Take it seriously, human
Over 100,000 Americans die each year from adverse drug reactions. So reporting adverse events (“AEs”) can be deadly serious. If you are managing an influencer campaign that can have comments, you absolutely must report AEs. You’ll be required to monitor and report them by the pharma; but should feel compelled to help your fellow members of the human race.
What exactly are Adverse Events?
“My hubby is diabetic and took this (drug for high cholesterol). A week later his blood glucose level is more stable than ever!”
The above is an example of a reportable AE, believe it or not! But the FDA’s definition is deceptively simplistic: “An adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.”
It’s simplistic because in practice, AEs are far more nuanced. To summarize, there are four types:
1. Life threatening
2. Serious
3. Suspected
4. Unsuspected
No need to get into each of these beyond their labels but know they are deep with nuance and a good deal of subjectivity. The most typical AEs resemble the following:
“I lost a bunch of hair 3 months after starting (drug).”
“My daughter felt dizzy and horrible just after taking (drug).”
The usual answer from pharma risk managers is this: “if you think it may be an AE, report it.” Head over to the FDA for a full definition if you’d like to read up on each of them.
RELATED: TO BRAND OR UNBRAND INFLUENCER CAMPAIGNS FOR PHARMA?
The big “no-no”
Depending on the pharma who owns the prescription drug you’ll either have to report it to them or directly to the FDA, which has an online submission process. If you happen to be external to the pharma you’ll need to go through fairly extensive training on AEs and how to report them.
In most all cases, AEs must be reported within 24 hours. Most pharmas will require you to check comments more than once per day, so you’ll really want a solid partner or platform.
The one big no-no is deleting the comment, or asking the influencer to delete it, after it may have been seen by the audience. And no, you can’t easily get away with it! Pharmas will have the option to audit comments you’ve collected and will compare them to what they see online.
Nike said it right
Just do it. If you have the means, leverage a platform like Mattr’s, which provides comments and will alert you if keywords are found. If you don’t have a solid platform, you’ll be doing it manually, which means you’ll have to convince the pharma you have the manpower. You’ll have to download all of them, too.
Adverse events and reactions are such a serious matter. Monitor and report even if you don’t think the pharma is looking closely – a fellow human might thank you for saving their life.