A New Prescription for Patient Information

Image 1. Rosuvastatin with information sheet attached.

This is a bottle of the prescription cholesterol-lowering drug rosuvastatin (generic Crestor) as delivered by a pharmacy, highlighting the Prescribing Information and Patient Information sheet glued to the lid.

When detached and unfolded (see Image 2. below), that sheet is 28" x 19.5" or 7.5 square feet (front and back) and contains nearly 14,000 words. For comparison, that’s three times longer than the U.S. Constitution, nine times longer that the Declaration of Independence. Or, put another way, reading this sheet in its entirety would be like reading every word on 7 ½ pages of The New York Times. [ 1 ]

Image 2. The sheet, unfolded and shown front and back.

From a communications viewpoint, that makes no sense.

In 2019 there were 27, 041,319 prescriptions written for rosuvastatin. [ 2 ] How many of those 27 million patients do you think read all (or even part) of that information? How many prescribing physicians do you think read it? For that matter, how many of the millions more patients and physicians read similar sheets for all the other medications prescribed each year?

Typically, when companies over-communicate like this it’s because lawyers are trying to limit the firm’s liability. But in the U.S., this excruciating level of detail is required by the Food and Drug Administration, as spelled out in the Code of Federal Regulations (CFR), Title 21, Volume 4, Part 201. [ 3 ] You can map section headings, precise wording, numbering, etc. directly between the Code and the sheet.

None of this is to say that this information isn’t important and shouldn’t be available to the public; it most certainly should. But how effective is this format in actually communicating to patients and physicians?

Think of your own behavior when presented with a long and complicated document. Do you read your new car’s manual cover-to-cover before driving off the lot? Do you read the entire instruction manual when your new TV is installed? Probably not. Odds are that you don’t even read a few opening paragraphs to get the gist of it. Instead, you look for a Quick Start page or wait until you run into a problem or question before looking through the index for the…