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December 14, 2011

Optimizing REMS: FDA Blueprint for Long-Acting and Extended Release Opioid REMS as a Case Example

On November 4, 2011, FDA announced the availability for public comment of a draft "Blueprint" for continuing education (CE) which contains a basic outline of content that the FDA believes should be conveyed to prescribers of long-acting and extended-release (LA/ER) opioid drugs.  The Blueprint will be eventually posted on the FDA website for use by CE providers for developing CE courses that will be offered to prescribers as part of the REMS for LA/ER opioid drugs.

The call for review of this Blueprint is an excellent case study of the need to optimize REMS by means of applying evidence-based methods.  In the absence of standardized methodology, what is the basis for comment on the Blueprint?  Personal preference?  Professional judgment?  Intuition?  All of these are relevant, but not objective.  

In this program, we will review the results of a gap analysis that used standardized methods to evaluate the relevance of the Blueprint in addressing failures and medical errors that may lead to patient injury or death.  


  • Describing the need for optimizing risk communications and REMS
  • Reviewing selected standardized methods for optimizing REMS
  • Reviewing the FDA Blueprint for physician education content and their request for comment
  • Evaluating gap analysis case study
  • Identifying best practices for implementing complex programs among multiple stakeholders

Guest Speakers:

  • Jeff Fetterman, President - ParagonRx
  • Marc Deluca, Clinical Services Manager- ParagonRx
  • Mike Menta, Vice President  – Campbell Alliance


Webinar Slide Set



Session Replay

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