Consumers Better Understand and Prefer Simplified Written Drug Information: An Evaluation of 2 Novel Formats Versus the Current CMI

Abstract

Patients in the United States receive multiple forms of written drug information with their prescription medicines. This study solicited consumers' preferences about formatting of information, their motivation to read drug information, and their ability to navigate and understand the information. A 3 × 3 study design was used in which 3 prototypes for 3 prescription drugs, ORTHO TRI-CYCLEN (norgestimate/ethinyl estradiol), COUMADIN (warfarin sodium), and PARNATE (tranylcypromine sulfate), were evaluated. The prototypes included 2 novel formats ("new" and "bubble") and the "current" format that patients now commonly receive with their prescriptions. A total of 105 consumers participated in the study. Consumers correctly answered more questions about the medicine when presented with a new (70%-95%) or a bubble prototype (83%-92%) than with the current format (53%-74%). All attributes scored higher with both prototypes compared with the current format. However, in terms of overall preference, consumers favored the new prototype and indicated that they would be more motivated to read it. Consumers also reported that simple icons assisted them in finding important information. The new and bubble prototypes were favored by participants more than the current format. Key attributes preferred by consumers must be considered as new formats for patient medication information are developed.

Preventing Hepatitis B Reactivation During Anti‐CD20 Antibody Treatment in the Veterans Health Administration

“…In parallel with professional development activities, we developed brief patient educational information (at a fifth‐grade reading level) on HBV infection, reactivation, and preventive treatment as slides posted to the public VHA patient website ( ) as well as a pamphlet (Supporting Material S3). Using a one‐page format selected by patients, ( ) we created HBV antiviral patient medication information at a sixth‐grade reading level (Supporting Material S4). For easy provider access, we created a VHA Oncology SharePoint for HBV reactivation and posted frequently asked questions on HBV reactivation (Supporting Material S5), provider and patient educational material, our published VHA national analysis of HBV testing and treatment with anti‐CD20 Ab, and ASCO and American Gastroenterological Association clinical guidance documents.…”

An update on medication guides

“…As MGs evolved, however, FDA provided recommendations on written medical information for consumers that is developed by entities other than the drug manufacturer and researchers published their findings on the design, evaluation, and impact of such information . Therefore, recently approved MGs are more likely than their predecessors to incorporate key content and formatting features aimed at improving their usability and boosting patient comprehension including, but not limited to: plain language (eg, simplified, specific, and legible information with minimal redundancy) better section ordering based on patient and consumer responses a streamlined layout with bulleted text formatted into boxes (ie, readable “chunks” of information) framed text with white space visually discriminable headings (eg, in bold ) larger font sizes (eg, ≥10 point) sans‐serif fonts (eg, Arial) …”

“…• plain language (eg, simplified, specific, and legible information 12,15,16,18,19 with minimal redundancy)…”

“…• a streamlined layout with bulleted text formatted into boxes (ie, readable "chunks" of information) 12,[16][17][18] • framed text with white space 12,16 • visually discriminable headings (eg, in bold) 12,20 • larger font sizes (eg, ≥10 point) 14,17,18 • sans-serif fonts (eg, Arial) 14 Although MG evaluations have been conducted, some evaluations have concluded that FDA-approved MGs have changed little over time. 8,21,22 However, we caution against relying on evaluations that focus on older MG models.…”

What is the quality of drug safety information for patients: An analysis of REMS educational materials

“…While patients in the United States can receive information regarding their prescription drugs in a variety of ways, the main approved source is via the product label, including patient package inserts and medication guides (MGs) . Beyond the product label, patients can also receive educational materials developed under the aegis of a risk evaluation and mitigation strategy (REMS), a type of drug safety program that the United States Food and Drug Administration (FDA) can impose on drug marketing authorization holders to ensure that the benefits of a drug or biological product outweigh its risks .…”