Morbidity and Mortality Conference

1. Morbidity and Mortality Conference Anne Zbaracki, MD Northeast Iowa Family Practice Jan 20, 2016

2. Case:HPI • 61 yr old male testicular pain from bilateral hydrocele, right spermatocele continues to c/o pain due to testicular swelling, drainage and open wound following right hydrocelectomy , hx of CAD with occasional c/o CP

3. Case: PMH- CAD cath 6/2014 Dr.Dib, lmca 20% ostial stenosis, lad normal 1st, 2nd, and 3rd diagonal very small and normal, Circ normal 1st marginal 70% stenosis, rca 40% diffuse disease, left main OM1 with promus stent, ef 65%, lexiscan stress test 10/1/15 no evidence for ischemia ef 71-77%, 11//3/15 saw Dr.Majood started imdur 30mg daily and increase to 60mg if needed f/u 1 yr, echo 11/11/14 nmlef 56% no phtn, dchf I, tietze’s HTN borderline intellectual functioning Mood disorder follows BHGMH OSA with sleep titration done, noncompliant hx of drug use, cocaine, meth, marijuana Obese hx rib fracture 7/3/14 hxhep c completed treatment, 2007 interferon tobacco abuse Depression with GAD, and insomnia hyperlipidemia Gerd RBBB Constipation Cirrhosis- normal lft’s, stable weight DJD

4. PSH- 9/8/15 testicular surg Dr.richardson, cataract removal Dr.Mauer, cervical spine fusion 2003, right olecranon bursitis bursa removal 2000, Colonoscopy in 2009 (negative), Liver bx (1990) • FH- mother cad, father emphysema

5. SH- lives in apt, denies current etoh use, denies drug use, help thru cedar valley community support services for transportation and medications, • Marital Status:  Single, divorced   Children:   None   Occupation:  SSI since Dec 2014, stopped working may 2014 was a Janitor, part time.   Education: High school   Alcohol:  abstains to occasional, hx of etoh abuse, more than 20 dui in CA   Smoking:   down to 8 cig day now, 40 pack years   Illicit drugs:  hx of Cannibis, heroin, meth, LSD, over 30 years ago, hx of prison for selling meth 2004- 2014

6. Medications • Rx: CLONAZEPAM 1MG Tablet - days, , Ref: 0 Rx: OLANZAPINE 15MG 2 Tablet - days, , Ref: 0 Rx: VENLAFAXINE HCL 75MG 2 Tablet at bedtime - days, 60, Ref: 11 Rx: VENLAFAXINE HCL 100MG 2 Tablet daily - days, 60, Ref: 2 Rx: MULTI VITAMIN/MINERALS 1 Tablet daily - days, 30, Ref: 2 Rx: ZOLPIDEM TARTRATE 10MG 1 Tablet - days, 30, Ref: 0 Rx: ASPIRIN 325MG 1 Tablet daily - days, 30, Ref: 11 Rx: NAPROXEN 500MG 1-2 Tablet twice daily PRN - days, 60, Ref: 1 Rx: PANTOPRAZOLE SODIUM 20MG 1 Tablet DR daily - days, 30, Ref: 1 Rx: NITROSTAT 0.4MG Tab Sublingual - days, 30, Ref: 2     Instructions: Place 1 tab under tongue for chest pain     every 5 minutes. Maximum of 3 doses. Call     911 after first dose.Rx: PRAVASTATIN SODIUM 40MG 1 Tablet DAILY - days, 30, Ref: 2 Rx: FUROSEMIDE 20MG 1 Tablet daily - days, 30, Ref: 1 Rx: LISINOPRIL 40MG 1 Tablet daily - days, 30, Ref: 1 Rx: HYDROCODONE-ACETAMINOPHEN 5-325MG 1 Tablet every 6 hours PRN - days, 60, Ref: Imdur 30mg daily • No allergies

7. Last PE Vital Signs: Bp: 119/85, Left Arm, Pulse: 104 Temperature: 96.70 F, Height: 5'4", Weight: 199 lbs BMI: 34.24 kg/m2 Respirations: 16 Physical Exam Eyes: EOM intact Conjunctiva clear. Sclera clear. Ears: bilateral TM(s) clear. Landmarks visualized. EAC's clear bil. Nose: No lesions visible. Mouth: Mucosal membranes are moist. Mucosa normal. Pharynx: Mucosa normal. Neck: Supple. No lymphadenopathy. Heart: Regular rate and rhythm. Normal S1, S2. No murmur. No gallop. No rub. No thrills. Lungs: Clear to auscultation bilaterally. Nonlabored respirations. Abdomen: soft non-tender Nondistended.

