AstraZeneca Medical Education Grants...

If you need technical assistance please e-mail us at [email protected] 1

For technical assistance e-mail [email protected]

AstraZeneca AstraZeneca Medical Education Grants Medical Education Grants

OfficeOffice

Pamela Mason Pamela Mason Director, Medical Education GrantsDirector, Medical Education Grants

Melanie FaganMelanie FaganDirector, Medical Education Management Director, Medical Education Management


TopicsTopics

• Medical Education Grants Office at AstraZeneca

• Grant application & review process

• Types of requests

• Reasons for not funding a request

• Monitoring

• Satellite Symposia

• Reconciliation

• Metrics & Outcomes

• Questions

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AstraZeneca Medical Education Grants Office (MEGO) • Interim process 4thQ 2004• Grants office launched 1stQ 2005

• Online application launched 1stQ 2006

• Enhance customer service line (RAPID) launched 2ndQ 2006

Higher scrutinyof pharma industry activities

- Promotional- Commercial support of CME

Increasedcomplexity

What does “independent”

mean?

OIG

Need to alignwith

education guidelines

Creation of MEGO

Guidelines subject

to

interpretation

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AstraZeneca GoalsAstraZeneca Goals

An Ongoing Commitment to Independent Medical Education

• AstraZeneca strives to be the industry leader in supporting & enabling quality independent medical education that enhances thelevel of patient care in the United States

– We do this through the funding of grant requeststo appropriate institutions or entities

Exceeding the Highest Ethical Standards• AstraZeneca places great value on individual integrity, ethical conduct and full compliance with the laws, regulations and guidelines that govern the US healthcare community

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What does “Independence” Mean?

•AstraZeneca must not control or influence the:– Content

– Selection of topics, faculty or speakers

– Selection of attendees

•AstraZeneca personnel must not:– Solicit grants from medical education providers

– Be involved in submitting grant requests on behalf of the independent education provider

– Assist the independent education provider in the completion of the application form

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The Grant Application and

Review Process

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The Starting Point

FIELDIf asked about grants,

refers customerto AstraZeneca

MEGO

Grant Requesters• Academic Medical Centers• Medical Education & Communication Companies• Hospitals & Intrastate Accredited Providers• Medical Specialty Societies

AstraZeneca MEGO• Web Site

•www.astrazenecagrants.com• Email

•[email protected]• Phone

•1-877-AZGRANT•RAPID line

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RAPID (Rapid Assessment of Potential Interest & Direction)

•Call the RAPID Line at 877-AZGRANT (877-294-7268)•Select the RAPID option

•The RAPID administrator will request information– Caller’s name

– Organization Name and Type

– Program Topic

– Program Type

– Program Date

– Amount Requested

•The RAPID administrator will inform you:– if program is in one of our educational areas of interest

– if we are currently accepting grants in that area

– NOT a pre-screening review

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How to Submit a Grant Request

� Access the MEGO website: www.astrazenecagrants.com

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�� Click on: On-Line Grant Application

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� Read Through or Print Out the Instructions

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� Go to the On-line Application Form

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� Sign in or Create a New Account

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�� Fill in all data fields

� Proceed to Page 2 to attach documents

� Use AstraZeneca Budget Form

� Include all related documents at once to help decrease processing time

� You can save the form and come back later to complete

� Questions? Call 1-877-294-7268

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Grant Application – What’s Needed to Complete a Package for Review

• Complete online application– Requester information plus partners if applicable

– Attach all documents

– If requesting assistance, must be a written request (distribution of invitations)

– For CME programs, letter of request from accrediting group or proof of application for credits

• Proposal– Needs assessment

– Educational objectives

– Topic(s) or agenda

– Proposed Budget using AstraZeneca form

– Metrics & Outcomes

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Grant Application Process

Communication to Customer

CustomerSubmits

CompletedApplication

MEGOChecks

For Completion

MEGOReview

•Medical Education•Medical Affairs

•Legal•Compliance

FundingDecision

• Implement robust review & approval process • Support quality medical education• Assess application vs. AstraZeneca educational areas of interest• Ensure compliance with AZ policies and guidelines• Adherence to PhRMA Code, FDA, ACCME & other accrediting bodies • Confirm budget• Identify high quality/reputable educators

Not Funded• Letter• Survey

Funded• LOA• Payment• Monitoring• Reconciliation• Survey

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AstraZeneca Areas of Educational Interest

Review Team will consider the following:• provides valuable disease state information to enhance patient care?

