Prescriptions

Jakob Nielson notes this urgent usability upgrade in his January 23, 2006 email newsletter:

“Kudos to the U.S. Food and Drug Administration for a rare example of a government agency employing usability guidelines to save lives. The FDA has changed the rules for the “prescribing information” which is the leaflet that goes into medication packages. Now, the leaflets will place the information that patients and doctors need first, in a highlights section. Not exactly a new idea in usability, but in the past, these leaflets were dominated by useless warnings that served no practical use for the vast majority of readers; the first several pages of stuff didn’t do any good except act as a defense against predatory trial lawyers.

The new FDA rules state that, ‘Overwarning, just like underwarning, can similarly have a negative effect on patient safety.’ Exactly: if you bury useful info in masses of useless info, then users won’t see the truly important warnings.

Poor usability of drug information = dead patients.

The FDA has finally recognized the need to save lives by fighting back against the lawyers and writing drug info for users instead of courts. The new regulations explicitly prohibit several types of law suits where trial lawyers have harassed the medical system into making the prescribing information harder to understand.”

The rule had been under consideration by the FDA for more than five years — and is the first major change to drug labels in 25 years! For a more information, see the FDA press release or the NY Times article, New Drug Label Rule Is Intended to Reduce Medical Errors. New rules also affect drug advertising on TV and in print.