Faculty Disclosure Providing Optimal Care for Neonates with Neonatal Abstinence Syndrome by Karen D Apolito, Ph.D., APRN, NNP-BC, FAAN Professor & Program Director, NNP Specialty Vanderbilt University School of Nursing I have no affiliation with any of the drug companies that produce the medications I will be discussing. I am the developer of the inter-observer reliability program for the Finnegan Scoring Tool. Objectives 1) Describe the incidence of NAS in the US and hospital costs 2) Identify drugs associated with NAS. 3) Describe the appropriate way to assess neonates for signs of NAS. 4) Identify non-pharmacologic, pharmacologic and caregiving strategies for managing neonates with NAS. Also known as Neonatal Withdrawal Syndrome Constellation of behavioral and physiologic signs caused by cessation of exposure to licit and illicit drugs. What is NAS? Hamdan, 2010 Two types: Maternal use during pregnancy Postnatal use (fetanyl, morphine) What is NAS? What is NAS? Causes alterations in functioning: CNS disturbances Metabolic, vasomotor, Respiratory Disturbances Gastro-Intestinal Disturbances Hamdan, 2010 Finnegan, et al, 1975 1
Drugs Associated with NAS Opioids: Heroin Methadone Fentanyl Morphine Demerol OxyContin Nonopioid CNS Depressants May present with some or mimic symptoms of NAS Benzodiazepines SSRI s Barbiturates Anticonvulsants Antipsychotics Alcohol Epidemic of Prescription Opiate Use/Abuse Prescription drug abuse is a growing national epidemic. Addiction, overdoses and deaths involving non-medical prescription drug use have risen significantly over the last decade. Hansen et al. 2011 Epidemic of Prescription Opiate Use/Abuse In 2006 the estimated total cost in the United States of nonmedical use of prescription opioids was $53.4 billion $42 billion was attributable to lost productivity, $8.2 billion to criminal justice costs $2.2 billion to drug abuse treatment $944 million to medical complications. Opiate Pain Relievers (OPR s) Deaths from OPR s: increased 5 fold between 1999 and 2010 for women. More women have died each year from drug overdoses than from motor vehicle accidents. In 2010 enough OPR s were prescribed to medicate every adult in US with a typical dose of 5 mg of hydrocodone taken every 4 hours for 1 month. Hansen et al. 2011 CDC MMWR, July 5, 2013 Illicit Drug Use In Pregnancy (2011) Mothers Use of Opiates per 1,000 Hospital Births 20.9% pregnant teens 8.2% - pregnant women 18 to 25 years old 5.0% - overall (less than non-pregnant 10.8%) http://www.samhsa.gov/data/nsduh/2k11results/nsduhresults2011.pdf Patrick, 2012 2
Magnitude of Problem Estimated that 13,500 babies are born each year with NAS from noniatrogenic causes in 2009 One baby born each hour in the US with signs of neonatal abstinence. Cost of Care 2000 - $190 million 2009 - $720 million 5 fold # women using opioids during pregnancy 3 fold in babies diagnoses with NAS Patrick et al, 2012 Patrick et al, 2012 Reported LOS 8-79 days with average of 30 days LOS is varied because optimal treatment for NAS has not been identified 60-80% of these babies will require pharmacologic management Langenfeld, et al, 2005; Lainwala et al, 2005; Jackson et al, 2004; Sarkar & Dunn, 2006 NAS in Tennessee 10 fold increase between 2000 2010 TennCare represents a cost of 5.6 times more than a baby without NAS in 2010 Infants in TennCare system are 18 times more likely to enter state custody than infants without NAS http://health.state.tn.mcn/pdfs/ NAS/NAS_FAQ.pdf Ohio Statistics Department of Health, Tennessee Dr Michael Warren Slides from NAS reporting webinar March 19, 2013 Massatti, R., et al., 2013 3
