Debbie Dowell, MD, MPH

Noah Aleshire, JD

National Center for Injury

Prevention and Control

Centers for Disease Control and Prevention

A CDC Primer on the

Prescription Opioid

Overdose Epidemic

National Center for Injury Prevention and Control

Division of Unintentional Injury Prevention

National Vital Statistics System

Overdose deaths since 1999

145,000Rx opioid deaths in 10 years.

4x as many deathsIn 2013 as 1999.

Rise of the prescription opioid overdose epidemic

CDC, National Center for Health Statistics, National Vital Statistics System

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

Cocaine

Heroin

Quarter billion opioid prescriptions in 2012.

Nationally, sharp increases in opioid prescribing

sharp increases in Rx opioid deaths

0

1

2

3

4

5

6

7

8

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

National Vital Statistics System, DEA’s Automation of Reports and Consolidated Orders System.

Opioid Sales (kg per 10k)

Rx Opioid Deaths (per 100k)

States with more opioid pain reliever sales tend to

have more drug overdose deaths

Death rate, 2013, National Vital Statistics System. Opioid pain reliever sales rate, 2013, DEA’s Automation of Reports and

Consolidated Orders System

The Role of Opioid Prescribing

Upper Midwest Appalachia

Death rate, 2013, National Vital Statistics System. Opioid pain reliever sales rate, 2013, DEA’s Automation of Reports and Consolidated Orders System

The Role of Opioid Prescribing

Texas & OklahomaCalifornia & Nevada

Death rate, 2013, National Vital Statistics System. Opioid pain reliever sales rate, 2013, DEA’s Automation of Reports and Consolidated Orders System

Interventions andthe Continuum of Risk

Risk

Interventions for People at an Elevated Risk

Interventions for People at the Highest Risk

JAMA 2011;305:1315-1321

Risk of opioid-related overdose death increases

with number of prescribers and pharmacies

Baumblatt JAG et al. High Risk Use by Patients Prescribed Opioids for Pain and its

Role in Overdose Deaths. JAMA Intern Med 2014; 174: 796-801.

Majority of opioid overdose deaths associated

with multiple sources and/or high dosages

94%

45%

6%

55%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

control patients patients with fatal overdose

multiple sources (> 3 prescribers orpharmacies) and/or high dosages(>100 MME) of opioids

fewer sources and dosages of opioids

Baumblatt JAG et al. High Risk Use by Patients Prescribed Opioids for Pain and its Role in Overdose Deaths. JAMA

Intern Med 2014; 174: 796-801.

Increased risk of overdose death among patients receiving methadone for pain

Ray WA et al. Out-of-Hospital Mortality Among Patients Receiving Methadone for Noncancer Pain. JAMA Intern Med.

2015;175(3):420-427.

Methadone-related overdose deaths associated with methadone sales

Paulozzi et al. Risk for Overdose from Methadone Used for Pain Relief — United States, 1999–2010. MMWR Weekly. July 6,

2012 / 61(26);493-497:

January 2008:

manufacturers limited

distribution of

40mg formulation

Risk of opioid-related overdose increases

with increased regularity of opioid use

89%

31%

10%

44%

25%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

All patients (N=7,405,800) Opioid overdoses (N=188)

Daily users

Other users

Non-users

1%

Paulozzi et al. Risk of adverse health outcomes with increasing duration and regularity of

opioid therapy. J Am Board Fam Med. 2014 May-Jun;27(3):329-38

Longer durations and higher doses of opioid

treatment are associated with opioid use disorder

Edlund, MJ et al. The role of opioid prescription in incident opioid abuse and dependence among individuals with chronic

noncancer pain. Clin J Pain 2014; 30: 557-564.

opioid dose

Half of US opioids market is treatment

for chronic, non-cancer pain

CDC’s prescription drug overdose prevention work

• Improve data quality and track trends

• Supply healthcare providers with

resources to improve patient safety

• Strengthen state efforts by scaling up

effective public health interventions

Health system strategies to prevent prescription drug overdose

• Guidelines and other guidance for providers

• Prescription Drug Monitoring Programs (PDMPs)

