Inpatient Management of Opioid Use Disorder: Buprenorphine
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1 Inpatient Management f Opiid Use Disrder: Buprenrphine Authrs: Diana Cffa, MD, Kristin Harter, PharmD, Sky Lee, MD, Hannah Snyder, MD, Katherine Wei, MD Advisrs: Jadine Cehand NP, CNS, Curtis Geier, PharmD, Michelle Geier, PharmD, Crinna Gamez, MD, Tamara Lenhff, PharmD, Kelly Pfeiffer, MD, Brad Shapir, MD, Sctt Steiger, MD, Becky Tsui, MD, Sarah Windels, Barry Zevin, MD Disclaimer: These clinical practice guidelines d nt set a standard f care, rather they are an educatinal aid t practice. They d nt set a single best curse f management, nr d they include all available management ptins. They were develped by an interdisciplinary team based n published evidence and expert pinin; as the literature develps best practices may change. They shuld never be used as a substitute fr clinical judgement. Individual prviders are respnsible fr assessing the unique circumstances and needs f each case. Adherence t these guidelines will nt ensure successful treatment in every situatin. This infrmatin is intended fr healthcare prviders and subject matter experts, it is nt intended fr use by patients and the general ppulatin. This guideline applies t patients in inpatient medical settings. If any f the fllwing pints are different fr pregnant patients, it is nted in each segment f the fllwing dcument.
2 Inpatient Management f Opiid Use Disrder: Buprenrphine Gal f Treatment: COWS (Clinical Opiid Withdrawal Scre See Appendix A) f 5 r less fr hurs Eliminatin f drug hunger r cravings N sedatin r respiratry depressin frm medicatin If patient uses illicit piids while n buprenrphine, they shuld nt feel substantially intxicated Mnitring: COWS scre is used t mnitr a patient s respnse t buprenrphine, it can be dne by a prvider r RN COWS assessments shuld be dne per prtcl (See Appendix B) and shuld be dcumented after every check Each COWS must be reprted t a supervising prvider if perfrmed by an RN Based n the COWS, the prvider will decide if there will be a change in mnitring frequency Pregnancy Only : Fetal mnitring beynd what is necessary fr initial fetal evaluatin is nt necessary slely fr methadne administratin unless rdered by the prvider. Patients n utpatient buprenrphine r buprenrphine-nalxne: 1) Cnfirm dse by calling their pharmacy r checking the PDMP (in Califrnia this is ) 2) Determine whether the patient has been taking their medicatin as prescribed, and cntinue based n #3-6 belw 3) Buprenrphine shuld typically be cntinued during acutely painful events, but buprenrphine alne will nt cntrl severe acute pain see separate acute pain guidelines 4) Unless patient has severe alteratin in mental status r intxicatin, cntinue utpatient dse 5) If patient has missed utpatient dsing and has nt used piid agnists in the interim, prvider may rder patient s full utpatient dse 6) If patient has missed >1 day f buprenrphine AND has use piid agnists in the interim, use clinical judgement t determine whether they are at risk fr precipitated withdrawal. If, based n their perid f time withut buprenrphine, piid use, and lack f current bjective withdrawal yu are cncerned fr precipitated withdrawal, please cnsider them a new inductin and fllw prtcls in Appendix B. Fr questins r cncerns, please cnsider cnsulting the UCSF Clinician Cnsultatin Center Substance Use Warmline at (855) Mnday thrugh Friday, between 10 a.m. and 6 p.m EST r 12/1/2017 Page 2 f 9