Tennessee Exposure Over Time Ohio Massatti, R., et al., 2013 Frequency of NAS 50-80% of heroin exposed infants develop NAS 60-90% of methadone and buprenorphine exposed infants develop NAS 50-75% of infants with NAS will require pharmacologic management Presentation Depends upon: Type of drug Additional Substances Timing of maternal dose Infant metabolism Gestational age and birth weight Genetics???? Hudak, 2012 Detection and Screening Testing for drug exposure: Urine Obtain as soon as possible after birth High false-negative (up to 60%) rate because only reports recent drug exposure Meconium Better than urine Drug exposure from 16 weeks GA Ostrea, 2001 4
Detection and Screening Hair Analysis: Radio immunoassay Grows 1 cm/month Metabolite present for life of hair Tells you drug use for months Gets into microfibrils Can use neonatal hair Detection and Screening Umbilical Cord 10 cm section of cord at delivery Rise with sterile saline Place in sterile container ELISA based test Information: www.usdtl.com Ostrea, 2001 Montgomery et al, 2008 Compared to Meconium Drug UC Amphetamine Agreement 96.6% Specificity 97% Sensitivity 95% Opiates Agreement 95% Specificity 96% Sensitivity - 78% Compared to Meconium Drug UC Cocaine Agreement 99% Specificity 100% Sensitivity 75% Cannabinoids Agreement 91% Specificity 91% Sensitivity 89% Montgomery, et al, 2005 Montgomery, et al, 2005 Detection and Screening Maternal history History of drug use Methadone treatment (high dose does not mean infant will have NAS) Family history of drug abuse Prior involvement with CPS Incarceration for drug abuse Detection and Screening Differential Diagnosis: Infection Hypocalcemia Hypomagnesemia Hyperthyroidism Hypoglycemia CNS injury Clancy et al, 2010 Hamdan, et., al, 2012 5
Detection and Screening Drugs Associated with NAS Assess infant for signs of withdrawal Central Nervous System Excitability Gastrointestinal Dysfunction Autonomic signs Hamdan et., al, 2012 Opioids: Heroin Methadone Fentanyl Morphine Demerol OxyContin Nonopioid CNS Depressants Benzodiazepines Antidepressants (SSRI s) Barbiturates Anticonvulsants Antipsychotics Alcohol Common Signs of NAS Physiologic Alcohol Marijuana Barb Sneezing - - X Stuffy Nose - - - Spitting/drooling - - - Diarrhea X - - Vomiting X - - Poor Feeding X - - Sweating X - - Tachypnea X - - Tachycardia - - - Neurobehavioral Alcohol Marijuana Barbiturates Fist sucking - - - Irritability X X X Restlessness - - X Tremors X - X High-pitched cry X - - Seizures X - - Yawning - - - Disturbed sleep - X X Increased crying - - X Convulsions - - X Hypertonicity X - - Drowsiness - - - Increased sleep - - - Common Signs of NAS Physiologic SSRI Cocaine Meth Sneezing - - - Stuffy Nose - - - Spitting - - - Diarrhea - - - Vomiting - - - Poor X X X feeding Sweating - - - Tachypnea - - - Tachycardia - - - Neurobehavioral SSRI Cocaine Metham Fist sucking - - - Irritability X - - Restlessness X - - Tremors X - - High-pitched cry - - - Seizures X - - Yawning - - - Disturbed sleep X - - Increased crying X - - Convulsion X - - Hypertonicity X - - Drowsiness - X X Increased sleep - X X 6
Tobacco Linked to: LBW infants Prematurity Placental Abruption Intrauterine Death SIDS Signs of Tobacco Exposure Excitability Increased muscle tone More handling to be calmed Increased sucking Gaze aversion Abnormal sucking Salihu and Wilson, 2007 Law et al., 2003 Tobacco Inability to self regulate (inability to quiet self) 2-4 weeks & 7 months More negative effect Sadness Distress in response to limitations Decreased ability to be soothed Preterm Infants Lower risk of having signs of NAS < 35 weeks (Doberczak, et al, 1991) More immature CNS (Liu AJ, 2010) Less fat stores (Hudak & Tan, 2012) Differences in total drug exposure Schuetze and Eiden, 2007 Onset of NAS Several factors Half-life of the drug Timing of maternal last dose Infant metabolism of the drug Onset of NAS Heroin or opioids with short half-life within 12 to 24 hours with peak 72 hours (Kraft et al, 2012) Methadone: 48 hours to as long as 7-14 days ( longer half-life) Ashraf et al, 2014 Hamdan et, al, 2012 7
