rems program companies (rpc) 2013 ce provider information...

-1- Copyright © 2013 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary.

Copyright © 2013 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary.

REMS Program Companies (RPC) 2013 CE Provider Information Webinar

June 13, 2013


2013 Provider Information Webinar Housekeeping

Before We Begin…

Participants are asked to mute their lines when they are not speaking

Questions submitted in advance of this webinar will be addressed during the latter part of today’s presentation

The slides from today’s webinar will be posted on the RPC Website: http://www.er-la-opioidrems.com

Please note that this webinar is not being recorded, however, the Q/A transcript will be made available with the slides following this meeting

Responses to questions received during today’s Webinar will be included in the final deck when posted

http://www.er-la-opioidrems.com/






2013 Provider Information Webinar Agenda

Provider Information Webinar Agenda Item Facilitator Time

Introductions and Welcome Campbell Alliance 2:00pm-2:05pm

REMS Compliant CE: 2013 RFA

Introduction to the RPC and REMS CE CE Subteam 2:05pm-2:10pm

REMS Target Audience Overview CE Subteam 2:10pm-2:20pm

REMS-compliant CE Requirements and Current Grantees CE Subteam 2:20pm-2:35pm

2013 REMS Compliant CE RFA Summary CE Subteam 2:35pm-2:50pm

Grant Request Evaluation Criteria CE Subteam/ Campbell

Alliance 2:50pm-3:05pm

Provider Questions /Wrap up CE Subteam/ Campbell

Alliance 3:05pm-3:30pm


2013 Provider Information 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. They are the primary authors of the 2013 CE RFA and will play a key role in the 2013 grant review process.

RPC CE Subteam Members

Company Name

Endo Pharmaceuticals, Inc. Linda Kitlinski

Mallinckrodt, Inc. (Covidien) Nathan Kopper

John Decker

Mylan Technologies, Inc. Jill A. Olexa

Pfizer, Inc. Bob Kristofco

Purdue Pharma John Fitzgerald

Lori Ladd

Teva Pharmaceuticals USA, Inc. Sue McGuinness

RPC Project Management Office Members

Company Name

Campbell Alliance Stephanie Cordato

John West


2013 Provider Information Webinar Introduction to the RPC and REMS CE

The REMS Program Companies are hosting this Webinar to provide information about the 2013 CE Grant RFA and grant request evaluation criteria to CE Providers.

Background Information on the RPC and the ER/LA Opioid Analgesics REMS

The REMS Program Companies (known collectively as RPC) are the 17 companies with extended-release (ER) and long-acting (LA) opioid analgesics.

The full list of current RPC Participants and products can be found on the RPC Website, under the “Medication Guides” tab.

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 ER/LA opioid analgesics to be an appropriate treatment option).

ER/LA Opioid Analgesics REMS represents the first use of accredited CE to fulfill a REMS “training” requirement.

REMS CE activities must include ALL elements described in the “Blueprint” developed by the FDA, which focuses on the safe prescribing of ER/LA opioid analgesics.

HCPs who prescribe ER/LA opioid analgesics are in key position to help address this public health problem.

Lifelong learning is an important part of a HCP’s responsibility and Continuing Education (CE) plays an important role.

The 2013 RFA was released on May 21, 2013; the deadline for submitting applications is 5 pm ET, July 16, 2013.

RPC Website: http://www.er-la-opioidrems.com







*FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics (July 2012)

2013 Provider Information Webinar REMS 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 first FDA-mandated CE goal* stipulates that 80,000 ER/LA opioid analgesic prescribers will have successfully completed REMS-compliant CE by Feb 28, 2015.

The definition of an “ER/LA opioid analgesic prescriber” was determined by the MedBiquitous Working Group:

“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.”

Note: the definition of prescriber was slightly modified by the MedBiquitous Working Group following release of the 2013 RFA

The revised definition appears above, and can be found on the MedBiquitous website:

http://www.medbiq.org/mems/definitions#ER/LA_opioid_prescriber)

Following final approval of the definition by MedBiquitous Working Group in late June, RPC will post an updated version of the RFA containing the new definition

The revised definition is also displayed on the GMS portal

http://www.medbiq.org/mems/definitions


2013 Provider Information Webinar REMS Target Audience Overview

Given the importance of the REMS to patient safety and public health, other health care professionals 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


*Collaborative For REMS Education: http://www.core-rems.org/ (accessed 6/10/13)

2013 Provider Information Webinar REMS-compliant CE Requirements and Current Grantees

The RPC awarded five grants as a result of the 2012 RFA cycles. The Providers who received funding did an excellent job of ensuring REMS-compliance in their programs and detailing their activities, approach, and methodology.

