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Effect of substance abuse on the mother and the newborn: Experience of WVU Healthcare Collaboration on Substance Abuse in Pregnancy. Panitan (Pete) Yossuck M.D. Associate Professor SOM. Pediatrics: Neonatology. Patrick Marshalek M.D. Assistant Professor SOM. Behavioral Medicine & Psychiatry. Laura Lander MSW, LICSW. Assistant Professor SOM. Behavioral Medicine & Psychiatry. Courtney Sweet PharmD, BCPS. Pharmacy Clinical Specialist, Pharmaceutical Services WVUH Disclosure. • Nothing to disclose. • All drugs (in neonate) discussed are off label. Objectives • To be aware of the WVU Healthcare Collaboration for Substance Abuse in Pregnancy. • To understand the current situation of substance abuse in pregnancy; prevalence, societal cost, drugs of abuse and treatment. • To be familiar with substance abuse and addiction program at WVU Healthcare at Chestnut Ridge Center. • To understand the WVUCH Neonatal Abstinence Syndrome (NAS) QI project and describe the postnatal management of newborn infants with NAS. Effects of Substance Abuse in pregnancy on mother and newborn Patrick Marshalek, MD Laura Lander, MSW, LICSW Prevalence • NSDUH 2009-2010 illicit drug use – Pregnant women age 12-17 – 16.2% – Pregnant women age 18-25 – 7.4% – Pregnant women 26-44 – 1.9% • Stitely, 2010 – 759 samples or chord blood taken – 142 + for drugs or alcohol (19.2%) • Most common THC and opioids • Montgomery, 2008 – Among patients at high risk for substance abuse, 32% of infant cord tissue tested positive for drugs • Over 1 million babies are born every year to mothers who abuse substances • 4,000 in WV • Treatment improves birth outcomes Delivery/Infant Complications • Higher incidence of premature labor – Breathing problems – Feeding problems • Withdrawal – – – – – NAS - opioids Nicotine Cocaine Sedative/Hypnotic Amphetamine Post Delivery issues • • • • • • • • NAS/NOWS Breast feeding Increase risk of relapse Increased risk of dropping out of treatment Post partum depression Pain management Negative family interactions Guilt and Shame The Disease of Addiction • Biological • Dependence, Tolerance, Withdrawal • Psychological • Obsession and Compulsion • Social • Consequences Drugs of Abuse • Classification – Opioids, sedatives, stimulants… • Intoxication/Withdrawal/Tolerance – Use to feel normal • Routes of Administration – Like in medicine • Detection – BAL/UDS Pregnant Women with substance use disorders • • • • • • • • Higher rates of domestic violence High levels of shame and guilt Fear CPS intervention Women with addiction often do not have regular menses so may not realize they are pregnant right away Childcare issues Transportation issues Employment issue/financial limitations At risk for medial complications Treatment • Biological – Medication Assisted Treatment (MAT) • • • • Methadone Buprenorphine Naltrexone Vivitrol – Detoxification Medication Assisted Treatment • Why MAT (Volkow, NEJM, 2014) – Safe – Cost effective – Reduced overdoes rates – Improved retention in treatment – Improved social functioning – Reduced risk of infectious disease transmission – Reduced criminal activity Treatment • Psychological – Individual therapy – Group therapy – Approaches • • • • Supportive Motivational Cognitive Behavioral Therapy Contingency management Treatment • Social – 12 Steps • NA, AA, Al-Anon, others – Self help meetings for patient and family members • Treatment improves outcomes for whole family • Abstinence versus Recovery Levels of Care • Outpatient (COAT) – MAT • COAT/OTP • Intensive Outpatient (AIOP) – Dual diagnosis • Partial Hospitalization (PHP) • Acute Inpatient – Detox needs or safety concerns • Residential Chestnut Ridge