An SBIRT Approach to Pain and Addiction

Transcription

1 An SBIRT Approach to Pain and Addiction J. Paul Seale, MD, Daniel P. Alford, MD, MPH, and H.E. Woodall, MD Southeastern Consortium on Substance Abuse Training September 1,

2 J. Paul Seale, MD, Daniel P. Alford, MD, MPH, and H.E. Woodall, MD Disclosures The authors have no relevant financial conflicts of interest to disclose. 2

3 Planning Committee, Disclosures AAAP aims to provide educational information that is balanced, independent, objective and free of bias and based on evidence. In order to resolve any identified Conflicts of Interest, disclosure information from all planners, faculty and anyone in the position to control content is provided during the planning process to ensure resolution of any identified conflicts. This disclosure information is listed below: The following developers and planning committee members have reported that they have no commercial relationships relevant to the content of this webinar to disclose: AAAP CME/CPD Committee Members Dean Krahn, MD, Kevin Sevarino, MD, PhD, Tim Fong, MD, Tom Kosten, MD, Joji Suzuki, MD; and AAAP Staff Kathryn Cates-Wessel, Miriam Giles, Sharon Joubert Frezza, and Justina Andonian. All faculty have been advised that any recommendations involving clinical medicine must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. All scientific research referred to, reported, or used in the presentation must conform to the generally accepted standards of experimental design, data collection, and analysis. The content of this CME activity has been reviewed and the committee determined the presentation is balanced, independent, and free of any commercial bias. Speakers must inform the learners if their presentation will include discussion of unlabeled/investigational use of commercial products. 3

4 Target Audience The overarching goal of PCSS-O is to offer evidence-based trainings on the safe and effective prescribing of opioid medications in the treatment of pain and/or opioid addiction. Our focus is to reach providers and/or providers-in-training from diverse healthcare professions including physicians, nurses, dentists, physician assistants, pharmacists, and program administrators. 4

5 Educational Objectives At the conclusion of this activity participants should be able to: Describe negative consequences that may occur in patients who receives prescriptions for opioid medication. Construct an initial assessment and baseline measurement of a patient requesting opioid therapy. Use a monitoring framework to protect the safety of patients receiving ongoing opioid therapy. Treat concerning behaviors of patients on chronic opioid therapy. 5

6 SBIRT Approach Screening Initial Assessment: before prescribing, check PMP & medical records, assess for risk factors & obtain baseline measures using the PEG/6 A s Implement Universal Precautions: agreement, UDS, pill counts Monitor for benefit & concerning/aberrant behaviors Brief Intervention: Address concerning/aberrant behaviors: express concern, ask pt to explain Increase monitoring Taper if there s no benefit or behaviors continue Referral to Treatment: if abuse/addiction, refer for formal treatment, buprenorphine or methadone 6

7 Opioid User s Pyramid Addiction (4 Cs: Loss of control, compulsive use, craving, continued use despite harm) Prescription Drug Misuse (recurrent harms related to use) Concerning (Aberrant) Medication Taking Behaviors &/or Multiple Risk Factors Low Risk Patient with No Concerning Behaviors 7

8 Risk Levels: Level 3: Rx Drug Misuse Level 4: Addiction (4 Cs) Loss of Control Compulsive use Continued use despite harm Craving Recurrent problems: Failure to fulfill major obligations Use in hazardous situations Substance-related legal problems Continued use despite social/interpersonal problems Risk Factors for Addiction or Abuse: Tobacco dependence History of alcohol, cannabis, or cocaine use Family history of substance abuse Lifetime history of substance use disorder History of severe depression or anxiety Legal problems Level 2: Aberrant Rx- Taking Behaviors, Multiple Risk Factors Level 1: No Concerning Behaviors Spectrum of severity Illegal activities Missing/lost prescriptions Non-adherent with monitoring Deterioration in function Resistance to change therapy Runs out of Rx early Requests specific brand Requests increased dose Non-adherence with other therapies No concerning behaviors (no early refill requests or dose escalation; keeps appts, brings pill bottle; Rx count correct, UDS OK ) Pre-visit Assessment: Obtain records from previous providers Check state Prescription Monitoring Program Scan available hospital/clinic records Analgesia (P) Assessment: 6 As: What number (0-10) best describes your Pain level on average last week? Affect (E) Activities (G) Adjuncts What number (0-10) best describes how, during the past week, pain has interfered with your Enjoyment of life? What number (0-10) best describes how, during the past week, pain has interfered with your General activity? Measure PEG score every visit. Taper meds at 3-6 months if PEG score does not improve. What else have you done to try to reduce/manage your pain (non-opioid meds, exercise, physical therapy, guided imagery, yoga, cognitive behavioral therapy, injections, pumps)? Adverse Effects Constipation, nausea, sedation, decreased cognition, loss of control Aberrant Behaviors (See Level 2 above) Not at all cm Extremely 1 8

