REMS Program Companies (RPC)
2015 CE RFA Webinar
March 26, 2015
-1Copyright © 2015 Campbell Alliance, Ltd. All Rights Reserved.
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2015 CE RFA Webinar
Agenda
REMS Provider Information Webinar Agenda Item
Facilitator
Introductions and Welcome
Campbell Alliance
ER/LA Opioid Analgesic REMS Compliant CE: 2015 RFA
Introduction to the ER/LA Opioid Analgesic REMS CE and the RPC
Achieving ER/LA Opioid Analgesics REMS Goals – Key Collaborations
ER/LA Opioid Analgesic REMS CE: Considerations and Challenges
Primary Target Audience Overview
ER/LA Opioid Analgesics REMS-Compliant CE Requirements
Overview of the 2015 CE RFAs
Grant Request Evaluation Criteria
ER/LA Opioid Analgesic REMS: Key Learnings
Wrap up / Provider Questions
CE Subteam
Marsha Stanton
CE Subteam
Marsha Stanton
CE Subteam
Marsha Stanton
CE Subteam
Marsha Stanton/Eka Walker
CE Subteam
Bernie Hahn
CE Subteam
Nathan Kopper/Marsha Stanton
CE Subteam
Nathan Kopper/Marsha Stanton
CE Subteam
Nathan Kopper/Marsha Stanton
CE Subteam/ Campbell Alliance
-2Copyright © 2015 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary.
2015 CE RFA Webinar
Introductions – RPC Continuing Education Subteam
The Continuing Education (CE) Subteam is the group within RPC that is responsible for all CE-related aspects of the
REMS. The CE Subteam are the primary authors of the 2015 CE RFA and also serve as the RPC Educational Grant
Review Committee.
RPC CE Subteam Members
Company
Mallinckrodt, Inc.
Pfizer, Inc.
Purdue Pharma
Zogenix, Inc.
Name
Nathan Kopper
John Decker
Bob Kristofco
(CE Subteam co-chair)
RPC Project Management Office Members
Company
Meghana Rao
John West
Campbell Alliance (Primary
Points of Contact)
Grant Coordinator
Company
Name
Marcus Bender
Raj Patel
Polaris Solutions
Ekaterina Walker
Marsha Stanton
(CE Subteam co-chair)
Name
CE Consultant
Company
Name
RPC CE Subteam
Linda Kitlinski
-3Copyright © 2015 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary.
2015 CE RFA Webinar
Introduction to the ER/LA Opioid Analgesic REMS CE and the RPC
The purpose of the ER/LA Opioid Analgesics REMS is to ensure that the benefits of ER/LA opioid analgesics outweigh
the risks in patients whose clinicians have determined these medications to be an appropriate treatment option.
Background Information on the RPC and the ER/LA Opioid REMS
 The FDA requires a Risk Evaluation Mitigation and Strategy (REMS) for extended-release (ER) and long-acting (LA)
opioid analgesics to reduce adverse outcomes (addiction, overdose, death) resulting from inappropriate
prescribing, misuse, and abuse while maintaining patient access to pain medications.
 The REMS Program Companies (known collectively as RPC) are the 20 companies with ER/LA opioid analgesics.
 Since 2012, the RPC has awarded funding to support >400 REMS-compliant activities through nineteen grants to
accredited CE Providers and their 100+ Educational Partners
February 28, 2013
Date of First REMSCompliant Training
2013
As of 2/28/14:
20,345 ER/LA
Prescribers
Completers
2014
Goal:
80,000 ER/LA
Prescribers
(February 2015)
Goal:
160,000 ER/LA
Prescribers
(February 2016)
Goal:
192,000 ER/LA
Prescribers
(February 2017)
2015
2016
2017
2018
The ER/LA Opioid REMS represents the first use of accredited CE to fulfill a REMS “training” requirement.
REMS CE provides an excellent opportunity for Providers to join a nation-wide Continuing Education effort
-4to reduce ER/LA opioid
abuse,
misuse,
addiction,
unintentional
overdose and death.
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All Rights Reserved.
Confidential and Proprietary.
2015 CE RFA Webinar
Achieving ER/LA Opioid Analgesics REMS Goals – Key Collaborations
Since the start of the ER/LA Opioid Analgesics REMS program, the RPC has continuously worked with external
stakeholders to adapt and improve upon this unprecedented educational directive.
ER/LA Opioid REMS Key Stakeholders
RPC- Supported CE Providers
 Continued engagement with RPCsupported CE Providers allows for
open exchange of share
information, insights, and
suggestions on how to best
educate the ER/LA Opioid REMS
target audience.
Conjoint Committee on Continuing
Education (CCCE)
 Recent collaboration with CCCE
and RPC Awareness Campaign
Vendor (Ogilvy & Mather) will
better inform the Health Care
Professional community of the
availability of ER/LA Opioid CE.
