Michael D. Warren, MD MPH FAAP Division of Family Health and Wellness
Tiny Victims of a Massive Problem: Neonatal Abstinence Syndrome and Tennessees Prescription Drug Epidemic Michael D. Warren, MD MPH FAAP Division of Family Health and Wellness Sheri Smith, RN Nursing Director, Critical Care Services Disclosures We have no relevant financial disclosures.
We will not be discussing any unapproved or off-label uses of therapeutic agents of products. Objectives Review signs, symptoms, and treatment related to Neonatal Abstinence Syndrome. Describe the scope of the NAS epidemic and the larger prescription drug problem in Tennessee. Identify state-level initiatives to prevent NAS. Discuss collaboration between state and community partners on this topic. Neonatal Abstinence Syndrome: Signs, Symptoms, and Treatment NAS Background Describes withdrawal symptoms in neonates 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 NAS Outcomes Prenatal drug exposure associated with increased risks:
Cesarean delivery (OR ) Pre-term birth (OR ) Low birth weight (OR ) Feeding problems (OR ) Respiratory distress syndrome (OR ) Prenatal opioid use associated with increased risk of: Spina bifida (OR ) Gastroschisis (OR ) Any heart defect (OR ) Creanga AA, et al.Maternal drug use and its effect on neonatesa population-based study in Washington state.Obstetrics and Gynecology (5): 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 Neonatal Abstinence Syndrome: Scope of the Problem in US & TN 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, Journal of the American Medical Association. 2012;307(18): NAS Hospitalizations in TN: 1999-2011
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 Note that these are discharge-level data and not unique patient data. 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 Note that these are discharge-level data and not unique patient data.Denominator is number of live births.For BSS data, county is mothers county of residence. TNs 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. TNs 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: Opioid Prescription Rates by CountyTN, 2007-2011
2008 2009 2010 2011 Data source: Tennessee Department of Health; Controlled Substance Monitoring Database. TNs 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 TNs 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. US Prescription Drug Problem
Rates of prescription painkiller sales, deaths and substance abuse treatment admissions ( ) Graphic Source:CDC. Vital Signs, November Prescription Painkiller Overdoses in the US.Available at: US Prescription Drug Problem
Graphic Source:CDC. QuickStats: Number of Deaths From Poisoning, Drug Poisoning, and Drug Poisoning Involving Opioid AnalgesicsUnited States, 1999 Available at: Narcotics and Contraceptive Use: TennCare Women, CY2012*
Demographics TennCare Women Women PrescribedNarcotics (>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% 84,398 2,054 24.3 987 48% 1,067 52% 44,620 3,897 87.3 1,432 37% 2,465 63% 53,333 8,689 162.9 2,199 25% 6,490 75% 48,912 10,442 213.5 1,699 16% 8,743 84% 37,483 9,319 248.6 805 9% 8,514 91% 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:.For opioid-abusing women:Heil SH et al.Unintended pregnancy in opioid-abusing women.Journal of Substance Abuse Treatment March; 40(2): 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 TennCares 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 TennCares records based on Social Security Number. Neonatal Abstinence Syndrome: State-Level Efforts NAS Subcabinet Working Group
Convened in late Spring 2012 Committed to meeting every 3-4 weeks Cabinet-level representation from Departments: Public Health (TDH) Childrens Services (DCS) Human Services (DHS) Mental Health and Substance Abuse Services (DMHSAS) Medicaid (TennCare) Childrens Cabinet The Levels of Prevention
PRIMARY Prevention SECONDARY Prevention TERTIARY Prevention Definition An intervention implemented before there isevidence of a disease or injury An intervention implemented after a disease has begun, but before it is symptomatic. An intervention implemented after a diseaseor 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 ; 41(RR-3); Available at: TennCare Prior Authorization Form
Form available at: https://tnm.providerportal.sxc.com/rxclaim/TNM/TC%20PA%20Request%20Form%20(Long%20Acting%20Narcotics).pdf NASReportable 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 NASReportable Disease
