Which drugs are specifically required to have a Patient Package Insert (PPI)?

The correct answer identifies oral contraceptives and estrogenic substances as drugs specifically required to have a Patient Package Insert (PPI). The requirement for a PPI is a regulatory measure aimed at ensuring that patients receive essential information about specific medications, promoting safe and effective use of these drugs.

Oral contraceptives are well-known for needing PPIs due to the risks associated with their use, such as thromboembolic events. Similarly, estrogenic substances also require PPIs due to their potential side effects and the importance of having patients informed about proper usage, contraindications, and warnings.

The other options include drugs that do not universally require a PPI, such as statins and antihistamines. While medications like statins have important safety profiles, they are not mandated to have a PPI. The criteria for including a drug on the PPI list are tied more closely to the need to convey critical information about serious risks associated with certain prescriptions, which is why the selected answer represents the correct category of drugs that necessitate a PPI.