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