Dr. Hilary Heart, a renowned researcher and cardiologist, has been a frequent presenter for Bright Ideas University for the last two years. She has been a speaker so often that the CME coordinator, Cindy Ivory-Tower, has grown weary of reviewing Dr. Heart's disclosure form.
Recently, BIU received a $90,000 educational grant from a pharmaceutical company to hold a satellite symposium at a cardiology conference. The symposium is to cover the latest products for treating cardiac arrhythmias and there will be ample time for the participants to ask questions of. During a phone conversation with Dr. Heart, Cindy validated that neither the presenter nor her significant other had financial relationships with the commercial supporter. In the syllabus, Cindy listed all the faculty members and the financial relationships with the commercial supporter that they disclosed, along with the nature of the relationship. Beside Dr. Heart's name Cindy noted “nothing to disclose.” The satellite symposium went off like clockwork. However, during the final question-and-answer session, Dr. Heart recommended two cardiac arrhythmia products manufactured by one of the supporter's competitors, based on her clinical research funded by that company.
Was there a violation of the Accreditation Council for CME's Standards for Commercial Support regarding disclosure information provided by the faculty member?
Parochka: Yes, Cindy asked the wrong question. Instead of asking faculty members to declare all relevant financial relationships with any commercial interests, she asked only whether there were relationships with the grantor.
Overstreet: You're right, as usual, Jackie. Cindy should have asked for relationships related to the content of the presentations.
Parochka: Partial disclosure information, as in this case, does not satisfy Standard 2.1. Providers should develop procedures to ensure compliance with requests for disclosure information.
Do you believe participants will indicate commercial bias on the post-activity evaluation form?
Parochka: If participants are savvy enough, they'll catch this provider error, but sometimes this is not the case. Providers cannot rely totally on participant evaluation data to indicate whether there was commercial bias based on disclosure omissions. Other safeguards need to be in place.
Overstreet: It's often difficult for providers to anticipate what will be discussed during Q&A sessions, and even more difficult to foresee what will come out of the mouths of some faculty members. Faculty guidelines for addressing participants' questions might help mitigate the situation.
Parochka: This case represents an opportunity to involve a CME advisory board/committee. Providers should develop quality-assurance questionnaires based on the Standards for Commercial Support and ask advisors to audit CME activities. Audit results would not only detect noncompliance in individual activities, but would also serve to evaluate all activities based on annual aggregate data.
Karen Overstreet, EdD, RPh, FACME, is president, Indicia Medical Education, LLC, North Wales, Pa. Reach her at firstname.lastname@example.org. Jacqueline Parochka, EdD, FACME, is president, Excellence in Continuing Education Ltd., Gurnee, Ill. Reach her at email@example.com.
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