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Enhancing Healthcare Through Improved Patient Labeling

When patients receive a prescription drug or biological product in an outpatient setting, it may be accompanied by one or more types of written information approved by the US Food and Drug Administration (FDA). The quality of that information, known as the patient labelling, plays a decisive role in whether patients take their treatment properly – or at all.

“Studies have found that the current system for written information for prescription drugs and certain biological products can be confusing, conflicting, incomplete, or repetitive,” Robert M. Califf, MD, MACC, the Commissioner of Food and Drugs, said in a statement issued in May 2023.1 He noted that difficulty in comprehending information can cause patients to become frustrated, stop taking their medications, or not take them as directed. Medication nonadherence, Califf said, “can contribute to nearly 25% of hospital admissions, 50% of treatment failures, and approximately 125,000 deaths” yearly in the US.

Labelling for prescription medicines is the FDA’s primary tool for communicating drug information to healthcare professionals and to patients and their caregivers. The three most common types of FDA-approved patient labelling are patient package inserts, Medication Guides, and Instructions for Use. These documents are proposed by the sponsor and reviewed and approved by the FDA, and their content is based on the Prescribing Information. With the intent to “improve health outcomes,” the FDA has proposed to require Patient Medication Information (PMI),2 a new type of Medication Guide for prescription drugs and certain biological products (both brand name and generic) that are used, dispensed, or administered on an outpatient basis, as well as for blood and blood components transfused in an outpatient setting.

As paper handouts that accompany many prescription medicines, Medication Guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events (SAEs). The agency might require that Medication Guides be issued with certain prescribed drugs and biological products when it determines that 1) specific information is necessary to prevent SAEs, 2) patient decision-making should be informed by information about a known serious risk or risks, or 3) patient adherence to directions for the use of a product are essential to its effectiveness. The FDA has a Medication Guides database3 that houses these documents (but excludes FDA-approved allergenic or cellular/tissue products).

In the May 2023 statement, Califf noted that PMI “would provide patients with clear, concise, accessible, and useful written information for prescription drugs and certain biological products and would be delivered in a consistent and easy-to-understand format” to help patients use these products safely and effectively. PMI would consist of one-page documents highlighting critical information that patients should know in a standardised format, including the drug/biological product name, a concise summary of the indications and uses, important safety information, common side effects, and directions for use. This information would be provided along with the medication in person and available online for public access.