rems program companies - food and drug · pdf fileco-3 rpc is consortium of 24 companies...
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CO-1
REMS Program Companies
AADPAC & DSRMAC
May 3 - 4, 2016
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CO-2
Introduction and REMS Design
Paul Coplan, ScD, MBA
RPC Metrics Subteam Chair
Purdue Pharma L.P.
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CO-3
RPC Is Consortium of 24 Companies
Actavis, Inc.
Apotex Inc.
Aurolife Pharma, LLC
Depomed, Inc.
Endo Pharmaceuticals Inc.
Impax Laboratories, Inc.
Inspirion Delivery Technologies
Janssen Pharmaceuticals, Inc.
Mallinckrodt Pharmaceuticals
Mylan Technologies, Inc.
Nesher Pharmaceuticals LLC
Novel Laboratories, Inc.
Noven Pharmaceuticals, Inc.
Pernix Therapeutics
Perrigo Company plc
Pfizer, Inc.
Purdue Pharma L.P.
Ranbaxy Pharmaceuticals, Inc.
Rhodes Pharmaceuticals L.P.
Roxane Laboratories, Inc.
Sandoz, Inc.
The PharmaNetwork LLC
Upsher-Smith Laboratories, Inc.
VistaPharm, Inc.
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CO-4
RPC initial framework
FDA joint advisory committee (July 2010)
FDA task force
Development of REMS Framework
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CO-5
REMS Design &
Implementation
Paul Coplan, ScD, MBARPC Metrics Subteam Chair
Purdue Pharma LP
Continuing Education
Activities: Design and Results
Marsha Stanton, PhD, RNRPC Continuing Education Subteam Chair
Pernix Therapeutics
Public Health ImpactCharles Argoff, MDProfessor of Neurology
Albany Medical College and Albany Medical Center
REMS Assessments:
Design and Results
M. Soledad Cepeda, MD, PhDRPC Metrics Subteam Member
Janssen Pharmaceuticals, Inc.
Surveillance Database ResultsRichard Dart, MD, PhDRocky Mountain Poison & Drug Center, Denver Health
Professor of Emergency Medicine, University of Colorado
Lessons LearnedLaura Wallace, MPHRPC Metrics Subteam Member
Purdue Pharma LP
Conclusion Paul Coplan, ScD, MBA
Agenda
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CO-6
Additional Experts
Daniel P. Alford, MD Boston University School of Medicine
Daina Esposito, MPH HealthCore, Inc.
Syd Philips, MPH IMS Health
Valerie Smothers, MA MedBiquitous
Annette Stemhagen, DrPH,
FISPEUnited BioSource Corporation
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CO-7
Abuse/addiction of prescription opioids
Immediate release (IR) opioids
Extended-release/long-acting (ER/LA)
opioids
Abuse/addiction of illegal drugs
Heroin
Illicitly produced fentanyl
Opioid Abuse Includes Multiple Abuse Categories
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CO-8
Opioid Analgesic Prescriptions
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CO-9
Drug Overdose Deaths Involving Opioids By Type of Opioid
Source: Rudd MMWR 2016, National Vital Statistics System.
Deaths
per
100,000
population
Year
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CO-10
“The goal of this REMS is to reduce serious
adverse outcomes resulting from inappropriate
prescribing, misuse, and abuse of extended-
release or long-acting opioid analgesics while
maintaining patient access to pain medications.
Adverse outcomes of concern include addiction,
unintentional overdose, and death.”
-FDA, ER/LA REMS, July 2012
Goal of REMS for Extended Release/ Long Acting Opioid Analgesics
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CO-11
Educate prescribers to select and manage
patients
Educate patients to understand and prevent
risks
Did not include specific actions targeted at
abusers
RPC Committed to Fulfilling Goal of REMS
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CO-12
ER/LA REMS first to require
Collaboration by many companies
Accredited CE as primary tool
Complexities
Rules governing industry support of CE
FDA’s rules for REMS implementation
Processes for decision-making
Contracting by many companies
ER/LA Opioid REMS is Novel in Scope and Tools
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CO-13
Communication components
Dear Prescriber Letter
Call center
Website
Education and training
Patient education
Medication Guide (pharmacists)
Patient Counseling Document (prescribers)
Continuing education for prescribers
Assessment studies of the REMS
Components of the REMS
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CO-14
Tool for patient education
Proper storage and taking ER/LA opioids
Preventing abuse, addiction and overdose
Distributed by pharmacists to patients when
opioids dispensed and part of product labelling
Tailored for methadone, patch or oral
formulation
1-Page Medication Guide
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CO-15
1-Page Patient Counseling Document
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CO-16
Target is 1.3 million prescribers registered to
prescribe Schedule 2 and 3 narcotics, state
licensing boards, and professional societies
Letter sent twice
Letter now sent annually to new prescribers
Dear Prescriber Letters
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CO-17
Train prescribers using CE activities
FDA Blueprint for Prescriber Education
CE providers develop course content
REMS allows for CE courses not funded by
RPC to count toward goals as long as content
in FDA Blueprint is covered
CE Activities to Train Prescribers
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CO-18
Date
Years
REMS
Active
Performance
Target
March 2013 0 Start
March 2015 2 80,000
March 2016* 3 160,000
March 2017 4 192,000
CE Completers versus Target
*Unaudited data provided by CE provider organizations for RPC-funded courses
Other
Completers of
REMS-
compliant CE
44,619
91,274
-
ER/LA Opioid
Prescriber
Completers
37,512
66,219
-
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CO-19
RPC maintains toll-free call center
Provides REMS information and answer
queries
1.800.503.0784
REMS Call Center to Answer Questions
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CO-20
Website Contains Comprehensive Information on REMS
http://www.er-la-opioidrems.com/IwgUI/rems/home.action
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CO-21
Timing of REMS Implementation
Pre-REMS Period
REMS Aproval
2010 2011 2012 2013 2014 2015
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
JULY 2012
REMS Active Period Implementation
MARCH 2013
1st CE course
available
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CO-22
REMS Assessments
Assessment
Dear Prescriber Letters sent to prescribers
Number of trained* prescribers
Audit of CE trainings
Prescriber survey
Long-term evaluation of trained* prescribers
Patient survey
Surveillance monitoring for abuse, misuse, overdose & death
Evaluation of drug utilization patterns
Evaluation of changes in prescribing behavior
Changes in patient access to opioids assessed by prescribing patterns
* Prescribers who completed REMS-compliant CE course
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CO-23
Assessing behaviors in prescribers who
