ParagonRx® builds appropriate use programs for medications and medical devices to mitigate risks and optimize use

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  • Complimentary Webinar to Address: Is a ‘Voluntary REMS’ a Good Risk?
    Are the risk mitigation measures within a REMS (Risk Evaluation and Mitigation Strategy) adequate enough to ensure optimal benefit-risk management? Even if the FDA doesn’t require a REMS for a product, does it make sense to undertake risk management measures anyway? These are the questions that will be addressed in a free webinar, “Voluntary Risk [...]
News: May 15, 2012
FDA Puts New Limits on Oral MS Drug
Reacting to a death associated with the multiple sclerosis drug fingolimod (Gilenya), the FDA said patients with certain cardiac risk factors should not take the oral agent...
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Effective Risk Management and Quality Improvement by Application of Failure Mode and Effects Analysis

Read this in-depth discussion about Failure Modes and Effects Analysis (FMEA) as used in the aerospace and airline industries and why FMEA, extended with appropriate top-down, probabilistic, and feedback methods, is an excellent framework for risk management and quality improvement in the post-design/post-manufacture environment.

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Five Possible Barriers to Product Adoption

  1. The drug does not fit well into an existing patient care process resulting in increased work load.
  2. Severe known risks of an existing drug are easier to manage than unknown risks of a new drug.
  3. The definition of an “appropriate” patient may be different from one physician to another.
  4. Actual barriers to adoption may be different than the ones verbalized by physicians.
  5. The physician is not always the one making the treatment decision.  The nurse and/or other allied health professionals play a major influential role.

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Benefits of Systematic Failure Analysis as Part of Successful REMS Design

Case study that demonstrates how scientific methods, including RxFMEA®, are often a critical component of successful REMS Design.

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