The Case: Jane Juniper, director of education at Accreditation Council for Continuing Medical Education–accredited Make It Right LLC, just got a phone call from Sita Patel, MD. Dr. Patel, a professor at ABC Medical School, has lectured on the topic of dietary supplements for several years, and serves as a part-time CME director at Zip And Zest Inc., a nutraceutical company.

Dr. Patel was calling to ask if Make It Right would
jointly sponsor a series of activities in the U.S. with Zip and Zest.

Dr. Patel assured Jane that the company, which she said was not a commercial interest as defined by the ACCME, would fund the educational endeavor. While Dr. Patel wanted to schedule the activities, Jane wanted to conduct some follow-up research before making a commitment.

Voyage of Discovery

How can Jane determine the company’s eligibility as a joint sponsor and grantor?
Parochka: She could begin by conducting a computer search of Zip and Zest Inc., reviewing the list of products and determining whether ACCME’s definition of a commercial interest applies. She also could send a message to colleagues through the National Alliance of Medical Education Companies or Alliance for CME listservs and determine if other providers have been approached for similar requests of joint sponsorship.

Overstreet: That’s a great way to start the research, Jackie. Several providers have contacted ACCME regarding the status of supplement manufacturers and have been informed that ACCME does not consider these CIs.

What products are considered “dietary supplements”?
Parochka: Congress defined the term “dietary supplement” in the Dietary Supplement Health and Education Act of 1994 as a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The dietary ingredients in these products may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites.

Overstreet: Dietary supplements can also be extracts or concentrates and may be found in many forms such as tablets, capsules, soft gels, gel caps, liquids, powders, and bars. DSHEA places dietary supplements in a special category under the general umbrella of “foods.”

Are products people buy to supplement dietary needs considered to be healthcare products?
Parochka: Not according to DSHEA. The dietary supplement label is the responsibility of the manufacturer, which must include a disclaimer that the product is not intended to “diagnose, treat, cure, or prevent any disease” because only a drug can legally make that claim.

What other factors should providers consider before moving forward with a jointly sponsored activity?
Parochka: Although the company does not fit the definition of a CI and does not produce drugs, I would stay away from this relationship since information related to dietary supplements does not fit the definition of CME: “The content of CME is the body of knowledge and skills generally recognized and accepted by the profession as within the basic medical sciences, the discipline of clinical medicine, and the provision of health care to the public.” (HOD policy #300.988).

Overstreet: There are likely situations in which supplements could appropriately be included in the content of a CME activity, given an identified practice gap and the right clinical context. However, I would not feel comfortable entering into a joint sponsorship agreement with a supplement manufacturer in this case.

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.

 

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