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Opioid Abuse Prevention Plan – 2.0
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
18,000
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
opioid analgesic 4,030 4,400 5,528 7,456 8,517 9,857 10,92 13,72 14,40 14,80 15,59 16,65 16,91 16,00 16,23
cocaine 3,822 3,544 3,833 4,599 5,199 5,443 6,208 7,448 6,512 5,129 4,350 4,183 4,681 4,404 4,944
heroin* 1,963 1,843 1,784 2,092 2,084 1,879 2,010 2,089 2,402 3,041 3,278 3,036 4,397 5,927 8,260
NumberofDeaths
Drug Poisoning Deaths Involving Opioid Analgesics,
Cocaine and Heroin: United States, 1999–2013
% CHANGE
2010 to 2013
- 2%
+18%
+ 172%
Note: Not all drug poisoning deaths specify the drug(s) involved, and a death may involve more than one specific
substance. The rise in 2005-2006 in opioid deaths is related to non-pharmaceutical fentanyl (see
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5729a1.htm). *Heroin includes opium.
1/2015
Source: Centers for Disease Control and Prevention, National Center for Health Statistics [NCHS]. Multiple Cause of Death 1999-2012 on CDC WONDER
Online Database, released 2014. Data for 1999 to 2012 were extracted by ONDCP on November 20, 2014. Data for 2013 are from unpublished
analysis by NCHS December 30, 2014).
2
0
200
400
600
800
1,000
1,200
1,400
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
NumberofUsers(Thousands)
Persons Aged 12 or Older
Non-medical users of pain relievers
Heroin users
Source: SAMHSA, 2013 National Survey on Drug Use and Health (September 2014).
9/2014
Heroin Use or Non-Medical Use of Pain Relievers in the
Past Year among Persons Aged 12 or Older: 2002-2013
3
In 1999, there was one drug
overdose death every 30 minutes.
4
In 2013, there was one drug
overdose death every 12 minutes.
5
Opioid Prevention Plan 2.0
• Education
• Monitoring
• Disposal
• Enforcement
• Treatment/Overdose Prevention
vsYears
11 hours
In four years of medical school,
students receive, on average, only
11 hours of pain medication training.
Since 2011, Six States Passed Legislation
Mandating Prescriber Education
Now, prescribers in the Departments of Defense and
Health and Human Services and in the Federal Bureau of
Prisons are receiving training
In the past eight years, state prescription drug
monitoring programs have more than doubled.
In 2006, only 20 states had prescription drug
monitoring programs.
Today, all but one have laws authorizing programs
– and 48 are operational and 28 have some data
sharing capacity.
• This September, we joined the Drug
Enforcement Administration to
announce the final rule of the Safe
Drug Disposal Act of 2010.
Data show state monitoring
Data show state monitoring programs and
pain clinic regulations have worked.
Data show state monitoring programs
and pain clinic regulations have
worked.
Data show state monitoring programs
and pain clinic regulations have
worked.
Now, police across the country are carrying
naloxone – and a majority of states and the
District of Columbia enacted legislation to
decrease overdose deaths.
• Naloxone is a prescription opioid antidote delivered by injection.
– National Institute on Drug Abuse is supporting contracts on forms of naloxone approved for use without
injection administer
– Food and Drug Administration (FDA) is providing fast-track review of new formulations
– FDA approved naloxone for use by autoinjector
• Working with health plans, pharmacy benefits management plans to raise awareness of naloxone.
• VHA now has naloxone policy and naloxone available in mail order pharmacies
• With Department of Justice (DOJ) and SAMHSA created a Naloxone toolkit for Law
Enforcement.
• DOJ encouraging naloxone adoption by federal law enforcement
• Administration approved by executive action Department of Defense law enforcement use of
naloxone
Expanding Access to Overdose Education/Naloxone
For More Information:
WHITEHOUSE.GOV/ONDCP
Opioid Mortality,
United States, 1999-2013
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
18,000
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
NumberofOverdoseDeaths
Rx Opioids
Heroin
Source: CDC/NCHS NVSS Multiple Cause of Death Files 1999-2014.
Past Year and Past Month Use
Rx Opioids and Heroin,
United States, 2002-2013
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
NumberofNonmedicalUsers(inthousands)
Past Year Rx Opioids Past Month Rx Opioids
0
100
200
300
400
500
600
700
800
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
NumberofUsers(inthousands)
Past Year Heroin Use Past Month Heroin Use
*
Source: SAMHSA National Survey on Drug Use and Health.
*
* * *
*
*
*
*
*
*
* * *
* *
* * *
* Estimate is significantly different than 2013 estimate
Past Year Abuse or Dependence
Rx Opioids and Heroin,
United States, 2002-2013
0
500
1,000
1,500
2,000
2,500
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
NumberofIndividuals
Rx Opioid Abuse or Dependence
Heroin Abuse or Dependence
* *
* *
*
*
*
*
*
*
*
* Estimate is significantly different than 2013 estimate
Source: SAMHSA National Survey on Drug Use and Health.