3 Inpatient Management f Opiid Use Disrder: Buprenrphine Patients cnsidering buprenrphine inductin: 1. Determine clinical indicatin fr buprenrphine therapy: Indicatin Opiid use disrder, with r withut cmrbid chrnic pain and Desire fr buprenrphine treatment t assist with cessatin r reductin in use Cntraindicatins Allergy t buprenrphine Medically unstable and unable t tlerate mild withdrawal safely Cautin Severe psychiatric illness that limits ability t take daily medicatin, mania Acute pain requiring piid agnist therapy EtOH r benzdiazepine use disrder Liver disease Use f methadne in the last week Pregnancy nly: inductin may ccur at utpatient clinic r inpatient under bstetric team guidance If the patient falls under the cautin categry, call the UCSF Substance Use Warmline ( r r yur lcal addictin specialists. 2. Discuss ptins with patient and determine whether methadne r buprenrphine wuld be preferable (See Appendix C Nn-pregnancy Decisin Guide; Pregnancy Only: See Appendix D Pregnancy Only Decisin guide). In the inpatient setting clinicians can legally rder buprenrphine r methadne if the patient is admitted primarily fr anther medical reasn, regardless f if they have an X license/data 2000 waiver. Additinally, prir t starting buprenrphine, ensure that smene in yur hspital will be able t write a shrt prescriptin n discharge and that there are prviders in the patient s area wh are willing t prescribe buprenrphine after discharge fr maintenance therapy. Fr questins r cncerns, please cnsider cnsulting the UCSF Clinician Cnsultatin Center Substance Use Warmline at (855) Mnday thrugh Friday, between 10 a.m. and 6 p.m EST r 12/1/2017 Page 3 f 9
4 Inpatient Management f Opiid Use Disrder: Buprenrphine 3. Prir t inductin: Verify DSM 5 criteria fr piid use disrder Check baseline LFTs (rarely can cause hepattxicity), urine pregnancy test, check urine tx and CURES reprt fr cllateral infrmatin abut substance use Pregnancy Only: als check baseline maternal vital signs, NST as indicated, and a urine tx (utx can nly be perfrmed after patient verbal cnsent) If a patient is experienced mixed alchl and piid withdrawal, be very cautius and cnsult with experts t determine which pathlgy predminate as the cmbinatin f benzdiazepines and piids can be high risk Fllw the attached flwsheet (appendix B) t ensure that the patient des nt have fully activated piid receptrs, as this can lead t precipitated withdrawal frm buprenrphine (very uncmfrtable). Pregnancy nly: precipitated withdrawal can cause withdrawal symptms in the fetus. Precipitated withdrawal is unlikely t ccur if ne f the fllwing is true: COWS scre > 8 with sme bjective signs f piid withdrawal Patient wh has been abstinent fr a prlnged perid, usually weeks (eg recently incarcerated, prlnged hspitalizatin withut piids) Cnsider adjunctive medicatins t help t cntrl withdrawal symptms, prir t starting and during inductin. Of nte, this will lwer COWS scres therefre may prlng the inductin. Diphenhydramine mg, PO three times daily prn insmnia/anxiety Ondansetrn 4 mg PO every 6 hurs PRN nausea Ibuprfen mg, PO fur times daily prn pain (Pregnancy Only : Ibuprfen is cntraindicated) Acetaminphen 650 mg PO 6 fur times daily PRN pain Lperamide 4mg PO x 1 initially, then 2mf prn each additinal lse stl (NTE 16 mg/24 hurs) Clnidine 0.1 mg PO q4 hurs prn w/d symptms (NTE 2 dses/24 hurs and include BP parameter) DO NOT ORDER benzdiazepines as standard PRN adjunctive therapy. 4. Fllw attached algrithm fr dsing. MD r RN must evaluate befre and 1 hur after each dse. Dcument each COWS scre n the scring sheet belw and keep in patient chart. If sedatin (Ramsey scre 4) r RR<8 ccurs, hld dsing. Ttal dse n the first day shuld nt exceed 12 mg. On day tw, start with day ne ttal daily dse and give additinal as needed per the algrithm. If precipitated withdrawal is suspected at any pint, r if withdrawal symptms are uncntrlled n the maximum daily dse, call the Substance Use Warmline (see item 3) r yur lcal addictin specialist. Management usually invlves repeating buprenrphine dse, r if patient is unstable giving full piid agnist with strng affinity. Fr questins r cncerns, please cnsider cnsulting the UCSF Clinician Cnsultatin Center Substance Use Warmline at (855) Mnday thrugh Friday, between 10 a.m. and 6 p.m EST r 12/1/2017 Page 4 f 9
