West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

Which labeling must be given with each new fill and refills according to the USP guidelines?

1. Consumer Medication Information only

2. MedGuide only

3. Patient Package Insert and/or MedGuide

4. REMS paperwork only

The correct answer is: Consumer Medication Information only

The correct response involves understanding the requirements outlined by the United States Pharmacopeia (USP) regarding medication labeling. Each new fill and refill must include a comprehensive form of patient information. This is essential for ensuring that patients receive the necessary information about their medications to promote safe and effective use. Consumer Medication Information (CMI) is specifically designed for the patient, providing basic information about the drug, including how to take it, potential side effects, and interactions. This information is required for each prescription dispense, reinforcing the importance of patient education for every fill or refill. In addition to CMI, there are situations involving specific medications where additional materials like Patient Package Inserts (PPIs) and Medication Guides (MedGuides) are also mandated. PPIs are usually associated with certain prescription medications, particularly those that require more detailed information for safe use. MedGuides are required for specific drugs that pose a serious and significant public health concern. However, while MedGuides and PPIs are critical for specific medications, the question focuses on the labelings that must accompany each new fill and refill according to general USP guidelines, where CMI fulfills that requirement. Therefore, Consumer Medication Information is the primary labeling requirement for all new fills and refills under these guidelines