Accrediting Organizations
 Accrediting Organizations ensure
that RPC-supported CE covers all
sections of the FDA Blueprint and
meets the standards for
Commercial Support.
 The CCCE provides a forum to
discuss ER/LA Opioid REMS CE
with the FDA.
“The CCCE’s goal is to use the continuing education of health professionals to improve the performance of the U.S.
health care system. The CCCE’s strategic focus is to voluntarily educate prescribers of long-acting opioid analgesics
in Risk Evaluation and Mitigation Strategies (REMS). It is the hope of the various health professions that we can use
our educational tools to stem this public health crisis.”
-5-
Excerpt from February 24, 2014 Conjoint Copyright
Committee
on
Continuing
Meeting
chaired
by Dr. Norman Kahn & Dr. Murray Kopelow
© 2015
Campbell
Alliance, Education
Ltd. All Rights REMS
Reserved.
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and Proprietary.
2015 CE RFA Webinar
ER/LA Opioid Analgesic REMS CE: Considerations and Challenges
Based on feedback received from external REMS stakeholders, the RPC has identified the following considerations
and challenges specific to ER/LA Opioid Analgesic REMS CE.
Considerations and Challenges
 Relatively low “REMS awareness,” as well as ambiguity about “what REMS is” contributes to lack of motivation for
HCPs to complete REMS CE.
 While clinicians are well-aware of the patient safety/public health issues related to opioids, the term “REMS”
itself is not particularly meaningful to HCPs.
 Since there are many REMS, HCPs do not necessarily equate “REMS” with the ER/LA Opioid Analgesics REMS.
 REMS-compliant CE requirements are daunting to busy clinicians as a substantial investment of time (2-3 hours) is
required in addition to completion of a REMS-compliant assessment tool in order for prescriber completers to
count toward the FDA goals.
 The prescriptive nature of REMS-compliant CE, as well as the fact that there is presently no way for knowledgeable
clinicians to demonstrate evidence of prior learning/competence, reduces learners’ incentive to complete the
training.
 Concurrent non-REMS-compliant opioid related CE targets the same audience as the REMS-compliant programs.
 Learners can be reluctant to self-report that they have prescribed ER/LA opioid(s) within past year.
 Reduced numbers of clinicians writing ER/LA opioid prescriptions may limit number of HCPs interested in
completing REMS CE.
Efforts to address challenges include collaboration with Conjoint Committee for Continuing Education (CCCE) and
-6RPC-selected Awareness
Vendor
help
raise
ER/LA
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Reserved.
Confidential
and Opioid
Proprietary. REMS awareness.
2015 CE RFA Webinar
Primary Target Audience Overview
The FDA REMS defines the primary audience for REMS-compliant CE as those clinicians who are actively prescribing
ER/LA opioid analgesics.
Primary Audience for REMS-compliant CE
 The ER/LA Opioid REMS CE education/training goals have been defined by the FDA.
 The definition of an “ER/LA opioid analgesic prescriber” was determined by the FDA and described MedBiquitous
MEMS Specifications:
 “An individual clinician who is registered with the DEA to prescribe Schedule 2 and/or 3 controlled substances,
and has written at least one ER/LA opioid script in the past year.”
 This definition, as well as other REMS-related information which Providers of REMS CE will need to utilize in
reporting their data can be found on the MedBiquitous website.
 MedBiquitous Medical Education Metrics (MEMS) Specifications http://medbiq.org/sites/default/files/files/MedicalEducationMetricsSpecification_pointrelease.pdf
 Implementation Guidelines for REMS CE Data Exchange http://www.medbiq.org/sites/default/files/files/MEMSImplementationGuidelines.pdf
 MEMS Summary Page - http://medbiq.org/mems_20_summary
It is critical that CE Providers understand the MedBiquitous definition of “ER/LA Opioid Prescriber Successfully
Completing” REMS CE since these are the only learners who may be counted toward FDA goals.
*FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics (December 2014)
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2015 CE RFA Webinar
Primary Target Audience Overview (continued)
The US map below highlights the location of prescribers who wrote at least one ER/LA Opioid Analgesic prescription in
the 12 months ending January 2015 by ZIP Code.
Primary Audience for REMS-compliant CE
What do we know about the target audience of ER/LA opioid prescribers?
The data indicates that
prescribers of ER/LA
opioid products are
distributed throughout
the US, with great
concentrations occurring
in large urban areas, as
expected.
Source: IMS Health Incorporated, IMS Xponent Plantrak January 2015
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2015 CE RFA Webinar
Primary Target Audience Overview (continued)
Given the importance of the REMS to patient safety and public health, other health care
professionals, beyond the primary target audience, are also strongly encouraged to participate in
REMS-compliant CE.
