Taking the pain out of prescribing: An opioid primer for the primary care provider

Transcription

1 Taking the pain out of prescribing: An opioid primer for the primary care provider Amy K. Paul, PharmD PGY1 Pharmacy Resident Pharmacy Grand Rounds April 26, MFMER slide-1

2 Objectives Describe the literature supporting newly released guidelines on prescribing opioids for chronic pain Identify treatment strategies for opioid initiation and patient follow-up Develop an appropriate strategy for tapering opioid therapy as needed 2016 MFMER slide-2

3 Definitions Chronic non-cancer pain (CNCP) Pain lasting 3 months or past the time of normal tissue healing 2016 MFMER slide-3

4 Poll Question I would be confident in assisting with or initiating and managing opioid medications for chronic non-cancer related pain. 1. True 2. False 2016 MFMER slide-4

5 You are Not Alone Keller et al primary care physicians 91.4% prescribe opioids for chronic pain Unsatisfactory medical school training To address chronic pain 40% To address opioid dependence 45.7% Hwang et al. 420 primary care physicians Confidence in clinical skills 32% Comfort in prescribing opioids 13% Subst Abus 2012;33: JAMA Intern Med. 2015;175(2): MFMER slide-5

6 A Land Of Opportunity 2016 MFMER slide-6

7 Closer to Home Controlled Substance Prescribing Plans* BA FM BA PCIM NE Clinic NW Clinic SE Clinic BA Baldwin Clinic FM Family Medicine PCIM Primary Care Internal Medicine NE- North East NW North West SE South East * Required for patients on controlled substance > 3 months 2016 MFMER slide-7

8 Social sexual function Impaired relationships activities Emotional Anger Depression Anxiety Untreated Pain Physical mobility sleep fatigue Societal Healthcare costs Lost work days Substance abuse 2016 MFMER slide-8

9 CDC Guideline for Prescribing Opioids for Chronic Pain United States, 2016 MMWR Recomm Rep 2016;65: MFMER slide-9

10 Guideline Audience Providers Primary care clinicians Treating chronic pain in outpatient settings Patients Age 18 years Chronic pain outside of palliative and end of life care 2016 MFMER slide-10

11 Guideline Consensus - LACKING Dosing thresholds Cautious titration Risk assessment tools Dose reductions Concurrent BZD use? MME/day? Weekly to monthly? Frequency? 25-50% or moderately? Risk Contraindicated Audience range Primary care vs. Specialists MME Morphine Milligram Equivalents BZD - Benzodiazepine Ann Intern Med. 2014;160:38-47 AHRQ 14-E005-EF 2016 MFMER slide-11

12 Guideline Clarifications 12 recommendations Dosing thresholds Assessing risks and harms Monitoring and discontinuation 2016 MFMER slide-12

13 Opioid initiation and management Practical applications utilizing a patient case scenario 2016 MFMER slide-13

14 Patient Case: ML ML is a 55 yo male who receives primary care at your clinic. He presents today for evaluation of chronic pain from a back injury sustained 6 months ago. PMHx: Depression, hypertension, asthma Current medications: Additional Information: bupropion 150mg daily PHQ-9 (4/1/16) = 3 lisinopril 10mg daily Physical Therapy = 3X weekly albuterol prn Weight: 115kg ( from 130kg 11/1/15) acetaminophen 500mg 2 tab q6h sertraline 200mg daily ibuprofen 800mg TID PHQ-9 Patient Health Questionnaire 2016 MFMER slide-14

15 Patient Case: ML You are thinking about initiating opioids to help manage ML s chronic pain. What about his history should assist you in making this decision? 2016 MFMER slide-15

16 Opioids vs Non-Opioids Systematic review of opioids compared to nonopioids for CNCP No significant difference in pain reduction Non-opioids superior in improved physical function Higher dropout rate due to adverse effects of opioids Schmerz 2015;29(1): MFMER slide-16

17 Non-Opioid and Non-Pharmacologic Preferred for chronic pain Consider comorbid conditions Physical therapy and behavioral therapy Consider opioid addition When functional goals have not been achieved with non-opioid therapies 2016 MFMER slide-17