8. Genitourinary: No lesions visible. No hernias. Penis w/o lesions. has open wound to testicles for drainage of hydrocele Extremities: No edema. Peripheral pulses intact. Neurologic: Alert and oriented. Musculoskeletal: Normal gait and station. No atrophy appreciated. Skin: No rash. No lesions visible. Good turgor. Hair: Normal texture. Normal distribution. Nails: Normal color. no deformities Lymphatics: No lymphadenopathy in cervical, axillary, or inguinal areas. Psychiatric: Normal mood and affect. Intact recent and remote memory. Good judgement. Insight appropriate. Denies suicidal ideations.

9. Appt timeline 2/7/14 neifp 1st appt establish care 2/26/14 neifp right leg radicular pain, PT start gaba 3/20/14 neifp f/u neuropathy, abinml, refused PT, lumbar xray DJD 3/31/14 neifp f/u neuropathy, contgaba 4/5/14 cmcedcp r/o admit, neglexiscanef 73%, ddimerneg 4/15/14 neifp f/u CP ro at CMC, neglexiscan 4/29/14 neifp c/o sob, ordered pft 5/7/14 cmced right calf pain, soft tissue injury 6/2/14 neifp f/u sob pftnml, referred to Dr.Kabel 6/11/14 Dr.Kabel, sent to Dr.Dib for cath 6/23/14 neifp f/u doe, sent to dr dib cath 1 stent 1stcirc marginal, minimal disease 7/3/14 cmced rib fx, 6&7th no etoh or drug screen done, no rx for pain was given morphine at ed 7/7/14 neifp f/u rib fx, fell over railing, c/o pain, trouble sleeping 7/22/14 neifp f/u rib pain 7/29/14 Dr.Kabel no changes, plavix until june, f/u 6mo 8/3/14 cmcedabd pain, ctfatty liver, healed fx’s , left ama 8/18/14 neifp f/u rib pain, f/u cmcedabd pain, mention of scrotal swelling, us shows hydrocele, spermatocele, elevated psa, referred to urology 9/24/14 cmcedtesti pain, given vicodinrx 10/7/14 neifp f/u rib pain, testicle swelling saw Dr. Mong not doing anything at this time, sleep study ordered 10/13/14 neifph&p for cataract 10/23/14 cmcedtesti pain, given bactrim , us shows bilateral hydrocele 10/28/14 Dr.Kabel, c/o sob repeat echo nml, pending sleep study, determines non cardiac 11/6/14 cmcedtesti pain, rxvicodin 11/11/14 Dr.Kabel no changes questioned copd, f/u june 11/14/14 cmcedtesti pain Dr.Mong refer to uihc

10. Appts continued 11/17/14 neifp f/u sleep study, + needs titration, refer to UIHC from Dr. Richardson 12/17/14 neifp testi pain 1/5/15 neifp h&p for uihc 1/12/15 uihc urology, voiding done, nml 2/4/15 uihc, cyctoscopy set up, no chnages 2/9/15 uihc cyctoscopy nmp 2/28/15 cmc ed, fell on ice no fx , rx tramadol 3/11/15 neifp c/o cough, no tusing cpap. Smoking 8 cigs 3/28/15 cmc ed testi pain, us worsening hydrocele, sent home wth cephalexin 6/9/15 Dr.Kabel sob better, can walk 2mi w/o cp, stop plavix cont asa 6/26/15 neifp hip pain, sent to PT off plavix now 8/5/15 uihc us renal l7r cyst, cxr neg, scheduled hydrocelectomy 9/14/15 which he canceled 9/4/15 neifp h&p for hydroelectomy , Dr,Richardson, decided didn’t want to go to uihc 9/8/15 Dr.Richarson hydrocelectomy, left wound open to drain, cultures negative 9/16/15 cmc ed teste pain, epididymitis, given levaquin, percocet 9/19/15 cmc ed testi pain, Dr.richardson ok lortabs 9/22/14 neifp testi pain, started morphine 9/29/15 Dr.Richardson c/o cp go to fpc, given keflex rx #20 hydrocodone 9/29/15 neifp c/o cp, refused admit 9/30/15 neifp cp and teste pain, agreed lexiscan, 10/1/15 was negative 10/6/15 Dr.Sarsfield, testi pain, f/u 2 weeks 10/7/15 neifp testi pain, f/u cp 10/20/15 neifp f/u testi pain, c/o cp ekg no st, t wave changes 11/3/15 Dr.Majood started imdur 30mg daily may increase to 60mg , f/u 1 yr 11/23/15 neifp h&p for cataract, no c/o cp, tried fentanyl patch not covered, morphine makes tired and stomach upset, started methadone 5mg daily, drug screen sent this day was pos bz and marijuana

