Standardized Labels to Improve Low Health Literacy

Low health literacy contributes to medication errors, noncompliance, low quality of life, and poor health outcomes. With an aging population on a never-ending stream of prescription and over-the-counter medications, the risk of confusion and misunderstanding of drug regimens is substantial. A new study published in Archives of Internal Medicine reports that most patients cannot even organize their own medications in an efficient way, let alone understand them.

The study included almost 500 adults, aged 55 to 74 years, receiving primary care at facilities or academic medical centers in Chicago. Researchers presented the participants with a hypothetical prescription regimen of 7 drugs. The participants were asked how they would take the medications in a 24-hour period. (The regimen was designed to be divided into 4 dosing periods per day.)

The average number of dosing periods organized by the participants was 6, with a range of 3 to 14 times. Nearly one-third of the patients divided the medications into 7 dosing periods. Only 15% reported 4 dosing periods per day.

Low health literacy contributed to the results, with patients misunderstanding that some of the medications had the same instructions, but were presented with slightly different wording. For example, 31% of patients did not take two drugs with identical dosing instructions at the same time. More than three-quarters of patients did not consolidate medications that were ordered to be taken “every 12 hours” and “twice daily.”

There are many steps in the prescription-dispensing process, and, thus, many places for misinterpretation or errors to occur. Though not a mistake, per se, a different interpretation of a time interval or word choice when preparing a prescription label may cause unnecessary confusion to the patient and lead to noncompliance or poor health outcomes. To combat these types of issues, the Agency for Healthcare Research and Quality has proposed universal medication labeling standards that call for a more patient-centered approach to prescription labels. The standards would include features like writing out explicit time intervals, using numeric characters for dosing and frequency designations, and providing visual aids for increased patient understanding.

Several studies have examined the effects of standardized, patient-centered medication labels, and have reported positive results. In one study of 500 adults given medication labels that included easy-to-understand labeling and icons, patients reported an increased understanding of their medication regimen. The same group of adults reported an increased understanding of warning labels when they were presented in a similar format.

Ideally, all patients will understand why they are on certain medications, and understand how to take them safely. But, this is not always the case. There are many barriers to health literacy, including language, culture, education levels or physical disabilities. But, one of the most obtrusive barriers to health literacy is apathy on the part of physicians and pharmacists. Time constraints and staffing issues are blamed for a lack of time to appropriately counsel patients when medications are prescribed by physicians and dispensed by pharmacists. But, if these health professionals had the patient’s best interest at heart, they would take the time to make sure patients are comfortable with their medication regimens.

Could a nice, neat, standardized label help some patients better organize their medications? Probably. Could healthcare providers do a better job of educating patients? Most definitely. Pharmacists should not rely on a cute color-coded system or a fancy label with bold icons to do their job for them. Pharmacists relinquish this responsibility every day when patients sign away their right to be counseled by a pharmacist when they pick up a prescription. Most patients think they are signing that they received the prescription, but pharmacists are not even educating their patients enough to let them know that they are allowed to ask questions.

No physician or pharmacist should be comfortable with a patient receiving a prescription that he or she does not fully understand or know how to take. If that means sitting down with an elderly woman to help her organize her daily medications, or explaining to a man why he has been prescribed a new blood pressure medicine, or describing to a mother the best way to administer a medication to her child, then that is what a responsible healthcare provider should do. A standardized label might make this job easier, but it should not replace the job entirely.

Advise patients to ask questions and learn about their medication from appropriate sources. Because, if healthcare providers do not provide the answers, friends, family, television, and the internet will. Educated and empowered patients will lead to increased health outcomes and an overall increased quality of healthcare.


Macabasco-O’Connell A, Dewalt DA, Broucksou KA, Hawk V, Baker DW, Schillinger D, Ruo B, Bibbins-Domingo K, Holmes GM, Erman B, Weinberger M, & Pignone M (2011). Relationship Between Literacy, Knowledge, Self-Care Behaviors, and Heart Failure-Related Quality of Life Among Patients With Heart Failure. Journal of general internal medicine PMID: 21369770

Osborn CY, Paasche-Orlow MK, Bailey SC, & Wolf MS (2011). The mechanisms linking health literacy to behavior and health status. American journal of health behavior, 35 (1), 118-28 PMID: 20950164

Wolf MS, Curtis LM, Waite K, Bailey SC, Hedlund LA, Davis TC, Shrank WH, Parker RM, & Wood AJ (2011). Helping patients simplify and safely use complex prescription regimens. Archives of internal medicine, 171 (4), 300-5 PMID: 21357804

Wolf MS, Davis TC, Bass PF, Curtis LM, Lindquist LA, Webb JA, Bocchini MV, Bailey SC, & Parker RM (2010). Improving prescription drug warnings to promote patient comprehension. Archives of internal medicine, 170 (1), 50-6 PMID: 20065199

Wolf MS, Davis TC, Curtis LM, Webb JA, Bailey SC, Shrank WH, Lindquist L, Ruo B, Bocchini MV, Parker RM, & Wood AJ (2011). Effect of standardized, patient-centered label instructions to improve comprehension of prescription drug use. Medical care, 49 (1), 96-100 PMID: 21150800

Jennifer Gibson, PharmD

Jennifer Gibson, PharmD, is a practicing clinical pharmacist and medical writer/editor with experience in researching and preparing scientific publications, developing public relations materials, creating educational resources and presentations, and editing technical manuscripts. She is the owner of Excalibur Scientific, LLC.
See All Posts By The Author