Past Year Heroin Use
By Past Year Rx Opioid Nonmedical Use
United States, 2002-2004 and 2008-2010
379
176
58 46
99
588
171
115
100
202
0
100
200
300
400
500
600
700
Overall Past Year
Heroin Use
No Past Year NMU
Opioids
1-29 Days Past Year
NMU Opioids
30-99 Days Past
Year NMU Opioids
100-365 Days Past
Year NMU Opioids
Numberofpastyearusersamongpersons≥12years
old(numbersinthousands)
2002-2004 2008-2010
Jones, C.M., Heroin use and heroin use risk behaviors among nonmedical users of prescription opioid pain relievers – United
States, 2002–2004 and 2008–2010. Drug Alcohol Depend. (2013), http://dx.doi.org/10.1016/j.drugalcdep.2013.01.007
*
*
*
*
* Estimate is significantly different than 2013 estimate
Past Year Heroin Use Incidence Rate of Persons
Aged 12 to 49 at Risk for Initiation of Heroin Use,
United States, 2002-2004, 2005-2008, 2009-2011
0%
1%
2%
3%
4%
5%
6%
7%
8%
0 Days 1-29 Days 30-99 Days 100-199 Days 200-365 Days No Past Year
Abuse/Dependence
Past Year
Abuse/Dependence
PercentReportingPastYearHeroinUse
2002-2004 2005-2008 2009-2011
Muhuri et al. , Associations of Nonmedical Pain Reliever Use and Initiation of Heroin Use in the United States. SAMHSA, 2013
* *
* *
*
*
**
* Estimate is significantly different than 2013 estimate
Demographic Shift in Heroin Use
Shift from inner-city, minority-centered problem to one with
more widespread geographical distribution, involving
primarily white men and women in their late 20s living
outside of large urban areas
Source: Cicero et al. JAMA Psychiatry. 2014;71(7):821-826
Rx Opioid-Heroin Connection
What The Data Tell Us
• Nonmedical use of opioid pain relievers is a risk
factor for future heroin use
• Very small percent of nonmedical users of pain
relievers initiate heroin use
• Increased accessibility, affordability, and high
potency of heroin are likely driving increased use
and transitions from prescription opioids
• Evidence linking recently enacted prevention
policies regarding prescription opioids to a shift to
heroin is limited and non-definitive
Hepatitis C
Between 2006 and 2012
• Acute hepatitis C incidence
increased significantly in young
people
– 13% annually in nonurban counties
– 5% annually in urban counties
• 30 of 34 states (88%) had higher
incidence in 2012 compared to
2006
• Data indicate an emerging US
epidemic of HCV infection among
young nonurban predominantly
white persons
• Prescription opioid abuse at an
early age was commonly reported
Source: Anil G. Suryaprasad et al. Clin Infect Dis. 2014;59:1411-1419
Hepatitis C
• Lankenau et al., 2015
– aOR=2.69 (95% CI; 1.07-6.78) for people who injected
prescription opioids
– aOR=2.28 (95% CI; 1.02-5.10) for people who substituted
prescription opioids for heroin
• Zibbell et al., 2014
– aOR=5.53 (95% CI; 1.92-15.91) for people who injected
prescription opioids
• Tsui et al., 2015
– aHR=0.39 (95%CI; 0.18-0.97) among young adult
injection drug users who received medication-assisted
treatment
Source: Lankenau et al, 2015; Drugs; Zibbell et al., 2014; AJPH; Tsui et al., 2014; JAMA Internal Medicine
Medication Assisted Treatment
• Data show small percentage of people with
substance use disorders actually get treatment
• Well-documented access and coverage issues
• Numerous provider and patient barriers
Medication Assisted Treatment
• Treatment Coordination Group at Federal level
• Work with states to expand MAT as the
standard of care
• Work with insurers and PBMs to ensure
adequate coverage and reimbursement
policies
Naloxone
• Reverses the potentially fatal respiratory
depression associated with opioid overdose
• Increased attention on community-based
naloxone programs
• Good Samaritan laws
• Propagation of innovative models to expand
access to and use of naloxone
– Co-prescription
– Pharmacy protocols
– First responder and law enforcement
Naloxone
• HHS working to support development and
approval of new naloxone formulations
• Engagement with insurers and PBMs to raise
awareness of naloxone
• DOJ and SAMHSA have created toolkits for
stakeholders
• VA engaged in various initiatives to expand
naloxone access
• DOJ encouraging naloxone adoption by federal
law enforcement
Safe Storage and Disposal 2.0
Drug Disposal Accomplishments
and Remaining Action Items
 Congress passed the Secure and Responsible Drug
Disposal Act of 20101
 FDA website on safe disposal of unused
medicines2
 DEA conducted interim take back activities
o 9 National Take-Back Days/over 2,100 tons returned
 DEA Published Disposal of Controlled Substances
Final Rule 3
 Final rule went into effect October 9, 20143
Promote community-based medication disposal
programs4
1. http://www.deadiversion.usdoj.gov/drug_disposal/non_registrant/s_3397.pdf
2. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/Sa
feDisposalofMedicines/ucm186187.htm#MEDICINES
3. http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/2014-20926.pdf
4. http://www.whitehouse.gov/sites/default/files/ondcp/policy-and-research/rx_abuse_plan.pdf
Community Efforts
Educate the Community: DEA encourages voluntary,
educational outreach to the public on the abuse
potential and proper disposal of pharmaceutical
controlled substances, whether it be through law
enforcement, community groups, or professional
organizations.
Conduct Take-Back Events: Entities may choose to
establish disposal programs for various reasons,
including for profit, to build goodwill in the
community, to attract customers, to advertise
businesses, and to preserve the environment.
