office of the governor and the oscar for best actor goes to…hydrocodone? prescription drug abuse...

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


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


Prologue

So, what’s the big deal?


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.


Drug Overdose Mortality in the U.S. (2010)

CDC/NCHS National Vital Statistics System, CDC Wonder. Updated 2010..


Drug Overdose Mortality Trends (1979-2010)



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


8

Opioid and Benzodiazepine Trends Different thanHeroin and Cocaine in the US (1999-2010)


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


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


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


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.

http://www.insurancefraud.org/downloads/drugDiversion.pdf




Cost of Prescription Drug Abuse on theU.S. Economy (2006)

Hansen et al. Clin J Pain 2011; 27(3): 194-202.


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.



Sales of Opioid Pain Relievers and Nonmedical Opioid Use (2010-11)

#37 in U.S.


Sales of Opioid Pain Relievers and Nonmedical Opioid Use (2010-11)

#2 in U.S.(Oregon = 6.4)


Scene #1

Nonmedical Use: The Beginnings


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


Other Paths to Nonmedical Use

From 1967…Valley of the Dolls

http://youtu.be/t054GSzRywg





Other Paths to Nonmedical Use

From 2014…in your own home

https://www.youtube.com/watch?v=0bZOgj5HEAE

https://www.youtube.com/watch?v=0bZOgj5HEAE


Sources of Opioids among Nonmedical Users



Scene #2

Getting Worse: Scamming and Stealing


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)


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


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

http://www.orpdmp.com/orpdmpfiles/PDF_Files/Reports/Statewide_10.01.11_to_03.31.12.pdf





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.


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.


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


Stealing Can Turn to Robbery…and Worse

From 1989…Drugstore Cowboy

http://youtu.be/puXEHhZgXaY





Scene #3

Rock Bottom: Heroin and Overdose


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…


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



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.


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


The Heroin Lifestyle

From 1996…Trainspotting

http://www.youtube.com/watch?v=Naf_WiEb9Qs&list=PLBA06889EA057B4C0&feature=share






Scene #4

The Way Out: Treatment and Recovery


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


Substance Abuse Treatment Gap (2011)

SAMHSA/NSDUH 2011 survey


Physicians Authorized to Treat Addiction (Buprenorphine/Methadone)

SAMHSA. National Expenditures for MH Services and Substance Abuse Treatment, 1986-2009. Pub SMA-13-4740.


Scene #5

The Way Forward: Coordinated Responses


39


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)


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)


42

Pill Mill Laws

CDC PHLP 2013 Brandeis TTAC Best Practices Report 2013.Trust for America’s Health Report 2013..


43

Doctor Shopping Laws



44

Physical Exam Requirements



45

Tamper Resistant Forms



46

Prescription Limits



47

Patient ID Requirements



48

Immunity from Prosecution



49

PDMP Proactive Reporting

Brandeis TTAC Best Practices Report 2013.Trust for America’s Health Report 2013..


Here in Colorado…


In 2010…


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.


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


Epilogue

Making an Impact: One Patient at a Time


Aaron: Where is he now?

http://www.riseaboveco.org/rx/rx4.html

http://www.riseaboveco.org/rx/rx4.html


What can I do for my patients?


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


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)


Questions?

office of the governor and the oscar for best actor goes to…hydrocodone? prescription drug abuse...

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