By: Lana Pauls | December 21, 2016
A look at the FDA’s approach to using social media to track and manage adverse event reports.
Monitoring adverse events is a critical component of any effective pharmacovigilance practice. The best monitors actively search for information through a variety of channels that could suggest a new or known adverse event has occurred and is potentially caused by the treatment in question. Early and accurate identification of these events is the cornerstone of clinical safety management.
But as new sources of data become avenues to report such events, it has become increasingly challenging for research teams to determine what data streams to watch and how to assess these new, non-traditional sources of information.
Some of the data streams, including electronic health records, pharmaceutical records, and registries, are relatively accessible for monitors to track adverse event reports. But others sources are tougher to follow. Most notably, social media.
If someone in a clinical trial tweets about a headache or muscle-cramp, is that worth following up? If they name a drug specifically or mention a product category in combination with their complaint, does that make it more relevant? And how accountable are monitors for finding these posts?
These are important questions that regulators have struggled to answer – but not for lack of trying. The U.S. Food and Drug Administration (FDA) has been exploring the potential for social media to garner insights from the patient community. Harvesting social media posts to find reference to specific drugs or related complications can help address the problem of adverse event underreporting and increase the amount of safety information available to the FDA after a drug launches. It also aligns with the industry’s efforts to engage with the patient community via channels they prefer, and to make their communications and engagement efforts more patient-centric.
It hasn’t been an easy process defining how biopharma companies can talk to patients via social media, as well as the privacy, safety and regulatory issues that need to be considered when harvesting comments for reporting. Over the past several years, the FDA has taken several steps to evaluate the value of social media in adverse event reporting, and what guidance – if any – should be produced to help drug developers navigate this new age of social patient engagement.
Here’s a look at their journey.
Guidance for social media communication. In 2009, the FDA held a public hearing to gather comments and questions on how it can best provide guidance on the promotion of FDA-regulated medical products using the Internet and social media tools. Over the next five years, the Office of Prescription Drug Promotion (OPDP) released four draft guidances that address various topics related to the public hearing, including how to present risk and benefit information on platforms with character limitations, and how to address misinformation about prescription drugs and medical devices shared on social media.
“Listening” for adverse events. From 2012 to 2015, the FDA collaborated with health informatics company Epidemico to develop a digital listening platform designed to automatically collect and categorize social media information from publicly available posts about drug safety events and experiences with medical products. The tool looks for posts on Facebook and Twitter that refer to both medical products and adverse events, then the data is analyzed to identify potential safety issues and trends.
The first study to come out of this project, in 2014, identified similarities between the highest number of events reported in social media and those reported to FDA, and found that patients reporting adverse events on Twitter showed “a range of sophistication when describing their experience.” The authors believe this demonstrates that patients have the ability to accurately describe medical problems, making these posts a valuable tool for drug safety. The second analysis, which hasn’t yet been published, will explore whether social media can provide earlier signals for known safety events.
Google it. Last year, FDA representatives reportedly met with Google to discuss potential collaboration efforts to identify adverse drug events using Google technologies and data. The meeting included an engineer from Google who has conducted research on the effectiveness of mining search queries for adverse event reports by pairing common symptoms – such as "cramps" and "tired" – with the name of a drug.
A guidance of sorts. The FDA hasn’t published specific guidance on using social media for adverse event reporting yet. However, Dr. Gerald Dal Pan, director of the Office of Surveillance and Epidemiology in the FDA’s Center for Drug Evaluation and Research (CDER) argues that FDA’s Postmarketing Safety Reporting for Human Drug and Biological Products guidance for industry covers adverse event reporting using information received from the Internet. “The principals of adverse event reporting apply regardless of the forum in which the industry learns about it,” he said in a 2015 interview. He added that the FDA realizes sites such as Twitter and Facebook offer an important communication channel between patients and the biopharma community, and that they will continue to explore how these communication channels play a role in reporting.
The biopharma industry is making great strides to be more patient-centric and to communicate more fluidly with patients via multiple channels, including social media. Listening to these conversations gives them another way to engage with patients, to hear their concerns and to proactively address potential risks related to their treatments.
Despite the lack of specific guidance, biopharmaceutical companies ought to consider the potential ramifications that social media posts could have on their signal management and pharmacovigilance strategies. While the FDA has been somewhat passive to officially define how social media posts should be used for adverse event reporting, they are clearly heading in that direction.
For now, the best approach biopharma companies can take is to work with experts who understand how social media data mining works, and to keep track of the FDA’s positon on the use of social media as it evolves as well as other global regulatory agencies. Having social media experts on the team with experience working with social media listening tools is one example that may help companies with tracking efforts. These data streams can be a valuable source of information, but companies need to be sure they are capturing this data in a way that protects the patients, the product and the reporting process.