When asked if there are any regulatory controls on herbal or dietary supplements, the nurse responds to the client by informing him that herbal and dietary supplements are regulated by the:
Food, Drug and Cosmetic Act
Joint Commission on the Accreditation of Healthcare Organizations
Health and Human Services (HHS)
Dietary Supplement Health and Education Act (DSHEA)
The Correct Answer is D
A. Food, Drug and Cosmetic Act:
The Food, Drug, and Cosmetic Act (FD&C Act) is a federal law that regulates the manufacturing, labeling, and distribution of food, drugs, cosmetics, and medical devices in the United States. While the FD&C Act does provide some regulatory authority over certain aspects of dietary supplements, such as labeling requirements and good manufacturing practices, it is not the primary law governing the regulation of herbal and dietary supplements.
B. Joint Commission on the Accreditation of Healthcare Organizations:
The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), now known as The Joint Commission, is an independent, nonprofit organization that accredits and certifies healthcare organizations and programs in the United States. However, The Joint Commission is not responsible for regulating herbal and dietary supplements.
C. Health and Human Services (HHS):
The Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government. While HHS oversees various health-related agencies, including the Food and Drug Administration (FDA), it is not the primary regulatory authority for herbal and dietary supplements.
D. Dietary Supplement Health and Education Act (DSHEA):
The Dietary Supplement Health and Education Act (DSHEA) of 1994 is the primary law that regulates herbal and dietary supplements in the United States. DSHEA defines dietary supplements, sets forth labeling requirements, establishes good manufacturing practices, and outlines the responsibilities of manufacturers and distributors of dietary supplements. Under DSHEA, dietary supplements are regulated as a category of food rather than as drugs.
Nursing Test Bank
Naxlex Comprehensive Predictor Exams
Related Questions
Correct Answer is C
Explanation
A. An infection that is difficult to treat:
This choice describes a challenging infection but does not specifically capture the concept of a superinfection. While superinfections can indeed be difficult to treat, they are defined more specifically as secondary infections that occur due to disruption of the normal microbial flora during the treatment of an initial infection.
B. An infection caused by a weakened immune system:
This choice describes an infection that occurs due to a compromised or weakened immune system, which can indeed increase the risk of developing infections, including superinfections. However, it does not fully encompass the definition of a superinfection, which specifically involves the overgrowth of opportunistic pathogens after the disruption of normal microbial flora by antimicrobial treatment.
C. A secondary infection that occurs when microorganisms normally present in the body are killed by the drug:
This choice accurately describes what a superinfection is. It highlights the key concept that a superinfection is a secondary infection that arises when antimicrobial treatment disrupts or kills the normal microbial flora of the body, allowing opportunistic pathogens to overgrow and cause infection.
D. A drug-resistant infection:
This choice describes an infection caused by microorganisms that are resistant to the effects of antimicrobial drugs. While drug resistance is a significant concern in healthcare, it does not specifically define a superinfection. Superinfections can involve drug-resistant microorganisms, but they are not solely characterized by drug resistance; rather, they are secondary infections resulting from the disruption of normal microbial flora during antimicrobial treatment.
Correct Answer is C
Explanation
A. Discoloration of body fluids:
Vancomycin can cause discoloration of body fluids, particularly urine, resulting in a brownish discoloration. However, this is not caused by histamine release.
B. Ototoxicity:
Ototoxicity refers to damage to the inner ear structures leading to hearing loss or balance problems. While vancomycin can cause ototoxicity, it is not specifically associated with histamine release.
C. Red-man syndrome
Red-man syndrome, also known as red-neck syndrome or red-person syndrome, is a hypersensitivity reaction characterized by flushing of the skin, particularly the upper body and face, resembling a "red man." This reaction is typically associated with the rapid infusion of vancomycin and is caused by the release of histamine from mast cells and basophils. It is not an allergic reaction but rather a non-immunologic response to vancomycin.
D. Nephrotoxicity:
Nephrotoxicity refers to kidney damage caused by certain medications or toxins. While vancomycin can cause nephrotoxicity, it is not specifically associated with histamine release.
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