Michael D. Warren, MD MPH FAAP Division of Family Health and Wellness Neonatal Abstinence Syndrome: Tennessee’s Epidemic and the State’s Response Michael D. Warren, MD MPH FAAP Division of Family Health and Wellness

Objectives Define the etiology, diagnosis, and management of Neonatal Abstinence Syndrome (NAS) Outline the scope of NAS in Tennessee Describe Tennessee interventions to reduce the burden of NAS

NAS Epidemiology, Diagnosis, and Treatment

Prenatal Drug Exposure Apparently “normal” Neonatal Abstinence Syndrome (NAS) Fetal Alcohol Syndrome Neurological abnormalities Prematurity Low birth weight Etc Infant with recognizable syndrome or signs “Drug Exposed” Tobacco Illicit Drugs Prescription Drugs Alcohol Etc… Pregnant women who use potentially harmful substances All pregnant women

Prenatal Drug Exposure All babies with neonatal abstinence syndrome are drug-exposed infants* *Almost always prenatal Not all drug-exposed infants will develop Neonatal Abstinence Syndrome All drug-exposed infants are potentially at risk for adverse outcomes

Prenatal Drug Exposure Withdrawal symptoms in neonates can be associated with exposure to: Alcohol Barbiturates Benzodiazepines Opioids Caffeine Anti-depressants Etc..

NAS Background

NAS Background NAS can be associated with: Prescription drugs obtained with prescription Includes women on pain therapy or replacement therapy Prescription drugs obtained without prescription Illicit drugs

NAS Background Opioid withdrawal symptoms primarily related to: Central Nervous System: Seizures • Hyperactivity Tremors Gastrointestinal System: Poor feeding • Vomiting Poor weight gain • Diarrhea Uncoordinated sucking

NAS Background Opioid withdrawal symptoms: May appear as early as within the first 24 hours May take as many as 4-5 days to appear Occur in 55-94% of exposed infants

NAS Identification NAS is a clinical diagnosis NAS diagnosis based on: History of exposure Evidence of exposure: Maternal drug screen Infant urine, meconium, hair, or umbilical samples Clinical signs of withdrawal (symptom rating scale)

NAS Treatment Initial treatment: Pharmacologic therapy may be needed Minimize environmental Stimuli Respond early to signals Support adequate growth Pharmacologic therapy may be needed

Prenatal Drug Exposure Outcomes Babies with prenatal drug exposure are more likely to: Be delivered by cesarean (OR 1.5-1.9) Be born pre-term (OR 3.7-4.6) Be born at low birth weight (OR 4.1-5.2) Have feeding problems (OR 8.2-10.3) Have respiratory distress syndrome (OR 3.4-5.3) Creanga AA, et al. Maternal drug use and its effect on neonates—a population-based study in Washington state. Obstetrics and Gynecology. 2012. 119(5): 924-33.

Prenatal Opioid Exposure Outcomes National Birth Defects Prevention Study (1997-2005) Increased risk of: Spina bifida (OR 1.3-3.2) Gastroschisis (OR 1.1-2.9) Any heart defect (OR 1.1-1.7) AVSD (OR 1.2-4.8) Tetralogy of Fallot (OR 1.1-2.8) VSD (OR 1.1-6.3) Hypoplastic Left Heart Syndrome (OR 1.4-4.1) RVOT defects (OR 1.1-2.3) Pulmonary valve stenosis (OR 1.2-2.6) Broussard CS, Rasmussen SA, Reefhuis J, et al. Maternal treatment with opioid analgesics and risk for birth defects. Am J Obstet Gynecol. 2011;204:314.e1-11.

