When are patient package inserts (PPIs) required?

Patient package inserts (PPIs) are specifically required for estrogen-containing products and oral contraceptives in order to ensure that patients receive essential information regarding the risks, benefits, and proper usage of these medications. This requirement is anchored in the belief that patients should have access to comprehensive information about their medications, particularly those that may carry significant health risks.

PPIs serve as a critical communication tool to enhance patient understanding and adherence, particularly with the potential adverse effects and specific usage instructions associated with these hormonal therapies. The regulation is guided by the FDA, which mandates that PPIs are included with these specific drug categories to help mitigate health risks and promote informed decision-making by patients.

While certain medications, including some prescription drugs, may require the provision of other informational materials or counseling, the particular focus on PPIs is designated to the specified classes of medications — specifically those related to estrogen and contraceptive use — to emphasize their importance in ensuring patient safety and informed consent regarding reproductive health.