FDA Proposes New, Easy-to-Read Medication Guide for Patients

WASHINGTON — The Food and Drug Administration wants to make it easier for patients to understand why they’ve been prescribed specific medications and how to ensure they don’t suffer any preventable adverse reactions when taking them.

Toward that end the agency has proposed requiring a new type of medication guide for prescription drugs and certain biological products.

The new Patient Medication Information guide will apply to both brand name and generic drugs used, dispensed or administered on an outpatient basis.

It will also include information for blood and blood components transfused in an outpatient setting.

“Providing people with accurate and timely information to help them take their prescription medications safely and effectively is an important priority for the Food and Drug Administration,” said FDA Commissioner Dr. Robert M. Califf, in a written statement.

“Evidence suggests that more easy-to-read information can help patients reduce preventable adverse drug reactions and improve health outcomes,” he said.

Unfortunately, Califf said, studies have found the current system for written information for prescription drugs and certain biological products can be confusing, conflicting, incomplete or repetitive. 

“When such critical information is difficult to understand, patients can become frustrated, stop taking their medications, or not take their medications as directed, which can be harmful to their health,” he said.

Califf’s statement is backed up by some sobering numbers. Researchers have found that taking medication in a way not prescribed by a doctor accounts for nearly 25% of all hospital admissions annually.

Such “nonadherence” to medication protocols has also led to treatment failures in about 50% of cases and approximately 125,000 deaths each year. 

“While medication nonadherence is complex, inconsistency with the existing types of written information for prescription drugs and certain biological products can negatively impact public health, and we are eager to fix it,” Califf said.

As outlined by the department, the proposed Patient Medication Information 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 their prescription drugs and certain biological products safely and effectively. 

In addition, the FDA is hopeful that the Patient Medication Information’s consistent formatting may help facilitate translations to other languages and make it easier for artificial intelligence or other technologies to convert the information, where feasible, to formats that assist the visually impaired. 

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

• Drug/Biological product name.
• Concise summary of the indications and uses.
• Important safety information.
• Common side effects.
• Directions for use.

Califf said the Patient Medication Information would be given to patients with their prescription drugs and certain biological products when provided in an outpatient setting and also be available online for the public to access. 

Comments on the proposal are being solicited through Nov. 27.

They can be submitted electronically at the federal eRulemaking Portal: https://www.regulations.gov, or in writing by mail or hand-delivery to Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Dan can be reached at [email protected] and at https://twitter.com/DanMcCue