Center Model Comprehensive Opioid Addiction Treatment (COAT) Participants must: • • • • understand and sign a written contract attend at least 4 AA or NA meetings per week Attend group therapy participate in random drug screens (occasionally observed) • Patient must actively work the 12 steps WVUCH NICU: Neonatal Opioid Withdrawal Syndrome (NOWS) Panitan (Pete) Yossuck. M.D. Section of Neonatology Pediatrics. School of Medicine The incidence of infants with history of maternal drug exposure admitted to WVUH NICU was significantly increased in 2011. (Nanda S. WVU Medical Journal ; in press 2014) The number of infants with history of in-utero buprenorphine exposure increased from 1 case in 2009 (0.18%), 2 cases in 2010 (0.37%) to 25 cases in 2011(4.5%), while the number of infants exposed to maternal methadone showed no drastic changed (1.5, 1.7 and 2.1% accordingly). (Nanda S. WVU Medical Journal ; in press 2014) The incidence of infants who developed NAS and required pharmacological therapy decreased significantly in 2011 ; only one third of infants had NAS that required pharmacological treatment. (Nanda S. WVU Medical Journal ; in press 2014) (Nanda S. WVU Medical Journal ; in press 2014) Background • Modified Finnegan NAS scoring system has been used without standardization. • No specific guidelines for scoring, diagnosis, treatment for NAS. • Care for infants with NAS was directed discretely based on neonatologist attending on service Clinical Aims • Develop the guideline for management of infants with NAS. • Clinical Parameter after two years of implementation: – Adherence to the guideline – LOS: shorten by 15% while maintain the mean LOS of untreated infant at 3 days – Reduce outliner by 25%( LOS more than 21 days) – Length of Treatment (LOT) VONS DATA: Soll R. 2014 100% 95% 92% 90% 88% 90% 84% 83% 80% 80% 78% 76% 76% 84% 81% 76% 72% 70% 67% 59% 60% 69% 66% 59% 68% 57% 55% 49% 50% 45% Audit 1 Audit 2 Audit 3 40% Audit 4 30% 20% 10% 0% Maternal Screening Evaluation and Treatment Standardization Non Pharmacological Feeding Breast of source pharmacological Treatment Milk Treatment Centers: 181, 170,125, and 119 Audited. 22% Level A, 60% Level B, and 18% Level C. Department of Pediatrics Section of Neonatology VONS DATA: Soll R. 2014 100% 89% 90% 82% 82% 82% 80% 70% Audit 1 60% Audit 2 50% Audit 3 40% Audit 4 30% 27% 24% 24% 20% 22% 16% 15% 16% 11% 10% 7% 10% 9% 9% 4% 3% 4% 0% 0% Morphine Methadone Clonidine Phenobarb DTO Infants: 1050, 991,797, and 620 Audited. Department of Pediatrics Section of Neonatology WVUCH NAS Quality Improvement Project Maternal Exposure Newborn Infants from Maternal Drug Use OB service •Identification •Screening (Antenatal visit, at labor admission) (universal vs risk based screening) •Prenatal education and expectation of neonatal outcome Infant diagnosed with NAS NAS infants required Drug Rx and NICU admission NICU •None PharmRx •NAS Scoring system •Initiation of drug Rx based on NAS score. •Wean and discontinue drug Rx based on NAS score. •Discharge disposition Postpartum nursery team •Identification •Screening: universal vs risk based, methods of screening •Diagnosis: NAS scoring system •Management: NonePharmRx •Identified NAS infant require DrugRx based on NAS score FLOW CHART OB ANC Pregnant Mother Labor ●Universal UDS: research project ●Education ●Referring to BMP Postpartum Service OB Exposed NB infant ●Universal UDS ●Univeresal CTDS ●NAS score (standardized) ●Diagnosis of NAS ●Provided ●NonePharmRx ●Identify PharmRx Candidate based on clinical and NAS score NICU admission NICU ●NAS score (standardized) Continue ●NonePharmRx ●Initiate PharmRx and follow the NAS guideline Department of Pediatrics Section of Neonatology Our