1. Tennessee Efforts to Prevent Neonatal Abstinence Syndrome Kelly Luskin, MSN, WHNP-BC Division of Family Health and Wellness

2. Objectives What is Neonatal Abstinence Syndrome (NAS)? Briefly review etiology, diagnosis, and treatment (NAS) Describe scope of NAS in TN and US Share TN efforts related to NAS prevention

3. NAS Background Describes withdrawal symptoms in neonates associated with exposure to: Alcohol Barbiturates Benzodiazepines Opioids Caffeine Anti-depressants Etc..

4. NAS Background

5. 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

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

7. 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 Depend on the half-life of the substance(s) used, time last taken by mother, infant metabolism, and gestational age and/or birthweight Not all babies experience NAS

8. 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)

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

10. 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

11. NAS Epidemiology (US) Over the past decade: –4.7-fold increase in maternal opioid use –2.8-fold increase in NAS incidence –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

12. US Prescription Drug Problem Graphic Source: CDC. Vital Signs, November 2011. Prescription Painkiller Overdoses in the US. Available at: http://www.cdc.gov/VitalSigns/pdf/2011-11-vitalsigns.pdf http://www.cdc.gov/VitalSigns/pdf/2011-11-vitalsigns.pdf Rates of prescription painkiller sales, deaths and substance abuse treatment admissions (1999-2010)

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

14. TN’s Prescription Drug Problem In 2011, Tennessee ranked 2 nd 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.

15. Opioid Prescription Rates by County—TN, 2007 Data source: Tennessee Department of Health; Controlled Substance Monitoring Database.

16. Opioid Prescription Rates by County—TN, 2008 Data source: Tennessee Department of Health; Controlled Substance Monitoring Database.

17. Opioid Prescription Rates by County—TN, 2009 Data source: Tennessee Department of Health; Controlled Substance Monitoring Database.

18. Opioid Prescription Rates by County—TN, 2010 Data source: Tennessee Department of Health; Controlled Substance Monitoring Database.

19. Opioid Prescription Rates by County—TN, 2011 Data source: Tennessee Department of Health; Controlled Substance Monitoring Database.

20. TN’s Prescription Drug Problem 51 pills per every Tennessean over age 12 22 pills per every Tennessean over age 12 21 pills per every Tennessean over age 12 275.5 Million Hydrocodone Pills 116.6 Million Xanax Pills 113.5 Million Oxycodone Pills Data source: Tennessee Department of Health; Controlled Substance Monitoring Database.

21. TN’s Prescription Drug Problem Increase in TN deaths due to prescription drug overdose –422 in 2001 –1,062 in 2011 More than deaths from: –Motor vehicle accidents, homicide, or suicide Opioids (methadone, oxycodone, and hydrocodone) are by far the most-abused prescription drugs

22. Risk factor % of All Patients % of Deaths ≥ 4 Prescribers 8.338 ≥ 4 Pharmacies 2.724 High dosage use 1.924 Relative Proportion of Patients With Risk Factors Versus Death

23. Number of Prescribers & Dispensers with Database Access and Actual Number Checking Data

24. Number of Queries by Quarter 2011 – Q2 2013 2011 - 1.5 M searches 2012 - 1.9 M searches 2013 - 1.9 M searches in 6 months

25. Total MME of Opioids 4/1/2012 - 3/31/2013 ̴ 12% decrease

26. Number of Doctor Shoppers in CSMD By Month, Jan 2012--- Mar 2013 ̴ 40% decrease from peak

27. NAS Hospitalizations in TN: 1999-2010 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. Note that these are discharge-level data and not unique patient data.

28. TN NAS Hospitalizations (2010) Data sources: Tennessee Department of Health; Office of Health Statistics; Hospital Discharge Data System (HDDS) and Birth Statistical System. Numerator is number of inpatient hospitalizations with age less than one and any diagnosis of neonatal abstinence syndrome (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. Note that these are discharge-level data and not unique patient data. Denominator is number of live births. For BSS data, county is mother’s county of residence.

