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Opiate Dosing and Safe Reductions Sunny Linnebur, Pharm.D., FCCP, FASCP, BCPS, CGP Professor Skaggs School of Pharmacy and Pharmaceutical Sciences Objectives • Identify concerns regarding opioid use/abuse in LTCFs • Discuss strategies for appropriate use and deescalation of opioid treatment in patients living in LTCFs • Evaluate alternative strategies to opioids to reduce pain in older adults living in LTCFs Pain and Analgesic Use in Older LTCF Patients in 1997 89 NHs and 2065 residents with pain • 77% had chronic pain diagnosis – Most common diagnosis: arthritis (42%) – No objective or subjective assessment of pain in 41% • Non-pharmacologic treatment – 20% received PT, 7% received heat/cold, 69% nothing • Pharmacologic treatment: 2542 prescriptions, 2/3 PRN – 68% opioids (propoxyphene 56%, codeine 33%) – 25% NSAIDs – 8% tramadol • Conclusions: inadequate pain assessments, little use of nonpharm interventions, PRN opioids should be changed to scheduled LA opioids, little use of other analgesics Cramer GW et al. J Am Geriatr SOC 48:398-404,2000. A Lot Has Changed Since 1997… 4 © 2012 Denver Health Colorado drug overdose death rates by county: 2002 © 2012 Denver Health Colorado drug overdose death rates by county: 2014 Strategies for Appropriate Use of Opioids in LTCF Patients 1. Maximize Non-Opioid Pain Relievers Non-Pharmacologic Pharmacologic • • • • • • • • • • • • • • • • • • • • • Physical therapy Massage Hot or cold applications TENS unit Relaxation Positive imagery Meditation/prayer Peer group support Exercise/Tai Chi Acupuncure Music Therapy Scheduled acetaminophen Topical voltaren gel 1%, 1.5% soln Transdermal lidocaine 4-5% Capsaicin Corticosteroid injections Duloxetine Gabapentin Pregabalin Naproxen Tramadol Makrus UE et al. JAMA. 2014;312(8):825-836; Weiner DK et al. Drugs & Aging 2001; 18 (1): 13-29 Park J, Huges AK. J Am Geriatr Soc 60:555–568, 2012; Malek M. Med Clin N Am 99 (2015) 337–350 Strategies for Appropriate Use of Opioids in LTCF Patients 2. Evaluate risk/benefit for patient initiating or continuing opioid therapy and establish goals for pain and function – Obtain accurate diagnosis (DORA) – Determine if opioids were utilized prior to hospitalization – Discontinue PRN opioids that were not utilized in the hospital setting or were new from hospitalization and pain not acute Strategies for Appropriate Use of Opioids in LTCF Patients 2. Evaluate risk/benefit for patient initiating or continuing opioid therapy and establish goals for pain and function – PEG: 3 item pain scale (http://mytopcare.org/wpcontent/uploads/2013/06/PEG-pain-screeningtool.pdf) – QOL: function, sleep, eating, socializing – Side effect risk: constipation, confusion, respiratory depression, falls PEG Strategies for Appropriate Use of Opioids in LTCF Patients 3. Assess risk with screening tools/check PDMP – Opioid Risk Tool (https://www.drugabuse.gov/sites/default/files/files/ OpioidRiskTool.pdf) – Urine drug screening – PDMP (https://copdmph.hidinc.com/cologappl/bdcopdmqlog/pmqhome.ht ml) Opioid Risk Tool Utilizing the PDMP in Your Practice • You can designate a delegate to check for you • Benefits – Review fill history for need for new Rx – Review if patient is doctor/pharmacy shopping – Review if patient is filling prescriptions through Medicare Part D or cash-pay – Review if patient is concomitantly taking benzodiazepines and other CS • Limitations: – Most recent fills are not always in system immediately – Return to stock fills do not delete out – ± Mail order scripts – ± Records for inpatient/LTCF/hospice – ± scripts from VA/military bases • Can call pharmacy to mitigate limitations Strategies for Appropriate Use of Opioids in LTCF Patients 4. Initiate short-acting opioids—not LA opioids – Determined by FDA, CDC and DORA as safer FDA Labeling Changes for ER/LA Opioids http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM367697.pdf FDA Post-Marketing Requirements for ER/LA Opioids • Requirements for post-marketing studies – Evaluation of long-term use and known serious risks • Misuse, abuse, addiction, overdose, and death • Risks of developing hyperalgesia and tolerance – Validation of medical coding for