FDA Proposes Amendment to Human Prescriptions Drug Labeling Guidelines
The FDA has proposed an amendment to the drug labeling guidelines for human prescription drugs, adding a Patient Medication Information section.
On May 30, 2023, the United States Food and Drug Administration (FDA) proposed an additional Patient Medication Information (PMI) section on human prescription drug labels, amending current regulations. These proposed modifications will apply to drug products in outpatient settings, including blood and blood component transfusions.
“We have long recognized the importance of providing patients with written information about their prescription drug products because there is evidence that such information may help patients use prescription drug products safely and effectively and may potentially reduce preventable adverse drug reactions and improve health outcomes,” stated the FDA in the proposal.
The PMI will highlight specific information relevant to patients, clarifying content that may otherwise get lost in the extensive jargon on most medical labels. Among the components listed on the PMI, pharmaceutical companies must include easy-to-understand directions.
According to the proposal, there will be at least four headings on the document, including what the drug is, important safety information, directions for use, and common side effects.
The one-sheet document would be distributed to patients alongside their prescriptions, acting as a point-of-care educational tool. In addition to patient distribution, a copy of the PMI will be available on the FDA’s labeling repository. A sample PMI can be found in the FDA press release.
Advocating for this amendment, the FDA noted that providing the PMI upon drug dispensation may reduce the costs of searching for information. Beyond that, readily available instructions to each patient may reduce the risk of adverse events associated with inaccurate dosing and medication nonadherence.
“We estimate that the present discounted value of these potential benefits from PMI over 10 years would range between $127.5 million and $4.3 billion using a 3%discount rate,” states the FDA proposal.
Even accounting for the costs associated with pharmaceutical companies creating a PMI, the FDA anticipates significant cost savings over time.
The regulation has yet to be finalized; however, the FDA has opened the proposal for public commentary until November 27, 2023.
