As part of the U.S. Food and Drug Administration's efforts to make information on prescription drugs more transparent and accessible to patients, the agency recently released a new guidance document aimed at standardizing the "Instructions for Use" section on product labels. Under the new requirements, pharmaceutical companies would need to follow stricter content and formatting guidelines for human prescription drugs, biological products and drug-device or biologic-device combination products. While the proposed rules are not yet in effect, they would apply to all products submitted under a new drug application or a biologics license application, Policy & Medicine reported.
Instructions for Use: A Brief Overview
The "Instructions for Use" section on prescription drug labels are meant to inform patients about how to appropriately administer their pharmaceutical products, and should include detailed information on dosage, storage, handling and more. Unfortunately, many new drugs have complicated patient-use instructions that can be difficult to follow for patients' who are unfamiliar with best practices in treatment and clinical care. To solve this issue, the FDA has proposed "developing consistent content and format across IFUs to help ensure that patients receive clear, concise information that is easily understood for the safe and effective use of such prescription products," per the recent guidance document.
Surveying the FDA's Recommended Updates
The FDA's proposed changes would not have much of an impact on the type of information drug and device manufacturers must include on their product labels. All pharmaceutical products that fall under the FDA's jurisdiction must already provide detailed instructions on proper use, dosage and administration, along with patient counseling information, Policy & Medicine reported. However, the draft guidance document makes it clear that IFU's should be created using "nontechnical language." More specifically, drug and device manufacturers are being asked to use active voice and "command language" to make the information easier to understand. The FDA also recommends starting sentences with action verbs and avoiding abbreviations to help prevent misinterpretation.
In terms of formatting, the guidance points out that clear and intuitive organization is crucial to patients' comprehension of medical information and instructions. As such, all labels should use capitalization, bolding, italics and underlines to help emphasize critically important text. The FDA has also made several recommendations for fonts and font sizes that may positively impact patients' retention of key information. One of the more disruptive recommendations is the inclusion of visuals alongside step-by-step instructions, as this may force drug and device manufacturers to completely overhaul their product labels.