U.S. Prescribing Information
When patient-directed labeling is considered necessary for proper use of a drug, the FDA requires patient labeling in nontechnical language in the form of Medication Guides (MedGuides). These have been required for certain prescription drugs that may pose a serious and significant public health concern and are determined necessary for a patient's safe and effective use of the medication. Medication Guides are required to be distributed to patients by the healthcare provider for certain medications. Medication Guides convey risk information that is specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.
Med Guides are required if the FDA determines that one or more of the following circumstances exists:
- Patient labeling could help prevent serious adverse effects.
- A medication has serious risk(s) (relative to benefits) that patients should be made aware of because information concerning the risk(s) could affect a patient's decision to use, or to continue to use, the product.
- Adherence to directions for use is crucial to the drug's effectiveness.
Like Patient Package Inserts, MedGuides are reviewed and approved by the FDA as part of the approved product labeling. Patients should read the medication guide that is included with the prescription drugs to ensure they are aware of important risks.
Patient Package Inserts
For some prescription drugs, such as oral contraceptives and estrogens, the FDA determined that the safe and effective use of the drug required additional labeling in nontechnical language to be distributed directly to patients by their healthcare provider or pharmacist. In such circumstances the FDA has required the distribution of a Patient Package Insert (PPI). The PPI also may be provided voluntarily by drug manufacturers for other drugs and are regulated by the FDA as product labeling. PPIs are reviewed and approved by the FDA and may include information about a products benefits, risks, and other information relevant to their safe and effective use.
For package insert, medication guide or other product specific information please refer to our Products page.