3 posts tagged “Drug Safety”

$70,000 at Stake in the “Reporting Safety Events Challenge”

Posted August 22nd, 2012 by

How serious is the U.S. Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) about increasing patient safety?   So serious that they are running a contest challenging the best and brightest developers to create a platform that makes it easier to report a patient safety event electronically.

Learn More About the "Reporting Safety Events Challenge" for Developers Here

The Reporting Patient Safety Events Challenge is offering $70,000 worth of prizes, with $50,000 (and a demo opportunity) awarded to the first place winner, $15,000 to the second place winner and $5,000 to third place winner.  The submission deadline is August 31, 2012.  Learn more about the contest guidelines and 30+ participating developer teams here.

“Ideally, we would live in a world of optimal care delivery,” says the ONC.  “Physicians, nurses and care delivery organizations across the country are continuously working to minimize and eliminate errors.  But, until this ideal world exists, we need to invest in infrastructure that helps enable better care quality, risk management and shared learning – all to ensure better care for patients.”

PatientsLikeMe fully supports this goal, which is why we introduced our first-of-its-kind adverse event reporting platform in 2009.  As part of a two-year pilot program, our members with multiple sclerosis (MS) were able to submit adverse events related to a medication, medical product or medical device directly to the U.S. Food and Drug Administration’s MedWatch program through PatientsLikeMe.  Our system automatically pulled relevant data from the patient’s profile into a FDA 3500 form, dramatically reducing completion time.

Since then, we’ve also developed an integrated and comprehensive drug safety reporting platform that monitors patient data for potential adverse events when we are collaborating with a sponsoring partner in designated disease areas. These data are then clinically triaged and curated using the Medical Dictionary for Regulatory Activities (MedDRA), an industry standard terminology. Adverse events are submitted to our partners electronically in FDA 3500A format to meet regulatory timelines and reporting criteria.  Of note, PatientsLikeMe is the only online health data platform in social media that has successfully passed multiple drug safety audits conducted by our partners’ pharmacovigilance and drug safety experts.

What’s the difference between patient safety and drug safety?  And what do we see ahead in this critical area of healthcare?  Tune in to a podcast with PatientsLikeMe Chairman and Co-Founder Jamie Heywood on this very topic.


Drug Safety: It’s About More Than Just Compliance

Posted September 30th, 2010 by

pillsEngaging in social media presents a number of uncertainties to pharmaceutical companies. In a world where much of the medical dialog has moved online, these uncertainties have emerged due to absent or unclear guidelines from the Federal Drug Administration (FDA), privacy and regulatory concerns about engaging directly with patients, and the potential for significant consequences.

When I recently spoke before the FDA, we highlighted how our pharmaceutical partners are taking a leadership role by navigating through these issues. In so doing, our partners are learning about real world experiences of patients and how to meet their adverse event reporting responsibilities in the PatientsLikeMe Epilepsy, Organ Transplant and Multiple Sclerosis communities.

“…as the FDA contemplates the Internet and social media as an emerging source of drug safety data, it is essential to consider what characteristics distinguish a social media site as being capable of contributing to drug safety in a meaningful, computable and quantifiable manner.”

Meaningful, computable and quantifiable are three words that underscore all that we do at PatientsLikeMe. This includes the creation of our patient safety program. Early on, we approached patient safety proactively with a pilot program in our Multiple Sclerosis Community. Launched in 2009, this program allows patients to voluntarily report adverse events that funnel to the FDA’s MedWatch system. Our system automatically pulls relevant data from the patient’s existing profile into an FDA 3500 form, dramatically reducing form completion time.

Going beyond that in areas where we work deeply with our pharma clients, we developed an integrated and comprehensive drug safety reporting platform that monitors patient data and free-text for potential adverse events. This data is then medically curated into standard MedDRA terminology and submitted electronically to meet regulatory timelines and reporting criteria. Of note, PatientsLikeMe is the only online health data platform in social media that has passed multiple drug safety compliance audits.

The reality today is that patients are sharing their real-life experiences with post-marketed drugs online. By using structured data collection tools within the PatientsLikeMe platform overseen by a drug safety professional, industry partners can improve patient safety.

This is about more than just compliance, though. We believe it’s about leadership – patients and pharma working together in new ways. Listening – to understand the positive and negative patient experience – is the right step in developing a trusted relationship. And this trust-based relationship is the only foundation upon which to build your social media strategy.

PatientsLikeMe member jamie


PatientsLikeMe Offers Adverse Event Reporting for MS Patients

Posted April 15th, 2009 by

PatientsLikeMe is proud to announce a pilot program in our multiple sclerosis community which helps patients submit treatment-related adverse events directly to the The U.S. Food and Drug Administration (FDA) through our site.

“Adverse events” are severe side effects or events that occur as a result of using a medication, medical product or device.  Understanding when these events occur helps the FDA better regulate the pharmaceutical and medical product industries to protect consumer safety and bring safer, more effective products to market.

medwatchplm

We are excited about this pilot as it marks the first time ever that an online patient community has helped its members identify and report adverse events.  We recently submitted our first batch of reports to the FDA’s MedWatch system.

Patients like you are becoming more and more influential in their treatment decisions. No longer are you simply consumers of pharmaceuticals and medical products, you are customers.  In this emerging world, you have become better educated about your treatment options, the risk and benefits of different treatments, and your overall quality of health.  Now you have the opportunity to tell the FDA if you’ve had an adverse event.

Welcome to the new world.

PatientsLikeMe member dwilliams