RoadNAS Map Quality Improvement Project WVUCH Distribution of work process to committee members. Screening process Scoring process Diagnostic criteria based on the NAS score None pharmacological management Drug of choice Criteria to initiate pharmacological treatment Weaning and discontinue pharmacological treatment based on the NAS score Discharge criteria (both with and without pharmacological treatment WVU Children Hospital Neonatal Abstinence Syndrome Quality Improvement Committee was established. Chaired and leaded by Stephanie Greyson (second year Neofellow), and Courtney B. Sweet (NICU PharmD). July 2012 Aug-Oct 2012 WVUCH NAS guideline were launched and in effect. all the NICU nursing staff have gone to mandatory trained to use standardized NAS scoring system. General pediatric nursing preceptors and PICU nursing preceptor were also trained and become the trainer for their unit. The WVUCH guideline was distributed to all NICU attending, fellow, pediatric house staff, Pediatric and NICU PharmD, hospitalists and PICU attending. Nov –Dec 2012 Jan 2013 All NICU admitted infants had universal MDS. Concern for missing MDS for postpartum normal newborn infants and unable to detect Buprenorphine from MDS were discussed. The option of obtaining universal cord tissue drug screen was discussed with the clinical laboratory department. The OB service agreed with universal cord tissue drug screening. universal MDS for every NICU admission was discussed. Meeting with clinical laboratory department resulted in the universal MDS. Feb 2013 Standardize the NAS scoring process for OB postpartum nursing staffs Collecting and analysis the data over the past year Breast feeding and use of MBM for NAS infant guideline Parent Brochure and education for NAS Non-pharmacological management re-education Universal cord tissue screening was started; Buprenorphine is part of the drug screened but not THC. OB department started “Maternal addiction screening” in antenatal care service and antepartum maternal education. March 2013 April 2013 VONs QI meeting in Chicago: Data Presentation Sep 2013 Oct 2013 July 2014 Department of Pediatrics Section of Neonatology Department of Pediatrics Section of Neonatology Modified Finnegan Score: 1986, CNS, GI, Metabolic. VONS audit: 61% used High Risk Neonate for NAS Obtain Modified Finnegan Scale every 2-4 hr before feed after birth. NAS if score ≥ 8 on two successive evaluations. Non-pharmacological Management NAS score ≥12 on three consecutive occasions, or combine consecutive NAS score of ≥28 OMS at 0.05 mg/kg/dose q 3 hr Dose escalation: If S&S of NAS persist or two consecutive NAS score >10, increase the dose to 0.075, 0.10 and 0.125 mg/kg/dose q 3 hr. Add phenobarb if need OMS more than 0.125 mg/kg/dose q 3 hr Two consecutive NAS score still ≥12, rescue dose of 0.025 mg/kg/dose and increase the dose to 0.075 mg/kg/dose q 3 hr Three days of stabilization and improvement of NAS Weaning: all NAS score <10 for the past 24 hr. Reduce the total dose by 10% of stabilized dose every day. Wean the interval to q 4, q 6 and then q 8 hr every other day as tolerated (but keep the 10% total reduction). Discharge: Total dose must be ≤30% of stabilized dose and the interval must be at least q 8 hr for 24 hr. Primary care provider must be notified and provided with weaning scale. Dose adjustment: Switching from OMS to morphine injection must be discussed with PedsPharmD as necessary Cessation of treatment: Total dose must be ≤10% of stabilized dose. If the cessation occurs in the hospital, the infant must be observed for at least 24 hr after the OMS was discontinued. (WVU Children Hospital Treatment Guideline for Neonate with NAS 2012) NAS (779.5) WVUCH NICU 2012 and 2013 10.00% 9.20% 9.00% 8.10% 8.00% 7.00% 6.00% NAS 779.5 5.00% 4.10% 4.00% 3.90% from MICC 3.00% 2.00% 1.00% 0.00% Total NICU admission 2012 2013 579 621 Department of Pediatrics Section of Neonatology 2012 2013 1336 1405 87 (6.5%) 85 (6.0%) Neonatal Opioid Withdrawal Syndrome (NOWS) 38/87 (43.7%) 57/85 (67.0%) NOWS and NICU admission 24/38 (63.2%) 24/57 (42.1%) MICC admission (n) Opioid exposure (n) code 760.72 Department of Pediatrics Section of Neonatology NOWS infants ≥ 35 wk GA in NICU and treated. 