75,000 Too Many: How Can States, Providers & Advocates Address and Reverse the Trend of Babies Born with Dependence on Opioids?

Transcription

1 75,000 Too Many: How Can States, Providers & Advocates Address and Reverse the Trend of Babies Born with Dependence on Opioids? National Council for Behavioral Health December 14 th, 2016 Jean Y. Ko, PhD Michael D. Warren, MD MPH FAAP

2 Welcome! Margaret A. Jaco MSSW Senior Policy Associate National Council for Behavioral Health

3 Housekeeping Technical Difficulties? Call Citrix Tech Support at

4 Webinar Agenda Neonatal Abstinence Syndrome (NAS) Implications of NAS Treatment & Costs Prevention Challenges Intervention Challenges CDC work around NAS The Opioid Epidemic: A Tennessee Perspective Generating Data for Action Data Action: Local Level Data Action: State Level Q&A

5 Guest Speaker #1 Jean Y. Ko, PhD LCDR, U.S. Public Health Service Epidemiologist, CDC s Division of Reproductive Health JeanKo@cdc.gov

6 Neonatal Abstinence Syndrome Jean Ko, PhD Epidemiologist LCDR, U.S. Public Health Service Division of Reproductive Health National Center for Chronic Disease Prevention and Health Promotion 6

7 What is Neonatal Abstinence Syndrome (NAS)? Drug withdrawal syndrome that occurs primarily among opioid-exposed infants shortly after birth Withdrawal symptoms most commonly occur hours after birth Tremors, hyperactive reflexes, seizures Excessive or high-pitched crying, irritability, yawning, stuffy nose, sneezing, sleep disturbances Poor feeding and sucking, vomiting, loose stools, dehydration, poor weight gain Increased sweating, temperature instability, fever Hudak ML, Tan RC, Committee on Drugs, et al. Pediatrics. 2012;129;e

8 Exposures Associated with NAS Cocaine, amphetamines, and barbiturates have been implicated Most commonly attributed to exposure to opioids Pain relievers: Vicodin, OxyContin, Percocet Illicit substances: Heroin Opioid maintenance therapy: Methadone, buprenorphine Maintenance therapy: Long-term treatment for opioid use disorder, under medical supervision, with a longer-acting but less euphoric opioid Recommended by American College of Obstetricians and Gynecologists (ACOG) during pregnancy 8 ACOG: American College of Obstetricians and Gynecologists ACOG Committee on Health Care for Underserved Women, American Society of Addiction Medicine. Obstet Gynecol May;119(5):

9 Prescribing of Opioids to Women of Reproductive Age 50% 40% 30% 20% 10% 0% Opioid Prescription Claims by Type of Health Insurance Among Women of Reproductive Age (15-44 years), United States, % Private Insurance 39.4% Medicaid-enrolled Ailes EC, Dawson AL, Lind JN, et al. MMWR Jan 23;64(2):

10 Opioid Abuse and Dependence Among Pregnant Women Opioid abuse or dependence per 1,000 deliveries, overall and by age in the U.S., Maeda A, Bateman BT, Clancy CR, et al. Anesthesiology Dec;121(6):

11 Drug Overdose Deaths Among Women cdc.gov/vitalsigns/prescriptionpainkilleroverdoses/index.html 11

12 Incidence of NAS in the United States, Patrick SW, Schumacher RE, Benneyworth BD, et. al. JAMA. 2012;307(18): Patrick SW, Davis MM, Lehmann CU, et al. J Perinatol Aug;35(8):650-5.

13 Incidence of NAS in the United States, Patrick SW, Schumacher RE, Benneyworth BD, et. al. JAMA. 2012;307(18): Patrick SW, Davis MM, Lehmann CU, et al. J Perinatol Aug;35(8):650-5.

