Neonatal Drug Withdrawal (Neonatal Abstinence Syndrome)

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1 Neonatal Drug Withdrawal (Neonatal Abstinence Syndrome) Deb McPherson, Pharm D Clinical Pharmacist, Pediatrics/Neonatology CHI St. Alexius Health Bismarck, ND

2 Neonatal Abstinence Syndrome ( NAS) Symptomatic withdrawal after intrauterine exposure to illicit or prescription drugs Symptoms occur after birth, following the abrupt cessation of drug exposure Often referred to as withdrawal

3 Incidence of Neonatal Abstinence Syndrome The use/abuse of prescription pain medications has increased among pregnant women, with a consistent increase in NAS The use of psychotropic drugs to control depression and anxiety has increased over the past decade

4 Incidence of Neonatal Abstinence Syndrome Increasing incidence in the US and elsewhere In 2009, 4.5% of pregnant women between years reported recent use of illicit drugs In 2011, 1.1% of pregnant woman abused opioids Increases in opioid use 1.2 mothers/1000 live births in mothers/1000 live births in 2009

5 Case 1 KB is a 37 week gestational age female, born vaginally, mother received Nubain within 4 hrs of delivery. Minimal prenatal care. Exam in nursery was within normal limits. At 8 hrs of age, the pediatrician is called due to concerns of extreme irritability, sneezing, and poor feeding. Finnegan scoring is done, score is 13. Infant is swaddled and held, second score is 14. Mom denies any drug use, admit history is negative. Attempted feeding with poor results, repeat score is 12, infant is transferred to NICU.

6 Case 2 GJ is a term infant, mother had good prenatal care, infant is admitted to nursery. Known history of mom taking a SSRI and benzodiazepine for depression/anxiety through out pregnancy, did not tolerate an attempt to discontinue/decrease doses. Infant is not sleeping, is a poor feeder and displays abnormal arching behaviors. NICU is called for evaluation and admission.

7 Neonatal Abstinence Syndrome Medication classes with reported symptoms following intrauterine exposure Opioids: Morphine, Codeine, Oxycodone, methadone, Heroin CNS stimulants: Amphetamines, Cocaine, Nicotine, caffeine CNS depressants: Alcohol, Barbiturates, Benzodiazepines, Marijuana Hallucinogens Selective Serotonin Reuptake Inhibitors

8 Clinical Features of Neonatal Withdrawal/Abstinence Neurological Gastrointestinal Autonomic Tremors Irritability Increased wakefulness High-Pitched crying Increased muscle tone Hyperactive deep tendon reflexes Frequent yawning Sneezing Seizures Poor feeding Uncoordinated and constant sucking Vomiting Diarrhea Poor weight gain Diaphoresis Nasal stuffiness Fever Mottling Temperature instability Elevated respiratory rate and blood pressure

9 A schematic withdrawal in neonates. A schematic illustration of the mechanism of opioid withdrawal in neonates. A schematic illustration of the mechanism of opioid withdrawal in neonates. Kocherlakota P Pediatrics 2014;134:e547-e by American Academy of Pediatrics

10 Neonatal Drug Withdrawal Scoring Modified Finnegan s Neonatal Abstinence Scoring Tool Semi-objective tool used to quantify the severity of withdrawal signs Serial scores assist with therapeutic decisions Cumulative score, observing for 21 clinical signs of withdrawal Lipsitz Neonatal Drug Withdrawal Scoring System Neonatal Withdrawal Inventory Neonatal Narcotic Withdrawal Index

11 Modified Finnegan s Neonatal Abstinence Scoring Tool

12 Modified Finnegan s Neonatal Abstinence Scoring Tool

13 Onset, severity, & duration Dependent upon characteristics of the drugs Type Amount Half-life Receptor - binding capacity & affinities

14 Time of withdrawal Alcohol Barbiturates Cocaine Marijuana Amphetamine/meth Opioids SSRIs 3-12 Hours 3-4 Days, range 1-14 Days Range of withdrawal symptoms Neurobehavioral abnormalities at Hours Usually No withdrawal signs Range of withdrawal symptoms Neurobehavioral abnormalities at Hours Hours, up to 5-7 Days Several hours to several days

