To err is human: patient misinterpretations of prescription drug label instructions.
OBJECTIVE
To examine the nature and cause of patients' misunderstanding common dosage instructions on prescription drug container labels.


METHODS
In-person cognitive interviews including a literacy assessment were conducted among 395 patients at one of three primary care clinics in Shreveport, Louisiana, Jackson, Michigan and Chicago, Illinois. Patients were asked to read and demonstrate understanding of dosage instructions for five common prescription medications. Correct understanding was determined by a panel of blinded physician raters reviewing patient verbatim responses. Qualitative methods were employed to code incorrect responses and generate themes regarding causes for misunderstanding.


RESULTS
Rates of misunderstanding for the five dosage instructions ranged from 8 to 33%. Patients with low literacy had higher rates of misunderstanding compared to those with marginal or adequate literacy (63% versus 51% versus 38%, p<0.001). The 374 (19%) incorrect responses were qualitatively reviewed. Six themes were derived to describe the common causes for misunderstanding: label language, complexity of instructions, implicit versus explicit dosage intervals, presence of distractors, label familiarity, and attentiveness to label instructions.


CONCLUSIONS
Misunderstanding dosage instructions on prescription drug labels is common. While limited literacy is associated with misunderstanding, the instructions themselves are awkwardly phrased, vague, and unnecessarily difficult.


CONCLUSIONS
Prescription drug labels should use explicit dosing intervals, clear and simple language, within a patient-friendly label format. Health literacy and cognitive factors research should be consulted.
Wolf
Michael S
MS
Health Literacy and Learning Program, Institute for Healthcare Studies, Division of Internal Medicine, Northwestern University, Chicago, IL 60611, USA. mswolf@northwestern.edu
Davis
Terry C
TC
Shrank
William
W
Rapp
David N
DN
Bass
Pat F
PF
Connor
Ulla M
UM
Clayman
Marla
M
Parker
Ruth M
RM
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001288:Attention; D001294:Attitude to Health; D015984:Causality; D002641:Chicago; D032882:Comprehension; D004334:Drug Administration Schedule; D004348:Drug Labeling / Q000379:methods* / Q000592:standards; D011307:Drug Prescriptions; D004522:Educational Status; D005260:Female; D006801:Humans; D008145:Louisiana; D008297:Male; D008508:Medication Errors / Q000379:methods / Q000517:prevention & control* / Q000523:psychology; D008824:Michigan; D008875:Middle Aged; D010353:Patient Education as Topic / Q000379:methods* / Q000592:standards; D036301:Qualitative Research; D012660:Semantics; D016037:Single-Blind Method; D011795:Surveys and Questionnaires