Vermont Guidelines for Medication Assisted Treatment (MAT) for Pregnant Women

Transcription

1 Vermot Guidelies for Medicatio Assisted Treatmet (MAT) for Pregat Wome

2 medicatio-assisted Treatmet (MAT) for Pregat wome Overview... 1 Opioid Maiteace Durig Pregacy... 1 medicatio ad treatmet settig optios... 1 Methadoe... 2 bupreorphie... 2 medicatio selectio... 2 medicatio maagemet... 3 Methadoe or Bupreorphie Iitiatio... 3 Pregacy Maagemet for the Medicatio Provider... 4 Iitiatio of Pregacy Care... 4 Weekly Visit Recommedatios... 4 Labor, Delivery ad Postpartum... 4 Vermot Guidelies for Medicatio Assisted Treatmet (MAT) for Pregat Wome Breastfeedig... 5 Postpartum Pla for Opioid-Agoist Medicatio... 5 Cotraceptio ad Fertility... 5 Commo Cliical Challeges... 5 Treatmet No-Adherece... 6 Cliical Risk Maagemet Strategies... 6 Cliical Maagemet FAQs... 7 Legal issues uique to pregacy FAq... 8 Appedices Appedix 1: HIPAA Forms...10 Appedix 2: Treatmet Iformatio Sheet...11 Appedix 3: Patiet Assessmet Checklist for Office-Based Therapy...12 Appedix 4: Bupreorphie Treatmet Agreemet/Cotract...13 Appedix 5: Treatmet of Opioid Depedece Durig Pregacy Demographic Sheet...14 Appedix 6: COGS Cliic Fax Referral Form...15 Appedix 7: Opioid-Agoist Therapy Durig Pregacy Medicatio Provider Checklist...16 Appedix 8: Medicatio Provider Visit Flow Sheet...17 Appedix 9: Commuity-Based Nursig/ Social Services Checklist...18 Appedix 10: Commuicatio Tool Fax Form...19

3 Purpose/Disclaimer The Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome were created to provide Vermot practitioers with a cosolidated set of recommedatios for the maagemet of opioid depedece durig pregacy. The cotet of these guidelies is iteded to complemet stadard medical care, the Vermot Bupreorphie Practice Guidelies, ad other resources available through the America College of Obstetrics ad Gyecology ad Substace Abuse ad Metal Health Services Admiistratio ( ad Commuity-based Substace Abuse Treatmet ( These guidelies are ot iteded as requiremets for practitioers. They should ot be cosidered as medical advice. Ackowledgemets The Vermot Guidelies for the Treatmet of Opioid Depedece i Pregacy are a collaborative effort of the Vermot Departmet of Health, Divisio of Alcohol ad Substace Abuse Programs (VDH/ADAP) ad the Departmet of Vermot Health Access (DVHA), with the guidace of local treatmet providers. May people cotributed to developig these guidelies. Special thaks go to the followig idividuals: Joh R. Brookly, MD Barbara Cimaglio Peter Lee Todd W. Madell, MD Wedy Davis, MD Vicki Loer Jerily Metayer, RN Ae Johsto, MD Miriam Sheehey, RN Nacy Lefebvre, RN Marjorie Meyer, MD Eleaor Capeless, MD

4 Medicatio-Assisted Treatmet (MAT) for Pregat Wome Overview Opioid Maiteace Durig Pregacy Opioid addictio is a chroic, relapsig disease. Acute opioid withdrawal is physiologically stressful, characterized by profoud activatio of the sympathetic ervous system with hypertesio, tachycardia, ad gastroitestial symptoms. I the 1970s, a series of case reports ad aimal studies reported stillbirth ad mecoium aspiratio whe patiets preseted late i gestatio i acute opioid withdrawal. Coicidet with these reports, radomized trials i the geeral opioid depedet populatio demostrated that methadoe maiteace decreased opioid cravig ad allowed rehabilitatio more effectively tha acute withdrawal. As methadoe maiteace for the treatmet of opioid depedece became accepted as appropriate medical therapy, the use of methadoe durig pregacy to prevet materal (ad fetal) withdrawal was examied. Methadoe maiteace durig pregacy improved preatal care, reduced illicit drug use, ad miimized the risk of fetal i utero withdrawal. These demostrated beefits led to the curret recommedatio for opioid agoist maiteace for opioid depedet wome durig pregacy. Medicatio ad Treatmet Settig Optios Treatmet with a opioid-agoist improves pregacy outcomes for opioid-depedet wome. The best outcomes are observed whe wome are erolled i a comprehesive treatmet program. The overarchig goals of therapy for opioid depedece durig pregacy is to provide medical support to prevet withdrawal durig pregacy, miimize fetal exposure to illicit substaces, ad egage the mother as a leader i her recovery. Such egagemet provides her the opportuity to receive both medical ad acillary services which will allow her to successfully paret her child. Recogizig that egagemet ito a comprehesive treatmet program ca be a gradual process, medicatio providers may face the difficult task of distiguishig the patiet that eeds a bit more time to become egaged i a treatmet pla from the patiet that is ot ready for treatmet. Assessmet of treatmet progressio over some weeks may be eeded. Office-based therapy durig pregacy favors the patiet that is highly motivated to recovery ad paretig. Such wome usually agree to substace abuse couselig ad the assistace of commuity-based ursig to assist i recovery. Patiets uwillig to egage these services may ot be optimal cadidates for office-based therapy ad may beefit from the structure of a methadoe program or residetial treatmet before proceedig to office-based therapy. Iclusio of substace abuse couselig ad wrap aroud services should be strogly ecouraged for all patiets, as medicatio aloe is ot sufficiet for optimal pregacy ad paretig outcome. The decisio regardig the most appropriate medicatio should be made joitly with the opioid-agoist provider, the obstetricia, ad the patiet. Wome that are pregat but are ot a cadidate for office-based therapy should Greatest Beefit Greatest Risk Comprehesive treatmet program opioid-agoist therapy (methadoe or bupreorphie) OPTIMAL TREATMENT Bupreorphie without couselig; o illicit use Methadoe or bupreorphie with cotiued other illicit substace use Cotiued illicit drug use with o treatmet Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome 1