• Insurance/payer strategies

Patient Review and Restriction (PRR) programs

Drug Utilization Review

Drug Utilization Management (e.g. prior authorization)

Prescribing guidelines

Prescribing guidelines

• Opioid prescribing guidelines have been developed by

Professional societies

State task forces

Government agencies (e.g., VA/DoD)

• The most recent national guidelines are several years

old and do not incorporate the most recent evidence

(e.g. risks related to prescribed dosage)

Prescribing guidelines

• CDC is developing opioid prescribing guidelines for

chronic pain incorporating recent evidence

AHRQ systematic review on effectiveness and risks of long-term

opioid treatment of chronic pain*

Supplemental evidence on alternative treatment options,

patient/provider values and preferences, cost

• Focus on chronic pain outside end-of-life care

• Targeted to primary care providers

*The Effectiveness and Risks of Long-term Opioid Treatment of Chronic Pain (Chou et al., 2014)

Primary care providers prescribe the most opioids

IMS Health, National Prescription Audit, United States, 2012

Pain specialists prescribe opioids most frequently

Coordinated care plans (CCPs) for patients on chronic opioid therapy

Coordinated care plans (CCPs) for patients on chronic opioid therapy

• Group Health CCP to improve opioid prescribing

Enrolled 85% of a chronic non-cancer pain population

Increased precautions for patients taking high opioid dosages

Reassessed patient willingness to discontinue or lower doses

Offered additional treatment resources for patients with

substance use disorder

• CDC developing, implementing, and evaluating a CCP

Informed by Group Health’s CCP

Intended to assist clinicians and health systems in safely

managing patients already on chronic opioid therapy

Prescription drug monitoring programs (PDMPs)

PDMPs

• Databases of controlled prescription drugs dispensed

by pharmacies

• Contain critical clinical data that can help

Identify patients at risk for opioid-related overdoses

Inform providers of other medications the patient is receiving

that may interact with those prescribed

Identify patients struggling with substance-use disorder

*Prescription Drug Monitoring Program Center of Excellence at Brandeis. Mandating PDMP participation by

medical providers: current status and experience in selected states. COE Briefing. Available at

http://www.pdmpexcellence.org/sites/all/pdfs/COE%20briefing%20on%20mandates%20revised_a.pdf.

Patient review and restriction programs (PRRs)

Patient review and restriction programs (PRRs)

• Require patients to use one prescriber and/or

pharmacy for all controlled substance prescriptions

• Examples of PRR selection criteria:

• > 6 claims in 2 months; or

• > 3 prescribers in 2 months; or

• Referral

11+ prescriptions of CSII, II, or IV obtained

from

o 4+ prescribers; or

o 4+ pharmacies

PRR programs associated with cost savings and changes in utilization*

• Decreased use of multiple medications and of schedule

II drugs (Louisiana)

• Reductions in dosage for opioid analgesics (>40% in

Ohio and in Washington)

• Decreased use of multiple pharmacies and physicians

(Oklahoma)

• Decreases in pharmaceutical costs (Louisiana)

• Reductions in ED visits, physician, and hospital costs

(Washington)

*Haegerich TM et al. What we know, and don’t know, about the impact of state policy and systems-level interventions on

prescription drug overdose. Drug Alcohol Depend. 2014;145:34-47.

Drug utilization review (DUR)

Drug utilization review (DUR)

• Retrospective claims review to identify potentially

dangerous or inappropriate use and alert prescribers

• A randomized trial found sending alerts to providers

whose patients were receiving opioids from multiple

prescribers and pharmacies was associated with

reductions in prescribers, pharmacies, and filled

prescriptions

Gonzalez AM and Kolbasovsky A. Impact of a Managed Controlled-Opioid Prescription Monitoring Program on Care Coordination.

Am J Manag Care. 2012 Sep;18:516-24.