completed REMS training was limited by firewalls
preventing industry influence in CE
Survey samples not fully generalizable to the
population of ER/LA opioid patients and
prescribers
The REMS was part of a multi-faceted program to
prevent opioid abuse and its individual
contribution is difficult to assess
Key Limitations of Assessments
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CO-24
REMS Continuing Education Progress and Results
Marsha Stanton, PhD, RN
RPC Continuing Education Subteam Chair
Pernix Therapeutics
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CO-25
REMS
Components Accomplishments/Key Findings Evidence-based Improvements
Number of trained
prescribers• Increasing numbers per year
• Make Blueprint more concise
• Increase to healthcare team
Audit of CE
trainings • 100% alignment with Blueprint
• Remediation of those that
did not meet financial
disclosure requirements
REMS
assessments
• Patient: High awareness of
Medication Guide
• Prescribers: Low awareness of
REMS communications materials
• Prescribers: Training associated
with higher knowledge scores
• Prescribers: Product-specific
knowledge is limited
• Opioid prescriptions decreasing
• Improvements in inappropriate
prescribing
• Launch of awareness
campaign
• More representative survey
populations
Surveillance
monitoring
• Significant decreases in some, but
not all, safety outcomes
• Expanded access to Medicaid
data
• Use of National Death Index
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CO-26
1st time integral component to a REMS
1st used to address major public health issue
Offers in-depth learning
Fulfills general CE requirement of various
state licensure boards
REMS is Focused on Accredited Education
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CO-27
FDA Blueprint is roadmap
CME and CE
Providers use Blueprint to create activities
Print, live lecture, interactive discussions,
internet
> 3 hours
Pre-test and periodic evaluations throughout
the educational activities
Overview of CE Training
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CO-28
1. Assessing patients for treatment
REMS CE Includes 6 Content Sections of FDA Blueprint
2. Initiating therapy, modifying dosing, and
discontinuing use
3. Managing therapy
4. Counseling patients and caregivers on safe use
5. General drug information
6. Specific drug information
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CO-29
CE Trainings Audited
Assessment
REMS communication activities
Number of trained* prescribers
Audit of CE trainings
Patient survey
Prescriber survey
Long-term evaluation of trained* prescribers
Evaluation of drug utilization patterns
Evaluation of changes in prescribing behavior
Surveillance monitoring
Monitoring patterns of prescribing to identify changes in access
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CO-30
29* audits performed (Mar 2014 – Feb 2015)
100% met all requirements for content,
accuracy, and assessment
9 audits had non-content-related observations
Failure to prominently display financial
disclosure
All remediated
CE Audit Results
*36-Month Assessment Report
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CO-31
CE providers submit grant proposals to RPC
RPC provides grants
CE providers determine course content
Medication manufacturers cannot
participate in content development
Process for CE Development
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CO-32
151 proposals submitted
31 CE proposals approved
839 total CE activities have been conducted
Overview of REMS-Compliant CE Providers*
*As of 2/29/16
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CO-33
FDA Prescriber Completer Goals
Goal Date
Prescribers with ≥ 1 ER/LA Opioid Rx in Previous Year
(N=320,000)
Complete REMS-Compliant CE
Goals Set by FDA
Completers Goals
Set by FDA
% n
March 2015 25% 80,000
March 2016 50% 160,000
March 2017 60% 192,000
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CO-34
Numbers of Completers of REMS-Compliant CE Increasing by Year
Cumulative
Completers
(N)
37,512
66,219
82,131
157,493
0
50,000
100,000
150,000
200,000
Feb 2015 Feb 2016
ER/LA opioid prescribers counted
towards FDA completer goalsHCP completers
(inclusive)
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CO-35
Prescriber Completers by Specialty
67.4%
12.8%
19.7%
Primary Care
Pain
Specialist
Non-pain
Specialist
**Specialty reporting is not required of CE providers. N=20,704 ER/LA opioid analgesic prescribers of 37,512 total who
received training (2/28/13 – 2/28/15) from 36-month Assessment Report
0.002%
No response
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CO-36
National conferences
Primary and specialty organizations
Local/Regional conferences
State Medical Societies / Federation of State
Medical Boards
Medical schools
Health systems (e.g. Kaiser Permanente)
REMS-compliant CE Offered Nation-Wide
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CO-37
CE activities approved through 2018
CE providers submit proposals each year
Provided to FDA on an ongoing basis
Future Evaluation Deadlines
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CO-38
Limited ability to promote programs
Blueprint results in lengthy courses not tailored
to individual learner needs
Only ER/LA opioid prescribers “count” toward
REMS goals
Difficulties Achieving Completer Targets
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CO-39
Federal agencies including
Medscape/NIDA (115,000 completers)
Academic institutions
Prescriber Clinical Support System for Opioid
therapies (PCSSO)-SAMHSA
Non RPC-supported CE providers
Professional organizations
State medical associations
Other health systems
RPC Not Only Source of Education
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CO-40
Explore adaptive approaches
Increased online activities
Web casts
i-books
Blended learning (i.e. combining digital and
face to face formats)
Case-based studies to enhance participation
Evolution of RPC-Supported Activities
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CO-41
Development of many systems/processes
Open communications among stakeholders
Diverse and comprehensive CE courses
provided
Significant number of the target prescriber
population educated
Conclusion
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CO-42
Perspective of a Pain Medicine Physician and Educator
Charles Argoff, MD
Professor of Neurology, Albany Medical
College
Director, Comprehensive Pain Center,
Albany Medical Center
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CO-43
ER/LA opioid CE program has been
successful
Targets audiences that need information
HCPs are changing clinical behavior and
prescribing habits
Clinical Perspectives
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Education Is Cornerstone of Changing Behavior
Photographs provided with permission from American College of Physicians / Pri-Med
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Fine PG, et al., 2005.
