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+.
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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?
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
