The nurse explains that is regard to regulation by the Dietary Supplement Health and Education Act, dietary supplements:
do not have to demonstrate effectiveness
are determined to be safe before being placed on the market
are checked for label accuracy
are tested prior to marketing
The Correct Answer is A
- Do not have to demonstrate effectiveness:
This statement is generally true under DSHEA regulations. Unlike pharmaceutical drugs, dietary supplements are not required to undergo rigorous testing to demonstrate their effectiveness in treating, preventing, or curing specific health conditions before they are marketed. However, manufacturers are prohibited from making unsubstantiated claims about the effectiveness of their products.
B. Are determined to be safe before being placed on the market:
Under DSHEA regulations, dietary supplement manufacturers are responsible for ensuring the safety of their products before they are marketed. However, unlike pharmaceutical drugs, dietary supplements do not undergo premarket approval by the Food and Drug Administration (FDA) to verify their safety and efficacy. Instead, manufacturers are required to notify the FDA of their intent to market a new dietary ingredient (NDI) and provide evidence of the ingredient’s safety.
C. Are checked for label accuracy:
The FDA regulates dietary supplements to ensure that their labels are accurate and truthful. However, the extent of label accuracy checking varies, and the FDA does not routinely test every dietary supplement product on the market. Instead, the FDA relies on postmarket surveillance, consumer complaints, and other mechanisms to identify and address inaccuracies or violations of labeling regulations.
D. Are tested prior to marketing:
Unlike pharmaceutical drugs, dietary supplements are not required to undergo premarket testing to demonstrate their safety or efficacy before they are marketed. While manufacturers are responsible for ensuring the safety of their products, there is no formal premarket testing requirement under DSHEA regulations.
Nursing Test Bank
Naxlex Comprehensive Predictor Exams
Related Questions
Correct Answer is D
Explanation
A. Echinacea:
Echinacea is an herbal supplement commonly used to support the immune system and reduce the severity and duration of cold symptoms. However, there is limited evidence to support its efficacy in preventing urinary tract infections (UTIs). While it may have some immune-boosting properties, it is not typically recommended specifically for UTI prevention.
B. Saw palmetto:
Saw palmetto is an herbal supplement often used for prostate health and to alleviate symptoms of benign prostatic hyperplasia (BPH) in men. It is not typically used for preventing urinary tract infections in either men or women.
C. Black cohosh:
Black cohosh is an herbal supplement commonly used by women to alleviate symptoms of menopause, such as hot flashes and mood swings. It is not typically used for preventing urinary tract infections.
D. Cranberry juice:
Cranberry juice and cranberry supplements have long been studied for their potential role in preventing urinary tract infections, particularly in women. Cranberry contains compounds that may prevent bacteria, such as Escherichia coli (E. coli), from adhering to the walls of the urinary tract, reducing the risk of infection. While the evidence supporting cranberry's effectiveness in preventing UTIs is mixed, some studies suggest that it may be beneficial, especially in individuals prone to recurrent UTIs.
Correct Answer is A
Explanation
A. Ototoxicity:
Ototoxicity refers to damage to the auditory and vestibular nerves, leading to hearing loss and balance disturbances. Gentamicin, being an aminoglycoside antibiotic, is known for its potential to cause ototoxicity. Signs and symptoms of ototoxicity include changes in hearing, ringing in the ears (tinnitus), and imbalance. Ototoxicity is irreversible and can occur suddenly or gradually during gentamicin therapy. Therefore, any signs or symptoms of ototoxicity should be reported immediately to the physician for further evaluation and management.
B. Nausea:
Nausea is a common gastrointestinal side effect associated with gentamicin therapy. While it can be bothersome to the patient, nausea alone is not typically considered a severe adverse effect that requires immediate reporting to the physician. However, if nausea is severe or persistent and leads to dehydration or electrolyte imbalances, it should be addressed promptly.
C. Constipation:
Constipation is another potential gastrointestinal side effect of gentamicin therapy. Like nausea, constipation alone is not typically considered a severe adverse effect that requires immediate reporting to the physician. However, if constipation is severe or persistent and leads to discomfort or bowel obstruction, it should be addressed promptly.
D. Increased urinary output:
Increased urinary output may indicate improved renal function, which can be a desired effect during gentamicin therapy. Gentamicin is primarily excreted by the kidneys, and increased urinary output may help in the elimination of the drug from the body. Therefore, increased urinary output alone is not typically considered an adverse effect that requires immediate reporting to the physician. However, if there are signs of dehydration or electrolyte imbalances associated with increased urinary output, they should be addressed promptly.
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