opioid ADEs – Study to define and validate doctor/pharmacy shopping as outcomes of misuse/abuse • Study plans due 2014, with final results due in 2018 http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM367697.pdf Initiation of LA Opioids in NHs • Analysis of 2004-2005 Rhode Island Medicaid pharmacy claims data linked to the Minimum Data Set • 591 Medicaid residents who initiated therapy with an LAO – 232 (39.3%) were opioid naıve – Naive initiation was more frequent among those with advanced age, those with cognitive impairment, and those with chewing difficulties – Opioid-naive residents were also more likely to be initiated on fentanyl relative to other LAOs (60.3% vs. 46.4%) and to use higher initial dosages • Given the significance of FDA warning, including a BBW with transdermal fentanyl, rate of naive LAO initiation concerning Dosa DM et al. Journal of Pain and Symptom Management 2009;38(4):515-521 Strategies for Appropriate Use of Opioids in LTCF Patients 4. Initiate short-acting opioids—not LA opioids – Determined by FDA, CDC and DORA as safer • SA opioids can be crushed and come in liquid form for those who have difficulty swallowing • In patients with dementia, utilize nurses to observe patients after SA opioids to assess effects and/or schedule SA opioids for adequate pain relief Strategies for Appropriate Use of Opioids in LTCF Patients 5. Initiate at ¼ to ½ the recommended adult dose and maintain lowest effective total daily dose – DORA/Colorado Medical Board: MED ≤ 120 – CDC: MME ≤ 50 per day; avoid ≥ 90 per day – Examples of ≤ 50 MED • • • • • Morphine 15mg: 3 tabs Oxycodone/APAP 5/325: 6 tabs Oxycodone ER 10mg: 3 tabs Fentanyl transdermal 12.5 mcg/hr: 1 patch Q3 days Hydrocodone/APAP 5/325: 10 tabs MME = Morphine milligram equivalents MED = Morphine equivalents per day Malek M et al. Med Clin N Am 99 (2015) 337–350; CDC and DORA guidelines (see Resources slide) Prescribed Doses of Opioids in LongTerm Care Facilities in Australia • 94% of residents were prescribed opioids at doses below the max recommended for noncancer pain in Australia (100 MED) • Fentanyl was prescribed at a higher median daily dose • Opioid doses did not differ between residents ± dementia Leung, Brian B et al. JAMDA 2015;16(12):1100-02 Strategies for Appropriate Use of Opioids in LTCF Patients 5. Initiate at ¼ to ½ the recommended adult dose and maintain lowest effective total daily dose • Recognize increasing risk and diminishing benefit curves as evidence behind the MED’s • If patient’s dose exceeds, CDC recommends consulting a pain specialist and/or re-evaluating opioid use and working on a tapering plan – More documentation and risk management needed if continuing dose • FOR ACUTE PAIN: suggested prescription 3 days Malek M et al. Med Clin N Am 99 (2015) 337–350; CDC and DORA guidelines (see Resources slide) Strategies for Appropriate Use of Opioids in LTCF Patients 6. Monitor appropriately – Risk-benefit assessment within 1-4 weeks of initiation – Set specific functional goals and document response – Follow up more frequently if prescribing ER/LA opioids, the dose is ≥ 50 MED, or the patient has a history of mental health conditions, substance use disorder or overdose – Make an exit strategy and communicate it • Taper opioids when improvements are not sustained • Re-evaluate non-opioid therapies Malek M et al. Med Clin N Am 99 (2015) 337–350; CDC and DORA guidelines (see Resources slide) Strategies for Appropriate Use of Opioids in LTCF Patients • Additional strategies to mitigate risk – Consider prescribing naloxone • Especially for patients on higher doses and those with history of SUD or prior OD – Recheck PDMP periodically after initiation • At least every 3 months – Recheck urine drug test at least annually – Avoid co-prescribing opioids & BZDs – Refer patients with opioid use disorders to evidencebased treatments CDC and DORA guidelines (see Resources slide) Pain and Analgesic Use in Older LTCF Patients in 2004 Data from a survey of 1174 US NHs • Cancer primary diagnosis in 11.4% of patients Hanlon JT et al. J Am Med Dir Assoc. 