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Managing social media in the healthcare space can be challenging and must be approached with a unique strategy by brands.  In my experience, a brand’s objectives for organic social media can run the gamut from listening and research, to marketing and engagement, to sales and CRM.  (Not all at once, thankfully.) I'm focused on achieving success in the organic space, and leveraging insights to optimize a brand's paid social spend. However, in my research on the health industry, it often seems that companies eschew interaction on social platforms, with their best case scenario avoiding any kind of pique or penalty. As such, too many paid social efforts appear unfitted based on the audience they are serving.

Somewhat inevitably, this approach leads to a disregard for several social media fundamentals – authenticity, balance, connectivity – a scheme not ideal for controlling the message. To be fair, it’s a not a universal failing, for I did come across some modestly successful provider-as-lifestyle-partner posts, and message boards with brand-as-facilitating-host.  My first impulse was to diagnose a vicious cycle where lack of resources or talent led to a subsequent deficit in results, which in turn ensured a steadfast lack of commitment, and caused the under-investment in resources.

Learning the primary root of social media anxiety in pharma

I read industry blog after industry blog, which led me to the FDA’s Guidance for Industry documents. It is clear those drafts are daunting. During a recent poll conducted at an industry event, 95% of respondents cited compliance as the root of their reluctance to participate in social media.  It was not a lack of resources, nor talent, and not a difficulty in measuring ROI.

Understanding the FDA and compliance

Knowing the reason why most companies are reluctant to add paid social as a channel, I decided to read every line and footnote in each draft guidance from May 2009 to June 2014. I read every warning letter or notice of violation stemming from digital media over the past six years. I studied the FD&C Act and the Electronic Code of Federal Regulations.  I evaluated the advertising policies for each major social platform, even though I’m not a media buyer. I absorbed Mark Senak’s white paper, FDA Communications Oversight in a Digital Era, too.  Finally, I called the FDA.

My own point of view is that exposure to warning letters, notices of violation, or adverse events occasioned by social marketing, is evidently overstated. By my calculation, since 2009, the Office of Prescription Drug Promotion at the FDA have issued only three WLs/NOVs specific to social media.  As for the reporting of adverse events, I won’t make the mistake of downplaying their function. But I will say that of the sample studies I’m aware of, on average only 3% of posts include each of the four elements required for their reporting.  That’s a low number, whichever way it’s spun. I did not discuss my views with the FDA, and the FDA was not able to answer all of my questions. However, I emerged from that conversation with clarity.

We talked about social media platforms with character space limitations (Facebook ads are character-limited).  I also asked about reminder advertisements and reminder-like ads (which you should read more about, from the Food & Drug Law Institute’s Advertising & Promotion Conference, in October 2014).

What’s the risk?

The central tenet of my theory after the research, is that there is risk associated with any communication, but the notion that social media is some kind of unnavigable domain doesn’t stand up to scrutiny.  The legal and regulatory culture is different at every organization and remaining in compliance is no easy task.  Yet when a majority of violations are for omitting (or minimizing) risk, or because of unsubstantiated claims, one wonders how the content found its way out the door?  It is possible that small firms will take more chances, but when bigger players are using self-denial as a form of discipline, neither strategy provides the means to achieve meaningful ROI from social.

The solution with social media has to be audience-first. 

There are powerful listening and analytics tools that reveal a target audience: who the audience is, what the audience wants, when they want that, and how often to deliver it.  This information forms the bones of a basic social strategy which is allied to an objective. Regardless of whether it’s Pharma/Rx, OTC, or HCP, the underlying objective is conversion. Successful conversion is best achieved by understanding the organic audience, which in turn improves paid-social creative, targeting, and performance.

For this to work at scale, I’d recommend becoming familiar with the June 2014 Guidance for Industry , the forthcoming use of links to third party sites, and understanding how a reminder or a reminder-like ad can be customized and tested, be creative but not careless.

In terms of the big picture conversation; if other industries are deploying custom contact strategies, why isn’t health?  The most enduring social relationships originate from empowering exchange.

By developing and implementing solutions for handling adverse events in social media, your company has the opportunity to leverage key information from the largest focus group in the world.

In my previous column, I discussed how social media can be viewed as a “perpetual focus group.” The sheer and ever-expanding volume of these conversations represent a virtually infinite set of data that can be transformed into valuable information. All of this information — even Adverse Events (AEs) and Product Quality Complaints (PQCs) — can provide insights that power decisions and support action.

