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


2 Comments

  1. Hear hear Jamie. The world and mindset of traditional pharma companies has been shaped by the last 20 years of compliance activities and the evolution of a drug safety reporting system that always had to work with sparse data. Health 2.0 companies are growing up in, and creating, an era of rich data. At times there could not be a bigger divide between the vertical organizations specialized to take a small amount of data, refine it and add value, and the horizontal organizations that are producing health data at a startling rate.

    I think the willingness of PatientsLikeMe to address difficult issues like this head on has helped you build a safety system that begins to bridge the gap between the compliance needs created by the myriad regulations that the pharma industry must adhere to and the innovative and open health2.0 approach. Along this interface are great opportunities for patients, and for public health.

  2. […] stranger to this topic, Jamie has written about patient safety on our blog before.  ”By using structured data collection tools within the PatientsLikeMe […]

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