29. Data sources: Tennessee Department of Health; Division of Policy, Planning and Assessment; Office of Health Statistics; Hospital Discharge Data System (HDDS) and Birth Statistical System. Analysis included inpatient hospitalizations with age less than 1 and any diagnosis of drug withdrawal syndrome of newborn (ICD-9-CM 779.5). HDDS records contain up to 18 diagnoses. Infants were included if any of these diagnosis fields were coded 779.5. Note that these are discharge-level data and not unique patient data.

30. Data sources: Tennessee Department of Health; Division of Policy, Planning and Assessment; Office of Health Statistics; Hospital Discharge Data System (HDDS). Analysis included inpatient hospitalizations for liveborn delivery (identified using ICD-9-CM codes V270, V272, V273, V275, and V276) among females aged 15-44 years. Maternal substance abuse was defined using ICD-9- CM codes beginning with 304 (drug dependence) and codes beginning with 305.2-305.9 (nondependent drug abuse), which include use of opioids, sedatives, hypnotics, anxiolytics, cocaine, cannabis, amphetamines, and hallucinogens. HDDS records contain up to 18 diagnoses – women were classified as substance abusers if any of these diagnosis fields were coded with one of the above listed diagnoses. Note that these are discharge-level data and not unique patient data.

32. Narcotics and Contraceptive Use: TennCare Women, CY2011 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 Women299,98945,774152.68,40018%37,37482% 15 - 2088,6683,45038.91,66348%1,78752% 21 - 2444,8775,244116.91,75834%3,48666% 25 - 2953,5839,883184.42,36824%7,51576% 30 - 3448,17310,504218.01,50114%9,00386% 35 - 3937,1949,398252.77468%8,65292% 40 - 4427,4947,295265.33645%6,93195% Data source: Division of Health Care Finance and Administration, Bureau of TennCare.

33. TennCare NAS Costs, CY2011 Data source: Division of Health Care Finance and Administration, Bureau of TennCare. 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).

34. TennCare Infants in DCS Custody Within 1 Year of Birth, CY2011 Data source: Division of Health Care Finance and Administration, Bureau of TennCare. This sample contains only children that were directly matched to TennCare’s records based on Social Security Number.

35. NAS Efforts in TN Spring 2012 “Prescription Safety Act” required prescribers to register with Controlled Substances Monitoring Database (CSMD) Growing awareness of increasing NAS incidence among neonatal providers Initial discussions between public health (TN Department of Health) and Medicaid (TennCare)

36. 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

37. NAS Subcabinet Working Group Working principles: Multi-pronged approach Best strategy is primary prevention but clearly must address secondary and tertiary prevention Each department progresses independently, keep group informed of efforts Supportive rather than punitive approach

38. The Levels of Prevention PRIMARY Prevention SECONDARY Prevention TERTIARY Prevention DefinitionAn 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 IntentReduce 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.htmhttp://www.cdc.gov/mmwr/preview/mmwrhtml/00016403.htm

39. NAS—Primary Prevention Prevent addiction from occurring –Letter to FDA encouraging black box warning –Provider education Letter to providers to increase awareness Possibly add to “responsible prescribing” CME –TennCare limitations on opioid availability Requirement for counseling as part of prior authorization Limitations on available quantity

40. Request for Black Box Warning

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

42. NAS—Primary Prevention Prevent pregnancy from occurring –Provider education Counseling by providers at initial prescription Promotion of contraceptives, particularly long- acting reversible contraceptives (LARCs) –Work with non-traditional partners to promote counseling re: addition during pregnancy and contraceptives A&D Pain clinics Drug courts

43. NAS—Secondary Prevention Identify pregnant women who may be opioid addicted –Identify reproductive-aged women via CSMD whose fill patterns suggest risk of dependence –Referral to TennCare managed care organization case management programs –Screen pregnant women for drug use Consent of patient Supportive rather than punitive approach

44. NAS—Tertiary Prevention Minimize complications for women who are addicted (and their neonates) –Can addicted pregnant women be weaned? –What are best strategies for treating NAS infants?