NAS Outcomes No definitive long-term syndrome associated with neonatal opioid withdrawal Limited studies show: Mixed outcomes of developmental assessment scores (hyperactivity, short attention span, memory and perceptual problems) Resolution of seizures Confounding by social/environmental variables

Scope of NAS in TN & US

NAS Epidemiology (US) Over the past decade: 2.8-fold increase in NAS incidence 4.7-fold increase in maternal opioid use Increase in hospital costs $39,400$53,400 78% charges to state Medicaid programs Source: Patrick SW et al. Neonatal Abstinence Syndrome and Associated Health Care Expenditures, United States, 2000-2009. Journal of the American Medical Association. 2012;307(18):1934-1940

NAS Hospitalizations in TN: 1999-2012 Data sources: Tennessee Department of Health; Office of Health Statistics; Hospital Discharge Data System (HDDS) and Birth Statistical System. Analysis includes inpatient hospitalizations with age less than 1 and any diagnosis of drug withdrawal syndrome of newborn (ICD-9-CM 779.5). HDDS records may contain up to 18 diagnoses. Infants were included if any of these diagnosis fields were coded 779.5.

NAS Unique Patients in TN: 2008-2012 Data sources: Tennessee Department of Health; Office of Health Statistics; Hospital Discharge Data System (HDDS) and Birth Statistical System. Analysis includes inpatient hospitalizations with age less than 1 and any diagnosis of drug withdrawal syndrome of newborn (ICD-9-CM 779.5). HDDS records may contain up to 18 diagnoses. Infants were included if any of these diagnosis fields were coded 779.5.

TN’s Prescription Drug Problem In 2011, Tennessee ranked 49th highest in the country for the number of prescriptions filled per capita 17.6 prescriptions filled per person National average: 12.1 Kentucky and West Virginia tied for highest (19.3 prescriptions per person) Data source: Henry J. Kaiser Family Foundation. Retail Prescription Drugs Filled at Pharmacies (Annual Per Capita), 2011.

TN’s Prescription Drug Problem Prescription Painkillers Sold By State, 2010 TN: 2nd highest in country for kilograms of prescription painkillers sold per 10,000 people Data source: CDC, Policy Impact Brief: Prescription Painkiller Overdoses. Available at: http://www.cdc.gov/homeandrecreationalsafety/rxbrief/

Opioid Prescription Rates by County—TN, 2007-2011 2008 2009 2010 2011 Data source: Tennessee Department of Health; Controlled Substance Monitoring Database.

TN’s Prescription Drug Problem 51 pills per every Tennessean over age 12 275.5 Million Hydrocodone Pills 22 pills per every Tennessean over age 12 116.6 Million Xanax Pills The top three most prescribed controlled substances in Tennessee in 2010 were: 275.5 million pills of hydrocodone (e.g., Lortab, Lorcet, Vicodin) 51 pills per every Tennessean over age of 12 116.6 million pills prescribed for alprazolam (e.g., Xanax: used to treat anxiety) 22 pills per every Tennessean over age of 12 113.5 million pills prescribed for oxycodone (e.g., OxyContin, Roxicodone) 21 pills for every Tennessean over age of 12 21 pills per every Tennessean over age 12 113.5 Million Oxycodone Pills Data source: Tennessee Department of Health; Controlled Substance Monitoring Database.

TN’s Prescription Drug Problem Increase in TN deaths due to prescription drug overdose 422 in 2001 1,093 in 2012 More than deaths from: Motor vehicle accidents, homicide, or suicide Opioids (methadone, oxycodone, and hydrocodone) are by far the most-abused prescription drugs

NAS Hospitalizations by County—TN, 2010-2012 2011 2012

Narcotics and Contraceptive Use: TennCare Women, CY2012* Demographics TennCare Women Women Prescribed Narcotics (>30 days supplied) Narcotic Users Rate per 1,000 Women Prescribed Contraceptives and Narcotics % of Women on Narcotics and Contraceptives Women Prescribed Narcotics without Contraceptives % of Women on Narcotics Not on Contraceptives All Women 296,687 42,082 141.8 7.538 18% 34,544 82% 15 - 20 84,398 2,054 24.3 987 48% 1,067 52% 21 - 24 44,620 3,897 87.3 1,432 37% 2,465 63% 25 - 29 53,333 8,689 162.9 2,199 25% 6,490 75% 30 - 34 48,912 10,442 213.5 1,699 16% 8,743 84% 35 - 39 37,483 9,319 248.6 805 9% 8,514 91% 40 - 44 27,940 7,681 274.9 416 5% 7,265 95% Data source: Division of Health Care Finance and Administration, Bureau of TennCare. *CY2012 data is provisional.

