Refining Prescription Warning Labels Using Patient Feedback: A Qualitative Study

• Published in: PloS one 2016-06, Vol.11 (6), p.e0156881-e0156881
• Main Authors: Shiyanbola, Olayinka O, Smith, Paul D, Mansukhani, Sonal Ghura, Huang, Yen-Ming
• Format: Article
• Language: English
• Subjects: Adult; Aged; Alcohol use; Alcohols; Alertness; Biology and Life Sciences; Clarity; Content analysis; Demographics; Drinking water; Drug labeling; Drug Labeling - standards; Drug Prescriptions - standards; Drugs; Feedback; Feedback (Communication); Female; Health Literacy; Humans; Labels; Literacy; Male; Management; Medication Errors; Medicine and Health Sciences; Middle Aged; Patients; Physical Sciences; Pictures; Placement; Prescription Drugs - standards; Prescriptions (Drugs); Qualitative analysis; Qualitative Research; Social Sciences; Surveys and Questionnaires; Warning; Warning labels; Young Adult
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0156881

The complexity of written medication information hinders patients' understanding and leads to patient misuse of prescribed medications. Incorporating patient feedback in designing prescription warning labels (PWLs) is crucial in enhancing patient comprehension of medication warning instructions. This qualitative study explored patient feedback on five newly designed PWLs. In-depth semi-structured face-to-face interviews were conducted with 21 patients, who were 18 years and older, spoke English, and took a prescription medication. These patients were shown different variations of the five most commonly used PWLs-Take with Food, Do not Drink Alcohol, Take with a Full glass of Water, Do not Chew or Break, and Protect from Sunlight. The 60-minute interviews explored feedback on patient comprehension of the PWL instructions and their suggestions for improving the clarity of the PWLs. At the end of the interview, patient self-reported socio-demographic information was collected with a 3-minute survey and a brief health literacy assessment was completed using the Newest Vital Sign. Twenty-one patients completed the interviews. Most patients were female (n = 15, 71.4%) with ages ranging from 23 to 66 years old (mean: 47.6 ± 13.3). The mean health literacy score was 2.4 on a scale of 0-6. Qualitative content analysis based on the text, pictures, and placement of the PWLs on the pill bottle showed preferences for including 'WARNING' on the PWL to create alertness, inclusion of a picture together with the text, yellow color highlighting behind the text, and placement of the PWL on the front of the pill bottle. Although patients had positive opinions of the redesigned PWLs, patients wanted further improvements to the content and design of the PWLs for enhanced clarity and understandability.