9 Prescription Opioid Monitoring Framework: Risk/benefit discussion Explore non-opioid treatment options Opioid test/trial Define treatment goals Encourage patient responsibility Potential benefits: Analgesia, function, quality of life Potential risks: Toxicity/side effects (sedation, constipation), functional impairment (driving, heavy machinery), interactions (alcohol, sedatives), physical dependence, increased pain sensitivity, loss of control/ addiction (3-19%), overdose/death Non-opioid analgesics (oral, topical), injections, pumps Exercise/flexibility training Physical therapy If appropriate, talk about opioid test/trial of 3-6 months. Yoga/meditation/guided imagery Cognitive behavioral therapy Add gabapentin to opioids Work with patient to identify specific, measureable, realistic, functional goals & measure using the PEG. Use these goals jointly to measure benefit. Remind patient that pain is unlikely to go away completely. Explain legal responsibilities (safeguarding, lockbox, disposing, not sharing or selling). Encourage patient to look out for early signs of harm. (Safe to drive or operate heavy machinery? Trouble controlling the use of meds?) Explain opioid monitoring measures including agreement/contract Why? Patient safety, standard policy with all patients. Universal Precautions are used to protect patient safety: Agreements (1 provider, no early refills) Urine Drug Testing for evidence of: Therapeutic adherence Non-use of illicit drugs Pill Counts Prescription Monitoring Programs Phone Follow-up Agreement/contract is scanned into chart. Caution with higher opioid doses (OD risk lowest at 1-20 mg/d morphine equivalent, 3.7x higher with mg/d, 8.9x higher with >100mg/d). Set level of monitoring to match risk (more visits/monitoring in high-risk patients or those with aberrant behaviors). Consider tapering or switching to buprenorphine or methadone if: PEG shows no benefit at 3-6 months & /or repeated aberrant behaviors Taper Guidelines: emphasize risk/benefit & safety issues, show empathy, taper meds by 10-20% per week, use comfort meds for withdrawal symptoms, continue non-opioid Rx Differential Diagnoses: Assessment Balance Risk vs. Benefits Brief Intervention Talking Points Guidelines for Discontinuing Opioids: Inadequate analgesia (pseudoaddiction); Addiction; Opioid analgesic tolerance; Self-medication of psychiatric or other physical symptoms (not pain); Criminal intent (diversion). Assess PEG; Assess for aberrant behaviors; Check state prescription monitoring program. Discussion with patient: Nonjudgmental, open-ended questions, express concerns, examine for patient flexibility (is the patient focused more on the opioid or pain relief?). Assess & document benefits and harms. Benefits must outweigh observed or potential harms to continue opioids. Not necessary to prove addiction or diversion to stop opioids. When pain not responsive to opioids: Treat underlying disease, comorbidities, offer adjuncts. If benefit lacking, STOP opioids (or taper and reassess). When concerned about abuse or addiction: Increase monitoring; switch to buprenorphine/methadone, stop opioids or refer to Tx Empathize with patient remaining collaborative and respectful Reiterate lack of benefit with no good fix Focus on patient strengths Encourage other therapies for coping with pain Commit to continue care without opioids Stress some patient s pain improves when opioids are stopped Clarify not discharging patient, discontinuing ineffective Tx Taper slowly to prevent withdrawal Tapering Decrease by 10-20% per week Medications: Allow supply of short-acting meds for breakthrough symptoms Treatment clonidine Schedule close follow-ups Comfort ibuprofen, dicyclomine, antiemetics, muscle relaxants, antidiarrheals, sleep aids Funded by: Discontinuation Strategy Discuss possible addiction: specific feedback on concerns, agree to disagree, risks outweigh benefits, menu of options (detox & opioidfree treatment, buprenorphine, or methadone) Rev. Apr

10 Part 1: SCREENING--Initial Assessment & Baseline Measurement 10

11 SCREENING--Initial Assessment Starts before the office visit: Obtain records from previous MDs Check state Prescription Monitoring Program Scan available hospital &/or clinic records Defer prescribing if data are unavailable 11

12 Prescription Monitoring Programs better than a urine drug screen Identify patients using multiple providers Beware limitations: time lag, often will not include information from neighboring states 12 12

13 OPIOID RISK TOOL Mark each Item Score Item Score box that applies If Female If Male 1. Family History of Substance Abuse Alcohol [ ] 1 3 Illegal Drugs [ ] 2 3 Prescription Drugs [ ] Personal History of Substance Abuse Alcohol [ ] 3 3 Illegal Drugs [ ] 4 4 Prescription Drugs [ ] Age (Mark box if 16 45) [ ] History of Preadolescent Sexual Abuse [ ] Psychological Disease Attention Deficit Disorder, Obsessive Total Score Risk Category: Low Risk 0-3, Compulsive Disorder, Moderate Risk 4-7, Hi Risk 8 Bipolar, Schizophrenia [ ] 2 2 Reprinted by Permission: Lynn Webster, MD Depression [ ] 1 1 TOTAL Webster LR, Webster R. Predicting aberrant behaviors in Opioid-treated patients: preliminary validation of the Opioid risk tool. Pain Med. 2005;6 (6):432 13

14 Assessment: The PEG/ACA (6 A s) Analgesia Affect Activity Adverse effects Concerning (Aberrant) behaviors Adjuncts Jackman RP & Mallett BS, AFP 2008; 78:

15 Analgesia, Affect & Activity (PEG*) 1. What number best describes your Pain on average in the past week? (0=No pain 10=Pain as bad as you can imagine) 2. What number best describes how, during the past week, pain has interfered with your Enjoyment of life? (0=Does not interfere 10=Completely interferes) 3. What number best describes how, during the past week, pain has interfered with your General activity? (0=Does not interfere 10=Completely interferes) *Add these 3 numbers to generate a validated measure you can follow over time Krebs EE, et al. J Gen Intern Med

16 Pain Assessment Note with PEG (Sample) FAMILY HEALTH CENTER PAIN/OPIOID ASSESSMENT NOTE 1. PAIN LOCATION and ETIOLOGY: 2. ANALGESIC REGIMEN: 3. PAIN SCALE (PAST 24 HOURS; 0=NO PAIN to 10=WORST PAIN POSSIBLE) NOW: WORST: BEST: 4. 6 A s: (1)ANALGESIA: WHAT NUMBER BEST DESCRIBES YOUR PAIN ON AVERAGE IN THE PAST WEEK? (0=No pain to 10=Worst pain possible) (2)AFFECT: WHAT NUMBER BEST DESCRIBES HOW, DURING THE PAST WEEK, PAIN HAS INTERFERED WITH YOUR ENJOYMENT IN LIFE? (0=Does not interfere to 10=Completely interferes): (3)ACTIVITY: WHAT NUMBER BEST DESCRIBES HOW, DURING THE PAST WEEK, PAIN HAS INTERFERRED WITH YOUR GENERAL ACTIVITY? (0=Does not interfere to 10=Completely interferes): TOTAL PEG SCORE(1+2+3): BASELINE: LAST WK: TODAY: (4)ADJUNCTS: WHAT OTHER METHODS ARE YOU USING TO DECREASE YOUR PAIN? (5)ADVERSE EFFECTS: ANY SIDE EFFECTS FROM YOUR MEDICINES? (6)ABERRANT BEHAVIORS: a. URINE DRUG TEST RESULTS-- DATE: RESULTS: REVIEWED and DISCUSSED WITH PATIENT: b. PILL COUNT: DATE of Rx: NUMBER OF PILLS FILLED: NUMBER OF PILLS REMAINING: c. OTHER: UNIVERSAL PRECAUTIONS: 1. GOALS, BENEFITS and RISKS OF TREATMENT discussed with patient and understood 2. CONTROLLED SUBSTANCE AGREEMENT SIGNED ON: ASSESSMENT and PLAN: PATIENT STICKER HERE 16

17 Pain Assessment Note with PEG (Sample Side 2) Potential Aberrant Drug-Related Behavior This section must be completed by the physician Please check any of the following items that you discovered during your interactions with the patient. Please note that some of these are directly observable (eg, appears intoxicated), while others may require more active listening and/or probing. Use the Other section below to note additional details. Purposeful over-sedation Negative mood change Appears intoxicated Increasingly unkempt or impaired Involvement in car or other accident Requests frequent early renewals Increased dose without authorization Reports lost or stolen prescriptions Attempts to obtain prescriptions from other doctors Changes route of administration Uses pain medication in response to situational stressor Insists on certain medications by name Contact with street drug culture Abusing alcohol or illicit drugs Hoarding (ie, stockpiling) of medication Arrested by police Victim of abuse Other: 17

18 Concerning (Aberrant) Medication Taking Behaviors The spectrum of Severity o o o o o o o o o Illegal activities forging scripts, selling opioid prescription, buying drugs from illicit sources Multiple lost or stolen opioid prescriptions Non-adherence with monitoring requests (e.g. pill counts, urine drug tests) Deterioration in function at home and work Resistance to change therapy despite adverse effects (e.g. over-sedation) Running out early (i.e., unsanctioned dose escalation) Requests for specific opioid by name, brand name only Requests for increase opioid dose Non-adherence with other recommended therapies (e.g., physical therapy, behavioral therapy) Butler et al. Pain Note: for most of these, need to track pattern & severity over time 18

19 Adjuncts What else have you done to try to reduce or manage your pain? Non-opioid drugs (NSAIDs, anticonvulsants, etc.) Exercise with flexibility training Nondrug treatments Physical therapy Complimentary therapies Cognitive behavioral therapy Injections Pumps 19

20 Provide Feedback on Patient s Risk Level Addiction (4 Cs: Loss of control, compulsive use, craving, continued use despite harm) Prescription Drug Misuse (recurrent harms related to use) Concerning (Aberrant) Medication Taking Behaviors &/or Multiple Risk Factors Low Risk Patient with No Concerning Behaviors 20

21 Part 2--ONGOING SCREENING using a Monitoring Framework Why? Increasing evidence that structured care programs can assist patients in reducing or resolving concerning/aberrant behaviors Weidemer, Harden, Arndt & Gallagher, Pain Medicine, 2007 Jamison et al, Substance Misuse Treatment for High Risk Patients on Opioid Therapy: A Randomized Clinical Trial, Pain 2010; 21

22 Universal Precautions Can Protect Patients & Detect Concerning Behaviors Agreements Urine Drug Testing Pill Counts Prescription Monitoring Programs Phone Follow-up Naloxone prescription 22