 While the primary audience for REMS CE defined by the FDA is ER/LA Opioid
prescribers, the RPC also encourages other groups of health care
professionals to participate:
Clinicians who currently do not prescribe ER/LA opioids
Short-acting or immediate-release (IR) opioid prescribers
Hospital or practice support team members
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2015 CE RFA Webinar
ER/LA Opioid Analgesics REMS-Compliant CE Requirements
REMS-compliant CE requirements are specifically defined by the FDA and all RPC-supported CE activities must
adhere to all of these requirements.
Requirements for REMS-Compliant CE
 “REMS-compliant CE” must:
 Include ALL elements of FDA Blueprint* in the educational activity/materials
 Include post-activity assessment covering ALL sections of FDA Blueprint
 Be subject to independent audit ** (CE Accreditors serve as independent auditors)
—At least 10% of RPC-supported activities will be audited for compliance with Blueprint, compliance with
assessment requirements & compliance with Accreditors’ standards for commercially-supported CE
—Audits should occur prior to the time learners encounter the activity, to assure compliance with REMS
requirements & that Blueprint content is represented accurately
—RPC-supported Providers agree to submit all materials to their Accreditor at least 45 days before
activity start date
 No promotional content: REMS-related information only
 “Training” (in this instance, CE) will be made available to all HCPs who prescribe ER/LA opioid analgesics
*FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
**FDA Approved REMS for ER/LA Opioid Analgesics (December 2014):
http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM311290.pdf
-10Copyright © 2015 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary.
2015 CE RFA Webinar
Overview of the 2015 CE RFAs
Approach to RFA
Development
Goal
Common
Goals
The RPC CE Subteam determined that two RFAs will help to accrue ER/LA opioid prescriber completers. One RFA
will fill gaps in learning modalities and the extension RFA will maintain momentum of currently funded programs.
 Accrue ER/LA opioid prescriber completers towards FDA REMS goal
 Ensure there are sufficient CE Activities available for HCPs for 2016 and 2017
 List the challenges associated with REMS CE and key learnings from the RPC CE Subteam and RPC Supported CE
Providers
RFA 050315
RFA 060315 Extension
Focus on specific educational modalities that are likely to
yield more completers that prescribe ER/LA Opioids
(ID gaps in modalities)
Maintain momentum for successful RPC-supported CE
Providers
(ID gaps in audience)
 Develop an RFA for specific educational modalities
(e.g. print, unique online activities with low
development costs w/ smart phone tablet
capabilities, step-wise, “prior learning” approach)
 Open RFA to both new CE Providers and RPCsupported CE Providers
 Develop an RFA specifically for CE Programs currently
supported by the RPC
 Emphasize that higher consideration will be given to
large networks of ER/LA opioid prescribers (e.g. IDN,
ACO)
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2015 CE RFA Webinar
Overview of the 2015 CE RFAs (continued)
There are five components to the 2015 ER/LA Opioid REMS RFA that outlines the scope of the problem, RFA
submission information, and grant application review criteria.
1
Scope of Problem and
Background on ER/LA
Opioid Analgesic REMS
 General information around chronic pain in the US and potential for misuse and abuse of opioids
 Introduction of the ER/LA opioid analgesics REMS and the focus of RPC on REMS-compliant CE
 FDA expectations and goals of RPC REMS CE; key REMS-related definitions and considerations
Funding Opportunity and
Award Information
 Award details including general information such as number of awards, budget considerations,
RPC Sunshine/Open Payments-related requirements, award project period and other information
around program diversity and partnerships
Applicant Eligibility
Information
 All Providers submitting application must be currently approved by a national accrediting body to
provide CE
 Accredited Provider submitting application must serve as Provider of Record and must
demonstrate their organization is in good standing at the time of submission
RFA Submission Information
 Outline of application components including items such as partnerships, audience focus, scope of
program, budget and a description of the educational program design, including timelines, needs
assessment, knowledge assessment, content validation process, and any optional activities
Grant Application
Evaluation Criteria
 Outline of specific items required for inclusion in the grant application and several references to
additional information for grant requestors to review during the application process (details on
following slide)
2
3
4
5
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2015 CE RFA Webinar
Grant Request Evaluation Criteria: Overview
While all RPC-supported CE must be REMS compliant and will be evaluated based on all criteria outlined in the 2015
CE RFA, there are several criteria that are especially important for Providers to consider.
