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The Potential Role of Therapeutic Drug Monitoring in the Treatment

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					    2007 Asilomar PAETC Faculty
      Development Conference

Pharma Support, CMEs, and You:
   Ensuring Independence in
 Commercially Supported CME
           Donna M. Jacobsen
       International AIDS Society–USA

                              The International AIDS Society–USA
                                                      Slide #2
Ensuring Independence in Commercially
Supported CME

Learning Objectives:
• Describe the Standards for accepting (and
  managing) support from pharmaceutical companies
  for AETC-sponsored CME programs
• Identify strategies for soliciting pharmaceutical
  company support for AETC CME programs
• Ensure that AETC training programs meet ACCME
  requirements (for commercial support)
                                            Slide #3

Question

Are you familiar with the ACCME Standards for
   Commercial Support
1. Yes, very familiar with the Standards and apply
   them regularly
2. Somewhat familiar in that I know they exist but
   am not as familiar with each one
3. No, not really
4. No, not at all
                                                 Slide #4

International AIDS Society-USA
• Not-for-profit professional educational
  organization founded in 1991
• Mission-based
• Accredited with commendation by the ACCME to
  sponsor continuing medical education (CME)
  programs for physicians
• Guided by a volunteer Board of Directors
• Select activities are supported by industry funding;
  IAS-USA has developed a highly effective model
  for ensuring independence
                                            Slide #5
Ideally, What Are the Companies Looking
For in Supporting CME
• Contributing to the improvement in clinical
  knowledge/skills and thus in patient care and
  well being
• Recognition for contributing to worthy
  activities at the Corporate level
• Charitable contribution benefits?
• Building and maintaining relationships
                                                    Slide #6

What Are the Companies Also Looking
For In Supporting CME
• Dissemination of positive information about
  their products
  – New research
  – Off label uses
  – Positive ―spin‖
  – Negative information about their competitors‘
    products
• Safe harbor from FDA oversight
Has CME become a “tactic”?
Slide #7
                                 Slide #8
• Committee on Finance concerned
  with drug payment increases under
  Medicaid
• Became aware of use of CME to
  market more expensive drugs/those
  with less clinical experience
• Contacted 23 Pharma companies
  and ACCME about CME grants
• Concluded that industry does use
  CME to market; some efforts made
  to separate grants from marketing
  but grey area exists; numerous
  cases of influence; lack of real time
  or proactive oversight; ACCME is
  slow to address violations
                                                        Slide #9

CME: Definition and Purpose
Definition: Educational activities [that] serve to
 maintain, develop, or increase the knowledge,
 skills, and professional performance and
 relationships that a physician uses to provide
 services for patients, the public, or the profession.
Purpose:
• Help physicians change and learn
• Transmit current and accurate information
• Provide an unbiased learning environment
                                                B. Wilson, 2004
                                         Slide #10

ACCME
• Governing body for CME providers; 7
  member organizations
• Accredited CME providers are held to
  specific guidelines
   – Essentials
   – Standards for Commercial Support
                                                      Slide #11
ACCME Standards for Commercial
Support of CME
• It is the accredited provider‘s responsibility to ensure
  that the purpose of the CME activity is to enhance
  physicians‘ abilities to care for patients
• The Standards describe appropriate behaviors of
  accredited providers in planning, designing,
  implementing, and evaluating certified CME activities
  that receive commercial support
• Implementation of the Standards varies among
  Accredited providers, but the spirit of the Standards
  are consistent –it has to do with improving patient
  care, not product marketing
                                                       Slide #12

Question
SF Pharma Inc, the maker of a popular NNRTI, has
   developed a lecture on the signs and symptoms of HIV
   infection. They have 50 HIV experts (3 are medical
   directors within PAETC) who have been trained to give
   the talk and want to support a talk to your ETC. There is
   no mention of drug therapy at all, and no mention of their
   drug in particular.
Would having one of these lectures at your training be an
  independent educational activity or an SFP
  promotional event?
1. Independent activity
2. Promotional event
                                            Slide #13
Pharmaceutical Promotion

• Does not necessarily “promote” a product
  (FDA definition)
• Any activity under the company’s control
  – advertising
  – brochures and detail materials
  – company trainings
  – speakers bureaus
• Subject to regulation (eg, labeling and
  claims)
                                                  Slide #14
Standards for Commercial Support
September 28, 2004
1. Independence
2. Resolution of personal conflicts of interest
3. Appropriate use of commercial support
4. Appropriate management of associated
   commercial promotion
5. Content and format without commercial bias
6. Disclosures relevant to potential commercial bias
                                                 Slide #15