Multimodal TherapeuticStrategies
for Pain and Associated Disability
Pharmaco-
therapy
Interventional
Approaches
Psychological
Support
Lifestyle
Change
Complementary
and Alternative
Medicine
Physical
Medicine and
Rehabilitation
Pain Management Involves Many Treatment Modalities
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Positive outcomes from REMS-compliant CE
include
Changes in practice
Increased urine drug testing and patient
counseling
Improved awareness of potential for misuse
and abuse
Reduction in number of opioid scripts
A Physician Perspective: Benefits
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Initial Study Linking Training with Prescriber Behavior and Outcomes
Design Retrospective observational study
Data Source Electronic Health Records (EHR): (Pri-Med)
Population
All HCPs who use EHR, stratified by whether or
not they took REMS-compliant CE
Patients of these HCPs
Study neither reviewed by FDA nor provided in RPC Briefing Document
Outcomes
Changes before / after training implementation in:
1. Prescribing patterns for all, ER/LA and IR opioids
2. Patient outcomes, including abuse/dependence
and overdose based on ICD codes in EHR
Time Period Jun 2013 – Jan 2016
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Changes in Prescribing After Training
Opioid
prescriptions
Trained HCPs1
(N=441)
Control HCPs
(N=4,669)
ER/LA 10% decrease 4% increase
IR 3% increase 3% increase
1) HCPs who took REMS-compliant CE
Study neither reviewed by FDA nor provided in RPC Briefing Document
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Improvements in Outcomes Among Patients of Trained Prescribers
Outcomes1
Patients of
Trained HCPs2
Patients of
Control HCPs
Abuse / dependence 50% decrease 29% increase
Overdose 53% decrease 17% increase
1) Assessed based on ICD-9 and ICD-10
2) HCPs who took REMS-compliant CE
Study neither reviewed by FDA nor provided in RPC Briefing Document
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Prescribing-behavior and patient-outcome
data suggest positive impact of REMS
Evidence of effect within trained group
compared to control group
Study Conclusion
Study not provided in RPC Briefing Document
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EHR Data Supported by Other Published Studies
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REMS education making impact
Appropriate use of ER/LA opioids can be
facilitated by greater prescriber knowledge
Overall Conclusion
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REMS Assessment Metrics: Education Contributed to Improvements
M. Soledad Cepeda, MD, PhD
RPC Metrics Subteam Member
Janssen Research & Development
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Overview of Assessments
Assessment
REMS communication activities
Number of trained* prescribers
Audit of CE trainings
Patient survey
Prescriber survey
Long-term evaluation of trained* prescribers
Evaluation of drug utilization patterns
Evaluation of changes in prescribing behavior
Surveillance monitoring
* Trained = completed REMS-compliant training
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REMS
Components Accomplishments/Key Findings Evidence-based Improvements
Number of trained
prescribers• Increasing numbers per year
• Make Blueprint more concise
• Increase to healthcare team
Audit of CE
trainings • 100% alignment with Blueprint
• Remediation of those that did
not meet financial disclosure
requirements
REMS
assessments
• Patient: High awareness of
Medication Guide
• Prescribers: Low awareness of
REMS communications
materials
• Prescribers: Training associated
with higher knowledge scores
• Prescribers: Product-specific
knowledge is limited
• Opioid prescriptions decreasing
• Improvements in inappropriate
prescribing
• Launch of awareness
campaign
• More representative survey
populations
Surveillance
monitoring
• Significant decreases in some, but
not all, safety outcomes
• Expanded access to Medicaid
data
• Use of National Death Index
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20 minute
80 survey items
22 knowledge questions
Administered by HealthCore
Commercially insured patients
Completed either by phone or online
Patient Survey
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Does the patient understand the risks
associated with ER/LA opioids?
Did the patient receive and understand the
Medication Guide?
Was the Patient Counseling Document used
during the office visit?
Is the patient satisfied with access to ER/LA
opioids?
