In a recent post regarding our institutional perspective and approach to potential CME faculty who participate in speaker’s bureaus as defined by our policy, I mention that one reason to avoid use of such faculty in our activities was that their presence could impact funding. In fact, just recently, our office had a grant for an activity rejected because on review of the program, a commercial entity indentified at least one speaker that the company had a promotional relationship with during the past 12 months. The commercial entity did not provide the names of those involved. Readers should be reminded that the commercial entity definition of a promotional activity may be even broader than our definition related to speaker’s bureaus as the commercial entity likely categorizes all activities into two domains; certified CME and promotional. This approach is commonly taken because of how the FDA regulations are written. What is important for physicians to be aware of is that they may believe they are providing an educational presentation, but if the company labels it promotional, downstream consequences can apply. It behooves all potential speakers to clarify how the commercial entity will categorize their activity in advance so as to avoid these conflicts.
Archive for September, 2009
The Impact of Promotional Activities
Monday, September 28th, 2009Speaker’s Bureau Policy
Monday, September 14th, 2009At the CME Advisory Board meeting held December 2008, the Board voted to extend the Hopkins’ ban on involvement in Speakers’ Bureaus as defined by the Hopkins policy to all invited speakers at CME activities. This change will require a full understanding of the policy definitions by planners and program directors, an extended phase-in period, and a change in workflow so that potential speaker’s are assessed very early in the process in order to avoid last minute surprises that could adversely affect your planned speakers and topics and thus the activity.
Allow me to try to explain this change further: In 2008, the Johns Hopkins School of Medicine passed a new policy that took full effect December 31, 2008. This policy prohibits faculty involvement in a specific activity commonly referred to as a speakers’ bureau. A speakers’ bureau is defined by a set of characteristics as described below. Just because an activity is named ‘speakers’ bureau’ does not automatically make it banned. In reverse, an activity that fits the definitions below but is not labeled ‘speakers’ bureau’ still remains banned.
Definition
Faculty service as a speaker for industry is prohibited if the arrangement has any of the following characteristics:
- • the company has the contractual right to dictate or control the content of your presentation or talk, and/or
- • the company creates the slides or presentation material and has final approval of the content and edits, and/or
- • you are expected to act as a company’s agent or spokesperson for the purpose of disseminating company or product information
The Johns Hopkins policy states that participation in a Speakers’ bureau as defined above is considered unprofessional. The CME Advisory Board felt that
- We believe as an institution that participating in a Speakers’ bureau is unprofessional and not permitted to our faculty
- Outside speakers shall be held at Johns Hopkins CME activities to the same standard as Johns Hopkins faculty
- Inequity would be created if we continue to allow outside speakers participating in Speakers’ bureaus.
The accreditation body (ACCME) is considering banning participation in Speaker Bureaus for any contributor to any CME activity. The Institute of Medicine has recommended against participation in such activities and the Council on Ethical and Judicial Affairs of the AMA has also recommended against such activities.
Finally, there are now several legal judgments that have implications for this decision. For instance, a judgment against Merck that also applies to Pfizer and soon other commercial entities states that if someone serves in a capacity consistent with a speakers’ bureau function then any activity seeking grants from those companies must be rejected if such a speaker is to appear. This series of judgments thus puts our grants and with it the financial viability of many activities at risk. Taking all of these facts into consideration in addition to other considerations that included ethical concerns and brand management led the board to passing unanimously this new policy.
Cognizant of the potential impact of such a decision and well aware that many activities are planned far in advance, the board wisely agreed that an information phase was required, that would precede a phase-in followed by a full prohibition no later than Dec 31, 2010, but with a hoped for full implementation date of July 1, 2010. As mentioned, such a prohibition will require a change a workflow. For instance, activity directors will need to acquire disclosure information prior to formally inviting a speaker so as to avoid difficulties closer to the activity. Remember, given that Hopkins’ faculty are now prohibited from serving in a capacity as defined by the preset characteristics listed above, you will only need to acquire disclosure information early on faculty from outside institutions or practices.
This serves as the second step in the awareness campaign. A letter was sent to all activity directors a few months ago as the initial step. Everyone involved in a CME activity conducted through this office should begin taking this new policy into consideration for any faculty member who will be asked to contribute to your activity as of July 1, 2010. You will also receive a reminder of this new policy in the next few months.
Shortly we will have prepared a letter that will be distributed to all faculty at our activities making them aware of this coming change in policy so that they hear this from us directly. At about the same time our disclosure forms will be upgraded to include these specific characteristics so that faculty will be able to adequately fill in the disclosure forms and return them in a timely fashion.
We will also be making this information available to the Society for Academic CME (SACME) and the AAMC so that all academic health centers will be well aware of this change in policy well in advance of full implementation.
Filling the Gap
Tuesday, September 8th, 2009Most physicians trained in an era in which the major educational model was an apprenticeship model. This has been mostly replaced with an adult educational model principally derived from the Malcolm Knowles perspective. Thus most physicians who then contribute to educational endeavors at the medical student, houseofficer and practicing physician level have little experience with the principals and often resist the andragogical approach developing educational activities. Thus, it seems that the major problem is that physicians have a gap in knowledge regarding the educational cycle that needs to be filled as if they understood the steps they could more easily follow them and would grow to appreciate the benefits of such an approach.
Physicians are also very busy and have limited time to learn all of the approaches in great detail especially if the training takes a protracted period of time. With the need for the gap to be filled utilizing a time conscious approach we have created a series of training sessions we are calling “QuickFacts”. These include slides and audio and can be viewed in multiple formats. None last more than 5 minutes and the majority are under 3 minutes. Check these out on our resource page. Send us feedback about the series that we have finished or if you have ideas for future sessions.