The Case

Dr. Ima Payne, vice president of medical affairs for Voodoo Health (a large multinational pharmaceutical company), posted a call for CME proposals on the company Web site. The Association for Curing Headaches (an accredited provider) submitted a proposal, including a lengthy needs assessment, and was granted funding in the amount of $100,000 for the creation of a monograph titled Reducing Headaches in Pregnancy. After sending the initial grant payment and the signed letter of agreement, Dr. Payne notifies the provider that it is considered a courtesy to send the draft content to her for review before producing copies of the enduring material. She wants to ensure that all cited data accurately reflect the latest research results and ensure public safety.

The Solution

Can commercial supporters review content before the activity is finalized?

Parochka: There is no Accreditation Council for CME requirement that accredited providers must extend commercial supporters a courtesy review of content, and some providers do not allow such review. On the other hand, nothing specifically prohibits a content review, as long as the provider remains in control of the content. Allowing review of complicated data would be one mechanism to ensure dissemination of accurate information.

How can this provider avoid noncompliance?

Overstreet: Some providers are developing detailed policies regarding supporter review, documenting its purpose and how it will be handled. Typically, such review is limited only to scientific accuracy.

Parochka: Accredited providers would be wise to create policies documenting the customary and usual circumstances surrounding courtesy review of content.

Overstreet: In addition, providers could summarize their policies in grant requests to avoid questions about review during the development of the activity.

What should the provider do if content changes are recommended by the medical affairs VP?

Parochka: No one wants to argue with the commercial supporter's medical affairs department. However, since providers have the ultimate responsibility for content, they should ask the course chairperson or other faculty members to validate the accuracy and appropriateness of the recommended changes. Keeping a paper trail of these exchanges is absolutely critical in terms of documenting the planning process.

Overstreet: I agree. I'd also ask the supporter to provide copies of published references to document the accuracy and completeness of any suggested corrections. Changes should be made only upon review and approval by the faculty and provider.

Parochka: And some providers might request an external peer review process to validate the data and ensure that the content is fair, balanced, and scientifically rigorous.

Karen Overstreet, EdD, RPh, FACME, is president, Indicia Medical Education, LLC, North Wales, Pa. Reach her at karen.overstreet@indiciaed.com. Jacqueline Parochka, EdD, FACME, is president, Excellence in Continuing Education Ltd., Gurnee, Ill. Reach her at jaquelineparochka@comcast.net.

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