Onset of NAS Cocaine/Methamphetamine After the first week of life First week: signs are drug effect Irritability Hyperactivity Tremors Increased crying Increased sucking Oro & Dixon, 1987 Onset of NAS SSRI s Several hours to several days Resolve in 1-2 weeks Withdrawal linked to 3 rd trimester use Alcohol Within the first 3-12 hours Sedatives 1-3 days Tierney, 2013 Multiple Drug Use Neonatal Abstinence Scoring System (Finnegan) Diagnostic tool Divided into 3 systems with 21 total items 1) CNS disturbances 2) Metabolic, vasomotor and respiratory 3) Gastrointestinal Finnegan, et al, 1975 8
Reliability in Scoring Will everyone on your unit score the infant using the same criteria? Item definitions Staff training Inter-observer reliability on the unit Crying Score 2 if excessive high pitched and unable to self console in 15 sec or continuous up to 5 minutes despite intervention. Score 3 if unable to self console in 15 sec or continuous >5 min despite intervention. Sleep Based on longest period of sleep light or deep after feeding. Score 3 if <1 hour Score 2 if <2 hours Score 1 if <3 hours 9
Hyperactive: elicit from quiet infant. Score 2 for hyperactivejitteriness that is rhythmic, symmetrical, and involuntary. Markedly Hyperactive: Score 3 for jitteriness as above with clonus of hands/arms. May test at hands or feet if unclear (more than 8 to 10 beats). Moro Reflex Tremors Disturbed Tremors are involuntary, rhythmical muscle contraction and release involving to and from movements Disturbed: Score 1 for mild/disturbed- of hands or feet while being handled. Score 2 for moderate/severe disturbed - of arms or legs while being handled. Tremors Undisturbed NOT touching baby after the infant has been handled (wait 15-30 seconds) Score 3 for mild undisturbed - Tremors of hands or feet when not handled. Score 4 for moderate/severe undisturbed - Tremors of arms and/ or legs or both when not handled. Increased Muscle Tone To test: perform pull to sit maneuver. Score 2- no head lag with total body rigidity. Do not test while asleep or crying. Other maneuvers may be used. Score 1 if present at nose, chin, cheeks, elbows, knees, or toes. Do not score for diaper area. This is related to loose or watery frequent stools. Excoriation Myoclonic Jerks Involuntary twitching of muscle. Score 3 for twitching at face/ extremities or jerking at extremities (more pronounced than jitteriness of tremors). 10
Generalized Seizure Score 5 for tonic seizures with extension or flexion of limb(s). Does not stop with containment. May include few clonic beats and/or apnea. Score 1 for wetness at forehead, upper lip, or back of neck. Do not score related to the environment (be consistent with linen) Sweating Score 1 if 37.2-38.3 C (101F or <). Score 2 if 38.4 C (>101F) Fever Frequent Yawning Score 1 if >3 within interval. D Apolito & Finnegan, 2010 Individual or serial within testing interval Score 1 for >3 during scoring interval. Sneezing D Apolito, 2010 11
Mottling Marbled appearance (pink or bluish & white). Score 1 if present at chest, trunk, arms, or legs. Nasal Stuffiness Nares partially blocked from drainage with noisy respiration. Score 1 if present with/without runny nose. D Apolito & Finnegan, 2010 Nostrils flared out during respirations. Score 2 if present. Nasal Flaring Respiratory Rate Tachypnea >60 with/without retractions. Excessive Sucking Rooting with attempts to suck fist, hand, or pacifier before or after feeding. Score 1 for >3 attempts noted. Excessive sucking as above but infrequent or uncoordinated with feeding. Gulping with frequent rest periods to breath. Score 2 for either. Poor Feeding 12
