Final answer:
The FDA requires manufacturers to develop REMS (Risk Evaluation and Mitigation Strategies) when a medication has significant risks. REMS programs include various components to ensure patient safety and effective postmarket drug surveillance. They are crucial for continuous monitoring to assess long-term safety and effects on specific patient populations.
Step-by-step explanation:
If a medication poses a significant health risk, the FDA requires manufacturers to develop REMS, or Risk Evaluation and Mitigation Strategies, for providers and patients to follow. This strategy is designed to ensure that the benefits of a medication outweigh its risks and can include requirements for additional lab work, check-ins with doctors, or restrictions on how a medication is prescribed and dispensed.
REMS programs are critical components of postmarket drug safety surveillance and management. These programs may also include elements such as Medication Guides, patient package inserts, communication plans for healthcare providers, and even required patient registries or enrollment in a special program to receive the medication.
Even after a drug receives FDA approval, it is essential to engage continuous monitoring through an effective pharmacovigilance system. This ongoing evaluation helps in understanding the potential long-term safety concerns and the effects on specific patient subgroups, thereby protecting patients from adverse reactions and harmful effects.