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Office of the Governor
And the Oscar for Best Actor Goes to…Hydrocodone?
Prescription Drug Abuse in Modern American Film:Lessons for Treatment, Prevention, and Public Health
Robert Valuck, PhD, RPh
Professor of Pharmacy, Epidemiology, and Family MedicineCoordinating Center Director, Colorado Consortium for
Prescription Drug Abuse Prevention
May 18, 2014
Office of the Governor
Objectives
• Using a sample (real, but identity protected) patient and clips from modern American films as examples…
– Describe the scope of the prescription drug abuse problem in the United States and Colorado
– Discuss some of the factors contributing to the growth in prescription drug abuse
– Highlight policy initiatives and programs at the federal and state levels (including Colorado) to address the problem
– Offer examples of actions that physicians can take to promotesafe use, safe storage, and safe disposal of prescription drugs
Office of the Governor
Prologue
So, what’s the big deal?
Office of the Governor
Drug Overdose Mortality
• In 2010, 38,329 people died from a drug overdose in the U.S.– One every 14 minutes– Nearly 60% of those deaths involved prescription drugs– Painkillers (opioids) were involved in 75% of those deaths
• In Colorado, drug overdose deaths range from 250-500/year• Since 2003, more overdose deaths have involved opioids
than heroin and cocaine combined• Rates of misuse and overdose death are highest among men,
persons aged 20-64, non-Hispanic whites, and poor and rural• Two main at-risk populations: long term medical users (>10
million) and nonmedical users in past month (>6 million)
CDC/MMWR Jan 13, 2012; 61(01):10-13. Colorado Rx Abuse Task Force data SAMSHA/NSDUH 2009 survey.
Office of the Governor
Drug Overdose Mortality in the U.S. (2010)
CDC/NCHS National Vital Statistics System, CDC Wonder. Updated 2010..
Office of the Governor
Drug Overdose Mortality Trends (1979-2010)
CDC/NCHS National Vital Statistics System, CDC Wonder. Updated 2010..
Office of the Governor
Drug Overdose Death Rates in the US
NCHS Data Brief, December, 2011, Updated with 2009 and 2010 mortality data
1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 20100
5
10
15
20
25
Motor Vehicle Traffic Drug Poisoning (Overdose)
Year
Dea
ths
per
100,
000
popu
latio
n
Office of the Governor
8
Opioid and Benzodiazepine Trends Different thanHeroin and Cocaine in the US (1999-2010)
CDC/NCHS National Vital Statistics System, CDC Wonder. Updated 2010..
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 20100
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
18,000
Opioids Heroin Cocaine Benzodiazepines
Year
Num
ber
of D
eath
s
Office of the Governor
9
Prescription Drugs: primary driver of Overdose Deaths in US (2010)
Jones et al. JAMA 2013; and CDC/NCHS 2010.
Rx Opioids
Benzo
diazep
ines
Cocaine
Antidepressa
nts
Heroin
Other
unspec
ified narc
otics
Illicit
stimulan
ts
Antiepileptic a
nd antipark
insonism
drugs
Syste
mic and hem
atologic
al dru
gs
Antipsych
otic and neu
rolep
tic dru
gs
Acetaminophen
Respira
tory
drugs
Cardiova
scular d
rugs
Barbitu
rates
Autonomic n
ervous s
ystem
drugs
NSAID
s
Anesth
etics
and therap
eutic g
ases
Cannibas
Hormones
, insu
lins,
gluco
corti
coids
Anti-infec
tives
Diuretics an
d other
drugs
Topica
l dru
gs
Other
psych
otropic d
rugs
Muscl
e rela
xants
Other
analgesic
s
Gastro
intestinal
drugs
LSD and oth
er psy
chodys
leptics0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
18,000
Drug or Drug Class
Num
ber
of D
eath
s
Office of the Governor
10
Opioids more likely to be involved in single drug class deaths (US, 2010)
Jones et al. JAMA 2013
Opioid Analgesics (
n=16651)
Antiepileptic a
nd Antiparkinsonism
Drugs (
n=1717)
Benzodiaze
pines (n=6497)
Barbiturates (
n=296)
Antidepressants
(n=3889)
Antipsych
otic and N
euroleptic Drugs (
n=1351)
Other Psy
chotro
pic Drugs (
n=24)0
5
10
15
20
25
30
35
29.4
6.23.7
9.110.5
6.48.3
Psychotherapeutic Pharmaceuticals
Perc
ent
Office of the Governor
11
Deaths are the Tip of the Iceberg…For every opioid overdose death in 2011
SAMHSA NSDUH, DAWN, TEDS data setsCoalition Against Insurance Fraud. Prescription for Peril. http://www.insurancefraud.org/downloads/drugDiversion.pdf 2007.
