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…)
ParagonRx Blog
The latest in pharmaceutical appropriate use, risk management & REMS
News from ParagonRx- FDA Panel Looks at CNS Depressant for Fibromyalgia September 1, 2010A joint FDA advisory committee wіƖƖ meet here Friday tο consider whether tһе narcolepsy drug sodium oxybate (Xyrem) ѕһουƖԁ receive аח additional indication tο treat fibromyalgia. Sodium oxybate, currently approved аt a 500 mg/ml dose fοr narcolepsy-associated cataplexy аחԁ...
- Bristol-Myers Squibb, Pfizer's apixaban reduces risk of stroke versus aspirin: study August 31, 2010Late-stage results presented Tuesday at the European Society of Cardiology Congress demonstrated that Bristol-Myers Squibb and Pfizer's apixaban reduced the risk of stroke in patients with atrial fibrillation by more than half compared with aspirin. Lead trial investigator, Stuart Connolly,...
- FDA puts back review of GSK/Valeant epilepsy drug August 31, 2010GlaxoSmithKline and partner Valeant Pharmaceuticals International have suffered a slight setback with the news that regulators in the USA need another three months to evaluate new data, and decide on final approval, of the firms' new epilepsy treatment Potiga. ...
- Genzyme rejects Sanofi-Aventis offer August 30, 2010Biotechnology company Genzyme Corp. said Monday it rejected Sanofi-Aventis SA's $18.5 billion buyout offer because it undervalues the company. On Sunday, French drug developer Sanofi-Aventis ( SNY - news - people ) offered $69 per share for Genzyme (...
- FDA Panel Looks at CNS Depressant for Fibromyalgia September 1, 2010