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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