In 2001, ParagonRx first employed the science-based risk assessment methodology Failure Mode and Effect Analysis (FMEA) to proactively assess patient safety in the emerging field of Pharmaceutical Risk Management. While a novel approach for assessing drug safety issues, FMEA has a long history in other risk intensive industries used to mitigate process and design failures, including the aerospace, military, nuclear, and even pharmaceutical manufacturing. Research into how FMEA was used to mitigate risks across other industries and references made in FDA Draft RiskMAP Guidance, provided the rational for applying FMEA to pharmaceutical product and patient safety. RxFMEA®, ParagonRx’s proprietary adaption of the FMEA process, applies the principles of process mapping complex systems and systematically evaluating a process for potential failures. RxFMEA® is a proactive, bottom-up assessment that identifies the behavioral causes of medication use failures and prioritizes interventional opportunities to mitigate adverse events. RxFMEA® was specifically designed as a Pharmaceutical Risk Management tool and is now utilized in REMS development for the pharmaceutical and biotech industries. (more…)
Posts Tagged ‘RxFMEA’
Grounding Your REMS in a Science-Based Approach – The ParagonRx RxFMEA® Approach to Assessing Medication-Use Risk
Wednesday, April 7th, 2010An excerpt from Expert Evaluation of RxFMEA™, a white paper by Benjamin A. Berman
Thursday, September 24th, 2009Description of RxFMEA™
RxFMEA™ is a proprietary modification and extension of the basic FMEA methodology and that of Healthcare FMEA (HFMEA™), an adaptation of FMEA that was developed by the U.S. Veteran’s Administration. My review of the process suggests that the objective of RxFMEA™ is the comprehensive management of risks in the pharmaceutical industry. Because of the active involvement of trained personnel and untrained consumers in the distribution and use of pharmaceuticals, RxFMEA™ extends the basic FMEA and HFMEA™ processes in the following ways (more…)
