QUALITY CONSUMER MEDICATION INFORMATIONS

To support efforts by the Food and Drug Administration (FDA) and other stakeholders to improve the quality, consistency, accessibility, targeting, and simplicity of consumer medication information (CMI); further,

To encourage the FDA to work in collaboration with patient advocates and other stakeholders to create evidence-based models and standards, including establishment of a universal literacy level and standardized, patient-focused templates for CMI; further,

To advocate that research be conducted to validate these models in actual-use studies in pertinent patient populations; further,

To advocate that the FDA explore alternative models of CMI content development and maintenance that will ensure the highest level of accuracy, consistency, currency, and conformity with health literacy requirements; further,

To advocate that the FDA maintain a highly structured, publicly and easily accessible central repository of CMI in a format that is suitable for ready export; further,

To advocate for laws and regulations that would require all dispensers of medications to comply with FDA-established standards for content, format, and distribution of CMI.

Rationale

Providing easy-to-read and accurate information to patients about medications is essential for ensuring their safety and efficacy. Nonadherence to and incorrect use of medications can lead to hospital admissions, treatment failures, and death. Multiple types of written information are provided to patients with prescription medications and biological products, but much of this information can be conflicting, confusing, and incomplete. Furthermore, only 12% of Americans have proficient health literacy skills according to the National Assessment of Adult Literacy, decreasing the likelihood that these patients will comprehend the provided information.

Consumer medication information (CMI) is written information for patients or caregivers about a prescription drug. CMI is developed by individuals or organizations; drug companies and the FDA do not review or approve CMI. Currently available patient labeling available in the United States include Medication Guides (MG), Patient Package Inserts (PPI), and Instructions for Use. Medication Guides are a type of labeling for patients or caregivers that are required by the FDA if certain criteria are met, for example, when the medication has serious side effects or if following the directions is particularly important for effectiveness or avoiding serious side effects. PPIs provide patient information that can be a part of FDA-approved labeling and are developed by the manufacturer and approved by the FDA. PPI are required for estrogen-containing products and estrogens, but creation of PPI for other prescription medications is voluntary.

In 2023, the FDA proposed a rule that would create a new medication guide called “Patient Medication Information” (PMI) for prescription medications and biological products that are administered, dispensed, or used in an outpatient setting. These manufacturer-developed, FDA-approved, standardized, one-page documents will be provided in either paper or electronic format. PMI would replace the current MG and PPI and will be stored electronically in FDA’s labeling repository. The FDA is in the process of reviewing comments and a final rule has not been issued.

The Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health’s Healthy People 2030 initiative defines health literacy in two ways: personal health literacy is the degree to which individuals have the ability to find, understand, and use information and services to inform health-related decisions and actions for themselves and others; and organizational health literacy is the degree to which organizations equitably enable individuals to find, understand, and use information and services to inform health-related decisions and actions for themselves and others. 

Programs that support education and training around self-assessment of health literacy and general communication skills and methods for practitioner assessments of patient health literacy are needed to ensure full adoption and appropriate implementation. Barriers to health literacy include language barriers such as limited English proficiency and communication barriers such as those experienced by the deaf or hard of hearing community. Each of these barriers, along with disability, transportation, and cultural barriers require practice resources to accommodate patients with specific communication needs.

Use of plain-language and patient-centered formats of CMI is essential for optimal health-related outcomes of medication use. Design elements and interventions, however, lack high-quality evidence and are thus unable to be considered “best-practice.” Incorporating new methods of providing CMI and innovative practices should be a focus of future investigations.