Neonatal Abstinence Syndrome:

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Neonatal Abstinence Syndrome: Reconsidering the Standard Approach Matthew Grossman, M.D. Assistant Professor of Pediatrics Yale School of Medicine Quality and Safety Officer Yale-New Haven Children s Hospital

DISCLOSURE The content of this presentation does not relate to any product of a commercial entity; therefore, I have no relationships to report.

Opioids in the US Prescriptions grew 4-fold over last decade More deaths than car accidents 91 people die each day from opioids In 2012, enough opioids were prescribed to give every adult in the US one prescription Patrick, et al. Journal of Perinatology. 2015; 35:650-655 Source: http://familytalk.ca/heroin/

NAS per 1000 Hospital Births Incidence of NAS in the US, 2000-2012 7.0 6.0 5.0 4.0 3.0 2.0 1.0 0.0 2000 2003 2006 2009 2010 2011 2012 Year Patrick SW, et. al. Neonatal Abstinence Syndrome and Associated Healthcare Expenditures United States, 2000-2009. JAMA. 2012 May 9;307(18):1934-40. Patrick SW, Davis MM, Lehman CU, Cooper WO. Increasing incidence and geographic distribution of neonatal abstinence syndrome: United States 2009 to 2012. J Perinatol. Apr 30 2015.

Source: Grossman Family Album

Source: http://wings.buffalo.edu/aru/preprohibition.htm Langenfeld, et al. Drug and Alcohol Dependence 2005;77:31 6.

Source: http://olivier-dogot.blogspot.com Jackson L, et al. Archives of Disease in Childhood 2004;89: F300 4.

Source: http://www.bad-drug.net Coyle MG. Journal of Pediatrics 2002;140:561 4

Source: http://www.projectknow.com MS Brown et al. Journal of Perinatology 2014; (1-6)

Agthe, et al. Pediatrics 2009;123:e849 56. Source: http://www.recovery.org

Standard Approach Medications NICU Finnegan Scores Medication Dosing Staff cares for the baby

LOS (days) Length of Stay: Methadone-Exposed Infants 30 25 20 15 P <.02 10 5 0 2003-June 2006 July 2006-2009

Medication Studies DTO vs. DTO plus clonidine: 17 days vs. 12 days Morphine vs. Phenobarbitone: 8 days vs. 12 days Morphine vs. DTO 30 days vs. 27 days DTO vs. DTO plus Phenobarbitone 79 days vs. 38days Methadone vs. Morphine 17 days vs. 24 days

% Treated with Morphine Percent of NAS Patients Treated with Morphine 100.0% 90.0% 80.0% 70.0% 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% 2003 2004 2005 2006 2007 2008 2009 2010 Year

LENGTH OF STAY (Days) Length of Stay: Methadone exposed infants 70.0 60.0 50.0 Mean=22.5 UCL 47.1 40.0 30.0 20.0 10.0 0.0 LCL 0.0 ADMIT DATE

The standard approach: why? Medications

Source: Grossman Family Album Abraham, et al. J Obstet Gynaecol Can 2010;32(9):866 871

Intervention 1 Focus on non-pharmacologic care 26

LENGTH OF STAY (Days) Length of Stay: Methadone exposed infants 70.0 Standardized non-pharm care 60.0 50.0 UCL Mean=22.5 40.0 Mean=13.2 30.0 29.1 20.0 10.0 0.0 LCL 0.0 ADMIT DATE

The standard approach: why? Medications NICU

Source: http://medicine.yale.edu

Source: http://adamandsarahcoats.blogspot.com

Intervention 2 Direct transfer to the general inpatient unit 32

1/30/08 6/12/08 7/18/08 10/15/08 12/1/08 1/13/09 2/7/09 4/6/09 5/13/09 6/14/09 9/10/09 10/5/09 12/18/09 2/23/10 3/19/10 6/23/10 9/23/10 11/23/10 12/18/10 2/17/11 3/8/11 4/27/11 5/19/11 7/26/11 9/16/11 10/7/11 12/1/11 12/26/11 2/11/12 4/17/12 5/13/12 6/8/12 7/16/12 9/27/12 10/14/12 11/17/12 1/25/13 2/23/13 3/21/13 4/15/13 5/21/13 6/9/13 8/21/13 9/26/13 11/21/13 11/30/13 12/30/13 2/4/14 3/26/14 4/19/14 5/10/14 LENGTH OF STAY (Days) Length of Stay: Methadone exposed infants 70.0 60.0 Standardized non-pharm care Direct transfer to inpatient unit 50.0 UCL Mean=22.5 40.0 Mean=13.2 Mean=10.2 32.5 30.0 CL 20.0 10.0 10.2 0.0 LCL 0.0 ADMIT DATE