Patient Knowledge Studied
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Inclusion criteria
Commercially insured patients*
≥ 1 ER/LA opioid Rx over the past year
Target sample size: 400 patients
423 patients completed survey
2,441 were randomly selected
ER/LA Opioid Patient Survey Population
*HealthCore Integrated Research Database (HIRD)
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Patient Survey Responders Compared to Commercially Insured ER/LA Opioid Users
*HIRD database
Responders more often
Female
Younger
Geographically similar
94% white
23% lower than high school degree
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Overall score
Number of questions answered correctly by
≥ 80% of responders
Knowledge Assessed in Two Ways
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Mean Score Was 86%
73% met or exceeded
FDA target
Number
of
Patients
3 2 04.5
1018
26
44
62
101
41
70
34
0
10
20
30
40
50
60
70
80
90
100
110
<5 <5<5
40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79 80-84 85-89 90-94 95-99 100
Score
FDA Recommended Target ≥ 80% Correct
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Patients Demonstrated High Understanding of Risks
Risk
% Patients Who
Responded
Correctly
(N=423)
Do not give ER/LA opioid analgesics to other people who
have the same condition as you98%
Selling or giving away ER/LA opioid analgesics is against
the law98%
Seek emergency medical help for side effects such as
trouble breathing, shortness of breath, fast heartbeat,
chest pain, or swelling of their face, tongue, or throat after
taking or using ER/LA opioid analgesics
97%
Talk to a healthcare provider about taking or using more
ER/LA opioid analgesics if the current dose doesn't
control the pain
96%
It is not okay to drink alcohol while taking or using ER/LA
opioid93%
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Five Questions Answered Correctly by <80% of Responders
Areas of Low Knowledge
%
Correct
(N=423)
Do not use a hot tub or sauna while using ER/LA opioid analgesics
if pain persists (patch only)77%
ER/LA opioid analgesic pills should not be split or crushed
(oral formulations)76%
Do not store ER/LA opioid analgesics in a medicine cabinet with
other medications in the household.71%
Inform healthcare provider of any fever (patch only) 70%
Read the attached Medication Guide every time an ER/LA opioid
prescription is filled55%
Includes all questions with response rates <80%
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98% reported reading guide at least once
Average knowledge score = 86% correct
2% reported not reading
Average knowledge score = 72% correct
Medication Guide Widely Read
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43% reported
receiving Patient
Counseling
Document from
provider
26% reported
providers referenced
Patient Counseling
Document
Less than Half of Patients Received Patient Counseling Document
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71% of patients able to obtain prescription
when needed for pain
78% of patients satisfied with access
Patients Generally Satisfied with Access to ER/LA Opioids
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REMS Includes Prescriber Assessments
* Trained = completed REMS-compliant training
Assessment Metrics
REMS communication activities
Number of trained* prescribers
Audit of CE trainings
Patient survey
Prescriber survey Prescriber Knowledge, Awareness
of REMS Materials
Long-term evaluation of trained*
prescribersKnowledge Retention
Evaluation of drug utilization patterns
Evaluation of changes in prescribing
behavior
Surveillance monitoring
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~25 minutes
124 survey items
68 knowledge questions
Prescribers with training
REMS-compliant CE providers
Prescribers without training
National prescription database (IMS)
Prescriber Survey Design
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Prescriber Survey Population
Inclusion criterion
≥ 1 ER/LA opioid Rx over the past year
Target sample size: 600 prescribers
Feb to April 2015
612 prescribers completed survey
301 with training1
311 without training2
1. Completed REMS-compliant CE program; 2. IMS database; 54% reported participation in REMS-compliant CE
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Prescriber Survey: Baseline Characteristics of Responders With and Without Training
Prescribers split based on self-reported
training
Trained responders
Similar gender
More likely to be physicians
Have pain management training
Fewer years in practice
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Limited Awareness of REMS Materials by Prescribers
REMS Material
Prescribers
Recruited
by
CE Providers
(N=301)
IMS Recruited
Reported NOT
Completing a
REMS-compliant
CE Activity
(N=179)
Reported
Completing a
REMS-compliant
CE Activity
(N=132)
% % %
Medication Guide 67.4 40.2 71.2
Patient Counseling
Document53.5 22.3 48.5
ER/LA Opioid
Analgesics Website49.5 11.7 55.3
Dear DEA-Registered
Prescriber Letter44.5 16.8 47.7
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Prescriber Behavior
Prescribers
Recruited by
CE Providers
(N=301)
Prescribers Recruited Through
IMS Data
Reported NOT
Completing a
REMS-compliant
CE Activity
(N=179)
Reported
Completing a
REMS-compliant
CE Activity
(N=132)
% % %
Use the Patient
Counseling Document
with patients
70% 50% 68%
Use of Structured
Interview Tools or
Screening Tools
69% 53% 76%
Completion of Patient-
Prescriber Agreement77% 70% 84%
Perform Urine Drug
Tests70% 64% 80%
Trained Prescribers Used Patient Counseling Document More
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Prescriber Survey Assessed Understanding of Blueprint Knowledge Areas
Prescribers
Completing a REMS-
compliant CE Activity
(N=433)*
Reported NOT
Completing a REMS-
compliant CE Activity
(N=179) Difference
Mean score Mean score Est. 95% CI
Assess patients 91.9 87.7 -4.2 (-6.6, -1.8)
Initiate, modify,
discontinue dose80.2 74.6 -5.6 (-7.3, -3.8)
Manage therapy 86.1 84.3 -1.8 (-3.4, -0.3)
Counseling 92.2 89.2 -3.1 (-4.5, -1.6)
