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In this exclusive Q&A, Marie Flanagan, offering management director, IQVIA, reveals how patients are reporting adverse events in large numbers on social media.
Social media has been a game-changer for the industry in many ways—some of which have proven to be surprising developments. One such evolution is how social media has changed how adverse events (AEs) are reported by non-healthcare providers (HCPs). Patients are now also self-reporting AEs, and companies must find a way to capture and utilize this new source of data.
Marie Flanagan, offering management director, IQVIA, shares with Meg Rivers, managing editor of Pharmaceutical Executive, a few insights into how AEs have historically been reported, how social media can be utilized in safety measures, as well as how organizations can better manage complaints.
Flanagan: AE reporting has historically been a manual, fractured, and time-consuming process. Reporting was traditionally reliant on either structured data capture networks that existed in a pre-approval landscape or from HCPs in a post-approval landscape. Recently, there has been a change in reporter dynamics within post-market safety reporting. Patients and consumers now represent the majority of contributors. New avenues have also arisen, such as direct-to-regulator reporting and social media, encouraging patients to report and marking a huge shift in patient engagement and traditional AE reporting. As the channels for reporting grow, companies are overloaded with data that needs to be evaluated and investigated for potential AEs and complaints.
The data that comes in from HCPs and consumers are pooled together with AE reporting from other investigational, solicited, unsolicited, and spontaneous sources and managed through the regulated safety workflows. As a result, life science companies must sort through a lot of unstructured data to verify what is relevant to safety from a lot of noise.
Flanagan: Ideally, all AEs would be comprehensively captured, automatically identified, and ingested into a downstream safety or complaints system without any manual review required. Unfortunately, we are not there yet. But safety technology is making great strides in automating the identification of safety risks using natural language processing (NLP), process automation, and advanced analytics and helping us inch closer to this future vision.
Technology is evolving rapidly to keep pace with changes in the landscape, such as the ability to monitor social media channels and voice files for these AEs. The way we get to AE reporting in an ideal world is to invest in technology that can align with reporting dynamics and invest in the expertise to optimize the workflow to ensure technology serves the unique requirements of your safety organization.
Flanagan: The number of social media users continues to rise, expected to reach 4.89 billion by the end of 2023, according to a 2017–2022 Statista survey.1 Consumers use social media platforms to voice their experiences with products and this naturally extends to side effects and complaints. This new channel of information, via social media posts, represents a major volume consideration for post-marketing safety. This channel brings more complexity and a huge amount of noise to AE reporting that has the potential to distract from the potential to harness this data for new and emerging safety insights.
Combining the reported events from HCPs, traditional post-market safety sources, and now consumers via social media, the increase in AEs and complaints is unsustainable for pharmaceutical and MedTech organizations relying solely on manual review. The noise in the social space is becoming too overwhelming and deafening.
Flanagan: Millions of conversations around AEs happen weekly. In 2020 alone, 50 million conversations around COVID-19 alone took place weekly.2 With such a large number of posts and conversations occurring day to day, automation technology is necessary to complement manual reviews. Automating the identification of potential safety risks is key. Once identified, additional data extraction components can be layered on to highlight the product, reporter, and patient. Finding every risk is a challenge, as all company-owned handles need to be monitored. Not only that, but all publicly accessible data from social channels being used in any capacity by an organization also needs to be monitored. We have found that technology can reduce up to 74% of the noise from social media complaints, opening the door for more efficient and effective monitoring.
Flanagan: The simplest answer is automation. We know technology exists that benefits this process. The key to success is making that technology work with your organization’s ecosystem and optimizing your processes to maximize returns. The occurrence of AEs and complaints continues to grow; and as more channels emerge for hidden complaints, more technology should be relied on. Bringing together human expertise with tools like AI and NLP results in easier and more accurate complaint management, especially as the language of social media continues to change (e.g., slang, colloquialisms, and emojis need to be catered to with a regularly updated NLP tool).
Flanagan: AE data is gathered from a variety of sources and is not limited to any regulated set of channels. Call center audio, emails, patient support programs, customer relationship management systems, apps, and literature are but a few sources where you would expect to find post-market safety data. That list is not exhaustive and that will give a flavor of just how complex this environment is and how challenging omnichannel reporting can become. Real-world data (RWD) is becoming more and more important to regulators in their decision making and monitoring RWD sources is encouraged. It’s important we make this possible and accessible for every organization.
Rivers: Do you have any final thoughts you’d like to share?
Flanagan: It is widely known that social media represents a huge challenge for companies. Finding a safety event of relevance is akin to finding a needle in a haystack. Regulators are working hard to revise the regulation surrounding what organizations are required to monitor in relation to social media, and we eagerly await upcoming changes to the existing regulations in the coming one to two years. There is no question that our adoption of social media as a society will continue to grow, and we need to be clever about the way in which we harness that data for the ultimate benefit of patient safety globally.
Meg Rivers is the managing editor of Pharmaceutical Executive.