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PP01-15: Effective Educational and Training Methods Applicable to Risk Evaluation and Mitigation Strategies (REMS): A Scoping Review

Poster Presenter

      Janifer Quick

      • ORISE Fellow, Division of Risk Management, OSE, CDER
      • FDA
        United States


To access the evidence on the effectiveness of educational and training methods to better inform Risk Evaluation and Mitigation Strategies (REMS).


A scoping review was conducted using an evidence synthesis tool based on core steps of a systematic review. Selected systematic and scoping reviews published 01/01/2000 - 12/31/2019 were retrieved from PubMed, Embase, PsycINFO and gray literature and screened by three independent raters.


A total of 2058 articles were identified meeting inclusion criteria of full-text, English, systematic or scoping review, practicing healthcare professional, and training element. Random testing of 1% of the articles against the inclusion criteria yielded an interrater reliability of 74%. After removing duplicates and screening titles and abstracts, 1471 articles were excluded leaving 450 articles for full-text assessment of eligibility. Results of a critical appraisal and a synthesis of data will include targeted healthcare professionals and training methods characterized by thematic analysis. Factors that may influence training methods – specifically, evaluation methods, interventional outcomes, and settings – if discussed in the articles will be reported. (*NOTE FOR REVIEWERS ONLY: Results are not available for the deadline of this call but will be available at the time of the conference.)


Healthcare professionals play a critical role in ensuring that drugs with serious risks requiring REMS are prescribed and used safely by patients. A variety of tools including slide decks and program brochures have been used to train healthcare professionals and assure safe use behaviors. In many of these cases, a single tool is the sole source used to deliver the information on the risks the REMS is intended to mitigate and REMS requirements. Findings of this scoping review may inform on single or multimodal methods, as well as how these interventions are provided, that can facilitate learning and improve knowledge and reinforce desired safe use behaviors. Additionally, this review has the potential to identify gaps in the existing systematic and scoping review literature regarding training methods available for healthcare professionals.