Office of the Governor
Cost of Prescription Drug Abuse on theU.S. Economy (2006)
Hansen et al. Clin J Pain 2011; 27(3): 194-202.
Office of the Governor
How did we get into this mess?
• An enormous amount of opioids moves through U.S. channels – 1997: 96mg “morphine equivalents” dispensed per person (in the U.S.)– 2007: 700mg per person (in the US) – an increase of >600%– That 700mg per person is enough for every person in the U.S. to take
a typical 5mg dose of Vicodin every 4 hours for 3 weeks– While accounting for about 5 percent of the world’s population, the U.S. now
consumes 99 percent of the world’s Vicodin and 84 percent of its Oxycontin
• Causes of the increase? There are many, including…– Increased recognition of pain, undertreatment of pain– Pain as the “fifth vital sign”, JCAHO quality measure, etc.– Drug company advertising and promotion– Practitioners are not well trained in opioid pharmacology, addiction– Drugs are very powerful, highly addictive if not used properly– Scamming, doctor/pharmacy shopping, black market for opioids
CDC/MMWR Jan 13, 2012; 61(01):10-13. SAMHSA/NSDUH 2009 survey.
CDC/MMWR Jan 13, 2012; 61(01):10-13. SAMHSA/NSDUH 2009 survey.
Office of the Governor
Sales of Opioid Pain Relievers and Nonmedical Opioid Use (2010-11)
#37 in U.S.
Office of the Governor
Sales of Opioid Pain Relievers and Nonmedical Opioid Use (2010-11)
#2 in U.S.(Oregon = 6.4)
Office of the Governor
Scene #1
Nonmedical Use: The Beginnings
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A Typical Patient: Aaron
• Aaron is a 22 year old male, who started using prescription opioidswhen he was in high school
• He was a typical high school student, from an upper middle class family, played sports, was looked up to by siblings and friends
• Aaron started experimenting with prescription drugs at a “pharming” party, where students raid their (parents’) medicine cabinets, bring anyRx drugs they can find to the party, dump them all into a bowl, stir them around, and “pick one or two and chase them with a beer”
• This led to further nonmedical use: trying one or two of his parents’ Vicodin, then one or two more; getting more from friends; and gradually falling into the spiral of increased use, leading to tolerance, leading to increased use, leading to dependence, and ultimately addiction
Office of the Governor
Other Paths to Nonmedical Use
From 1967…Valley of the Dolls
http://youtu.be/t054GSzRywg
Office of the Governor
Other Paths to Nonmedical Use
From 2014…in your own home
https://www.youtube.com/watch?v=0bZOgj5HEAE
Office of the Governor
Sources of Opioids among Nonmedical Users
CDC/MMWR Jan 13, 2012; 61(01):10-13. SAMHSA/NSDUH 2009 survey.
Office of the Governor
Scene #2
Getting Worse: Scamming and Stealing
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Aaron: Spiraling Downward
• As his addiction became stronger, Aaron started to scam doctors for opioid medications (later described it as easy: “Google ‘how to get opioids from a doctor’ and you’ll get lots of ideas”)
• He estimated that he visited between 40 and 50 doctors over an 18 month period, and went to about an equal number of pharmacies, to “spread myself around and stay beneath the radar”
• Most of the doctors gave him at least an initial Rx for Vicodin (his drug of choice due to the ability to request and get refills from doctors, their weekend colleagues covering for them, etc.)