14 NAS Incidence by Geographic Region, 2012 NAS per 1,000 Hospital Births Patrick SW, Davis MM, Lehmann CU, et al. J Perinatol Aug;35(8):

15 Incidence of Neonatal Abstinence Syndrome 25 States, Incidence rates per 1,000 hospital births Ko JY, Patrick SW, Tong VT, Patel R, Lind JN, Barfield WD. MMWR Morb Mortal Wkly Rep 2016;65:

16 Infants with NAS: Treatment and Costs Exposed infants can require pharmacologic treatment (e.g. morphine, methadone, phenobarbital) 30%, 68%, and 91% of NAS infants required pharmacologic treatment in separate studies Mean length of hospital stay: 23 days Mean hospital charge: $93,400 per infant Total cost: $1.5 billion Medicaid is most common payer ($1.2 billion) 16 Strauss ME, Andresko M, Stryker JC, et al. Am J Obstet Gynecol Dec 1;120(7): Ebner N, Rohrmeister K, Winklbaur B, et al. Drug Alcohol Depend Mar 16;87(2-3): Patrick SW, Davis MM, Lehmann CU, et al. J Perinatol Aug;35(8): Kuschel C. Semin Fetal Neonatal Med Apr;12(2): Greig E, Ash A, Douiri A. Arch Gynecol Obstet Oct;286(4):

17 Prevention Challenges Nearly 50% of all pregnancies in the United States are unintended 86% of pregnancies are unintended among women who abuse opioids Unmet need for increased access to preconception healthcare Including effective contraception among women who do not intend to become pregnant 17 Finer LB, Zolna MR. N Engl J Med. 2016;374: Heil SH, Jones HE, Arria A, et al. J Subst Abuse Treat Mar;40(2):

18 Prevention Challenge: High Opioid Prescribing Rates Number of opioid prescriptions per 100 people cdc.gov/vitalsigns/opioid-prescribing/infographic.html cdc.gov/drugoverdose 18 cdc.gov/vitalsigns/opioid-prescribing/infographic.html cdc.gov/drugoverdose

19 Intervention Challenges Universal verbal screening for substance use recommended by ACOG but not implemented Few screening instruments validated for use among pregnant woman Debate on when and how often to screen, whether biological specimens should be used in conjunction Varying state laws and policies Unmet need for referrals and resources Standardization of care for NAS infants Assessment Treatment (first line medication, quantity) ACOG Committee on Health Care for Underserved Women, American Society of Addiction Medicine. Obstet Gynecol May;119(5):

20 CDC Recommendations: Providers for Preconception and Pregnant Women Reproductive-aged women discuss family planning and how long-term opioid use might affect any future pregnancy Pregnant women Carefully weigh risks and benefits when making decisions about whether to initiate opioid therapy Pregnant women with opioid use disorder medication-assisted therapy with buprenorphine (without naloxone) or methadone has been associated with improved maternal outcomes and should be offered Dowell D, Haegerich TM, Chou R. MMWR Recomm Rep. 2016;65(No. RR-1):

21 Prescription Drug Monitoring Programs (PDMPs) State-based databases of controlled prescription drugs dispensed by pharmacies Currently in 49 states (not Missouri) Contain critical clinical data that can help: Identify patients at risk for opioid-related overdoses On high total doses, receiving from multiple sources Inform providers of other medications the patient is receiving that may interact with those prescribed Identify patients struggling with opioid use disorder pdmpexcellence.org/sites/all/pdfs/coe_briefing_mandates_2nd_rev.pdf 21

22 CDC s Treating for Two Initiative Treating for Two: Safer Medication Use in Pregnancy initiative focuses on improving the health of women and babies and preventing birth defects and other adverse pregnancy outcomes. Expand and accelerate research to fill knowledge gaps Deliver up-to-date information to support decision making among prescribers, pharmacists, and consumers Evaluate evidence to facilitate reliable guidance 22 National Center on Birth Defects and Developmental Disabilities