5 Inpatient Management f Opiid Use Disrder: Buprenrphine Discharge Planning 1) Call lcal buprenrphine prescriber (see SAMHSA database at t arrange appintment fr patient after discharge. Ideally, this appintment will be within 3 days f discharge. 2) On discharge, prvide enugh buprenrphine t last until appintment at utpatient clinic. Of nte, depending n pharmacy frmularies inpatients may receive buprenrphine alne (Subutex), hwever buprenrphine-nalxne (Subxne) shuld be dispensed n discharge t discurage diversin. Medi-Cal cvers buprenrphine and buprenrphine-nalxne, with sme ther insurance prviders a TAR may be necessary. Discharge prescriptin must be written by X licensed prvider. 3) Skilled nursing facilities (SNFs) that are nt classified as hspitals can nly keep patients n buprenrphine if they have an utside prvider discuss these details with the SNF early in the prcess 4) Please prescribe nalxne in case f relapse and verdse, als cnsider PREP/PEP if indicated. Other Dsing Cnsideratins Prduct Selectin: The standard apprach is t use sublingual films r tablets fr treatment f piid use disrder Split Dsing: In the hspital, either buprenrphine mnprduct r cmbinatin buprenrphine-nalxne may be used On discharge, the cmbinatin buprenrphine-nalxne is recmmended due t decreased diversin and des nt have increased rates f side effects Buprenrphine shuld be dsed sublingually and allwed t fully disslve, nt be swallwed. Up t 2 tablets can be administered sublingually at ne time Pregnancy Only : In pregnancy, a prvider must nly prescribe buprenrphine and NOT the buprenrphine/nalxne cmbinatin medicatin Split dsing may be necessary fr patient with acute r chrnic severe pain Pregnancy Only: As gestatinal age increases, plasma levels f buprenrphine change secndary t a decrease in half-life and an increase in clearance and vlume f distributin. This generally ccurs during the secnd and third trimester. As such, a prvider may strngly cnsider splitting the daily buprenrphine dse t an AM and PM dse if the patient experiences withdrawal symptms r cravings at night. Breastfeeding Guidelines Buprenrphine fr piid use disrder is nt a cntraindicatin fr breastfeeding. Patients taking buprenrphine fr piid use disrder wh are nt currently abusing ther substances and wh wish t breastfeed shuld be encuraged t regardless f the buprenrphine dse. Current evidence shws that breastfeeding while n buprenrphine is beneficial t nenates with nenatal abstinence syndrme (NAS). Nenates receiving breast milk frm these patients experience lwer NAS scres, require less pharmaclgic treatment such as mrphine, and have shrter lengths f hspital stay. Fr questins r cncerns, please cnsider cnsulting the UCSF Clinician Cnsultatin Center Substance Use Warmline at (855) Mnday thrugh Friday, between 10 a.m. and 6 p.m EST r 12/1/2017 Page 5 f 9
6 PATIENT NAME: PATIENT DATE OF BIRTH: DATE OF ASSESSMENT: MEDICAL RECORD NUMBER: Clinical Opiid Withdrawal Scre (COWS) Fr each item, write in the number that best describes the patient s signs r symptm. Rate nly the apparent relatinship t piate withdrawal. Fr example: If heart rate is increased because the patient was jgging just prir t assessment, the increased pulse rate wuld nt add t the scre. Enter scres at time zer, 30 minutes after first dse, 2 hurs after first dse, etc. Time: Time: Time: Time: Resting Pulse Rate : Recrd beats per minute after patient is sitting r lying dwn fr ne minute 0 - pulse rate 80 r belw 1 - pulse rate pulse rate pulse rate greater than 120 Sweating : Over past ½ hur nt accunted fr by rm temperature r activity 0 - n chills r flushing 1 - subjective chills r flushing 2 - flushed r bservable mistness n face Restlessness : Observatin during assessment 0 - able t sit still 1 - reprts difficulty sitting still, but is able t d s Pupil size 0 - pupils pinned r nrmal size fr light 1 - pupils pssibly larger than nrmal fr light 3 - beads f sweat n brw r face 4 - sweat streaming ff face 3 - frequent shifting r extraneus mvement f legs/arms 5 - unable t sit still fr mre than a few secnds 2 - pupils mderately dilated 5 - pupils dilated that nly rim f the iris is visible Bne r jint aches : If patient was having pain previusly, nly the additinal cmpnent attributed t piate withdrawal is scred 0 - nt present 1 - mild/diffuse discmfrt 2 - patient reprts severe diffuse aching f jints/muscles Runny nse r tearing : Nt accunted fr by cld