Key Grant Evaluation Criteria
Essential Elements
Compliance
Alignment – clear “mapping” of
proposed activity to FDA Blueprint
Assessment covers all 6 sections of FDA Blueprint
Elements of High Importance
Needs Assessment specific to the
target audience for the activity
Number of ER/LA opioid prescribers expected to
complete activity(ies) covering full Blueprint plus
assessment on all sections of Blueprint
Qualifications of Provider and Partners
Educational Design/Methods
(may include one or more)
Needs Assessment Should Include
One or More of the Following:
(a) Evidence and rationale for choosing a specific
target audiences (“new” target audience for
extension applicants)
(b) Evidence of knowledge, practice, and/or
educational modality gaps specific to your
target audience in the geographic area where
the proposed program will occur
(c) Results from any surveys or assessments you
have executed with your specific target
audience, where the survey tool was
specifically based on the FDA Blueprint
This needs assessment should be specific to knowledge, audience and educational modality gaps that are
-13addressed
by
unique
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2015 CE RFA Webinar
Grant Request Evaluation Criteria: Timeline for Evaluation
The submission date for all grant proposals in response to the 2015 CE RFA is Tuesday, April 21 at 5:00pm ET. The CE
Subteam and the RPC will evaluate proposals and anticipate final decisions being made in mid-to-late July, 2015.
March
2
9
16
April
23
30
6
13
20
May
27
4
11
18
June
25
2
9
16
July
23
2015 RFA CE Provider Webinar
7
14
21
Legend
CE Subteam Activity
Initial Rolling Grant Reviews
We Are Here
30
Major Milestones
Grant Application Deadline 5:00pm ET 4/21/15
Post Submission Grant
Reviews
Initial Recommendations Developed by
Grant Review Committee
Oversight Committee
Review
Final Recommendations to RPC
Tentative RPC Approval Week Mid to Late-July
Applicants will be notified in late-July/early August. Grant recipients will be expected to sign a CE Letter of
-14- the first of four grant payments.
Agreement in advance of receiving
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28
2015 CE RFA Webinar
ER/LA Opioid Analgesic REMS CE: Key Learnings
CE Providers applying to the 2015 RFAs should considering the following key learnings when developing a proposal.
Key Learnings from RPC-supported CE Providers to Date
 On average, 40-50% of all “participants” who begin REMS CE will go on to “successfully complete” REMS CE.
 On average, 40-50% of “successful completers” of REMS CE have written at least 1 ER/LA opioid Rx in the
past year and can therefore “be counted” toward the FDA goals.
 CE Providers have reported that integrating the learning assessment throughout the activity (vs. administering it at
the end of the activity) has been key to optimizing the number of learners “successfully completing” REMS CE.
 Modular approaches require prompt and repeated reminders to encourage/engage learners to “successfully
complete” the full activity (i.e. modules and assessment covering all 6 sections of the FDA Blueprint).
 To help allay concerns and increase likelihood of accurate self-reporting, it is important for Providers to explain the
rationale for asking learners whether they have prescribed an ER/LA opioid in the past year.
 Offering REMS “Certificates of Participation” appears to be valued by learners and may increase the likelihood of
learners “successfully completing” the full activity, including learning assessment.
 Innovative partnerships with professional organizations, malpractice insurance companies, health systems,
institutional credentialing bodies, etc. increase awareness of REMS CE, engage learners to participate, and may
increase the likelihood that participants will “successfully complete” the full activity.
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2015 CE RFA Webinar
Summary of Key RFA Information
Grant Request Information
 The 2015 CE RFA is accessible on the RPC CE Website: http://ce.er-la-opioidrems.com
 The RPC Grant Management System will be accepting applications until 5:00pm ET on Tuesday, April 21st
 If you have not previously registered on the RPC Grant Management System (GMS), you are encouraged to do so in
advance of April 21st to avoid any potential last-minute issues
 If you have questions on the RFA or the Grant Management System, please email Marcus Bender, the RPC GMS
coordinator, at [email protected]
Important Links:
 FDA Blueprint: http://www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/ucm277916.pdf
 ER/LA Opioid Analgesics REMS:
http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM
311290.pdf
Additional Notes:
 These slides will be posted in PDF format on the RPC Website and distributed to webinar attendees.
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2015 CE RFA Webinar
FDA Goals
The FDA has clearly defined goals for the RPC around REMS-compliant continuing education programs.
Summary of FDA-Defined REMS CE Goals
FDA has set goals/time frames for the number of ER/LA opioid prescribers completing REMS-compliant CE.
 The first FDA-mandated CE goal stipulates that 80,000 ER/LA opioid analgesic prescribers will have successfully
completed REMS-compliant CE, as defined at the bottom of page 1 of the RFA, by Feb 28, 2015.
 Subsequent goals established by FDA in the REMS are:
 160,000 ER/LA opioid analgesic prescribers will have successfully completed REMS-compliant CE
by Feb 28, 2016
 192,000 ER/LA opioid analgesic prescribers will have successfully completed REMS-compliant CE
by Feb 28, 2017
-18Copyright © 2015 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary.