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For quick release:
Statement from:

Robert M. Calif, MD, MACC
Food and Drug Commissioner – Food and Drug Administration

Providing accurate and timely information to help people take prescription drugs safely and effectively is a priority for the US Food and Drug Administration. Evidence shows that easy-to-read information can help patients reduce preventable drug reactions and improve health outcomes.

Currently, patients may receive one or more written information for prescription and certain biologic products, depending on the drug being prescribed. Studies have shown that the current written information system for prescription drugs and some biological products can be confusing, conflicting, incomplete, or repetitive.

When such critical information is difficult to understand, patients may become frustrated, stop taking their medication, or not take their medication as directed, which may be harmful to their health. Studies indicate that nonadherence to medication can account for nearly 25% of hospitalizations, 50% of treatment failures, and approximately 125,000 deaths in our country each year. While medication nonadherence is complex, nonadherence to written information for prescription drugs and some biologics can have a negative impact on public health, and we are committed to addressing it.

To address this problem, today, we are proposing a new medication guide for prescription drugs and certain biologics (brand name and generic) as well as outpatient. For blood and blood components taken in an outpatient setting.

Patient drug information provides patients with clear, concise, accessible, and useful written information about prescription drugs and certain biological products and is delivered in a consistent and easy-to-understand format to help patients use prescription drugs and certain biological products safely. And effectively. A consistent format for patient medication information can facilitate translation into other languages, and artificial intelligence or other technologies can help convert the information into formats that are as accessible to the visually impaired as possible.

These FDA-approved one-page documents highlight important information patients need to know in a standardized format, including:

  • Pharmaceutical / biological product name
  • A brief summary of indications and uses
  • Important safety information
  • Common side effects
  • Directions for use

Patient medication information is available online for patients receiving prescription drugs and certain biological products in an outpatient setting, as well as for public access. In addition to the primary goal of helping patients use medications safely and effectively, patient drug information replaces two types of FDA-approved prescription drug patient information and certain biologic product information. This reduces duplicate data. Be more cost-effective for manufacturers of pharmaceuticals and certain biological products.

Additionally, this proposal is one way to combat our nation’s problem of health care misinformation and disinformation, which is the agency’s primary mission. Access to straightforward and easy-to-understand information on prescription drugs and some biological products in a consistent format can reduce accidental and intentional misinterpretations.

The legislation proposed today is a practical step to improve the health of the nation. Our public health mission is to ensure that medicines and certain biological products are used safely and effectively, help people feel empowered and confident in managing their care, and prevent adverse health outcomes.

We encourage public comments for the Medication Guide: Patient Medication Information proposed rule during public comment. As always, FDA will review and consider feedback as we develop the final rule.

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The FDA, an agency within the US Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products and medical devices for human use. The agency is responsible for regulating the safety and security of our nation’s food supply, cosmetics, dietary supplements, electronic radiation-dissolving products, and tobacco products.


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