Standard 1. Independence
According to SCS Element 1.1: When planning a
CME activity, the provider must make the following
decisions free of the control of a commercial
interest:
    • Identification of needs
    • Determination of education objectives
    • Selection and presentation of content
    • Selection of all persons and organizations that
       will be in a position to control the content
    • Selection of educational methods
    • Evaluation of the activity
                                       Slide #16
Opinion Question
It is appropriate for an academic or
community physician to be serve on a
company speakers bureau.
1   strongly agree
2   somewhat agree
3   no opinion
4   somewhat disagree
5   strongly disagree
                                        Slide #17

Opinion

It is appropriate for an academic or community
physician to be a paid product spokesperson.
1   strongly agree
2   somewhat agree
3   no opinion
4   somewhat disagree
5   strongly disagree
                                                  Slide #18

COI Disclosure
You received signed disclosure forms for each
speaker at your annual conference and printed the
information (with a list of the corporate supporters) in
the syllabus handed to attendees at check-in.
Is showing speaker disclosure slides/verbalizing
before each talk now needed to satisfy the new
requirements for conflict of interest?
1. Yes
2. No
                                                       Slide #19
    Standard 2: Resolution of Personal
    Conflicts of Interest
•    Everyone who is in a position to control content* of
     an education activity has disclosed all relevant*
     financial relationships with any commercial interest*
•    One who refuses to disclose will be disqualified from
     being a planning committee member, teacher, or an
     author, and cannot have control of, or responsibility
     for, the development, management, presentation or
     evaluation
•    The provider must implement a mechanism to
     identify and resolve all conflicts of interest prior to
     the activity
                                                       Slide #20
Resolving Conflicts
1.  Attest that the PCCs will not influence content
2.  Use non-conflicted PCCs
3.  Divest oneselves of the relationship(s)
4.  Replace the conflicted PCC
5.  Modify the role of the conflicted PCC
6.  Have another speaker discuss clinical implications or
    results
7. Alter or modify content
8. Change the focus of the activity
9. Peer review of content with independent certification
10. Disqualify the speaker
From UUHCC CME Booklet (www.uuhsc.utah.edu)
                                                    Slide #21
    Standard 3: Appropriate Use of
    Commercial Support (cont’d)
•    Provider, joint sponsor, or partner must pay
     honoraria and out-of-pocket expenses
•    No other payment to director, planning committee,
     teacher, author, or joint sponsor from funder
•    Social events or meals cannot compete with
     educational events. Limits on costs?
•    Commercial support cannot be used for travel,
     lodging, honoraria, or personal expenses for non-
     teacher or non-author participants (except those in
     training)
                                           Slide #22

Standard 4: Appropriate Management of
Associated Commercial Promotion
• Commercial exhibits or advertisements cannot
  influence planning or presentation, and cannot
  be a condition of support
• Product-promotion or advertisement of any
  type is prohibited in CME activities
• Educational materials cannot contain any
  advertising, trade names, or product-group
  messages
                                        Slide #23

Question

Dr Reyes is an attendee at your CME
conference. He walks into the session
with a giant robin’s-egg blue
SELZENTRY bag over his kaftan. Does
ACCME prohibit this as “product
promotion” in the CME activity?

1. Yes
2. No
3. It depends
                                           Slide #24
Standard 5: Content and Format
Without Commercial Bias
• The content or format must promote
  improvements or quality in healthcare and not
  a specific propriety business interest of a
  commercial entity
• Presentations must give a balanced view of
  the issue; use of generic names contributes to
  this impartiality
                                                  Slide #25
Question

VeryBig Pharma offers to donate the use of their ARS
system to your next lecture, whatever the HIV topic is.
They will leave the agenda and speaker absolutely up to
you, and will not collect the data from the questions
used. The only thing the rep asks is that you not print
that the lecture is supported by VeryBig because there
was no grant given and it might “look bad”. Is it OK to
leave disclosure of this gift off the materials?

1. Yes
2. No
                                                          Slide #26

Question
Dr Bernstein very much wants to speak at your AETC training
in July 2008, but you are concerned that she is on the
speaker‘s bureaus for Melck and Prizar companies and her
husband holds stock in Turbotime Pharma. She resigns from
the SBs and her husband sells the stock to his cousin. What
should be disclosed at the July activity?
1. No relationships
2. Her SBs
3. Her SBs and her husband‘s stock
4. Her SBs, his cousin‘s stock
5. Her SBs, her husband‘s stock, and his cousin‘s stock
                                            Slide #27
Standard 6: Disclosure Relevant to
Potential Commercial Bias

• Individual: Name, type of interest of any $$
  amount, name of institutions (disclose if no
  relationship), back 1 year. Spouse or partner
  disclosure.
• Commercial Support: Must be made (even in
  kind support). Never include trade names or
  product names or messages
• Disclosure to be made to the learners prior to
  the activity start
                                             Slide #28

