What must a pharmacist ensure when dispensing a biosimilar agent?

When dispensing a biosimilar agent, it is crucial for a pharmacist to ensure that the biosimilar has been designated as interchangeable by the FDA. Interchangeable status is a specific designation that allows a pharmacist to substitute the biosimilar for a reference biologic without the intervention of the prescribing physician.

This designation is significant because it confirms that the biosimilar is expected to produce the same clinical result as the reference product in any given patient, and that the risk of switching between the two products is not greater than using the reference product alone. Thus, when a pharmacist confirms the interchangeable status, they are upholding safety standards and ensuring that they are compliant with regulatory requirements regarding substitution.

In contrast, the requirements for physician approval for substitution apply mainly to biologics that do not have interchangeable status. If they lack this status, the substitution requires the taking of additional steps, such as confirming with the prescribing physician. Additionally, while it may seem intuitive to think that pharmacists cannot substitute biologic drugs, there are specific circumstances where substitution is permissible based on the designations provided by the FDA. Hence, the focus on the biosimilar's interchangeable status is paramount, as it is what allows a pharmacist to substitute safely and legally.