RPC-Supported Grants Awarded to Date

Primary Provider Partners Title Activity Format

Boston University CME/CNE

Fed. of State Med. Boards (FSMB) & Council of Med. Specialty Societies (CMSS)

SCOPE of Pain: Safe and Competent Opioid Prescribing Education

National program, consisting of enduring and live activities focused on

diverse groups of HCPs.

Calif. Acad. of Family Phys. (for CO*RE)*

13 National & State Medical Societies, Medscape, and 50+

cooperating organizations

CO*RE REMS Initiative: A Collaborative Solution to the ER/LA

Opioid Public Health Crisis

National program with live and enduring activities including multiple

modules, videos, demonstrations, cases, tools, and references

American College of Physicians

Pri-Med SAFE Opioid Prescribing: Strategies.

Assessment. Fundamentals. Education.

National course focused on diverse groups of HCPs with both web-based

enduring and live components

Utah Med. Assoc. Foundation

8 Utah-based governmental and professional organizations

Utah ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) Educational Programming

Project

Pilot model utilizing a statewide CE program with multiple learning

modalities to educate HCPs, inform patients and reduce abuse/misuse-

related morbidity/mortality

Assoc. for Hospital Med. Education

20 Teaching Hospitals utilizing CO*RE curriculum &

resources

AHME Collaborative for REMS Education

National program, consisting of enduring and live activities focused on

hospital-based clinicians, including residents

http://www.core-rems.org/




*FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics **FDA Approved REMS for ER/LA Opioid Analgesics (July 2012): http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM311290.pdf

2013 Provider Information Webinar REMS-compliant CE Requirements and Current Grantees

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 to 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 to occur prior to the time learners encounter the activity, to assure all elements of FDA Blueprint, plus assessment on all 6 sections of Blueprint are included in the REMS- CE

No promotional content: REMS-related info only

“Training” (in this instance, CE) will be made available to all HCPs who prescribe ER/LA opioid analgesics

http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM311290.pdf



2013 Provider Information Webinar Overview of the 2013 CE RFA (Sections 1-5)

The 2013 CE RFA has been updated from the 2012 document. The 2013 RFA places a strong emphasis on organization and demonstration of REMS-compliance while incorporating innovative learning elements.

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

1

Funding Opportunity and Award Information

Differentiating features of 2012 vs 2013 CE RFA

Award details including general information such as number of awards, cost-per-learner range, award project period and other information around program diversity and partnerships

2

Eligibility Information

Accredited Provider submitting application must serve as Provider of Record & be engaged in or represent HCPs responsible for delivery of patient care

Applicants must have demonstrated a history of design & successful implementation of interactive multimodal educational activities exhibiting solid partnerships & collaboration

3

RFA Submission Information Outline of application components including items such as partnerships, audience focus,

geographic coverage, budget and a description of the educational program design, including timelines, knowledge assessment, and any optional activities

4

RFA Review Information 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)

5


While all RPC-supported CE must be REMS compliant and will be evaluated based on all criteria outlined in the 2013 CE RFA, there are several criteria that are

especially important for Providers to consider.

2013 Provider Information Webinar Grant Request Evaluation Criteria: Overview

The 2013 CE RFA has clearly defined evaluation criteria that outline ways in which Providers can demonstrate the strength of their proposals.

Elements of High Importance

Needs assessment specific to audience proposed by the Provider

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)

Essential Elements

Compliance with Prescriber eligibility requirements

Alignment – clear “mapping” of proposed activity to FDA Blueprint elements


2013 Provider Information Webinar Grant Request Evaluation Criteria: Timeline for Evaluation

The submission date for all grant proposals in response to the 2013 CE RFA is Tue, July 16 at 5:00pm ET. The CE Subteam and the RPC will evaluate proposals and anticipate final decisions in late August, 2013.

June July August

3 10 17 24 1 8 15 22 29 4 11 18 25

CE Subteam Activity

Major Milestones

Today

Proposal Submission Deadline 5:00pm ET 7/16/13

Initial Rolling RPC Grant Reviews

Initial Recommendations Developed

Final Recommendations to RPC

Tentative RPC Approval Week Aug 25

CE Provider Informational Webinar (Today, 6/13/13)

Post-Submission Continued RPC Grant Reviews

Review by the RPC Oversight Committee


2013 Provider Information Webinar Review of Questions (Slide 1 of 4)

The following questions were received for the Webinar.

Question Response

Could the learning format for this activity be both online and live? I know several of our physicians in larger cities (2 – 3 hours away) would be interested in the material but may not be able to drive into live meetings.