23 CDC s Division of Reproductive Health Activities Improving surveillance data Pregnancy Risk Assessment Monitoring System- capabilities to capture prescription opioid use Understanding Knowledge, Attitudes, and Practices of Ob/Gyns regarding pregnant patients who use opioids Funding a study to compare and validate substance use screening tools Comparing 5 existing screening tools and their performance (sensitivity, specificity) Funding Perinatal Quality Collaboratives 23

24 Public Health Grand Rounds and Technical Assistance Primary Prevention and Public Health Strategies to Prevent Neonatal Abstinence Syndrome ( 2016/august2016.htm) Technical assistance to states to improve availability and quality of data collection and surveillance activities regarding NAS Authorized by Protecting Our Infants Act,

25 25 Questions?

26 Guest Speaker #2 Michael D. Warren, MD MPH FAAP Deputy Commissioner for Population Health Tennessee Department of Health

27 The Opioid Epidemic: A Tennessee Perspective Michael D. Warren, MD MPH FAAP Deputy Commissioner for Population Health National Council for Behavioral Health December 14, 2016

28 Objectives Describe the implementation of a real-time surveillance system for neonatal abstinence syndrome (NAS) in Tennessee Identify examples of using NAS surveillance and other data to drive state-level program, policy, and legal efforts to address neonatal abstinence syndrome in the broader context of an opioid epidemic

29 Generating Data for Action

30 Number of Hospitalizations NAS in Tennessee: NAS Hospitalizations in Tennessee, Number Rate What our partners were telling us What our state administrative data were showing us Rate per 1,000 Live Births 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

31 NAS in Tennessee: 2012 What we knew in 2012 What we didn t know in 2012 Hospital discharge data through 2010 showed sharp increase in NAS cases 2011 or 2012 case numbers State rules re: release of hospital discharge data Feedback from hospitals (particularly in East TN): Busting at the seams with NAS babies Source of prenatal exposure Not easily identifiable via administrative claims Increase in drug overdose deaths We have a problem

32 NAS as a Reportable Disease Add NAS to state s Reportable Diseases and Events list State Health Officer (Commissioner) has authority to add conditions to list as appropriate Effective January 1, 2013 Reporting hospitals/providers submit electronic report Reporting Elements Case Information Diagnostic Information Source of Maternal Exposure

33 Number of Cases Neonatal Abstinence Syndrome Surveillance Summary Week 48: November 27 December 3, 2016 Year to Date Reporting Summary Total Cases Reported: 909 Cumulative Cases NAS Reported 2016 Cases 2015 Cases 2014 Cases 2013 Cases Sex Male 481 Maternal County of Residence Female 428 # Cases % Cases 2 Davidson East Week Hamilton Jackson/Madison Knox Mid-Cumberland North East Shelby South Central South East Sullivan Upper Cumberland West TOTAL Source of Exposure # Cases 3 % Cases Medication assisted treatment Legal prescription of an opioid pain reliever Legal prescription of a non-opioid Prescription opioid obtained without a prescription Non-opioid prescription substance obtained without a prescription Heroin Other non-prescription substance No known exposure Other Summary reports are archived weekly at: 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. 4. Other exposure may include cases reported to the archived surveillance system with classifications not captured in the current system.

34 NAS Exposure Source, 2015 Mix of prescription and illicit substances 22.1% Substance exposure unknown 5.5% Only illicit/diverted substances 25.9% Only substances prescribed to mother 46.5% Tennessee Department of Health. Neonatal Abstinence Syndrome Surveillance System.

35 Percent, % NAS Exposure Source by Region, Unknown (%) Prescription Drugs Only (%) Prescription and Illicit Drugs (%) Illicit Drugs Only (%) Tennessee Department of Health. Neonatal Abstinence Syndrome Surveillance System.

