What is required to be dispensed with estrogen-containing medications filled in an outpatient setting?

When estrogen-containing medications are dispensed in an outpatient setting, it is essential to provide a Patient Package Insert (PPI) to the patient. The PPI is a document that offers important information about the medication, including its uses, risks, benefits, and instructions for safe use. This requirement is particularly significant for estrogen products due to potential health risks, such as an increased risk of blood clots, strokes, or certain types of cancer, which must be communicated clearly to patients.

The provision of a Patient Package Insert ensures that patients have access to crucial information that can influence their decision-making regarding treatment and help them recognize potential side effects and precautionary measures. While a Medication Guide is also important for certain high-risk medications, estrogen products specifically require the distribution of a PPI as part of the risk management and patient education process.