15 Toxicology Confirmation Analysis of the urine or meconium: Urine Screen: Immunoassay technique, using specific lower cutoff concentrations for each drug. Confirmation required for quantitative and definitive results Meconium Test: More sensitive, longer window of detection ( from 20 weeks). Best on first meconium. Chain of Custody

16 Medications of Use/Abuse Opiates Cross the placenta and blood brain barrier - small lipophilic molecular weight compounds Highly addictive Readily available Active/passive maternal detoxification is associated with increased fetal distress or loss Methadone can improve prenatal course, generally prolonged course of NAS Synthetic opioids - buprenorphine or buprenorphine/naloxone are used as first-line agents in pregnancy for heroin addiction

17 Medications of Use/Abuse Cocaine, Amphetamines & Stimulants Can screen in urine and meconium Increased risk of preterm birth, abruption, distress and IUGR Cocaine Abstinence syndrome not well defined, usually day 2-3. especially in-utero exposed infants, equivocal studies Symptoms include irritability, hyperactivity, tremors, high-pitched cry, excessive sucking, EEG abnormalities Methamphetamine/amphetamine Low percentage of patients treated, concomitant abuse Adverse neurotoxic effects - behavior, cognitive, physical

18 Medications of Use/Abuse CNS Depressants, Barbiturates Alcohol, benzodiazepines, barbiturates Marijuana Concomitant use issues Impair observation of symptoms in infant Wide range of symptoms May delay onset of symptoms

19 Medications of Use/Abuse Selective Serotonin Reuptake Inhibitors Multiple medications in the class Varied symptoms of NAS, diverse presentation in infants Most frequently prescribed medication in pregnancy Not well studied - case reports Pregnancy complications - IUGR, pre-eclampsia Infant complications - teratogenic, preterm birth, LBW, PPHN Poor Neonatal Adaptation Syndrome (PNAS) - behavioral, psychosocial, cognitive, developmental

20 Poor Neonatal Adaptation Syndrome - Approximately 30% of exposed infants will develop symptoms, usually transient and mild - Symptoms develop within first few days of life, possibly later - Affect CNS, respiratory, gastrointestinal and motor functions - May be due to withdrawal or serotonin toxicity or both - Symptomatic management - Recommendations to decrease dose or discontinue SSRI prior to the 3 rd trimester has not been shown to improve outcomes

21 The Problem: A recent survey noted that 4.5% of pregnant women between ages 15 and 44 reported recent use of illicit drugs There is little data on the disposition of affected newborns at discharge Additionally, the incidence of neonatal abstinence syndrome (NAS) has increased nationwide There has been an observed upward trend in both the number of infants presenting with symptoms of neonatal abstinence syndrome and urine and meconium drug screens performed at a local hospital in Bismarck, ND With this in mind, we decided to collect data to quantify the current problem in this area

22 Purpose: To quantify the number of meconium and urine drug screens that have been performed Identify trends in substances of abuse Quantify pharmacological interventions performed on affected infants Identify trends in disposition of the infant at discharge

23 Our Study: Analysis of 247 medical charts of mother/infant pairs who had a verified urine drug screen and/or a meconium drug screen performed during admission to a local hospital between 2009 and 2014 Evaluated the charts for demographic data including: Age and gestational age Maternal prescription medications and the medical factors leading to prescription medication use Urine or meconium drug screen results Medications administered Transfer to NICU Length of stay Finnegan neonatal abstinence score Diagnosis of neonatal abstinence syndrome Disposition of the patient at discharge Home Home with a different family member Foster placement Adoption Death

24 Number of Infants Screened:

25 Percentage of Infants Screened: 7.4% 8.0% 7.0% 6.0% 5.0% 3.7% 4.0% 3.0% 1.0% 1.5% 1.1% 1.4% 2.0% 1.0% %

26 Positive Meconium Screens:

27 Positive Urine Screens:

28 The need for pharmacological intervention in babies with withdrawal symptoms has been steadily increasing, culminating to 17% and 14% of opiate positive babies requiring morphine and phenobarbital respectively.