• enhances knowledge of emerging therapies based on a documented unmet need?

• incorporates evidence-based medicine, including core objectives & methodology?

• will assist healthcare professionals in carrying out their diagnosis & treatment strategies more effectively & efficiently?

• supports HCPs’ efforts to broaden patient knowledge & understanding of disease states & treatment options?

• covers an area of scientific interest?– Gastroenterology – Respiratory

– Cardiovascular – Psychiatry

– Oncology – Infectious Disease

– Special areas such as multicultural, appropriate pharmaceutical care, adherence

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What good looks like to AstraZeneca…

• Needs assessment provided identifying gap(s) in knowledge including methodology with supporting documentation

• Educational objectives provided that match the needs assessment

• Topic(s) or agenda items that fall within the AstraZeneca areas of educational interest

• Conflict of interest resolution process• Reasonable budget for activity• Proper audience of interest for activity• Indication of how activity will be evaluated • Reputable provider of education in good standing

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Needs Assessment

• Defines gap in knowledge for the target audience– What they know vs. what they need to know– Determines educational objectives & program topics

• Should include methodology and supporting documents• Requirements for application:

– Grants under $5,000 need clear learning objectives• referenced back to identified need or yearly curriculum

– Grants over $5,000 require needs assessment • at least one component

– Grants over $50,000 require more robust needs assessment • 2 or more components

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Needs Assessment (Continued)(Continued)

• Examples of Needs Assessment Components– Educational gap analysis survey of target audience– Previous program evaluations where attendees list topics of future

interest– Results of focus group discussion– Expert opinion from nationally or regionally known healthcare

professionals– Literature search: current/peer reviewed publications– Clinical Practice Guidelines– Describe need as part of yearly curriculum (grand rounds series)

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Grant Application to AstraZenecaWhat questions we ask…

• Is it CE or non-CE activity?

– If CE, request specific information on accredited provider

• What is the scope of program? (national, regional or local)

• Type of activity? (grand rounds, conference, print, etc)

• Purpose of the grant? What will it support?

• Who is the intended audience? Estimated # of participants?

• What are the logistics? (date, location)• Is there a Conflict of Interest Resolution Process?• Who is developing the content?

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Grant Application to AstraZenecaWhat questions we ask… (Continued)

• What needs assessment was done? What were the results?

• Do the educational objectives match the gap(s) identified?

• What are the topics of the presentations?

• Is there an agenda or brochure?• What data & measurements of education effectiveness will be used?

• What amount is being requested?

– How does this relate to the total cost of the activity?

– How will the AstraZeneca funds be used? • AZ costs only on budget form

• Are there other commercial supporters?

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Grant Support

• Credited-type educational activities• for physicians: ACCME-accredited, AAFP, AOA

• for pharmacists: ACPE

• for nurses: ANCC, NLN

• for nurse practitioners: AANP

• for physician assistants: AAPA

• Non-credited educational activities

• Examples of activities/programs:– Fellows programs (courses, travel grants, young investigator awards)

– National conferences & Regional conferences– Local programs (Grand rounds, hospital/medical center conferences)

– Enduring materials (journal articles, audio, web-based, supplements)

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Independent Medical Education Grants at AstraZenecaIndependent Medical Education Grants at AstraZeneca

Independent Medical

EducationGrants

SignageSponsorships

Researchclinical research studies

investigator-initiated studies

CharitableContributions

Exhibits

Supported byIME Grants

NOT supported by IME Grants

These are handled by other departments at AstraZeneca.