Drug utilization management (e.g. prior authorization)

Prior authorization (PA)

• Coverage requires review to ensure criteria met

• Medicaid programs with stricter PA policies for

controlled-release oxycodone had a 34%

decrease in use; those with more PA lenient

policies had a non-significant increase in use*

*Morden N. et al. Medicaid prioir authorization and controlled-release oxycodone. Med Care 2008; 46: 573-80.

PA: Massachusetts Blue Cross (2012)*

• Short-acting opioids Coverage limited to 15-day initial supply

Coverage available for additional 15-day supply

PA required for subsequent prescriptions

• Long-acting opioids PA required

• 50% reduction in claims for long-acting opioids**

• 20% reduction in claims for short-acting opioids**

Exemptions for end-of-life care, cancer pain

*New Quality and Safety Measures in Opioid Management, Effective July 1, 2012. Available at

http://www.bluecrossma.com/bluelinks-for-employers/whats-new/special-announcements/opioid-management.html

** Blue Cross Blue Shield of Massachusetts. Prescription Pain Medication Safety Program Shows Positive Results, Promotes

Quality & Prevention. Available at http://www.bluecrossma.com/visitor/newsroom/press-releases/2014/2014-04-08.html

PA: MaineCare (Maine Medicaid, 2013)

• Acute pain (expected to last <8 weeks)

Opioids covered for 15 days per 12 month period

14 additional days of opioid treatment may be covered with PA

• Chronic Pain (expected to last >8 weeks)

Patient must first try > 1 treatment plan interventions, e.g. physical therapy

Daily limit on opioid dose

• < 30 mg morphine equivalents (MMEs) - exempt from prior authorization

• <300mg of MMEs - maximum allowed dose

• Reductions in opioid prescriptions, dosages, costs for opioid

medications in 2013 vs. 2012

Exemptions for end-of-life care, cancer pain, nursing home patients, inpatient care, HIV/AIDS

PA: Oregon Medicaid

• PA for long-acting opioids (2009)

associated with 32% reduction in use

one year after implementation*

• Limits on methadone dosing (>100mg,

implemented 2010) associated with 57%

*Oregon State University, Drug Use Evaluation: Long-Acting Opioids (LAO). 2012. Available at

http://www.orpdl.org/durm/drug_articles/evaluations/2012_01_26_LAO_DUE.pdf

reduction in % of patients taking >100mg/day*

• 2012: prior authorization required for all high-dose

opioid prescriptions (>120 MME per day)

• Removed methadone from formulary in 2013

(implemented January 1, 2014)

Unintentional and undetermined prescription opioid

poisoning deaths and death rates, Oregon, 2000-2013

Oregon Health Authority. Prescription drug poisoning/overdose in Oregon. Updated January 5, 2014. Data available at

http://public.health.oregon.gov/DiseasesConditions/InjuryFatalityData/Documents/oregon-drug-overdose-report.pdf

2014 data include counts only; rates not available due to current lack of comparable population estimates. Counts for 2014 are

preliminary.

Boston prescribing study

Analysis of opiate prescribing in

Boston, MA

Examined prescribing data based on

prescriptions dispensed at local

pharmacies

Findings:

• Prescribed for wide range of diagnoses

• Extensive refills by patients

• “[B]eyond a doubt . . . it was the opiate qualities of the

medicine that afforded relief and caused the [prescription]

renewal.”

“[Opiates] effect[] immediate relief, and the

doctors, knowing this, and wishing to stand

well with their patients, prescribe it more and

more.”

“I was surprised to learn how extensively [opiates]

are used by physicians. I found them prescribed

for every ailment which flesh is heir to. They are

used for headache, sore eyes, toothache, sore

throat, laryngitis, diphtheria, bronchitis, congestion,

pneumonia, consumption, . . . and all general or

special maladies of the body. It is the great

panacea and cure-all.”

1888

Virgil G. Eaton. How the

Opium Habit is Acquired.