symptms r allergy 0 - nne present 1 - nasal stuffiness r unusually mist eyes GI upset : Over last ½ hur 0 - n GI symptms 1 - stmach cramps Tremr : Observatin f utstretched hands 0 - n tremr 1 - tremr can be felt, but nt bserved Yawning : Observatin during assessment 0 - n yawning 1 - yawning nce r twice during assessment Anxiety r irritability 0 - nne 1 - patient reprts increasing irritability r anxiusness Gseflesh skin 0 - skin is smth 4 - patient is rubbing jints r muscles and is unable t sit still because f discmfrt 2 - nse running r tearing 4 - nse cnstantly running r tears streaming dwn cheeks 2 - nausea r lse stl 3 - vmiting r diarrhea 5 - multiple episdes f diarrhea r vmiting 2 - slight tremr bservable 4 - grss tremr r muscle twitching 2 - yawning three r mre times during assessment 4 - yawning several times/minute 2 - patient bviusly irritable r anxius 4 - patient s irritable r anxius that participatin in the assessment is difficult 3 - pilerrectin f skin can be felt r hairs standing up n arms 5 - prminent pilerrectin 5 12 = mild; = mderate; = mderately severe; > 36 = severe withdrawal TOTAL OBSERVER INITIALS
7 Inpatient Management f Opiid Use Disrder: Buprenrphine Appendix B - Buprenrphine Inductin Algrithm Fr questins r cncerns, please cnsider cnsulting the UCSF Clinician Cnsultatin Center Substance Use Warmline at (855) Mnday thrugh Friday, between 10 a.m. and 6 p.m EST r 12/1/2017 Page 7 f 9
8 Inpatient Management f Opiid Use Disrder: Buprenrphine Appendix C Nn-Pregnancy Decisin Guide Methadne Buprenrphine Mechanism Full piid agnist Partial piid agnist, usually paired with nalxne (piid antagnist) Patients fr whm shuld use cautin r avid Risk f withdrawal when starting medicatin Allergy, severe liver disease, QTc prlngatin, drug-drug interactins, high risk jb Nne Allergy, severe liver disease, heavy EtOH r benz, need fr acute piids, recent methadne Sme, if nt in withdrawal prir t starting may have precipitated withdrawal Side effects/risks Hypgnadism, Trsades, cnstipatin, sweating GI upset, cnstipatin, headache, insmnia Sedatin/respiratry depressin Overdse risk frm piid replacement Retentin in treatment Visit frequency Diversin ptential Wh can prescribe after discharge? Mrtality At high dses in nn-tlerant patients r slw metablizers has ptential fr sedatin, wrse in cmbinatin with sme medicatins Lw-mderate, higher when initiating treatment r in cmb with ther medicatins 1 Higher in methadne, with pssible cntributin frm increased structure f prgrams Daily visits t maintenance treatment prgram, take-hmes may be allwed if stable fr lng term. This structure helps sme patients, sme dislike it. Lw fr directly bserved therapy (DOT), high fr take hme Opiid treatment prgram nly Bth ptins substantially decrease all-cause mrtality ver n treatment, 2 methadne may have higher mrtality but may be cnfunded Ceiling effect fr respiratry depressin therefre less risky (unless cncurrent use f sedating drugs, e.g., alchl/benzdiazepines) Lw, increased by cncurrent sedating medicatins May be slightly lwer than methadne, retentin imprves at dses ver 16mg Can range frm daily t mnthly depending n patient treatment needs, may be prvided in primary care setting. Als available in sme methadne clinics, increasing structure and decreasing diversin risk. Lw fr DOT, mderate fr take-hmes, reduced by c-frmulatin with nalxne Any physician, NP, r PA wh has been trained and pssesses DATA2000 waivers (aka X-number) Bth ptins substantially decrease all-cause mrtality ver n treatment, buprenrphine may have lwer mrtality but may be cnfunded Sme patients may decline buprenrphine r methadne, but still be interested in medicatin assisted treatment. In these cases, ne ptin is naltrexne, hwever it has been shwn t 3 have very high drp-ut rates s is nt cnsidered first line. Naltrexne can nly be started after a patient has cmpletely withdrawn frm piids rughly 5-7 day fr shrt acting and 7-10 days fr lng acting. One ptin is t give nalxne as a trial befre administering naltrexne, t make sure the patient desn t experience precipitated withdrawal. Dsing usually begins with 25mg n the first day, and is then increased t 50 mg daily. Fr IM frmulatin, the dse is usually 380 mg q4 weeks. The mst cmmn side effects are nausea, vmiting, and headache 1 McLellan A, Arndt I, Metzger D, Wdy G, O Brien C. Treatment Retentin amng Patients Randmized t Buprenrphine/Nalxne Cmpared t Methadne in a Multi-Site Trial. Addictin. 