Improving the Effect of FDA-Mandated Drug Safety Alerts with Internet- Based Continuing Medical Education
Carl N. Kraus, Alan T. Baldwin and R.G. McAllister
Affiliation: Nanotherapeutics, 13859 Progress Blvd., Suite 300 Alachua FL 32615, USA.
Keywords: Antibody, CME, education, FDA, ipilimumab, learning, melanoma, monoclonal, oncology, REMS, safety.
The US Food and Drug Administration (FDA) requires risk communication as an element of Risk Evaluation
and Mitigation Strategies (REMS) to alert and educate healthcare providers about severe toxicities associated with
approved drugs. The educational effectiveness of this approach has not been evaluated. To support the communication
plan element of the ipilimumab REMS, a Medscape Safe Use Alert (SUA) letter was distributed by Medscape via email
and mobile device distribution to clinicians specified in the REMS. This alert contained the FDA-approved Dear
Healthcare Provider (DHCP) letter mandated for distribution. A continuing medical education (CME) activity describing
ipilimumab toxicities and the appropriate management was simultaneously posted on the website and distributed to
Medscape members. Data were collected over a 6-month period regarding the handling of the letter and the responses to
pre- and post-test questions for those who participated in the CME activity. Analysis of the answers to the pre- and posttest
questions showed that participation in the CME activity resulted in an improvement in correct answer responses of
47%. Our experience shows that there are likely distinct information sources that are utilized by different HCP groups.
The ready availability of a brief CME activity was utilized by 24,063 individuals, the majority of whom showed enhanced
understanding of ipilimumab toxicity by improvement in post-test scores, educational data that are not available via
implementation of standard safety alert communications. These results demonstrate that improvement in understanding of
specific drug toxicities is enhanced by a CME intervention.
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