Inconsistencies and Irregularities Plague Pharma Social Compliance

- Emma Monks

Inconsistencies and Irregularities Plague Pharma Social Compliance

Now that the COVID-19 vaccines are being distributed globally, there is a light at the end of the tunnel. A light that, while signaling a return to some sort of normalcy by year’s end, has put pharma companies in the public eye like no other time in recent memory. They are not only confronted with a complex environment of meticulous oversight of industry and government regulators but also a more complicated social media landscape.

Across the pharmaceutical industry, unreported adverse events on social media pose a growing risk of operational and reputational harm. Non-compliance can result in audits, fines, regulatory sanctions, and legal actions.

Yet, according to our Q4 2020 survey of 100 seasoned pharmacovigilance and drug safety professionals, conducted in partnership with FiercePharma, optimum compliance can be undermined by subpar record-keeping, misplaced priorities, and inconsistencies in social media monitoring—made worse by inexperienced agency partners taking on the added burden of adverse event detection. Those were just a few of the points of contention cited by pharmacovigilance leaders, especially those in multinational companies contending with country- and region-specific regulations.

Because adverse events are not always captured in clinical trials, pharma companies use post-market safety surveillance—including medical literature, observational databases, and spontaneous reports—to detect adverse reactions that may occur as the drug is used by a broader range of patients.

These sources, however, are deficient due to potential under-reporting, lack of geographic diversity, and lapses in time between when the event occurred and when it was detected. Patient perspectives have always been an essential component of medicine safety monitoring, and social media offers an important opportunity to incorporate the patients’ voice in pharmacovigilance with greater reach and increased frequency.

The growing amount of information on social media, combined with the new intelligent capabilities of key emerging technologies, presents pharmacovigilance with enormous opportunities to collect and analyze compliance data. However, inconsistent management of brand-owned social media pages makes it far too easy to miss a potential adverse event. It also hinders pharma brand and digital teams from successfully engaging with patients online.

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THE VALUE AND THE RISK OF BEING ON SOCIAL MEDIA 

Participation on social media for pharma companies is a double-edged sword wielded by an unseen force of 4.14 billion people on social media platforms across all demographics. In the U.S., for example, smartphone use surpassed 85% percent in 2020, which means social media is with patients everywhere they go.

That means, in an increasing number of incidents, patients are liberally posting about adverse events—on blogs, forums, message boards, wikis, and podcasts, and on owned social media of pharma companies.

The Food and Drug Administration recognized this trend early on when it released a study seven years ago, Digital Drug Safety Surveillance: Monitoring Pharmaceutical Products on Twitter, which suggested that patients are “more likely to post drug-related adverse events on Twitter than report them to the FDA.”

The report noted, “Traditional adverse event reporting systems have been slow in adapting to online AE reporting from patients, relying instead on gatekeepers, such as clinicians and drug safety groups, to verify each potential event. In the meantime, increasing numbers of patients have turned to social media to share their experiences with drugs, medical devices, and vaccines.”

Unfortunately, according to our survey, these compliance solutions haven’t evolved much at all. In many cases, pharma brands still rely on internal social media teams that are also charged with launching marketing campaigns or, in some cases, they rely on interns. They might also work with external partner agencies who are talented at creating marketing campaigns, but who don’t include adverse event detection within their core competencies. This all happens while patients use social media hashtags for regulatory agencies, manufacturers, and specific products to be targeted in a very public way.

Despite the growing involvement of social media in adverse event reporting, the risks of damaging brand value or overstepping a regulatory boundary compelled the pharmaceutical industry to take a cautious approach to expand their digital marketing capabilities.

As recently as five years ago, pharma company compliance officers often advised against any involvement in social media, preferring to simplify their pharmacovigilance procedures at the expense of the social media engagement that consumers have come to expect in the digital age.

In our aforementioned recent survey, we asked pharmacovigilance leaders about the state of social media activity and how they balanced the compliance risks of online engagement with the value of insights gained by communicating with patients on their preferred social media platforms. More than half experienced a year-on-year increase in social media activity on brand-owned pages, and a majority anticipated a continued increase in that activity, raising compliance risks and making owned pages harder to manage.

One missed adverse event can create a compliance infraction, and only 14% of pharmacovigilance professionals we surveyed said they feel “completely in control” of keeping social media interactions compliant. More than half (55%) worry about how potential adverse events are detected and managed. 

ADAPTING TO THE REALITIES OF MEETING PATIENTS ONLINE 

Pharmacovigilance professionals must continuously adapt to the realities of meeting patients where they are in the social media age.

To the consternation of physicians who want to manage the expectations and worries of their patients, we are witnessing a fundamental shift in healthcare: a movement toward self-organized, online communities of patients, caregivers, clinicians, researchers, academics, and industry, often focused on a particular disease.

Patient-led sites offer support and information through moderated forums, blogs, advice, support, academic references, and a marketplace to shop for relevant products. In addition, spurred by the restrictions of the pandemic, consumers are relying on medication management apps and telemedicine and are using internet-connected devices to measure their own biometrics.

Online health communities have become a valuable source of first-hand adverse event information. Patients voluntarily share information about their health, treatments, and drug use on forums. Other platforms pool patient feedback about the efficacy of therapies, drug side effects, and disease progression.

A proactive approach to pharmacovigilance using social media data to detect adverse events can do more than meet strict regulatory compliance requirements for pharma companies, it can improve patient care and safety in relation to the use of medicines. The data also has the potential to become a critical tool for monitoring patients’ experience with medications in real-time, offering an early warning of new adverse events or providing clinical information that helps guide new drug development.

PHARMA COMPLIANCE MEANS KEEPING SOCIAL MEDIA PRESENCE SAFE 

The findings of our survey of pharmacovigilance leaders point to a clear strategy for pharma companies in a new age of social media: obtain protection from an experienced intelligence partner that understands the importance and difficulty of detecting potential adverse events on social media and the risks of harmful online content.

A trusted risk intelligence expert can help you confidently gather patient insights on social media and guarantee adverse event detection that delivers drug-specific, continually-tuned, 24/7 compliance with zero misses on potential adverse events.

The challenge of complying with the regulatory requirements for adverse event reporting is already a burden for pharmaceutical companies. Now the COVID-19 vaccines have brought added attention to the importance of reporting adverse events. 

When every development, success, and setback generate digital chatter—both welcomed and critical—pharma brands need to be in complete control of their owned social media pages. 

To do that, there are some questions to consider:

  • Have you adopted a global moderation policy?
  • Do you have consistent reporting templates in place?
  • Is there a time-stamped audit trail in the event it's needed?
  • Can you conduct quality assurance checks at random?
  • Does your social media monitoring take place 24/7?
  • Does your pharma social compliance solution also address harmful content?
  • Does it guarantee adverse events will never be missed?

If the answer is no to any one of these, an early-warning risk intelligence solution can help. It will not only detect harmful content such as falsified adverse events; it will allow pharma brands to seamlessly integrate adverse event detection with existing pharmacovigilance reporting and stay ahead of any unknown issues surfacing online.

With these safeguards in place, pharmaceutical companies no longer have to tread lightly around online engagement with consumers. Pharma brands can use social media as an integral part of pharmacovigilance to listen, interact, and communicate with consumers, building trust and their reputations along the way.

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