5 be referred to a methadoe treatmet ceter (Chittede Ceter or BAART); a alterative is a residetial program with reassessmet for office-based therapy followig successful completio of the residetial treatmet program. Methadoe: Opiate Program Ceter-Based Treatmet Methadoe is a pure mu opioid-agoist with a log half life (24 hours) which allows for daily dosig. Methadoe is the medicatio of choice for treatmet durig pregacy, owig to the simple fact that there are more data regardig eoatal outcomes followig i utero exposure. It is a pregacy category C drug ad is ot specifically approved for treatmet of opioid depedece durig pregacy by the FDA, despite widespread recommedatios as the medicatio of choice i pregacy. Iitiatig or switchig treatmet to methadoe should be offered to all opiate depedet pregat patiets. Methadoe for the treatmet of opioid depedece is available oly through opioid treatmet ceters. I Vermot, these ceters provide medical screeig ad substace abuse couselig, icludig a full social assessmet. Provisio of these acillary services has bee demostrated to improve retetio i treatmet ad treatmet outcomes. Pregat wome are a high priority for treatmet with methadoe ad will automatically be erolled i a treatmet program, despite log waitig lists for other patiets. I Vermot, the major barriers to methadoe treatmet are the restricted daily dosig times ad the travel time that is ofte eeded. These issues are particularly difficult for wome i school, workig, with small childre at home, ad those that live a distace from a treatmet ceter. Access to medicatio ad ability to realistically comply with a treatmet program ca be cosidered i the overall decisio regardig medicatio choice. Bupreorphie: Office-based Medicatio- Assisted Treatmet Bupreorphie is a partial mu opioid-agoist approved for the treatmet of opioid depedece. Ulike methadoe, bupreorphie is prescribed i medical offices rather tha at licesed cliics. The Vermot Bupreorphie Practice Guidelies outlie the backgroud of office-based medicatioassisted therapies ad guidace for prescribers o the maagemet of opioid depedet patiets. Brad ames for bupreorphie iclude Suboxoe, which is a bupreorphie/aloxoe combiatio ad Subutex, which is bupreorphie aloe. Small cohort studies have foud bupreorphie to be safe ad effective i the treatmet of opioid depedece durig pregacy. However, because it is a relatively ew medicatio, log term outcome data of eoates exposed to bupreorphie i utero are lackig ad patiets seekig treatmet should be iformed of this. Noetheless, risk/ beefit may favor bupreorphie if the patiet is otherwise a cadidate for office-based therapy ad there are barriers that preclude her attedig a methadoe program. The data suggest that treatmet with bupreorphie provides better outcomes for mother ad ewbor compared to o treatmet. Cadidates for bupreorphie are wome that are stable o bupreorphie prior to pregacy or those uable to atted a methadoe treatmet ceter AND are otherwise cadidates for office-based therapy. Pregacy does NOT make wome automatically cadidates for officebased therapy with bupreorphie, eve if that is the oly medicatio available i the commuity. Egagemet i couselig ad other services is vital durig pregacy ad recovery for successful postpartum trasitio. Some wome may beefit from residetial treatmet with office-based therapy followig stabilizatio. Medicatio Selectio Please see the Vermot Bupreorphie Practice Guidelies for detailed iformatio regardig the choice of medicatio ad how to determie whether a patiet, irrespective of pregacy issues, is a cadidate for office-based treatmet. Choosig the best medicatio for pregacy is a discussio ultimately best suited to the medicatio provider ad the patiet. Recogizig may pregat patiets will look to their obstetric care provider before iitiatig medicatio, it may be helpful for the medicatio provider ad obstetric provider to discuss the pla before presetig the fial decisio to the patiet. Methadoe is the medicatio of choice due to the log term eoatal outcome data. Bupreorphie is a reasoable alterative i select patiets. The discussio ad decisio for medicatio should be reviewed with the patiet ad documeted i the chart. Please see Appedix 2 for a sample Patiet Treatmet Iformatio sheet regardig medicatio durig pregacy, which ca be reviewed with the patiet. For patiets that are ot optimal cadidates for bupreorphie whe methadoe is ot available, a step wise approach of iitiatio with bupreorphie with close follow-up could be cosidered. I these istaces, bupreorphie with very close ad frequet follow-up could be cosidered with iitiatio of medicatio ad couselig. Residetial treatmet or methadoe could be cosidered for difficulty i bupreorphie treatmet adherece. If you are ucertai about the optimal medicatio for a pregat patiet, Fletcher Alle Health Care Comprehesive Obstetrics ad Gyecology Cliic or Neoatology Service ca assist i this decisio makig process ad provide care to ay opioid depedet patiet. The Fletcher Alle Comprehesive Obstetrics ad Gyecology Cliic is available to treat ay opioid depedet wome durig pregacy. (See Appedix 6 for referral forms). 2 Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome

