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# REMS Could Include Healthcare Provider Continuing Education: FDA
- URL: https://www.fdaweb.com/rems-could-include-healthcare-provider-continuing-education-fda/
- Published: 2017-11-03T12:00:00.000Z
- Updated: 2026-09-14T23:00:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140046

FDA has concluded that healthcare provider continuing education can be a useful method for providing continuing education (CE) under a risk evaluation and mitigation strategy (REMS). A [new report](https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM583775.pdf?ref=fdaweb.com), “REMS and Continuing Education for Health Care Providers — FDA Feasibility Report,” finds that it is generally not practical to incorporate CE as the method of providing healthcare professional training at the initial time of approval due to potential delays to product launches. “However, integrating CE activities into REMS in a postapproval setting would not present the same potential for delay to product marketing and therefore appears to be more practical,” the report says.

It also recommends that an FDA-developed blueprint will need to be included in REMS to guide CE providers on the risk messages, as well as on expectations as to when REMS requirements need to be implemented. “In addition, stakeholders involved in CE development will need to consider and address the following issues when including CE as a component of the REMS. 

- Minimizing \[healthcare professional\] burden in complying with REMS requirements by ensuring that content of the training focuses on messages pertaining to the risks and safe use of the drug.
- Providing the CE activity in formats that are readily accessible to targeted \[healthcare professional\].
- Ensuring that sufficient emphasis is placed on communicating the REMS risk information and REMS requirements and ensuring that this information remains current.
- Developing a process for documenting completion of the REMS CE and, when necessary, linking the completion of the CE to the appropriate REMS requirements.
- Assessing the effectiveness of the CE activity within the context of REMS assessments.”