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. “I cannot smoke while taking this medication."
This statement is not directly related to the proper use of clarithromycin (Biaxin). While smoking cessation is generally encouraged for overall health, it is not specifically required while taking clarithromycin. However, smoking may affect the effectiveness of antibiotics in general due to its impact on the respiratory system and immune function.
B. “I can quit taking this medication when I feel better."
This statement is incorrect. It is important to emphasize to the client that they should complete the full course of antibiotics as prescribed by their healthcare provider, even if they start to feel better before finishing the medication. Stopping the medication prematurely can lead to incomplete treatment and potentially contribute to antibiotic resistance.
C. “I cannot drive while taking this medication.”
This statement is not accurate. Clarithromycin (Biaxin) is not typically associated with sedation or impairment of driving ability. While some medications may cause drowsiness or other side effects that affect driving, this is not a common side effect of clarithromycin.
D. “I need to take this medication until it is gone."
This statement indicates an understanding of the importance of completing the full course of antibiotics as prescribed by the healthcare provider. Taking the medication until it is finished helps ensure that all bacteria are effectively treated and reduces the risk of antibiotic resistance.
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.
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