Final answer:
Patients must be informed about the equivalence, risks, benefits, and specific indications of a generically substituted drug. They should also be aware of any different inactive ingredients and the ongoing postmarket safety surveillance.
Step-by-step explanation:
When delivering a generically substituted drug, certain information must be communicated to the patient. Firstly, the patient should be informed that the generic drug is deemed equivalent in terms of safety and efficacy as determined by the FDA, through processes such as the Abbreviated New Drug Application (ANDA). It's important to discuss the risks and benefits of the generic medication, just as with the original brand-name drug. The patient should also be aware that the generic may contain different inactive ingredients, which is significant for those with allergies or sensitivities.
Continuous postmarket safety surveillance ensures that the generic medication's long-term safety remains acceptable as it is used in a wider population. Moreover, patients should be told about the specific indication for which the drug has been approved, and any potential off-label uses should be clearly acknowledged. When providing this information, the healthcare provider ensures that the patient's consent to medication therapy is truly informed.