General drug
information87.8 78.9 -8.8 (-11.1, -6.6)
Specific drug
information60.7 50.9 -9.8 (-14.0, -5.5)
Overall Score 84.7 79.7 -5.0 (-6.2, -3.7)
*Combines prescribers recruited by CE providers and prescribers recruited through IMS who reported completing a REMS-
compliant CE activity
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To determine knowledge retention and
practice changes
6-12 months following completion of REMS-
compliant training
Long-Term Evaluation Survey
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~30 minute survey
102 survey items
65 knowledge questions including case
scenarios
Prescribers identified through RPC supported
CE providers
Long-Term Evaluation Survey Design
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Recruitment target = 600 responders
328 completed survey
Feb to April 2015
Long-Term Evaluation Survey of REMS Prescribers
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56% male
66% MDs or DOs
60% in practice >15 years
46% prescribed ER/LA opioids >10 times in
last month
Prescribers who Completed Long-Term Evaluation Survey
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Long-Term Evaluation Survey: Topline Results
FDA Blueprint Message Mean score
1. Assessment 83.4
2. Initiation, modification, or
discontinuation of therapy67.8
3. Management of ongoing therapy 90.6
4. Patient counseling 93.4
5. General drug information 83.6
6. Product-specific drug information 57.0
Overall score 82.8
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Mean knowledge score 82.8% correct
~70% of questions were answered correctly by
at least 80% of participants
No questions on product-specific information
had a correct response rate above 80%
Insights from Long-Term Evaluation Survey
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Utilization Patterns Beginning to Change
Assessment
REMS communication activities
Number of trained* prescribers
Audit of CE trainings
Patient survey
Prescriber survey
Long-term evaluation of trained* prescribers
Evaluation of drug utilization patterns
Evaluation of changes in prescribing behavior
Surveillance monitoring
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4.3% decrease in ER/LA prescription volume
95% CI 2.4 to 6.1
20.7% decrease in ER/LA prescription volume
in patients between 19 - 40 years of age
7.6% decrease in IR prescription volume
Opioid Prescription Volume Decreasing Compared with Pre-REMS
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Prescribing Behavior Studied
Assessment
REMS communication activities
Number of trained* prescribers
Audit of CE trainings
Patient survey
Prescriber survey
Long-term evaluation of trained* prescribers
Evaluation of drug utilization patterns
Evaluation of changes in prescribing behavior
Surveillance monitoring
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Decreases in Prescriptions for Specialties with Less Compelling Reasons to Prescribe
Type of Prescriber %
ER/LA Opioids
Prescriptions
Dentist -49
Decrease
Emergency Medicine Physician -26
Surgeon -21
Neurologist -18
Other Prescriber Specialty -16
Pediatrician -16
Primary Care Physician -14
Rheumatologist -14
Oncologists -12
Hospice/Palliative Physician -6
Physician/Rehabilitation -2
Pain Physician 0.4 No significant change
Anesthesiologist +3
IncreasePhysician Assistant +31
Nurse Practitioners +34
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CO-84
Volume of Prescriptions Increasing Among Physician Assistants and Nurse Practitioners
Physician Assistants % Change
COX-2 Inhibitors 23%
Benzodiazepines 18%
Cholesterol Lowering Drugs 28%
Ulcer Medications 31%
Anti-Convulsants 40%
Anti-Depressants 27%
Nurse Practitioners % Change
COX-2 Inhibitors 22%
Benzodiazepines 22%
Cholesterol Lowering Drugs 30%
Ulcer Medications 34%
Anti-Convulsants 38%
Anti-Depressants 28%
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CO-85
Some Improvement in Inappropriate Prescribing
Areas of Problematic Prescribing Decrease
Concomitant prescribing of benzodiazepines
and ER/LA opioids-3.7%
Opioid-naïve patients starting on extended-
release hydromorphone-8.8%
Opioid-naive patients starting on fentanyl
patches-1.7%
Opioid-naïve patients starting on high-dose
extended-release morphine-2.9%
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CO-86
Surveillance Monitoring to Determine Impact on Outcomes
Assessment
REMS communication activities
Number of trained* prescribers
Audit of CE trainings
Patient survey
Prescriber survey
Long-term evaluation of trained* prescribers
Evaluation of drug utilization patterns
Evaluation of changes in prescribing behavior
Surveillance monitoring
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CO-87
Retrospective cohort study of commercially
insured patients
Medicaid data from one state
Patients who received ≥ 1 ER/LA opioid
Before REMS through August 2014
Opioid overdose defined using diagnosis
claims for poisoning/overdose by opioids
Emergency Department Visits and Hospitalization Due to Opioid Overdose
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CO-88
Characteristics
Commercially insured* Medicaid
Pre-REMS
(N=80,209)
Active Period
(N=43,730)
Pre-REMS
(N=3,488)
Active Period
(N=3,625)
% % % %
Alcoholism 5.0 6.2 14.7 19.3
Anxiety disorder 29.7 39.5 47.6 60.4
Bipolar disorder 4.6 5.6 19.7 24.7
Depressive disorder 28.2 35.8 45.8 56.0
History of suicide attempt 0.8 1.1 4.5 5.0
Post-traumatic stress disorder 1.8 2.7 6.2 9.9
Sleep disorder 30.3 37.8 38.5 50.7
Opioid type dependence 5.8 10.6 28.4 35.4
Other drug dependence 6.5 9.9 33.2 37.9
History of overdose/poisoning 0.9 1.3 2.3 3.6
History of benzodiazepine use 46.9 51.6 55.5 57.6
Changes in Baseline Characteristics After the REMS
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CO-89
Emergency Department Visits and Hospitalizations for Opioid Overdose
Commercially Insured Medicaid
Pre-REMS After REMS Pre-REMS After REMS
Duration (months) 24 14 24 14
Number of Patients 80,209 43,730 3,488 3,625
Number of Events 391 194 52 67
Person – Time 46,199 22,354 2,126 2,559
Unadjusted