18 Patient Case: ML ML is a 55 yo male who receives primary care at your clinic. He presents today for evaluation of chronic pain from a back injury sustained 6 months ago. PMHx: Depression, hypertension, asthma Current medications: Additional Information: bupropion 150mg daily PHQ-9 (4/1/2016) = 3 lisinopril 10mg daily Physical Therapy = 3X weekly albuterol prn acetaminophen 500mg 2 tab q6h sertraline 200mg daily ibuprofen 800mg TID 2016 MFMER slide-18

19 Patient Case: ML You decide to initiate a low dose of opioid for treatment of ML s pain. What additional labs/information would you like to gather at baseline? 1. Urine Drug Screen (UDS) 2. PDMP query 3. Hair sample for toxicologic testing 4. Both 1 and 2 PDMP=Prescription Drug Monitoring Program 2016 MFMER slide-19

20 Mitigating Risks - UDS Urine drug screen At baseline If suspect for diversion or abuse Annually Interpreting results ce.mayo.edu Go With the Flow 2016 MFMER slide-20

21 Mitigating Risks - PDMP Website: Accessibility Prescriber, delegate, dispenser, pharmacist, Board of Pharmacy, law enforcement, patient Reporting Schedules II-V and butalbital Daily uploads 12 month historical data 2016 MFMER slide-21

22 Mitigating Risks - PDMP PDMP At baseline Every three months With each prescription if high risk for abuse 2016 MFMER slide-22

23 Patient Case: ML ML s urine drug screen comes back negative, and PDMP shows no recent history of opioid prescriptions. What is an appropriate starting dose for ML? Opioid Codeine Hydrocodone Hydromorphone Methadone Oxycodone Tramadol Starting dose 15-30mg q4h 5-10mg q4h 2mg q4h 2.5mg q8-12h 5-10mg q4h 50mg q4-6h 2016 MFMER slide-23

24 Considerations Immediate release should be used Miller et al. Department of Veterans Affairs Unintentional overdose risk >2.5 times higher when initiating with long-acting 5 times higher during first 2 weeks JAMA Intern Med. 2015;175(4): MFMER slide-24

25 Dosing Thresholds 50 Morphine Equivalents Re-assess treatment goals Increase frequency of follow-up Drug Codeine Hydrocodone Hydromorphone Methadone Oxycodone Tramadol Dose (Oral) 330mg 50mg 12.5mg 12.5mg 35mg 200mg 2016 MFMER slide-25

26 Dosing Thresholds 90 Morphine Equivalents Consider opioid taper Consider referral to pain specialist Drug Codeine Hydrocodone Hydromorphone Methadone Oxycodone Tramadol Dose (Oral) 600mg 90mg 22.5mg 22.5mg 60mg 360mg 2016 MFMER slide-26

27 Controlled Substance Prescribing Plan Standard Required for CS use 3 months Set realistic expectations Establish treatment goals Discuss risk/benefit Discuss risk mitigation strategies Develop an exit plan 2016 MFMER slide-27

28 MCS7685rev MFMER slide-28

29 Patient Case: ML ML has been followed by your clinic for 3 months, and would like to taper off of opioids at this time MFMER slide-29

30 Indications for Opioid Taper Severe or unmanageable adverse effects Lack of therapy effectiveness Serious non-adherence to treatment plan Patient desire to discontinue Evidence of illegal or unsafe behaviors Decreased level of pain Misuse suggestive of addiction Unmet goals of treatment Lancet 1996; 13;347(8994): MFMER slide-30

31 Patient Case: ML If ML is receiving 80mg oxycodone daily (120 MME), what would you recommend as his total daily dose for the next week? 1. 70mg 2. 40mg 3. 75mg 4. 50mg 2016 MFMER slide-31

32 Patient Case: ML How should opioid therapy be tapered? Slow: Reduce by 10% of the original dose per week Here is what a taper may look like: Week Day Total mg/day MFMER slide-32

33 Tools for Prescribers 2016 MFMER slide-33

34 Resources for Taper Department of Veterans Affairs in/cot/opioidtaperingfactsheet23may2013v 1.pdf Washington State Medicaid ents/taperschedule.xls 2016 MFMER slide-34