The standard approach: why? Medications NICU Finnegan Scores

The infant with a score of 7 or less was not treated with drugs for the abstinence syndrome because, in our experience, he would recover rapidly with swaddling and demand feedings. Infants whose score was 8 or above were treated pharmacologically Finnegan LP, et al. Assessment and treatment of abstinence in the infant of the drug- dependent mother. Int Clin Pharmacol Biopharm. 1975;12(1 2):19 32

Problems with the Finnegan Long lengths of stay and lots of meds Purpose of treatment is to get the scores below threshold Must disturb the infant and exacerbate signs of withdrawal Can be slow to respond Powerful and potentially harmful meds to give to treat a sneeze or a yawn

Intervention 3 Discontinuation of the Finnegan Scoring tool and adoption of a functional scoring approach 38

1)Can the baby eat? 2)Can the baby sleep? 3)Can the baby be consoled?

ESC Study Analyzed 50 consecutive NAS babies admitted to our general inpatient unit from March 2014 to August 2015 Assessed every 2-6 hours using the FNASS, but did not guide management Management decisions based on ESC

Outcomes 1. Proportion of infants treated with morphine vs. proportion predicted to be treated with morphine using the FNASS approach 2. Days the two approaches disagreed 3. FNASS scores the day after the two approaches disagreed

Results Proportion of Infants that Received Morphine 80% 70% 60% 50% p<.001 62% 40% NAS infants (n=50) 30% 20% 10% 12% 0% Received Morphine (ESC) Would Have Received Morphine (Finnegan)

Results On 78 days (26.4%) the ESC Led to LESS Morphine than Predicted by The Finnegan The following day, the average Finnegan score decreased by 0.9 points, and decreased in 69% of cases. On 2 days (0.7%) the ESC Led to MORE Morphine than Predicted by The Finnegan In both cases the average Finnegan score increased by 1.7 Points the next day

Results No readmissions No seizures No ICU transfers

Source: http://www.mdnews.com

The standard approach: why? Medications NICU Finnegan Scores Medication Dosing

Intervention 4 Decrease in morphine up to 3 times per day 48

Intervention 5 PRN Dosing

1/30/08 7/2/08 8/30/08 11/19/08 1/13/09 2/19/09 5/5/09 6/13/09 9/10/09 10/21/09 2/2/10 3/12/10 6/23/10 10/10/10 12/10/10 2/9/11 3/8/11 5/10/11 6/10/11 9/10/11 10/7/11 12/1/11 1/5/12 4/3/12 5/13/12 6/26/12 8/20/12 10/12/12 11/17/12 1/25/13 3/6/13 4/4/13 5/21/13 7/4/13 9/10/13 11/20/13 11/30/13 1/12/14 2/19/14 4/12/14 5/10/14 6/14/14 6/26/14 8/7/14 9/23/14 11/19/14 1/6/15 2/16/15 4/14/15 LENGTH OF STAY (Days) Length of Stay: Methadone exposed infants 70.0 Standardized non-pharm care Novel assessment tool on inpatient unit 60.0 Direct transfer to inpatient unit Spread to NICU team Prenatal counseling 50.0 UCL Mean=22.5 Rapid med weaning 40.0 Mean=13.2 Mean=10.2 Mean=7.7 30.0 20.0 16.9 10.0 0.0 LCL 0.0 ADMIT DATE

The standard approach: why? Medications NICU Finnegan Scores Medication Dosing Staff cares for the baby

Cleveland, et al., JOGNN;43(3): 318-329

How do moms feel? Addiction is misunderstood Guilty Judged Mistrusting of nurses

His nurse was like his muscles are locking up because of his junkie mom. I didn t want to visit, I would call before and if that nurse was there, I wouldn t even go.

because we re gonna leave and he s gonna cry and they re gonna leave him crying because they re gonna be like, you know what? His parents are jerks!

if you re using while you re pregnant, you have a problem; a big problem... and you need help. You obviously don t care about your- self, about anything, except the drug. Make it a little bit easier on that mother if she s showing initiative... if she s taking the time to be there. If she loves her child, you can see it and you can feel it. If it s obvious that she s there for the baby then embrace it; make it easier. You don t know what her circumstances are. You don t know what she s been through or how hard her life has been. You don t know what she was feeling when she was pregnant... if she was being abused, if she was poor. Whatever the reason she was using while she was pregnant... you just don t know. So, try to make it easier for her.