29 Disposition with Positive Amphetamine Screens:

30 Disposition with Positive Cannabinoid Screens:

31 Trends: Increase in number of babies with positive UDS and drug meconium The three main drugs testing positive in this area include: cannabinoids, opiates, and amphetamines A vast majority of infants testing positive for substances are being sent home with their mother The need for pharmacological intervention in babies with withdrawal symptoms is increasing

32 Non-pharmacologic Treatment Minimize environmental stimuli Tight swaddling Comforting techniques Frequent feedings may require high calorie feedings due to increased energy expenditure

33 Historical Treatments Paregoric Diluted Tincture of Opium Morphine

34 Currently Used Medications Morphine narcotic agonist Methadone narcotic agonist Phenobarbital - barbiturate Buprenorphine narcotic partial agonist Clonidine alpha adrenergic agonist Clonazepam - benzodiazepine

35 Issues with Pharmacologic Therapy for NAS Lack of an FDA approved medication No controlled trials to evaluate dosing Issues with choice of medication Varied protocols for weaning Confounding factors tobacco, alcohol, polyabuse, non-pharmacologic interventions, feeding

36 Morphine An opiate Most commonly used for opiate withdrawal May be given orally or intravenously Dosing is established but varies Shorter half-life, dosed every 3-4 hours, weaning every hours

37 Methadone An opiate Used for opiate withdrawal Long half-life, dosed every 4-12 hours, weaning varies, extended intervals Generally thought of as maintenance therapy

38 Comparing Morphine and Methadone Retrospective chart review , NICU, inborn Evaluating length of stay and days in hospital/nicu Oral morphine, sugar/alcohol free, Finnegan scoring Graded morphine dosing ( mg) with wean protocol Oral methadone, Neonatal Withdrawal Index scoring Weight based dosing, q8 - q24hr, no protocol, no standardized wean (usually by 10%) Young ME, et al, Am J Health Syst Pharm 2015; 72 (Suppl 3): S162-S167

39 Comparing Morphine and Methadone 26 neonates included No significant difference between groups with respect to baseline characteristics, positive tox screens, prenatal care, polysubstance abuse 13 treated with morphine, 13 with methadone Average length of stay in hospital, lower with oral morphine Average length of stay in NICU, lower with oral morphine No significant difference in number of neonates receiving adjuvant therapy or maximum NAS scores Young ME, et al, Am J Health Syst Pharm 2015; 72 (Suppl 3): S162-S167

40 Phenobarbital A barbiturate, sedative effect Second line therapy, used for non-opiates Long half-life, dosed every hours Weaning protocols are varied Concerns with neurodevelopmental outcomes Often used for outpatient treatment

41 Clonazepam A benzodiazepine Second line therapy, adjunct Muscle relaxant, sedative Long half-life hours Dosed 6-12 hours May use other in drug class

42 Clonidine Alpha adrenergic blocking agent Second line therapy Dosed orally every 6 hours, tapered Limited information available

43 Buprenorphine Partial agonist/antagonist Not well studied in infants Administration issues Alcohol content May have a lower rate of withdrawal with maternal use

44 Medication Exposure Medication exposure in-utero Maternal dose, blood level, metabolism Medication exposure in breast milk Amphetamines milk:plasma ratio Methadone milk:plasma ratio Cocaine ratio not determined, present Infants with positive urine for all of the above

45 Medications and Breast milk Methadone neonatal toxicity reported Buprenorphine considered safe with treatment program Methamphetamine times maternal SSRI and SNRI variable amounts, variable half-life Benzodiazepines lipophilic, detected Cocaine variable levels, neonatal intoxication Marijuana 8 times maternal, 450+ components Phencyclidine reported high levels Alcohol - similar to maternal serum level

46 Discharge criteria - Feeding and sleeping well - No major signs of withdrawal - Stable withdrawal scores with med support - Resolution of acute clinical issues, infants are prone to both long term & short term problems.

