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…)
Archive for the ‘Appropriate Use’ Category
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…)
REMS Assessments: Designing and Evaluating REMS
Wednesday, May 26th, 2010Sponsors are struggling with how to adapt research survey methods to meet the regulatory reporting standards of REMS assessments. Assessments need to be designed in a way that measure risk mitigation. Reports and interpretation of findings are highly qualitative and declarations of success may be inconsistent with those findings.
REMS assessments should be designed in a meaningful manner for measuring specific objectives. It’s important to start with a rational design – balance the interests of regulators, customers, and manufacturers. The design should be evidence-based and include end users in the design process. (more…)
REMS Assessments: Insights and Strategies for a Successful Survey Program
Wednesday, May 12th, 2010REMS Assessments are now the hot topic in REMS. We’ve reached the 18-month mark and it’s not a coincidence that Draft Guidance includes a section on assessments and modifications. Companies need to begin to contemplate not just how to analyze and interpret their assessment findings, but they need to think about the best way to actually evaluate their REMS performance. (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…)
Balancing Interests While Keeping Patient Safety Priority #1
Thursday, July 30th, 2009One of the more challenging aspects of the new FDA world of REMS is the tension it can create among various functional groups such as Marketing, Risk Management, Safety and Medical within a Pharma or Biotech company. Rules are unclear. Territories are vaguely defined. New objectives seem similar to the old but may not be in reality. And it involves many players, across most internal disciplines. Maybe it’s time that we all think of this as a cross-disciplinary sport that no one really knows how to play well, yet.
The urgency of the new regulatory environment is simply demanding some quick innovative thinking and action.
Some of our clients and others are addressing this new “X-Disciplinary Sport” to good advantage. There are a number of principles that, if kept at the forefront of thinking, can help you re-organize and align your teams around this new REMS-driven world. (more…)