• He finally started running into difficulty when the Vicodin “didn’t do it for me”, and he progressed to OxyContin (oxycodone)
Office of the Governor
23
Majority of opioids consumed by small percentage of patients
(Arkansas Medicaid, 2005)
<17 17-22 23-27 28-31 32-38 39-45 46-56 57-75 76-99 100+0
10
20
30
40
50
60
70
0.1 0.3 0.6 1 1.6 2.95
8.9
16.4
62.9
Deciles of Daily Dosage in Morphine Equivalents
Perc
ent
of
tota
l opio
ids c
onsum
ed
Edlund et al. J Pain Symp Manage 2010;40:279-289
Office of the Governor
24
Top 8.1% of providers prescribe 79% of CII-CIV drugs (Oregon PDMP, 2011-12)
Oregon PDMP Report 2012: http://www.orpdmp.com/orpdmpfiles/PDF_Files/Reports/Statewide_10.01.11_to_03.31.12.pdf
60%19%
21%Top 2,000 Providers
2,001-4,000 Providers
Remaining 45,330 Providers
Office of the Governor
25
Top 20% of prescribers account for63% of Overdose Deaths
(Ontario Public Drug Program, 2006)
1 2 3 4 50
10
20
30
40
50
60
70
17.3 18.9 20.4 21.9 21.4
2.0 4.0
12.7
18.6
62.7Pct of total patients Pct of total deaths
Quintiles of Prescribers from lowest to highest prescribing rate
Perc
ent
Dhalla et al. Can Fam Physician 2011;57:e92-e96.
Office of the Governor
26
Overdose risk highest among small percentage of patients at high dosage
(Group Health, 1997-2005)
1-19 20-49 50-99 100+0
1
2
3
4
5
6
7
8
9
10
0
10
20
30
40
50
60
70
80
90
100
11.44
3.73
8.87
Opioid dosage (MME/d)
Ris
k (
Odds R
ati
o)
% P
ati
ent
Years
Dunn et al, Ann Int Med 2010;152:85-92.
Office of the Governor
27
More patients on opioids = more doctor shoppers
Cepeda et al. J Opioid Manag. 2013.
1-17 18-35 36-65 66-149 150-227 228-457 458-915 916-1831 1,832-29360
100
200
300
400
500
600
700
1.0 4.1 7.1 14.529.8
60.1
171.1
620.1
0.0
Number of patients on opioid analgesics per prescriber
Odd
s ra
tio o
f hav
ing
doct
or s
hopp
ers
as p
atien
ts
100% of patients
are doctor shoppers
Office of the Governor
Stealing Can Turn to Robbery…and Worse
From 1989…Drugstore Cowboy
http://youtu.be/puXEHhZgXaY
Office of the Governor
Scene #3
Rock Bottom: Heroin and Overdose
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Aaron: Spiraling Downward
• AD eventually started using OxyContin at very high doses, mixed it with Xanax and often alcohol, and overdosed at age 21
• AD had a difficult stay in the ICU, and while there had two myocardial infarctions, seizures, a staph infection and pneumonia, and underwent extreme withdrawal symptoms
• Doctors were preparing AD’s parents for his death, which appeared imminent and very likely
• Surprisingly, AD regained consciousness, and eventually recovered well enough to be discharged home with his parents
• The disposition of AD’s case will be shown at the end of the talk; his is certainly not the only example of the downward spiral…
Office of the Governor
31
Frequent Nonmedical Users of Opioids more likely to Engage in Risky Use Behaviors (US, 2008-2010)
Characteristic
1-29 Days of PYNMU of Opioid Pain Relievers
30-99 Days of PYNMU of Opioid Pain Relievers
100-365 Days of PYNMU of Opioid Pain Relievers
aOR (95% CI) aOR (95% CI) aOR (95% CI)
Past Year Heroin Use referent 2.8 (1.7-4.5) 6.4 (3.7-11.1)
Ever Inject Heroin referent 1.6 (0.9-2.9) 4.3 (2.5-7.3)
Ever Inject Opioid Pain Relievers referent 3.8 (1.9-7.8) 13.3 (7.7-23.0)
Past Year Heroin Abuse or Dependence referent 3.2 (1.7-6.1) 7.8 (4.7-12.8)
Past Year Opioid Pain Reliever Abuse or Dependence referent 2.9 (2.3-3.8) 8.9 (7.1-11.3)
Heroin Fairly or Very Easy to Obtain referent 1.4 (1.1-1.7) 2.1 (1.8-2.6)
Abbreviations: PYNMU, past year nonmedical use; aOR, adjusted Odds Ratio; 95% CI, 95% Confidence Interval
1Odds ratio adjusted for sex, age, race/ethnicity, total family income, and county type
Jones, CM. Drug Alcohol Depend 2013.
