By Jack E. Angel, Education Foundation Executive Director, Coalition for Healthcare Communication
Nov. 14, 2011 — In response to Opioid prescription drug misuse in this country, the FDA recently released a draft “blueprint” on the basic elements to be included in REMS (Risk Evaluation and Mitigation Strategies) educational programs required of the manufacturers by the FDA.
The guidelines set forth “core messages” intended for use by CME (continuing medical education) providers to develop educational materials for prescribers of long-acting and extended-use opioids. This Blueprint for Prescriber CME is a good foundation for what the FDA wants to accomplish, but raises questions that need to be addressed by the CME community.
In describing how
CME providers “will conduct prescriber education” in a Nov. 7 Federal Register notice, the agency stated the following:
“The REMS notification letter expressed FDA’s expectation that the training would be conducted by accredited, independent continuing education providers. FDA later elaborated on its vision for prescriber education stating that we expect the CE training to be provided without cost to the healthcare professionals and that sponsors would offer unrestricted grants to accredited CE providers to develop CE for the appropriate prescriber groups.”
The concern on the part of the CME community is whether the regulated industry’s involvement in the process violates the basic tenets of certified CME. Although the new guidelines likely will generate greater commercial support for certified CME, many in the CME community are fearful of undermining the independence of certified CME providers, a significant industry self-regulation advance over the past decade.
The Coalition for Healthcare Communication strongly supports the provider independence principles. Moreover, it also is dedicated to the thesis that truthful education and industry communication contribute greatly to more effective and efficient healthcare delivery. Industry collaboration is key to advancing patient care through education of doctors and other healthcare professionals.
So, the question here is how do we support these principles while helping to address a pressing national emergency? It seems to make sense for the stakeholders to put their heads together to figure out a way to assist the government by utilizing information, talents, and resources that it may not have. In our view, everyone wins with this effort.
The government is seeking comment on this blueprint and the Coalition intends to weigh in. What do you think? Let us know.