nas treating pregnant_women_final

Neonatal Abs,nence Syndrome (NAS): Trea,ng Pregnant Women and their Newborns

April 2 – 4, 2013 Omni Orlando Resort

at ChampionsGate

Introduc,ons

•  Rick McClead MD MHA –  Professor and Vice Chairman Department of Pediatrics, The Ohio State University

–  Medical Director, Quality Improvement, Na,onwide Children’s Hospital, Columbus Ohio

•  Mona Prasad DO MPH –  Assistant Professor, OBGYN, The Ohio State

–  Medical Director, STEPP program, The Ohio State University

•  Jacqueline Magers Pharm D BCPS –  Clinical Pharmacy Specialist-‐NICU

–  Na,onwide Children’s Hospital, Columbus, Ohio

•  Gail A. Bagwell RN, MSN, CNS –  Perinatal Outreach Program

–  Na,onwide Children’s Hospital, Columbus, Ohio

Disclosure Statement

•  Drs Prasad and Magers, and Ms Bagwell have nothing to disclose.

•  Dr McClead has been funded by Cardinal Health Founda,on 2010-‐2012 for a medica,on error preven,on program.

Learning Objec,ves

•  List 2 reasons why substance abusing pregnant women should not be detoxified during pregnancy

•  Describe how improvement science can be used to reduce the length of hospitaliza,on for neonates suffering from NAS

•  Describe the pharmacology of illicit drugs and of those medica,ons used to treat withdrawal

•  Describe challenges that nurses face when caring for babies and families struggling with NAS

Substance Abuse in the US

•  Opiates in pregnancy: at least 7000 births per year – Preterm birth – Low birth weight – Perinatal mortality

– Neonatal Abs,nence Syndrome (NAS) – ?Long term neurobehavioral abnormali,es

Methadone and Addic,on

•  Methadone has been used for more than 40 years in the treatment of addic,on

•  Important benefits include deterrent from high risk behaviors, incarcera,on, spread of STDs

•  Addicts remain opiate dependent, but func,onal

Methadone and Mothers

•  Similar benefits have been iden,fied in the pregnant woman maintained on methadone as in the non-‐pregnant popula,on

Methadone and Mothers

•  Methadone Maintenance associated with beeer prenatal care – Earlier, more compliant

•  Improved nutri,on and weight gain •  Beeer prepara,on for paren,ng •  Less children in the foster care system •  Improved enrollment in substance abuse treatment and recovery

To Detox or Not Detox


•  Why would you? – Pregnancy without exposures seems ideal

– Limit high risk behaviors: risk of infec,ons, incarcera,on, adverse social outcomes

– Limit the impact of NAS


•  Why wouldn’t you? – Data supports maintenance

– Possibly harmful to mother –  Intrauterine abs,nence syndrome (IAS) – Lack of resources to safely do it –  It isn’t effec,ve


•  Fetal Risk of detox – Asser,ons of fetal response to acute withdrawal

• Hypoxia • Meconium •  Seizures • Hyperac,vity • Catecholamine Excess • Asphyxia


•  Fetal Risk of Detox may be independent of maternal status

•  Recently coined IAS (Intrauterine Abs,nence Syndrome)


•  Zuspan 1975: Monitored fetal response to methadone taper and iden,fied elevated catecholamines in the face of normal maternal catecholamines, improved with increased methadone dose


•  Fetal Risk: Is there a role of IAS?

• 


•  Case report of withdrawal in 29 week EGA with IUGR and AEDF. Dopplers returned to normal aier administra,on of methadone

•  Suggests that withdrawal can acutely and reversibly affect fetal placental circula,on

– Dashe, et all reported on 34 opiate dependent women, enrolled in 12 day detox

– 59% successfully detoxed and did not relapse, 29% resumed antenatal opiate use, 12% did not complete the program


•  The largest single study of pregnant opiate dependent pa,ents

•  Retrospec,ve case series of 101 pa,ents who underwent a 21-‐day inpa,ent opiate detoxifica,on with methadone


•  Compared results of miscarriage and preterm delivery to published rates of miscarriage and preterm delivery in the standard popula,on

•  1 miscarriage in 5 women undergoing in detox in the first trimester, no losses in second trimester and one PTD in the third trimester


•  Effec,veness – 50% completed detox, and 1 pa,ent remained drug free at delivery

Aier Delivery… •  In utero drug exposure, followed by an abrupt cessa,on at birth, may cause infants to suffer from withdrawal symptoms, known as neonatal abs,nence syndrome (NAS).

