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

Nu

mb

er

of

De

ath

s

Drug Poisoning Deaths Involving Opioid Analgesics, Cocaine and Heroin: United States, 1999–2013

% CHANGE2010 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 Data for 2013 are from unpublished analysis by NCHS December 30, 2014).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

Nu

mb

er

of

Use

rs (

Tho

usa

nd

s)

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

Nu

mb

er o

f O

verd

ose

Dea

ths

Rx Opioids

Heroin

Source: CDC/NCHS NVSS Multiple Cause of Death Files 1999-2014.

Past Year and Past Month UseRx 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

Nu

mb

er

of

No

nm

edic

al U

sers

(in

th

ou

san

ds)

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

Nu

mb

er o

f U

sers

(in

th

ou

san

ds)

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 DependenceRx 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

Nu

mb

er

of

Ind

ivid

ual

s

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

115100

202

0

100

200

300

400

500

600

700

Overall Past YearHeroin Use

No Past Year NMUOpioids

1-29 Days Past YearNMU Opioids

30-99 Days PastYear NMU Opioids

100-365 Days PastYear NMU Opioids

Nu

mb

er o

f p

ast

year

use

rs a

mo

ng

per

son

s ≥

12

yea

rs

old

(n

um

ber

s in

th

ou

san

ds)

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 YearAbuse/Dependence

Past YearAbuse/Dependence

Per

cen

t R

epo

rtin

g P

ast

Year

Her

oin

Use

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 ConnectionWhat 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 Accomplishmentsand 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.pdf2. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/Sa

feDisposalofMedicines/ucm186187.htm#MEDICINES3. http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/2014-20926.pdf4. 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 OrdinanceAlameda 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/2014/09/09/2014-20926/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. Epub2013 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

Pe

rce

nt

Usi

ng

Illic

it D

rug

in t

he

Pas

t M

on

th*

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 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. 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.