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Cecelia Spitznas, Ph.D. , Senior Policy Advisor
Office of National Drug Control Policy
April 22, 2014
ONDCP Visioning Session
Neonatal 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 2009
p-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-
Mack
AUGUST 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) Education
2) 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:
o New 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
o New boxed warning that chronic maternal use during
pregnancy can result in neonatal opioid withdrawal
syndrome (NOWS)
o Changes 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

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Tue vs ondcp spitznas

  • 1. Cecelia Spitznas, Ph.D. , Senior Policy Advisor Office of National Drug Control Policy April 22, 2014 ONDCP Visioning Session Neonatal Abstinence Syndrome National RX Drug Abuse Summit
  • 2. • 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
  • 3. 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).
  • 4. 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
  • 5. 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.
  • 6. 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.
  • 7. Total Hospital Charges for NAS, 2000-2009 2000 2003 2006 2009 p-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.
  • 8. 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- Mack AUGUST 30, 2012 – LEADERSHIP MEETING ON MATERNAL ADDICTION, OPIOID EXPOSED INFANTS & NEONATAL ABSTINENCE SYNDROME Prescription Drug Abuse Interagency Members plus potential New Partnerships:
  • 9. 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
  • 10. • Coordinated effort across the Federal Government • Four focus areas: 1) Education 2) Prescription Drug Monitoring Programs 3) Proper Disposal of Medication 4) Enforcement Prescription Drug Abuse Prevention Plan
  • 11. • Safety Labeling Changes: In September 2013, FDA announced labeling changes for extended-release/long-acting (ER/LA) opioids. Changes include: o New 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 o New boxed warning that chronic maternal use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS) o Changes 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

Notes de l'éditeur

  1. Thank you, (Insert introductions information here) for your kind introduction. And thank you for the opportunity to speak to you today. It is an honor to be here.   We all have an important role to play in addressing drug use and its consequences, including opioid use, overdose, and other substance use issues facing communities across the country.  Today, I’d like to talk about the Office of National Drug Control Policy (ONDCP), our current activities, and the importance of substance use disorder intervention and treatment. I’d also like to talk about the value of investing in evidence-based approaches that will cut costs and save lives.
  2. ONDCP is a component of the Executive Office of the President, and was created by the Anti-Drug Abuse Act of 1988 to advise the President on drug-control issues. By statute, ONDCP annually engages in three primary efforts to guide drug policy: Develops the National Drug Control Strategy, which sets forth a comprehensive plan each year to reduce illicit drug use, the availability of drugs, and the consequences of drug use in the United States;Develops a consolidated National Drug Control Program Budget designed to implement the Strategy; and Coordinates and oversees the implementation by the Federal Drug Control Program Agencies of the policies, goals, objectives, and priorities established for the National Drug Control Program and the fulfillment of the responsibilities of such agencies under the Strategy. These three activities guide the Administration’s efforts to reduce illicit drug use, manufacturing and trafficking, drug-related crime and violence, and drug-related health consequences. The Obama Administration is committed to restoring balance to U.S. drug-control efforts by coordinating an unprecedented government-wide public health and public safety approach to reduce drug use and its consequences.  It is through this commitment that ONDCP is in the best position to advance a comprehensive public health approach for the delivery of substance use disorder intervention and treatment services, and works to ensure these services are not subsumed in a broader behavioral health care approach. This is particularly important as states move toward consolidating the delivery of mental health and substance use disorder services.  ONDCP’s goal is to make sure substance use disorder services remain a priority for our Nation. To this end, we are focusing on improving access to services and treating addiction across the continuum of care, from prevention and intervention to treatment and recovery.
  3. The Administration’s Strategy uses a public health approach and was developed, in part, to respond to the millions of Americans who have substance use disorders needing specialty treatment.  We know from the results of the 2012 National Survey on Drug Use and Health that 23.1 million people across the United States need treatment for an illicit drug or alcohol use, but that only 2.5 million of these people received treatment from a substance use disorder specialist.
  4. The Administration’s Strategy uses a public health approach and was developed, in part, to respond to the millions of Americans who have substance use disorders needing specialty treatment.  This slide shows 2.2 million people in need for treatment who had a substance use disorder related to non-medical use of prescription pain relievers. The results of the 2012 National Survey on Drug Use and Health shows that only 693,000 or 30.9% of these people who needed treatment actually received treatment from a substance use disorder specialist. Close to 70% of people did not receive treatment.
  5. This is based on a special tabulation calculated for ONDCP by SAMHSA combining 2010-2012 data from the National Household Survey. When the people who met criteria for a clinical substance use disorder in the year prior to answering the survey who did not get treatment were asked why they did not go A small number, less than 10% said they didn’t make the effort. Another very small group said they did make the effort but for some reason they didn’t enroll. These might be people who got turned away because of insurance reasons or got onto a waiting list but never made it in. Still this is a small number of people. The vast majority of people thought they did not need it. This is something we really need to change. Providers, law enforcement, faith leaders all need to realize that treatment works and treatment should be a priority. Now lets look at this for heroin use.
  6. Another emerging issue we are concerned about is the rise in births of opioid exposed infants showing signs of withdrawal because of substance use during pregnancy. ONDCP held a national leadership meeting and has been providing technical assistance on this issue to stakeholders and interested congressional staff. One of the co-sponsors of the meeting the Appalachian Regional Commission just held an experts meeting concerning this topic and ONDCP is very interested in developing solutions to this problem along with our federal partners. I understand ARC will be presenting their meeting results during their session.
  7. This graph describes the change in prevalence of change in maternal opiate us and abuse from 2000 to 2009.On the y-axis you will see the rate of opiate use and abuse per 1000 hospital birthsOn the x-axis is yearFrom 2000 to 2009, the rate of NAS increased nearly 5-fold to 5.6 per 1000 hospital births.
  8. And overall, the total US hospital bill grew from $190 to 720 million dollars
  9. To address the prescription drug problem, ONDCP and our Federal partners developed the Prescription Drug Abuse Prevention Plan.It should be noted that this plan was intended to augment the Strategy which emphasizes universal prevention and treatment. This plan is focused on addressing people who are prescription pharmaceuticals including potential non-medical use and those who are actively abusing or diverting these medicines.
  10. On September 10, 2013, ONDCP joined FDA in announcing significant new measures to enhance the safe and appropriate use of extended-release and long-acting (ER/LA) opioid analgesics.  By exercising its legal and regulatory authorities to take these actions, FDA will help ensure access to painkillers while reducing risks of abuse, misuse, and overdose. FDA is requiring class-wide labeling changes for these medications, including modifications to the products’ indication, limitations of use, and warnings, as well as post-market research requirements.  Post-market Study Requirements: FDA also announced that manufacturers of ER/LA opioids must conduct further studies and clinical trials to better assess risks of misuse, addiction, overdose, and death.
  11. For more information about the work of the Office of National Drug Control Policy, please visit our website at WhiteHouse.gov/ONDCP.  Thank you.