Management of Opioid Dependence During Pregnancy: Best Practices for Mother and Baby

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Laura Lyons, MD, CCFP (AM)

Associate Professor,

Medical Director of Family Medicine Obstetrics

March 21, 2019

Department of Family Medicine

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Objectives:

1.

Management options for OAT during pregnancy.

2.

Inpatient / intrapartum management of OUD

patients

3.

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Management of Opioid

Dependence During Pregnancy

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One third of patients on OAT treatment are women of

childbearing age.

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The rate of opioid use is 5.6% per 1,000 live births

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85% of pregnancies in women with a opioid use disorder

were unintended

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There is an increased fertility with treatment due to

psychosocial and physical stabilization

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In 2014, Tennessee became the first state to pass a

law criminalizing illicit drug use during pregnancy.

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18 states consider substance abuse during pregnancy

to be child abuse under civil child- welfare status.

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Largest barrier to women accessing prenatal care is

fear of child welfare consequences.

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US Congress has passed the Protecting Our Infants

Act of 2015.

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This act specifically calls for a critical review of current

treatment options for prenatal opioid abuse which may

ultimately lead to the development of better therapies

and a decreased incidence of neonatal abstinence

syndrome.

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Duty to report to the Children’s Aid Society

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Variance among regions in reporting practices and

intervention practices by CAS

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Reporting not required until birth.  Self referral to CAS

encouraged to pregnant patients actively using substances.

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Methadone maintenance treatment should be standard of care for opioid-dependent women during

pregnancy. (II-IA)

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Other slow-release opioid preparations may be considered if methadone is not available. (II-2B)

•

Opioid detoxification should be reserved for selected women because of the high risk of relapse to

opioids. (II-2B)

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Opiate-dependent women should be informed that neonates exposed to heroin, prescription opioids,

methadone, or buprenorphine during pregnancy are monitored closely for symptoms and signs of

neonatal withdrawal (neonatal abstinence syndrome). (II-2B)

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Hospitals providing obstetric care should develop a protocol for assessment and management of

neonates exposed to opiates during pregnancy. (III-B)

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:

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safer, medically supervised opioid use (stable supply, pure

quality, no fluctuating blood level, no exposure to contaminants)

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decreased risk of transmission of HIV (and potentially HCV and

other blood-borne pathogens) (including decreased risk of

transmission of HIV to infants)

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increased likelihood that infant will be discharged into his or her

parents' care; and

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increased retention in treatment

(Kandall et al, (1999), The methadone maintained pregnancy. Clin Perinatol, 26: 173-83)

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If emesis occurs less than 15 minutes after

consumption, consider replacing 50-75% of full dose

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If emesis occurs at between 15 and 30 minutes after

consumption, consider replacing 25-50% of full dose

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If emesis occurs at more than 30 minutes after

consumption, do not replace dose

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During pregnancy, methadone dose increases may be required due to increased

metabolism and blood volume.  This is often not required until the late

second or third trimester.

An alternative to increasing methadone dose is providing BID dosing.

Methadone dose should be titrated according to the woman’s symptoms, in order

not to escalate the dose beyond her clinical requirements.

 Methadone dose should not be kept low in an attempt to reduce neonatal

abstinence syndrome.

Health Canada, 2011

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Higher methadone doses in the third trimester are associated

with less illicit drug use

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Higher third trimester doses are also associated with an

increased fetal head circumference.

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Increased head circumference may reflect both increased

gestational duration and improved overall growth

(Hagopian et al,  Journal of Maternal Fetal Medicine, 1999)

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Has not demonstrated any increased incidence of

obstetrical complications or adverse neonatal outcomes

during first, second or third trimester 

(Maas et al., 1990, J Perinatal

Med, 18, 111-118, Jones et al, 2008, American Journal of Addictions, 17, 372-286.).

•

Associated with clinical instability and a high risk of

relapse to substance use

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Motivated women who have a short addiction

history, are medically and socially stable with a

good support network and have no concurrent

psychiatric disorder may have better outcomes

following a methadone withdrawal program.

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There is limited guidance in terms of the rate of methadone tapering or

detoxification

.

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Studies have proposed reducing the dose by 1-2 mg/day as an inpatient

or by 2-10 mg every 1-2 weeks as an outpatient

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In percentage of dose, maternal dose should be decreased slowly by 5-

10% per week.

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This process should be stopped if the pregnant woman reports any

adverse outcomes such as relapse to drug use, increased cravings,

intolerable withdrawal symptoms or obstetrical complications. 

(Archie 1998;

Finnegan 1991; Jarvis and Schnoll 1994; Kandall et al. 1999)

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Buprenorphine is an opioid agonist-antagonist.  It is a

sublingual tablet, approved for use in Canada in 2007 and is

first line in OUD maintenance treatment

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Partial mu-opioid agonist – produces opioid-like effects

equivalent to methadone

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Induction process places patient at risk for precipitated

withdrawal.

