Failure Mode and Effect Analysis: Evidence Based Methods
The Power of Fact - Evidence-based Methods like Failure Mode and Effect Analysis
This first step in the successful design of a risk management program is an evidence-based analysis such as Failure Mode and Effect Analysis using RxFMEA®
Failure Mode and Effect Analysis using RxFMEA®
Every medication has benefits and risks that need to be managed and traditionally the risks of focus for pharmaceutical manufacturers and FDA were the “intrinsic” adverse events of medications. As regulators and the public have elevated their expectations about the proactive management of risks, manufacturers have begun to focus on the risks associated with the care delivery process that could expose patients to medication AEs. For example, if a pharmacist doesn’t counsel a patient about a serious drug-drug interaction, what are the consequences?
The question for manufacturers is how to identify and manage risks associated with product use in the “real” world that appear to be beyond the control of the manufacturer? One solution is through a proven, systematic and scientific methodology such as Failure Mode and Effect Analysis (FMEA).
ParagonRx has developed a proprietary Failure Mode and Effect Analysis (FMEA) approach to risk, based on an FDA-approved approach. Our adaptation of failure modes and effect analysis (FMEA), called RxFMEA®, is a bottom-up assessment to identify key causes of suboptimal outcomes and to prioritize those behaviors that are most important to address.
Leveraging your cross-functional team, we identify and target interventions that directly mitigate the most frequent risks that are amenable to intervention. When regulators see this transparent process, negotiation can be based on facts and evidence, rather than on opinion and speculation.
The Advantage
Actions that mitigate identified risks, whether formalized in a REMS or other program, encourage prescribing the right product, for the right patient, and the right time, with the right administration. This approach contributes to creating improved outcomes and greater recognition of your product's value.