•  Maternal use of opioids is the most common cause of NAS – May be seen with barbiturates, alcohol, nico,ne and other psychoac,ve drugs.

Aier Delivery…

•  Drug withdrawal in the neonate is self-‐limi,ng.

– Withdrawal symptoms develop in 55% to 94% of infants exposed to opioids or heroin in utero.

– Severe cases require pharmacological interven,on.

– Presenta,on of withdrawal symptoms are variable and dependent upon the type of drug, amount of last maternal dose, ,ming of the last maternal dose, and infant and maternal metabolism.

Neonatal Abs,nence Syndrome Withdrawal symptoms

 High pitch crying  Sleeplessness /Cranky  Feeding problems

 Diarrhea/vomi,ng

 Shakes/tremors

 Overac,ve suck hep://www.flickr.com/photos/dey/

Neonatal Abs,nence Syndrome The Problem

•  AAP recommends therapy with same class as the prenatal substance used, and based on symptom severity. – No standardized therapy – High variability in prac,ces among providers – Best approach has not been determined – Hospitaliza,on is oien prolonged (8-‐79 days).

Why is a prolonged NICU LOS so bad? •  Increased risk of preventable harm •  Increased stress on families already

stressed •  Impaired parent-infant attachment •  Increased financial burden on families &

society. •  At Nationwide Children’s Hospital, nearly

half of the our neonates are fully-capitated Medicaid manage care patients.

Background

•  Na,onwide Children’s Hospital is a large, free-‐standing academic pediatric facility in Columbus, Ohio with 450 licensed beds

•  Neonatal Services –  8 Intensive care nurseries

•  191 Neonatal beds •  2200 admissions/year

•  22% < 1500 g birth weight

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Neonatal Abs,nence Syndrome Our Specific Problem

•  6-‐fold increase in the number of pa,ents at NCH with NAS from 2004-‐2008 – 200 NAS pa,ents in 2008 – NAS LOS exceed 58 days prior to 2009 – Methadone protocol established in early 2009

•  LOS decreased to 31 days •  Literature suggested decreased LOS with oral morphine

•  Established QI Team to reduced LOS for neonates with NAS

Aim & Key Drivers for NAS

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Reduce LOS of main campus NAS pa,ents from 31 to 24 days by December 31, 2010

Specific Aim

Nursing Documenta,on

Maternal Management

Compliance Monitoring

Collaborate with OBGYNs

Key Drivers Design Changes / Interventions

Balancing Measure: 30-‐day readmission

Weaning Protocol Develop oral morphine Weaning protocol

Nursing Assessment

RN educa,on re pa,ent assessment & Finnegan scoring

Pharmacologic Interven,ons


•  Pharmacology of illicit drugs

•  What drugs result in a withdrawal that needs pharmacological treatment and when?

•  When are adjunct medica,ons warranted?

Cocaine

•  CNS s,mulant blocks the reuptake of catecholamines (epinephrine and dopamine) –  Intense euphoria, decreased fa<gue, increased alertness

•  Complica,ons: cardiovascular events, fever

•  Withdrawal: characteris,c syndrome of withdrawal effects, although they are not life-‐threatening

Doering PL. Substance-‐related disorders: overview and depressants, s<mulants, and hallucinogens. In: Pharmacotherapy. 6th ed. Dipiro JT, ed. New York: McGraw-‐Hill; 2005.

Amphetamines / Methamphetamines / Bath Salts

•  CNS s,mulant increases ac,vity of catecholamines by increasing release, blocking reuptake, and inhibi,ng the degrada,ve enzyme –  Diminished fa<gue, increase alertness, suppress appe<te

•  Complica,ons: cardiovascular events, respiratory problems, extreme anorexia, agita,on

•  Withdrawal: strong craving, not life-‐threatening

Doering PL. Substance-‐related disorders: overview and depressants, s<mulants, and hallucinogens. In: Pharmacotherapy. 6th ed. Dipiro JT, ed. New York: McGraw-‐Hill; 2005.

Seda,ves / Hypno,c Agents

•  Focus on what we most commonly see: –  Benzodiazepines –  An<depressants –  Barbiturates

•  Complica,ons: lower blood pressure, drowsiness, memory impairment/confusion

•  Withdrawal: may be life-‐threatening in a neonate

Opiates / Opioids

•  Opiates vs. Opioids µ δ κ1 κ3

Morphine +++ + +

Methadone +++

Fentanyl +++

Buprenorphine P NA -‐-‐ NA

Naloxone -‐-‐-‐ -‐ -‐-‐ -‐-‐ + agonist, -‐ antagonist, P par<al agonist, NA data not available or inadequate.

