Adverse Event reporting and social media listening

In Blog Posts By Greg Rice, VP, Strategy - HCP

Adverse Event reporting and social media listening

This topic has seemingly been talked to death, but surprisingly there is little discussion about actual findings in the field from actual listening engagements. The problem with a lot of the discussion is that it is based on studies devised by companies that stand to profit from pharma companies pursuing social media listening. (Yes, Klick is in the same boat, but I’ll ask you to “suspend disbelief” until the end of the post and then you can decide whether we’re being accurate or not.)

The current studies

The granddaddy of all AE / SM reports is the Nielsen report: Listening to Consumers in a Highly Regulated Environment – How Pharmaceutical Manufacturers Can Leverage Consumer-Generated Media. This report, from 2009, is the one most cited with the number of 1 in 500 posts hold an FDA-recognized adverse event.

Jonathan Richman of Dose of Digital fame wrote a follow-up post that dug a bit deeper and estimated that, for all drugs across the industry, there are 166 AEs posted on social media channels. Remember, that’s for the entire industry … worldwide.

Just recently, Visible released its report on Adverse Events. This one is much more balanced in that it discusses the reports that your PV department will want to know about as well as those that contain the four elements required for reporting. Note that every PV department I’ve run across only requires two of the four elements, namely:

  • An adverse event that could possibly be tied to a drug, and
  • The name of a branded drug marketed by the company

Some highlights from this report:

  • Of social posts that were filtered to specifically look for AE terms
  • 3.3% of posts contain an adverse event description
  • 14% of those posts contained the four criteria necessary for official AE status

Our recent study

Finally, our own experience “in the wild” on multiple projects has produced in-house expertise on AE reporting. In a recent listening engagement for an oncology drug we found something on the order of 2% of all posts were reportable internally to the PV group. Because of the nature of the cancer and treatment this was not unexpected and the PV group was ready for the influx.

The main problem on the project was not reporting the AEs, that went smoothly. No, the main issue was ensuring that everyone on the team was aligned and sensitive to what was reportable. It can be easy to miss an AE when reading 100′s of posts a day if you don’t stay vigilant. We instituted a two-layer approach with a second analyst spot-checking the first analyst’s review of the source data. This alerted us when a segment of data needed to be reviewed.

So, when planning a listening engagement, follow these steps to keep the excitement to a minimum:

  • Include PV at the very first meetings about the project
  • Review the company’s AE reporting guidelines or education
  • Create a spreadsheet to report AEs to the PV group
  • Have a redundant process to ensure quality
  • Learn constantly and don’t shy away from changing process if necessary

 

Greg Rice, VP, Strategy - HCP

Greg has a proven track record in the planning and execution of more than 20 pharma and medical device brand launches on both client and agency side. He started as a pharmacist, then moved to Eli Lilly, positions included CME Management, Brand Marketing, and New Product Planning and finally a country Managing Director at Euro RSCG Life.
  • http://www.visibletechnologies.com Jackie Kmetz

    Great post and interesting info about your experience with reporting and the oncology drug specifically. We’ve been asked to do some followup research for a few drug types including oncology drugs where there is a known higher rate of AERs. We are looking to do a supplemental report covering that in the next few months.

    Your point about the “main issue was ensuring that everyone on the team was aligned and sensitive to what was reportable” is a very critical one to making sure a program dealing with social content works smoothly. In working with a number of pharma companies and consultants and discussing social media and the pharma industry, the next challenge on everyone’s plate is getting some better guidance from the FDA on where the level of responsibility is (and liability for that matter) as far as getting involved. By that I mean correcting misinformation, disclaimers, what can be said, not said, etc.

    Personally, I’ve been very impressed by the high standards that pharma’s have held themselves to in monitoring and engaging with social media to date and look forward to hopefully seeing some guidance come down to make it easier for the industry to participate in this rich consumer channel that is social media.