Evaluation of the Hazards due to the Misunderstanding of Patient Medication Information Sheets

Abstract

The U.S. Food and Drug Administration (FDA) mandates that all pharmacies provide customers with patient medication instruction (PMI) when distributing new prescription drugs. The information sheets describe instructions on proper usage and possible hazardous effects of the drug. The PMI is recommended to be written at a 6^th grade reading level. Previous research has shown that the material found on patient medication instructions is written above the 6^th grade reading level and that comprehension is directly correlated with reading and education levels. This study builds on previous work by showing that error rates, even among participants with college level reading skills, remains unacceptably high and that error rates are highest when the misunderstanding of an instruction is likely to cause greater harm.