2014; 109(1): Srd L, Barri G, Brav M, Indave B, Degenhardt L, Wiessig L, Ferri M, Pastr-Barrius R. Mrtality risk during and after piid substitutin treatment: systematic review and meta-analysis f chrt studies. BMJ. 2017:357:j Minzzi S, Amat Le Vecchi S, Davli M, Kirchmayer, U, Verster A. Oral naltrexne maintenance treatment fr piid dependence. Cchrane Database f Systematic Reviews: Reviews
9 Inpatient Management f Opiid Use Disrder: Buprenrphine Appendix D Pregnancy Decisin Guide Methadne Buprenrphine Mechanism Full piid agnist Partial piid agnist, usually paired with nalxne (piid antagnist) Patients fr whm shuld use cautin r avid Risk f withdrawal when starting medicatin Allergy, severe liver disease, QTc prlngatin, drug-drug interactins, high risk jb Nne Allergy, severe liver disease, heavy EtOH r benz, need fr acute piids, recent methadne Sme, if nt in withdrawal prir t starting may have precipitated withdrawal Side effects/risks Hypgnadism, Trsades, cnstipatin, sweating GI upset, cnstipatin, headache, insmnia Sedatin/respiratry depressin Overdse risk frm piid replacement At high dses in nn-tlerant patients r slw metablizers has ptential fr sedatin, wrse in cmbinatin with sme medicatins Lw-mderate, higher when initiating treatment r in cmb with ther medicatins 4 Higher in methadne (88% in the MOTHER study), with pssible Retentin in treatment cntributin frm increased structure f prgrams Visit frequency Diversin ptential Wh can prescribe after discharge? Mrtality Daily visits t maintenance treatment prgram, take-hmes may be allwed if stable fr lng term. This structure helps sme patients, sme dislike it. Lw fr directly bserved therapy (DOT), high fr take hme Opiid treatment prgram nly Bth ptins substantially decrease all-cause mrtality ver n treatment, methadne may have higher mrtality but may be cnfunded 5 Reduced preterm birth and lw birth weight rates Nenatal Outcmes 6 Higher dses d NOT crrelate with mre NAS NAS is 75% - in MOTHER study: 17.5 day average length f hspitalizatin 10.4 mg mrphine required during hspitalizatin Naltrexne is nt a gd ptin in pregnancy due t safety cncerns Ceiling effect fr respiratry depressin therefre less risky (unless cncurrent use f sedating drugs, e.g., alchl/benzdiazepines) Lw, increased by cncurrent sedating medicatins Slightly lwer than methadne (67% in the MOTHER study, with mst drp uts during inductin) Can range frm daily t mnthly depending n patient treatment needs, may be prvided in primary care setting. Als available in sme methadne clinics, increasing structure and decreasing diversin risk. Lw fr DOT, mderate fr take-hmes, reduced by c-frmulatin with nalxne Any physician, NP, r PA wh has been trained and pssesses DATA2000 waivers (aka X-number) Bth ptins substantially decrease all-cause mrtality ver n treatment, buprenrphine may have lwer mrtality but may be cnfunded Reduced preterm birth and lw birth weight rates Later average gestatinal age and higher average birth weight than methadne Higher dses d NOT crrelate with mre NAS NAS less severe than fr methadne in MOTHER study: 10 day average length f hspitalizatin 1.1 mg mrphine required during hspitalizatin 4 Jnes HE, Kaltenbach K, Heil SH, et al. Nenatal abstinence syndrme after methadne r buprenrphine expsure. N Engl J Med. 2010;363(24): Sr d L, Barri G, Brav M, Indave B, Degenhardt L, Wiessig L, Ferri M, Pastr-Barrius R. Mrtality risk during and after piid substitutin treatment: systematic review and meta-analysis f chrt studies. BMJ. 2017:357:j Jnes HE, Kaltenbach K, Heil SH, et al. Nenatal abstinence syndrme after methadne r buprenrphine expsure. N Engl J Med. 2010;363(24):
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