2012 (n=8) 2013 (n=13) P value Length of Stay (LOS) (day ± SD) 18.8 ± 4.9 15.5 ± 5.9 P=0.32 Length of Treatment (LOT) (day ± SD) 22.0 ± 7.5 14.4 ± 6.3 P=0.04 Department of Pediatrics Section of Neonatology 2012 2013 Max dose (mg/kg/day) 0.16-0.80 0.40-0.60 CPS involvement 12/23 (52.3%) 17/24 (70.8%) Discharge home with parents 23/23 (100%) 22/23 (95.6%) CTS 0/24 15/20 (7 bup, 4 methad) UDS 3/24 1/1 (bup) MDS 13/24 2/2 (1 methad) Department of Pediatrics Section of Neonatology CTDS: APRIL 2013 TO MARCH 2014 TOTAL OF 1430 SPECIMENS TESTED. CTDS (April2013 to March2014) 1600 1430 1400 1200 1000 800 CTDS (April2013 to March2014) 600 400 230 283 200 16.1% 19.8% Positive Drug Hit 0 Total Department of Pediatrics Section of Neonatology CTDS: APRIL 2013 TO MARCH 2014 PERCENTAGE OF POSITIVE DRUGS 12 * THC data: from October 2013 to March 2014 9.8 10 8.4 8 Opioids Bup/Metha 6 Sedative Stimulant THC* 4 3.3 2.6 2 1 0 Opioids Bup/Metha Sedative Stimulant THC* Department of Pediatrics Section of Neonatology DRUG CLASS # of POS %POS %ALL Opiates 120 47.5% 6.5% THC* 64 25.2% 3.4% Sedatives/Hypnotics 47 20.9% 2.8% Buprenorphine & Methadone 37 18.0% 2.5% Stimulants 15 2.9% 0.4% 283 Department of Pediatrics Section of Neonatology WVUCH BREAST FEEDING AND USE OF MATERNAL BREAST MILK FOR NAS INFANTS • Absolute Contraindications: – Evidence of active alcohol or drug abuse (illicit or prescriptive). – HIV or HTLV-II positive. – Galactosemia – Maternal medications contraindicated in lactation such as lithium, methotrexate, radioactive or immunosuppressive agent, antimetabolites and IV drugs of abuse. Department of Pediatrics Section of Neonatology WVUCH BREAST FEEDING AND USE OF MATERNAL BREAST MILK FOR NAS INFANTS • Absolute Contraindications: – For mothers with a history of substance abuse or those receiving treatment in an opioid maintenance program and: • Refusal of consent to speak with prescribing physician or treatment facility. • Relapse with illicit drugs 30 days before delivery. • No plans to follow in substance abuse treatment program. • Relapse of drug use after delivery. • Sobriety achieved and maintained only in inpatient setting. Department of Pediatrics Section of Neonatology WVUCH BREAST FEEDING AND USE OF MATERNAL BREAST MILK FOR NAS INFANTS • Relative Contraindications: – Perinatal providers, substance abuse providers, physicians, lactation consultants, NNP’s and nurses will work collaboratively to individually assess risks / benefits of breastfeeding in the following mothers: • No, limited or late prenatal care. • Women in treatment program, but relapsing 30 to 90 days prior to delivery. • THC: Any patient with a positive screen for THC needs to receive counseling. During discussion providers should determine if use is acute, recreational, or chronic. Mothers should be encouraged to discontinue ALL use if she desires to breast feed. This discussion should be documented in baby’s chart. • All maternal medications will be reviewed for lactation compatibility delivery. • Untreated, symptomatic psychiatric issues or non-compliance of treatment. Department of Pediatrics Section of Neonatology Department of Pediatrics Section of Neonatology Department of Pediatrics