Patient Medication Guides Would Get Update Under FDA Proposal

Prescription drugs and certain blood products distributed in outpatient settings would need to include updated guides for patients under a new rule the FDA proposed Tuesday.

The draft rule (RIN 0910-AH68) seeks to amend existing Food and Drug Administration regulations for medication guides, or paper handouts that the agency requires for certain prescription drugs and biologic products to inform patients on known side effects, directions for use, and other information to prevent serious adverse events.

The proposal would implement a new form of patient labeling, or Patient Medication Information, that must be submitted to and reviewed by the FDA for certain products prescribed by a physician or other outpatient care provider. Each PMI would be a one-page document that includes information divided among four subheadings: the drug’s name, important safety information, common side effects, and usage directions.

The rule, if finalized, would apply to all new and approved new drug applications (NDAs) and biologics license applications dispensed or administered on an outpatient basis. Medication guides are currently only required for certain prescription drugs that FDA decides “pose a significant and serious public health concern and are used primarily on an outpatient basis.”

The FDA’s Medication Guide database includes nearly 900 FDA-approved documents for prescription drugs and biologics like Adderall, Zoloft, and AbbVie’s Humira.

Existing FDA regulations require that medication guides include information on any other drugs, food, or other substances like alcohol that patients should avoid while taking a medication. The document should also include guidance for patients if they miss taking a scheduled dose, or if there’s any risk of a patient developing a dependence on the drug.