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…)
Posts Tagged ‘REMS design’
Grounding Your REMS in a Science-Based Approach – The ParagonRx RxFMEA® Approach to Assessing Medication-Use Risk
Wednesday, April 7th, 2010We’ve Grown to Better Support Our Clients
Friday, January 8th, 2010Since 2003, ParagonRx has helped design, document, or negotiate dozens of risk management programs and REMS for pharmaceutical products. Clients who choose to work with us have done so because of three operating principles:
- We believe in a balanced approach to REMS design in which safety objectives are achieved while preserving commercial viability.
- We employ science-based methods to reliably design and measure rational, defendable programs.
- We strive to inspire confidence in clients facing uncertain situations by providing specialized thinking, expert analysis and remarkable responsiveness by our experienced staff.
Those potential clients who did not choose to work with us often cited the need for a firm with broader capabilities to implement communication plans and elements to assure safe use.
At the start of this year, ParagonRx fulfilled its vision of being able to provide end-to-end REMS and risk management services by joining inVentiv Health. (more…)
REMS Assessments
Tuesday, December 22nd, 2009As we advise clients about REMS design and implementation, the most frequent concern we encounter is related to REMS assessment. A look at the math reveals why this is so. Over 63 REMS have been approved since FDAAA statutes for REMS became effective in March 2008. Of those, more than 90% are comprised of Medication Guides and/or Communication Plans, plus an assessment. (more…)
FDA’s Draft Risk Evaluation and Mitigation Strategy (REMS) Guidance – A Preliminary Review (Part V)
Thursday, October 15th, 2009On September 30th, FDA issued draft guidance, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments and Proposed REMS Modifications”. While much of this draft guidance is a codification of what’s already been happening in practice over the past 2 years, there are some interesting aspects in the guidance for those working in the REMS space to contemplate. This is the fifth in an ongoing series of blog articles about this important document.
Our first four articles covered the background of FDAAA and REMS, an overview of a REMS submission and greater detail about the “Proposed REMS” and “REMS Supporting Document”, and REMS submissions and communications with FDA.
In this fifth and final article, we address our preliminary interpretation of the draft guidance, as well as opportunities for industry to respond and propose further improvements. (more…)
Contingency Planning: Strategies to Negotiate the Barriers to Product Approval
Wednesday, September 2nd, 2009In a constantly changing regulatory environment, having a well planned contingency strategy is vital for successful Food and Drug Administration (FDA) negotiations. Today, this is more important than ever. The FDA is asking companies to prepare Risk Evaluation and Mitigation Strategies (REMS) to help ensure patient safety, and has issued a documentation template, but has yet to provide further guidance to the industry on how such REMS should be developed. (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…)
Thoughts Shared at FDLI Risk Management Conference
Wednesday, January 28th, 2009FDA and the industry share thoughts at FDLI risk management conference
Earlier this month, while Washington was bustling with Inaugural preparations, there was an excellent meeting in the capital on pharmaceutical risk management, hosted by the Food and Drug Law Institute (FDLI) at the offices of Morgan, Lewis & Bockius LLP. The impetus of the meeting was to provide a forum for some of the authors of the recently published text, Pharmaceutical Risk Management: Practical Applications (FDLI, 2008) as well as other experts within the industry and within the FDA. Industry veteran Wayne Pines, who edited the book along with me and my colleague at ParagonRx, Gary Slatko, chaired the conference.
I would like to share with you some of the more-intriguing thoughts to come out of the conference, as well as a few news tidbits – but first let me say that if you would like to obtain a complete transcript of the conference or to buy a copy of PRM: Practical Applications, please contact the FDLI website at www.fdli.org.
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