11. Uptodate • Conversion from oral opioids to oral methadone: Discontinue all other around-the-clock opioids when methadone therapy is initiated; fatalities have occurred in opioid-tolerant patients during conversion to methadone. Substantial interpatient variability exists in relative potency. Therefore, it is safer to underestimate a patient’s daily oral methadone requirement and provide breakthrough pain relief with rescue medication (eg, immediate release opioid) than to overestimate requirements. Patient response to methadone needs to be monitored closely throughout the process of the conversion. Sum the current total daily dose of oral opioid, convert it to a morphine equivalent dose according to conversion factor for that specific opioid, then multiply the morphine equivalent dose by the corresponding percentage in the table to calculate the approximate oral methadone daily dose. Divide total daily methadone dose by intended dosing schedule (ie, divide by 3 for administration every 8 hours). Round down, if necessary, to the nearest strength available. For patients on a regimen of more than one opioid, calculate the approximate oral methadone dose for each opioid and sum the totals to obtain the approximate total methadone daily dose, and divide the total daily methadone dose by the intended dosing schedule (ie, divide by 3 for administration every 8 hours). For patients on a regimen of fixed-ratio opioid/nonopioid analgesic medications, only the opioid component of these medications should be used in the conversion.

12. Note: Conversion factors in table are only for the conversion from another oral opioid analgesic to methadone. Table cannot be used to convert from methadone to another opioid (doing so may lead to fatal overdose due to overestimation of the new opioid). This is not a table of equianalgesic doses. • Daily oral morphine dose <100 mg: Estimated daily oral methadone dose: 20% to 30% of total daily morphine dose • Daily oral morphine dose 100 to 300 mg: Estimated daily oral methadone dose: 10% to 20% of total daily morphine dose • Daily oral morphine dose 300 to 600 mg: Estimated daily oral methadone dose: 8% to 12% of total daily morphine dose • Daily oral morphine dose 600 to 1000 mg: Estimated daily oral methadone dose: 5% to 10% of total daily morphine dose. • Daily oral morphine dose >1000 mg: Estimated daily oral methadone dose: <5% of total daily morphine dose. • Conversion from parenteral methadone to oral methadone: Initial dose: Parenteral: Oral ratio: 1:2 (eg, 5 mg parenteral methadone equals 10 mg oral methadone)

13. Alternative recommendations: Opioid-tolerant: • Conversion from oral morphine to oral methadone: 1) There is not a linear relationship when converting to methadone from oral morphine. The higher the daily morphine equivalent dose the more potent methadone is, and 2) conversion to methadone is more of a process than a calculation. In general, the starting methadone dose should not exceed 30 to 40 mg/day, even in patients on high doses of other opioids. Patient response to methadone needs to be monitored closely throughout the process of the conversion. There are several proposed ratios for converting from oral morphine to oral methadone (Ayonrinde, 2000; Mercadente, 2001; Ripamonti, 1998). The estimated total daily methadone dose should then be divided to reflect the intended dosing schedule (eg, divide by 3 and administer every 8 hours). Patients who have not taken an opioid for 1 to 2 weeks should be considered opioid naïve (Chou, 2014). • Titration and maintenance: Manufacturer's labeling: May adjust dosage every 3 to 5 days to a dose providing adequate analgesia and minimal adverse reactions. However, because of high interpatient variability, substantially longer periods between dose adjustments may be necessary in some patients (up to 12 days). Breakthrough pain may require a dose increase or rescue medication with an immediate-release analgesic. Some guidelines note that dose increases should not be more than 10 mg per day every 5 to 7 days (Chou, 2014).