Add NAS to states 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 Drug Dependent Newborns (Neonatal Abstinence Syndrome) Surveillance Summary For the Week of November 10-November 16, 2013 (Week 46)1 Reporting Summary (Year-to-date) Cases Reported:752 Male:441 Female:311 Unique Hospitals Reporting:50 Maternal County of Residence (By Health Department Region) # Cases % Cases Davidson 33 4.4% East 204 27.1% Hamilton 13 1.7% Jackson/Madison 2 0.3% Knox 86 11.4% Mid-Cumberland 49 6.5% North East 116 15.4% Shelby 15 2.0% South Central 23 3.1% South East 11 1.5% Sullivan 79 10.5% Upper Cumberland 98 13.0% West Total 752 100% Source of Maternal Substance (if known)2 # Cases2 % Cases Supervised replacement therapy 344 45.7% Supervised pain therapy 147 19.5% Therapy for psychiatric or neurological condition 58 7.7% Prescription substance obtained WITHOUT a prescription 294 39.1% Non-prescription substance 214 28.5% No known exposure but clinical signs consistent with NAS 11 1.5% No response 19 2.5% 1.Summary reports are archived weekly at: 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. NASReportable Disease
Maternal County of Residence (By HD Region) # Cases % Cases Davidson 33 4.4% East 204 27.1% Hamilton 13 1.7% Jackson/Madison 2 0.3% Knox 86 11.4% Mid-Cumberland 49 6.5% North East 116 15.4% Shelby 15 2.0% South Central 23 3.1% South East 11 1.5% Sullivan 79 10.5% Upper Cumberland 98 13.0% West Total 752 100% 64% of cases in East and Northeast TN 24% of cases in Middle TN and Plateau NASReportable Disease
Only substances prescribed to mother 41.7% Substance exposure unknown 4.0% Only illicit or diverted substances 33.4% Mix of prescribed and non-prescribed substances 20.9% Data source:Tennessee Department of Health, Neonatal Abstinence Syndrome Reporting Data.Data through 10/26/2013. NASReportable 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. Controlled Substance Monitoring Database
Established in 2006 Monitor prescribing of controlled substancesdrugs illegal to use except with prescription Drug Enforcement Agency (DEA) Schedule IIV Provider participation was previously voluntary Controlled Substance Monitoring Database
Prescription Safety Act of 2012 All prescribers required to register by 1/1/13 Starting 4/1/2013, prescribers required to check the database before prescribing any opioid or benzodiazepine as a new course of treatment and at least annually when said controlled substance remains part of the treatment Dispensers must report at least every 7 days to CSMD Controlled Substance Monitoring Database
Provider Opioid Prescription Tennessee Pharmacy I will now walk you through the algorithm of how data gets into the TNCSMP. A provider writes an opioid prescription for a patient. The patient takes the prescription to a pharmacy in Tennessee. The pharmacist dispenses the medication, manually logs onto the TNCSMP database and enters information about the prescription, the provider, the patient, and the pharmacy. Providers and pharmacies logging into the database now has access to patient prescription histories in the database. TNCSMP database Controlled Substance Monitoring Database
When a provider logs in the TNCSMP database to look up a patient, they are able to see the following information on their patient. CLICK Patient demographics, including name, date of birth and address, Prescription information, including type of controlled substance, date and quantity prescribed, prescriber and pharmacy at which prescription was dispensed. Controlled Substance Monitoring Database
Top 10 Prescriptions reported to CSMD, 2012 When a provider logs in the TNCSMP database to look up a patient, they are able to see the following information on their patient. CLICK Patient demographics, including name, date of birth and address, Prescription information, including type of controlled substance, date and quantity prescribed, prescriber and pharmacy at which prescription was dispensed. Controlled Substance Monitoring Database
Risk Factor Cases N=592 Number (%) Controls N=11,840 AORs 95% Confidence Interval Provider shopping 227 (38) 513 (4) 5.1 Pharmacy shopping 145 (24) 196 (2) 4.5 High dosage use 140 (24) 172 (1) 13.2 Source:Dr. Jane Baumblatt, TN Department of Health.Case control analysis of TN Controlled Substance Monitoring Database Neonatal Abstinence Syndrome: Opportunities for Prevention and Collaboration NASPrimary 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 NASSecondary 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 women for drug use Consent of patient Supportive rather than punitive approach NASTertiary 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? NASWhat Can You Do? Connect family with: Primary care medical home
TennCare or other insurance TN Early Intervention Services (TEIS) Help Us Grow Successfully (HUGS) Childrens Special Services (CSS) Family Planning WIC NASWhat 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 NASWhat Can You Do? Decide whether referral to Department of Childrens 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
Weekly Surveillance Summary Archive Contact Information Michael D. Warren, MD MPH FAAP Director, Division of Family Health and Wellness Tennessee Department of Health Sheri Smith, RN Nursing Director, Critical Care Services East TN Childrens Hospital