A Client Reports an Adverse Effect to the Adverse Event

question 34

Multiple Choice

A client reports an adverse effect to the Adverse Event Reporting System.The nurse recognizes if a potential safety concern is identified,the Food and Drug Administration (FDA) may take which actions?
Select all that apply.

• A)Determine the extent of the safety concern by conducting additional studies
• B)Require changes be made to the product's labeling information
• C)Recall the product
• D)Restrict the product's use in certain populations
• E)Continue to log in public concerns regarding the safety of the product before taking further action

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Definitions:

Depressed State

A condition or mood of feeling sad, helpless, and dispirited, often with a lack of energy and difficulty in maintaining daily activities.

Mental Illness

A disorder that affects a person’s mood, thinking, and behavior, often requiring medical or therapeutic intervention.

Biopsychosocial Approach

A holistic perspective that acknowledges the complex interplay between biological, psychological, and social factors in influencing health and illness.

DSM-5

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, a handbook used by healthcare professionals as the authoritative guide to the diagnosis of mental disorders.