The Popular Science

Monthly 33, Sept. 1888,

663-67.

“Pass a law that no prescriptions containing opium or its preparations can be filled more than once at the druggist's without having the physician renew it. . . Such a law would also make the doctors more guarded in prescribing opiates for trivial ailments.”

Virgil G. Eaton. How the Opium Habit is Acquired. The Popular Science Monthly 33, Sept. 1888, 663-67.

“It is one of the happy incidents

of the federal system that a

single courageous state may, if

its citizens choose, serve as a

laboratory; and try novel

social and economic

experiments without risk to the

rest of the country.”

–Justice Louis Brandeis

PDMPs

PDMP adoption

NAMSDL, Annual review of prescription drug monitoring programs. March 2015.

http://www.namsdl.org/library/3449DDCF-BB94-288B-049EB9A92BAD73DF/.

Status of PDMPS – September 2013

PDMP promising practices

Universal: Prescribers use of

the PDMP every time when

prescribing opioids and other key

controlled substances.

Real-Time: Timely dispensing

data, like in a “real-time” PDMP,

maximizes the utility of the

prescription history data.

Actively Managed: Using

PDMP data for public health

surveillance and to send

“proactive” reports to authorized

users to protect patients at the

highest risk.

Easy to Use and Access: Making PDMPs easy to use and

integrated into the clinical

workflow.

After NY instituted universal PDMP use, the average daily # of PDMP reports requested skyrocketed

~366

42,300

0

5000

10000

15000

20000

25000

30000

35000

40000

45000

Before Mandated Use After Mandated Use (Aug. 27, 2013—Feb. 17,

2014)

Source: Brandeis University, PDMP Center of Excellence. COE Briefing: Mandating PDMP Participation by Medical Providers: Current Status and Experience in Selected States. Feb. 2014.

After New York instituted universal PDMP use…

Multiple provider episodes decreased 74.8%

Number of opioid Rxs decreased 9.53%

Number of buprenorphine Rxs increased 14.6%

Source: Brandeis University, PDMP Center of Excellence. COE Briefing: Mandating PDMP Participation by Medical Providers: Current Status and Experience in Selected States. Feb. 2014.

Moving toward “real-time” PDMPs

NAMSDL, Annual review of prescription drug monitoring programs. March 2015. http://www.namsdl.org/library/3449DDCF-BB94-

288B-049EB9A92BAD73DF/.

Source: Arizona Prescription Monitoring Program, Arizona State Board of Pharmacy

Actively managed PDMP:PDMP report cards to outliers

Ease of use: allowing delegate PDMP access

NAMSDL, Annual review of prescription drug monitoring programs. March 2015. http://www.namsdl.org/library/3449DDCF-BB94-

288B-049EB9A92BAD73DF/.

Pain clinic laws

Just 3% of California workers compensation

opioid prescribers…

Swedlow et al. Prescribing patterns of schedule II opioids in California Workers’ Compensation, CWCI Institute, 2011

3% of prescribers

Swedlow et al. Prescribing patterns of schedule II opioids in California Workers’ Compensation, CWCI Institute, 2011

55% of all CSII

opioid Rx

62% of all

morphine

equivalents 65% of all

associated

payments

1% of prescribers

Swedlow et al. Prescribing patterns of schedule II opioids in California Workers’ Compensation, CWCI Institute, 2011

33% of all CSII

opioid Rx

41% of all

morphine

equivalents 42% of all

associated

payments

Pain clinic laws

“You just walk in, they ask you what hurts, they take

your blood pressure, they weigh you, and they say

actually – literally sometimes, ‘What do you want?’…

‘How many do you take a day?’ You could be

ridiculous and say 40. I mean, I could get 200 of

each, Roxi's and Oxy's at the same time, which

makes no sense, and Xanny bars (Xanax) at the

same time. They just ask you what you want.”

—White female, 41

Rigg KK, March SJ, Inciardi JA. Prescription drug abuse and diversion: role of the pain clinic. J Drug Issues. 2010 ; 40(3): 681–702.

