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

Answer and Explanation

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.

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Correct Answer is D

Explanation

A. Antagonistic reaction:

An antagonistic reaction refers to a response where one substance opposes the action of another substance. In the context of hypersensitivity reactions, this term does not accurately describe the immune system's response to an allergen. Hypersensitivity reactions involve an overreaction of the immune system to a harmless substance, rather than opposing actions between substances. Therefore, choice A is not the correct term to describe hypersensitivity reactions.

B. Drug idiosyncrasy:

Drug idiosyncrasy refers to an unusual or unexpected response to a medication that is not related to the known pharmacological properties of the drug or the patient's characteristics. While idiosyncratic drug reactions can sometimes involve immune-mediated mechanisms, they are not synonymous with hypersensitivity reactions. Hypersensitivity reactions specifically involve the immune system's exaggerated response to an allergen, which may or may not be a medication. Therefore, while drug idiosyncrasy may involve unpredictable reactions, it does not specifically address the immune-mediated nature of hypersensitivity reactions.

C. Synergistic reaction:

A synergistic reaction occurs when the combined effect of two substances is greater than the sum of their individual effects. In the context of hypersensitivity reactions, this term does not accurately describe the immune system's response to an allergen. Hypersensitivity reactions involve an exaggerated response of the immune system to an allergen, rather than a synergistic interaction between substances. Therefore, choice C is not the correct term to describe hypersensitivity reactions.

D. Allergic reaction:

An allergic reaction is the correct term to describe hypersensitivity reactions. Hypersensitivity reactions involve the immune system's exaggerated response to a harmless substance, known as an allergen. This response can manifest in various symptoms, ranging from mild to severe, depending on the individual's sensitivity and the nature of the allergen. Allergic reactions can affect different organ systems and can be triggered by a wide range of substances, including foods, medications, environmental allergens, and insect venom. Therefore, choice D accurately describes hypersensitivity reactions.

A. By assessing the temperature every 4 hours B. By repeating a culture and sensitivity test on day 3 C. By obtaining drug peak and trough levels D. By assessing for breathlessness

Correct Answer is C

Explanation

A. By assessing the temperature every 4 hours:

Monitoring temperature every 4 hours is a common practice in hospitalized patients to detect fever, which could indicate an infection or an inflammatory response. However, this method does not directly assess the therapeutic blood levels of vancomycin. Fever alone does not provide specific information about the effectiveness or concentration of the antibiotic in the bloodstream.

B. By repeating a culture and sensitivity test on day 3:

Culture and sensitivity tests involve taking a sample from the patient (such as blood, urine, or sputum) and growing the microorganisms in a laboratory to identify the causative organism and determine its susceptibility to antibiotics. While this test is essential for identifying the appropriate antibiotic therapy initially, repeating it on day 3 does not directly monitor therapeutic blood levels of vancomycin. It also doesn't provide real-time information about the concentration of vancomycin in the bloodstream.

C. By obtaining drug peak and trough levels:

This choice involves measuring the highest (peak) and lowest (trough) concentrations of vancomycin in the bloodstream. Peak levels are typically measured about 1 hour after the completion of a vancomycin infusion, while trough levels are measured just before the next dose is administered. These measurements allow healthcare providers to ensure that the drug concentration remains within the therapeutic range to effectively treat the infection while minimizing the risk of toxicity.

D. By assessing for breathlessness:

Assessing for breathlessness is important for monitoring respiratory status, particularly in patients receiving vancomycin, as rare side effects like red-man syndrome or anaphylaxis can cause respiratory distress. However, this method does not directly monitor therapeutic blood levels of vancomycin.

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The nurse explains that is regard to regulation by the Dietary Supplement Health and Education Act, dietary supplements:

Nursing Test Bank

Naxlex Comprehensive Predictor Exams

A patient asks the nurse to define hypersensitivity reaction. The nurse begins by telling the patient that a hypersensitivity reaction is also called:

Correct Answer is D

Explanation

What is the best method of monitoring therapeutic blood levels of vancomycin during therapy?

Correct Answer is C

Explanation

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