Alice Ordean, MD, CCFP, MHSc, FCFP, DABAM Medical Director, Toronto Centre for Substance Use in Pregnancy (T-CUP), St. Joseph's Health Centre ...

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Alice Ordean, MD, CCFP, MHSc, FCFP, DABAM Medical Director, Toronto Centre for Substance Use in Pregnancy (T-CUP), St. Joseph's Health Centre ...
Alice Ordean, MD, CCFP, MHSc, FCFP, DABAM
Medical Director, Toronto Centre for Substance Use in Pregnancy
                (T-CUP), St. Joseph's Health Centre, Toronto, ON

                                               February 1, 2017
Alice Ordean, MD, CCFP, MHSc, FCFP, DABAM Medical Director, Toronto Centre for Substance Use in Pregnancy (T-CUP), St. Joseph's Health Centre ...
Part 1
    •   Background
    •   Overview of 2010 NAS Work Group
    •   Highlights of Key Changes in Updated Guidelines (2016)

    Part 2
    •   Presentation of Updated Maternal and Newborn
        Recommendations and Implementation Resources (2016)
    •   Summary and Discussion

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Alice Ordean, MD, CCFP, MHSc, FCFP, DABAM Medical Director, Toronto Centre for Substance Use in Pregnancy (T-CUP), St. Joseph's Health Centre ...
Part 1 – Background

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Alice Ordean, MD, CCFP, MHSc, FCFP, DABAM Medical Director, Toronto Centre for Substance Use in Pregnancy (T-CUP), St. Joseph's Health Centre ...
•    Canada is the world’s second-largest per capita
          consumer of opioids

     •    Ontario has the highest rate of narcotic use in Canada

     •    2014 U.S. National Survey on Drug Use and Health:
          ~5% of pregnant women reported illicit drug use in
          past 30 days, 0.2% heroin use and 1% non-medical
          use of prescription opioids
    Canadian Centre on Substance Abuse. 2015 Prescription Opioids. http://www.ccsa.ca/Resource%20Library/CCSA-Canadian-
    Drug-Summary-Prescription-Opioids-2015-en.pdf

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Alice Ordean, MD, CCFP, MHSc, FCFP, DABAM Medical Director, Toronto Centre for Substance Use in Pregnancy (T-CUP), St. Joseph's Health Centre ...
Maternal opioid use (prescribed or illicit) during
    pregnancy is associated with negative pregnancy and
    neonatal outcomes:
     •   Premature delivery
     •   Intrauterine growth restriction, Low birth weight
     •   Neonatal abstinence syndrome (NAS)
     •   Possible adverse long-term effects

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Alice Ordean, MD, CCFP, MHSc, FCFP, DABAM Medical Director, Toronto Centre for Substance Use in Pregnancy (T-CUP), St. Joseph's Health Centre ...
Definition:
    • A constellation of symptoms and signs in newborn
      due to withdrawal from in utero drug exposure
        • Neurological (high-pitched cry, exaggerated startles,
          increased tone)
        • Gastrointestinal (poor feeding, vomiting, loose stools)
        • Respiratory symptoms
    •   Regular maternal drug use during the last two weeks
        preceding birth is a risk factor for NAS

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Alice Ordean, MD, CCFP, MHSc, FCFP, DABAM Medical Director, Toronto Centre for Substance Use in Pregnancy (T-CUP), St. Joseph's Health Centre ...
•    Canada:
           • 3.8 infants out of 1,000 births

     •    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-
    Drug-Summary-Prescription-Opioids-2015-en.pdf

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Alice Ordean, MD, CCFP, MHSc, FCFP, DABAM Medical Director, Toronto Centre for Substance Use in Pregnancy (T-CUP), St. Joseph's Health Centre ...
•    Canada:
           • 3.8 infants out of 1,000 births

     •    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-
    Drug-Summary-Prescription-Opioids-2015-en.pdf

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Rate of Neonatal Abstinence Syndrome
                                               (per 1,000 Births)
                            7.0