23 Sample Agreement Other examples at safeopioids.org 23

24 How to Set Up Ongoing Screening Using a Monitoring Framework 1. Have a risk/benefit discussion about opioids (include in your agreement) 2. Explore non-opioid treatment options 3. If appropriate, talk about an opioid test/trial 4. Explain opioid monitoring measures, emphasizing patient safety 5. Define treatment goals 6. Encourage patient responsibility 24

25 Dose-Related Risk: Beware High Dose Opioids Patients receiving morphine equivalent doses of mg/d or more have Twice the risk of medical visits for withdrawal, intoxication or overdose 8.9-fold increase in overdose risk 1.8% annual overdose rate Dunn KM et al. Ann Intern Med 2010 Braden JB et al. Arch Intern Med

26 Step 2: Explore Non-Opioid Treatment Options Nonopioid drugs (NSAIDs, anticonvulsants, etc.) Exercise with flexibility training Nondrug treatments Physical therapy Complimentary therapies (yoga, meditation, guided imagery, etc.) Guided imagery: online resources such as: healthtools/healthtoolspecialties.jsp#media_group=podcasts Cognitive behavioral therapy Injections Pumps 26

27 Step 3: If Appropriate, Offer an Opioid Test/Trial We lack strong accurate predictors of who will benefit from chronic opioid analgesics and who will be harmed Current evidence suggests that a 3-6 month trial may be appropriate In patients with no contraindications If not continued past the point of obvious failure Offer opioids on a trial basis 27

28 Opioid Efficacy in Chronic Pain Most literature surveys & uncontrolled case series RCTs are short duration <4 months with small sample sizes <300 pts Mostly pharmaceutical company sponsored Pain relief modest Modest to no functional improvement Not all chronic pain is opioid responsive Balantyne JC, Mao J. NEJM 2003 Martell BA et al. Ann Intern Med 2007 Eisenberg E et al. JAMA

29 Variability in Response to Opioids Mu Receptor >100 polymorphisms in the human mu opioid receptor gene Mu receptor subtypes Not all patients respond to same opioid in same way Not all pain responds to same opioid in the same way Incomplete cross-tolerance between opioids Mu opioid receptor Smith H, Pain Physician,

30 Long-Term Opioids Can Increase Pain Sensitivity (in some patients) Some patients obtain pain relief when tapered off opioids Animal studies chronic opioids increased pain sensitivity Methadone maintenance pts w/ increased pain sensitivity? neuroadaptation to chronic opioids Opioid withdrawal mediated pain Opioid-induced hyperalgesia Li X et al. Brain Res Mol Brain Res 2001 Doverty M et al. Pain 2001 Angst MS, Clark JD. Anesthesiology Southeastern Consortium for Substance Abuse Training

31 Step 4: Define Treatment Goals Work with patient to identify specific measurable realistic functional goals Use these goals jointly to measure benefit Remind patient that pain is unlikely to go away completely 31

32 Step 5: Encourage Patient Responsibility & Safety Explain legal responsibilities Safeguarding (lock box), disposing, not sharing or selling Encourage the patient to look out for early signs of harm Am I safe to drive or operate heavy machinery? Am I having trouble controlling the use of my medication? Give Rx for naloxone for OD reversal 32

33 Naloxone Prescription with Instructions Intramuscular Rx: Naloxone 0.4 mg/ml Quantity: 2-4 single-use 1 ml vials or 1 X 10 ml multi-use vial Sig: for suspected opioid overdose, inject 1 ml in shoulder or thigh. Repeat after 3 minutes if no or minimal response Refills: prescriber preference Intra-Nasal Rx: Naloxone 1mg/1mL Quantity: 2-4 x 2 ml prefilled Luer- Jet Luer-Lock needleless syringe Sig: For suspected opioid overdose, spray 1 ml (half of the syringe) into each nostril. Repeat after 3 minutes if no or minimal response Refills: prescriber preference Auto-Injector Rx: Naloxone 0.4 mg/ml Quantity: 1 kit containing 2 auto-injectors Sig: View instructional video. For suspected opioid overdose, inject 1 ml in thigh. Repeat after 3 minutes if no or minimal response Refills: prescriber preference 33

34 Part 3: BRIEF INTERVENTION-- Addressing Concerning (Aberrant) Behaviors 34

35 Concerning (Aberrant) Medication Taking Behaviors The Spectrum of Severity o o o o o o o o o Illegal activities forging scripts, selling opioid prescription, buying drugs from illicit sources Multiple lost or stolen opioid prescriptions Non-adherence with monitoring requests (e.g. pill counts, urine drug tests) Deterioration in function at home and work Resistance to change therapy despite adverse effects (e.g. over-sedation) Running out early (i.e., unsanctioned dose escalation) Requests for specific opioid by name, brand name only Requests for increase opioid dose Non-adherence with other recommended therapies (e.g., PT, behavioral therapy) Butler et al. Pain Note: for most of these, need to track pattern & severity over time 35

36 Concerning/Aberrant Medication Taking Behaviors: Differential Diagnosis Inadequate analgesia Pseudoaddiction 1 Disease progression Opioid resistant pain (or pseudo-resistance) 2 Withdrawal mediated pain Opioid-induced hyperalgesia 3 Addiction Opioid analgesic tolerance 3 Self-medication of psychiatric and physical symptoms other than pain Criminal intent - diversion 1 Weissman DE, Haddox JD. 1989; 2 Evers GC. 1997; 3 Chang C et al

