I don’t know how I missed this one, but thanks to the Pharma 2.0 blog and someone I follow on Twitter (sorry — I don’t remember who) for alerting me to a recently published (August 2008) EXCELLENT white paper by Nielsen Online on:

“Listening to Consumers in a Highly Regulated Environment — How Pharmaceutical Manufacturers Can Leverage Consumer-Generated Media” (registration required).

Melissa Davies (Nielsen Analyst and author of the article. Nice blog, too!) does a great job providing an overview of some fundamental issues that pharma struggles with when it comes to Social Media and UGC (user generated content). Chief among those is, of course, the issue of Adverse Event (AE) reporting, which is a key focus of this paper and is nicely called out with some great information.

She also goes on to provide many examples on how and where pharma can start with social media; all of which I completely agree with and some which are very similar to the suggestions I made in my presentation on Can Pharma Make a Business Case for Social Media.

Here are some excerpts from the whitepaper…

Any pharmaceutical company considering an entry into the social media space will naturally wonder about discussion of adverse events. Are consumers sharing information online that would indicate an adverse experience? Does social media monitoring trigger the AE reporting requirement? At this writing, there is no FDA guideline or regulation that specifically covers the content of online discussion in a way that is different from reporting AE information derived from any other source.

Current FDA guidelines give four parameters for submitting information about adverse experiences: the pharmaceutical company should have knowledge of (i) an identifiable patient; (ii) an identifiable reporter; (iii) a specific drug or biologic involved in the event; and (iv) an adverse event or fatal outcome…

In a recent Nielsen analysis of 500 healthcare-related messages posted online across multiple disease categories, Nielsen’s BuzzMetrics analysts found only one message that incorporated the information needed to meet all four of the FDA’s AE reporting requirements…

Most online discussion communities discourage the use of personally identifi able information. This is especially true within healthcare communities, where personal privacy is even more carefully guarded… In the recent analysis of 500 messages, Nielsen’s BuzzMetrics analysts found that 56 messages (11%) contained identifying information that could be used to reach out to an individual to follow up on a possible AE report…

It is clear that a pharmaceutical company that aggressively monitors social media may pick up the occasional AE within patient/caregiver online discussion. Nielsen Online’s experience is that this happens very rarely, with a volume that is entirely manageable within companies’ broader AE monitoring programs.

Source: Nielsen Online Healthcare Whitepaper (2008)

After the discussion on regulatory concerns and AE reporting, Davies goes on to present some great suggestions for “The Benefits of Listening” and some great ideas for “Getting Started”. Here are some of the subject headers for those ideas…

Listen to the Conversation

• Head online to a discussion board and start reading
• Conduct an online search on the brand
• Visit Wikipedia and see what information has been posted about the brand
• Check for consumer-created videos about the brand

Facilitate the Conversation

• Go where the audience is
• Provide materials that will help patients better understand their condition and its treatment
• Share condition information or how-to’s for treatment
• Incorporate the voices of actual patients through personal stories on the brand site
• Allow and encourage patients to link to these resources from other sites

Join the Conversation

• Consider starting a blog
• Appoint someone from the brand team to take an active role in online discussion

As you can see, many of these concepts/ideas are similar to what I presented in my slides as well, which is really great, since it shows that we are in agreement and share the same vision for where Pharma needs to head with Social Media.

Well, this one is definitely getting filed as a MUST READ. Great article, Melissa Davies!!! Looking forward to seeing more Social Media in Pharma articles.