The number of symbols is an indica<on of potency.

Reisine T, Pasternak G. Opioid Analgesics and Antagonists. In: The Pharmacological Basis of Therapeu8cs. 9th ed. Hardman JG, Limbird LE, eds. New York: McGraw-‐Hill; 1996.

Opiates / Opioids Receptor subtype

Agonists Antagonists

Analgesia

supraspinal

spinal

µ1, κ3, δ1, δ2

µ2, δ2, κ1

Analgesic

Analgesic

No effect

No effect

Respiratory func<on

µ2 drive No effect

GI tract µ2, κ transit No effect

Seda<on µ, κ No effect

•  Withdrawal: anxiety, piloerec,on, abdominal cramps, diarrhea, insomnia –  May progress to be life threatening in a neonate

Reisine T, Pasternak G. Opioid Analgesics and Antagonists. In: The Pharmacological Basis of Therapeu8cs. 9th ed. Hardman JG, Limbird LE, eds. New York: McGraw-‐Hill; 1996.

Pharmacologic Interven,ons •  When to add pharmacologic therapy?

–  When nonpharmacological measures have been unsuccessful in consoling/stabilizing the neonate •  Indica,ons: seizures, poor feeding, diarrhea and

vomi,ng resul,ng in excessive weight loss and dehydra,on, inability to sleep and fever unrelated to infec,on

•  What medica,on(s) should be used? –  Depends on what neonate was exposed to

Neonatal drug withdrawal. American Academy of Pediatrics Commi]ee on Drugs. Pediatrics. 1998;101:1079-‐1088.


•  Cocaine, amphetamines, methamphetamines –  Suppor,ve care

•  Bath salts –  Suppor,ve care –  Benzodiazepines if needed

•  Seda,ves/hypno,cs –  Phenobarbital

Morphine vs. Methadone •  Use: opioid/opiate exposure

Dose (mg/kg/dose)

Onset (min)

Peak T1/2 Metabolism

Morphine IV: 0.05-‐0.2 PO: 0.15-‐0.6

IV: 10 PO: 30

IV: 20 min PO: 1 hr

PT: 10-‐20hr FT: 4.5-‐13hrs

Liver M6G (ac<ve; 18hr), M3G (inac<ve)

Methadone PO: 0.05-‐0.2 PO: 30-‐60 PO: 2-‐4 hrs 16-‐25 hrs Liver inac<ve

metabolite

PT: preterm; FT: full term; M6G: morphine-‐6-‐glucuronide; M3G: morphine-‐3-‐glucuronide

Oral Morphine Ini,a,on Protocol Protocol should be ini,ated if an infant has 2 consecu,ve scores > 8 or 1 score > 12 within a 24 hour period (just as was done previously with the methadone taper).

Concentra,on of Enteral Morphine to be used for ALL doses: 0.2 mg/mL

Star,ng Dose: Enteral: 0.05 mg/kg/dose PO q3h IV: 0.02 mg/kg/dose IV q3h (IV morphine and enteral morphine doses are not equivalent)

Titra,on: Enteral: Increase by 0.025-‐0.04 mg/kg every 3 hrs un,l controlled (NAS <8) IV: increase by 0.01 mg/kg every 3 hrs un,l controlled (NAS <8)

*Rescue Dose*: If infant has 1 score of > 12, double the previous dose given (enteral or IV) x 1 and then adjust accordingly:

-‐ If NAS score now < 12: make the scheduled maintenance dose (MD) the same as the rescue dose that was just administered. The first higher MD should be given at the next scheduled care/feed. -‐ If NAS score s<ll > 12: increase next dose by 50%. Con<nue to do so un<l score is < 12. Once <12. then follow guideline listed above.

Oral Morphine Weaning Protocol Wean: Once stabilized on a dose for 72-‐96 hours, use this dose as the star<ng point of the wean (please note this dose on infant’s card). Begin weaning the dose by 10% (of the original dose when the first wean was started) every 24-‐48 hours. Drug may be discon<nued when a single enteral dose is < 0.02 mg/kg/dose.

*Ad lib infants*: Given the shorter dura<on of ac<on of enteral morphine, it is best suited to be dosed on a q3hr schedule. Infants should be allowed to ad lib feed volumes but kept on a q3hr schedule.