The Rule Allows
• Mailback programs
• All means of disposal allowed previously (e.g.,
takeback by DEA)
• Drop boxes in pharmacies
• Drop Boxes in law enforcement agencies
Promising Practice Example: Safe Drug
Disposal Ordinance
Alameda County, California
Bill Pollack, Program Manager, Household Hazardous Waste
Program
• County Drug Take-Back Program
• Pre DEA Regulations: 31 sites, managed & funded by nine agencies:
Wastewater, LEA’s Recycling & HHW program. One is a law enforcement
controlled substances site
Safe Drug Disposal Ordinance
Alameda County, California
Kathleen Pacheco, Senior Deputy County Counsel
• Lawsuit filed in federal court by pharmaceutical trade groups alleging unconstitutional
burden on interstate commerce, violating the dormant commerce clause.
Pharmaceutical Research And Manufacturers Of America; Generic Pharmaceutical Association; Biotechnology
Industry Organization v. County Of Alameda
• Summary Judgment in favor of Alameda County
“Defendants have adequately shown that the Ordinance serves a legitimate public health and safety
interest, and that the relatively modest compliance costs producers will incur should they choose to sell
their products in the county do not unduly burden interstate commerce.” Pharma v. County Of
Alameda (2013) 967 F.Supp.2d 1339, 1346.
• Appealed to US Court of Appeals, Ninth Circuit which upholds
lower court
“However, there is nothing unusual or unconstitutional per se about a state or county regulating the in-state
conduct of an out-of-state entity when the out-of-state entity chooses to engage the state or county through
interstate commerce.” Pharma, et al v. County Of Alameda (2014) 768 F.3d 1037, 1043.
“The fact that the county could run a similar program does not nullify the program's benefits. … Moreover,
even if the Ordinance did nothing other than save the county money, that is not equivalent to “no public
benefits.” 768 F.3d at 1045.
For More Information
• Drug Policy: http://www.whitehouse.gov/ondcp
• Diversion Control: http://www.deadiversion.usdoj.gov/
• Link to final rule:
https://www.federalregister.gov/articles/2014/09/09/201
4-20926/disposal-of-controlled-substances
• Alameda County District 4:
http://www.acgov.org/board/district4/contactus.htm
• ONDCP/DEA Disposal Rule Webinar
• https://www.whitehouse.gov/blog/2014/11/17/watch-
webinar-dea-s-final-rule-disposal-control-substances
•
Neonatal Abstinence Syndrome &
Maternal Substance Use
Change in NAS, 2000-2009
Source: Patrick SW, et. al. Neonatal Abstinence Syndrome and Associated Healthcare Expenditures – United States,
2000-2009. JAMA. 2012 May 9;307(18):1934-40.
Rate of Opioid Pills Circulating
Associated with NAS Rates
• Research looked at opioid pills dispensed per person at the
county-level in Florida in 2009
• Rate of opioid pills distributed to dispensers and rate of
oxycodone pills distributed to dispensers correlated with
Neonatal Abstinence Syndrome rates
• Finding suggests that reducing overprescribing may
reduce NAS by decreasing drugs available for misuse
Source: Sauber-Schatz EK, Mack KA, Diekman ST, Paulozzi LJ. Associations between pain clinic density and distributions
of opioid pain relievers, drug-related deaths, hospitalizations, emergency department visits, and neonatal abstinence
syndrome in Florida. Drug Alcohol Depend. 2013 Nov 1;133(1):161-6. doi: 10.1016/j.drugalcdep.2013.05.017. Epub
2013 Jun 14. PMID: 23769424
Rate of Opioid Pills Circulating
Associated with NAS Rates
• Research looked at opioid pills dispensed per person at the
county-level in Florida in 2009
• Rate of opioid pills distributed to dispensers and rate of
oxycodone pills distributed to dispensers correlated with
Neonatal Abstinence Syndrome rates
• Finding implies that reducing overprescribing will reduce
NAS by decreasing drugs available for misuse
Source: Sauber-Schatz EK, Mack KA, Diekman ST, Paulozzi LJ. Associations between pain clinic density and distributions of opioid pain
relievers, drug-related deaths, hospitalizations, emergency department visits, and neonatal abstinence syndrome in Florida. Drug Alcohol
Depend. 2013 Nov 1;133(1):161-6. doi: 10.1016/j.drugalcdep.2013.05.017. Epub 2013 Jun 14. PMID: 23769424
Types of Maternal Drug Use
That Can Contribute to NAS
• Controlled substances for medical treatment
• Misuse of these same medicines from own or
other’s prescribed medicines
• Certain schedule I drug use (heroin/fentanyl)
–Research suggests 80 percent of heroin
recent heroin initiates were prescription
opioid users before using heroin
Federal NAS Policy Stance
• NAS is an expected side effect of treatment with opioids;
• Policy initiatives should focus on ensuring prenatal care and
stability for mom and babies;
• Women must feel safe to enroll in prenatal and substance
use care;
• Unlike Fetal Alcohol Syndrome, NAS is treatable and does
not generally contribute to lifelong negative outcomes;
• Treatment with opioids during pregnancy may be necessary
for some conditions especially opioid use disorder
treatment;
• Treatment with opioids should not be discontinued during
pregnancy except under medical supervision.
Federal Partner NAS Topics 2015-2016
• ONDCP: Resource Center on NAS and Pregnancy
• SAMHSA:
– Collaborative Guidance for States, Tribes and Communities on Best
Practice Solutions for Child Welfare and Collaborating Service
Providers working with opioid dependent pregnant women, their
infants and families.