6 Methadoe or start with residetial treatmet if: Polysubstace abuse, icludig alcohol or bezodiazepies Ustable livig situatio Abused bupreorphie (sortig) Declies/ocompliat with couselig Iability to coordiate acillary services I a madatory recovery program (parole) Nocompliat with obstetric or pediatric care Office-based bupreorphie if: Iformed coset re: ew medicatio for pregacy Opioids are the oly substace of abuse Stable livig situatio Accepts couselig Ca coordiate acillary services or there is a commuity-based program that will do so Compliat with obstetric ad pediatric care There is o alterative ad the patiet uderstads treatmet may be iitiated o a trial basis Medicatio Maagemet The iformatio i this documet is additioal iformatio for medicatio iitiatio durig pregacy. For more detailed iformatio about iitiatio of medicatio, patiet selectio, or other issues surroudig iitiatio of bupreorphie, see the Vermot Bupreorphie Practice Guidelies i this booklet. Medicatio should ot be iitiated util both opioid depedece AND a viable itrauterie pregacy (ultrasoud with heartbeat) are cofirmed. Pregacy is a idicatio for priority treatmet but is ot a emergecy. For iitiatio of medicatio durig pregacy, there must be a diagosis/cofirmatio of pregacy. Urie home pregacy tests are ot sufficiet for iitiatio of treatmet. Obstetric providers, commuity health cliic or Plaed Parethood cliics ca assist with diagosis of or cofirmatio of a viable itrauterie pregacy. For a diagosis/cofirmatio of opioid depedece, a positive urie test for opioids ru as either a office-based poit of care test or a laboratory test ca be ru. Opioid depedece should be documeted by the presece of opioid withdrawal symptoms, such as COWS. (see Vermot Bupreorphie Practice Guidelies, Appedix 5, page 13) Query of the Vermot Prescriptio Moitorig System to assess prescriptio opioid use is recommeded. Occasioal use of opioids may ot cause physical depedece ad therefore may ot require agoist therapy; substace abuse couselig ad moitorig is imperative. Methadoe or Bupreorphie Iitiatio The provider should decide o medicatio of choice (refer to the Vermot Bupreorphie Practice Guidelies). Iductio of medicatio will be the same procedure used for o-pregat patiets i your practice (see Vermot Bupreorphie Practice Guidelies); pregat wome should be cosidered a priority iductio with a goal of iitiatio of medicatio withi oe week of the medicatio decisio. Mild or eve moderate (CINA rage) symptoms of opioid withdrawal are ot dagerous to pregacy. It is reasoable to ask the patiet to abstai from opioid use (ad have withdrawal symptoms) for the purposes of iductio. Patiets may be referred to a iductio ceter for bupreorphie if that is your usual approach. Bupreorphie moo-therapy is recommeded durig pregacy. Cotiuatio of Medicatio Durig Pregacy (after iductio or i a previously stable patiet): If bupreorphie is beig used, chage to bupreorphie mootherapy at the same dose. Assess for withdrawal symptoms weekly (see Medicatio Provider Visit Flow Sheet, Appedix 8) ad adjust dose as idicated; oe refill (total of two weeks of medicatios) may be cosidered for the stable patiet i couselig if ot well. Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome 3