The RPC invites Providers to offer multi-modal learning opportunities which could involve both online and live events. While multi-modal activities are not required, many of the CE Programs approved during the 2012 Grant Review cycle included more than one learning type, utilizing live meetings, workshops, online activities, or multi-module activities involving a series of meeting sessions.

Will this be the only RFA distributed in 2013/will there be other grant review cycles prior to the end of the year?

This is the only grant review cycle planned for 2013. The RPC encourages Providers to submit applications during this cycle and will be allocating grant funding for the year based only on this round of proposal submissions.

Is there any advantage to submitting a grant request significantly before the deadline?

There is no advantage to submitting your grant request early. The RPC is committed to evaluating each grant request thoroughly and your request will be reviewed by the RPC as long as it is submitted by the deadline of Tue, July 16 at 5:00pm ET.




Question Response

Can the CE Team expound on what is meant by the “pilot” programs that are mentioned in the 2013 CE RFA?

While the primary focus of the 2013 RFA remains on educating individual prescribers of ER/LA opioids, RPC understands that both individual and organizational factors simultaneously impact clinical practice and outcomes. As such, RPC will consider supporting a limited number of pilot programs that enhance individual learning through organizational change initiatives. Pilot programs should have a unique approach to learning and be able to demonstrate a success that could potentially be replicated. Pilot programs should have a rigorous approach to determine whether the activity had a positive impact and whether the program successfully engaged significant numbers of the targeted audience.

How many grants will be awarded in this round?

The number of grants awarded will depend on the applications received, the partnerships and collaborative opportunities proposed, and which activities are considered most likely to engage broad segments of the REMS target audience in “completing “ both education on the full Blueprint and the learning assessment. The eight-week deadline to encourage Providers to collaborate and think creatively about how to reach and engage learners.

What will be the approximate start and end date of the activities?

Specific start and end dates for the activities will be determined by the Providers. The initial activity within the proposed program must begin within 4 months of signing the LOA; if there are multiple activities in the proposed program, all must begin within 12 months of signing the LOA. Grants extending beyond one year will require the applicant to reapply for funding annually.




Question Response

What is the biggest challenge RPC members are seeing that we can all collectively work to solve on behalf of patients?

The single greatest challenge is engaging ER/LA opioid prescribers to complete the full activity and the assessment, both requirements for “counting” toward the FDA REMS goals. Participation in the REMS is voluntary for clinicians, and so Providers need to not only “reach” ER/LA opioid prescribers, but also successfully “engage” them in completing education on the full Blueprint plus the assessment. What we have learned from Providers’ experience to date suggest that integrating the assessment throughout the activity substantially increases the number of “completers.” (e.g. interspersing audience response questions within live activities or inserting assessment questions throughout online activities as opposed to placing them at the end.) Another observation based on the first six weeks of data is that approximately 50% of learners who have completed the CE and the assessment are prescribers who have not prescribed an ER /LA opioid within the last year. While FDA has indicated that only clinicians who (by self-report) have prescribed at least one ER/ LA opioid in the past year may be “counted” toward the REMS goals, all HCPs are encouraged to participate in this important patient safety/public health education.




Question Response

Is there a funding limit on individual awards?

There is no specified funding limit. RPC aims to award funding to a portfolio of grants which are most likely to engage significant numbers of the FDA’s primary target audience in completing the education and the assessment. The activities may be multi-modal and geographically diverse, but the most important underlying goals are engagement of the primary target audience in completing effective education covering the full Blueprint and assessment.

If there is a question about whether my organization qualifies for grant award funding, should I submit a request?

Additional information on the situation should be provided to Campbell alliance via the [email protected] inbox. The RPC will discuss the case internally and provide response to the organization that asked the question.

mailto:[email protected]


Grant Request Information

The 2013 CE RFA is accessible on the RPC CE Website: http://ce.er-la-opioidrems.com/IwgCEUI/rems/ce.action

The RPC Grant Management System will be accepting applications until 5:00pm ET on Tuesday, July 16

If you have questions on the RFA, please email Brad Hill, the RPC Grant Management System 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/UCM311290.pdf

Additional Notes:

These slides will be posted in PDF format on the RPC Website. If you would like an immediate copy of the links and contact information that appear on this slide, please email [email protected] with your contact information and we will be happy to send you a copy.

2013 Provider Information Webinar Summary of Key RFA Information & Concluding Remarks

Thank you for participating!

http://ce.er-la-opioidrems.com/IwgCEUI/rems/ce.action






http://www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/ucm277916.pdf




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