Office of the Governor
32
Majority of Heroin users in past year reported Nonmedical use of Opioids before heroin initiation
(US, 2002-2004 and 2008-2010)
Jones, C.M. Drug Alcohol Depend 2013.
2002-2004 2008-2010 2002-2004 2008-2010 2002-2004 2008-2010 2002-2004 2008-20101-29 Days PYNMU 30-99 Days PYNMU 100-365 Days PYNMU Any PYNMU
0
10
20
30
40
50
60
70
80
90
100
32.8
12.4 10.116.9
10.5 11.216.8 12.9
2.1
18.415.2
6.725.4
6.2
16.4
9.7
65.1 69.174.7 76.4
64.1
82.6
66.877.4
Age first use OPR same as heroin Age first use heroin before OPR Age first use OPR before heroin
Frequency of Past Year Nonmedical Use
Perc
ent
Office of the Governor
The Heroin Lifestyle
From 1996…Trainspotting
http://www.youtube.com/watch?v=Naf_WiEb9Qs&list=PLBA06889EA057B4C0&feature=share
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Scene #4
The Way Out: Treatment and Recovery
Office of the Governor
35
Rates of opioid overdose deaths, sales and treatment admissions increased in parallel (US, 1999-2010)
CDC/National Vital Statistics System
DEA ARCOS System
SAMHSA’s TEDS System
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 20100
1
2
3
4
5
6
7
8
Opioid Sales KG/10,000 Opioid Deaths/100,000Opioid Treatment Admissions/10,000
Year
Rate
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Substance Abuse Treatment Gap (2011)
SAMHSA/NSDUH 2011 survey
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Physicians Authorized to Treat Addiction (Buprenorphine/Methadone)
SAMHSA. National Expenditures for MH Services and Substance Abuse Treatment, 1986-2009. Pub SMA-13-4740.
Office of the Governor
Scene #5
The Way Forward: Coordinated Responses
Office of the Governor
39
Office of the Governor
Federal Initiatives (alphabet soup warning)
• FDA: REMS programs, stricter regulation on DTC advertising, support of rescheduling certain drugs (hydrocodone) to C-II
• CDC: Increased surveillance, grant funding, elevate topic in national discussion
• DEA: Takeback events (2X/year), new rules on returning unused controlled substances (pending), rescheduling
• ONDCP: Federal strategic plan, elevate topic in national discussion
• DOJ: Promote PDMP programs, interstate data sharing• CMS: Pharmacy/provider restrictions, quantity restrictions• NIH: Research funding (basic science, clinical science, policy,
collaborative mechanisms/center grants)
Office of the Governor
Other States and Policy Examples
• Tougher Pill Mill Laws, Doctor Shopping Laws• Physical Exam Requirements• Tamper Resistant Form Requirements• Prescription Limits• Patient ID Requirements• Immunity from Prosecution• Naloxone Laws• Prospective Reports from PDMP programs
(and other enhancements)
Office of the Governor
42
Pill Mill Laws
CDC PHLP 2013 Brandeis TTAC Best Practices Report 2013.Trust for America’s Health Report 2013..
Office of the Governor
43
Doctor Shopping Laws
CDC PHLP 2013 Brandeis TTAC Best Practices Report 2013.Trust for America’s Health Report 2013..
Office of the Governor
44
Physical Exam Requirements
CDC PHLP 2013 Brandeis TTAC Best Practices Report 2013.Trust for America’s Health Report 2013..
Office of the Governor
45
Tamper Resistant Forms
CDC PHLP 2013 Brandeis TTAC Best Practices Report 2013.Trust for America’s Health Report 2013..
Office of the Governor
46
Prescription Limits
CDC PHLP 2013 Brandeis TTAC Best Practices Report 2013.Trust for America’s Health Report 2013..
Office of the Governor
47
Patient ID Requirements
CDC PHLP 2013 Brandeis TTAC Best Practices Report 2013.Trust for America’s Health Report 2013..
Office of the Governor
48
Immunity from Prosecution
CDC PHLP 2013 Brandeis TTAC Best Practices Report 2013.Trust for America’s Health Report 2013..
Office of the Governor
49
PDMP Proactive Reporting
Brandeis TTAC Best Practices Report 2013.Trust for America’s Health Report 2013..
