The Case: Priscilla Purrfect, the CME coordinator of Quality Care Medical Center, a state-medical-society–accredited provider, is struggling to finalize the CME calendar for the second quarter of 2011. Luckily, Quentin Quickfix, president of Drugs 4 You Communication Co., calls her, eager to place a commercially supported educational seminar on KidneyCare, an FDA-approved product, at the medical center. He says he’ll send a summary of the educational need, as well as the objectives, slides, list of suggested speakers, and an evaluation tool for Priscilla’s review. He also states that, since his company is not an accredited provider, QCMC can certify the course for credit.

After receiving the materials, Priscilla decides to ask the QCMC CME committee for a review. If the QCMC CME committee approves the content and selects a presenter, Priscilla can pick a date for the offering and update the CME calendar of events.

What should Priscilla ask Drugs 4 You before asking the CME committee to review the course content?

Parochka:
Priscilla should determine whether Drugs 4 You is a commercial interest, which the Accreditation Council for CME defines as “any entity producing, marketing, reselling, or distributing healthcare goods or services consumed by, or used on, patients.” (Revised August 2007) If they are a commercial interest, they are ineligible to serve as a joint sponsor of the activity.

Overstreet: I would also want to know why a “communication” company is involved in CME. Nowadays the CME community needs to differentiate between education companies—those that focus exclusively on CME—and communication companies that focus predominately on promotion. I think Priscilla also should carefully determine how the “learning needs” (were practice gaps identified?) and other educational elements were determined to ensure they comply with QCMC’s policies and the requirements of the Standards for Commercial Support.

What else should Priscilla consider asking?

Parochka:
If the content relates to a single product, Priscilla could ask whether there is mention of off-label uses. If the answer is no, Priscilla should suggest to the CME committee that the activity slides be reviewed to validate this assertion and, if confirmed, recommend that the seemingly promotional activity be offered without certifying the content. If off-label information is included in the content, QCMC might pass on the offer of holding the activity in-house.

Overstreet: She needs to evaluate if the time and effort she will save by scheduling this seminar is worth the considerable risk. There are many important questions she should ask before referring this to her committee: Who developed the content? What role did the supporter have in developing the speaker list. Has a letter of agreement already been signed? What relationships does Quentin’s company have with the supporter? What relationships do the suggested speakers have?
I would definitely pass on this one.

Could offering single-product noncertified activities confuse physician participants?

Parochka: Staff physicians might be confused if the activity is slotted during their regular CME calendar of events. If the committee wants to pursue this plan, Priscilla could ask the CME committee to issue a notice of intent to offer the noncertified activity and make it clear the activity would not offer CME credit.

Karen Overstreet, EdD, RPh, FACME, CCMEP, is executive director, Lippincott CME Institute, Wolters Kluwer Health Medical Research, Blue Bell, Pa. Reach her at Karen.Overstreet@wolterskluwer.com.

Jacqueline Parochka, EdD, FACME, is president and CEO, Excellence in Continuing Education Ltd., Gurnee,
Ill.; and partner, PTR Educational Consultants. Reach her at JacquelineParochka@comcast.net.

Your Views Welcome / To share your comments on this case, or if you have an “ethical hypothetical” you’d like reviewed, e-mail spelletier@meetingsnet.com.