47 Case 1 KB is a 37 week gestational age female, born vaginally, mother received Nubain within 4 hrs of delivery. Minimal prenatal care. Exam in nursery was within normal limits. At 8 hrs of age, the pediatrician is called due to concerns of extreme irritability, sneezing, and poor feeding. Finnegan scoring is done, score is 13. Infant is swaddled and held, second score is 14. Mom denies any drug use, admit history is negative. Attempted feeding with poor results, repeat score is 12, infant is transferred to NICU.

48 Management Considerations - Clinical status of the infant, required interventions - Identification of substances involved - Protocol for treatment, drug of choice - Monitoring parameters, scoring - Maintenance therapy or weaning - Discharge considerations, intervention

49 Case 2 GJ is a term infant, mother had good prenatal care, infant is admitted to nursery. Known history of mom taking a SSRI and benzodiazepine for depression/anxiety through out pregnancy, did not tolerate an attempt to discontinue/decrease doses. Infant is not sleeping, is a poor feeder and displays abnormal arching behaviors. NICU is called for evaluation and admission.

50 Management Considerations - Clinical status of the infant, required interventions - Identification of substances involved - Protocol for treatment, drug of choice - Monitoring parameters, scoring - Maintenance therapy or weaning - Discharge considerations, intervention

51 Fetal/Neonatal Outcomes Alcohol Hyperactivity, tremors followed by lethargy Chronic Ingestion: CNS abnormalities, growth deficiency, facial features, cardiac and musculoskeletal anomalies Amphetamine/Meth IUGR, prematurity, placental abruption, fetal distress, cardiac anomalies Long term: Neuro effects- behavior, cognitive skills, and physical dexterity

52 Fetal/Neonatal Outcomes Cocaine Prematurity, low birth weight, placental abruption Neurologic abnormalities- infarct, IVH, cystic lesions Genitourinary & Gastrointestinal anomalies Marijuana short/ long term behavioral problems Increased incidence of tremors Altered visual responses

53 Fetal/Neonatal Outcomes Opioids Maternal detoxification may result in fetal distress/loss No adverse outcomes identified so far SSRIs No adverse neurodevelopmental outcomes identified

54 Pediatric Follow up Neurodevelopmental assessment motor deficits, cognitive delays, microcephaly Behavioral assessment irritability, hyperactivity, impulsivity, and attention deficit in preschool aged children

55 Pediatric Follow up Ophthalmologic assessment visual deficits, refractive errors, nystagmus, & strabismus Growth assessment adequate nutrition, avoid failure to thrive Family support

56 What is happening in ND? An increase in drug exposed infants and NAS Issues with treatment, placement and safety Long term concerns for development and at risk situations SB Committee to evaluate Protocols to mandate maternal/neonatal screening and assessment Community awareness and education

57 References Behnke M, Smith VC, Committee on Substance Abuse and Committee on Fetus and Newborn. Prenatal substance Abuse: Short- and Long-term Effects on the Exposed Fetus. Pediatrics 2013; 131:e1009 Hudak ML, Tan RC, The Committee on Drug and The Committee on Fetus and Newborn. Neonatal Drug Withdrawal, Pediatrics 2012; 129: e540 Jansson LM, Velez M, Harrow C, The Opioid exposed Newborn: Assessment and Pharmacologic Management. J Opioid Manag 2009; 5(1): Young ME, Hager SJ, Spurlock D, Retrospective Chart Review comparing Morphine and Methadone in Neonates Treated for Neonatal Abstinence Syndrome. Am J Health-Syst Pharm 2015; 72 (Suppl 3): s162-7 Weisskopf E, Fischer CJ, et al, Risk-Benefit Balance Assessment of SSRI Antidepressant Use During Pregnancy and lactation Based on Best Available Evidence. Expert Opin. Drug Saf. 2015; 14 (3): Kocherlakota P, Pediatrics 2014; 134:e547-e561

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