Neonatal Abstinence Syndrome:

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

2 Patrick, et al. Journal of Perinatology. 2015; 35: Source:

3 Patrick, et al Journal of Perinatology, 2015

5 Source: Grossman Family Album

Source: http://wings.buffalo.edu/aru/preprohibition.

8 Source: Langenfeld, et al. Drug and Alcohol Dependence 2005;77:31 6.

9 Source: Jackson L, et al. Archives of Disease in Childhood 2004;89: F300 4.

10 Source: Coyle MG. Journal of Pediatrics 2002;140:561 4

11 Source: MS Brown et al. Journal of Perinatology 2014; (1-6)

12 Agthe, et al. Pediatrics 2009;123:e Source:

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

14 Length of Stay: Methadone-Exposed Infants LOS (days) P < June 2006 July

15 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

19 Percent of NAS Patients Treated with Morphine 100.0% 90.0% 80.0% % Treated with Morphine 70.0% 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% Year

20 Length of Stay: Methadone exposed infants Mean=22.5 UCL 47.1 LENGTH OF STAY (Days) LCL 0.0 ADMIT DATE

21 Asti, et al., Pediatrics 2015;135

22 The standard approach: why? Medications

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

24 Intervention 1 Focus on non-pharmacologic care 24

25 Length of Stay: Methadone exposed infants 70.0 Standardized non-pharm care UCL Mean=22.5 LENGTH OF STAY (Days) Mean= LCL 0.0 ADMIT DATE

26 The standard approach: why? Medications NICU

27 Source:

29 Source:

30 Intervention 2 Direct transfer to the general inpatient unit 30

31 Length of Stay: Methadone exposed infants Standardized non-pharm care Direct transfer to inpatient unit 50.0 UCL Mean=22.5 LENGTH OF STAY (Days) CL Mean=13.2 Mean= LCL 0.0 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 ADMIT DATE

32 The standard approach: why? Medications NICU Finnegan Scores

34 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

35 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

36 Intervention 3 Discontinuation of the Finnegan Scoring tool and adoption of a functional scoring approach 36

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

38 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

39 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

001 62% 40% NAS infants (n=50) 30% 20% 10% 12%

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

41 Results by Hospital Day Hospital Days (n=296): ESC Approach FNASS Approach Predicted P value Increased Morphine 8 (2.7%) 76 (26%) <0.01 No Morphine 258 (87.2) 156 (52.7%) <0.01 Decreased Morphine 21 (7.1%) 35 (11.8%) <0.01 Same Morphine 9 (3%) 29 (9.8) <0.01

42 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

43 Results No readmissions No seizures No ICU transfers

44 Withdrawal from opioids or sedative-hypnotic drugs may be life-threatening, but ultimately, drug withdrawal is a selflimited process. Unnecessary pharmacologic treatment will prolong drug exposure and the duration of hospitalization to the possible detriment of maternalinfant bonding. The only clear benefit of pharmacologic treatment is the short-term amelioration of clinical signs. Hudak ML, Tan RC; COMMITTEE ON DRUGS; COMMITTEE ON FETUS AND NEWBORN; American Academy of Pediatrics: Neonatal drug withdrawal. Pediatrics 2012; 129:e540 e560

45 Source:

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

48 Intervention 5 Decrease in morphine up to 3 times per day 48

49 Intervention 6 PRN Dosing

50 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 LENGTH OF STAY (Days) Mean=13.2 Mean=10.2 Mean= LCL 0.0 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 ADMIT DATE

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

52 Cleveland, et al., JOGNN;43(3):

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

54 I would just tell (the nurses) to take it easy (on the mother). You know, after being addicted, I realized that this is really a disease. There are some who abuse, but if you re using while you re pregnant, you have a problem; a big problem and you need help

55 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.

56 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!

57 Intervention 7 Empowering messaging

58 Source:

59 Source:

Old Protocol Goal: suppress withdrawal signs NICU: Mom visits Finnegan Scores: treat the number supportive care feed on demand Morphine Surprise!

60 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

61 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 LENGTH OF STAY (Days) Mean=13.2 Mean=10.2 Spread to NICU team Rapid med weaning Mean=7.7 Meds as needed Empowering messaging Mean= LCL 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 ADMIT DATE 0.9

62 Average Length of Stay - Methadone Exposed Infants Average Length of Stay (Days) Protocol Change: More aggressive weans Focus on supportive management Transfers directly from WBN to Floor Discontinued Finnegan Scoring NICU included in effort Length of Stay (days) Year More aggressive weans

63 Percent of NAS Patients Treated with Morphine 100.0% 90.0% 80.0% % Treated with Morphine 70.0% 60.0% 50.0% 40.0% 30.0% % Treated with Morphine 20.0% 10.0% 0.0% Year

64 Percent Treated with Morphine 100.0% 90.0% 80.0% 70.0% Percent Treated 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% Date

65 Percent of NAS Patients Treated with Morphine 100.0% 90.0% 80.0% % Treated with morphine 70.0% 60.0% 50.0% 40.0% 30.0% NICU non-nicu 20.0% 10.0% 0.0% Year

