“Shows you — sooner or later you must answer for every good deed.” – Calvera (Eli Wallach), “The Magnificent Seven”
DURHAM, N.C. – Reading through Quintiles’ announcement Wednesday about its free mobile “app” to provide medical and health alerts as well as warnings about not mixing certain medications, the unforgettable, gritty, tough image of Calvera the silver-toothed bandit from “The Magnificent Seven” popped into The Skinny’s scattered brain.
Make a mistake and – boom – Quintiles (NYSE: Q) gets sued.
Quintiles is obviously proud of the site.
“We’ve received a number of anecdotes from registered MediGuard users who have told us MediGuard has literally saved their lives (reporting dangerous drug interactions) and one user who told us that she believes drug interactions were causing her to miscarry repeatedly,” Phil Bridges, director of corporate communications for Quntiles, says. “Once she began using MediGuard and addressed her pharmaceuticals issues, she was able to bring a child to term.”
That’s good news, but let’s face facts.
No matter the good intent of Quintiles’ free MediGuard website used by some 2.6 million people and the new app, can you imagine the money that lawyers would seek if a client became dependent on the alerts and missed one through some glitch? Or what if some notification about not mixing medications is inaccurate?
Nope – not when Quintiles is the world’s largest life science services firm and presents a lucrative ($$$$$) target.
It’s obvious that the company takes the quality of information provided through MediGuard quite seriously – from staff that monitors information 24 hours a day to working closely with the FDA.
Quintiles replied quickly and thoroughly to a series of questions:
In such a litigation-filled environment these days, how is Quntiles protecting itself from potential lawsuits should each of the following “alerts” lead to an incident of some kind:
- What if an alert about interactions is incorrect and a patient avoids using a medication leading to complications?
MediGuard alert information comes from communications published by the Food and Drug Administration (FDA) and pharmaceutical manufacturers. We’re confident in the data which originates from the FDA and manufacturers are obligated to provide accurate information as well, with all concerned working in the interest of patient safety.
- What if a patient becomes reliant on the alerts to take medications and for some reason does not receive an alert through a glitch of some sort?
Patients can elect to receive their alerts via email and also messages within the new mobile app, if they add the mobile option, so they are able to rely upon multiple sources.
- What if patient information made available through an app is compromised and data is exposed?
We never share personalized data with anyone. Personal data is stored in a secure, de-identified database. For us, “de-identified” means that personalized health information is never associated with identifiable individuals.
- What if Quintiles does not provide a safety alert or recall information in a timely fashion?
We have a 24 hour system in place that monitors relevant websites and media outlets to identify these communications about medication safety issues. The alternative, for non-MediGuard users, is no warnings or alerts at all.
- What if potential side effect information is inaccurate or incomplete?
We are confident that our approach is rigorous and extensive. Quintiles maintains a team of pharmacists which works on this. For the U.S., Quintiles’ MediGuard alert information comes from communications published by the Food and Drug Administration (FDA) and pharmaceutical manufacturers. We have a 24 hour system in place that monitors relevant websites and media outlets to identify these communications about medication safety issues. Our medical team reviews the communications highlighted by our monitoring system and will select the alerts to be written and sent to MediGuard members.
The FDA, manufacturers, and the medical literature are our primary sources for safety alert information. We will contact manufacturers directly to confirm news stories about recalled products if we can’t find an official press release from the company or the FDA.
In the other countries we support, it’s the same process, except we source from the medicine regulatory agency in for that country.
[QUINTILES ARCHIVE: Check out more than a decade of Quintiles stories as reported in WRALTechWire.]