37 Is There Evidence of Opioid Benefit? Are PEG scores improving? Is there specific functional improvement which is helping the patient achieve his/her activity goals? 37

38 Brief Intervention: Discuss Concerning (Aberrant) Medication-Taking Behavior Non-judgmental stance Use open-ended questions State your concerns about the behavior Examine the patient for signs of flexibility Is the patient focused more on the opioid or pain relief? Discuss the need for increased monitoring Passik SD, Kirsh KL. J Supportive Oncology

39 Prescription Opioid Monitoring Framework: Risk/benefit discussion Explore non-opioid treatment options Opioid test/trial Define treatment goals Encourage patient responsibility Potential benefits: Analgesia, function, quality of life Potential risks: Toxicity/side effects (sedation, constipation), functional impairment (driving, heavy machinery), interactions (alcohol, sedatives), physical dependence, increased pain sensitivity, loss of control/ addiction (3-19%), overdose/death Non-opioid analgesics (oral, topical), injections, pumps Exercise/flexibility training Physical therapy If appropriate, talk about opioid test/trial of 3-6 months. Yoga/meditation/guided imagery Cognitive behavioral therapy Add gabapentin to opioids Work with patient to identify specific, measureable, realistic, functional goals & measure using the PEG. Use these goals jointly to measure benefit. Remind patient that pain is unlikely to go away completely. Explain legal responsibilities (safeguarding, lockbox, disposing, not sharing or selling). Encourage patient to look out for early signs of harm. (Safe to drive or operate heavy machinery? Trouble controlling the use of meds?) Explain opioid monitoring measures including agreement/contract Why? Patient safety, standard policy with all patients. Universal Precautions are used to protect patient safety: Agreements (1 provider, no early refills) Urine Drug Testing for evidence of: Therapeutic adherence Non-use of illicit drugs Pill Counts Prescription Monitoring Programs Phone Follow-up Agreement/contract is scanned into chart. Caution with higher opioid doses (OD risk lowest at 1-20 mg/d morphine equivalent, 3.7x higher with mg/d, 8.9x higher with >100mg/d). Set level of monitoring to match risk (more visits/monitoring in high-risk patients or those with aberrant behaviors). Consider tapering or switching to buprenorphine or methadone if: PEG shows no benefit at 3-6 months & /or repeated aberrant behaviors Taper Guidelines: emphasize risk/benefit & safety issues, show empathy, taper meds by 10-20% per week, use comfort meds for withdrawal symptoms, continue non-opioid Rx Differential Diagnoses: Assessment Balance Risk vs. Benefits Brief Intervention Talking Points Guidelines for Discontinuing Opioids: Inadequate analgesia (pseudoaddiction); Addiction; Opioid analgesic tolerance; Self-medication of psychiatric or other physical symptoms (not pain); Criminal intent (diversion). Assess PEG; Assess for aberrant behaviors; Check state prescription monitoring program. Discussion with patient: Nonjudgmental, open-ended questions, express concerns, examine for patient flexibility (is the patient focused more on the opioid or pain relief?). Assess & document benefits and harms. Benefits must outweigh observed or potential harms to continue opioids. Not necessary to prove addiction or diversion to stop opioids. When pain not responsive to opioids: Treat underlying disease, comorbidities, offer adjuncts. If benefit lacking, STOP opioids (or taper and reassess). When concerned about abuse or addiction: Increase monitoring; switch to buprenorphine/methadone, stop opioids or refer to Tx Empathize with patient remaining collaborative and respectful Reiterate lack of benefit with no good fix Focus on patient strengths Encourage other therapies for coping with pain Commit to continue care without opioids Stress some patient s pain improves when opioids are stopped Clarify not discharging patient, discontinuing ineffective Tx Taper slowly to prevent withdrawal Tapering Decrease by 10-20% per week Medications: Allow supply of short-acting meds for breakthrough symptoms Treatment clonidine Schedule close follow-ups Comfort ibuprofen, dicyclomine, antiemetics, muscle relaxants, antidiarrheals, sleep aids Funded by: Discontinuation Strategy Discuss possible addiction: specific feedback on concerns, agree to disagree, risks outweigh benefits, menu of options (detox & opioidfree treatment, buprenorphine, or methadone) Rev. Apr

40 Continuation of Opioids Assess and document benefits and harms To continue opioids: Does the PEG show evidence of benefit? Does the benefit outweigh observed or potential harms? Note: you do not have to prove addiction or diversion to justify tapering opioids lack of benefit and/or high level of risk is enough 40

41 Options for Addressing Concerning (Aberrant) Behaviors & Continuing Pain 1. Increase monitoring more frequent visits, return for pill counts, call in for UDS 2. Consider non-opioid options to address continuing pain Re-attempt to treat underlying disease & comorbidities Re-explore possible adjuncts 3. If concerning/aberrant behaviors decrease or disappear, consider escalating dose as a test. 4. If simply no benefit after several months, begin opioid taper 5. If concerning/aberrant behaviors continue, consider a discontinuation strategy opioid taper switch to buprenorphine/methadone referral to treatment 41

42 View Video 3: Follow-up Interview Observe this clinician-patient encounter between a patient who is requesting increased medication and a clinician who discovers behaviors that concern him.