incidence rate per
10,000 person-
years (95% CI)
85(77 – 94)
87(75 – 100)
245(183 – 321)
262(203 – 323)
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CO-90
Adjusted Risk Ratio (RR) for Opioid Overdose after REMS
Unadjusted RR
After vs Before REMS
(95% CI)
Adjusted RR
After vs Before REMS
(95% CI)
Commercially
insured
1.0
(0.9 – 1.2 )
0.8
(0.7 – 1.0)
Medicaid1.1
(0.8 – 1.5)
0.8
(0.6 – 1.2)
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CO-91
Sensitivity Analysis Suggests Abuse Deterrent Formulations not Source of Overdose Decrease
Analysis excluded abuse deterrent
formulations
RR = 0.8
95% CI 0.7 – 1.0
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CO-92
Addressing Assessment Limitations
REMS Component Limitations Evidence-based solution
Patient survey
Only
commercially
insured sample
• Increase Medicaid and Medicare
representation
• Include caregivers
Prescriber &
Long-term
prescriber surveys
• Sample size
• Knowledge
• Closer communications and IT
support between survey vendor
and CE providers
• Already recruited 2/3 of sample
size in 3 weeks for the Long-
term survey
• Communication of results to CE
providers
ED &
hospitalizations due
to overdose
• Commercially
insured patients
• No death data
• Expanded access to 2 additional
states of Medicaid data
• Using National Death Index data
since it now has post-REMS data
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CO-93
Data show
Good reach of Medication Guide
Limited awareness of REMS materials
Knowledge of product-specific information
is limited
Decreases in inappropriate prescribing
Numerical reductions in ED visits and
hospitalizations due to opioid overdose
Conclusions
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CO-94
Surveillance Data of the Public Health Impact
Richard C. Dart, MD, PhD
RADARS® System
Rocky Mountain Poison & Drug Center
University of Colorado
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CO-95
REMS
Components Accomplishments/Key Findings Evidence-based Improvements
Number of trained
prescribers• Increasing numbers per year
• Make Blueprint more concise
• Increase to healthcare team
Audit of CE
trainings • 100% alignment with Blueprint
• Remediation of those that did
not meet financial disclosure
requirements
REMS
assessments
• Patient: High awareness of
Medication Guide
• Prescribers: Low awareness of
REMS communications materials
• Prescribers: Training associated
with higher knowledge scores
• Prescribers: Product-specific
knowledge is limited
• Opioid prescriptions decreasing
• Improvements in inappropriate
prescribing
• Launch of awareness
campaign
• More representative survey
populations
Surveillance
monitoring
• Significant decreases in some,
but not all, safety outcomes
• Expanded access to
Medicaid data
• Use of National Death Index
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CO-96
Significant decreases in some, but not all, safety outcomes
Began prior to implementation of REMS and were not
limited to ER/LA products covered by REMS
ER/LA decline > IR decline in most outcomes
Multi-faceted approach
Role of individual interventions can’t be determined
Survey methodology limitations
ER/LA product account for about 10-25% of total opioid
prescribed in United States
Longer monitoring and refinement of analyses are needed
to assess effect of ER/LA REMS program
Overview of Surveillance Results
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CO-97
Assessment Component Data Source
Emergency Department
Visits & Hospitalizations
HIRD
Medicaid Data
Intentional Exposures Among
Adolescents & Adults RADARS® System
NAVIPPRO®
Unintentional Exposures Among
Infants and Children
Substance Abuse
Treatment Programs
Mortality RatesWashington State Medical
Examiner Database
Data Sources Used for Surveillance
Table 15. Page 74, Sponsor Briefing Book
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CO-98
Independent entity under Denver Health and
Hospital Authority
Financed by subscriptions
Subscribers do not participate in developing
system, in data collection and do not have access
to raw data
Data sets provided to FDA as requested
Orientation to RADARS System
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CO-99
RADARS Examines Prescription Drug Abuse from Multiple Perspectives
Substance Abuse
Treatment Programs
College Student
Survey
Illicit Market Price Web Monitoring
Poison Center DataCriminal Justice:
Drug Diversion
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CO-100
Individual programs do not include every
geographic region
Spontaneous reporting susceptible to bias
Self-reporting involves recall bias
Cannot make direct causal links between
outcomes and drugs
RADARS System Limitations
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CO-101
Analyze trends and patterns of independent
RADARS programs and other data sources
Compare and contrast independent trends
Sensitivity analyses conducted
Methods to Address Limitations of RADARS Programs
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CO-102
Population
Children, adolescents, adults, elderly
Poison centers in 46 states, D.C., territories
85%-93% of US population
Definition/Type of Cases
Spontaneous reports of
acute events associated
with ≥ 1 Rx drug of interest
565,284 opioid exposures
Poison Center Program(2003 - Present)
2014 coverage
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CO-103
Poison centers in operation
for 20-50 years
Each case managed by a
specially trained nurse or
pharmacist
Every Rx opioid or stimulant
case submitted to RADARS
Standardized medical
record with mandatory data
fields and definitions
Poison Centers and Intentional Abuse Cases
Incoming Call
Initial Triage
Care Advice
Disposition
Reporting & QA/QC
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CO-104
“An exposure resulting from the intentional
improper or incorrect use of a substance
where the person was likely attempting to gain
a high, euphoric effect, or some other
psychotropic effect.”
National Poison Data System. Coding Users’ Manual©,
Version 3.1, 2014.
