Anyone who has tried reading a drug label knows how difficult it is to understand. It is especially difficult for consumers and patients to understand and evaluate the potential risks associated with the use of Rx drugs.

A new study in the September 10 issue of the Archives of Internal Medicine found multiple problems with drug labels. The authors suggest that one way to improve readability and patient understanding of labels is for FDA to initiate a national standard for their format and content — much like it did with the “Nutrition Facts” labels required on food packaging.

In fact, the FDA recently invited food companies, trade groups, watchdog organizations, medical experts and its overseas counterparts to share how front-label symbols, like the “traffic light” system used in Britain, can improve public health. Shouldn’t the FDA champion a similar system to rate risks on drug labels?

It may be a cold day in Hell before the FDA gets around to even suggesting such a system for Rx drug labels (see “FDA Considers Color Code for Food Labels, But Not for Drug Labels“).

Thankfully, however, the private sector is jumping in to fill the void!

iGuard, an organization initially funded by Quintiles Transnational, a contract research organization that manages clinical trials for drug companies, has developed a color-coded drug risk rating system (see image at left; click to enlarge).

iGuard’s Risk Rating system assigns color-coded risk labels to drugs to communicate the risk of developing serious side effects. This system is not intended for drug labels, however. It is an online solution that patients can customize for their own use depending on the drugs they are taking.

Dr. Hugo Stephenson, Founder and President of iGuard and the person responsible for the overall vision of the iGuard service and business, will be my guest next week on my weekly Pharma Marketing Talk LIVE podcast:

I invite you to listen in to my conversation with Dr. Hugo Stephenson at next Thursday’s
Pharma Marketing Talk Podcast
(listen live or the the audio archive here):

An Innovative System for Communicating Drug Risks to Patients
A Color-coded Risk Rating System That Delivers Personal Safety Alerts
Airs LIVE, Thursday, September 20, at 2 PM Eastern US time.
See more information here.


Before the show, I’d like to get comments and questions from readers that I can convey to Dr. Stephenson during my conversation with him. You can submit your comments here on this blog, or you can participate in the discussion thread I have set up over at the Forums at Pharma Marketing Network. Hope to see you there!

Here are some comments I have already received to my previous post on the topic of color-coded drug risk labels:

The Continuity Police said…

The issue that I see with your traffic light system for pharma is that there is no constant for a given chemical’s safety within a particular person’s extant chemistry. Which is to say, there are few to no ‘green light’ across the board cases.

Just as a quick example, I imagine that Aspirin might rate a green light – only my wife is allergic and that green light med would cause her great consternation or even grave illness. Similarly many medications are reactive, produce compound effects within the body, or otherwise alter the chemistry of a body in ways that are more complex than any green-yellow-red system could convey accurately.

I see that the idea is to help people understand risk better, but I think the method you posit introduces risk of a far mroe insidious variety. Better to just promote literacy and ask that people try to – you know – pay attention to what they put in their bodies. Try asking a doctor or reading a book, it’s much more informative than a misleading EZ-chart.

Cary said…

I think it is a great idea, and like you said, Obviously, if consumers need help understanding food labels, they need much more help understanding drug labels.

The previous commenter made the point that “no constant for a given chemical’s safety within a particular person’s extant chemistry. Which is to say, there are few to no ‘green light’ across the board cases.” -This is true, but is just a general guideline much like the system the FDA has implemented for food labels. It is a warning that would alert users in which a large group who has suffered adverse events. It may or may not affect or pertain to the individual, but it will at least urge them to ask there doctor and investigate the matter.