43 Part 4 Advanced Intervention and Referral to Treatment: Discontinuing Opioid Therapy 43

44 Discontinuing Opioids Opioids may be discontinued when the physician s assessment indicates: 1. Lack of benefit (monitor using PEG scores) 2. Risks that outweigh benefit 3. Persistently negative UDT 44

45 Discontinuation Strategy Talking Points Give specific feedback on what previous behaviors raise your concern for possible loss of control (addiction) State that benefits no longer outweighing risks I cannot responsibly continue prescribing opioids as I feel it could cause you more harm than good. Offer a menu of treatment options: Opioid taper & non-opioid pain management Switch to buprenorphine or methadone Referral to treatment for those who feel they have lost control ALWAYS MENTION THIS OPTION! 45

46 Discontinuation of Opioids: Discussing Lack of Benefit Give specific feedback lack of improvement in PEG or functional goals Stress how much you believe / empathize with patient s pain severity and impact. Encourage therapies for coping with pain Focus on patient s strengths. Offer to continue caring for the patient without using opioids 46

47 Discontinuation of Opioids: Discussing Lack of Benefit Stress that some patients experience improvement in function and pain control when chronic opioids are stopped Make it clear that you are not discharging the patient but discontinuing an ineffective treatment Taper patient slowly to prevent opioid withdrawal 47

48 Tapering Opioids Opioid withdrawal reactions are very uncomfortable but are not life threatening Build up alternative pain treatment modalities If possible, decrease by percent each week Allow supply of short-acting comfort medications to treat breakthrough symptoms (see next 2 slides) Schedule close follow-ups 48

49 Treatment: Clonidine Oral Dosing Oral Dosing Initial dosing: 0.1 mg po Watch BP carefully Titrate up to 0.1 to 0.3 mg po q4-6 hours, then taper Risk: HYPOTENSION Transdermal (Patch) Avoids cyclic hypotension and rebound. Dosed one patch per week ($10/patch). Dose range: mg hours to start to work -- can use oral clonidine initially while waiting for effect. 49

50 Comfort Meds Pain: Ibuprofen 600 QID Stomach cramps: Dicyclomine 20 mg QID Nausea/vomiting: Trimethobenzamide 250 mg po/ 200 mg IM q6-8 hours (beware mood altering effect of promethazine) Muscle cramps: Methacarbamol mg up to QID (beware cyclobenzaprine) Diarrhea: Kaolin with Pectin Bismuth subsalicylate Loperamide (less effective) Insomnia: Trazodone Doxepin mg Amitriptyline 50mg mg 50

51 INTERVENTION/REFERRAL FOR POSSIBLE ADDICTION Buprenorphine Methadone Referral to Formal Treatment Stay 100% in Benefit/Risk of Med mindset. 51

52 Buprenorphine Advantages Moderate pain relief Stops craving & withdrawal symptoms Low addiction risk (doesn t give a high) Low risk of overdose or respiratory depression (ceiling effect) Can be prescribed in primary care Covered by many insurance plans Typically involves counseling/other addiction treatment 52

53 Buprenorphine Disadvantages Expensive Risk of respiratory depression if used with benzodiazepines Less effective for pain management than other opioids Makes pain management more difficult in case of surgery or a severe accident Requires regular office visits with monitoring (UDS, pill counts, etc.) 53

54 Methadone Treatment: Advantages Also treats both addiction and pain (typically involves counseling/addiction treatment) Prescribed by physicians/staff with expertise in both Provides a highly structured environment Inexpensive 54

55 Methadone: Disadvantages For patients with opioid dependence methadone can only be prescribed in specialized treatment centers Requires daily visits (except weekends) Can cause respiratory depression at high doses, especially if mixed with other sedatives (alcohol, benzodiazepines, etc.) Risk of QTc prolongation and death by torsades de pointes 55

56 Referral for Opioid-Free Treatment Advantages: A good option for becoming drug-free for those who desire it Consistent with the philosophy of many traditional treatment programs and 12 step programs Tx of withdrawal is medically safe and often relatively brief (except for patients on long-acting opioids) May be used in conjunction with naltrexone p.o. or IM Disadvantages: Risk of relapse is very high Elevated risk of opioid overdose after detoxification 56

57 SBIRT Approach Screening Initial Assessment: before prescribing, check PMP & medical records, assess for risk factors & obtain baseline measures using the PEG/ACA Implement Universal Precautions: agreement, UDS, pill counts Monitor for benefit & concerning/aberrant behaviors Document! Brief Intervention: Address concerning/aberrant behaviors: express concern, ask pt to explain Increase monitoring Taper if there s no benefit or behaviors continue Referral to Treatment: if abuse/addiction, refer for formal treatment, buprenorphine or methadone 57

58 General Principles Not all chronic pain responds to opioids Opioids will not provide complete pain relief and may not improve function A trial period of 3-6 months with close monitoring to assess efficacy, adverse effects is usually adequate to establish opioid responsiveness Be mindful of the risk of high-dose opioids (> mg/d morphine equivalent doses) Misuse of opioids can be minimized by making expectations and goals explicit and by careful monitoring and documentation 58

