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Effective Risk Management Strategies in Outpatient Methadone Treatment: Clinical Guidelines and Liability Prevention Curriculum Module 9 Special Populations and Risk Pregnancy The Office of Applied Studies indicated that in 1999 of 400,000 women admitted to OTPs 4% were pregnant. Methadone Maintenance as the Standard of Care • Since 1970’s, methadone accepted to treat opioid addiction during pregnancy • Only opioid medication approved by the FDA • Same effective maintenance treatment benefits • Methadone reduces fluctuation in maternal serum opioid levels protecting fetus from withdrawal • Comprehensive MMT must include prenatal care ▫ Reduce obstetrical and fetal complications, in utero growth retardation, and neonatal morbidity and mortality (Finnegan, 1991) Diagnosing Opioid Addiction in Pregnant Patients • Establish admission priority for pregnant women ▫ Federal waiver -1 year history of opioid addiction • Establish pregnancy through onsite testing ▫ Screening– UDS at admission and monthly ▫ Confirmation testing • Establish protocols to educate patients about the pregnancy risks and neuroendrocrine process Medical and Obstetrical Concerns and Complications • Greater-than-normal risk of complication if: ▫ Abuse substances ▫ Are opioid addicted ▫ Lack prenatal care • Common complications include: ▫ Spontaneous abortion ▫ Premature labor ▫ Low birth weight Detoxification During Pregnancy • Rarely appropriate during pregnancy (ASAM 1990) ▫ Same recidivism as non-pregnant (Finnegan, 1990) • Withdrawal during pregnancy (MSW) for patients: ▫ Refusing to be placed on MMT. ▫ Living where MMT is not available. ▫ Stable during treatment and requests withdrawal. ▫ So disruptive to the treatment setting that removal from the program is necessary. Methadone Dosage & Management • Dose of methadone should be individually determined and adequate to control craving and prevent withdrawal syndrome • As pregnancy progresses, the same dosage produces lower blood methadone levels: ▫Increased fluid volume ▫Larger tissue reservoir for methadone ▫Altered opioid metabolism placenta and fetus (Weaver , 2003). Methadone Dosage & Management • MMT patients who become pregnant should be continued at established dose and titrated as indicated. • Altered pharmacokinetics during the third trimester often requires an increases and a split dose to “flatten the curve” and improve maternal and fetal stability. Methadone Dosage & Management • No consistent correlation between maternal methadone dose and severity of neonatal withdrawal syndrome (Stimmel et al., 1982) • Protocols are available for scoring signs of opioid withdrawal to guide use of medications to facilitate withdrawal of the passively addicted neonate (NAS) (Finnegan, 1985). Breastfeeding on Methadone • Mothers can breastfeed • APA approved breastfeeding at any dose in 2003 • Patients should be monitored for the use of both licit and illicit drugs and alcohol (Kalrenback et al. 1998) Buprenorphine During Pregnancy • Buprenorphine may be used in pregnant patients under certain circumstances. • Buprenorphine recommended only when the physician believes potential benefits justify risks. ▫ May continue on buprenorphine with careful monitoring. Buprenorphine During Pregnancy • Potential candidates: ▫ Opioid addicted but cannot tolerate methadone ▫ Program compliance difficult ▫ Adamant about avoiding methadone Buprenorphine During Pregnancy • Patient’s medical record should clearly document that patient: ▫ Refused methadone maintenance treatment or such services are unavailable ▫ Has been informed of the risks of using buprenorphine ▫ Understands these risks Buprenorphine During Pregnancy • When treating pregnant patients, providers should use buprenorphine monotherapy tablets (Subutex ®). • Patients already maintained on buprenorphinenaloxone combination tablets, who become pregnant, can be transferred directly to buprenorphine monotherapy tablets. Integrated Comprehensive Services • Establish a relationship between the methadone provider and the OB/GYN, PCP and/or specialist • Clear communications and linkages among all providers is a must ▫ Collaboration for medication management and prenatal evaluation follow up ▫ Case management assistance Recommendations • Establish a policy to see pregnant patients more often (especially in the third trimester) • Establish continuous patient education around pregnancy and contraception • Informed consent procedures • Adequate dose Co-Occurring Disorders • Co-occurring disorder (COD) refers to a mental disorder that co-exists with at least one substance use disorder • Sometimes COD patients exhibit behaviors or feelings that may interfere with opioid treatment • The COD should be distinguished by type/category and addressed appropriately Co-Occurring Disorders • Categorized according to Axis I and II disorders, as defined by the DSM-IV ▫ Axis I-Clinical disorders (include major mental disorders, learning disorders, and substance use disorders) ▫ Axis II- Personality disorders and intellectual disabilities Screening for Co-Occurring Disorders • Admission and ongoing assessment routinely screen for co-occurring disorders • Establish specific screening procedures for COD and cognitive impairment Making & Confirming a Psychiatric Diagnosis • Assure and confirm an accurate psychiatric diagnosis • Continuous patient education to enhance understanding of their co-occurring disorder is essential Prognosis for Patients with COD • Early identification and accurate diagnostic evaluation, combined with psychiatric and substance addiction therapies, improve outcomes. • Unidentified and untreated COD often lead to poor MAT outcomes. Treatment • COD patients not excluded from OTP treatment • TIP 43 lists principles of care for COD • Establish a protocol for identifying suicide and homicide risk • Pharmacological treatment for COD when indicated • Use of psychosocial interventions • Collaborating with prescribing psychiatric team • Understanding drug-drug interactions In Summary • Consult the TIP 43 for more specific information • Be proactive in policy and action in assessing clients for special circumstances such as pregnancy and/or COD • Educate patients