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, Toronto, ON February 1, 2017
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 2
• 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 4
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 5
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 6
• 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 7
• 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 8
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 9
• 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 10
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 11
Overview of 2010 NAS Work Group 12
• 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 13
Highlights of Key Changes in Updated Guidelines (2016) 14
• 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 16
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 17
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). 18
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. 19
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. 20
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. 21
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. 22
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. 23
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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. 26
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. 27
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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. 33
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. 34
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. 35
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. 36
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. 37
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). 39
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. 40
22. A primary health care provider who is comfortable following a baby with NAS should be confirmed prior to discharge. 41
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. 42
24. Every baby exposed to opioid agonists and other substances should be offered ongoing developmental assessments by a clinical expert. 43
Summary and Discussion 44
• 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 45
• 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 46
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 47
http://www.pcmch.on.ca/wp-content/uploads/2016/12/NAS- Clinical-Guideline-Update-2016Nov25.pdf 48
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 49
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