– Treatment Guidelines for Opioid Dependent Pregnant Women
• CDC:
– Treating For Two Initiative Activity
– Develop and disseminate guidelines for the use of opioids in
treating chronic pain. The guidelines will target primary care
practitioners and apply to patients > 18 years of age with chronic
pain outside end-of-life care. Special populations (e.g., pregnant
women – given potential adverse maternal and infant outcomes
associated with opioid use) will be addressed within the supporting
text of recommendations when relevant and when they can be
informed by the scientific literature.
2012 Neonatal Abstinence Syndrome
Leadership Meeting
Challenges/Opportunities
– Addressing consequences without contributing to
negative attitudes or discrimination for infants/families
– Research Gaps -- more data needed
– 4/5 newborns with NAS enrolled in Medicaid:
implications for state budgets
– Education of prescribers, pharmacists, and patients
regarding appropriate use of opioids and tools to monitor
therapies
– Build treatment capacity for families, especially
medication-assisted treatment
Highly NAS-Relevant Pillar #1
Prescriber Education as it relates to NAS.
– Prescriber education mandated in only 6
states:
• Massachusetts, Ohio, Iowa, Tennessee,
Kentucky, and Utah
– Prescriber education for Federal prescribers,
including those serving Indian Health Service
– FDA risk evaluation mitigation strategy
(REMS) for long acting/extended-release
opioids offers training for prescribers and
patient materials
Highly NAS-Relevant Pillar #2
• Monitoring
• Check the Prescription Drug
Monitoring Program
• Identify active substance use and
link to treatment
14.6
8.6
3.2
13.0
17.6
8.5
0
5
10
15
20
25
Age 15-17 Age 18-25 Age 26-44
PercentUsingIllicitDruginthePast
Month*
Pregnant Not Pregnant
Among Women of Child-Bearing Age,
Any Illicit Drug Use by Age Category Past Month
Source: Substance Abuse and Mental Health Services Administration, Table 6.72B, Illicit Drug Use in the Past Month among Females Aged 15 to
44, by Pregnancy and Demographic Characteristics: Percentages, Annual Averages Based on 2010-2011 and 2012-2013).
*Annual average percentage for 2012 and 2013
.
Source of Prescription Pain Relievers
Source: SAMHSA, Center for Behavioral Health Statistics and Quality, National Survey on Drug Use and Health, 2009-2010. Unpublished
special tabulations (March 2012).
ONDCP’s Role Regarding Maternal
Drug Use/Drug-Exposed Infants
• Coordinates Federal effort through
interagency processes
• Identifies pertinent science and policy
issues
• Raises awareness via consistent messaging
• Provides technical assistance
• Working with State Policy Teams to expand medication-assisted
treatment (MAT) for treatment of substance use disorders as the
standard of care (i.e., buprenorphine/naltrexone [Suboxone],
methadone, Vivitrol).
• Working with health plans and pharmacy organizations to offer
adequate coverage for screening and treatment, including MAT, for
substance use disorders.
• Working with Centers for Medicare and Medicaid Services to
inform states of substance use disorder health benefits that
insurance policies should contain.
• Inventory treatment availability and work within Affordable Care
Act/state-run health marketplaces to ensure proper resourcing.
Ways ONDCP & Federal Partners Are Working
To Expand Access to Evidence-Based Treatment
Beneficial Laws and Policies
• Provide a safe harbor for pregnant women
seeking medical treatment;
• Promote access to substance use disorder
treatment;
• Expand access to medication-assisted treatment
for opioid-using pregnant women; and
• Support prescriber behavior that reduces opioid
overprescribing.
Laws that Criminalize
Drug Use During Pregnancy
1. Treat substance use disorders as a moral failing;
2. Fail to recognize that most women who use drugs illicitly during pregnancy have
or are developing a serious medical disorder from which they can recover;
3. Can shortchange mothers and babies by prompting women to avoid prenatal
care and/or treatment to evade detection;
4. Ignore access to substance use disorder treatment issues faced by many
pregnant women;
5. Expose mothers to legal fees and the potential legal, housing, employment, and
parenting barriers associated with criminal history; and
6. Have not been shown to produce any better outcomes than policies that
motivate care via the child welfare system.
NAS Relevant Agency Activities
• Technical Assistance to Congress, Executive Agencies, Stakeholders
– Women’s Substance Use Forum (Senators Whitehouse & Portman)
– Policy Academies NGA/ASTHO/HHS
– Tennessee and Florida mapping
• National and Regional Meetings
– 2014 Rx Prevention Summit, NAS Vision Session
– Tennessee and Appalachian Regional Commission Experts Meeting
– Harold Rogers PDMP Meeting
• Bully Pulpit/Press
– Vanderbilt NICU visit
• Convenings
– White House Opioid/Heroin Summit
– Interagency Workgroup on Prescription Drugs
– Interagency Workgroup on Medication-Assisted Treatment
For More Information:
WHITEHOUSE.GOV/ONDCP
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 $720M <0.001
Patrick SW, et. al. Unpublished Analysis by Authors.
Mean LOS and Hospital Charges
for NAS, 2000-2009
2000 2003 2006 2009 p-for-trend
Mean LOS
(day)
15.8 15.9 15.3 16.4 0.21
Mean Charges
(2009 US$)
$39,400 $48,000 $44,600 $53,400 <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.

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Rx15 vision wed_200_ondcp_1_labelle_2jones_3spitznas

  • 1. Opioid Abuse Prevention Plan – 2.0
  • 2. 0 2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000 18,000 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 opioid analgesic 4,030 4,400 5,528 7,456 8,517 9,857 10,92 13,72 14,40 14,80 15,59 16,65 16,91 16,00 16,23 cocaine 3,822 3,544 3,833 4,599 5,199 5,443 6,208 7,448 6,512 5,129 4,350 4,183 4,681 4,404 4,944 heroin* 1,963 1,843 1,784 2,092 2,084 1,879 2,010 2,089 2,402 3,041 3,278 3,036 4,397 5,927 8,260 NumberofDeaths Drug Poisoning Deaths Involving Opioid Analgesics, Cocaine and Heroin: United States, 1999–2013 % CHANGE 2010 to 2013 - 2% +18% + 172% Note: Not all drug poisoning deaths specify the drug(s) involved, and a death may involve more than one specific substance. The rise in 2005-2006 in opioid deaths is related to non-pharmaceutical fentanyl (see http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5729a1.htm). *Heroin includes opium. 1/2015 Source: Centers for Disease Control and Prevention, National Center for Health Statistics [NCHS]. Multiple Cause of Death 1999-2012 on CDC WONDER Online Database, released 2014. Data for 1999 to 2012 were extracted by ONDCP on November 20, 2014. Data for 2013 are from unpublished analysis by NCHS December 30, 2014). 2
  • 3. 0 200 400 600 800 1,000 1,200 1,400 0 2,000 4,000 6,000 8,000 10,000 12,000 14,000 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 NumberofUsers(Thousands) Persons Aged 12 or Older Non-medical users of pain relievers Heroin users Source: SAMHSA, 2013 National Survey on Drug Use and Health (September 2014). 9/2014 Heroin Use or Non-Medical Use of Pain Relievers in the Past Year among Persons Aged 12 or Older: 2002-2013 3
  • 4. In 1999, there was one drug overdose death every 30 minutes. 4
  • 5. In 2013, there was one drug overdose death every 12 minutes. 5
  • 6. Opioid Prevention Plan 2.0 • Education • Monitoring • Disposal • Enforcement • Treatment/Overdose Prevention
  • 7. vsYears 11 hours In four years of medical school, students receive, on average, only 11 hours of pain medication training.
  • 8. Since 2011, Six States Passed Legislation Mandating Prescriber Education
  • 9. Now, prescribers in the Departments of Defense and Health and Human Services and in the Federal Bureau of Prisons are receiving training
  • 10. In the past eight years, state prescription drug monitoring programs have more than doubled.
  • 11. In 2006, only 20 states had prescription drug monitoring programs. Today, all but one have laws authorizing programs – and 48 are operational and 28 have some data sharing capacity.
  • 12. • This September, we joined the Drug Enforcement Administration to announce the final rule of the Safe Drug Disposal Act of 2010.
  • 13. Data show state monitoring Data show state monitoring programs and pain clinic regulations have worked. Data show state monitoring programs and pain clinic regulations have worked.
  • 14. Data show state monitoring programs and pain clinic regulations have worked.
  • 15. Now, police across the country are carrying naloxone – and a majority of states and the District of Columbia enacted legislation to decrease overdose deaths.
  • 16. • Naloxone is a prescription opioid antidote delivered by injection. – National Institute on Drug Abuse is supporting contracts on forms of naloxone approved for use without injection administer – Food and Drug Administration (FDA) is providing fast-track review of new formulations – FDA approved naloxone for use by autoinjector • Working with health plans, pharmacy benefits management plans to raise awareness of naloxone. • VHA now has naloxone policy and naloxone available in mail order pharmacies • With Department of Justice (DOJ) and SAMHSA created a Naloxone toolkit for Law Enforcement. • DOJ encouraging naloxone adoption by federal law enforcement • Administration approved by executive action Department of Defense law enforcement use of naloxone Expanding Access to Overdose Education/Naloxone
  • 18. Opioid Mortality, United States, 1999-2013 0 2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000 18,000 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 NumberofOverdoseDeaths Rx Opioids Heroin Source: CDC/NCHS NVSS Multiple Cause of Death Files 1999-2014.
  • 19. Past Year and Past Month Use Rx Opioids and Heroin, United States, 2002-2013 0 2,000 4,000 6,000 8,000 10,000 12,000 14,000 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 NumberofNonmedicalUsers(inthousands) Past Year Rx Opioids Past Month Rx Opioids 0 100 200 300 400 500 600 700 800 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 NumberofUsers(inthousands) Past Year Heroin Use Past Month Heroin Use * Source: SAMHSA National Survey on Drug Use and Health. * * * * * * * * * * * * * * * * * * * Estimate is significantly different than 2013 estimate
  • 20. Past Year Abuse or Dependence Rx Opioids and Heroin, United States, 2002-2013 0 500 1,000 1,500 2,000 2,500 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 NumberofIndividuals Rx Opioid Abuse or Dependence Heroin Abuse or Dependence * * * * * * * * * * * * Estimate is significantly different than 2013 estimate Source: SAMHSA National Survey on Drug Use and Health.
