A client reports an adverse effect to the Adverse Event Reporting ...

[londonang]

A client reports an adverse effect to the Adverse Event Reporting System. The nurse recognizes if a potential safety concern is identified, the Food and Drug Administration (FDA) may take which actions?
 
  1. Determine the extent of the safety concern by conducting additional studies
  2. Require changes be made to the product's labeling information
  3. Recall the product
  4. Restrict the product's use in certain populations
  5. Continue to log in public concerns regarding the safety of the product before taking further action

Question 2

A nurse is reinforcing discharge instructions concerning fooddrug interactions. Which statements by the client indicate correct understanding of the discharge instructions?
 
  1. I should take my medications with water to avoid any problems with my medications being absorbed.
  2. I cannot take one of my medications with grapefruit juice because it will decrease the absorption of the medication.
  3. I need to be sure to read the prescription label because the pharmacist will indicate if I need to take my medication with food or without food.
  4. I should take my daily vitamin 2 hours after my medication so they do not affect each other.
  5. If I take my medication with hot tea, it will not affect absorption.

[C.mcnichol98]

Answer to Question 1

Correct Answer: 1,2,3,4
Rationale 1: The FDA will conduct additional epidemiologic studies to determine the validity or extent of the concern.
Rationale 2: The FDA will require the pharmaceutical company to change the product's label to reflect this concern.
Rationale 3: The FDA will recall a product that may have performance concerns.
Rationale 4: The FDA will restrict the product's use in certain populations.
Rationale 5: The FDA will not just continue to log in concerns regarding the safety of the product. At this point, additional studies, additional product labeling, recall, or removal of the product will occur.
Global Rationale: The FDA will conduct additional epidemiologic studies to determine the validity or extent of the concern, require the pharmaceutical company to change the product's label to reflect this concern, recall a product that may have performance issues, and restrict the product's use in certain populations. The FDA will not just continue to log in concerns regarding the safety of the product. At this point, additional studies, additional product labeling, recall, or removal of the product will occur.

Answer to Question 2

Correct Answer: 1,2,3,4
Rationale 1: The safest fluid to take with medications is water.
Rationale 2: Grapefruit juice can increase absorption of certain drugs and should be avoided.
Rationale 3: The pharmacist will indicate on the medication label if the medication should be taken with or without food.
Rationale 4: Herbal supplements and vitamins can cause adverse effects when taken with medication.
Rationale 5: Taking medication with caffeine or a hot drink can affect absorption and the effectiveness of medication.
Global Rationale: The safest fluid to take with medications is water. Grapefruit juice can increase absorption of certain drugs and should be avoided. The pharmacist will indicate on the medication label if the medication should be taken with or without food. Herbal supplements and vitamins can cause adverse effects when taken with medication. Taking medication with caffeine or a hot drink can affect absorption and the effectiveness of medication.