Definition of Intentional Abuse
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CO-105
Rate of ER/LA Opioid Intentional Abuse Reported to Poison Centers Decreased
% Change
Assessment1
ER/LA
Opioids
IR
Opioids
Prescription
Stimulants
Population
Adjusted
(95% CI)
-44%*
(-51%, -37%)
-31%
(-36%, -25%)
-13%
(-19%, -7%)
Prescription
Adjusted
(95% CI)
-44%*
(-50%, -38%)
-25%
(-30%, -19%)
-26%
(-33%, -19%)
Dosing Unit
Adjusted
(95% CI)
-37%*
(-43%, -31%)
-25%
(-31%, -18%)
-26%
(-31%, -20%)
1) Change from 3Q 2010 to 4Q 2014
* p<0.001 compared to prescription IR opioids and stimulants
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CO-106
Poison Center Intentional Abuse Decreased for all ER/LA REMS Products
Page 190 FDA BB*Image from FDA Briefing document
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CO-107
Treatment Centers Abuse Decreased for Most ER/LA REMS Products
*Image from FDA Briefing document
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CO-108
Multiple Programs Indicate Improvement in ER/LA Opioids
Poison Center-Adolescent Abuse
Poison Center-Misuse
Poison Center-Adult Unintentional Exposures
Poison Center-Child and Adolescent
Unintentional Exposures
Poison Center-Major Medical Outcome
Hospitalization or Death
Poison Center-Death
Washington Medical Examiner Deaths
NAVIPPRO ASI-MV
College Survey – Nonmedical use
-100 -50 0 50 100 150 200
Worsened following REMS
ER/LA Opioids
Improved following REMS
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CO-109
Relation Between RADARS System and other Data Sources
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CO-110
0
0.7
1.4
2.1
2.8
3.5
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Strong Correlation of Prescription OpioidAbuse: Poison Centers and Drug Abuse Warning Network (DAWN)
Rate of Opioid Abuse
See also Davis J, Pharmacoepidemiol Drug Safety (Epub 2013)
0
20
40
60
80
100
120
140
160
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
RADARS
Poison Center
DAWN
R=0.95
RADARS
oxycodone
abuse
population
per
100,000
DAWN
oxycodone
drug-related
ED visits
population
per
100,000
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CO-111
Strong Correlation of Deaths: Poison Centers and National Mortality Data (NVSS)
NVSS
R=0.67
RADARS
Poison Center1
National and Semisynthetic (2005 to 2015)
RADARS
Poison Center
deaths
per
1,000,000
population
R=0.67
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
-0.5
0.5
1.5
2.5
3.5
4.5
5.5
6.5
200
3
200
4
200
5
200
6
20
07
200
8
200
9
20
10
201
1
201
2
20
13
201
4
201
5
Year
-0.5
6.5
5.5
4.5
3.5
2.5
1.5
0.5
NVSS
deaths
per
100,000
population
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CO-112
Strong Correlation of Heroin Mortality: Poison Centers and National Mortality Data (NVSS)
0.00
0.05
0.10
0.15
0.20
0.25
0.00.51.01.52.02.53.03.54.04.55.0
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
Year
Heroin Deaths, 2005 to 2015
NVSS
RADARS
Poison Center
R=0.90
NVSS
deaths per
100,000
population
RADARS
Poison Center
deaths per
1,000,000
population
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CO-113
0
10
20
30
40
50
60
70
0
5
10
15
20
25
30
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Strong Correlation of Prescription Opioid Abuse Reported to RADARS Treatment Centers and Treatment Episode Dataset (TEDS)
RADARS
Treatment
Center
rate per
100,000
population
RADARS
TEDS
R=0.94
Individuals Entering Treatment for Prescription Opioids
(2005 to 2015)
SAMHSA
TEDS
rate per
100,000
population
0.7
0.6
0.5
0.4
0.3
0.2
0.1
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CO-114While Total Opioid Deaths Rose Through 2014, Natural & Semisynthetic Opioids Plateaued in 2011
YearNVSS=National Vital Statistics System
0.5
0.6
0.7
0.8
0.9
1
1.1
1.2
0
0.5
1
1.5
2
2.5
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
2.5
2.0
1.5
1.0
0.5
0
2005
NVSS Total
Opioid
Deaths
NVSS Natural &
Semisynthetic
Relative
change
in rate
since 2011
Relative
change
in rate
since 2003
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CO-115
0
0.2
0.4
0.6
0.8
1
1.2
1.4
0
0.5
1
1.5
2
2.5
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Deaths from Natural & Semisynthetic Category Plateaued in 2012
- NVSS Total Opioid Deaths
- NVSS – Nat & Semisynth
- NSDUH Nonmedical use
- WA Medical Examiner
- RADARS Treatment Ctrs
Relative change in NVSS
rates since 2003
- RADARS Poison Deaths
- RADARS Poison Ctr Abuse
Year
Relative
change
Relative change
in rate since 2011
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CO-116
Deaths from Natural & Semisynthetic Category Plateaued in 2012
0
0.2
0.4
0.6
0.8
1
1.2
1.4
0
0.5
1
1.5
2
2.5
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
- NVSS Total Opioid Deaths
- NVSS – Nat & Semisynth
- NSDUH Nonmedical use
- WA Medical Examiner
- RADARS Treatment Ctrs
- RADARS Poison Deaths
- RADARS Poison Ctr Abuse
Relative
change
Relative change in NVSS
rates since 2003
Year
Prescription Monitoring Plans
Take Back Programs
Abuse Deterrent Form
ER/LA REMS
Florida
Relative change
in rate since 2011
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Generally consistent trends across multiple
independent sources
Abuse decreases for ER/LA greater than IR
opioids in several, but not all outcomes
NVSS deaths plateau between 2011 and 2014
for Natural & Semisynthetic opioids
Decrease in Poison Center mortality
Multi-faceted contributions to these trends
Not possible to determine role of individual
interventions
Surveillance Detected Decreases in Abuse and Misuse for ER/LA Opioids
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Lessons Learned from the REMS and Recommended Improvements
Laura Wallace, MPH
RPC Metrics Sub team member
Purdue Pharma L.P.
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CE courses
Scope
Consortium of 24 companies
19 CE providers
839 accredited education programs
Range of assessments and data sources
REMS is Novel Program
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>800 REMS-compliant CE courses
Consistent messaging
Positive ratings by completers
Resulting in generally good knowledge of
safe opioid prescribing
Due to collaboration of RPC, FDA, CE
community, data providers, etc.