2010; 11(8): 579–583. Opioid Tapering • Indicated for patients: – Who request dosage reduction – If improvements in pain/functioning are not sustained or clinically meaningful (e.g. ≥ 30% improvement on 3-item PEG) – If dosages ≥ 50 MED are used without evidence of benefit – If opioids are combined with BZDs – If benefits no longer outweigh risks – If patient experiences warning signs of harms (e.g drowsiness, slurred speech, difficulty controlling use) • Patients generally tolerate weaning to 30%-50% of original dose CDC and DORA guidelines (see Resources slide) General Tapering Principles • Reduce dosage by about 10% every week or if patients have been on opioids for years, reduce dosage by about 10% every month • When smallest dosage is reached, interval between doses can be extended • Non-addicted patients generally tolerate more rapid weaning schedules Taper by 20-50 percent per week (of original dose) The goal is to minimize adverse/withdrawal effects The rapid detoxification literature indicates that a patient needs 20% of the previous day’s dose to prevent withdrawal symptoms. If patient is using fentanyl 12.5mcg/hr patch, switch to oral opioid to complete taper CDC and DORA guidelines; VAMC Opioid Tapering Fact Sheet (see Resources slide) Example Slow Tapering Schedule 10% reduction • Starting dose morphine SR 60 mg BID + oxycodone 5/325 mg 6 tabs/day 1. Start by converting to total morphine milligram equivalents = 165 mg 2. Taper SA oxycodone weekly as it is >10% total MED (this will take 5 weeks) 3. Taper LA morphine next (this will take 13 weeks) https://www.hca.wa.gov/; VAMC Opioid Tapering Fact Sheet (see Resources slide) Example Tapering Schedule: Washington Form Example More Aggressive Tapering 20% Reduction = 30mg MED Starting dose: morphine SR 60 mg BID + oxycodone 5/325 mg 6 tabs/day 1. Start by converting to total morphine milligram equivalents = 165 mg 2. Week 1: 20% reduction to MED 130 mg – Morphine SR 60 mg BID + 1-2 oxycodone/apap per day 3. Week 2: 100 mg MED – Morphine SR 45 mg BID + 1-2 oxycodone/apap per day 4. Week 3: 70 mg MED – Morphine SR 30mg BID + 1-2 oxycodone/apap per day 5. Week 4: 40 mg MED – Morphine SR 15 mg BID + 1-2 oxycodone/apap per day 6. Week 5: 10 mg MED: 1-2 oxycodone/apap per day 7. Week 6: no opiates Opioid Interruptions and Withdrawal Symptoms in NH Residents • 66 patients from 3 NH receiving opioids were followed for a mean of 10.9 months and experienced a total of 104 acute illnesses • During 39 (38%) illnesses, patients experienced a significant opioid interruption – Mean duration of interruption (range): 3 days (1-118) – Complete discontinuation, n (%): 22 (21) • Symptoms were assessed with the Clinical Opioid Withdrawal Scale • Withdrawal scores were not associated with opioid interruption regardless of dose before interruption Redding SE et al. Clin Ther. 2014;36:1555–1563 Opioid Tapering Success Krumova EK et al. 2013 • Significant decreases in pain after opioid withdrawal • 41% relapse rate at 1-2 years • Significant relation between relapse probability and pain intensity immediately after opioid withdrawal Huffman KL et al 2013 • 22.5% relapse rate at 1 year • Post-treatment depression increased probability of relapse • If aggressive tapering is instituted, patient may need clonidine 0.1-0.2 mg two to four times daily Krumova EK et al. Clin J Pain 2013;29:760–769; Huffman KL et al. Pain Medicine 2013; 14: 1908–1917; https://www.hca.wa.gov/; VAMC Opioid Tapering Fact Sheet (see Resources slide) Want More Info-Use the CDC App! Includes major points and links to resources Includes MME Opioid Calculator Includes Motivational Interviewing Questions, discussion of how to approach tapering opioids and coping with withdrawal, and tapering pocket guide Links to SAMHSA Behavioral Health Treatment Services Other Resources • DORA QUAD Policy – http://www.ucdenver.edu/academics/colleges/PublicHealt h/research/centers/CHWE/Documents/DORA%20Opioid% 20Policy%20Revised%2010.15.14.pdf • CDC Guideline for Prescribing Opioids for Chronic Pain – https://www.cdc.gov/drugoverdose/prescribing/guideline. html • Washington Taper Schedule – https://www.hca.wa.gov/ – Search website for “Medical opioid taper plan calculator” • VA/DoD Fact Sheet: – http://www.healthquality.va.gov/guidelines/Pain/cot/Opio idTaperingFactSheet23May2013v1.pdf Questions?