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.
Should You Ground Your REMS in RxFMEA®?
Is now the time to ground your REMS development with the science-based process of RxFMEA®? The RxFMEA® methodology is a proven, highly valuable risk-assessment tool in the REMS approval and implementation processes. RxFMEA® can assist in:
- Establishing a rigorous framework for the underlying approach to risk mitigation in the development of a proposed REMS for a drug or biologic
- Preparing strategic contingency plans to respond promptly to FDA questions and requests that come late in the approval process
- Implementing a plan that introduces redundancy into the process and interventions that are best suited to minimize risks of a product by utilizing multiple stakeholders in the medication use process
- Assessing REMS performance through identified safety signals and adverse events of interest to assist in the overall understanding of how, when, and where those risks may occur and ways to improve the REMS design
FDA and RxFMEA®
Case studies are often the catalyst that allows the re-evaluation of what is being done and open your processes up to potential new approaches. Recently, a pharmaceutical company that applied the RxFMEA® process to their REMS experienced the direct benefits of their risk assessment investment. Initially, the RxFMEA® was used to assess potential product risks and provide framework for their proposed REMS design. After submission, the Sponsor was contacted by the FDA on a Friday with unexpected questions and concerns regarding the proposed REMS. Despite extensive scenario and contingency planning, it was the RxFMEA® that anticipated the FDA inquiry, enabling timely response without delaying the regulatory process. This was by no means a coincidence, but rather an artifact of the inherently rigorous approach of the RxFMEA® process. During the negotiation process, regulators must respond to the scientifically-based, transparent, rigorous processes of RxFMEA®, leading to discussions with the Sponsor that are evidence-based, rather than opinion-based.
For any company preparing for a regulatory filing, the RxFMEA® process provides an unmatched approach to address the potential or real risks of a product. Actions that mitigate identified risks, whether formalized in a REMS or other programs, encourage prescribing the right product, for the right patient, and the right time, with the right administration. This approach, grounded in the rigors of a scientific process like RxFMEA®, contributes to creating improved outcomes and greater recognition of a pharmaceutical product’s value while providing the FDA with something more than just anecdote or professional opinion.