for longer than intended 2. unsuccessful efforts to stop or cut down use 3. spending a great deal of time obtaining, using, or recovering from use 4. craving for substance. Social impairment: 5. failure to fulfill major obligations due to use 6. continued use despite problems caused or exacerbated by use 7. important activities given up or reduced because of substance use. Risky use: 8. recurrent use in hazardous situations 9. continued use despite physical or psychological problems that are caused or exacerbated by substance use. Pharmacologic dependence: (10) tolerance to effects of the substance # of criteria met: A general measure of severity: mild(2 3 criteria) moderate(4 5 criteria) severe(6 or more criteria) * Persons prescribed meds such as opioids may exhibit these 2 criteria, but would not (11) withdrawal symptoms when not using or using less.* necessarily considered to 31 have a substance use disorder. All to prevent Addiction A primary, chronic, neuro-biologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations A clinical syndrome presenting as Loss of Control Compulsive use Continued use despite harm Craving Aberrant Medication Taking Behaviors Savage SR et al. J Symptom Manage Risk of addiction Published rates of substance abuse and/or addiction in chronic pain populations are 3-19% Risk factorsfor addiction to any substance are good predictors for problematic prescription opioid use: Past cocaine use, h/o alcohol or cannabis use Lifetime h/o substance use disorder H/o severe depression or anxiety FMHx of substance abuse, a h/o legal problems, drug & alcohol abuse Tobacco dependence Ives T et al. BMC Hlth Svcs Rsch 2006 Reid MC et al JGIM 2002 Michna E el al. JPSM 2004 Akbik H et al. JPSM MA ACP Annual Scientific Meeting 11

12 More than they need Study: Oral surgeons opiate Rx practices after 3 rd molar extraction. > 20% of surgeons Rx d a higher # of pills than considered necessary. Study: Pt s opioid use s/p OutPt upper extremity surgery Pts recv d avg ~30 pills (OC, HC, or propoxyphene). Used only 14 of those pills at most. Mean # pills consumed by pts: ~10 pills. (1/3 of # Rx d!!) Patients receiving more opioids than needed to manage post-surgical pain. Bates C, et.al. J. Urology. 2011; Fischer B, et.al. Addiction Rodgers J, et.al. J. of Hand Surgery Mutlu I, et.al. J. of Oral & Maxillofacial Surgery and more likely to keep taking them. Despite for Short-term care of acute pain, Narcotic Rx immediately post surgery a/w eventual long-term use. Pts Rx d Opioids w/in 7 d of day Sx: 44% more likely continue long-term vs patients not prescribed. Longitudinal cohort s/p Surgery (n-172): Despite pain & function > 50% continued opioid pain meds. Of Pts not previously Rx d opioids prior to Sx -20% continued opioid pain meds > 1 year MA ACP Annual Scientific Meeting 12