14. Medicaid Prior auth Prior authorization is required for all non-preferred long-acting narcotics. Payment will be considered under the following conditions: 1) There is documentation of previous trials and therapy failures with two (2) chemically distinct preferred longacting narcotics (such as extended-release morphine sulfate and methadone) at therapeutic doses, and 2) A trial and therapy failure with fentanyl patch at maximum tolerated dose, and 3) A signed chronic opioid therapy management plan between the prescriber and patient must be included with the prior authorization, and 4) The prescriber must review the patient’s use of controlled substances on the Iowa Prescription Monitoring Program (PMP) website at https://pmp.iowa.gov/IAPMPWebCenter/ prior to requesting prior authorization. 5) Requests for long-acting narcotics will only be considered for FDA approved dosing. The required trials may be overridden when documented evidence is provided that use of these agents would be medically contraindicated.

15. Iowa medicaid prior auth Drug Name:___________________________________________ Strength:______________________________________ Dosage Instructions:______________________________________ Quantity:__________ Days Supply: _____________ Diagnosis: Document 2 chemically distinct preferred long-acting narcotic treatment failure(s) including drug names, strength, exact date ranges and failure reasons: Preferred Long-Acting Narcotic Trial #1: Name/Dose: _______________________________ Trial Dates: _______________ Failure reason: _______________________________________________________________________________________ Preferred Long-Acting Narcotic Trial #2: Name/Dose: ________________________________Trial Dates: _______________ Failure reason: _______________________________________________________________________________________ *Please refer to the methadone dosing guidelines located at www.iadur.org under the Report Archive tab.

16. Trial of fentanyl patch: Dose: ____________ Trial Dates:__________________ Failure Reason: ____________________ Medical or contraindication reason to override trial requirements: _______________________________________________ Prescriber review of patient’s controlled substances use on the Iowa PMP website: No Yes Date Reviewed:___ Attach signed chronic opioid therapy management plan between the prescriber and patient. Prescriber signature (Must match prescriber listed above.) Date of submission IMPORTANT NOTE: In evaluating requests for prior authorization the consultant will consider the treatment from the standpoint of medical necessity only. If approval of this request is granted, this does not indicate that the member continues to be eligible for Medicaid. It is the responsibility of the provider who initiates the request for prior authorization to establish by inspection of the member’s Medicaid eligibility card and, if necessary by contact with the county Department of Human Services, that the member continues to be eligible for Medicaid.

17. Conversion from hydrocodone to morphine is 1:1 20mg hydrocodone = 20mg of morphine 20-30% of this is 4-6mg methadone Started 5mg 11/30/15 Wanted refill 12/18/15 was taking 4 tabs daily, gave rx for 10 mg bid, ua drug screen done that day came back neg for methadone, was positive for BZ and marijuana 12/21/15 was found dead at home, reported 24 of 60 tabs left, no autopsy done, no drug or etoh levels, was reportedly drunk day before, died natural causes according to coroner at scene

18. differentials • ??? PE, MI, intentional od, respiratory arrest from etoh and BZ, hepatic encephalopathy, liver failure

19. Adverse events/outcomes triggering case presentation

20. Review of Pertinent Literature: • Title: Oral methadone for chronic noncancer pain: a systematic literature review of reasons for administration, prescribing patterns, effectiveness, and side effects • Level of Evidence: 2a • Type of Study: 21 studies doses ranging 20-930mg daily

21. Factors contributing to adverse outcome

22. People Procedure Equipment Adverse Outcome Environment Policy Other Root Cause AnalysisFishbone Diagram Causes: Causes: Causes: _______multiple caregivers _____________________ _____medications_______________________ ____________________________ ____________________________ ____________________________ ____________________________ Causes: Causes: Causes:

23. People Procedure Equipment Outcome Environment Policy Other Root Cause AnalysisFishbone Diagram Solutions: Solutions: Solutions: __better communication coordination of care__________________________ ____slower titration________________________ ____________________________ ____________________________ ____________________________ ____________________________ Solutions: Solutions: Solutions:

24. Comments &Discussion