  • 21. Past Year Heroin Use By Past Year Rx Opioid Nonmedical Use United States, 2002-2004 and 2008-2010 379 176 58 46 99 588 171 115 100 202 0 100 200 300 400 500 600 700 Overall Past Year Heroin Use No Past Year NMU Opioids 1-29 Days Past Year NMU Opioids 30-99 Days Past Year NMU Opioids 100-365 Days Past Year NMU Opioids Numberofpastyearusersamongpersons≥12years old(numbersinthousands) 2002-2004 2008-2010 Jones, C.M., Heroin use and heroin use risk behaviors among nonmedical users of prescription opioid pain relievers – United States, 2002–2004 and 2008–2010. Drug Alcohol Depend. (2013), http://dx.doi.org/10.1016/j.drugalcdep.2013.01.007 * * * * * Estimate is significantly different than 2013 estimate
  • 22. Past Year Heroin Use Incidence Rate of Persons Aged 12 to 49 at Risk for Initiation of Heroin Use, United States, 2002-2004, 2005-2008, 2009-2011 0% 1% 2% 3% 4% 5% 6% 7% 8% 0 Days 1-29 Days 30-99 Days 100-199 Days 200-365 Days No Past Year Abuse/Dependence Past Year Abuse/Dependence PercentReportingPastYearHeroinUse 2002-2004 2005-2008 2009-2011 Muhuri et al. , Associations of Nonmedical Pain Reliever Use and Initiation of Heroin Use in the United States. SAMHSA, 2013 * * * * * * ** * Estimate is significantly different than 2013 estimate
  • 23. Demographic Shift in Heroin Use Shift from inner-city, minority-centered problem to one with more widespread geographical distribution, involving primarily white men and women in their late 20s living outside of large urban areas Source: Cicero et al. JAMA Psychiatry. 2014;71(7):821-826
  • 24. Rx Opioid-Heroin Connection What The Data Tell Us • Nonmedical use of opioid pain relievers is a risk factor for future heroin use • Very small percent of nonmedical users of pain relievers initiate heroin use • Increased accessibility, affordability, and high potency of heroin are likely driving increased use and transitions from prescription opioids • Evidence linking recently enacted prevention policies regarding prescription opioids to a shift to heroin is limited and non-definitive
  • 25. Hepatitis C Between 2006 and 2012 • Acute hepatitis C incidence increased significantly in young people – 13% annually in nonurban counties – 5% annually in urban counties • 30 of 34 states (88%) had higher incidence in 2012 compared to 2006 • Data indicate an emerging US epidemic of HCV infection among young nonurban predominantly white persons • Prescription opioid abuse at an early age was commonly reported Source: Anil G. Suryaprasad et al. Clin Infect Dis. 2014;59:1411-1419
  • 26. Hepatitis C • Lankenau et al., 2015 – aOR=2.69 (95% CI; 1.07-6.78) for people who injected prescription opioids – aOR=2.28 (95% CI; 1.02-5.10) for people who substituted prescription opioids for heroin • Zibbell et al., 2014 – aOR=5.53 (95% CI; 1.92-15.91) for people who injected prescription opioids • Tsui et al., 2015 – aHR=0.39 (95%CI; 0.18-0.97) among young adult injection drug users who received medication-assisted treatment Source: Lankenau et al, 2015; Drugs; Zibbell et al., 2014; AJPH; Tsui et al., 2014; JAMA Internal Medicine
  • 27. Medication Assisted Treatment • Data show small percentage of people with substance use disorders actually get treatment • Well-documented access and coverage issues • Numerous provider and patient barriers
  • 28. Medication Assisted Treatment • Treatment Coordination Group at Federal level • Work with states to expand MAT as the standard of care • Work with insurers and PBMs to ensure adequate coverage and reimbursement policies
  • 29. Naloxone • Reverses the potentially fatal respiratory depression associated with opioid overdose • Increased attention on community-based naloxone programs • Good Samaritan laws • Propagation of innovative models to expand access to and use of naloxone – Co-prescription – Pharmacy protocols – First responder and law enforcement
  • 30. Naloxone • HHS working to support development and approval of new naloxone formulations • Engagement with insurers and PBMs to raise awareness of naloxone • DOJ and SAMHSA have created toolkits for stakeholders • VA engaged in various initiatives to expand naloxone access • DOJ encouraging naloxone adoption by federal law enforcement
  • 31. Safe Storage and Disposal 2.0
  • 32. Drug Disposal Accomplishments and Remaining Action Items  Congress passed the Secure and Responsible Drug Disposal Act of 20101  FDA website on safe disposal of unused medicines2  DEA conducted interim take back activities o 9 National Take-Back Days/over 2,100 tons returned  DEA Published Disposal of Controlled Substances Final Rule 3  Final rule went into effect October 9, 20143 Promote community-based medication disposal programs4 1. http://www.deadiversion.usdoj.gov/drug_disposal/non_registrant/s_3397.pdf 2. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/Sa feDisposalofMedicines/ucm186187.htm#MEDICINES 3. http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/2014-20926.pdf 4. http://www.whitehouse.gov/sites/default/files/ondcp/policy-and-research/rx_abuse_plan.pdf
  • 33. Community Efforts Educate the Community: DEA encourages voluntary, educational outreach to the public on the abuse potential and proper disposal of pharmaceutical controlled substances, whether it be through law enforcement, community groups, or professional organizations. Conduct Take-Back Events: Entities may choose to establish disposal programs for various reasons, including for profit, to build goodwill in the community, to attract customers, to advertise businesses, and to preserve the environment.