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Effective dose range: 8-24 mg/day

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Pregnant women may be treated with buprenorphine mono-product

(Subutex) – available through Health Canada exceptional access program

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Available as buprenorphine-naloxone combination (4:1 ratio) to deter

intravenous misuse  = Suboxone

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Naloxone: lack of safety data during pregnancy.

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Transfer from MMT to buprenorphine not advised during pregnancy.

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Safety of buprenorphine during lactation unclear but it’s use is not

contraindicated when breastfeeding.

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Double-blind, double-dummy RCT [MOTHER study]

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Buprenorphine compared to methadone use in 175

pregnant women with opioid dependence

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Percentage of neonates requiring treatment for

withdrawal did not differ

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Buprenorphine results in reduced severity NAS

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Neonates exposed to buprenorphine required:

•

89% less morphine

•

spent 43% less time in hospital

•

58% less time in hospital receiving medication for

NAS

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Management of Opioid

Dependence During Pregnancy

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Two main concerns:

1. safety issue for the fetus

2.  high rate of relapse following detoxification, including

overdose.

Management of Opioid

Dependence During Pregnancy

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Luty et al (2013) 101 women underwent a 21 day

inpatient methadone detoxification program.

Conclusion: opioid withdrawal may be associated with an

increased risk of miscarriage in first trimester but likely

safer in second and third.

Management of Opioid

Dependence During Pregnancy

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Bell,H, Towers,CV, Hennessy,MD, Heitzman,C, Smith,B,

Chattin,K

American Journal of Obstetrics and Gynecology,

2016;215:374e1-6

Management of Opioid Dependence

During Pregnancy

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University of Tennessee Medical Centre, Knoxville, TN

Data analysis of complications of intrauterine fetal demise,

fetal distress and preterm labour leading to delivery in

pregnancies that underwent detoxification.

Management of Opioid

Dependence During Pregnancy

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:

1.

Incarcerated patients undergoing acute withdrawal

2.

Inpatient drug detoxification using buprenorphine –

fully detoxifying patients in 5-8 days.  Followed by

intense behavioural program

3.

Inpatient detoxification without behavioural program

4.

Outpatient slow buprenorphine detoxification program

Management of Opioid

Dependence During Pregnancy

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Management of Opioid

Dependence During Pregnancy

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Management of Opioid

Dependence During Pregnancy

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“

In conclusion, detoxification of opiate addicted women

does not appear to be harmful.  In addition, the rate of

neonatal abstinence syndrome can also be reduced if

continued long term behavioural follow up  occurs

once the patient is drug free.”

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Results: 2 miscarriages and 1 premature birth, no fetal

assessments during rapid detoxification process.

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Zuspan and colleagues’ case study

Tapered off methadone while monitoring serial amine

(epinephrine and norepinephrine) levels in amniotic fluid.

Amine levels increased as methadone dose was decreased.

Amine levels return to baseline and stabilized after methadone

tapering was discontinued.

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•

Crude fetal mortality rates are not adequate outcome

measures.

•

Acute maternal withdrawal results a catecholamine surge,

uterine contractions and reduced placenta blood flow and

oxygen supply.

•

Corticosteroid excess associated with withdrawal can

signal rapid modification of neurotransmitter systems and

transcriptional machinery.  This may trigger permanent

modifications of behaviour and brain morphology.

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Maternal opioid withdrawal does decrease incidence and

duration of NAS however it is uncertain the effects on fetal brain

development

•

Maternal relapse ranges from 59-99%

•

Conclusion: detox is inferior to OAT due to risk of maternal

relapse, with inherent overdose mortality risk – this outweighs the

potential reduction in NAS

•

The effects of detoxification on fetal well-being is a key area of

future research.

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Management of Opioid

Dependence During Pregnancy

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Pregnancy category C drug – non selective-opioid receptor antagonist.

•

Effective for treatment by decreasing drug seeking behaviours, drug craving

and increasing treatment retention.

