The Case for Applying Principles of Universal Design to Prescription Drug Labeling

Almost a quarter of the U.S. adult population cannot determine what time they should take a medication based on instructions printed on prescription drug labels. Taking medication at an incorrect dosage or alongside incompatible foods can lead to severe health complications. To uphold the value of non-maleficence, healthcare has an ethical obligation to improve prescription drug labels. The principles of Universal Design can be applied to more effectively communicate informational elements on prescription drug labels. Universal Design aims to create designs that can be accessed and understood by people of all abilities and characteristics. This approach would improve comprehension of the purpose of medications and their intended usages. Though Universal Design has had a significant impact on the built environment and safety in other industries, these principles have not been applied to prescription drug labeling. By proposing a prescription label modification framework that retains legally required elements while simplifying components that can be flexibly altered, intuitive use can be enhanced while reducing the risks of patient and physician communication errors. Employing Universal Design principles, prescription labels may be altered to include widely understood pictorials that describe how to take a medication, changes in physician-modifiable language, and consolidating existing elements – such as pharmacy information – to create space for patient-friendly information. Applying these principles to prescription drug labeling can address health care inequity and create a safer, more reliable drug information system for patients.

Grayson Holt – Jack, Joseph and Morton Mandel School of Applied Social Sciences – Case Western Reserve University; Jeffrey Zabinski – Psychiatry – Columbia University Irving Medical Center; Martin Calabrese – Investigation - Medicare Drug Integrity Contractor (I-MEDIC) – Qlarant Integrity Services