Treatment Track, National Rx Drug Abuse Summit, April 2-4, 2013. Neonatal Abstinence Syndrome: Treating Pregnant Women presentation by Dr. Rick McClead, Mona Prasad, Jacqueline Magers and Gail A. Bagwell
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 • Fetal Risk of Detox may be independent of maternal status • Recently coined IAS (Intrauterine Abs,nence Syndrome)
To Detox or Not Detox • 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
To Detox or Not Detox • Fetal Risk: Is there a role of IAS? •
To Detox or Not Detox • 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
To Detox or Not Detox• 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
To Detox or Not Detox • 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
To Detox or Not Detox • 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 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 29
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 Design Changes / Interventions Key Drivers RN educa,on re pa,ent assessment & Finnegan Nursing Assessment scoring Specific AimReduce LOS of main Nursing Documenta,on Compliance Monitoring campus NAS pa,ents from 31 to 24 days by December 31, 2010 Weaning Protocol Develop oral morphine Weaning protocol Balancing Measure: Maternal Management Collaborate with OBGYNs 30-‐day readmission 31
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 Agonists Antagonists subtype Analgesia supraspinal µ1, κ3, δ1, δ2 Analgesic No eﬀect spinal µ2, δ2, κ1 Analgesic No eﬀect Respiratory µ2 drive No eﬀect func<on 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.
Pharmacologic Interven,ons • Cocaine, amphetamines, methamphetamines – Suppor,ve care • Bath salts – Suppor,ve care – Benzodiazepines if needed • Seda,ves/hypno,cs – Phenobarbital
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 • 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 Design Changes / Interventions Key Drivers RN educa,on re pa,ent assessment & Finnegan Nursing Assessment scoring Specific AimReduce LOS of main Nursing Documenta,on Compliance Monitoring campus NAS pa,ents from 31 to 24 days by December 31, 2010 Weaning Protocol Develop oral morphine Weaning protocol Balancing Measure: Maternal Management Collaborate with OBGYNs 30-‐day readmission 49
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
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 Years of NICU experience RNs= 130 (78%) 0-‐5 years= 50 (30%) LPNs= 5 (3%) 6-‐10 years= 37 (22%) 11-‐20 years= 29 (17%) APNs= 30 (18%) Over 20 years= 48 (28%) MD=1 (0.6%) Unknown= 3 (2%) Unknown=1 (0.6%)
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 for5. “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
2013 NCH NAS Taskforce Ac,on Plan 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
2013 NCH NAS Taskforce Ac,on Plan 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.
How are we doing? Length of Stay for NAS Infants Admieed to the Main Campus NICU* Morphine Failures RN staﬀ reeduca,on Modiﬁca,on of morphine protocol (March 2011) Modiﬁca,on of morphine protocol (March 2010) Ini,a,on of morphine protocol (December 2009) Ini,a,on of NAS Taskforce (November 2009) Implementa,on of methadone protocol (May 2009) • Excludes infants admieed with LOS due to other factors such as prematurity, low birth weight, birth defects, etc.
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• 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 68
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. 69