Changes in Medication Package Inserts
In order to improve patient safety, the FDA recently announced a revision to the format of medication package inserts. The new format will be easier to read, and will highlight the most important parts of information regarding the medication, making the inserts easier for the prescribing physicians (and patients) to use. The new format will include a "Highlights" section which will provide prescribing information about risks and benefits, warnings, indications, dosages, etc. There will also be a "Table of Contents" section for easy reference regarding safety and efficacy, a section regarding the date of initial product approval, and a section regarding how to report suspected adverse events. There is also a section entitled "Patient Counseling Information" to help with communication between the patient and health care provider. Read more about the new format here.