•

Australian case reports have shown no teratogenic effects (Hulse et al,

2002)

•

In comparison to MMT implanted naltrexone shows lower:



lower rate of preterm labour, higher birth weights and higher APGAR score



no significant difference in gestational age at birth, or birth weight



Does not demonstrate tolerance leading to increased dosing during pregnancy (Hulse et al,

2004)

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Risks of medication induction that may lead to vulnerability with

regard to relapse, physical dependence re-establishment, increased

risk behaviors, treatment dropout and resulting opioid overdose

•

Risk of detoxification prior to medication induction on fetal well being

•

Potential drug interactions during labour leading to difficulty in

providing effective analgesia

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Limited data of the effects on the breastfeeding infant

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Ethical difficulties in including pregnant women in clinical trials

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Presentation Title Here

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Direct effect on fetal growth leading  to possible intrauterine

growth restriction and low birth weigh

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1

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, 2

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 and 3

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 trimester ultrasounds to assess

growth and placenta sufficiency

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NST:  decreased beat to beat variability, decreased

fetal movements and suppressed FHR

accelerations (higher incidence of nonreactive NST

and longer interval to achieve reactive NST)

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Biophysical Profile: suppressed fetal breathing

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Initiate methadone or buprenorphine for patients

experiencing withdrawal symptoms and reporting

substance use.

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UDS and screening blood work according to risk factors

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Develop a birth plan for mother identifying her supports and

medical requirements including discharge planning

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Continue with regular methadone/buprenorphine dosing during

labour

Adequate analgesia required – may need larger and/or more

frequent doses because of tolerance

Urine toxicology if suspect illicit drug use – carries vs. non

carries

CAS notification if active illicit substance use or additional

concerns

Methadone metabolites will not be identified unless requested

i.e.  Opioid results will reflect non-methadone opioid use

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Dose reduction after giving birth is recommended practice.

The maintenance dose should be reviewed in 2-4 days

following birth, and regularly as indicated thereafter.

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anagement of Opioid

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In Canada:

3.8 infants out of 1,000 births

In Ontario:

0.9 infants out of 1,000 births (2002-2003)

5.1 infants out of 1,000 births (2011–2012)

Canadian Centre on Substance Abuse. 2015 Prescription Opioids.

http://www.ccsa.ca/Resource%20Library/CCSA-Canadian

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Up to 85% of neonates will exhibit NAS born to

women on Methadone and/or Buprenorphine

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Neonatal withdrawal occurs in 40-60% of infants

born to women on opioids such as heroin

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The presentation of withdrawal can depend on

the timing of the mother’s last dose of opioid

before delivery

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CNS disturbances (excessive high pitched cry, poor

sleeplessness, increased muscle tone, tremors and

convulsions, excoriation)

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Gastrointestinal disturbances (excessive/poor sucking,

regurgitation, projectile vomiting, loose/watery stools, weight

loss)

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Metabolic disturbances (sweating, hyperthermia, mottling,

nasal stuffiness, sneezing, nasal flaring, dyspnea)

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Multiple factors contribute to the severity of NAS in children

born to opioid-dependent women including maternal

smoking, heroin use, and benzodiazepine dependence.

There is no clear dose–response relationship between

methadone and risk of NAS.

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Withdrawal symptoms usually present by 12 hours after birth and peak

within 36 to 48 hours.

Minimum 72 hour stay as per LHSC policy

May increase mother baby unit stay to 120 hours

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21 symptoms classified in the 3 categories of

physiological disturbance:

CNS/Autonomic/Gastrointestinal

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Assess for the presence of symptoms and degree

of severity of symptoms over time

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2 to 4 hour intervals – baseline at 2 hours of age

then begin 4 hour intervals

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Finnegan’s NAS scoring system was designed for

term babies on four-hourly feeds (modify for preterm

infants)

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Scoring should be performed 30 minutes to one hour

after a feed, before baby falls asleep

Finnegan L. Management of neonatal abstinence. Adapted from: Current Therapy in Neonatal-Perinatal Medicine, N.

Nelson (Ed). B. C. Decker, Inc., Publisher, Ontario, Canada, 1985, pp. 262-270.

 Doberczak T, Kandall S, Wilets I. Neonatal opiate abstinence syndrome in term and preterm infants. J Pediatrics

1991;118:933-937.

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Recent literature on the safety of MMT during lactation included women on

medium to high-dose (up to 180mg) methadone maintenance

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Amount of methadone in breast milk is very small & dependent on maternal

methadone dose

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These small amounts are unlikely to have any clinical effect & not sufficient to

prevent or treat NAS

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Methadone is compatible with breastfeeding

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Women who are using other drugs should be counseled on the risks of breast

milk exposure 

(Selby & Kahan, 2008)

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Less babies required treatment for withdrawal

More babies went home with mom

R. Abrahams, S. Payne, P. Thiessen

Canadian Family Physician Oct 07

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OAT continues to be first line for treatment of pregnant women with opioid dependence.

Buprenorphine may be considered as a first line alternative to methadone and is associated

with less severe NAS.  Buprenorphine induction carries the risk of maternal and fetal stress.

Consider twice a day dosing for women in their third trimester of pregnancy.

Detoxification or tapering of methadone or buprenorphine should only be considered on an

exceptional basis.

Women should be informed of the risks of NAS and be prepared for a minimum post partum

hospital stay of 72-120 hours.