59 General Principles Maintain risk-benefit model, not a police-offender model Reassure patient that you understand pain severity Reflect on patient strengths (self-efficacy) Effective treatment is available if patients lose control Success needs to be defined on case-by-case basis Opioids are only one part of the treatment plan Exploit synergism with NSAIDs, adjuvants Know and adhere to your state s PMP and prescribing guidelines 59

60 Additional Materials Visit PCSS-O.org & sbirtonline.org for additional materials including: CME & mentoring opportunities Videos demonstrating interview techniques Model Controlled Substances Agreement Model Pain Assessment Form Practice Role Plays (scripts for patient, clinician and observer scripts) Pocket Card on Pain and Addiction 60

61 Thanks! Questions? Comments? Suggestions? Contact info: 61

62 References Akbik, H., Butler, S.F., Budman, S.H., Fernandez, K., Katz, N.P., Jamison, R.N. Validation and clinical application of the screener and opioid assessment for patients with pain (SOAPP). J Pain Symptom Manage. 2006;32: Arnold, Robert, Han, Paul, Seltzer, Deborah. Opioid Contracts in Chronic Nonmalignant Pain Management: Objectives and Uncertainties. The American Journal of Medicine. Volume 119, Issue 4, April 2006, Pages Ballantyne, Jane C M.D., and Mao, Jianren M.D., Ph.D. Opioid Therapy for Chronic Pain N Engl J Med 2003; 349: November 13, 2003 Braden, J.B., MD, Edlund, Mark, J., MD, PhD., Martin, Bradley C. PharmD, PhD, Fan, Ming-Yu, PhD, MPH, Devries, Andrea PhD. An Analysis of Heavy Utilizers of Opioids for Chronic Noncancer Pain in the TROUP Study Volume 40, Issue 2, Pages Bridget A. Martell, MD, MA; Patrick G. O'Connor, MD, MPH; Robert D. Kerns, PhD; William C. Becker, MD; Knashawn H. Morales, ScD; Thomas R. Kosten, MD; and David A. Fiellin, MD. Systematic Review: Opioid Treatment for Chronic Back Pain: Prevalence, Efficacy, and Association with Addiction. Ann Intern Med. 2007;146(2): Butler, Stephen F. Budman, Simon H. Fernandez, Kathrine C. Houle, Brian. Benoit, Christine. Katz, Nathaniel. Jamison, Robert N. Corrigendum to Development and validation of the current opioid misuse measure [Pain 130 (2007) ] Pain, Volume 142, Issues 1 2, March 2009, Page 169. Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain 2009;10(2): Doe-Simkins, M., Quinn, E., Xuan, Z., Sorensen-Alawad, A., Hackman, H., Ozonoff, A., & Walley, A. Y. (2014). Overdose rescues by trained and untrained participants and change in opioid use among substance-using participants in overdose education and naloxone distribution programs: a retrospective cohort study. BMC public health, 14(1), 297. Dunn, K.M., Saunders, K.W., Rutter, C.M., Banta-Green, C.J., Merrill, J.O., Sullivan, M.D. et al, Opioid prescriptions for chronic pain and overdose. Annals of Internal Medicine. 2010;152:

63 References Doverty, M., White, J.M., Somogyi, A.A., Bochner, F., Ali, R., Ling, W. Reply to Dr. Clark s comment on Doverty et al., Hyperalgesic responses in methadone maintenance patients (Pain 2001;90:91 96) Pain, Volume 99, Issue 3, Pages Elon Eisenberg, MD; Ewan D. McNicol, RPh; Daniel B. Carr, MD. Efficacy and Safety of Opioid Agonists in the Treatment of Neuropathic Pain of Nonmalignant OriginSystematic Review and Meta-analysis of Randomized Controlled Trials. JAMA. 2005;293(24): Evers G.C: Pseudo-opioid-resistant pain. Support Care Cancer 1997, 5: Fishman, Scott M. M.D.; Kreis, Paul G. M.D. The Opioid Contract. Clinical Journal of Pain: July/August Volume 18 - Issue 4 - pp S70-S75 FSMB Guidelines Gourlay, D.L., Heit, H.A., Almahrezi, A. Universal precautions in pain medicine: A rational approach to the treatment of chronic pain. Pain Medicine. 2005;6: Gourlay, Douglas, MD, MSc, FRCPC, FASAM, Heit Howard, MD, FACP, FASAM, and Almahrezi, Abdulaziz, MD, CCFP. Universal Precautions in Pain Medicine: A Rational Approach to the Treatment of Chronic Pain. Pain Medicine 2005, Volume 6, Number 2. Pages Heit, Howard A, Gourlay, Douglas L. Urine drug testing in pain medicine. Journal of Pain and Symptom Management, Volume 27, Issue 3, March 2004, Pages Ives, TJ. Chelminski, PR. Hammett-Stabler, CA. et al. Predictors of opioid misuse in patients with chronic pain: a prospective cohort study. BMC Health Serv Res