Section of Neonatology NON-PHARMACOLOGICAL TREATMENT GUIDELINES FOR NAS WVU CHILDREN HOSPITAL – Swaddle, Cuddle, Kangaroo care – High caloric content formula (24 cal/oz) and frequent feeding. – Feeding on demand: q 2-4 hr. – Consider reduce the caloric content back to regular formula (20 cal/oz) when infant consumes volume more than 160 ml/kg/day. – Place in a quiet, reduce stimulus environment etc. – Consider using Infant Motion Soothing Machine. – Consider early application of cream/paste to prevent perianal skin breakdown. Department of Pediatrics Section of Neonatology NAS NON-PHARMACOLOGICAL NURSING TOOL KIT Department of Pediatrics Section of Neonatology THE 5 S’S OF SOOTHING: HOW TO RAPIDLY CALM YOUR FRANTIC BABY • Swaddling • Side/stomach position • Shushing sounds • Swinging • Sucking Department of Pediatrics Section of Neonatology OTHER NURSING INTERVENTIONS FOR NON-PHARMACOLOGIC TREATMENT OF NAS INFANTS • Encourage Family to stay & Participate in cares; holding/cuddling, feeding, settling/console, changing diaper (promote bonding) – The parent is the best constant care giver: The more the parent is here the better he/she will do – Teach them the 6 basic principles and 5 S’s • Cluster Care • Gently Rocking • Swaddling tight & proper – Swaddle with hands up or hands at side Department of Pediatrics Section of Neonatology OTHER NURSING INTERVENTIONS FOR NONPHARMACOLOGIC TREATMENT OF NAS INFANTS • Hold close to body • Decrease noise and lights • Speak softly & remind those visiting and around to use quiet voices • Protect from scratching/rubbing- use mittens or socks • Patting buttocks/back gently & rhythmically Department of Pediatrics Section of Neonatology OTHER NURSING INTERVENTIONS FOR NONPHARMACOLOGIC TREATMENT OF NAS INFANTS • Frequent Diaper changes • Discuss with physician/NNP possibility of ordering aquaphor prior to breakdown • Feed as ordered • Support/Encourage Breast feeding • Encourage kangaroo care • Infant Massage Department of Pediatrics Section of Neonatology OTHER NURSING INTERVENTIONS FOR NONPHARMACOLOGIC TREATMENT OF NAS INFANTS • Use of relaxation techniques • Use of Boppy, infant chair or Mamaroo • Pacifier/ Wubbanub • Soft linens to help reduce with excoriation • Soft gentle touch • Utilize ancillary staff (CA's, PT, OT, cuddlers) Department of Pediatrics Section of Neonatology Standardized Pharmacologic Treatment of NAS: A Year in Review Courtney Sweet, PharmD, BCPS Baseline Data • Timeframe: January 2009- December 2011 • All infants admitted to WVU Children’s Hospital with an ICD-9 of 760.7x (Noxious influences affecting fetus or newborn via placenta or breast milk) or 779.5 (Drug withdrawal syndrome in newborns) 358 infants in total • 129 patient born at less than 37 weeks gestation • 155 patients born at 37 weeks or more and did not receive morphine or methadone • 61 patients born at 37 weeks or more and received morphine or methadone • 13 term infants excluded due to congenital heart of GI anomaly Baseline Data- Treated • 39% (61/ 216) of term infants received pharmacologic therapy • 60 infants received morphine (98%) • 2 infants received methadone (3.3%) • Mean length of stay= 22 days (SD 10.7) • Median length of stay= 20 days (Range 5-61 days) • 46 % of treated infants required a LOS greater than 21 days • 5% of treated infants received any breast milk 24 hours prior to discharge Timeline • July 2012 NAS Committee’s 1st Meeting • December 2012 NICU Nurses completed training on Finnegans scoring tool • January 1st 2013 Treatment algorithm Go-Live January 1st 2013 • February 2013 MICC Nurses completed training on Finnegans scoring tool • June 2014 Parent education pamphlet distribution began • September 2014 Initiation