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 B
Explanation
A. Headaches:
Headaches are a common symptom that can occur for various reasons, including stress, tension, dehydration, or as a side effect of medications. While headaches can sometimes occur as a side effect of certain drugs, they are not specific indicators of a drug allergy. Allergic reactions to medications typically involve other symptoms such as rash, hives, itching, swelling, or respiratory symptoms.
B. Hives or shortness of breath:
Hives (urticaria) are raised, red, itchy welts on the skin that can occur as an allergic reaction to medications. They are a common manifestation of drug allergies. Shortness of breath (dyspnea) can occur as part of a severe allergic reaction known as anaphylaxis. Anaphylaxis is a life-threatening allergic reaction characterized by a rapid onset of symptoms, including difficulty breathing, swelling of the throat or tongue, rapid heart rate, and low blood pressure. Both hives and shortness of breath are significant signs of a potential drug allergy and require immediate attention.
C. Diarrhea:
Diarrhea can occur as a side effect of medications, including antibiotics. However, it is not typically a specific indicator of a drug allergy. Diarrhea is more commonly associated with gastrointestinal disturbances or as a reaction to changes in gut flora due to antibiotic use.
D. Nausea:
Nausea is a common side effect of many medications, including antibiotics. While it can be bothersome, nausea alone is not a specific indicator of a drug allergy. Allergic reactions to medications typically involve other symptoms such as rash, hives, itching, swelling, or respiratory symptoms.
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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