66 Average Length of Stay - Methadone Exposed Infants Average Length of Stay Average Length of Stay Year

67 Average Length of Stay - Methadone Exposed Infants Average Length of Stay NICU non-nicu Year

68 Average Maximum Morphine Dose 0.6 Average maximum morphine dose (mg/dose) p <.001 Average maximum morphine dose (mg/dose) Year

69 60.0% Breastfeeding Rate 50.0% 40.0% % Breastfeeding 30.0% 20.0% % Breastfeeding 10.0% 0.0% Year

70 Total Average Cost of NAS Care p <.001 Total Cost ($) Total Cost ($) Year

BMC QI Initiative 2016-2017 Cycle 1: May 2016 Staff

symptom prioritization Cycle 2: July 2016 Methadone No Tx in

71 BMC QI Initiative Cycle 1: May 2016 Staff education Prenatal messaging Non-pharm care bundle Finnegan symptom prioritization Cycle 2: July 2016 Methadone No Tx in the first 24 hours Cycle 3: Dec 2016 Eat, Sleep, Console (ESC) Cuddlers

72 Symptom Prioritization Central Nervous System Disturbances Excessive High Pitched Crying 2 Continuous High Pitched Crying - 3 Sleep < 1 Hr After Feeding 3 Sleep < 2 Hr After Feeding 2 Sleep < 3 Hr After Feeding 1 Hyperactive Moro Reflex 2 Markedly Hyperactive Moro 3 Mild Tremors Disturbed 1 Mod Sev Tremors Disturbed 2 Mild Tremors Undisturbed 3 Mod Sev Tremors Undisturbed - 4 Metabolic, Vasomotor, and Respiratory Disturbance Gastrointestinal Disturbance Sweating 1 Excessive Sucking 1 Fever < 101 ( C) 1 Fever > 101 (38.4 C) 2 Poor feeding 2 Frequent Yawning (>3) 1 Regurgitation 2 Projective Vomiting 3 Mottling 1 Loose Stools 2 Watery Stools 3 Nasal Stuffiness 1 Increased Muscle Tone - 2 Sneezing (>3) 1 Excoriation 1 Nasal Flaring 2 Myoclonic Jerk 3 Respiratory Rate (>60) 1 Respiratory Rate (>60 Retractions) 2 Seizures 5

73 ESC EPIC flowsheet

74 ESC EPIC Flowsheet

75 Percent of infants pharmacologically treated _ _ % Treated Average UCL and LCL Percent 100% UCL Non-Pharm Care Bundle Symptom prioritization Prenatal education 90% 80% Percent treated 70% 60% 50% 40% 30% LCL ESC Care Tool Cuddlers 20% 10% Mean 86% Staff QI education 0% 1/1/14 2/1/14 3/1/14 4/1/14 5/1/14 6/1/14 7/1/14 8/1/14 9/1/14 10/1/14 11/1/14 12/1/14 1/1/15 2/1/15 3/1/15 4/1/15 5/1/15 6/1/15 7/1/15 8/1/15 9/1/15 10/1/15 11/1/15 12/1/15 1/1/16 2/1/16 3/1/16 4/1/16 5/1/16 6/16/16 7/16/16 8/1/16 9/1/16 10/1/16 11/1/16 12/1/16 1/1/17 2/1/17 3/1/17 Mean 44% Month of admission

76 Pharmacologically treated infants who received adjunctive medication _ _ % Adjunctive Medications Average UCL Percent Percent with adjunctive medication 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 1/1/14 UCL LCL 2/1/14 3/1/14 4/1/14 5/1/14 6/1/14 7/1/14 8/1/14 9/1/14 10/1/14 Mean 34% 11/1/14 12/1/14 1/1/15 2/1/15 3/1/15 4/1/15 5/1/15 6/1/15 7/1/15 8/1/15 9/1/15 10/1/15 11/1/15 12/1/15 Month of admission Non-Pharm Care Bundle Symptom prioritization Prenatal education Staff QI education 1/1/16 2/1/16 3/1/16 4/1/16 5/1/16 Methadone 6/16/16 7/16/16 8/1/16 9/1/16 ESC Care Tool Cuddlers 10/1/16 11/1/16 12/1/16 Mean 0% 1/1/17 2/1/17 3/1/17

77 Length of hospital stay for all opioid-exposed infants Measure Hospital days UCL Mean 18.4 days Non-Pharm Care Bundle Symptom prioritization Prenatal education _ _ LOS Average UCL and LCL Staff QI Education Methadone ESC Care Tool Cuddler s Mean 10.4 days 10 0 LCL Jan 2014 Feb 2014 March 2014 April 2014 May 2014 June 2014 July 2014 Aug 2014 Sept 2014 Oct 2014 Nov 2014 Dec 2014 Jan 2015 Feb 2015 March 2015 April 2015 May 2015 June 2015 July 2015 Aug 2015 Sept 2015 Oct 2015 Nov 2015 Dec 2015 Jan 2016 Feb 2016 March 2016 April 2016 May 2016 June 2016 July 2016 Aug 2016 Sept 2016 Oct 2016 Nov 2016 Dec 2016 Jan 2017 Feb 2017 March 2017 Month of admission

78 LCL 0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% % Measure Mean 80% Percent Parental Presence Mean 50%

79 New ESC Tool

80 Additional Spread

81 Long-Term Outcomes?

82 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

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

Neonatal Abstinence Syndrome:

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