When must a Medication Guide be dispensed to patients?

The requirement for dispensing a Medication Guide hinges on the presence of a "serious and significant concern" regarding adverse drug reactions (ADRs) associated with a particular medication. Medication Guides serve as essential tools designed to inform patients about the risks, benefits, and proper use of certain medications that have been identified as having these concerns.

When a medication falls into this category, it is imperative for pharmacists to ensure that patients receive the Medication Guide at the time of dispensing, especially when the potential for serious ADRs exists. This practice helps empower patients with the information they need to understand the potential side effects and encourages them to make informed decisions regarding their therapies.

The other choices lack the specificity required for Medication Guide dispensation. For instance, dispensing a Medication Guide for every new prescription does not consider the necessity outcome based on safety concerns. Similarly, counseling is not strictly tied to the need for a Medication Guide; while counseling is beneficial, it is not a regulatory requirement that triggers the need for a Medication Guide. Providing the guide before a refill is also not mandated unless the conditions outlined in the law are met, which hinges on the assessment of serious ADR concerns.