What is the requirement for certain drugs that have known serious risks?

The requirement for certain drugs that have known serious risks is the provision of a Medication Guide. Medication Guides are essential patient education tools that accompany specific prescriptions and are mandated by the FDA for medications that carry significant risks of adverse effects. These guides provide vital information about the risks, benefits, and safe use of the medication, ensuring that patients are well-informed before starting treatment.

The purpose of Medication Guides is to enhance patient safety by informing patients about potential side effects and the importance of adhering to the prescribed regimen. They are designed to promote proper use of the medication and help prevent medication errors or misuse.

In contrast, while patient consent is important in a clinical setting to ensure that patients are adequately informed and agree to treatment, it does not specifically pertain to the requirement for distributing information about drugs with serious risks. Drug efficacy review relates to assessing how effective a medication is, which is important but not specifically required for communicating risks. Lastly, a screening process refers to the procedures that may assess a patient's appropriateness for a particular treatment, but it does not directly address how information about risks is conveyed to the patient. Thus, the Medication Guide stands out as the key requirement for drugs associated with known serious risks.