Table 4 Label table design process and evaluation
Study | Label | Label design process | Evaluation method |
|---|---|---|---|
Chan 2013 [21] | Standard label | 25 of the 81 pharmaceutical pictograms from the US Pharmacopeia were used | A questionnaire for capturing participants’ particulars was designed for use, and a sign evaluation sheet was prepared for participants to give ratings for the pictograms |
Label design 1 | |||
Label design 2 | |||
Bhansali 2016 [18] | Standard label | Based on FDA guidelines | Based on the information processing constructs of the OTC Label Evaluation Process Model (LEPM) |
Label design 1 | Based on the concepts of information congruency where the author defined uses, directions, and other information on the Drug Facts panel as a single chunk and placed congruent information after the warnings section | ||
Label design 2 | Based on the concepts of information congruency, directions, and other information on the Drug Facts panel as a single chunk and placed congruent information before the warnings section | ||
You 2011 [22] | Standard label | Current standard drug warning label for prescription containers | - Structured cognitive interview protocol developed by the research authors, along with actual prescription pill bottle containers - Rapid Estimate of Adult Literacy in Medicine (REALM) |
Label design 1 | Patient-centered text on the labels was designed based on patient feedback and pilot testing | ||
Label design 2 | - Patient-centered text and icons developed based on patient feedback and pilot testing - Guidelines established by the International Organization for Standardization for the development and testing of universal icons | ||
McCarthy 2013 [23] | Standard label | Current standard label | Via structured interview and REALM |
Label design 1 | Patient-centered, Take-Wait-Stop label developed based on previous research | ||
Label design 2 | |||
Sahm 2012 [24] | Standard label | Standard Rx label | Via structured interview and REALM |
Label design 1 | A patient-centered label that specified explicit timing with standard intervals (morning, noon, evening, bedtime) or with mealtime anchors based on a Universal Medication Schedule (UMS) | ||
Label design 2 | Patient-centered label with instruction and a graphic aid to visually depict dose and timing based on a Universal Medication Schedule (UMS) | ||
Tong 2018 [19] | Standard label | - Existing standard label where the Medicine Information label was based on the design outlined in the Australian TGA consultation paper released in August 2014 and the Drug Facts label was based on the Drug Facts standardized OTC label format implemented in the USA | Interview consisting of the administration of a user testing questionnaire |
Label design 1 | - Medicine Facts label: Navy blue print on white background; information split across two panels (of the box) - Based on a consumer-proposed label title and needs analysis findings - Aspects of previously implemented and tested written medicine information formats such as the US Drug Facts label and Australian Consumer Medicine Information formats were also integrated | ||
Label design 2 | - Consumer Desires label: Navy blue print on light blue background with warnings section presented in red using a pictograph system highlighting indications and contraindications using ticks and crosses - Based on suggestions proposed by consumers in the earlier needs analysis phase of this research | ||
Tai 2016 [25] | Standard label | Current Rx label standard | Short Test of Functional Health Literacy in Adults (STOFHLA) and Modified LaRue Tool (MLT) scores |
Label design 1 | - Patient-centered label with additional “when to take this drug” feature, highlights of the drug name, quantity, refills, dose strength in yellow, highlights of direction and time to take meds in purple and packed with more warning information - Based on previous research and the US Pharmacopeia (USP) recommendations on labeling changes | ||
Label design 2 | - Patient-centered label with an educational intervention - Based on previous research and the US Pharmacopeia (USP) recommendations on labeling changes | ||
Freidman 1997 [20] | Standard label | Current label | A 2-part questionnaire to test comprehension |
Label design 1 | - “Symbols” version—incorporated a bar graph showing dosage efficacy and universal symbols to highlight usage “do’s and don’ts” - Based on the treatment guidelines outlined in the Second Report of the NCEP Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, the existing prescription labeling, input from physician experts - Label was analyzed by a software program, Flesch Reading Ease Formula, and revised | ||
