The Opioid Epidemic Overview and a Look to the Future

June 12, 2015 Christopher M. Jones PharmD, MPH

Senior Advisor Office of Public Health Strategy and Analysis

Office of the Commissioner Food and Drug Administration

2

Overview

• Trends • Emerging Successes • Federal Initiatives

– Prescribing – Medication assisted treatment – Naloxone

3

ABUSE AND OVERDOSE TRENDS

4

Past Month Nonmedical Use of Prescription Drugs, US, 2002-2013

Source: Substance Abuse and Mental Health Services Administration, NSDUH 2013

5

Past Year Abuse or Dependence, US, 2002-2013

0

500

1000

1500

2000

2500

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

Num

ber o

f per

sons

12

year

s and

old

er (i

n th

ousa

nds)

Pain Relievers Tranquilizers Stimulants Sedatives

Source: Substance Abuse and Mental Health Services Administration, NSDUH 2013

6

Drug Overdose Deaths, US, 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

Rx Opioids Benzodiazepines Psychostimulants

Source: Centers for Disease Control and Prevention, NVSS, 2013

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Rx Opioid Overdose Deaths, Sales and Treatment Admissions, US, 1999-2011

United States, 1999-2011. National Vital Statistics System, DEA’s Automation of Reports and Consolidated Orders System, SAMHSA’s TEDS. Treatment admission rates are per 10,000 people ages 12+.

8

Rx Opioid Prescribing Rates by State, US, 2012

Source: CDC Vital Signs, 2014

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Rx Opioid Dose and Risk of Overdose Death

Source: Baumblatt et al., High-risk use by patients prescribed opioids for pain and its role in overdose deaths. JAMA IM. 2014;174:796-801.

10

Source of Nonmedically Used Rx Opioids by Frequency of Use, US, 2008-2011

Source: Jones CM, Paulozzi LJ, Mack KA. Sources of prescription opioid pain relievers by frequency of past-year nonmedical use: United States, 2008-2011. JAMA Internal Medicine. 2014

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Rx Opioid, Benzodiazepine, and Psychostimulant Prescribing, US, 2010-2014

2010 2011 2012 2013 2014Psychostimulants 45,299,514 49,566,341 51,521,221 54,828,818 57,769,880Benzodiazepines 91,658,926 93,712,150 94,532,404 95,273,213 94,858,571Opioid Analgesics 278,808,753 279,508,416 282,170,040 274,308,717 267,279,109

0

50,000,000

100,000,000

150,000,000

200,000,000

250,000,000

300,000,000

Num

ber o

f Pre

scrip

tions

Dis

pens

ed

Psychostimulants Benzodiazepines Opioid Analgesics

Source: IMS Health, National Prescription Audit, Data extracted 6/1/205

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Rx Opioid Prescribing by Medical Specialty, US, 2007-2012

-10

-5

0

5

10

15

2007 2008 2009 2010 2011 2012

Perc

ent c

hang

e fr

om b

asel

ine

in ra

te o

f opi

oid

rx/t

otal

rx

Family Practice Internal Medicine General PracticeEmergency Medicine Non-Physician Prescribers SurgeryPhysical Medicine/Rehab Pain Medicine Dentistry

PMR

PM

GP IM

NPP FP

Surg

Dent

EM

Source: Levy, Paulozzi, Mack, Jones. AM J Prev Med, 2015

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Rx Opioid and Heroin-Related Overdose Deaths 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

Num

ber o

f Ove

rdos

e De

aths

Rx Opioids

Heroin

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

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Past Year Heroin Use by Past Year Rx Opioid Nonmedical Use

US, 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 YearHeroin Use

No Past Year NMUOpioids

1-29 Days Past YearNMU Opioids

30-99 Days PastYear NMU Opioids

100-365 Days PastYear NMU Opioids

Num

ber o

f pas

t yea

r use

rs a

mon

g pe

rson

s ≥1

2 ye

ars

old

(num

bers

in th

ousa

nds)

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),

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Past Year Heroin Use Incidence Rate Among People Aged 12 to 49 at Risk for Heroin

Initiation, US, 2002-2011

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

Perc

ent R

epor

ting

Past

Yea

r Her

oin

Use

2002-2004 2005-2008 2009-2011

Source: Muhuri et al. , Associations of Nonmedical Pain Reliever Use and Initiation of Heroin Use in the United States. SAMHSA, 2013

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FEDERAL INITIATIVES

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HHS Activities Behavioral Health Coordinating Committee

Prescription Drug Abuse Subcommittee

• Surveillance • Drug Abuse

Prevention • Patient and Public

Education • Provider Education

• Clinical practice tools • Regulatory and

Oversight Activities • Drug Abuse

Treatment • Overdose Prevention

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HHS Secretary’s Initiative

• Improve opioid prescribing • Increase use of naloxone to reverse opioid

overdose • Expand use of Medication-Assisted Treatment

(MAT) for opioid use disorders

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Improve opioid prescribing

• Opioid prescribing guidelines • EHR clinical decision support • Educational opportunities

– FDA ER/LA Opioid Analgesic REMS – NIDAMED and Centers of Excellence in Pain

Education • Funding and Technical Assistance to enhance

PDMPs • CDC Prevention for States funding

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Increase use of naloxone

• July 1-2 public meeting on naloxone • FDA and NIDA support to facilitate development

of new formulations of naloxone – Evzio approval April 2014

• NIDA supported research to optimize development and delivery of overdose education and naloxone distribution programs

• Funding for communities and other entities to support purchase and use of naloxone

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Expand access to and use of MAT

• NIDA supported research to optimize MAT implementation and delivery

• FDA expedited review programs to incentivize development of addiction treatments

• SAMHSA grants to states to support uptake of MAT

• Continued oversight and provision of technical assistance on MAT

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EMERGING SUCCESSES

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Washington State

• Multi-faceted approach – State-wide chronic pain and ED guidelines, PDMP, Medicaid

innovations, Patient Review and Coordination program, etc.

• Decline in opioid overdose death rate since 2008 • Decline in opioid hospitalizations for first time in 2012

Source: Franklin, Sabel, Jones, et al. A comprehensive approach to address the prescription opioid epidemic in Washington State: milestones and lessons learned. AJPH 2015

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Florida

• Multi-faceted approach targeting inappropriate prescribing and use behaviors – Pill mill law, PDMP, prohibit dispensing of controlled

substances from MD office, aggressive action against illegal prescribing

• 27% decline in opioid overdose death rate between 2010 and 2012

• 28.4% decline in benzodiazepine overdose death rate during same time period

• Reductions paralleled declines in prescribing

Source: Johnson et al. MMWR Morb Mortal Wkly Rep. 2014 Jul 4;63(26):569-74.

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Other States • KY, TN, NY

– Required mandatory PDMP checks before prescribing certain controlled prescription drugs

– Initial results are positive • KY: 8.5% decline in doses of controlled substances • TN: 7% decline in opioid Rxs, 6% decline in MMEs, 36%

decline in multiple provider episodes • NY: 9.5% decline in opioid Rxs, 75% decline in multiple

provider episodes

• Oregon – Declines in rx opioid overdose deaths that coincided

with declines in opioid prescribing after multi-pronged approach

Source: CDC, 2014 & 2015.

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Conclusions

• Prescription opioid abuse is a significant public health issue in the U.S.

• Some successes are emerging – states continue to be leaders on this issue

• Federal government response must compliment and support response by state and local governments, healthcare community, and the public

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Questions?

Christopher.M.Jones@fda.hhs.gov

The findings in this presentation do not represent the official position of the US Food and Drug Administration, the Department of Health and

Human Services, or the U.S. Government