Patients, social media, and adverse event reporting

Andrew Tolve explores social media strategies that can help pharma firms gain real-world data to improve health outcomes—and corporate images



The beauty of social media is that it gives everyone a voice, no matter his or her health, nationality, class, culture, religious views, or political persuasion. When it comes to the pharmaceutical industry, this parity of expression has raised concerns.

For one, the FDA is yet to determine the guidelines for how pharma companies can engage with this broad array of patients and opinions in social media. Without formalized guidelines, companies worry they will be penalized at the FDA’s discretion.

Secondly, companies fear that opening themselves up to the limitless chatter of social media will create an overwhelming burden of adverse event reporting on their legal and regulatory departments. Some have labeled this latter fear a myth. A frequently cited Neilson analysis found that just four out of every 500 messages in the online healthcare discussion contain adverse event information, and just one out of 500 (or 0.2 percent) meet all of the FDA’s criteria for an AE report.

“It is not as big an issue as companies perceive it to be,” says Wendy Blackburn, executive vice president of Intouch Solutions, which monitors social media and adverse events for big pharma companies. “If you see an adverse event, report it, but at the end of the day social media hasn’t opened up the huge avalanche of adverse events that pharma feared it would.” (For more from Wendy Blackburn, see Future Pharma: A closer look at the iPad in pharma/physician relations.)

Nonetheless, legal and regulatory departments must take all possible adverse events (not just the reportable ones) seriously, which means that wading into social media is bound to increase these departments’ responsibilities. Therefore, pharma companies need to devise a structured approach to social media that limits the burden on legal and regulatory departments while unleashing the benefits of patient-centric outreach.

Monitoring the conversation

If companies want to mitigate administrative burden, the first step is to delineate sensible user policies for their sites.  Companies can create strict a priori terms of use that govern what user-generated content can consist of, which types of topics and language are permissible and which will be removed, and how the company will respond to each.

“Companies need to be very clear about establishing these terms of use,” says Kim Bercovitz, president and founder of The Research Doctor, which specializes in patient-centered market research and social media. (For more on responsibly fostering social media, see Patients’ Week 2011: Social media and the empowered patient.)

Next, companies need to establish a monitoring team that ensures that users abide by these terms of use. The team can consist of in-house employees or external agencies. Whenever any misinformation is posted to the site, the team should immediately correct it or bring it to the attention of an internal social media committee at the company, says Bercovitz.

Furthermore, the team should be adverse-event trained so that when a possible adverse event surfaces, they know what to look for and the protocol for how to process it. According to the FDA, a reportable adverse event must include an identifiable patient, an identifiable reporter, a specific drug or biologic involved in the event, and an adverse event or fatal outcome—criteria that more than 99 percent of social media complaints fail to meet.

Allison Blass, a type 1 diabetic and former social media monitor for several big pharma brands, says that of those legitimate adverse event reports that surface in social media, most fall into a discernable pattern. “There’s a finite number of complaints that anyone will have about your product,” says Blass, who recently joined DiabetesMine.com. “Companies should not shy away from these complaints. It’s a way to make a product better and respond to real patient needs.”

Return on investment

Setting up a social media monitoring team costs money, of course, as does investing in a patient-focused site. Although the return on investment is yet to be proven, there are some clear ways in which companies can profit. The first is from real-world data.

UCB has partnered with PatientsLikeMe to establish a free online community for people living with epilepsy in the US. The site is heavily monitored, not to stem the free flow of conversation but rather to learn from it and improve products in the process.

“As a patient-centered company, we are constantly seeking innovative ways to enhance and adjust our approaches to meet patient needs,” says Iris Loew-Friedrich, executive vice president and chief medical officer, UCB. “We believe this community will be a source of information that will allow us to better understand people living with epilepsy and may help us design clinical programs that incorporate real-world patient needs and experiences in a measurable way.”

“Adverse events are the best market research you can get,” seconds Blass. (For more on real-world data, see A patient-centric approach to marketing and The impact of value-based pricing on market access and patience compliance.)

Additionally, addressing complaints and adverse events can create a prevailing sense of goodwill between patients and a company, an all-too-often rare phenomenon these days. Patients may be quick to rant against pharma companies, but they’re also quick to pass along positive stories to friends and strangers when they arise.

“If you want to know where to go on your next vacation, odds are you’ll listen to your best friend before you go to a travel website,” says Blass. “It’s the same thing here. We’re always recommending what we like and what we don’t like, and in doing so we influence purchasing power.”

For more on patients and social media, see Special report: Pharma and social media and Special report: Patient's Week 2011.

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