Final answer:
Off-label use is when a medication is prescribed for conditions or dosages not approved by the FDA. Doctors can prescribe drugs off-label, but drug companies are restricted to promoting them only for approved indications. Postmarketing surveillance continues to monitor drug safety once it is widely available to the public.
Step-by-step explanation:
When a prescriber writes for a medication for an unapproved use, this is referred to as B) Off-label use. Off-label use means that the medication is prescribed for conditions or in dosages that are not specifically approved by the U.S. Food and Drug Administration (FDA). While drug companies may only advertise or promote a drug for the approved indications, and must provide a fair balance of benefits and risks, healthcare providers can legally prescribe drugs off-label based on their clinical judgment and experience.
Postmarketing Safety Surveillance is the monitoring of drugs after they have been released on the market and essentially looks at the safety experience with the drug after it is used in a much larger population than during clinical trials. Drugs, especially new drugs, must go through the New Drug Application (NDA) process and meet rigorous FDA requirements, ensuring that they are safe and effective when used as directed on the label. However, once a drug is on the market, physicians may discover additional uses beyond those already approved, resulting in an off-label prescription.