64 References Katz, N., Panas, L., Kim, M., Audet, A. D., Bilansky, A., Eadie, J.,... & Carrow, G. (2010). Usefulness of prescription monitoring programs for surveillance analysis of Schedule II opioid prescription data in Massachusetts, pharmacoepidemiology and drug safety, 19(2), Krebs, Erin. Kroenke, Kurt. Bair, Matthew. Pharmacotherapy of chronic pain: a synthesis of recommendations from systematic reviews. General Hospital Psychiatry, Volume 31, Issue 3, May June 2009, Pages Li, Xiangqi MD; Angst, Martin S. MD; Clark, J. David MD, PhD. Opioid-Induced Hyperalgesia and Incisional Pain. Anesthesia & Analgesia. July Volume 93 - Issue 1 - p Liebshultz, Jane. Saitz, Richard. Weiss, Roger. Averbuch, Tali. Schwartz, Sonia. Meltzer, Ellen. Claggett-Borne, Elizabeth. Cabral, Howard. Samet, Jeffrey. Clinical Factors Associated With Prescription Drug Use Disorder in Urban Primary Care Patients with Chronic Pain. The Journal of Pain, Volume 11, Issue 11, November 2010, Pages Martin S. Angst, J. David Clark. Comment on Koltzenburg et al.: Differential sensitivity of three experimental pain models in detecting the analgesic effects of transdermal fentanyl and buprenorphine. Pain 2006;126: Michna, E. Ross, E.L. Hynes, W.L. Nedeljkovic, S.S. Soumekh, S., Janfaza, D., Palombi, D., Jamison, R.N.Predicting aberrant drug behavior in patients treated for chronic pain: Importance of abuse history. J Pain Symptom Manage. 2004;28: Paterick, Timothy J., Carson, Geoff V., Allen, Marjorie C., Paterick. Timothy E. Medical Informed Consent: General Considerations for Physicians. Mayo Clinic Proceedings, Volume 83, Issue 3, March 2008, Pages Passik, Stephen D. Issues in Long-term Opioid Therapy: Unmet Needs, Risks, and Solutions. Mayo Clinic Proceedings, Volume 84, Issue 7, July 2009, Pages

65 References Passik, Steven, PhD, and Kirsh, Kenneth, PhD. Managing Pain in Patients With Aberrant Drug-Taking Behaviors. The Journal of Supportive Oncology. Volume 3, Number 1, January/Febuary Pages Reid, M.C. Engles-Horton, L.L. Weber, M.B. Kerns, R.D. Rogers, E.L. O'Connor, P.G. Use of opioid medications for chronic noncancer pain syndromes in primary care. J Gen Intern Med. 2002;17: Savage, Seddon. Joranson, David. Covington, Edward. Schnoll, Sidney. Heit, Howard. Gilson, Aaron. Definitions related to the medical use of opioids: Evolution towards universal agreement. Journal of Pain and Symptom Management, Volume 26, Issue 1, July 2003, Pages Standridge, John B. Translating and communicating the mechanisms of Alzheimer's disease to practicing physicians. Alzheimer's & Dementia, Volume 6, Issue 4, Supplement, July 2010, Page S379. Starrels, Joanna L, MD, MS; Becker, William C, MD; Alford, Daniel P, MD, MPH; Kapoor, Alok, MD, MSc; Williams, Arthur R, MA; and Turner, Barbara J, MD, MSEd, Executive Deputy Editor. Systematic Review: Treatment Agreements and Urine Drug Testing to Reduce Opioid Misuse in Patients With Chronic Pain. Ann Intern Med. 2010;152(11): Webster LR, Webster R. Predicting aberrant behaviors in Opioid-treated patients: preliminary validation of the Opioid risk tool. Pain Med. 2005;6 (6):432. Weissman, David. Haddox, J. David. Opioid pseudoaddiction an iatrogenic syndrome. Pain, Volume 36, Issue 3, March 1989, Pages

66 PCSS-O Colleague Support Program PCSS-O Colleague Support Program is designed to offer general information to health professionals seeking guidance in their clinical practice in prescribing opioid medications. PCSS-O Mentors comprise a national network of trained providers with expertise in addiction medicine/psychiatry and pain management. Our mentoring approach allows every mentor/mentee relationship to be unique and catered to the specific needs of both parties. The mentoring program is available at no cost to providers. For more information on requesting or becoming a mentor visit: Listserv: A resource that provides an Expert of the Month who will answer questions about educational content that has been presented through PCSS-O project. To join pcss-o@aaap.org. 66

67 PCSS-O is a collaborative effort led by American Academy of Addiction Psychiatry (AAAP) in partnership with: Addiction Technology Transfer Center (ATTC), American Academy of Neurology (AAN), American Academy of Pain Medicine (AAPM), American Academy of Pediatrics (AAP), American College of Physicians (ACP), American Dental Association (ADA), American Medical Association (AMA), American Osteopathic Academy of Addiction Medicine (AOAAM), American Psychiatric Association (APA), American Society for Pain Management Nursing (ASPMN), International Nurses Society on Addictions (IntNSA), and Southeast Consortium for Substance Abuse Training (SECSAT). For more information visit: For questions pcss-o@aaap.org Funding for this initiative was made possible (in part) by Providers Clinical Support System for Opioid Therapies (grant no. 1H79TI025595) from SAMHSA. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department 67 of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.