A New Prescription for Patient Information

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 specific information you need. You’d think we’d be more concerned about our own health (and read more about it) than we are for our cars or TVs,… but I doubt it.

What could be done to make this information easier to read, and more likely to be read?

Focusing on patient information and with the understanding that the FDA would need to amend its regulations…

1. Change the Location of the Patient Information Section and Bring it all to One Side
Notice that with the full sheet unfolded, the Patient Information section is located on the right-hand edge of the page (see the red highlight in Image 3. below) and then continues onto the back side. Since English reads from left to right, this could easily get skipped. So, a simple change would be to move the Patient Information to the left-hand side of the sheet and bring the rest of the Patient Information (currently on the back) onto the same side, placed in the second column. I suspect the right-hand placement had something to do with how the manufacturers imagined people would unfold the document so the Patient Information would be prominent after some (but not all) of the unfolding. But I think it more likely that people would unfold the entire sheet first before reading any of it, and I see no reason why “unfolding prominence” couldn’t be maintained with a left-hand placement. (In fact, I tried it and of course the sheet can be folded so that the left-hand column is the first portion to be seen when the sheet is unfolded.)

Image 3. First half of Patient Information highlighted.

2. Split the Prescribing Information and the Patient Information into Two Documents
This is not as radical a suggestion as it might seem. As the close-up of the sheet shows (Image 4. below) the manufacturer actually wants patients to create two documents by separating the Patient Information from the Prescribing Information. Notice the dashed line and the scissors icon.

Image 4. Close-up of sheet cutting suggestion.

But the difference between suggesting that patients separate the documents and providing them already separated is probably great, in terms of whether the Patient Information will actually be read. It’s hard to imagine many people actually cutting the sheet apart. But it’s less hard to imagine that when presented with two physically separate documents, one less than a quarter as long as the other and printed with a larger type face, the shorter document would be the one more likely read.

3. Put the Information on the FDA Website
For some reason, all these information sheets can be found on the various manufacturers’ websites, but not on the FDA’s site itself. Thinking again about likely patient behavior, I’ll bet most patients throw away the information sheet and will only later search for it online when some question arises about an adverse reaction or whether the drug can be taken with some other medication. Rather than search for the manufacturer’s site, wouldn’t it be easier if these information sheets were in one place, prominently located on the FDA’s own site?

4. Require the Manufacturer to Place its Website URL on both the Bottle and the Information Sheet
The rosuvastatin shown in Image 1. was manufactured by a company called Biocon. Its website address is not on the information sheet or anywhere on the bottle. It should be. And as far as I can see, company URLs do not appear on bottles of Crestor or other manufacturers of rosuvastatin, nor on their information sheets either. Again, it should be.

5. Study/Invest in Human Behavior Research
Nowhere in the FDA’s CFR specifications does it say that information sheets should be devoid of design, but to look at this one you’d think the intent was to discourage reading by making it difficult to read and actually somewhat off-putting. Drug manufacturers, or possibly an industry group like PhRMA, should study the literature and do their own research to determine what design elements make such sheets (a) likely to be read, (b) likely to be understood, and perhaps most importantly, (c) likely to be followed. Given the roughly $19 million cost of clinical trials for every new drug, a study of this sort would easily be affordable. [ 4 ]

Some beneficial changes would cost nothing. For example, we know that documents that are text-heavy and use small-sized fonts are more easily read when the typeface is a serif font, instead of the Frutiger-like font used here for rosuvastatin. (The serif “legs” of the letters are subconsciously read as if the words were typed on a line, allowing the eye to more easily move forward in reading.) Other no-cost suggestions would be to look at the optimal kerning and line spacing for a font of a specific point size, determine if more than two levels of headers are helpful, and introduce icons to guide patients to different kinds of information.

Other changes might cost minimally more. For example, use a combination of paper and ink that doesn’t bleed through to the other side. (Look again at Image 4. above.) Or use color in an instructive way (e.g., green for dos like “Tell your doctor if you have unexplained muscle aches or weakness,” and red for don’ts like “Do not change your dose or stop taking rosuvastatin tablets without talking to your doctor.”)

And do the focus groups, surveys, and tests to see what combination of these (and other) changes is most effective in making this information actually informative.

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Notes

[ 1 ] The sheet contains 13,877 words. The Constitution, including signatures and states but not amendments, is 4,609 words long. The Declaration of Independence, again, including signatures and states, is 1,480 words. The front page of the January 10, 2022 New York Times contained 1862 words. You can see the sheet’s text here: https://medicalinformation.astrazeneca-us.com/home/prescribing-information/crestor-pi.html, The Constitution here: https://www.archives.gov/founding-docs/constitution-transcript, The Declaration of Independence here: https://www.archives.gov/founding-docs/declaration-transcript, and The New York Times here: https://static01.nyt.com/images/2022/01/10/nytfrontpage/scan.pdf .

[ 2 ]  https://clincalc.com/DrugStats/Drugs/Rosuvastatin

[ 3 ] The last time these regulations were revised was December 4, 2014. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=201.56&SearchTerm=patient%20information

[ 4 ] “Clinical trials that support FDA approvals of new drugs have a median cost of $19 million, according to a new study by a team including researchers from Johns Hopkins Bloomberg School of Public Health. … The $19 million median figure represents less than one percent of the average total cost of developing a new drug, which in recent years has been estimated at between $2 to $3 billion.”
https://publichealth.jhu.edu/2018/cost-of-clinical-trials-for-new-drug-FDA-approval-are-fraction-of-total-tab