Patient Medication Guides and Patient Privacy Policies: Understandable or Not?

(March 10, 2019)

A recent study by researchers at the University of Victoria examined the readability of privacy policies for 300 popular web sites in England and Ireland, including the giants Google, YouTube, and Amazon. Under the new "GDPR" data privacy regulations, meant to protect consumers in Europe, web sites are required to use "clear and plain language" in their privacy agreements, and must obtain informed consent from users if they want to collect data from site visitors.

While text written at a seventh or eighth grade reading level is considered to be acceptable for a consumer audience, researchers found that the readability of the sites' lengthy and often incomprehensible privacy policies have not changed much since the implementation of GDPR in May of 2018. They found that the average privacy policy requires its readers to have more than 13 years of formal education, not eight.

How do patient medication guides, pharmacy privacy policies, and other prescription-related information meant for the consumer rate in terms of readability? We put a small sample of patient medication guides and pharmacy privacy policies to the test, using the "Flesch-Kincaid" readability assessment. This test is based on the average number of words per sentence and the average number of syllables per word, and is a proofing tool available within the Microsoft Word word processing application. On average, patient medication guides in our sample were written at a ninth grade reading level and tended to be about five pages long.

Certain types of information, such as clinical trials data on side effects, are not included in patient medication guides. For that information, the patient must turn to the official drug label, which is longer and more complex, often requiring college-level reading skills. Here are the readability results for our sample of U.S. documents:
Readability of Drug Information
Medication Guides Level Length
Abilify - bipolar 10.6 6 pages
Lexapro - depression 9.2 6 pages
Prolia - osteoporosis 7.8 4.5 pages
Tamiflu - flu 8.8 3.5 pages
Xarelto -blood thinner 9.5 5 pages
Product Labels
Tamiflu Official Label 15.6 39 pages
Lexapro Official Label 15.9 42 pages
Xarelto Official Label 14.1 59 pages
Pharmacy Privacy Policies
CVS 12.6 5.5 pages
Walgreen 11.6 3 pages
Rite Aid, with state info 15.7 14 pages
Rite Aid, basic 12.8 5 pages
Costco 13.6 7 pages
Walmart 11.2 6 pages
Note: Reading levels were calculated using Flesch-Kinkade Reading Level tool. Walmart Patient Privacy Policy includes "Patient Bill of Rights."

Sources and more reading on this topic:
- Medication guides and product labels were obtained from [email protected] database or DailyMed database, National Library of Medicine
- Pharmacy patient privacy policies were obtained from pharmacy patient inserts or pharmacy web sites.
- Study: Law in Books and Law in Action: The Readability of Privacy Policies and the GDPR by Shmuel Becher and Uri Benoliel. March 6, 2019.
- The following article, "Should online users be bound by their privacy agreements?" provides highlights of the study:

- What are medication guides and how are they different from "Consumer Medication Information?" FDA Consumer Updates