45. 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

46. NAS—Reportable Disease Add NAS to state’s Reportable Disease list –Effective January 1, 2013 Collaborated with state perinatal quality collaborative (TIPQC) to define reporting elements –Align required reporting elements with same data elements reported in hospital QI projects

47. NAS—Reportable Disease Reporting hospitals/providers submit electronic report Reporting Elements –Case Information –Diagnostic Information –Source of Maternal Exposure

48. Drug Dependent Newborns (Neonatal Abstinence Syndrome) Surveillance Summary For the Week of August 4-10, 2013 (Week 32) 1 Source of Maternal Substance (if known) 2 # Cases 2 % Cases Supervised replacement therapy21543.9% Supervised pain therapy10220.8% Therapy for psychiatric or neurological condition408.2% Prescription substance obtained WITHOUT a prescription19339.4% Non-prescription substance13828.2% No known exposure but clinical signs consistent with NAS91.8% No response112.2% Reporting Summary (Year-to-date) Cases Reported: 490 Male: 279 Female: 211 Unique Hospitals Reporting: 47 Maternal County of Residence (By Health Department Region) # Cases % Cases Davidson234.7% East12725.9% Hamilton91.8% Jackson/Madison10.2% Knox5912.0% Mid-Cumberland316.3% North East7214.7% Shelby102.0% South Central183.7% South East71.4% Sullivan5310.8% Upper Cumberland6513.3% West153.1% Total490100% 1. Summary reports are archived weekly at: http://health.tn.gov/MCH/NAS/NAS_Summary_Archive.shtmlhttp://health.tn.gov/MCH/NAS/NAS_Summary_Archive.shtml 2. Multiple maternal substances may be reported; therefore the total number of cases in this table may not match the total number of cases reported.

49. NAS—Reportable Disease Through Week 32 (August 4-10, 2013) –490 cases 279 male, 211 female –47 unique reporting hospitals

50. NAS—Reportable Disease

51. Maternal County of Residence (By HD Region) % Cases Davidson4.7% East25.9% Hamilton1.8% Jackson/Madison0.2% Knox12.0% Mid-Cumberland6.3% North East14.7% Shelby2.0% South Central3.7% South East1.4% Sullivan10.8% Upper Cumberland13.3% West3.1% Total100% 63% of cases in East and Northeast TN 24% of cases in Middle TN and Plateau Sevier County ~5% of cases in TN and 18% of cases in East Region

52. NAS—Reportable Disease Source of Maternal Substance (if known) # Cases* % Cases Supervised replacement therapy21543.9% Supervised pain therapy10220.8% Therapy for psychiatric or neurological condition408.2% Prescription substance obtained WITHOUT a prescription19339.4% Non-prescription substance13828.2% No known exposure but clinical signs consistent with NAS91.8% No response112.2% *Multiple maternal substances may be reported; therefore the total number of cases in this table may not match the total number of cases reported.

53. NAS—Maternal Source of Exposure (Analysis by Exclusive Category as of 8/10/2013) Maternal Source of Exposure State # State % Only substances reported were prescribed 20742.2% Only substances reported were not prescribed (illicit or diverted) 16433.5% Both prescribed and non-prescribed substance(s) reported 9920.2% No substance reported or no known history of substance use 204.1% TOTAL 490100.0

54. NAS—Maternal Source of Exposure (Analysis for East Region—as of August 10, 2013) n = 127n = 490n = 23

55. 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.

56. 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

57. 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

58. 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

59. NAS Resources NAS Main Page –http://health.tn.gov/MCH/NAS/http://health.tn.gov/MCH/NAS/ Weekly Surveillance Summary Archive –http://health.tn.gov/MCH/NAS/NAS_Summary _Archive.shtmlhttp://health.tn.gov/MCH/NAS/NAS_Summary _Archive.shtml

60. Contact Information Michael D. Warren, MD MPH FAAP –Director, Division of Family Health and Wellness –Michael.D.Warren@tn.govMichael.D.Warren@tn.gov Kelly Luskin, MSN, WHNP-BC –Women’s Health Nurse Consultant, Division of Family Health and Wellness –Kelly.Luskin@tn.govKelly.Luskin@tn.gov