*Backslide*: If infant’s NAS scores become consistently elevated (ex: 2 consecu<ve > 8) during the weaning process, assure that nonpharmacological measures are op<mized (ie: swaddling, holding, decreased s<muli, etc.) before going back to pervious dose at which pa<ent was stable. If infant’s scores con<nue to be elevated (even amer physical exam to ensure nothing else is wrong/bothering the infant), either weight adjust medica<on and/or con<nue to back up in a stepwise fashion un<l pa<ent’s scores are < 8. Once stabilized on a new dose for minimum 48 hrs. resume 10% wean but consider weaning at longer intervals.

Discharge: Observe in-‐house x 48-‐72 hours off of medica<on before discharge.

Adjunct Therapy -‐ Phenobarbital •  Consider star<ng phenobarbital if:

–  Polysubstance exposure is suspected/confirmed or if majority of NAS score is due to CNS disturbances (hyperac<ve reflexes, tremors, increased muscle tone, presence of jerks, etc).

•  Loading Dose (up to physician discre,on if needed): 10 mg/kg/dose PO q12hr x 2 doses –  Enteral formula<on contains a high percentage of alcohol. Recommend

dividing dose to decrease risk of emesis and/or seda<on. •  Maintenance Dose: 5 mg/kg/dose PO once daily, preferably in the

evening. Dose may be divided BID if concern for excess seda<on. Do NOT rou<nely weight adjust.

•  Wean: Recommend discharging infant home on phenobarbital with subsequent weaning to be done either in Neo Clinic or by infant’s PCP.

•  Phenobarbital levels should not be needed for this indica<on unless the infant experiences seizures or seizure-‐like ac<vity. If suspected, a phenobarbital level and/or a neurology consult may be warranted at that <me.

Adjunct Therapy -‐ Clonidine •  Consider star<ng clonidine if:

–  Majority of NAS score is due to autonomic over-‐s,mula,on (swea<ng, fever, yawning, mo]ling, sneezing, etc.)

–  Infant is requiring > 0.1 mg/kg/dose of morphine q3hr and is s<ll not stabilized. •  Maintenance Dose (0.1 mg/mL suspension):

–  Given that the infant will be receiving morphine on a q3hr basis, for ease of administra<on recommend 1 mcg/kg/dose PO every 6 hrs (range: 4-‐6 mcg/kg/DAY divided q4-‐6hr)

•  Side effects of clonidine include bradycardia, hypotension upon ini<a<on and then rebound hypertension when drug is discon<nued.

•  Do NOT recommend discharging pa<ent home on clonidine. Amer pa<ent has shown stabiliza<on off of morphine for minimum of 24hrs, discon<nue the clonidine and monitor in-‐house for minimum of 48hrs due to risk of rebound hypertension.

Agthe , et al. Pediatrics. 2009;123:e849-‐e856. Hoder. Psychiatry Research. 1984;13:243-‐251.

Caregiver Educa,on and Support

Caregiver Educa,on and Support

•  Pa,ent Assessment •  Finnegan Scoring tool •  Maternal Substance Use/Abuse

•  Ongoing educa,on and training

Staff concerns in 2009:

•  Poor communica,on and inconsistency of plans of care

•  Poor competency with assessment and documenta,on of symptoms

•  Stress related to neonatal care •  Stressful family dynamics & interac,ons •  Discharge planning

Aim & Key Drivers for NAS

49

Reduce LOS of main campus NAS pa,ents from 31 to 24 days by December 31, 2010

Specific Aim

Nursing Documenta,on

Maternal Management

Compliance Monitoring

Collaborate with OBGYNs

Key Drivers Design Changes / Interventions

Balancing Measure: 30-‐day readmission

Weaning Protocol Develop oral morphine Weaning protocol

Nursing Assessment

RN educa,on re pa,ent assessment & Finnegan scoring

I. Nursing Assessment and Scoring

•  Finnegan Training Courses ( March-‐ April 2010) •  Two half day NAS Workshops •  Train the trainer format

•  Implement standardized training of new staff with commercially produced program

•  Ongoing competency for all staff

Workshop Intra-‐rater Reliability

Pre-‐Workshop

Post-‐ Workshop

II. NCH NAS Taskforce •  Repository of informa,on, resources, and ideas for poten,ally

beeer prac,ces

•  Monthly interdisciplinary collabora,ve mee,ngs: •  Interprofessional educa,on •  Developed prac,ce guidelines •  Enhanced antenatal professional communica,on, collabora,on •  Provided educa,on and training of L/D and WBN staff •  Outreach educa,on and support for providers in the Region.

