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 ‘FMEA’
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…)
Airplanes and Medications
Thursday, September 3rd, 2009Airplanes and medications seem like items that don’t mix well. In fact, the discussion of a recent webinar suggests otherwise, at least as it relates to risk management. Captain Ben Berman shared experiences from his role as former Chief of Major Investigations of the U.S. National Transportation Board in which he served as a member of the major accident go-team responsible for safety studies about flight crew human factors. (more…)
Pharmaceutical Safety Risk Management
Wednesday, April 8th, 2009What a difference a year makes…
In early 2008, the topic of risk management was greeted with aversion by most pharmaceutical managers responsible for commercial activities. “If I encounter a drug with genuine safety concerns, I’ll call you” was a frequent response.
Today, everyone is talking about risk management… and for good reason. The FDA Amendment Act (FDAAA) of 2007 granted FDA sweeping new authority to require Risk Evaluation and Mitigation Strategies (REMS) of any product at any stage of lifecycle. In response to FDAAA, industry had three immediate questions:
- What determines if REMS will be necessary?
- How actively will FDA implement the REMS provisions?
- Who should be thinking about risk management?
