Social media use is exploding, and the pharmaceutical industry could be in for a major headache.
Resulting symptoms for pharma brands can include aggravating audits, heavy fines, and disrupted marketing—all potential consequences of the failure to comply with adverse event reporting requirements in accordance with FDA, EMA, and HIPAA regulations.
Recognizing the keen interest in healthcare and the advantages of engaging directly withconsumers online, pharma brands have cautiously become more active on social media channels. Beyond a means of communicating with consumers and those seeking information about medications and therapies, a social media presence gives them the ability to raise brand or product awareness and gain insights into patient experiences.
Invariably, those experiences include the mention of side effects or the revelation of personal health information that can quickly overwhelm pharmacovigilance and drug safety teams responsible for compliance, if not managed properly.
With the continued rise of social media—and certainly the rise of online conversations about the COVID-19 vaccines—the intensifying amount of user-generated content related to drug interactions makes it more and more likely that adverse events could be missed and go unreported, posing the threat of regulatory action and lasting harm to marketing efforts.
According to a recent Crisp survey, those concerns are very real. And it’s not just the pharma companies that are missing the adverse events—their external agency partners are, too.
NEW SURVEY REVEALS CONCERNS ABOUT ADVERSE EVENT REPORTING
The survey, conducted in partnership with FiercePharma, the pharmaceutical industry’s daily monitor, casts light on the gravity of the problems with adverse event reporting on social media. The respondent group consisted of 100 pharma leaders responsible for either pharmacovigilance, compliance, or drug safety.
The results show potential adverse events are being missed both internally and by their external agency partners.
Nearly every respondent (97%) reported at least one potential adverse event was missed in the last year and more than half (51%) confirmed that their marketing teams or their contracted agency partners were the ones to miss them.
This troubling figure corresponds with a generalized anxiety from pharmacovigilance and drug safety team leaders about how their social media is being handled by their external agency partners. Fifty-five percent described themselves as “concerned” about the way that potential adverse event detection is being managed by these outside companies, with 60% reporting instances where the responsibility of detecting potential adverse events was surprisingly delegated to an intern.
What’s worse, 40% cited working with inexperienced agency partners as a primary concern, and 29% added that working with an external agency partner that doesn't understand the pharma space and its requirements for remaining compliant is an additional worry.
MAINTAINING A SAFE AND COMPLIANT SOCIAL MEDIA PRESENCE
The surveyed pharma leaders are not alone in their concerns about missed adverse events on social media. While it’s not a topic that’s discussed or covered extensively, a Quarterwatch review of adverse event reporting did find the flood of low-quality reports from drug manufacturers render the FDA's Adverse Event Reporting System unreliable.
Proactively maintaining a safe and compliant social media presence requires pharma brands to work closely with an expert partner who specializes in pharma social media compliance who can offer pharmacovigilance, compliance, and drug safety leaders peace of mind while giving marketers and agency partners the confidence to focus on patient engagement and gather insights.
In addition to detecting potential adverse events on brand-sponsored social media pages, advertisements and social listening platforms, an expert partner specializing in adverse event monitoring can ensure compliance with reporting requirements and support internal reporting processes. They should also guarantee that all potential adverse events on owned social media properties are detected, with zero misses.
Consider the following three-pronged approach to pharma social compliance in order to keep your social media presence safe and in line with regulatory guidelines:
Owned Social Adverse Events Compliance. Ensures compliance with FDA and EMA regulations for adverse event reporting, removing content that contains the personal health information of others to adhere to HIPAA regulations, and maintains a friendly and safe environment for patient engagement by removing harmful content that is likely to upset, offend, or mislead.
Social Listening Adverse Events Compliance. Gives pharma brands the freedom to engage in social listening by detecting potential adverse events in social listening search results.
Paid Social Adverse Events Compliance. Reviews patient comments and reactions to paid social media advertising, so that they remain compliant with regulations for adverse event reporting, and removes content that contains personal health information.
GET A PRESCRIPTION FOR PROTECTION FROM ADVERSE EVENTS
In the highly regulated pharmaceutical industry, it’s no surprise that brands have been hesitant to embrace social media. That hesitancy has been amplified by the challenge of adhering to the strict regulations around potential adverse events reporting.
Pharma brands need external partners they can trust with the responsibility of identifying and alerting to potential adverse events to allow them to confidently participate in social media marketing.
These partners must not operate using generalized solutions that have not been built specifically for faultless adverse event detection. Equally, delegating adverse event reporting to the interns or relying solely on algorithms to find them does not work. Compliance solutions, by definition, need to treat every potential adverse event with consistent, immediate attention.
Pharma brands should embrace a social media compliance solution designed to detect potential adverse events on owned social media and paid social media advertising. One that allows machines to gather social media comments and then relies on triaged humans to determine if they are genuine or not. With this approach, pharma brands can seamlessly integrate adverse event detection with existing pharmacovigilance reporting.
If this sounds ambitious, that’s because it is. But pharma companies can’t afford to settle for an external partner whose gaps in compliance reporting lead to regulatory fines, compromised marketing activities, and sleepless nights spent worrying about what adverse events are slipping through the cracks.
There is undeniable value in the opportunity of being online and engaged with consumers where they are congregating in droves. No matter how daunting the prospect of catching all potential adverse events may seem, your social media presence can be expertly managed, and your brand can reap the benefits.
Instead of focusing on the potential pain of social media, get a prescription to connect with consumers, promote your products, and grow your business.