Refining Prescription Warning Labels Using Patient Feedback: A Qualitative Study

<div><p>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.</p></div

Protect from sunlight- Patient Preferences for the Variations of the five Prescription Warning Labels.

<p>Protect from sunlight- Patient Preferences for the Variations of the five Prescription Warning Labels.</p

Patient Feedback on the Improvement of Each Specific Prescription Warning Label.

<p>Patient Feedback on the Improvement of Each Specific Prescription Warning Label.</p

Descriptive statistics of the study population (n = 21).

<p>Descriptive statistics of the study population (n = 21).</p

Do not chew or break- Patient Preferences for the Variations of the five Prescription Warning Labels.

<p>Do not chew or break- Patient Preferences for the Variations of the five Prescription Warning Labels.</p

Take with a full glass of water- Patient Preferences for the Variations of the five Prescription Warning Labels.

<p>Take with a full glass of water- Patient Preferences for the Variations of the five Prescription Warning Labels.</p

Positioning of the Prescription Warning Labels (PWLs) on the Pill bottle.

<p>Positioning of the Prescription Warning Labels (PWLs) on the Pill bottle.</p

Patient Feedback across all Five Prescription Warning Labels (n = 21).

<p>Patient Feedback across all Five Prescription Warning Labels (n = 21).</p

AZD6244 induced increase of <i>Bim</i> mRNA levels and Bim protein stabilization in lung cancer cells.

<p>(A) Total RNA was isolated in parallel. Expression of <i>Bim</i> was measured by real-time PCR, and normalized to the level of <i>GAPDH</i>. Data shown are representative of three independent experiments with similar results. <i>Columns</i>, mean; <i>bar</i>, SD. * , <i>P</i><0.05, compared with untreated cells. (B) Calu-6, H2347, H3122 and H196 cells were treated with 30 µM MG132 for 2, 4, 6, and 8 hours and Western blot analysis with Bim expression was performed. (C) Calu-6, H2347, H3122 and H196 cells were treated with DMSO, 3 µM AZD6244, or 30 µM MG132 for 6 hours, and then with 25 µg/ml of cycloheximide to block protein synthesis. Western blot analysis with Bim expression was performed. Data represent one of three independent experiments with similar results.</p

Effect of constitutively active AKT (caAKT) on FOXO3a-mediated Bim expression.

<p>(A) Lung cancer cell lines Calu-6 and H3122 were transfected with an empty retroviral vector or a caAKT-expressing vector. After a brief selection, AKT activity and p-Thr32-FOXO3a and p-Ser-FOXO3a expression were measured in caAKT transfected cells. α-Tubulin was used as a loading control. (B) Expression of Bim and p-FOXO3a were measured in vector- and caAKT-transfected cells after AZD6244 treatment. (C) Dose-response curves are shown for AZD6244 in vector-transfected and caAKT-transfected Calu-6 and H3122 cells. Cells were exposed to increasing concentrations of AZD6244 for 96 hours. Cell viability was determined by SRB. (D) Apoptosis induction by AZD6244. Cells were treated with 3 µM AZD6244 for 72 hours, and apoptosis was analyzed as described in <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0013026#pone-0013026-g003" target="_blank">Fig. 3C</a>. Numbers represent percentages of apoptotic sub-G₁–phase cells. Data represent one of three independent experiments with similar results. <i>Columns</i>, mean; <i>bar</i>, SD. *, <i>P</i><0.05, compared with the control vector transfected cells. (E) TUNEL assay were conducted as described in <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0013026#pone-0013026-g003" target="_blank">Fig. 3D</a>. The representative photographs of Calu-6 are shown.</p