This article was co-authored by Josephine Borrillo, a Digital Health Consultant that advises healthcare enterprises on best practices for the development, adoption, and marketing of digital health technologies.
Effective monitoring for adverse events in the form of adverse drug reactions presents both opportunities and risks to drug and device manufacturers. In previous posts, we have discussed the role of social media in adverse event monitoring and highlighted some of the ongoing projects in this arena (see here and here, for example).
In this post, we discuss why pharmaceutical and medical device companies should not ignore adverse event data related to social media (e.g., Facebook, Twitter, blog posts) simply because there are no current guidelines as to how to handle this information. Indeed, social media has generated a wealth of valuable data related to adverse event reporting, and healthcare product manufacturers must figure out how to appropriately pay attention to this large and growing body of data. For example, social media may have played a major role in the FDA’s decision to add a black box warning to Essure (a contraceptive implant). The Agency received thousands of complaints from women reporting chronic pain, bleeding and other more serious health problems. Importantly, many of these complaints were shared through social media, such as the “Essure Problems” Facebook page, which has more than 25,000 members.
Here are four reasons why pharmaceutical and medical device companies need to pay attention to these data.
1: Adverse Event Data from Social Media Are Part of a Comprehensive Safety Assessment Program
Safety monitoring once was simple. Clinical trial investigators or physicians would complete forms submit them to the manufacturer, and companies would inform the respective regulatory agencies of adverse events. But the landscape has changed. Today, there are many more relevant sources to consider and track. Today’s sources include literature databases, hospitals, call-centers, regulatory public databases, comments on websites and the various other social media outlets, such as Twitter, Facebook, and Instagram. In today’s world, a comprehensive safety monitoring program must include all of these outlets to ensure maximum patient safety.
These complexities were captured nicely in a presentation by Phil Tregunno (Signal Management Unit Manager, WEB-RADR project lead) at the recent SMi (Social Media in the Pharmaceutical Industry Conference (see Tweet, below).
2: The New Landscape is Complex
Traditional processes of identifying and reporting adverse events are no longer efficient, making compliance with regulations challenging. Although companies have a very limited timeframe to report adverse events, they still reply on paper, use faxes, need paper trails and a staff of regulatory experts. While some pharmaceutical companies are certainly using social media “listening” tools, the value of this method is often overlooked.
Digital activities cannot succeed in siloed and fragmented systems. Whether it is the marketing department with their digital promotional platforms or the CEO on Twitter or LinkedIn, efforts must be coordinated and organic throughout the corporate structure across all departments.
3: Proactivity is Critical
It is no longer a question of whether social media platforms are a source of adverse events. The question is now how to best implement a program to capture and monitor these events. Fear of discovering new or additional adverse events on social media has been the reason that many pharmaceutical companies do not participate in online conversations. But with as these social networks continue to grow and more information potentially pertinent to safety is posted online, it is critical to have a proactive plan to deal with this information.
Let’s look at one example of a monitoring system launched in 2016 by IMS Health and Hootsuite. Essentially, IMS Health and Hootsuite formed an alliance with the goal of helping life science companies increase engagement on social media channels and to support compliance. Together, they launched the IMS Health AETracker application for Hootsuite. This technology integrates with social media monitoring and is one of a handful of solutions for identifying, tracking and reporting adverse events, product complaints and off-label usage in real time.
Critical to the success of tracking adverse event online is having experienced and capable social media experts comfortable with working with social media listening tools. Although these data streams can be overwhelming, having the right system in place makes the monitoring efficient and manageable.
4: Discover Valuable Product and Patient Insights From Monitoring Social Media
In addition to a more effective assessment of safety, there is also great opportunity for pharmaceutical companies that have a rigorous social listening platform in place to learn other valuable insights about their products. There are numerous “quick wins” from social listening that can benefit pharmaceutical companies beyond learning more about adverse events, including the following:
- Patient concerns and behaviors
- Product abuse and misuse
- Tolerance, and compliance (including reasons for stopping drugs)
- Product use patterns in the “real world”
- Additional indication concepts
- Insights related to brand awareness and sentiment
- Understand content that patients will find valuable
- Show company values other than just promoting products
- Create and share follow-up resources
Overall, social media is going to play an increasingly important role in the detection and evaluation of adverse event monitoring. An effective social platform and associated processes can help minimize risk and maximize potential opportunities. If you would like to learn more about how we can help you with your social media and adverse event strategy, get in touch with us.
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