FPGEE for National Association of Boards of Pharmacy (NABP) Practice Exam

Which of the following products requires a Patient Package Insert (PPI)?

1. Ibuprofen

2. Isotretinoin

3. Aspirin

4. Omeprazole

The correct answer is: Isotretinoin

A Patient Package Insert (PPI) is a document that provides essential information to patients about a specific medication, including its uses, risks, and potential side effects. Certain medications, particularly those that carry significant risks or require careful monitoring, mandate the inclusion of a PPI to ensure patients are well-informed. Isotretinoin is a powerful medication used primarily for severe acne and is associated with severe side effects, including teratogenic effects (risk of causing birth defects). Due to these risks, it is required by the FDA to provide patients with a PPI that clearly outlines the necessary precautions, potential side effects, and the importance of patient monitoring. This ensures that patients are aware of how to take the medication safely and understand the risks involved, especially in regards to pregnancy. In contrast, while ibuprofen, aspirin, and omeprazole each have important safety information, they do not all qualify for mandatory PPIs under the FDA guidelines. For example, over-the-counter medications like ibuprofen and aspirin provide information through labeling rather than a PPI. Additionally, omeprazole, which is also often used without the requirement for a PPI, provides sufficient information through standard patient medication guides instead of a formal PPI. Thus, isot