7 Provide oly oe week of medicatio at a time to miimize diversio/theft/loss of medicatio. Pregacy specific dosig otes: 70% of patiets stable prior to pregacy will eed a modest dose icrease (3-5 mg) durig pregacy (Fletcher Alle data); prescribed gradually throughout gestatio The average dose at the ed of pregacy i wome started durig pregacy is 16 mg (Fletcher Alle data) Large icreases i bupreorphie requiremets have ot bee oted durig pregacy; if such icreases are eeded, cosider alterative diagoses If the patiet has difficulty i egagig i acillary services ad couselig, cosider switch to residetial program or a methadoe treatmet program If methadoe is beig used, methadoe dose may eed to be split if very high doses are eeded due to icreased excretio. Pregacy Maagemet for the Medicatio Provider: As the provider of methadoe or bupreorphie, you will have the logest history with the patiet ad the best visit compliace. Referrals for acillary services durig pregacy are best made through your medicatio visits. At Iitiatio of Pregacy Care: Referral to your district Childre s Itegrated Services Coordiator (CIS) should occur. See the resource sectio i this booklet for the agecy i your district that houses the CIS itake coordiator. See the patiet i weekly visits ad for urie drug screes. The stresses of pregacy ad havig a ewbor warrat closer follow-up eve if substace abuse couselig has ot bee eeded i the past. Obtai HIPAA cosets to permit commuicatio with obstetric provider, couselor, ad plaed pediatric provider. This coset should be a coditio of office-based treatmet. (See Appedix 1 for samples). Cotact the obstetric provider ad pediatric provider directly to documet medicatio (methadoe or bupreorphie) use i pregacy (they will kow whether delivery i your local/regioal hospital is appropriate). Refer to the Services for Opioid-Depedet Pregat Wome i Vermot at the begiig of this documet. There should be documetatio of estimated due date (patiet report is sufficiet). Weekly Visit Recommedatios (ca be doe by a urse): Urie drug scree Assessmet of withdrawal symptoms or evidece of fuctioal impairmet. Cofirmatio of adherece with couselig recommedatios Cofirmatio of adherece with commuity-based ursig (paretig) plas Cofirmatio of adherece to obstetric care (mothly visits util 28 weeks; every 2 week visits weeks; weekly visits 36 weeks to due date at 40 weeks) Assessmet ad pla for difficulty with adherece to the treatmet pla (i.e.: preatal care, couselig, coectio with acillary services) should be made with each weekly prescriptio Reassess whether the patiet should remai i a officebased treatmet program for repeated lack of adherece Provide prescriptio Betwee weeks establish these referrals (either sed the patiet directly OR specifically request the obstetric provider): Pediatric provider cosultatio for evaluatio ad treatmet of eoatal abstiece sydrome (with specific emphasis o ability to receive all care at the hospital of plaed delivery) Aesthesia cosultatio for pai maagemet pla (reasoable for all patiets; most importat for those plaig cesarea delivery) weeks: Delivery ad Postpartum plaig Update the obstetric provider with the appropriate dose of medicatio ear delivery Remid the obstetric provider that NALBUPHINE ad BUTORPHANOL are CONTRAINDICATED as they ca precipitate withdrawal Childre ad Ifat Services referral for acillary social services Ecourage Breastfeedig Commuity-based ursig for paretig skills Parter treatmet if ot already doe Labor, Delivery ad Postpartum: Durig labor ad delivery, as well as the postpartum process, reassure the patiet that providig her adequate pai cotrol is importat. Coversatios with obstetric ad aesthesia providers should reflect that i a stable patiet, there is o reaso to suspect drug seekig if requestig pai medicatio i the appropriate cliical settig. Pediatrics should be otified that a opioid exposed eoate will be delivered soo. A referral ca be made to hospital based social work to evaluate ay eeds of the patiet postpartum. Durig labor ad delivery, cotiue scheduled methadoe or bupreorphie durig hospitalizatio. The obstetric provider ca order these medicatios i the hospital eve if ot a bupreorphie prescriber, but will ot be able to prescribe this medicatio after hospital discharge. A aesthesia cosult should be made whe the patiet arrives i labor as idicated. Neuraxial aalgesia (spial, epidural) is effective for pai cotrol durig labor or for cesarea delivery i opioid depedet wome. 4 Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome

8 Itraveous short-actig Nalbuphie ad Butorphaol are Cotraidicated as they may precipitate withdrawal. If iadvertet admiistratio occurs ad the patiet has withdrawal symptoms, a opioidagoist should be admiistered to alleviate withdrawal symptoms; moitor for respiratory depressio. After the delivery, cotiue medicatio-assisted therapy as idicated ad have hospital based social work see the patiet. For pai cotrol, acetamiophe ad o-steriodal atiiflammatory agets should be used for mild ad moderate pai with short-actig opioid aalgesics used as eeded. I a vagial birth, short-actig opioids ca be made available o a PRN basis, just as for o-opioid depedet patiets. Opioids for pai cotrol should ot be eeded followig discharge for a routie delivery. I the case of a cesarea delivery, cotiuous short-actig aalgesics for 48 hours patiet cotrolled aalgesia with itraveous morphie or hydromorphoe ca be used the first 24 hours. Oral opioids ca also be used. You may expect a 70% icrease i short-actig opioid aalgesic requiremet; ofte a more potet oral aget (hydromorphoe) is required. Patiet cotrolled epidural aalgesia is effective for severe pai if available. Expect that short-actig opioids will be eeded i decreasig amouts for 5-7 days followig cesarea delivery. Breastfeedig Breastfeedig is ecouraged for all patiets (except those with HIV). If Breastfeedig is declied, switch the patiet back to combiatio bupreorphie/aloxoe immediately after delivery or cotiue methadoe. If breastfeedig is accepted, cosult with pediatric provider to cofirm that they are aware of patiet s medicatio-assisted treatmet use. If ewbor is ot receivig methadoe or morphie for eoatal abstiece sydrome, switch mother back to bupreorphie/aloxoe. If the ewbor is beig treated with methadoe or morphie for eoatal abstiece sydrome, cotiue bupreorphie mootherapy util eoate is off medicatio or weaed from breastmilk. There may be some patiets i whom combiatio bupreorphie/ aloxoe is recommeded; give evidece of miimal bioavailability i breastmilk, breastfeedig should be ecouraged. Postpartum Pla for Opioid-Agoist Medicatio: There is curretly o evidece that dose chages of methadoe or bupreorphie are eeded postpartum. Special attetio for somolece is warrated. Pay special attetio to relapse, especially 3-6 moths postpartum. There is aecdotal evidece to suggest that this is a particularly vulerable time for a woma i recovery. Ecourage cotiuatio of commuity ursig for paretig support (or start iitial referral at discharge if ot doe previously). Esure each patiet has a follow-up appoitmet with BOTH her medicatio provider ad substace abuse couselor. Cotraceptio ad Fertility As with may uderlyig diseases, as the patiet s recovery proceeds, her fertility may also icrease. Patiets should ot assume that because they have had ifertility problems i the past that it will cotiue after treatmet is iitiated. If a patiet is plaig a pregacy (or sexually active without cotraceptio), preatal vitamis (800 mcg folic acid) are recommeded prior to coceptio to reduce birth defects. If a patiet is sexually active ad ot usig cotraceptio, preatal vitamis should be recommeded give high risk of pregacy. Cotraceptive couselig ad treatmet are available at low cost (or free) from commuity health cliics ad Plaed Parethood. There is o evidece of medicatio iteractio betwee oral cotraceptives ad methadoe or bupreorphie. To afford the patiet the best chace for a successful recovery, address her parter/family substace abuse treatmet ad pla, as idicated. Commo Cliical Challeges: Wome with a history of substace abuse ofte have chaotic lives, experiece domestic violece, ad have teuous housig. The structure imposed by treatmet programs ca be a difficult adjustmet. Relapses are Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome 5