Intervention 6 Empowering messaging

Source: http://potomachospital.blogspot.com

Source: http://potomachospital.blogspot.com

Old Protocol Goal: suppress withdrawal signs NICU: Mom visits Finnegan Scores: treat the number supportive care feed on demand Morphine Surprise! Staff takes care of infant New Protocol Goal: have infant function as a normal neonate Mother and child together Eat/Sleep/Console: treat the infant SUPPORTIVE CARE No feeding schedule Meds on page 3 Prenatal preparation Staff coaches parents

1/30/08 7/12/08 11/10/08 1/21/09 4/6/09 6/13/09 9/18/09 12/23/09 3/19/10 9/18/10 12/10/10 2/21/11 4/27/11 7/4/11 9/29/11 12/1/11 2/11/12 5/7/12 6/26/12 10/9/12 11/17/12 2/23/13 3/28/13 5/22/13 8/21/13 11/20/13 12/10/13 2/11/14 4/19/14 6/8/14 6/26/14 9/8/14 11/14/14 1/9/15 3/11/15 5/26/15 7/17/15 8/22/15 10/21/15 12/4/15 4/28/16 7/7/16 8/31/16 9/27/16 10/29/16 12/21/16 1/19/17 3/3/17 4/3/17 4/30/17 5/28/17 6/25/17 LENGTH OF STAY (Days) Length of Stay: Methadone exposed infants 70.0 Standardized non-pharm care 60.0 Direct transfer to inpatient unit 50.0 UCL Mean=22.5 Novel assessment tool on inpatient unit Prenatal counseling 40.0 Mean=13.2 Mean=10.2 Spread to NICU team Rapid med weaning Meds as needed 30.0 Mean=7.7 Empowering messaging Mean=5.9 20.0 10.0 10.8 0.0 LCL 0.9 ADMIT DATE

Average Length of Stay (Days) Average Length of Stay - Methadone Exposed Infants 35 30 25 Focus on supportive management 20 Transfers directly from WBN to Floor 15 NICU included in effort Length of Stay (days) 10 5 Protocol Change: More aggressive weans Discontinued Finnegan Scoring 0 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Year More aggressive weans

% Treated with Morphine Percent of NAS Patients Treated with Morphine 100.0% 90.0% 80.0% 70.0% 60.0% 50.0% % Treated with Morphine 40.0% 30.0% 20.0% 10.0% 0.0% 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Year

Percent Treated Percent Treated with Morphine 100.0% 90.0% 80.0% 70.0% 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% 2008 2009 2010 2011 2012 2013 2014 2015 2016 Date

Average maximum morphine dose (mg/dose) Average Maximum Morphine Dose 0.6 0.5 0.4 p <.001 0.3 Average maximum morphine dose (mg/dose) 0.2 0.1 0 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Year

% Breastfeeding 60.0% Breastfeeding Rate 50.0% 40.0% 30.0% % Breastfeeding 20.0% 10.0% 0.0% 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Year

Total Cost ($) Total Average Cost of NAS Care 60000 50000 40000 p <.001 30000 Total Cost ($) 20000 10000 0 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Year

Boston Medical Center Had been using FNASS approach Finnegan prioritization from June-November 2016 Developed ESC approach as a scoring tool Piloting since December 2016

Eat, Sleep, Console Flowsheet TIME EATING Poor feeding due to NAS Y/N SLEEPING < 1 hr after feeding due to NAS Y/N CONSOLABILITY Please rate the infant s consolability: Soothes with little support 1 Soothes with some support 2 Soothes with great support 3 Did the infant require >10 minutes to console Y/N

Boston Medical Center Results Use of morphine decreased from 82% to 40% Length of stay decreased from 18 days to 10 days No readmissions

Additional Spread

Long-Term Outcomes?

Conclusions Hugs before drugs Empower families Rooming-in Non-Pharmacologic care as 1 st line treatment ESC approach PRN meds Ask why Source: Grossman Family Album

Acknowledgements David Hersh, MD Adam Berkwitt, MD Erin Nozetz, MD Marcelle Applewaite, RN Kim Carter, RN Liz O Mara, RN Matt Bizzarro, MD Yogangi Malhotra, MD Jonathan Miller, MD Camisha Taylor, RN Rachel Osborn, MD