FDA Proposes New Patient Medication Information Guide to Improve Patient Understanding and Adherence

The US Federal Food and Drug Administration (FDA) proposes Patient Medication Information (PMI) as a new type of Medication Guide to provide patients with clear, concise information about their prescription medications to improve patient understanding and adherence.

Patients often receive informational documents with their prescription medication to help them take their drugs safely and effectively. These documents aim to reduce preventable adverse drug reactions and improve health outcomes. However, the FDA found that existing Consumer Medication Information is not always clear to patients. 

“The information in these documents can be difficult to understand, repetitive, incomplete, or conflicting, which may cause some patients to take their prescription medication incorrectly,” said Christopher Diamant, JD, regulatory counsel in the Center for Drug Evaluation and Research (CDER) Office of Medical Policy. “Although studies have found several reasons some patients don’t take their prescription medications as directed, a patient’s knowledge about a prescription medication plays a key role in their ability to use the drug as intended. Communications that do not provide clarity regarding prescription medications may lead to patient nonadherence, which may, in turn, be responsible for increased hospitalizations, treatment failures, and even increased death rates in the United States each year.” 

To develop a PMI, CDER conducted research and obtained input from various stakeholders to develop document prototypes. Patients prefer a simple, one-page format due to difficulty understanding lengthy information materials, shared Diamant. 

After conducting studies and workshops, CDER focused on key elements for patient safety and effectiveness in using prescription drugs. The finalized PMI format includes sections for drug name, important safety information, common side effects, and directions for use.

“PMI would be distributed to patients who receive prescription drugs in an outpatient setting, such as retail pharmacies and hospital outpatient care pharmacies. Authorized dispensers, such as pharmacists, would provide the FDA-approved PMI to patients with their prescription drugs. Transfusion services would also be required to provide PMI to each patient who receives blood or blood components on an outpatient basis,” explained Diamant. 

Patients can choose to receive PMI in either paper or electronic format, with paper being the default method unless electronic delivery is requested. PMI will eventually replace Medication Guides and Patient Package Inserts but not Prescribing Information, Instructions for Use, or patient counseling. The PMI will be stored in an online central repository managed by CDER and available to the public, with a batch download option for convenience.

Reference
Patient Medication Information: a 2023 proposed rule to help patients understand their prescription medication information. FDA. April 18, 2024. Accessed April 23, 2024. https://www.fda.gov/drugs/cder-conversations/patient-medication-information-2023-proposed-rule-help-patients-understand-their-prescription