The role of adverse events on social media

Social media, like any other media, is a source of AEs and PQCs. Given the immense volume of tweets, Facebook status updates, Instagram photos, blog posts, and conversations on forums, it is to be expected that while people are sharing their health experiences, AEs and PQCs are bound to be mentioned. These can occur either intentionally (for example, “I took Drug Rx and I woke up to a rash on my leg”) or incidentally (“I’m so grateful for the nurses who took such good care of me when I was in the hospital after my car accident. Also, Drug Rx has been working well for me.”).

Since the early days of social media, there have been two opposing schools of thought on the best ways to handle AEs on social media. One school of thought views AEs as an absolute obstacle to any pharmaceutical company getting involved in social media. The other school does not view AEs as a problem, but rather, in my opinion, projects a nonchalant attitude about the nuances of social conversations and the identification of AEs.

I am not a student of either school of thought. Based on my professional experience within clinical settings and my knowledge of drug safety, I believe the best stance is to acknowledge the challenges that AEs present while, at the same time, to develop and implement practical day-to-day solutions — systems that ensure proper identification and triaging of AEs, as well as the ability to leverage AEs for analytics and insights.

How to monitor and categorize adverse events

Fundamentally, AEs can yield useful information when monitored closely, safely, and properly. Over a period of several months, for instance, thousands of AE posts can be classified according to an objective-based process. Then, identified and triaged appropriately, these AEs can be classified into categories.

Let’s explore one example: “Drug Rx has been a life-changer for me. So far, it’s been doing what my doctor says it’s supposed to do. Occasionally, I get a little rash on my right arm, but other than that, I'm truly grateful.”

In this scenario, we have an AE (assuming we can identify the person reporting it). We also have references that can be classified. “It’s doing what my doctor says it’s supposed to do” could be classified as Effectiveness, and “a little rash” could be classified as, say, Immunity. Over time, these AEs can help companies better understand conversations. At the end of the set time period, a company may find that 50% of AEs were Immunity-related, 25% were Cardiovascular, 15% were Respiratory, and so on — providing valuable information for understanding the adverse side effects of a particular agent.

Furthermore, if these posts were also categorized by other data, such as the social media outlet, the topics discussed and the behaviors expressed, the aggregate data offers information beyond purely clinical, perhaps even helping to inform a company’s messaging or marketing strategy.

Establishing well-defined protocols for success

The above example illustrates the basic concept of leveraging social media AE data. In essence, the close monitoring and careful categorization of social media AE data can transform a seemingly complex and vast landscape into a navigable road. But that’s not to ignore the challenge of scalability. The best approach is to start small, evaluate results and evolve incrementally.

Companies need to plan for how they will monitor social media for AEs, because the greatest pitfall is missing AEs altogether and risking patient safety. Training staff in the identification of AEs and the enterprise’s triaging protocol is crucial. In my company’s training program, our agents receive training in the nuances of social media, in addition to traditional AE and PQC training, to ensure they do not miss AEs. After identification, the documentation and communication protocols need to be established and clearly understood by all team members.

The first step of merely identifying AEs can be challenging within itself, as information related to AEs or potential AEs are often ambiguous or sparse, especially due to the word or character limitations on certain social media platforms, such as Twitter. Furthermore, a company cannot publicly respond to a tweet that simply says, “My inhaler isn’t working” by asking, “What do you mean by working”? So the company is left wondering, is this an AE (lack of efficacy), a PQC (a malfunction), both an AE and a PQC, and/or an opportunity for patient education? In the inhaler example, the company could respond with, “We’re interested in learning more. Please contact us at 800-555-5555.” This is where the pharmaceutical company’s ability to interact publicly in social reaches its limit, but still presents an opportunity to demonstrate a caring, human voice, while adhering to regulations. Training must include steps for evaluating an AE and how to extract the key data.

Exploring ethical implications

Because the general principles of monitoring for AEs also apply to social media, compliance with FDA regulations is, for the most part, straightforward. Yet beyond the regulatory responsibilities of AEs, ethical issues arise. For example, it is inevitable that companies may stumble upon mentions of a competitor’s agent with a potential AE, either on their own branded properties or within the broad social media space. Companies are not required to report another company’s AEs to the FDA, but should they? Well-established processes, understood by all within a company, can help guide these and other ethical decisions.

Pharmaceutical companies are committed to patient safety, product safety, and effectiveness. By investing in and developing resources to ethically and efficiently manage AEs on social media, companies can transform the fear of these AEs into mutually beneficial results. In the long run, better understanding of all AEs — social media or otherwise — can help expand the knowledge of drug researchers, providers, and marketers; advance the industry; and improve the well-being of the patients we serve.