Cecelia Spitznas, Ph.D. , Senior Policy AdvisorOffice of National Drug Control Policy

April 22, 2014

ONDCP Visioning SessionNeonatal Abstinence Syndrome

National RX Drug Abuse Summit

• Component of the Executive Office of the President

• Coordinates drug-control activities and related funding across the Federal Government

• Produces the annual National Drug Control Strategy

Office of National Drug Control Policy

Persons Aged 12 or Older Needing Treatment

for Illicit Drug or Alcohol Use and Obtaining Specialty Treatment, 2012

23.1 Million Needing Treatment* for Illicit Drug or Alcohol Use

*Treatment need is defined as having a substance use disorder or receiving treatment at a specialty facility

within the past 12 months.

11%

Did Not Receive Treatment

(20.6 million)Received Specialty

Treatment(2.5 million)

89%

Source: SAMHSA, 2012 National Survey on Drug Use and Health (September 2013).

LEADERSHIP MEETING ON MATERNAL ADDICTION,

OPIOID EXPOSED INFANTS & NEONATAL ABSTINENCE

SYNDROME

Cece Spitznas, Ph.D. White House Office of National Drug Control Policy

August 30, 2012

Newborn Drug Withdrawal Diagnoses: 2000-2009-3 Fold Increase

Patrick SW, et. al. Neonatal Abstinence Syndrome and Associated Healthcare Expenditures – United States, 2000-2009. JAMA. 2012 May 9;307(18):1934-40.

Change in Maternal Opiate Use and Abuse, 2000-2009

Patrick SW, et. al. Neonatal Abstinence Syndrome and Associated Healthcare Expenditures – United States, 2000-2009. JAMA. 2012 May 9;307(18):1934-40.

Total Hospital Charges for NAS, 2000-2009

  2000 2003 2006 2009p-for-trend

Medicaid $130M $200M $260M $560M <0.001

Private Payer $36M $57M $69M $130M <0.001

Self Pay $17M $18M $20M $20M 0.5

Other Payer $8M $11M $7M $14M 0.44

Total Charges $190M $280M $360M $720M <0.001

Patrick SW, et. al. Neonatal Abstinence Syndrome and Associated Healthcare Expenditures – United States, 2000-2009. JAMA. 2012 May 9;307(18):1934-40.

10

American Academy of Pediatrics, American College of Obstetrician’s and Gynecologists, March of

Dimes, National Advocates for Pregnant Women, Florida Attorney General’s Office, Oklahoma Commissioner of Health

and Staff from Senators Rockefeller, Casey & Schumer’s offices, Senate Appropriations

Committee, and staff from offices of Congressman Rogers, and Congresswomen McCaskill & Bono-

MackAUGUST 30, 2012 – LEADERSHIP MEETING ON MATERNAL

ADDICTION, OPIOID EXPOSED INFANTS & NEONATAL ABSTINENCE

SYNDROME

Prescription Drug Abuse Interagency Members plus potential New Partnerships:

ONDCP Strategy & RX Prevention Plan Relevance

– Seek Early Intervention Opportunities in Health Care (e.g., action items on SBIRT and Educate Prescribers About Opiate Painkiller Prescribing)

– Integrate Treatment for Substance Use Disorders into Mainstream Health Care and Expand Support for Recovery (action item :Review Laws and Regulations That Impede Recovery from Addiction)

– Break the Cycle of Drug Use, Crime, Delinquency, and Incarceration (action item: Align the Criminal Justice and Public Health Systems To Intervene With Heavy Users)

– RX Prevention Plan: Educate Providers and Public about Rx abuse, monitoring program utilization by public health providers

• Coordinated effort across the Federal Government

• Four focus areas:

1) Education2) Prescription Drug

Monitoring Programs

3) Proper Disposal of Medication

4) Enforcement

Prescription Drug Abuse Prevention Plan

• Safety Labeling Changes: In September 2013, FDA announced labeling changes for extended-release/long-acting (ER/LA) opioids. Changes include:oNew language stating ER/LA opioids are indicated

only for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

oNew boxed warning that chronic maternal use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS)

oChanges to several sections of drug labeling, including Dosage and Administration; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information, and the Medication Guide

Recent NAS Relevant FDA Actions

For More Information:

WHITEHOUSE.GOV/ONDCP