35 Clinical Tools for Assessing Withdrawal Clinical Opiate Withdrawal Scale (COWS) Resting pulse rate: record beats per minute (measured after patient is sitting or lying for 1 minute) 0= pulse rate 80/min 1= pulse rate /min 2= pulse rate /min 4= pulse rate >120/min Sweating: during past ½ hour not accounted for by room temp or patient activity 0= no report of chills or flushing 1= subjective report of chills or flushing 2= flushed or observable moistness on face 3= beads of sweat on brow or face 4= sweat streaming off face Restlessness observation during assessment 0= able to sit still 1= reports difficulty sitting still but is able to do so 3= frequent shifting or extraneous movements of legs or arms 5= unable to sit still for more than a few seconds Pupil size 0= pupils pinned or normal size for room light 1= pupils possibly larger than normal for room light 2= pupils moderately dilated 5= pupils so dilated that only the rim of the iris is visible Bone or joint aches (if patient was having pain previously, only the additional component attributed to opioid withdrawal is scored) 0= not present 1= mild diffuse discomfort 2= patient reports severe diffuse aching of joints or muscles 4= patient is rubbing joints or muscles and is unable to sit still Gooseflesh skin 0= skin is smooth 3= piloerection of skin can be felt or hairs standing up on arms 5= prominent piloerection Runny nose or tearing not accounted for by cold symptoms or allergies 0= not present 1= nasal stuffiness or unusually moist eyes 2= nose running or tearing 4= nose constantly running or tears streaming down cheeks Gastrointestinal upset: during the last ½ hour 0= no gastrointestinal symptoms 1= stomach cramps 2= nausea or loose stool 3= vomiting or diarrhea 5= multiple episodes of diarrhea or vomiting Tremor observation of outstretched hands 0= no tremor 1= tremor can be felt but not observed 2= slight tremor observable 4= gross tremor or muscle twitching Yawning observation during assessment 0= no yawning 1= yawning once or twice during assessment 2= yawning 3 times during assessment 4= yawning several times per minute Anxiety or irritability 0= none 1= patient reports increasing irritability or anxiousness 2= patient obviously irritable or anxious 4= patient so irritable or anxious that participation in the assessment is difficult Score Totals: 0-4= No withdrawal 5-12= Mild withdrawal 13-24= Moderate withdrawal 25-36= Moderately severe withdrawal > 36 = Severe withdrawal LKB 2016 MFMER slide-35

36 Slide 35 LKB1 Will audience be able to see the content? It's small, so I think that is a risk and something they will comment on. Is there a way that you could summarize instead? Lisa K Buss Preszler, 4/14/2016

37 Clinical Tools for Assessing Withdrawal Subjective Opiate Withdrawal Scale (SOWS) Not at all (0) A little (1) Moderately (2) Quite a bit (3) Extremely (4) I feel anxious I feel like yawning I am perspiring My eyes are teary My nose is running I have goose bumps I am shaking I have hot flashes I have cold flashes My bones and muscles ache I feel restless I feel nauseous I feel like vomiting My muscles twitch I have stomach cramps I feel like taking medication now Mild Withdrawal 1-10; Moderate Withdrawal 11-20; Severe Withdrawal MFMER slide-36

38 Drug Metabolism Considerations Codeine Morphine Oxycodone Oxymorphone Hydrocodone Hydromorphone Fentanyl Renal 2016 MFMER slide-37

39 Opportunity to Close the Gap Prospective studies regarding long-term use Increased patient-provider discussion 2016 MFMER slide-38

40 Conclusions Literature is sparse regarding long-term outcomes of opioid treatment for chronic pain. Ensure adequate non-pharmacologic and nonopioid trial When choosing to initiate opioid therapy, clinicians should start low and reassess often. Utilize tools such as UDS, PDMP and CSA to assist with monitoring and treatment goals When indicated, taper slowly and assess for symptoms of withdrawal N Engl J Med 374; MFMER slide-39

41 Amy K. Paul, PharmD PGY1 Pharmacy Resident Pharmacy Grand Rounds April 26, 2016 Questions & Discussion 2016 MFMER slide-40