Learnings from the REMS: Collaboration and Project Management
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Systematic review of activities
Many under-performed
Lower awareness of REMS
Learnings from the REMS: Communication Activities
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Learnings From the REMS: Assessments
Assessments
Survey Surveillance Studies
Patient survey Drug utilization patterns
Prescriber survey Changes in prescribing behavior
Prescriber long-term evaluation
Surveillance monitoring
(including ED visits and
hospitalization)
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ER/LA opioids = 10% of opioid prescribing
IR opioids = 90% of opioid prescribing
ER/LA Opioids Only Part of the Issue
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To ensure balance between
Reducing abuse, misuse, and addiction
Avoiding undue burden to healthcare
system
Allow access to appropriate patients
Goals of RPC’s Recommendations
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Improve REMS CE website
Planned launch of awareness campaign
RPC Recommendation #1: Enhance Communication
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Current REMS: focus on recent ER/LA opioid
prescribers
Clinicians report education of all team
members is critical for implementation of
REMS learning
RPC Recommendation #2: Expand to Extended Healthcare Team
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Pharmacy, nurse, other professional societies
critical partners
Availability of accredited CE to new healthcare
providers & those in underserved communities
Expand REMS to Extended Healthcare Team - Implementation
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Prescriber education to reflect evolving
stakeholder input and feedback
Needs of adult learners
RPC Recommendation #3: Revise the FDA Blueprint
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Include tools to manage risks (such as
co-prescribing of naloxone)
Condense content
Utilize case studies
Use adaptive approaches or a demonstration
of knowledge/competence
Emphasize general principles of safe ER/LA
opioid prescribing
Address other topics in pain management
Establish standard assessment across CE
RPC Recommendations: Revise the Blueprint
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If training is made mandatory, consider
tying Schedule 2 and 3 narcotic DEA
registration to either completion of
prescription opioid education or other
attestation of knowledge, such as board
certification in pain medicine
Ensure all prescribers have appropriate
training in use of ER/LA opioids
No undue burden on prescribers or
pharmacists
RPC Recommendation #4: If Training is Required, Tie to DEA Registration
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RPC Recommendation #5: Harmonize Federal Course Content
Yes31%
No61%
Partial8%
Overall Analysis of NIDA Course to FDA Blueprint
N=76
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Based on lessons learned
Improve provider knowledge and further
reduce misuse and abuse
Improve REMS in Evidence-Driven Ways
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Conclusions
Paul Coplan, ScD, MBA
RPC Metrics Subteam Chair
Purdue Pharma L.P.
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Communication components
3 million copies of the Dear Prescriber Letter sent
In prescriber survey, 33% of prescribers reported
reading it
CE Training
839 CE courses conducted
438,000 participants, 157,493 completers, 66,219
ER/LA prescriber completers
Survey Results
Knowledge score: Patients = 86%, Prescribers = 83%
questions correct
Summary: Communication and Education Components
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Abuse
44% abuse decrease in RADARS Poison Center Program
21% abuse decrease in ASI-MV System
46% abuse decrease RADARS Drug Treatment Center Program
Misuse
23% decrease in patient misuse in RADARS Poison Center
Program
Overdose
Numerical decrease in overdose ER visits
Death
39% decrease in fatalities involving opioid analgesics
(Washington state)
Summary: Results of Surveillance Assessments
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Prescribing metrics
Some decrease in inappropriate
prescribing
Summary: Prescribing Changes
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Dear Prescriber Letter, key tool to inform
prescribers about REMS, not sufficient
Need for aligning competing CE courses on
opioids
Consistent post-training measures for CE
courses
Concise Medication Guide can have good
reach
Lessons Learned
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Other Company Initiatives to Reduce Opioid Abuse and Misuse
Post-marketing studies of ER/LA opioids to assess
Long-term efficacy of opioids
Addiction, abuse, overdose, death in people with pain
Measure incidence
Identify risk factors
Develop validated measures
Unused medication take-back programs
Abuse-deterrent formulations
New molecular entities to treat pain
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First phase: Development and Implementation
DSaRM and AADP joint meeting July 2010
2011 White House Prescription Drug Abuse
Prevention Plan
Results from first 3-4 years after approval
Second phase: Evaluation and Revision
Califf/Woodcock 2016 NEJM opioid article
CDC Guidelines for Opioid Treatment
National Pain Strategy
DSaRM and AADP joint meeting May 2016
Phases of ER/LA Opioid REMS
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RPC Acknowledgements
CE Subteam
Brian Kilmartin (Teva)
Ekaterina Walker
(Purdue)
Lisa Zimmerman (Pernix)
Mark Tyrrell (Impax)
Marsha Stanton (Pernix)
Michelle Zachman
(Upsher-Smith)
Nathan Kopper
(Mallinckrodt)
Terry Lumati (Depomed)
Metrics Subteam
Greg Wedin (Upsher-
Smith)
Kal Elhoregy (Endo)
Karla Werre
(Mallinckrodt)
Laura Wallace
(Purdue)
Linda Noa
(Mallinckrodt)
Mark Tyrrell (Impax)
Nathan Kopper
(Mallinckrodt)
Paul Coplan (Purdue)
Soledad Cepeda
(Janssen)
RPC Members and External Collaborators
Actavis – Tara Brolly
Endo – Mark Collins & Tina
Latch
HealthCore
Linda Kitlinski
inVentiv Health Consulting
IMS Health
Ogilvy CommonHealth
Worldwide
Pfizer – Robert Kristofco, Ken
Petronis, Sharon Reid & Gary
Wilson
Polaris
Purdue – Jaren Howard, Robert
Josephson & Nelson Sessler
RADARS System
RPC Supported CE Providers
United BioSource Corporation
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Novel approach that includes CE activities
Contributed to increased awareness and
knowledge among patients and prescribers
Contributed to decreases in serious risks of
ER/LA opioids
Identified areas for improvement
REMS - Overall Conclusions
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RPC (REMS)
AADPAC & DSRMAC
May 3 - 4, 2016
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