Office of the Governor
Here in Colorado…
Office of the Governor
In 2010…
Office of the Governor
Office of the Governor
Office of the Governor
Recommendations to Reduce Prescription DrugMisuse and Abuse in Colorado
Colorado Consortium for
Prescription Drug Abuse Prevention
• The Colorado Consortium for Prescription Drug Abuse Prevention, housed at the CU School of Pharmacy, will serve as the operational lead for the CO Plan to Reduce Rx Abuse with participation from the Governor’s Policy Office, a variety of state agencies, and community partners. The Consortium will help to facilitate and implement Workgroup Recommendations mentioned below.
Provider & Prescriber Education
• Change state board policies (or rules) for all DORA-licensed prescribers to include pain management guidelines.
• Enlist and support DORA to provide education about the existence and utilization of PDMP as part of the licensing processes for prescribers and pharmacists.
PDMP • Form taskforce with representation from various agencies to examine the use of PDMP as a public health
tool.
• Improve usability and appropriate accessibility of the PDMP system through the use of information technology and increased stakeholder access.
Disposal
• Expand take-back program in law enforcement agencies – develop permanent drop-off sites with Law Enforcement.
• Expand take-back program to pharmacies (pending DEA approval).
• Establish Colorado guidelines on flushing.
Public Awareness
• Develop (or utilize existing) social marketing campaign that targets the General Public and overcomes existing obstacles and misperceptions.
• Develop (or utilize existing) social marketing campaign that targets Youth and Young Adults (12-25 year olds) and overcomes existing obstacles and misperceptions.
Data & Analysis
• Map out all sources of data related to prescription drug use, misuse and overdose in the state in order to monitor trends, educate the public and inform decision making by multiple stakeholders.
• Identify other efforts that successfully use crosswalks between diverse data sources and successfully standardize their data collection tools across agencies.
Office of the Governor
Prescriber and Provider
Education Workgroup
Agency Co-Chair: Cathy Traugott, HCPF
Univ Co-Chair:Lee Newman, MD
PDMP Workgroup
Agency Co-Chair:Chris Gassen, DORA
Univ Co-Chair: Jason Hoppe, DO
Safe DisposalWorkgroup
Agency Co-Chair:Shannon Breitzman,
CDPHE
Univ Co-Chair: Sunny Linnebur,
PharmD
Public AwarenessWorkgroup
Agency Co-Chair:Stan Paprocki, OBH
Univ Co-Chair: Carol Runyan, PhD
TreatmentWorkgroup
Agency Co-Chair:Denise Vincioni, OBH
Univ Co-Chair:Paula Riggs, MD
Data/AnalysisWorkgroup
Agency Co-Chair:Barbara Gabella,
CDPHE
Univ Co-Chair: Ingrid Binswanger, MD
Coordinating Center CU School of Pharmacy
+Coordinating Committee
Governor
Policy Lead
CO AttorneyGeneral
Substance Abuse Trend & Response
Task Force
CO Legislature
Colorado Consortium for Prescription Drug Abuse PreventionA coordinated, statewide, interuniversity/interagency network
LEGEND
= New
= Existing
Subcommittee
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Epilogue
Making an Impact: One Patient at a Time
Office of the Governor
Aaron: Where is he now?
http://www.riseaboveco.org/rx/rx4.html
Office of the Governor
What can I do for my patients?
Office of the Governor
Six Things You Can Do
1. Take C.E. courses, get all the additional training you can2. Find and follow guidelines for safe opioid prescribing3. Be willing to prescribe less (smaller quantities, other
alternatives), and see patients more often4. Check the PDMP more often (more on this shortly)
5. Educate patients on the importance of safe storageand disposal of unused medications
6. Talk with your colleagues, family, friends and neighbors about this…tell them stories about affected patients
Office of the Governor
Office of the Governor
HB14-1283 (PDMP Enhancement Bill)
• Passed this Spring, will be signed into law on Weds 5/21/14• Several key provisions:
– Mandatory registration for PDMP account (not mandatory use) – Delegated access (up to three delegates per provider)– Unsolicited reports of potential doctor/pharmacy shoppers– CDPHE access to system for public health surveillance– Advisory Board (consortium PDMP work group) to guide
implementation and future directions
Not requiring legislation: daily reporting of dispensing data (Rx’s filled) by pharmacies, system/interface enhancements, batch querying and reporting, fewer clicks and fewer attestations (monthly or quarterly)
Office of the Governor
Questions?