36 Data to Action: Local Level

37 NAS Incidence, by TN Region, 2013 Month NAS Cases Births* Rate (per 1,000 births) Davidson 35 9, East 268 7, Hamilton 17 4, Jackson/Madison 2 1, Knox 102 5, Mid-Cumberland 58 14, Northeast 138 3, Shelby 24 13, South Central 29 4, Southeast 12 3, Sullivan 86 1, Upper Cumberland 117 3, West 33 5, TOTAL , *Provisional count of births, 2013

38 NAS: 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:

39 Narcotics/Contraceptive Use, TennCare, 2014 Demographics TennCare Women Women Prescribed Narcotics (>30 days supplied) Narcotic Users Rate per 1,000 Women Prescribed Contraceptive s and Narcotics % of Women on Narcotics and Contraceptives Women Prescribed Narcotics without Contraceptives % of Women on Narcotics Not on Contraceptives All Women 320,327 38, ,625 15% 32,585 85% ,174 1, % % ,169 2, % 1,973 71% ,165 6, ,561 22% 5,437 78% ,614 9, ,459 15% 8,024 85% ,963 9, % 8,477 91% ,241 8, % 7,882 95% Data source: Division of Health Care Finance and Administration, Bureau of TennCare. CY2014 data. Available at:

40 East TN NAS Primary Prevention Project Primary Prevention Initiative (PPI): Department-wide initiative Vision by State Health Officer Focus upstream Engage community partners to address local issues East TN PPI Project: Started in Cocke and Sevier counties Partnership with local jails Health education sessions Focus on NAS prevention Information on effective contraception Partnerships with jails to refer inmates to local health department for family planning

41 East TN NAS Primary Prevention Project All services are voluntary Any patient referred to health department for family planning services is offered a variety of acceptable and effective contraceptive methods Selected results from East TN PPI project: 442 referrals in % with history of drug use 30% reported drug use during pregnancy 19% had delivered infant with NAS 73% reported no contraceptive method Among referred patients: 94% received a contraceptive method (N=406) 84% chose a voluntary reversible long-acting contraceptive (N=361)

42 Data to Action: State Level

43 Number of Hospitalizations NAS in Tennessee: 2012 NAS Hospitalizations in Tennessee, Number Rate Rate per 1,000 Live Births 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

44 TennCare NAS Costs, CY2011 Metric TennCare Paid Live Births 1 TennCare non-lbwt Births TennCare Live LBWT Births 2 NAS Infants Number of Births 45,205 40,437 4, Cost for Infant in first year of life $350,936,293 $171,336,964 $179,599,329 $33,249,612 Average Cost per child $7,763 $4,237 $37,668 $62,973 Average length of stay (days) % of infants 9.5% of costs 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).

45 Infants in DCS Custody, TennCare, CY2011 Infants born in CY 2011 NAS infants Total # of Infants 55, Total # infants in DCS % in DCS 1.4% 22.7% 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.

46 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

47 Request for Black Box Warning

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49 TennCare Prior Authorization Form Form available at:

50 Related Laws Encourages opioid antagonist prescribing for atrisk individuals Immunity for antagonist administrators Collaborative pharmacy practice agreement Priority to pregnant women for statefunded treatment Treatment as affirmative defense (sunset in 2016) Naloxone Treatment Clinic operations, medical director (pain medicine specialist), and ownership defined All must be licensed by 2017, licensure tied to medical director Prescription Drug Monitoring Program Opioid-Related Laws in Tennessee Pain Management Clinics Shall-check for most controlled substances Data reported from dispensers daily TDH Chronic Pain Management Guidelines 2-hr CME requirement Prescribing Tamper-proof prescription pads Identify/investigate top 50 prescribers and top 10 rural prescribers Dispensing 30-day limit for dispensing of opioids/benzos Limitations on direct dispensing by prescribers ID required for pickup On-site inspection every other year No cash payment (except copay) Guidelines forthcoming