9 commo, especially early i treatmet. A combied treatmet pla developed by the patiet with the obstetricia ad medicatio provider that appropriately balaces materal ad fetal risk is imperative. Treatmet No-Adherece The iability to remai abstiet, o adherece with couselig, or demostratio of other high-risk behavior costitutes treatmet o-adherece. Optios iclude: Evaluate for more itesive services to more structured program (itesive outpatiet program, residetial treatmet, methadoe) usig ASAM criteria. Discharge the patiet from office-based therapy if she declies other optios 6. Commuicatio with the obstetricia, pediatricia, social work team at the hospital of plaed delivery ad the Departmet of Childre ad Families (DCF) should occur promptly. Useful cross disciplie strategies for treatmet oadherece iclude likig the ability to pick up a bupreorphie prescriptio or methadoe dose with preatal care by requirig a visit to the obstetric provider office first. Cosider likig the ability to pick up a bupreorphie prescriptio or methadoe dose to couselig ad referral to residetial treatmet or cosider switch to methadoe if adherece to officebased care is ot possible For recurret positive drug screes with bezodiazepies, particular care must be take i maagemet of patiets depedet upo bezodiazepies ad opioids, due to syergistic respiratory depressio,eve if the bezodiazepies are prescribed. Provisio for coordiatio of care must be made ad cosideratio give to admissio for bezodiazepie detoxificatio. Educatio should be give about the potetial syergy betwee methadoe, bupreorphie ad bezodiazepies which icludes warigs about drivig or machie operatio. This itervetio should be documeted i the medical record. Other strategies iclude a icrease i couselig ad cosideratio of alterative medicatio for axiety (i.e.: sertralie). Patiet may ot be a cadidate for officebased therapy if usig bezodiazepies ad might be better served at a opioid treatmet ceter or residetial treatmet ceter. For recurret positive drug screes with cocaie, discuss the specific dagers of cocaie use i pregacy icludig fetal loss, bleedig, preterm labor ad fetal stroke. The patiet may ot be a cadidate for office-based therapy if usig cocaie ad should be referred to a opioid treatmet ceter or residetial treatmet for a more structured program. Educatio should be provided ad documeted regardig potetial Levamasole cotamiatio of cocaie. For recurret positive drug screes with caabis, use of ay illicit substace should be discouraged. Give the relatively little data that THC is harmful i pregacy combied with the clear beefit of opioid maiteace therapy, cosider cotiuatio with close follow-up or residetial treatmet. No-adherece due to trasportatio ad other social barriers preset complex problems to successful recovery. Referral to commuity-based ursig/social work to develop a trasportatio pla (i.e.; Medicaid sposored trasportatio) should be made. Offer residetial treatmet for itesive couselig which ca allow for less frequet (oce a week) couselig after discharge. Iadequate housig, parter use of illicit substaces, ad domestic violece are commo issues to be addressed with couselig ad commuity-based ursig. Cliical Risk Maagemet Strategies: Documetatio is crucial ad the followig elemets must be covered: referral for treatmet, treatmet refusal ad plaed use of medicatios ot approved by the FDA, icludig use of methadoe vs. bupreorphie. Documet whe Departmet of Childre ad Families otificatio of drug use is made. Acillary services provided should be documeted. 6 Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome

10 Cliical Maagemet FAQs The followig scearios may help the obstetricias ad medicatio providers uderstad treatmet decisios. Close commuicatio betwee providers will eable the optimal medical approach (as for ay other medical illess): Do I have to offer bupreorphie to a pregat patiet because she refuses methadoe? The patiet should receive the optimal care durig pregacy If she is ot a cadidate for bupreorphie, the she should receive methadoe or referral to residetial treatmet Cosider offerig residetial treatmet ad trasfer to bupreorphie after successful completio of the residetial program Do I have to start bupreorphie immediately because the patiet is pregat? Pregacy is ot a emergecy; simply a priority Cofirm opioid depedece Cofirm viable pregacy May I stop prescribig bupreorphie to the ocompliat patiet durig pregacy? It is usafe for the mother ad fetus to cotiue to egage i risky behavior Medicatio ca be discotiued for ay medical reaso whe there is lack of beefit; alteratives should be offered (residetial treatmet; methadoe treatmet ceter) Cotiued high-risk behaviors i the office-based settig suggest the eed for residetial or ceter-based care. Documet o-compliace ad offers of alterative, more structured care How do I kow whe to declie further office-based care with bupreorphie? Cocurret use of bezodiazepies Cocurret use of cocaie Difficulty egagig i couselig Ca deped o ease of switchig to methadoe: assessmet of overall materal/fetal risk/beefit of cotiued treatmet if o treatmet is the optio; the medicatio provider has some latitude if it is decided that risk/beefit favors office-based care What should I do whe I decide I caot prescribe to a patiet durig pregacy? Documet ratioale i medical record Offer methadoe eve if the patiet eeds to travel If optio is bupreorphie versus o treatmet: Cosider residetial treatmet Cosider supervised pregacy residece Cotact local child protectio services whe you discotiue medicatio; they ca ofte follow-up i the hospital at delivery Tell the patiet you must do this ad documet the coversatio Suggested scripted approaches to discussig treatmet optios Iitial visit script: Good for you i seekig help with addictio We eed to cofirm that you are pregat ad clarify the level ad ature of your opioid abuse We routiely check the Vermot Prescriptio Moitorig System i all patiets seekig treatmet at our cliic Methadoe is the medicatio of choice for the treatmet of opioid depedece durig pregacy because we have years of experiece with eoatal exposure I uderstad you would like to be treated with bupreorphie Bupreorphie is ot approved for use i pregacy ad we do ot have may years of experiece; the oldest childre are oly 5 or 6 Substace abuse couselig ad egagemet i commuity-based services to help with paretig is ecessary for recovery ad paretig Will you agree to atted couselig ad receive help from commuity-based ursig? Follow up sessios: I see that your have cotiued to use cocaie based o your toxicology scree. How shall we address this together? Let us review our pla for maagemet of your pregacy usig bupreorphie/methadoe Have you bee able to keep your appoitmets with couselig ad other medical providers? Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome 7

11 Legal Issues Uique to Pregacy FAQ Misperceptios about legal issues are a importat reaso that opioid-depedet ad pregat wome avoid treatmet. Commo miscoceptios regardig treatmet of the pregat patiet are addressed below. Example: A 19 year-old with heroi addictio lears she is pregat at a commuity health cliic. Miscoceptio: She should stop heroi immediately or she will go to jail Fact: The America College of Obstetrics ad Gyecology has a series of Committee Opiios that address ethical issues i Obstetrics ad Gyecology, with the use of alcohol ad illicit substaces specifically cosidered. Pregat wome should be allowed to make decisios o their ow behalf Most wome will choose to proceed with treatmet for the health of the fetus/ewbor Icarceratio, where there are few services, results i worse outcomes (mother: less preatal care, less treatmet, higher relapse; ewbor: worse outcome i foster care tha with a recoverig mother) Miscoceptio: She should ot use opioid-agoist therapy because her baby will be a addict Fact: Radomized trials have demostrated the log-term (3 year) beefit of methadoe treatmet versus taper. Studies show less relapse ad eoatal outcomes similar to cotrols (after demographic adjustmet). Miscoceptio: She must receive opioid-agoist therapy although she requests a taper Fact: Opioid-agoist therapy is clearly the treatmet of choice as it improves preatal care, reduces relapse, ad reduces exposure to other illicit drugs. There are o data to suggest medicatio-assisted withdrawal early i pregacy (before 24 weeks) is harmful Abrupt withdrawal from heroi late i gestatio is associated with i utero withdrawal, icreased mecoium aspiratio, ad may be associated with fetal death Oce iformed, if the patiet would like to taper, a gradual taper of 10% per week is reasoable. May patiets will become ucomfortable ad stop a taper eve after requestig it. 8 Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome

12 Miscoceptio: If she has ay relapses, she will lose custody of her child Fact: Reportig laws vary by state, but most have some madatory reportig of ay materal behavior that ca impair the wellbeig of a child. However: Most states will work closely with a patiet i recovery to allow her to maitai custody May caot itervee util after delivery (Vermot: case ca be opeed 30 days prior to expected delivery) Reiforce to the patiet that treatmet durig pregacy, eve if has a few slips, will improve the chaces of custody retetio Reportig durig pregacy allows social work time to uderstad all aspects of patiet care Reiforce to patiet that the goal of all is to help her maitai custody ad receive appropriate treatmet for her to paret her child. The opioidagoist treatmet provider ca play a importat patiet advocacy role here. Risk Maagemet Refereces: (2005). ACOG Committee Opiio #321: Materal decisio makig, ethics, ad the law. Obstet Gyecol 106(5 Pt 1): (2007). ACOG Committee Opiio No. 363: patiet testig: ethical issues i selectio ad couselig. Obstet Gyecol 109(4): (2007). ACOG Committee Opiio No. 390, December Ethical decisio makig i obstetrics ad gyecology. Obstet Gyecol 110(6): (2008). ACOG Committee Opiio No. 422: at-risk drikig ad illicit drug use: ethical issues i obstetric ad gyecologic practice. Obstet Gyecol 112(6): SAMHSA Tip 40 Guidelies for the use of bupreorphie ad the Vermot Bupreorphie Practice Guidelies are excellet resources for the office-based treatmet for opioid depedece. These guidelies below cotai acillary iformatio for those providers that choose to prescribe opioid-agoist medicatio for wome durig pregacy. Providers that do ot choose to prescribe durig pregacy ca cotact Marjorie Meyer MD or Eleaor Capeless MD at Fletcher Alle Health Care for questios or arrage for trasfer of the patiet through the Comprehesive Obstetrics ad Gyecology Service at Fletcher Alle Health Care at Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome 9

13 Appedix 1: HIPAA Form MRN Patiet ame patiet date of birth Notice of privacy practices I have received the Notice of Privacy Practices at Fletcher Alle Health Care iformig me of how Fletcher Alle Health Care will use my persoal health iformatio. My uderstadig of this Notice will help me esure the accuracy of my health iformatio, better uderstad who, what, where ad why others may access my health iformatio. I ackowledge receipt of the Notice ad uderstad ay questios pertaiig to Fletcher Alle Health Care s privacy policies may be aswered by cotactig the Fletcher Alle Health Care Patiet Relatios Departmet at (802) PATIENT / GUARDIAN DATE of RECEIPT RELATIONSHIP TO GUARDIAN Patiet uable to sig Patiet refused to sig Reaso: WITNESS 10 Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome

14 Appedix 2: Treatmet Iformatio Sheet Healthy moms are certaily more likely to have a healthy baby. It is commo for wome to decide to take actio to treat medical problems for the health of their growig baby. A decisio to receive medical treatmet for opioid depedece durig pregacy is a importat step i your life ad that of your baby. Medical treatmet ca reduce other drugs i your system ad icrease the chaces of a full recovery. Both methadoe ad bupreorphie are used for the treatmet of opioid depedece. Below are some facts to cosider as you ad your physicia decide which medicatio is best for you: We have the most data about how you ad your baby do i the log term whe treated with methadoe Bupreorphie is a ew drug ad while it appears to be safe whe we examie ewbors, we do ot kow about log term effects o the baby The ability to receive medicatio close to home may be a cosideratio i decidig what medicatio to use Neoatal abstiece symptoms ca occur followig treatmet with either methadoe or bupreorphie It is importat that you ca be compliat with whichever treatmet you are o Couselig is a essetial part of treatmet, regardless of medicatio Not all people are cadidates for office-based treatmet with bupreorphie; i those cases methadoe is strogly advised If bupreorphie treatmet does ot seem to be effective for you, treatmet with methadoe may be recommeded eve if it would be difficult Some wome that strogly desire bupreorphie may do best to start treatmet i a residetial treatmet settig Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome 11

15 Appedix 3: Patiet Assessmet Checklist for Office-Based Therapy The followig guidelies will help i decidig whether to treat with bupreorphie i the office. They assume the perso is opioid depedet. Scorig Key 0-5: Excellet cadidate for office-based treatmet. 6-10: Good cadidate for office-based treatmet : Good cadidate, but oly with tightly structured program providig supervised dosig ad o site couselig : Cadidate for office-based treatmet by board certified addictio physicia i a tightly structured program or hub iductio with follow-up by office-based provider or methadoe cliic referral : Cadidate for methadoe program oly. For each aswer check yes or o ad add poits for Yes ad No below. Questios Poits: Yes No Possible Is the perso employed? 1 1 Is the family itact? 1 1 Does the perso have a parter who uses drugs or alcohol? 1 1 Is the perso s housig stable? 1 1 Does the perso have legal issues? 1 1 Does the perso have ay covictios for drug dealig? 2 2 Is the perso o probatio? 1 1 Does the perso have psychiatric problems, e.g., major depressio, bipolar, severe axiety, PTSD, schizophreia, persoality subtype of atisocial, borderlie, or sociopathy? 2 2 Does the perso have a chroic pai sydrome that eeds treatmet? 2 2 Does the perso have reliable trasportatio? 1 1 Does the perso have a reliable phoe umber? 1 1 Has the perso bee o medicated assisted treatmet before? 1 1 Was the medicated assisted treatmet successful? 2 2 Does the perso have a problem with alcohol? 2 2 Does the perso have a problem with cocaie? 1 1 Does the perso have a problem with bezodiazepies? 2 2 Is the perso motivated for treatmet i the office? 1 1 Is the perso curretly goig to couselig, AA, or NA? 2 2 Total poits possible: 25 T total each colum: total both colums: Provided by Joh R. Brookly, MD, May 21, Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome

