What’s in a label? An exploratory study of patient-centered drug instructions

• Published in: European journal of clinical pharmacology Vol. 68; no. 5; pp. 777 - 782
• Main Authors: Sahm, Laura J., Wolf, M. S., Curtis, L. M., Behan, R., Brennan, M., Gallwey, H., Mc Carthy, S.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer-Verlag 01.05.2012; Springer; Springer Nature B.V
• Subjects: Adult; Age Factors; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Cross-Sectional Studies; Descriptive labeling; Drug Administration Schedule; Drug Labeling; Epidemiology; Female; Health Literacy; Hospitals, Teaching; Humans; Ireland; Male; Medical sciences; Medication Adherence; Outpatient Clinics, Hospital; Patient education; Patient Education as Topic - methods; Pharmacoepidemiology and Prescription; Pharmacology; Pharmacology. Drug treatments; Pharmacology/Toxicology; Precision Medicine; Prescription drugs; Prescription Drugs - administration & dosage; Urban Health; Ireland; Drugs; Health literacy; Pharmaceutical care; Communication; Patient centred care; Human; Drug; Health; Instruction
• ISSN: 0031-6970; 1432-1041
• DOI: 10.1007/s00228-011-1169-2

Objective To assess the efficacy of patient-centered label (PCL) instructions on the knowledge and comprehension of prescription drug use compared to standard instructions. Methods A total of 94 participants recruited from an outpatient clinic in Ireland were each randomly assigned to receive: (1) standard prescription instructions written as times per day (usual care), (2) PCL instructions that specify explicit timing with standard intervals (morning, noon, evening, bedtime) or with mealtime anchors (both PCL), or (3) PCL instructions with a graphic aid to visually depict dose and timing of the medication (PCL + Graphic). The outcome was correct interpretation of the instructions. Results PCL instructions were more likely to be correctly interpreted than the standard instructions [adjusted relative risk (RR) 1.08, 95% confidence interval (CI) 0.98–1.18]. The inclusion of the graphic aid (PCL + Graphic) decreased the rates of correct interpretation compared to PCL instructions alone (RR 0.98, 95% CI 0.91–1.05). There was a significant interaction between instruction type and health literacy ( p  = 0.01). Those with limited health literacy were more likely to correctly interpret the PCL labels (91%) than the standard labels (66%), and those with adequate health literacy performed equally well. Conclusion The PCL approach may improve patients’ understanding and use of their medication regimen.