When should Patient Package Inserts (PPIs) be distributed in an ambulatory setting?

Patient Package Inserts (PPIs) are required to be distributed to patients in ambulatory settings at the initial fill of a prescription and with every subsequent refill. This requirement is based on the recognition that PPIs contain important information about the drug, including indications, usage, precautions, and potential side effects, which are crucial for the patient's safety and informed decision-making.

Providing PPIs at both the initial fill and every refill ensures that patients continuously receive updated information, particularly concerning any recent changes in safety information or usage recommendations that may not have been present during the first counseling. This regular distribution is key to promoting safe medication use and enhancing patient understanding of their therapy over time.

While some options suggest distributing PPIs only upon patient request or at the time of medication counseling, this could lead to gaps in patient knowledge and safety. Ensuring that every patient receives a Patient Package Insert along with their medication helps reinforce the information and supports optimal therapeutic outcomes.