Which of the following is a legal requirement contained in the DSHEA?

The herbal product must contain only one active ingredient

Effectiveness must be demonstrated by the manufacturer

Dietary supplements must state that the product is not intended to diagnose, treat, cure, or prevent any disease

Dietary supplements must be tested for safety prior to marketing

Answer and Explanation

The Correct Answer is C

A. The herbal product must contain only one active ingredient:

This statement is not a legal requirement contained in DSHEA. Many dietary supplements contain multiple active ingredients, such as vitamins, minerals, herbs, amino acids, and other substances. DSHEA does not mandate that dietary supplements contain only one active ingredient.

B. Effectiveness must be demonstrated by the manufacturer:

DSHEA does not require manufacturers to demonstrate the effectiveness of dietary supplements before marketing. Unlike pharmaceutical drugs, which must undergo premarket approval by the Food and Drug Administration (FDA) to demonstrate safety and efficacy, dietary supplements do not need to prove effectiveness to be marketed. Instead, manufacturers are responsible for ensuring the safety of their products and making truthful claims on product labels.

C. Dietary supplements must state that the product is not intended to diagnose, treat, cure, or prevent any disease:

This statement accurately reflects a legal requirement contained in DSHEA. Under DSHEA, dietary supplement labels must include a disclaimer stating that the product is not intended to diagnose, treat, cure, or prevent any disease. This disclaimer helps to clarify that dietary supplements are intended to support general health and well-being rather than to treat specific diseases or medical conditions.

D. Dietary supplements must be tested for safety prior to marketing:

While DSHEA requires manufacturers to ensure the safety of their dietary supplements, it does not mandate standardized premarket testing for safety by regulatory authorities. Instead, manufacturers are responsible for conducting safety assessments and ensuring that their products are safe for consumers. The FDA may take action against manufacturers if a product is found to be unsafe or if it violates regulatory requirements, but premarket testing is not a specific legal requirement under DSHEA.

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Correct Answer is C

Explanation

A. "Expect your urine to turn pink or red while taking this medication."

This statement is incorrect. Vancomycin does not typically cause urine discoloration. However, red man syndrome, characterized by flushing of the skin, particularly on the face and upper body, can occur with rapid infusion of vancomycin. This is not related to urine color change.

B. "Discontinue the medication once your symptoms subside."

This statement is incorrect. It's crucial for the client to complete the full course of antibiotics as prescribed, even if symptoms improve before completing the treatment course. Discontinuing the medication prematurely can lead to the development of antibiotic resistance and recurrence of the infection.

C. "Notify your provider if you experience any changes in your hearing."

This statement is correct. Vancomycin can potentially cause ototoxicity, which may manifest as changes in hearing, including ringing in the ears (tinnitus) or hearing loss. Clients should be instructed to report any such symptoms to their healthcare provider promptly.

D. "Decrease your fluid intake to 1000ml per day."

This statement is incorrect. Adequate hydration is essential, especially when taking medications like vancomycin, to help prevent kidney damage and promote drug elimination. Restricting fluid intake is not advisable unless specifically instructed by the healthcare provider for a particular medical reason.

A. Penicillins B. Fluoroquinolones C. Aminoglycosides D. Sulfonamides

Correct Answer is B

Explanation

A. Penicillins:

Penicillins are a class of antibiotics commonly used to treat various bacterial infections. While they are generally well-tolerated and have a low incidence of adverse effects, they are not typically associated with cartilage toxicity or tendon rupture, including the Achilles tendon.

B. Fluoroquinolones:

Fluoroquinolones are broad-spectrum antibiotics known for their effectiveness against a wide range of bacteria. However, they are associated with several significant adverse effects, including cartilage toxicity and tendon rupture. These adverse effects, particularly tendon rupture, are most commonly observed in weight-bearing tendons such as the Achilles tendon. Fluoroquinolones should be used cautiously, especially in populations at higher risk for tendon injuries.

C. Aminoglycosides:

Aminoglycosides are another class of antibiotics used to treat severe bacterial infections. While they have their own set of potential adverse effects, such as nephrotoxicity and ototoxicity, they are not associated with cartilage toxicity or tendon rupture.

D. Sulfonamides:

Sulfonamides are antibiotics that inhibit bacterial growth by interfering with the synthesis of folate. While they can cause various adverse effects, including skin reactions and hematologic abnormalities, they are not associated with cartilage toxicity or tendon rupture.

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Which of the following is a legal requirement contained in the DSHEA?

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Naxlex Comprehensive Predictor Exams

A nurse is reinforcing teaching about vancomycin with a client who has an infection. Which of the following information should the nurse include in the teaching?

Correct Answer is C

Explanation

Which class of antibiotic is associated with cartilage toxicity and rupture of the Achilles tendon?

Correct Answer is B

Explanation

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