Final answer:
A pharmacist must communicate with the prescribing doctor and follow FDA regulations if a different biosimilar drug is dispensed. They are responsible for monitoring pharmacovigilance and must ensure the safety and efficacy of medication substitutions, adhering to strict guidelines.
Step-by-step explanation:
If a pharmacist dispenses a biosimilar drug that is different from the one prescribed by a physician, it is crucial to adhere to proper protocols to ensure patient safety and medication efficacy. The pharmacist must communicate with the prescribing doctor to clarify whether the substitution is acceptable and to ensure that the biosimilar is in fact interchangeable with the prescribed medication. This is a matter of pharmacovigilance, as the long-term safety and specific subgroup effects of a new drug must be monitored continuously post-approval.
Furthermore, as part of their career focus, pharmacists are responsible for advising on the selection, dosage, interactions, and potential side effects of medications. Given this responsibility, pharmacists must have an in-depth understanding of chemistry and biology. Should an incorrect dispensing occur, rectifying the situation promptly is key to maintaining trust and safety in the pharmacist-patient relationship.
In the context of the U.S. Food and Drug Administration (FDA) regulations, pharmacists must follow strict guidelines and ensure that any substitutions of medication, including biosimilars or generics, have been approved for such use, aligning with an Abbreviated New Drug Application (ANDA) when applicable.