16 Appedix 4: Bupreorphie Treatmet Agreemet/Cotract As a participat i the bupreorphie protocol for treatmet of opioid abuse ad depedece, I freely ad volutarily agree to accept this treatmet agreemet/cotract, as follows: I agree to keep, ad be o time to, all my scheduled appoitmets with the doctor ad his/her assistat. I agree to atted substace abuse couselig at least weekly; more ofte at the iitiatio of treatmet. I uderstad that urie collectios will be performed to sed for drug screes. I agree to coduct myself i a courteous maer i the physicia s office. I agree ot to arrive at the office itoxicated or uder the ifluece of drugs. If I do, the doctor will ot see me, ad I will ot be give ay medicatio util my ext scheduled appoitmet. I agree ot to sell, share, or give ay of my medicatio to aother idividual. I uderstad that such mishadlig of my medicatio is a serious violatio of this agreemet ad would result i my treatmet beig termiated without recourse for appeal. I agree ot to deal, steal, or coduct ay other illegal or disruptive activities i the doctor s office. I agree that my medicatio (or prescriptios) ca be give to me oly at my regular office visits. Ay missed office visits will result i my ot beig able to get medicatio util the ext scheduled visit. I agree that the medicatio I receive is my resposibility ad that I will keep it i a safe, secure place. I agree that lost medicatio will ot be replaced regardless of the reasos for such loss. I agree ot to obtai medicatios from ay physicias, pharmacies, or other sources without iformig my treatig physicia. I uderstad that mixig bupreorphie with other medicatios, especially bezodiazepies such as valium ad other drugs of abuse, ca be dagerous. I also uderstad that a umber of deaths have bee reported amog idividuals mixig bupreorphie with bezodiazepies. I agree to take my medicatio as the doctor has istructed ad ot to alter the way I take my medicatio without first cosultig the doctor. I uderstad that medicatio aloe is ot sufficiet treatmet for my disease, ad I agree to participate i the patiet educatio ad relapse prevetio programs, as provided, to assist me i my treatmet. I uderstad that I will be trasitioed to Suboxoe (bupreorphie/aloxoe) followig delivery (exceptio: breastfeedig ad baby i treatmet). patiet sigature date prited ame Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome 13

17 Appedix 5: Treatmet of Opioid Depedece Durig Pregacy Demographic Sheet NAME DATE of birth medicatio obstetric provider fax o. pediatric provider fax o. medicatio provider fax o. substace abuse couselor fax o. home health urse fax o. hospital for delivery 14 Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome

18 Appedix 6: Cogs Cliic Fax Referral Form Patiet ame: Referrig provider (with cotact ad fax umber): Reaso for referral: LMP (or gest age): US doe: yes o (attach record) Prior preatal care: yes o Provider: Medicatios (dose ad prescribig physicia; ote if you will cotiue prescribig medicatio or request trasfer of prescribig resposibility ad last day of medicatio): Substace abuse couselor after discharge (ote if we eed to set this up): Appoitmet: Date ad time: Place: Provider: Social worker appoitmet: Fax to COGS cliic: Phoe: (provider to provider oly): marjorie.meyer@uvm.edu Note: please do ot use patiet idetifiable iformatio i the Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome 15

19 Appedix 7: Opioid-Agoist Therapy Durig Pregacy Medicatio Provider Checklist patiet NAME DATE of birth MRN DATE Discuss risk beefits/patiet give risk beefit fact sheet Methadoe Bupreorphie No Treatmet/wea Substace abuse couselor Name: Refer to couselig if ot already i treatmet (couselig is strogly recommeded i pregacy) Obstetricia Name: Hospital of Delivery: Aesthesia cosult weeks Pediatricia Name: Refer at weeks Home Visitig Nurse Name: Urie Drug Screes or OB Medicatio Provider 16 Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome

20 Appedix 8: Medicatio Provider Visit Flow Sheet Due date: Medicatio/dose: Symptoms of withdrawal (check all withdrawal symptoms/physical fidigs that apply): Cravig Sweatig Lacrimatio Ruy ose Gooseflesh Yawig Adbomial pai Diarrhea Have you see a substace abuse couselor i the last week? Whe is the ext appoitmet with your obstetric care provider? Have you see commuity-based ursig recetly? Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome 17

21 Appedix 9: Commuity-Based Nursig/Social Services Checklist patiet NAME DATE of birth MRN DATE OB Provider: Medicatio Provider: Substace Abuse Provider: Primary Care Provider: Pediatricia: WIC Social Services Ecoomic services Housig Employmet Child care 18 Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome

22 Appedix 10: Commuicatio Tool Fax Form To: Fax: Phoe: from: Pages: date: Name: Date of birth: Due date: Medicatio/dose: Visit type: Couselig OB visit Commuity urse Pediatric visit Date of visit: Vermot Guidelies for Medicatio-Assisted Treatmet (MAT) for Pregat Wome 19