  • 34. The Rule Allows • Mailback programs • All means of disposal allowed previously (e.g., takeback by DEA) • Drop boxes in pharmacies • Drop Boxes in law enforcement agencies
  • 35. Promising Practice Example: Safe Drug Disposal Ordinance Alameda County, California Bill Pollack, Program Manager, Household Hazardous Waste Program • County Drug Take-Back Program • Pre DEA Regulations: 31 sites, managed & funded by nine agencies: Wastewater, LEA’s Recycling & HHW program. One is a law enforcement controlled substances site
  • 36. Safe Drug Disposal Ordinance Alameda County, California Kathleen Pacheco, Senior Deputy County Counsel • Lawsuit filed in federal court by pharmaceutical trade groups alleging unconstitutional burden on interstate commerce, violating the dormant commerce clause. Pharmaceutical Research And Manufacturers Of America; Generic Pharmaceutical Association; Biotechnology Industry Organization v. County Of Alameda • Summary Judgment in favor of Alameda County “Defendants have adequately shown that the Ordinance serves a legitimate public health and safety interest, and that the relatively modest compliance costs producers will incur should they choose to sell their products in the county do not unduly burden interstate commerce.” Pharma v. County Of Alameda (2013) 967 F.Supp.2d 1339, 1346. • Appealed to US Court of Appeals, Ninth Circuit which upholds lower court “However, there is nothing unusual or unconstitutional per se about a state or county regulating the in-state conduct of an out-of-state entity when the out-of-state entity chooses to engage the state or county through interstate commerce.” Pharma, et al v. County Of Alameda (2014) 768 F.3d 1037, 1043. “The fact that the county could run a similar program does not nullify the program's benefits. … Moreover, even if the Ordinance did nothing other than save the county money, that is not equivalent to “no public benefits.” 768 F.3d at 1045.
  • 37. For More Information • Drug Policy: http://www.whitehouse.gov/ondcp • Diversion Control: http://www.deadiversion.usdoj.gov/ • Link to final rule: https://www.federalregister.gov/articles/2014/09/09/201 4-20926/disposal-of-controlled-substances • Alameda County District 4: http://www.acgov.org/board/district4/contactus.htm • ONDCP/DEA Disposal Rule Webinar • https://www.whitehouse.gov/blog/2014/11/17/watch- webinar-dea-s-final-rule-disposal-control-substances •
  • 38. Neonatal Abstinence Syndrome & Maternal Substance Use
  • 39. Change in NAS, 2000-2009 Source: Patrick SW, et. al. Neonatal Abstinence Syndrome and Associated Healthcare Expenditures – United States, 2000-2009. JAMA. 2012 May 9;307(18):1934-40.
  • 40. Rate of Opioid Pills Circulating Associated with NAS Rates • Research looked at opioid pills dispensed per person at the county-level in Florida in 2009 • Rate of opioid pills distributed to dispensers and rate of oxycodone pills distributed to dispensers correlated with Neonatal Abstinence Syndrome rates • Finding suggests that reducing overprescribing may reduce NAS by decreasing drugs available for misuse Source: Sauber-Schatz EK, Mack KA, Diekman ST, Paulozzi LJ. Associations between pain clinic density and distributions of opioid pain relievers, drug-related deaths, hospitalizations, emergency department visits, and neonatal abstinence syndrome in Florida. Drug Alcohol Depend. 2013 Nov 1;133(1):161-6. doi: 10.1016/j.drugalcdep.2013.05.017. Epub 2013 Jun 14. PMID: 23769424
  • 41. Rate of Opioid Pills Circulating Associated with NAS Rates • Research looked at opioid pills dispensed per person at the county-level in Florida in 2009 • Rate of opioid pills distributed to dispensers and rate of oxycodone pills distributed to dispensers correlated with Neonatal Abstinence Syndrome rates • Finding implies that reducing overprescribing will reduce NAS by decreasing drugs available for misuse Source: Sauber-Schatz EK, Mack KA, Diekman ST, Paulozzi LJ. Associations between pain clinic density and distributions of opioid pain relievers, drug-related deaths, hospitalizations, emergency department visits, and neonatal abstinence syndrome in Florida. Drug Alcohol Depend. 2013 Nov 1;133(1):161-6. doi: 10.1016/j.drugalcdep.2013.05.017. Epub 2013 Jun 14. PMID: 23769424
  • 42. Types of Maternal Drug Use That Can Contribute to NAS • Controlled substances for medical treatment • Misuse of these same medicines from own or other’s prescribed medicines • Certain schedule I drug use (heroin/fentanyl) –Research suggests 80 percent of heroin recent heroin initiates were prescription opioid users before using heroin
  • 43. Federal NAS Policy Stance • NAS is an expected side effect of treatment with opioids; • Policy initiatives should focus on ensuring prenatal care and stability for mom and babies; • Women must feel safe to enroll in prenatal and substance use care; • Unlike Fetal Alcohol Syndrome, NAS is treatable and does not generally contribute to lifelong negative outcomes; • Treatment with opioids during pregnancy may be necessary for some conditions especially opioid use disorder treatment; • Treatment with opioids should not be discontinued during pregnancy except under medical supervision.
