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 program’
Grounding Your REMS in a Science-Based Approach – The ParagonRx RxFMEA® Approach to Assessing Medication-Use Risk
Wednesday, April 7th, 2010Organizing for REMS Effectiveness: A View from the Field
Tuesday, March 30th, 2010- Guest blog by Andrea J. Simon, PhD -
This blog by Andrea Simon, PhD, a corporate anthropologist, is one in a series that ParagonRx has initiated to help our readers better understand some of the trends taking place in the field of Risk Evaluation and Mitigation Strategies (REMS) and risk management under the FDA draft guidance. We know you will find them of value and encourage you to comment on them.
In April, ParagonRx is hosting its Wednesday FoREMS webinar on the topic of organizing to effectively manage Risk Evaluation and Mitigation Strategies (REMS). And, in May, the Wednesday FoREMS will host a panel of industry leaders discussing how their organizations are building REMS capabilities and resourcing them in their product development and commercialization functions. In preparation for these upcoming webinars, I thought I would share with you some of my observations from the field and encourage you to share your own company’s perspectives on how you are reorganizing to create and effectively manage REMS. (more…)
inVentiv Advance Insights will be presenting at the AMCP 22nd Annual Meeting and Showcase
Friday, March 26th, 2010Jennifer Restivo, VP and Managing Director, Managed Markets at inVentiv Advance Insights, and Kevin Cast, VP, Pharmaceutical Sales at ESI-Curascript, will discuss Risk Evaluation and Mitigation Strategies (REMS). The podium presentation is scheduled on Friday, April 9, 2:45 PM – 3:45 PM. Please check your program schedule for location.
The session will assess the current and future impact of emerging REMS trends. Jennifer and Kevin will present learnings, based on original research, from manufacturers and payers, as well as provide an overview of key considerations for optimal REMS implementation. (more…)
The REMS Sensitivity Index
Tuesday, March 23rd, 2010Below is a qualitative index of the likelihood that FDA may require a REMS for a specific development compound as part of the NDA submission.
The presence of any attribute increases the probability of a REMS requirement; some items may be more highly weighted than others: (more…)
Are You Attending the FDLI’s Important REMS Conference in Washington?
Friday, February 5th, 2010- Guest blog by Roger Morris, The LondonBritain Company -
Having worked in communications in the pharmaceutical industry for more than 25 years, I continue to be amazed at how even strong competitors remain so open to sharing information and experiences. Perhaps it’s the academic nature of pharmaceutical research that filters out to everyone else in the business, but the industry is constantly talking within itself - from scientific publications about new compounds to physician disease-state annual meetings to specialty conferences.
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…)
FDA REMS programs place undue burdens on clinicians
Wednesday, August 19th, 2009Dr. Jenkins–
I have seen your recent comments on providing REMS programs for opioids. Since you are the director of OND, I was hoping to give you some feedback on these programs, and to alert you to the adverse effect on patient care that they can have.
I am a clinical hematologist and oncologist. I have to contend with many drugs under these programs, including Promacta, Nplate, Thalomid, Tysabri, and Revlimid. Looks like opioids are next on the list. (more…)
REMS Effectiveness Management
Wednesday, August 12th, 2009Your company wouldn’t launch a new product and wait for the end-of-year results before assessing whether the launch strategy was effective, correct? In fact, the process most pharmaceutical product managers employ includes weekly measurement of prescription volume, tracking product inventory, assessing distribution patterns of promotional materials, measuring knowledge/attitude/practices of prescribers, and adjusting marketing activities to achieve success.
So why would tracking and adjusting risk management activities be any different? FDA requires an assessment of REMS performance at intervals no less frequently than 18 months, 3 years, and 7 years post launch. What are you doing before and between formal assessments to actively manage and maximize the effectiveness of the REMS? (more…)
Big Lessons Learned in this New World of REMS
Monday, July 20th, 2009Today we want to focus on key lessons learned from our clients’ experiences. We are very grateful to these clients for allowing us to share their experiences with you so that you can do a better job in your REMS process.
Let’s begin with something that happened recently as we were working with a client during the tight 90-day period before they presented their PDUFA.
Expect the Unexpected
As we work with our clients on their REMS process, we are learning a lot about the uncertainties of interfacing with an internal FDA process that is itself a work in process. One thing that has become very apparent is that no matter how much advanced preparation you believe you have done, the FDA might just surprise you. (more…)