                            6.0
    Rate per 1,000 Births

                            5.0

                            4.0

                            3.0

                            2.0

                            1.0

                            0.0
                                     2011-2012           2012-2013          2013-2014           2014-2015      2015-2016

                                                                 Ontario           National

                                  Data Source: CIHI DAD; Birth Data extracted from Statistics Canada
                                  http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/demo04a-eng.htm

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•   Prolonged length of stay in hospital for specialized
         care and support to both the baby with NAS and the
         mother/family
     •   Increased utilization of scarce resources in the Level II
         and III neonatal units
     •   Possible developmental and psychological problems
         may pose long term challenges requiring support
         from the health care system, social services and the
         education system

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Utilization of Beds per Day for Infants
                                          with NAS as Any Diagnosis (Ontario)
                                  1,200                                                                 40.0
     Number of Infants with NAS

                                                                                                               NAS Beds Utilized per Day
                                                                                                        35.0
                                  1,000
                                                                                                        30.0
                                   800
                                                                                                        25.0
                                   600                                                                  20.0
                                                                                                        15.0
                                   400
                                                                                                        10.0
                                   200
                                                                                                        5.0
                                     0                                                                  0.0
                                            2011-2012   2012-2013   2013-2014   2014-2015   2015-2016

                                          NAS Beds Utilized per Day         Number of Infants with NAS

                 Data Source: CIHI DAD; Birth Data extracted from Statistics Canada
                 http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/demo04a-eng.htm

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Overview of 2010 NAS
         Work Group

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•   Provincial task force comprised of experts in clinical
         care and social support of pregnant women and high
         risk infants
     •   Conducted an environmental scan and literature
         review of social and medical interventions for the
         management of NAS secondary to opioid use
     •   Developed recommendations for harm reduction
         strategies and optimal management of NAS
         = Neonatal Abstinence Syndrome Clinical Practice Guidelines 2012

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Highlights of Key Changes in
     Updated Guidelines (2016)

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•   Smaller group of experts reconvened in May 2016 to
    update the guidelines

Key changes between 2012 and updated 2016 versions:
    1. Overall more streamlined and condensed recommendations
    2. Updated references to support recommendations and
       expanded list of resources under Implementation
       Considerations
    3. Removed routine toxicology testing recommendation
       [e.g. “Toxicology testing may be done on all known and
       suspected cases of NAS.” – 2012 NAS Clinical Practice Guidelines]
Part 2 – NAS Clinical Practice
            Guidelines 2016

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Routine screening by primary health care providers of all women
     of childbearing age for use of licit and illicit substances, namely
     opioids, is recommended as part of the routine health history.
       • Can lead to early identification of women at risk for opioid
         use
       • Helps normalize the conversation about this sensitive topic
       • Screening should be comprehensive and not restricted to
         opioid use only (polysubstance use)
       • Positive self-report may indicate a need for assessment using
         a validated screening tool and/or a more comprehensive
         evaluation by a specialist

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Women who are identified to have an opioid use disorder should
     be educated about the risks that continued opioid use may have
     on their reproductive health, including pregnancy.

     Contraception counseling should be a routine part of substance
     use treatment among women of reproductive age, in order to
     minimize the risk of unplanned pregnancy (especially when a
     woman switches to sustained-release opioid agonist preparations
     such as methadone or buprenorphine).

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1.   Health care providers should routinely screen all
          pregnant women for use of opioids and other licit
          and illicit substances.
     2.   Every pregnant opioid using woman should be
          offered comprehensive care, including obstetrical
          care, addiction care, community care, and
          psychosocial counselling and support.

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3.   Every pregnant opioid using woman and her partner
          and family should receive written material
          explaining NAS, hospital stay expectations, the role
          of the parent, and resource contacts, in order to
          prepare and educate the opioid using woman and
          her support persons.
     4.   Methadone Maintenance Treatment (MMT) is the
          standard of care for the management of opioid use
          disorders in women during pregnancy.

