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White Paper
​Engage with Confidence: Managing Online Adverse Event Reporting
​Ensuring digital engagement between healthcare companies and their consumers aligns with regulatory requirements
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  • Engage with Confidence Managing Online Adverse Event Reporting
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The healthcare industry, and, specifically, consumer health companies, are waking up to the enormous potential offered by social media and other online data sources to make better informed decisions around brand, product development and commercialization, but these opportunities don’t come without a degree of risk.

FINDING THE HEALTHCARE INDUSTRY’S NEEDLE IN THE ELECTRONIC HAYSTACK

The mention of adverse events through online chatting by consumers on social media could be causing healthcare executives to have sleepless nights. However, the phenomenon actually pre-dates the Facebook generation by some time.

“Adverse events have been reported by people on the internet ever since there were chat rooms or an ability to post online,” says Joy Liu, a partner at law firm Ropes & Gray, suggesting the issue first reared its head in the early 1990s.

So how big is this problem for the consumer health industry? Initially, the regulatory risk from direct twoway online dialogue was clear. “There was recognition that if consumer health companies let people leave comments on one of their pages, the company, having viewed these comments, would therefore be obliged to respond and take action,” elaborates Liu, resulting in early online consumer healthcare-related activities being mostly didactic one-way communication.

As the digital space has evolved, healthcare gradually ventured further into online dialogue, with forums and Facebook pages offering an opportunity to build connectivity with healthcare professionals and consumers. In 2011, however, companies could no longer “turn off” comments in their Facebook pages, leading companies to withdraw from the channel completely. Slowly and uncertainly they have returned, but it is to an environment where the reporting of online adverse effects is not straightforward. The challenges in managing adverse events tracking within social media remain, despite guidance published in 2014 by:

  • The FDA on “Fulfilling regulatory requirements for post-marketing submissions of interactive promotional media”
  • The AESGP to “promote self-regulatory mechanisms to ensure appropriate and effective monitoring and implementation”

Recognizing that the industry faces a number of difficulties around taking a responsible and compliant approach towards tracking online adverse events, Siva Nadarajah, General Manager, Nexxus Social at IQVIA, started working to identify solutions to two main challenges.

Firstly, the high volume of comments from online channels potentially makes screening and tracking of adverse events difficult.

Secondly, adverse events from such unstructured data sources are not always obvious, with Nadarajah highlighting that “identifying these adverse events and a lack of clarity on those cases where you cannot identify the consumer” can cause problems.

It is something the regulators are grappling with, too. Whilst the easy answer might be to simply apply existing adverse event reporting guidelines to online activities, in practice this is ambiguous.

For example, guidelines from the U.S regulators state that four criteria must be met for a reportable adverse event:

  1. An identifiable consumer
  2. An identifiable reporter
  3. A suspect product
  4. An adverse experience or fatal outcome suspected to be due to the product consumed

In reality, only some of these criteria may be met with online comments. For example, an anonymous forum poster would not fulfil criteria (1) or (2), even with a clearly reported side effect and product. Some companies take a proactive stance and actively seek the missing information but data protection can be an issue here. “If a consumer has purposefully commented from a closed profile we have to be careful not to infringe privacy,” says Nadarajah. As a result, Liu notes that healthcare companies prefer to manage these issues offline and “would much rather have someone call the hotline so that the person answering the phone can ask them all the relevant questions.”

After years of waiting for the FDA to provide some clarity on the subject, the recent draft guidance is helpful in that it says that companies are only responsible for the content that they produce or sponsor on behalf of their brands. However, this doesn’t resolve the issue of how to run effective and compliant post-marketing surveillance activities on the online content they are responsible for.


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