The pharmaceutical industry has become a favorite “bad guy” among the public, media, and legislators. There is a perception that the many risks of medications is proof that the industry does not care about the safety of patients. Nonsense. (more…)
Posts Tagged ‘medication use’
No Free Lunch: An Intuitive Approach to Benefit-Risk Management
Tuesday, November 16th, 2010Computed Tomography (CT) Imaging Ethnography
Wednesday, September 29th, 2010Computed Tomography (CT) diagnostic scans are performed on thousands of patients daily throughout the world. CT scanning suites are under multiple pressures to optimize their process and improve their financial situations. The diagnostic value of certain scans can be enhanced by the use of intravenous iodinated contrast agents (IVCA) as they allow for increased anatomical visualization. A supplier of IVCAs contacted ParagonRx to map the administration of these agents to help identify ways to help optimize suite operation. (more…)
Grounding Your REMS in a Science-Based Approach – The ParagonRx RxFMEA® Approach to Assessing Medication-Use Risk
Wednesday, April 7th, 2010In 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…)
