Wyoming MPJE (Pharmacy Jurisprudence) Practice Exam

What is the purpose of including a toll-free number in the highlights section of a drug’s package insert?

1. To report adverse events

2. To investigate new drug applications

3. To request medication samples

4. To get in contact with the FDA's HR department

The correct answer is: To report adverse events

Including a toll-free number in the highlights section of a drug's package insert serves the purpose of allowing individuals to report adverse events related to the use of the drug. This practice helps regulatory bodies and pharmaceutical companies monitor the safety and efficacy of the medication by collecting data on any unexpected or harmful effects experienced by patients. Reporting adverse events through the toll-free number facilitates pharmacovigilance efforts and promotes post-marketing surveillance to ensure patient safety. Options B, C, and D are incorrect because a toll-free number in the highlights section of a drug's package insert is not primarily intended for investigating new drug applications, requesting medication samples, or contacting the FDA's HR department.