51 Public Health Approach to the Opioid Abuse Epidemic Tennessee Department of Health Strategic Map, 2016 Reduce Opioid Misuse, Abuse & Overdose Adopted 1/11/16 A B C D Improve Primary Prevention Improve Monitoring and Surveillance Improve Regulation and Enforcement Increase Utilization of Treatment (2º Prevention) E Increase Access to Appropriate Pain Management 1 Improve education for consumers, families & HCWs Optimize use of the CSMD Provide prescriber/ dispenser education on regulation & enforcement Destigmatize & approach addiction as a treatable chronic illness Require pain management clinic physicians to have specialty certification 2 Expand use of optimal prescribing guidelines Link other data sources to the CSMD Improve collaboration with law enforcement Expand SBIRT training and use Develop a model for desirable integrated pain practices 3 Actively support community coalitions Improve the high risk patient model Expedite investigations supporting Board oversight of prescribers Expand appropriate use of MAT Increase access for uninsured 4 Expand efforts to reduce NAS Develop a high risk prescriber model for individuals and practices Eliminate Pill Mills Expand treatment alternatives to incarceration Work with academic partners to improve training of prescribers 5 Facilitate community interventions, including safe disposal of drugs Develop a high risk dispenser model Improve legislation to allow proactive regulation Partner with Mental Health to expand treatment options for opioid misuse Describe how patient care is impacted by sudden clinic closure 6 Reduce harm from needle use Improve proactive use of clinical monitoring tools Advocate for Prescription for Success including treatment and care Expand the availability and use of Naloxone Expand and Strengthen Key Partnerships and Collaborative Infrastructure Secure/Realign Resources and Infrastructure to Implement Comprehensive Approaches Use Data, Evaluation and Research to Inform Interventions and Continuous Improvement

52 State Policy Efforts Mandatory prescriber education Opioid Prescribing Guidelines Eliminating Pill Mills Prescription Drug Monitoring Programs Increased Access to Naloxone Availability of Opioid Use Disorder Treatment Source: National Security Council. Prescription Nation 2016: Addressing America s Drug Epidemic.

53 Process Impact: PDMP Law Tennessee Department of Health. Controlled Substance Monitoring Database Report to the 109 th General Assembly.

54 MME Outcome Impact: MME Dispensed 10,000,000,000 9,000,000,000 8,000,000,000 7,000,000,000 6,000,000,000 5,000,000,000 4,000,000,000 3,000,000,000 2,000,000,000 1,000,000,000 Opioid MMEs and Prescriptions Dispensed to TN Patients and Reported to the CSMD, * 14.3% decrease in MME from 2012 to Year MME filled by all patients in CSMD *Excluding prescriptions reported from VA pharmacies. MME filled by TN patients Tennessee Department of Health. Controlled Substance Monitoring Database.

55 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 RESEARCH TOPICS Development of a predictive model for NAS Barriers to contraception in women attending substance abuse programs Optimal management of the pregnant woman taking opioids Understanding and improving provider knowledge and behavior Understanding optimal management of the infant with NAS

56 Summary Real-time surveillance for emerging issues like NAS is possible using low-cost solutions NAS surveillance in TN has allowed for more robust description of exposure sources Utilization of data from multiple sources allows for targeting of local prevention efforts as well as state programs and policies Addressing NAS and the broader opioid epidemic requires a multi-faceted, long-term approach

57 For More Information Weekly NAS Surveillance Archive Monthly and Annual NAS Reports

58 Acknowledgements TDH Commissioner John J. Dreyzehner, MD, MPH, FACOEM TDH Chief Medical Officer David R. Reagan, MD, PhD TDH NAS Surveillance Angela M. Miller, PhD, MSPH East TN Regional Health Office Staff Danni Lambert, RN Janet Ridley, RN, BSN, MSN Brittany S. Isabell, MPH

59 Comments & Questions?

60 Thank you for joining us for today s 75,000 Too Many How Can States, Providers & Advocates Address & Reverse the Trend of Babies Born with Dependence on Opioids? webinar!