If received via MEGO, then forwarded to appropriate group.24



Areas of concern for us…

• Indication of non-independence

• Conflict of interest not being resolved

• Learning objectives do not match needs assessment

• Excessive amount of time on off-label discussion

• Recreation time vs. education time

• Venues giving the appearance of recreation focus

• Excessive budget amounts

– (honoraria, travel, meals, administrative costs)

• Medical education company doing both promotional and independent programs for AstraZeneca in same therapeutic area

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Reasons for “Not Funded” Decisions

•Not enough time to review grant application (Less than 45 days from program date)

•Needs assessment and learning objectives do not match our criteria for funding

•Not an area of educational interest

• Budget limitations

• Emerging area of interest and funding not fully established

•Not consistent with policies and practices as established by AstraZeneca

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Requests, Monitoring &Reconciliation

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Our Expectations After a Grant is Approved

• Reconciliation of budget expenses

– will be reflected in final payment

• Outcome measurements

– Impact of learning

– Summary of program evaluations

• Customer Service Survey on application process

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After the Grant is Approved

• For grants over $50,000, a MEGO contact will be assigned

• At that time, all communications with AstraZeneca should be directed to the assigned MEGO contact

• AstraZeneca will monitor supported educational activities– Ensure 3rd party adherence to legal and regulatory guidelines

– Confirm scope of activity stays within proposed budget and format

– Representative from AZ may attend live programs

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Requests for assistance from educational providers MUST be in writing

– Distribution of invitations

– Scientific accuracy review

– Speaker recommendations

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Satellite Symposia at Major Conferences

Associations are using different models:1. Reserve slots

• Slot fees paid by company to association• Company sends RFPs to MECCs & selects best program• Submitted to association for consideration

2. Choose topics• Topics submitted to companies for funding consideration• MECCs develop programs for association

3. Choose MECC• Companies request MECC to submit proposal to association

4. Choose funding source• MECCs or MECCs + opinion leaders develop program ideas &

approach company• Proposals submitted with funding source recommendation to

association for consideration31


Satellite Symposia

• If outlined by the Association, AstraZeneca can initiate a Request for Proposal (RFP) specific for satellite symposia during the Association’s Conference

• Educational Partner selection is open

• Recommend calling the RAPID line to determine attendance at major medical meetings

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Reconciliation Process

• Reconciliation includes:– Financial Reconciliation– Content Reconciliation

• Submission Deadline is 60 days from program completion

• Content Reconciliation• Key educational learnings• Aggregated metrics data• Evaluation summary• Outcomes studies (if applicable)• Invitational brochures, final agenda, program syllabus or

workbook

• Final payment made when completed reconciliation has been received by MEGO for grants over $50,000

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Reconciliation

Grants under $50,000– Financial Reconciliation

• Actual expenditures listed on budget schedule

– Unused funds- returned to AstraZeneca upon final reconciliation

– Receipts not required (available upon request)

– Content Reconciliation• Evaluation summary and Comments from Participants

• Invitations, agenda, program syllabus/workbook

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Reconciliation (Continued)

Grants $50,001 or more– Financial Reconciliation

• Actual expenditures listed on budget schedule– Unused funds- returned to AstraZeneca upon final reconciliation

– Receipts not required (available upon request)

– Content Reconciliation• Evaluation summary and Comments from Participants• Invitations, agenda, program syllabus/workbook

– Final grant payment made upon complete reconciliation– If the program is under budget, the final payment will

reflect the difference between the original proposal and the actual spend

– Any unused funds must be returned to AZ – AstraZeneca does not automatically pay overages

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Metrics & Outcomes

AstraZeneca is committed to supporting quality educational programs that will ultimately

improve patient care

• Capture robust information about participants, program quality, effectiveness, and value of educational program

• Evaluation metrics aligned with MEGO’s mission to provide high quality medical education that will help improve patient outcomes

• Address the adult learning components of participation, satisfaction, learning, and performance

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Metrics• Measures– Attendee demographics and professional profile

• Appropriateness of target audience for learning activity

– Educational value of the program

– Content specific questions

– Faculty – expertise, delivery style, objectivity

– Format of program• amount of interactivity, case based vs didactic, use of ARS

– Attendee preferences for learning• live, web-based, audio

– Areas of future interest• Utilize for development of future needs assessments

– Venue and logistics

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Outcomes

• We evaluate educational activities for effectiveness in:– meeting identified educational needs or stated learning objectives

– Attendee satisfaction

– Acquired knowledge or skills

• Beyond this minimum evaluation data, we encourage additional metrics and outcome measurement components that demonstrate a change in practice behavior to improve patient care

• At the conclusion of your program, a comprehensive summary report of the participant evaluations should be forwarded to MEGO within 60 days post-program

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QuestionsQuestions??

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