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5.   Buprenorphine Maintenance Treatment (BMT) may
          be considered as an alternative to methadone for
          the management of opioid use disorders in women
          during pregnancy.
     6.   If methadone or buprenorphine are not available,
          other sustained-release preparations may be
          considered for the management of opioid use
          disorders in pregnancy.

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7.   Referral to Child Protection Services (CPS) should be
          considered on a case-by-case basis.
     8.   During labour and delivery, the pregnant woman
          should continue to take her daily dose of opioid
          agonist treatment to avoid withdrawal.
     9.   Additional pain management (i.e. analgesia) may be
          required for women on opioid agonist treatment.

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10.   Narcotic antagonists (e.g. naloxone, nubain) should
           be avoided as they are contraindicated in women
           with opioid use disorder.
     11.   Implement a partnership plan that focuses on all
           aspects of infant care, including feeding, handling,
           skin- to-skin care, rooming-in, and the frequency of
           follow-up visits after the mother is discharged, in
           order to enhance communication between care
           providers and parents, and to support the parents’
           involvement in the care of their infant.

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12.   Identification of infants with NAS should be based
           on the mother’s antenatal history and the care
           provider’s clinical assessment/ suspicion.

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13.    A Standardized NAS Scoring Tool is recommended to
            assess suspected or known cases of in utero opioid
            exposure:
       a)    In cases of exposure to short-acting preparations of opioids, infants
             should be scored for a minimum of 72 hours.
       b)    In cases of exposure to sustained-release preparations of opioids,
             infants should be observed for 120 hours, since onset of withdrawal
             may be delayed.
       c)    Infants should be scored with each care interaction, typically every 2-4
             hours.
     14. Mother-baby dyad care, including rooming-in
     or care-by-parent, should be promoted.

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Non-pharmacological interventions should be utilized
     for all infants with NAS.
     Pharmacological interventions should be considered for
     the treatment of NAS when non-pharmacological
     measures fail to adequately ameliorate the signs of
     withdrawal.
      • Medication is indicated when 3 consecutive scores are ≥8 on
        the Standardized NAS Scoring Tool or when the average of 2
        scores or the scores for 2 consecutive intervals is ≥12.

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15.   The baby’s environment should be modified to
           reduce sensory stimulation, including limiting
           visitors, minimizing overhead lighting, and
           decreasing noise.
     16.   Soothing behaviours, positional support, swaddling,
           gentle handling, kangaroo care, and frequent,
           hypercaloric, smaller volume feedings are beneficial
           and should be considered in the treatment of
           newborns with NAS, both in the hospital and the
           home environment.

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17.   Breastfeeding should be recommended and
           supported in methadone/ buprenorphine-
           maintained mothers, assuming absence of absolute
           contraindications.
     18.   Preventive skin care should be initiated at birth to
           prevent excoriation.

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19.   Cardio-respiratory monitoring is recommended for
           all infants started on morphine and continued for 4
           days and/or until the dose is reduced. Further
           monitoring should then be at the discretion of the
           physician in charge.

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20.   Morphine should be considered the first line
           pharmacological treatment of NAS when supportive
           measures fail to adequately ameliorate the signs of
           withdrawal.
     21.   Infants whose signs of withdrawal are difficult to
           control on morphine may require an additional
           medication such as clonidine or phenobarbital.

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Medication                                                                              Dosing Guidelines
     Morphine
     Morphine is indicated when three consecutive scores are ≥ 8 according to the    Score          Oral Morphine Dose
     Standardized NAS Scoring Tool or when the average of two scores or the score     8-10     0.32 mg/kg/day divided q4-6h
     for two consecutive intervals is  12.                                          11-13     0.48 mg/kg/day divided q4-6h
     If the scores remain ≥ 8 for 3 consecutive scores or ≥ 12 on 2 occasions, the   14-16     0.64 mg/kg/day divided q4-6h
     morphine dose is increased to the next range i.e. by 0.16 mg/kg/day. If 0.80     17 +     0.80 mg/kg/day divided q4-6h
     mg/kg/day fails to control signs of withdrawal, morphine may be increased to
     0.96 to 1.0 mg/kg/day. Clonidine (see below) should be considered at this
     point.