Unintended Pregnancy Among All Women & Opioid Abusers Data source: For general population: Tennessee Department of Health. Pregnancy Risk Assessment Monitoring System, 2009 Summary Report. Available at: http://hit.state.tn.us/Reports/HealthResearch/PregancyRisk2009.pdf . For opioid-abusing women: Heil SH et al. Unintended pregnancy in opioid-abusing women. Journal of Substance Abuse Treatment. 2011. March; 40(2): 199-202.

Unintended Pregnancy Among All Women & Opioid Abusers In TN, women with unintended pregnancy: More likely to have no preconception counseling (77.7% vs. 55.4%) More likely to have short interpregnancy interval (45.0% vs. 15.6%) More likely to have late or no prenatal care (28.1% vs. 10.9%) More likely to not take folic acid daily (82.6% vs. 64.7%) National sample of opioid-abusing women Women with unintended pregnancy 60% more likely to have used cocaine within past 30 days compared to women with intended pregnancy Data source: For Tennessee: Tennessee Department of Health. Pregnancy Risk Assessment Monitoring System, 2009 Summary Report. Available at: http://hit.state.tn.us/Reports/HealthResearch/PregancyRisk2009.pdf . For opioid-abusing women: Heil SH et al. Unintended pregnancy in opioid-abusing women. Journal of Substance Abuse Treatment. 2011. March; 40(2): 199-202.

TennCare NAS Costs, CY2012* Metric TennCare Paid Live Births1 TennCare non-LBWT Births TennCare Live LBWT Births2 NAS Infants Number of Births 42,171 37,576 4,595 736 Cost for Infant in first year of life $352,516,166 $177,959,049 $174,557,118 $45,870,410 Average Cost per child $8,359 $4,736 $37,988 $62,324 Average length of stay (days) 3.5 2.0 15.8 26.2 Data source: Division of Health Care Finance and Administration, Bureau of TennCare. *CY2012 data is provisional. 1. This sample contains only children that were directly matched to TennCare’s records based on Social Security Number. 2 . Any infant weighing under 2,500g at the time of birth was considered low birth weight (LBWT).

TennCare Infants in DCS Custody Within 1 Year of Birth, CY2012* Infants born in CY 2012 NAS infants Total # of Infants 54,984 736 Total # infants in DCS 906 179 % in DCS 1.6% 24.3% Data source: Division of Health Care Finance and Administration, Bureau of TennCare. *CY2012 data are provisional. This sample contains only children that were directly matched to TennCare’s records based on Social Security Number.

TN Efforts to Prevent NAS

NAS Subcabinet Working Group Convened in late Spring 2012 Committed to meeting every 3-4 weeks Cabinet-level representation from Departments: Public Health (TDH) Children’s Services (DCS) Human Services (DHS) Mental Health and Substance Abuse Services (DMHSAS) Medicaid (TennCare) Children’s Cabinet

The Levels of Prevention PRIMARY Prevention SECONDARY Prevention TERTIARY Prevention Definition An intervention implemented before there is evidence of a disease or injury An intervention implemented after a disease has begun, but before it is symptomatic. An intervention implemented after a disease or injury is established Intent Reduce or eliminate causative risk factors (risk reduction) Early identification (through screening) and treatment Prevent sequelae (stop bad things from getting worse) NAS Example Prevent addiction from occurring Prevent pregnancy Screen pregnant women for substance use during prenatal visits and refer for treatment Treat addicted women Treat babies with NAS Adapted from: Centers for Disease Control and Prevention. A Framework for Assessing the Effectiveness of Disease and Injury Prevention. MMWR. 1992; 41(RR-3); 001. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/00016403.htm

Request for Black Box Warning

TennCare Prior Authorization Form Form available at: https://tnm.providerportal.sxc.com/rxclaim/TNM/TC%20PA%20Request%20Form%20(Long%20Acting%20Narcotics).pdf

