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. 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.
Correct Answer is D
Explanation
A. Substance that can inhibit the growth of bacteria:
This definition is incorrect. The term "virulence" does not refer to a substance that inhibits bacterial growth. Instead, it pertains to the ability of a microorganism to cause disease.
B. Permanent, inheritable changes to DNA:
This definition is incorrect. Permanent, inheritable changes to DNA are typically referred to as mutations. While mutations can impact the characteristics of microorganisms, the term "virulence" specifically relates to disease-causing ability rather than genetic changes.
C. When a microbe is no longer affected by a drug following treatment with anti-infectives:
This definition is incorrect. The phenomenon described here is known as drug resistance or antimicrobial resistance. It refers to the ability of microorganisms to survive and multiply in the presence of antimicrobial agents, rendering the drugs ineffective.
D. The severity of disease that an organism is able to cause:
This definition is correct. Virulence refers to the degree or severity of disease that an organism, such as a bacterium or virus, is capable of causing. Microorganisms with high virulence can cause severe illness or death in infected hosts, while those with low virulence may cause milder symptoms or no symptoms at all.
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