Source: NCSL, CDC Prevention Status Report

Pain clinic laws, 2013

Anatomy of pain clinic law

Louisiana

Statute passed in ‘05; rules in Jan. ‘08

Passes a pain management clinic law

Brings heightened scrutiny to pain

clinics

Requirements:

Pain specialist physician ownership

Licensure from Department of Health and Hospitals

Inspections

50% on-site requirement

Urine drug screen for each patient

30-day supply limit

Naloxone and Good Samaritan laws

Naloxone access

Naloxone Access Laws

April 2015

Source: Public Health Law Research - phlr.org

Good Samaritan laws

PHLR, Law Atlas. April 2015.

Good Samaritan Laws

April 2015

2010 2013

Florida: a case study

The epidemic in microcosm:Florida and prescription drug overdose

2003-2009 (CDC MMWR)

84% increase in prescription

drug overdoses

264% increase in oxycodone

overdoses

In 2009, 8 people died of

overdoses every day

MMWR. Drug overdose deaths — Florida, 2003–2009. 869-72. 60(26). July 8 2011.

2010:

90 of the top 100 oxycodone purchasing physicians in US were

in Florida

900+ pain clinics

In 7 years, Rx opioid deaths in Florida doubled

Johnson H; Paulozzi L; Porucznik C. Mack K. Herter B. Decline in Drug Overdose Deaths After State Policy Changes —Florida,

2010–2012. MMWR. 63(26). 569-74. July 2014.

0

2

4

6

8

10

12

14

16

2003 2004 2005 2006 2007 2008 2009 2010

Oxycodone overdoses

Opioid pain reliever overdoses

Benzodiazepine overdoses

De

ath

s p

er

10

0k

Florida’s policy response

Jan. 2010: State legislature required pain clinics register with the state

Feb. 2010: DEA and various Florida law enforcement agencies began to work

together in Operation Pill Nation

Late 2010: Pain clinic regulations further expanded

Feb. 2011: Law enforcement conducted statewide raids

July 2011: State legislature prohibited physician dispensing of schedule II or

III; activated regional strike forces to address the emergency.

Sept. 2011: Mandatory dispenser reporting to the newly established PDMP

2012: State legislature expanded regulation of wholesale drug distributors

Between 2010 and 2012, key prescribing rates in Florida dropped

Oxycodone prescribing dropped 24%

Hydrocodone prescribing dropped 10%

Alprazolam prescribing dropped 11%

Methadone prescribing dropped 10%

Johnson H; Paulozzi L; Porucznik C. Mack K. Herter B. Decline in Drug Overdose Deaths After State Policy Changes —Florida,

2010–2012. MMWR. 63(26). 569-74. July 2014.

56% Decrease in Multiple Provider Episodes

Florida Prescription Drug Monitoring Program. Presentation by Lucy Gee. Director, Medical Quality Assurance, Department of Health

July 17, 2014.

2864

21742017

18611726

1613 1680

1415 1468

1254

105 68 45 43 46 36 38 31 35 25

Q1 2012 Q2 2012 Q3 2012 Q4 2012 Q1 2012 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014

5+ Prescribers and 5+ Pharmacies 10+ Prescribers and 10+ Pharmacies

As prescribing rates dropped, Florida Rx overdoses fell sharply

Johnson H; Paulozzi L; Porucznik C. Mack K. Herter B. Decline in Drug Overdose Deaths After State Policy Changes —Florida,

2010–2012. MMWR. 63(26). 569-74. July 2014.