     Weaning:
     Weaning is initiated when scores are
Medication                                                                                      Dosing Guidelines
     Clonidine
     Clonidine has been explored as a possible therapeutic option in combination         0.5 -1 mcg/kg orally q4-6h
     with morphine. There is Level 1 evidence from one small randomized                  Much higher doses (0.5 to 3 mcg/kg/h)
     controlled trial demonstrating that clonidine in addition to standard opioid         have been used as a continuous infusion
     therapy reduces the duration of pharmacotherapy for neonatal abstinence.39
     Therefore clonidine may be considered as an adjunct to morphine when high       Please Note:
     doses (see above) fail to control withdrawal symptoms.                          Adequate clinical trials to establish an efficacious
                                                                                     and safe dose still are required
     Some studies gradually increased doses over 1 to 2 days to begin therapy, and
     tapered doses by 0.25 mcg/kg every 6 hours to discontinue (or by 25% of the
     total daily dose every other day).

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Medication                                                                             Dosing Guidelines
     Phenobarbital
     Phenobarbital may be used in combination with morphine in infants exposed                     Oral Morphine Dose
     to polysubstance abuse (sedatives, alcohol or barbiturates in addition to      Score          in combination with
     opiates).                                                                                         Phenobarbital
                                                                                     8-10     0.16 mg/kg/day divided q4-6h
     Phenobarbital 10 mg/kg is given every 12 hours for 3 doses, then 5 mg/kg/day   11-13     0.32 mg/kg/day divided q4-6h
     is continued as a maintenance dose. The doses of morphine used in              14-16     0.48 mg/kg/day divided q4-6h
     combination with phenobarbital are lower than those given when morphine is      17 +     0.62 mg/kg/day divided q4-6h
     used alone.

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22.   A primary health care provider who is comfortable
           following a baby with NAS should be confirmed
           prior to discharge.

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23.   Discharging the infant home on morphine should only be
           undertaken if the clinical team is confident that the social
           risk is low, the infant is stable and there is a clear and
           comprehensive plan for weaning the infant and a designated
           supervisor of that plan is identified, who will follow the
           infant with, at minimum, a weekly visit.

           Following consultation with the clinical team, the final
           decision to discharge an infant on pharmacological treatment
           is at the discretion of the physician.

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24.   Every baby exposed to opioid agonists and other
           substances should be offered ongoing
           developmental assessments by a clinical expert.

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Summary and Discussion

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•   Narcotic use in Ontario and NAS rates increasing
     •   Prevention of pregnancy is paramount to influencing
         incidence of NAS
     •   Pregnancy offers high motivation to change
         • MMT/ BMT assist with relapse prevention and stabilizing
           social risks
     •   Supporting family is most promising intervention to
         facilitate optimal management of NAS

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•   The physical factors of NAS are complex but treatable
         • Need consistent approach

     •   The psychosocial factors of NAS are much more
         complicated
         • Addressing psychosocial risk factors is critical to ensuring
           positive life changes, newborn safety and overall family
           wellness

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The recommendations produced by the Work Group expert
     panel provide the framework which has the potential
     to reduce both the incidence and the impact of NAS through:
       • implementation of prevention strategies
       • assessment of risk
       • standardization of both maternal and neonatal treatment

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http://www.pcmch.on.ca/wp-content/uploads/2016/12/NAS-
     Clinical-Guideline-Update-2016Nov25.pdf

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Thank you everyone who participated in the original Work Group
     and contributed to the development of the 2010 NAS Clinical
     Practice Guidelines.

     Thank you to those who volunteered their time and contributed
     to the development of the 2016 guidelines update:
     • Alice Ordean

     • Kim Dow

     • Henry Roukema

     • Christina Cantin

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