Which of the following complaints by a man taking gentamycin would be most indicative that he is experiencing ototoxicity?

A. Penicillin will be effective in treating the infection:

This interpretation is correct. When the culture and sensitivity test results show that the bacteria causing the infection are sensitive to penicillin, it means that penicillin will effectively inhibit the growth of these bacteria, leading to the resolution of the infection. This sensitivity indicates that penicillin is an appropriate and effective choice for treating the infection.

B. Penicillin will not be effective in treating the infection:

This interpretation is incorrect. If the bacteria are sensitive to penicillin, it means that penicillin will be effective in treating the infection. Sensitivity to penicillin indicates that the bacteria are susceptible to the antimicrobial activity of penicillin, and therefore, penicillin is expected to be effective in eradicating the infection.

C. The test must be repeated to obtain accurate results:

This interpretation is not warranted based on the information provided. If the culture and sensitivity test results indicate that the bacteria causing the infection are sensitive to penicillin, there is no need to repeat the test for accuracy. Sensitivity testing provides valuable information about the susceptibility of bacteria to specific antibiotics, helping healthcare providers make informed decisions about appropriate treatment.

D. Ms. Robertson is allergic to penicillin:

This interpretation is unrelated to the information provided in the scenario. The culture and sensitivity test results indicate the susceptibility of bacteria to penicillin, not whether the patient has an allergy to penicillin. Allergy testing is a separate diagnostic process used to determine if a patient is allergic to penicillin or other medications. Sensitivity testing does not provide information about the patient's allergy status.

1. 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.