0

2

4

6

8

10

12

14

16

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Oxycodone overdoses

Opioid pain reliever overdoses

Benzodiazepine overdoses

De

ath

s p

er

10

0k

Washington State: a case study

Washington State Policies

Washington Agency Medical Directors’

Opioid Dosing Guidelines

Pain Management Rules

ED prescribing guidelines

Good Samaritan Law

PDMP

Medicaid Narcotic Review Program

Expanded Patient Review and

Coordination program

Expanded Medication Assisted

Treatment

Washington State Rx opioid overdoses

declined after interventions

Washington State Department of Health, Death Certificate and Hospital Discharge Data. Franklin et al. A Comprehensive

Approach to Address the Prescription Opioid Epidemic in Washington State: Milestones and Lessons Learned. Am J Public

Health. 2015 Mar;105(3):463-9.

Essential elements of Washington’s approach

Collaboration among state agencies

Strong pain management laws

Dosing and best-practice guidelines and rules

Effective PDMP

Robust surveillance

Incentivize use of best practices

Overdose education programs to reduce risk to opioid users

Increase access to medication-assisted treatment

Evaluation of interventions

Washington State Department of Health, Death Certificate and Hospital Discharge Data. Franklin et al. A Comprehensive

Approach to Address the Prescription Opioid Epidemic in Washington State: Milestones and Lessons Learned. Am J Public

Health. 2015 Mar;105(3):463-9.

Prescription Drug Overdose: Prevention for States

Advance comprehensive state-level

interventions for preventing prescription

drug overdose in 4 areas:

• Enhancing and maximizing PDMPs

• Implementing community and insurer/health system

interventions

• Evaluating state-level laws, policies, and regulations

• Innovative, rapid response prevention

The findings and conclusions in this presentation are those of the author and do not necessarily represent the views of the

Centers for Disease Control and Prevention.

National Center for Injury Prevention and Control

Division of Unintentional Injury Prevention

EXTRA SLIDES for possible use in Q and A

Daubressee M. et al. Ambulatory Diagnosis and Treatment of Nonmalignant Pain in the United States,

2000–2010. Medical Care. 2010; 51: 870–878

“Using nationally representative data on ambulatory

practice in the United States, the overall prevalence of

patient-reported pain has not changed during the past

decade….

Despite large increases in opioid use, there were not

similar increases in the prescribing of alternative

analgesics, such as NSAIDs, acetaminophen, and other

therapies.”

While the amount of opioids prescribed

quadrupled, the amount of pain

Americans report has not changed

No good evidence for pain relief or improved

function from long-term opioid use for chronic pain

Systematic

Review

Findings

Cochrane

review, 2010

“Weak evidence” for clinically significant pain relief

Furlan, 2006 “Other drugs produced better functional outcomes than

opioids”

Manchikanti,

2011

“Poor evidence for all other drugs and conditions” (except

tramadol for osteoarthritis)

Martell, 2007 “The evidence in favor of opioids… when supportive, only

supports this treatment for short periods.” (<4 months)

Trescott,

2008

“Weak” evidence for lower pain scores than before therapy

Noble M et al. Long-term opioid management for chronic noncancer pain (Review). The Cochrane Collaboration 2010. Available at http://www.theCochranelibrary.comFurlan AD, Sandoval JA, Mailis-Gagnon A et al. Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects. CMAJ 2006;174:1589-1594Manchikanti et al. A systematic review of randomized trials of long-term opioid management for chronic non-cancer pain. Pain Physician 2011; 14: 91-121Martell BA, et al. Systematic review: opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction. Ann Intern Med. 2007;146:116-27Trescott A et al. Effectiveness of opioids in the treatment of chronic non-cancer pain. Pain Physician 2008; 11:S181-S200

Doctors most common source of opioids

for most frequent nonmedical users

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

A majority of people newly dependent on

heroin report abusing prescription opioids first

Cicero TJ, Ellis MS, Surratt HL, Kurtz SP. The Changing Face of Heroin Use in the United States:

A Retrospective Analysis of the Past 50 Years. JAMA Psychiatry.2014;71(7):821-826.

Change in heroin overdose death rates compared

with change in opioid overdose death rates –

18 states, 2010-2012

Rudd RA et al. Increases in heroin overdose deaths – 28 states, 2010 to 2012.

MMWR Weekly 2014; 63: 849-854.