  • 44. Federal Partner NAS Topics 2015-2016 • ONDCP: Resource Center on NAS and Pregnancy • SAMHSA: – Collaborative Guidance for States, Tribes and Communities on Best Practice Solutions for Child Welfare and Collaborating Service Providers working with opioid dependent pregnant women, their infants and families. – Treatment Guidelines for Opioid Dependent Pregnant Women • CDC: – Treating For Two Initiative Activity – Develop and disseminate guidelines for the use of opioids in treating chronic pain. The guidelines will target primary care practitioners and apply to patients > 18 years of age with chronic pain outside end-of-life care. Special populations (e.g., pregnant women – given potential adverse maternal and infant outcomes associated with opioid use) will be addressed within the supporting text of recommendations when relevant and when they can be informed by the scientific literature.
  • 45. 2012 Neonatal Abstinence Syndrome Leadership Meeting
  • 46. Challenges/Opportunities – Addressing consequences without contributing to negative attitudes or discrimination for infants/families – Research Gaps -- more data needed – 4/5 newborns with NAS enrolled in Medicaid: implications for state budgets – Education of prescribers, pharmacists, and patients regarding appropriate use of opioids and tools to monitor therapies – Build treatment capacity for families, especially medication-assisted treatment
  • 47. Highly NAS-Relevant Pillar #1 Prescriber Education as it relates to NAS. – Prescriber education mandated in only 6 states: • Massachusetts, Ohio, Iowa, Tennessee, Kentucky, and Utah – Prescriber education for Federal prescribers, including those serving Indian Health Service – FDA risk evaluation mitigation strategy (REMS) for long acting/extended-release opioids offers training for prescribers and patient materials
  • 48. Highly NAS-Relevant Pillar #2 • Monitoring • Check the Prescription Drug Monitoring Program • Identify active substance use and link to treatment
  • 49. 14.6 8.6 3.2 13.0 17.6 8.5 0 5 10 15 20 25 Age 15-17 Age 18-25 Age 26-44 PercentUsingIllicitDruginthePast Month* Pregnant Not Pregnant Among Women of Child-Bearing Age, Any Illicit Drug Use by Age Category Past Month Source: Substance Abuse and Mental Health Services Administration, Table 6.72B, Illicit Drug Use in the Past Month among Females Aged 15 to 44, by Pregnancy and Demographic Characteristics: Percentages, Annual Averages Based on 2010-2011 and 2012-2013). *Annual average percentage for 2012 and 2013 .
  • 50. Source of Prescription Pain Relievers Source: SAMHSA, Center for Behavioral Health Statistics and Quality, National Survey on Drug Use and Health, 2009-2010. Unpublished special tabulations (March 2012).
  • 51. ONDCP’s Role Regarding Maternal Drug Use/Drug-Exposed Infants • Coordinates Federal effort through interagency processes • Identifies pertinent science and policy issues • Raises awareness via consistent messaging • Provides technical assistance
  • 52. • Working with State Policy Teams to expand medication-assisted treatment (MAT) for treatment of substance use disorders as the standard of care (i.e., buprenorphine/naltrexone [Suboxone], methadone, Vivitrol). • Working with health plans and pharmacy organizations to offer adequate coverage for screening and treatment, including MAT, for substance use disorders. • Working with Centers for Medicare and Medicaid Services to inform states of substance use disorder health benefits that insurance policies should contain. • Inventory treatment availability and work within Affordable Care Act/state-run health marketplaces to ensure proper resourcing. Ways ONDCP & Federal Partners Are Working To Expand Access to Evidence-Based Treatment
  • 53. Beneficial Laws and Policies • Provide a safe harbor for pregnant women seeking medical treatment; • Promote access to substance use disorder treatment; • Expand access to medication-assisted treatment for opioid-using pregnant women; and • Support prescriber behavior that reduces opioid overprescribing.
  • 54. Laws that Criminalize Drug Use During Pregnancy 1. Treat substance use disorders as a moral failing; 2. Fail to recognize that most women who use drugs illicitly during pregnancy have or are developing a serious medical disorder from which they can recover; 3. Can shortchange mothers and babies by prompting women to avoid prenatal care and/or treatment to evade detection; 4. Ignore access to substance use disorder treatment issues faced by many pregnant women; 5. Expose mothers to legal fees and the potential legal, housing, employment, and parenting barriers associated with criminal history; and 6. Have not been shown to produce any better outcomes than policies that motivate care via the child welfare system.
  • 55. NAS Relevant Agency Activities • Technical Assistance to Congress, Executive Agencies, Stakeholders – Women’s Substance Use Forum (Senators Whitehouse & Portman) – Policy Academies NGA/ASTHO/HHS – Tennessee and Florida mapping • National and Regional Meetings – 2014 Rx Prevention Summit, NAS Vision Session – Tennessee and Appalachian Regional Commission Experts Meeting – Harold Rogers PDMP Meeting • Bully Pulpit/Press – Vanderbilt NICU visit • Convenings – White House Opioid/Heroin Summit – Interagency Workgroup on Prescription Drugs – Interagency Workgroup on Medication-Assisted Treatment
  • 57. 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 $720M <0.001 Patrick SW, et. al. Unpublished Analysis by Authors.
  • 58. Mean LOS and Hospital Charges for NAS, 2000-2009 2000 2003 2006 2009 p-for-trend Mean LOS (day) 15.8 15.9 15.3 16.4 0.21 Mean Charges (2009 US$) $39,400 $48,000 $44,600 $53,400 <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.