•  MOD Grant: improved maternal Methadone treatment reten,on rate by 25%

Staff Stress

•  Nurses struggle with issues of beneficence and non-‐maleficence, frustra,on, burnout and dissa,sfac,on when caring for this popula,on of pa,ents and families

•  We surveyed our staff to determine what they were experiencing

2013 NCH NAS Taskforce Goal

1. Determine NCH staff level of comfort in caring for the NAS pa,ents and families

2. Determine if addi,onal educa,on, training and resources are needed to help staff care for and cope with NAS pa,ents and families

The Survey

•  Qualita,ve and quan,ta,ve data •  Sent to all nursing staff of Neonatal Services (LPN, RN, APN) via email. N= 580

•  Returns= 167 •  Response rate= 28%

Demographic Data

N=167

RNs= 130 (78%) LPNs= 5 (3%) APNs= 30 (18%)

MD=1 (0.6%) Unknown=1 (0.6%)

Years of NICU experience 0-‐5 years= 50 (30%) 6-‐10 years= 37 (22%) 11-‐20 years= 29 (17%) Over 20 years= 48 (28%) Unknown= 3 (2%)

What are some of the biggest challenges that you experience caring for babies with NAS

1. Finnegan Scoring -‐ “subjec,ve” -‐ Comfort with r/t competency -‐ Struggle between NNPs and RNs

2. Parents/Families -‐ Level of involvement -‐ Awtudes: resenxul, denial, lying, level of knowledge

3. Pa,ent Care -‐ Seemingly ineffec,ve care-‐ fussiness, skin breakdown -‐ Lack of consistency between providers and prac,,oners

What are some of the biggest challenges that you experience caring for babies with NAS

4. Workload –  Not enough time to console –  Too many babies to care for

5. “Ethics” –  Patience for self and of others –  “Prejudiced nurses”

2013 NCH NAS Taskforce Ac,on Plan

1.   Staff Educa,on: – NAS quarterly taskforce mee,ngs

– VON iNICQ NAS Webinar series – Annual NCH conference-‐ NAS Postconference – Ohio Opiate Summit

– Podcasts by Neonatologist and Addic,on Specialist – Ethics lectures for staff


2. Staff Resources – Develop website or sharepoint for

•  Guidelines, references, ar,cles • Mee,ng minutes

•  iNICQ proceedings – Bedside resource packet – EPIC EMR with best prac,ce alerts – Unit based NAS commieees with Superusers


3. Staff Training – FNAST ongoing competency training

–  Inter-‐rater reliability tes,ng

4. Re-‐survey in 2013

References •  D’Apolito, K. and Finnegan, L. Assessing the Signs and Symptoms

of Neonatal Abs,nence using the Finnegan Scoring Tool: an inter-‐observer reliability program. Neo Advances, 2010.

•  Maguire D, Webb M, Passmore D, Cline G. NICU Nurses' Lived Experience: Caring for Infants With Neonatal Abs,nence Syndrome. Adv Neonatal Care. 2012 Oct;12(5):281-‐5.

•  Murphy-‐Oikonen J, Brownlee K, Montelpare W, Gerlach K. The Experiences of NICU Nurses in Caring for Infants with Neonatal Abs,nence Syndrome. Neonatal Network. Sept/Oct 2010; 29 (5): 307-‐313.

h]p://www.eecs.umich.edu/dco/services/courseservices.php

Ini,a,on of morphine protocol (December 2009)

Ini,a,on of NAS Taskforce (November 2009)

Morphine Failures

How are we doing? Length of Stay for NAS Infants Admieed to the Main Campus NICU*

•  Excludes infants admieed with LOS due to other factors such as prematurity, low birth weight, birth defects, etc.

Modifica,on of morphine protocol (March 2010)

Modifica,on of morphine protocol (March 2011)

Implementa,on of methadone protocol (May 2009)

RN staff reeduca,on

Spread to Local Maternity Center

Methadone Morphine Protocol

All Cause Readmissions

•  28 Readmissions 2010-‐2012(N= 440) – NAS symptoms (2)

– CNS symptoms unrelated to NAS Hx (3) – Feeding issues unrelated to NAS Hx (4) – BPD exacerba,on (1) –  Infec,ons (13) – Surgical problems (5)

Summary

Summary •  Substance abusing pregnant women should

not be routinely detoxed prenatally •  Formal training of staff in the use of the

Finnegan tool led to better assessment and documentation of withdrawal symptoms, and a more reliable weaning program.

•  Standardize pharmacotherapy can impact LOS of NAS patients

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Summary

•  Oral morphine weaning protocol associated with a significant decrease in LOS for NAS patients.

•  Morphine weaning failures due to high maternal methadone dosing and polypharmacy

•  Maternity centers with NAS babies can achieve LOS of < 20 days.

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