Rx15 workshop mon_200_aleshire_dowell_no_notes

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

145,000
Rx opioid deaths in 10 years.
4x as many deaths
In 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 and
the Continuum of Risk
Risk

Interventions for People
at an Elevated Risk

Interventions for People
at the Highest Risk

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 or
pharmacies) 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
• 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)
• 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

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/.

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
55% of all CSII
opioid Rx
62% of all
morphine
equivalents 65% of all
associated
payments

1% of prescribers
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
Deathsper100k

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%
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
2174
2017
1861
1726
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
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
Deathsper100k

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.com
Furlan AD, Sandoval JA, Mailis-Gagnon A et al. Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects. CMAJ 2006;174:1589-1594
Manchikanti et al. A systematic review of randomized trials of long-term opioid management for chronic non-cancer pain. Pain Physician 2011; 14: 91-121
Martell BA, et al. Systematic review: opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction. Ann Intern Med. 2007;146:116-27
Trescott 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.

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