Effortless (not associated with burp). Score 2 for 2 or > episodes. Regurgitation Projectile Vomiting Forceful during or after feed. Score 3 for 1 or > episodes. Stools Score 2 : Loose, curdy, seedy, or liquid without water ring. Score 3: Soft, liquid or hard with water ring. Accuracy in Assessing Infants for Neonatal Abstinence Know item definitions Complete a training program Monitor inter-observer reliability frequently Re-educate if reliabilities are low Reliability Testing Initial Each new staff member caring for the baby Two staff score at same time Annual Accuracy in Assessing Infants for Neonatal Abstinence Percent Score Total Number Total Number of of Item Agreements Item Disagreements Score 21 0 100% 20 1 95% 19 2 90% 18 3 85% 90% or greater 13
How Long Should We Assess for Signs? Low dose prescription opioid such as hydrocodone discharge after 3 days of age Opioid with long half-life such as methadone observe for minimum of 5-7 days Outpatient follow-up Plan of Care with Scores Score of 0 is optimal. Scores of 1 to 7: manage with conservative measures. Scores of 8 to 10: require pharmacological intervention. Scores >10: increased scores require increased dosing. Hudak & Tan, 2012 Plan of Care: Non-pharmacological Swaddling, holding firmly & close to body, and slow rocking. Modify environmental stimulation such as light & noise. Soothing music Minimal handling Non-nutritive sucking Plan of Care: Non-pharmacological Consider small frequent feedings of hypercaloric (24 cal/oz) formula and total caloric intake to provide 150-250 cal/kg/day to maintain growth Do not overfeed Gavage feeding may be necessary with disorganized suck Valez & Jansson, 2008 Velez & Jansson, 2008 Plan of Care with Scores Withdrawal from Opiates give oral morphine Withdrawal from other substances (e.g. barbiturates, ethanol, sedatives, hypnotics, give Phenobarbital Kocherlakota, P., 2014 14
NAS Treatment Control withdrawal signs Attain a score of < 8 on Finnegan Scoring Tool Provide non-pharmacologic interventions Provide pharmacologic treatment Oral morphine or methadone Second line treatment Pharmacologic Management Withdrawal from Opiates give oral morphine Withdrawal from other substances (e.g. barbiturates, ethanol, sedatives, hypnotics, give Phenobarbital AAP, 1998 Pharmacologic Management Oral Morphine Diluted solution: 0.4mg/ml dilution from concentrated oral morphine sulfate solution. Administered Q 3 or 4 hours AAP, 1989 Oral Morphine Concentration - 2 and 4 mg/ml Dosing High dose: 0.08 to 0.1 mg/kg PO q 4 h Low dose: 0.03 to 0.04 mg/kg PO q 4 h Increase by 20% of initial dose q 8 h until symptoms controlled Maximum: 0.2 mg/kg per dose Taper dose by 20% every other day after 3 days of controlled signs AAP, 1998; Burgos & Burke, 2009 Methadone PO q 6-8 h Increase by 0.05 mg/kg until symptoms controlled Decrease frequency to q 12 to 24 h once symptoms controlled Taper dose by 10% to 20% every week to a dose of 0.05 mg/kg per day before discontinuing AAP, 1998; Burgos & Burke, 2009 Phenobarbital Not drug of choice for opioid withdrawal Ok for non-opioid NAS Can be used as second line drug when infants have NAS due to poly-drug exposure in utero O Grady, Hopewell & White, 2009 15
Phenobarbital Does not prevent seizures Does not prevent GI signs Depressant effects may produce poor feeding Can prolong hospital stay Phenobarbital LD of 16 mg/kg IV per 24 h MD of 2 to 8 mg/kg IV or PO per 24 h May taper MD by 10% to 20% every day or Q other day once signs controlled Goal plasma concentration: 20 to 30 mg/ml O Grady, Hopewell & White, 2009 AAP, 1998; Burgos & Burke, 2009 Clonidine Α 2 adrenergic receptor Located on vascular pre-junctional terminals in CNS & PNS Inhibits the release of norepinephrine (noradrenaline) in a form of negative feedback Causes decrease in heart rate and blood pressure Baker, 2012 Clonidine ID - 0.5 to 1.5 g/kg PO Increase over 1 to 2 d to target dose 3 to 5 g/kg per day divided every 4 to 6 hours t½ 44-72 hours Duration of action 6-10 hours Taper 25% of the total daily dose every other day as tolerated Gold, et al, 1980 OK, providing mother is being monitored in a methadone treatment program Small amounts of the drug are transferred to the breast-milk Suggested that breastfeeding may decrease the severity of withdrawal signs Breastfeeding Abdel-Latif, et al, 2006; AAP, 2001 ACOG Guidelines Negative for HIV Abstain from using alcohol, Illicit drugs and amphetamines Have no other contraindications for breastfeeding ACOG, 2012 16
