Wednesday, August 18, 2010

5 areas to assess when designing and evaluating REMS: insights from ParagonRx

In addition to sharing my perspective on branding developments, I enjoy the insights of companies we partner with at Stinson Brand Innovation.  You can read their views by clicking the links in right hand column under “Other Health Science & Technology Blogs.”

Today, I’ve updated that list to include ParagonRx and its blog on pharmaceutical appropriate use, risk management & REMS.

In recent posting I liked, Karen Lenoir, Client Services Director, offers tips on designing REMS assessments in a meaningful manner for measuring specific objectives – balancing the interests of regulators, customers, and manufacturers.  She says there are five areas to consider the following when designing and evaluating a REMS:
  1. Baseline testing – to test for utility
  2. Program implementation – to proactively track and gauge indicators of progress
  3. Stakeholder adoption – to easily integrate REMS into the workflow of the physician’s office
  4. REMS assessment survey – to measure stakeholder (patients, healthcare professionals) knowledge and understanding of the serious risks associated with a product
  5. Safety surveillance – to establish mechanisms for reporting serious adverse events
Karen emphasizes the need to go beyond regulatory obligations. She says, “The value of voluntarily assessing more parameters more often cannot be overstated.”

Click here to read the entire blog, along with the specific questions to guide your REMS assessment.

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