Controlled Substance Monitoring Database Prescription Safety Act of 2012 TCA 53-10-300 Required prescribers to register “Shall check” provision CSMD Successes: 4.5M searches (240% increase from 2012) 50% decrease in doctor shopping Change in provider behavior: 71% have changed tx plan after viewing CSMD report 73% more likely to discuss substance abuse issues or concerns with a patient Report available at: http://health.tn.gov/statistics/Legislative_Reports_PDF/CSMD_AnnualReport_2014.pdf

Additional Legislative Actions Safe Harbor Act (TCA 33-10-104, 2013) Pregnant women get priority for treatment Child cannot be removed solely due to maternal substance use if treatment initiated by 20 weeks gestation HB1427/SB1631 (2014) Authorizes licensed practitioners to prescribe opioid antagonist to person at risk of overdose (or family member, friend or other person in position to assist) Immunity for prescribers and for people who administer antagonist

Additional Legislative Actions Public Chapter 820 (2014) Mother can be prosecuted for misdemeanor if mother illegally uses narcotic drug and child born “addicted or harmed” Addiction recovery program is affirmative defense Two year sunset

Drug Drop-Off/Take Back TDH partnered with Department of Environment & Conservation to place 92 drop-off boxes across Tennessee Funded in part with CDC Core Violence and Injury Grant funds (TDH) Local “Take Back Days” 23 locations in 2013 Department of Mental Health and Substance Abuse Services Partnership w/ county substance abuse coalitions

SBIRT Pilot Screening, Brief Intervention, and Referral to Treatment (SBIRT) Partnership with Department of Mental Health and Substance Abuse Services SAMHSA Center for Substance Abuse Treatment, State SBIRT Grant Putnam County HD Pilot Family Planning and Primary Care patients Partnership with local mental health provider to facilitate referrals Billable through TennCare

Collaborative Research Projects 5 grants awarded to collaborative research partnerships Address key NAS research questions Answerable: With TN data and expertise Within one year Funded with MCH Block Grant funds and Medicaid Infant Mortality/Women’s Health grant

Funded Research Proposals Development of a predictive model for NAS Vanderbilt, with collaboration of East TN Children’s Hospital, TDH, and United Healthcare Barriers to contraception in women attending substance abuse programs Knox County Health Dept., with collaboration of UT Dept. of Public Health, Knoxville MIST program Optimal management of the pregnant woman taking opioids Cherokee Health Systems, with collaboration of UT Dept. of Public Health, and the High Risk Obstetrical Consultants Group in Knoxville

Funded Research Proposals Understanding and improving provider knowledge and behavior ETSU, with collaboration of the Appalachian Research Network Understanding optimal management of the infant with NAS Vanderbilt, with collaboration of East TN Children’s Hospital

Additional Activities Knox County Health Department and East TN Regional Health Office Partnership with methadone clinics—provide Depo-Provera and referral to Family Planning Clinic for long-acting reversible contraceptive East TN Regional Health Office Primary Prevention Initiative (PPI) Project Partnership with jails in Sevier and Cocke counties Voluntary provision of long-acting reversible contraceptives to female inmates of childbearing age 19 women have received LARCs thus far

Additional Activities TDH: Pilot w/ Families Free (Johnson City) Recovery support and wraparound services for mothers delivering NAS infants Funded with mix of MCH Block Grant and Medicaid Infant Mortality/Women’s Health grant DCS: Hospital Liaison (Connie Gardner) Coordinate efforts between hospital and regional DCS staff TIPQC: Reducing NAS Length of Stay Perinatal Quality Collaborative Kickoff in February 2013 with 15 hospitals

NAS—Reportable Disease Previous estimates of NAS incidence came from: Hospital discharge data (all payers but ~18 month lag) Medicaid claims data (only ~9 month lag but only includes Medicaid) Need more real-time estimation of incidence in order to drive policy and program efforts