Label design 2 | - Text-only version—the container label copy was presented in text format, without bar charts or symbols - Graphic-text version—presented container label copy in text form with a bar graph indicating the dosage efficacy, but without the universal symbols - Based on the treatment guidelines outlined in the Second Report of the NCEP Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, the existing prescription labeling, input from physician experts - Label was analyzed by a software program, Flesch Reading Ease Formula, and revised | ||
Law 2010 [26] | Standard label | Current label | Patient interviews |
Label design 1 | - Simple language for directions intended for 5th-grade reading skills (age range 10–11 years), inserting a table for times of administration, and adding indication to the instructions; color backgrounds and white space were manipulated to improve the cosmetic appearance of the label; bigger font size (for patient name, medication name, and dosage and directions); and addition of a box for warnings and precautions; size: 2.25″ × 3.75″ (5.715 × 9.525 cm) - The content of the label was based on 2008 California State law requirements for prescription drug labels (Sect. 4076) - The framework developed and used was categorized as content, cosmetic appearance, and convenience | ||
Label design 2 | |||
Dowse 2005 [27] | Standard label | Antibiotics that appear in the local Essential Drugs List were chosen based on level of usage | Recall and understanding of instructions were assessed using a series of structured questions; adherence was determined by self-reporting and “pill count” |
Label design 1 | Pictograms used on the labels had been previously developed locally and tested in the South African population | ||
Label design 2 | |||
Davis 2009 [9] | Standard label | Current label | Via a structured interview; patient literacy was assessed using the Rapid Estimate of Adult Literacy in Medicine (REALM) |
Label design 1 | - Variations in the frequency of use for the drug’s daily administration: number of times per day, hourly intervals, periods, or specific times; variations of the dosage instructions were used per drug, ranging from vague to most explicit - Three physicians and one pharmacist identified a typical dose for each medication, along with variations in the frequency of use for the drug’s daily administration | ||
Label design 2 | |||
Yin 2017 [28] | Standard label | Current label | - Parental health literacy was measured by using the Newest Vital Sign (NVS) - Dosing assessments (each subject participated in 9 total trials; they were asked to measure three dose amounts (2, 7.5, and 10 mL) using three tools (5- and 10-mL–capacity oral syringes and dosing cups with 15 mL as the largest marking)) - Survey to assess parents’ sociodemographic and health literacy |
Label design 1 | - Text and pictogram instructions, “mL”-only label and tool; text and pictogram instructions, “mL/tsp” label and tool - Based on variations by type of instruction on the medication label and measurement units on the label and dosing tool | ||
Label design 2 | - Text-only instructions, “mL”-only label and tool and text-only instructions, “mL/tsp” label and tool - Based on variations by type of instruction on the medication label and measurement units on the label and dosing tool | ||
Wolf 2016 [29] | Standard label | Common template used by a national pharmacy chain at the time of trial initiation | - Demonstrated proper use of a prescribed drug in a patient’s regimen (questions) - Patient Medication Adherence Questionnaire (PMAQ) - Pill count - Rapid Estimate of Adult Literacy in Medicine (REALM) for English patients - Short Assessment of Health Literacy for Spanish Adults (SAHLSA) for Spanish Patients |
Label design 1 | - Patient-centered label (PCL): changes included dose instructions that were written in UMS form, a graphic aid placed in the center of the label, below the instructions, to visually display the dose, a large, bolded font (12 point), increased whitespace - Followed only evidence-based practices for information format and content and supported by patient focus groups | ||
Label design 2 | |||
Malhotra 2019 [30] | Standard label | Standard English text label | Sixteen label-related questions regarding instructions indicated on the prescription medication labels |
Label design 1 | - English text label with pictograms - Bilingual text label - Via the usage of the International Pharmaceutical Federation (FIP) pictograms | ||
Label design 2 | - Bilingual text label with pictograms - Via the usage of the International Pharmaceutical Federation (FIP) pictograms |