Breastfeeding The AAP previously advised women not to breastfeed if the maternal methadone dose was more than 20 mg/24 hours This has been rescinded Breastfeeding Opioid-dependent women can be informed that regardless of maternal methadone dose, the treatment of NAS with breast milk that contains methadone has been found to be safe and effective AAP, 2012 Ballard, 2000; Jansson, et al., 2007; 2008a; 2008b Breastfeeding Concentrations of methadone and buprenorphine found in human milk are low, there may be enough of the substance in the breast milk to help Other elements of breastfeeding that play a role in ameliorating the NAS symptoms suck as skin-to-skin, rooming in and swaddling New Ideas Keep infant with his or her mother in the room (Jambert-Gray, 2009) Manage infant in a unit outside the NICU where monitoring can occur (Saiki, et al, 2010) Outpatient management (Backes et al, 2012). At methadone treatment clinic Mother and baby can be managed Pritham, 2013 References 1 References 2 American College of Obstetricians and Gynecologists. (2012). Opioid abuse, dependence, and addiction in pregnancy. Committee opinion No. 524. Obstetrics & Gynecology, 119, 1070 1076. Alwan S, Friedman JM. Safety of selective serotonin reuptake inhibitors in pregnancy. CNS Drugs. 2009;23(6):493 509Abdel-Latif, et al, 2006. Effects of breast milk on the severity and outcome of neonatal abstinence syndrome among infants of drug-dependent mothers. Pediatrics 117(6), e1163-e1169. American Academy of Pediatrics. Committee on Drugs. The transfer of drugs and other chemicals into human breast milk. Pediatrics 2001 (108), 776-779. American Academy of Pediatrics. Neonatal Drug Withdrawal. Policy Statement. June, 1998 101 (6), 1079-1088. Ashraf, H., (2014). Neonatal abstinence syndrome. Medscape. http://emedicine.medscape.com/article/978763-overview#showall Backes, C., et al., (2012). Neonatal abstinence syndrome: Transitioning methadone-treated infants from an inpatient to an outpatient setting. Journal of Perinatology 32, 1-6. Ballard, J. (2000). Treatment of neonatal abstinence syndrome with breast milk containing methadone. Journal of Perinatal Neonatal Nursing, 15(4), 76 85. Baker, R., (2012). Cardiovascular Physiology. Strand Street Press CDC, (2013). Vital Signs: Overdoses of prescription opioid pain relievers and other drugs among women United States, 1999-2010. Burgos A,, & Burke,B.,(2009). Neonatal abstinence syndrome. NeoReviews. 10:e222 e229. Chasnoff, IJ, Bussey ME, Savich R, & Stack, CM. (1986). Perinatal cerebral infarction and maternal cocaine use. Journal of Pediatrics. 108 (3):456 459 Clancy, et al., (2010). Methadone dose and neonatal abstinence syndrome a systematic review and meta-analysis, Addiction 105, 2071-2084. Doberczak TM, Kandall SR, Wilets I. Neonatal opiate abstinence syndrome in term and preterm infants. J Pediatr. Jun 1991;118(6):933-7. Finnegan, L., et al, (1975). Neonatal abstinence syndrome: Assessment and management. Addictive Diseases: An International Journal 2(1), 141-158. Gold, M., Pottash, A., Sweeney, D., & Kleber, H,. (1980). Efficacy of clonidine in opiate withdrawal: a study of thirty patients. Drug Alcohol Depend. 1980;6:201 208 Hudak, M., (2012). Neonatal Drug Withdrawal. Committee on Drugs, Fetus & Newborn. Pediatrics 129(2), e540-560. Hansen, et al., (2011). Clinical Journal of Pain 27(3), 194-202 Hamdan, A., (2010). Neonatal Abstinence Syndrome. http://emedicine.medscape.com/article/978763-overview Hudak ML,& Tan RC. Neonatal Drug Withdrawal. AAP Committee on Drugs. Pediatrics. January 2012;129(2):e540-560 17
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