Changes in Pharma Grant Applications

• On-line submissions and independent grant
  committee review (centralizing)
• Elimination of the term ―unrestricted‖ to
  describe the grants (these grants are usually
  restricted—to use in education)
• Outcomes assessment data
                                             Slide #29
Changes in Pharma Grant Applications
(cont’d)

• Additional requirements for reporting at
  completion of activity
• Staggering of grant payments
• Return of unused funds
                                               Slide #30

Web-based Grant Applications

• Not uniform (budget formats, agenda
  requirements, etc)
• Templates are often geared toward MCCs
• Usually focus on single activities, largely live
• Reviewed by a committee that may have no
  background in your disease or health focus
                                               Slide #31

Submitting Pharma Grants
• Base the program on the needs of your
  audience
• Read the grant criteria
• Incorporate compliance with/understanding of
  the Standards where possible
• Find out key areas of interest or off-limit issues
• Focus on your experience, reach, expertise
• Promote your relationships with respected
  individuals
                                             Slide #32

CME Tips
• Be wary of MCCs (or other agents for industry)
  with packages
• Terminology: ―Sponsor‖
• Disclosure
• Providers are accredited, activities are not
• Paragraphing of the Accreditation Statement (2
  separate paragraphs)
• Inclusion of the Accreditation Statement
• No ―CME credits have been applied for‖
                                                           Slide #33
IAS-USA Additional Measures to Ensure
Independence
•   For efforts that do allow commercial support, funds must be
    received from several companies, including those with
    competing products (BMS+Gilead or Pfizer+Monogram—
    doesn‘t count!)
•   Firewall between funders and content
•   For some activities, commercial support is not appropriate
    (guidelines)
•   All aspects are handled internally; no collaborations with
    agents of industry
                                                            Slide #34
IAS-USA Additional Measures to Ensure
Independence (cont’d)
•   Potential contributors are pre-screened for ability to present
    balanced perspectives
•   Conflicts of interest collected prior to confirmation
•   Contributors with financial relationships to only 1 company
    generally—but not always—avoided
•   Chair peer review of overall materials
•   Group peer review of near-final materials
                             Slide #35

Thank You!

And many thanks to

Mona, E. Michael, Michelle
Michelle Tayag
                              Slide #36

Additional Discussion Items
                                                                         Slide #37
What’s Wrong with This Picture?
―The funds should be in the form of an educational grant. Note that a
recent (1999) amendment to ACCME policy allows grants to be paid to a
third party, such as a communications company, and the
communications company then pays the CME provider — "Joint
Sponsorship". You are still required to have a Letter of Agreement with
the CME provider and the CME provider is still ultimately in control of
everything. Some CME providers are sticking to the grant being paid to
them directly. If they have the resources to handle timely distribution to
vendors, then it is no big deal. Something to watch out for here is to
make sure that the CME provider is aware that there is a third party up
front. As in this example, the communications company you are working
with usually selects the CME provider. Make certain you have direct
conversation with the CME provider to ensure that they are on the up-
and-up and can handle the job.‖

Excerpted for FCG Institute website, guide to CME for Product Managers
                                                                    Slide #38
ACCME FAQs
3) Is the following scenario allowed?...A CME provider is hired by a drug
company to run an event where a doctor (hired by the same drug company)
would present a CME seminar, talk, or author a CME paper. (SCS 1.1)

This should not occur as described under either the 1992 the Updated SCS.
There is a requirement that the provider ensure that critical elements of
activity planning be done independently of a commercial interest (SCS1.1).
The accredited provider is not ‗hired‘ but rather receives commercial support
and is required to fulfill SCS Standard 3, in this regard. The teacher or
author must be selected and paid by the accredited provider (SCS 1.1, SCS
3.8). No funds can go directly from the commercial supporter to the
teacher/author (SCS 3.9).
Complaints: http://www.accme.org/dir_docs/doc_upload/5425eedc-f494-
4859-9451-e3b1cfabbeb8_uploaddocument.doc
From www.ACCME.org
                                                              Slide #39
Under what circumstance(s) do you think being listed as an
author on a manuscript that has been ghostwritten by a
medical writer is appropriate? (check all that apply)
1. Never
2. If the author wrote the outline and carefully edited the
   manuscript and reviewed it for/ensured balance
3. if the author has carefully edited the manuscript and reviewed it
   for balance
4. If the medical writer is independent from a commercial company
   and is not being paid by a company (eg, hired by a journal)
5. If the manuscript discloses that the manuscript was drafted by a
   medical writer
6. If it is the report of a company study in which one (or more) of
   the authors is a company employee, and the medical writer is
   employed by or hired by the company

				
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