of nursing education related to non-pharmacologic care January 2013-June 2014 1.5 YEARS AND COUNTING Demographics • Discharge Timeframe: January 2013- June 2014 • All infants coded with 760.7x or 779.5 • 74 patients were treated with a pharmacologic agent • 63 patients born at 37 weeks or more and received morphine or methadone Treated Infants • All 63 patients (100%) received morphine therapy For 37 term, treated infants: • Mean length of stay= 18 days (SD 5.3) • Reduced 4 days from baseline • Median length of stay= 18 days (Range 8-36 days) • Reduced 2 days from baseline • 2nd Quarter 2014 the median was 16 days • 30% of treated infants required LOS greater than 21 days • 14% of infants received breast milk 24 hours prior to discharge All patients (74 patients) ALGORITHM RESULTS Medication Use • 100% of infants received morphine • 84% (62 patients) received a stabilization dose of 0.05 mg/kg every 3 hours • 11% (8 patients) received 0.075 mg/kg every 3 hours • 5% (4 patients) received 0.1 mg/kg every 3 hours • None received 0.125 mg/kg every 3 hours • Average time stabilization dose utilized= 2.4 days • 8 patients weaned one day after stabilization dose Medication Use • Average number of weaning steps required= 8.4 • (Min=2; Max= 17) • 79% of infants discharged into the care of their parent(s) • 35% of infants were discharged on morphine therapy • 2 infant received phenobarbital 15 months (1st Quarter 2013-1st Quarter 2014) 49 patients COMPLIANCE Compliance • Morphine initiated for 3 consecutive scores greater than 12 • 46 patients started after admission • 78% met criteria to initiate morphine at time of initiation • Morphine initiated at 0.05 mg/kg/dose every 3 hours • 89% received appropriate initial dose • 75% effectively stabilized on this dose • Morphine increased for scores greater than 10 • 9 patients (18%) were not increased for elevated scores • Stabilization dose utilized for 3 days- 60% of patients • 84% utilized for 2-3 days Compliance Compliance with Treatment Algorithm Percentage 90 80 70 60 Goal 50 40 30 20 10 0 1st Q 14 4th Q 13 3rd Q 13 2nd Q 13 1st Q 13 Compliance • Addition of phenobarbital • 2 patients – not compliant • 100% discharged at 30% of stabilization dose Avg. Duration Between Weans 2 p= 0.004 1.5 Compliant Weans 1 Non-Compliant 0.5 0 Days Outliers? • 10 patients required LOS > 21 days • Using Fisher’s exact and t-test comparing these patients to patients with a LOS < 21 days Characteristic ≤ 21 days > 21 days (N= 27) (N= 10) p-value Outborn 15 6 P= 1.0 Parental custody 24 8 p= 0.59 Use of breast milk 24 hours prior to d/c 6 0 p= 0.16 Medication at discharge 12 1 p= 0.065 Not increased with elevated scores 3 5 p= 0.02 Length of Stay For term, treated infants (63 infants) • 71% of infants were discharged in 21 days or less • Of note: 78% were discharged in 22 days or less Length of Stay Days 35 30 25 20 15 10 5 0 2nd Q 14 1st Q 14 4th Q 13 3rd Q 13 2nd Q 13 1st Q 13 4th Q 11 3rd Q 11 2nd Q 11 1st Q 11 4th Q 10 3rd Q 10 2nd Q 10 1st Q 10 4th Q 09 3rd Q 09 2nd Q09 1st Q 09 What the Data Showed… • Initiate therapy for elevated scores (> 12); soothe for fussiness • Increase dose for elevated scores (consistently > 10) • Utilize stabilization dose for 3 days • If excessive sleepiness occurs, consider weaning by 20% and document • Wean according to guideline 10% and alternate between dose and interval changes What We Have Learned… • Standardization of practice has led to a more consistent treatment of infants with NAS • Length of stay and duration of therapy have been reduced • Future directions • Formal education for all nursing staff related to nonpharmacologic care • Focus on parent education and involvement in nonpharmacologic care