NAS—Reportable Disease Add NAS to state’s Reportable Disease list Effective January 1, 2013 Reporting hospitals/providers submit electronic report Reporting Elements Case Information Diagnostic Information Source of Maternal Exposure

Drug Dependent Newborns (Neonatal Abstinence Syndrome) Surveillance Summary For the Week of October 5 – October 11, 20141 Reporting Summary (Year-to-date) Cases Reported: 747 Male: 400 Female: 347 Unique Hospitals Reporting: 49 Maternal County of Residence (By Health Department Region) # Cases % Cases2 Davidson 39 5.22 East 211 28.25 Hamilton 11 1.47 Jackson/Madison 2 0.27 Knox 80 10.71 Mid-Cumberland 66 8.84 North East 103 13.79 Shelby 29 3.88 South Central 26 3.48 South East 18 2.41 Sullivan 55 7.36 Upper Cumberland 85 11.38 West 22 2.95 Total 747 100.0 Source of Maternal Substance (if known)2 # Cases3 % Cases Supervised replacement therapy 394 52.7 Supervised pain therapy 103 13.8 Therapy for psychiatric or neurological condition 49 6.6 Prescription substance obtained WITHOUT a prescription 303 40.6 Non-prescription substance 162 21.7 No known exposure but clinical signs consistent with NAS 2 0.3 No response 14 1.9 1. Summary reports are archived weekly at: http://health.tn.gov/MCH/NAS/NAS_Summary_Archive.shtml 2. Total percentage may not equal 100.0% due to rounding. 3. Multiple maternal substances may be reported; therefore the total number of cases in this table may not match the total number of cases reported.

Source of Exposure 2013 NAS Surveillance Mutually Exclusive Sources of Exposure Source Cases Percent, % Prescription Drugs Only 384 41.7 Illicit/Diverted Drugs Only 305 33.2 Prescription and Illicit Drugs 199 21.6 Unknown 32 3.5 *Percentages may not equal 100% as women may be exposed to drugs from more than one class

NAS Incidence by Region, 2013 Maternal County of Residence (By HD Region) # Cases % Cases Davidson 35 3.8% East 268 29.1% Hamilton 17 1.8% Jackson/Madison 2 0.2% Knox 102 11.1% Mid-Cumberland 58 6.3% North East 138 15.0% Shelby 24 2.6% South Central 29 3.1% South East 12 1.3% Sullivan 86 9.3% Upper Cumberland 117 12.7% West 33 3.6% Total 921 100% 65% of cases in East and Northeast TN 23% of cases in Middle TN and Plateau

NAS Rate by Region, 2013

NAS Reported Cases Exposure Sources (2013) Substance exposure unknown 3.5% Only substances prescribed to mother 41.7% Mix of prescribed and non-prescribed substances 21.6% Only illicit or diverted substances 33.2%

NAS Reported Cases Exposure Sources (2013) by Region *The distribution of exposure source is statistically significant by region; P<0.0001.

NAS—Reportable Disease Important caveat: Reporting is for surveillance purposes only. Does not constitute a referral to any agency other than the Tennessee Department of Health. Does not replace requirement to report suspected abuse/neglect.

NAS—What Can You Do? Connect family with: Primary care medical home TennCare or other insurance TN Early Intervention Services (TEIS) Help Us Grow Successfully (HUGS) Children’s Special Services (CSS) Family Planning WIC

NAS—What Can You Do? Promote long-acting reversible contraceptives (LARCs) Intrauterine devices Subdermal implant Collaborate with local prescription drug “drop-off” efforts For prescribers: Register for and use CSMD

NAS—What Can You Do? Decide whether referral to Department of Children’s Services is appropriate State law requires all persons to make a report when they suspect abuse, neglect or exploitation of children

NAS Resources NAS Main Page Weekly Surveillance Summary Archive http://health.tn.gov/MCH/NAS/ Weekly Surveillance Summary Archive http://health.tn.gov/MCH/NAS/NAS_Summary_Archive.shtml

Contact Information Michael D. Warren, MD MPH FAAP Director, Division of Family Health and Wellness Michael.d.warren@tn.gov