Nokea
Because of their site of action, bile acid sequestering resins:
- A. Should be administered separately from other drugs by at least 4 hours
- B. May increase the risk for bleeding
- C. Both 1 and 2
- D. Neither 1 nor 2
Correct Answer: A
Rationale: Bile acid resins bind drugs in the gut, requiring separation by 4 hours.
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The nurse is caring for a patient who had a severe, acute, previously unseen adverse effect of a drug in Phase III testing. The patient asks, After all the testing done on this drug, didn't they know this adverse effect could occur? What is the nurse's best response? (Select one that does not apply.)
- A. Pharmaceutical companies sometimes underreport problems to make more money.
- B. Your response to this medication will be reported to the drug company and the Food and Drug Administration (FDA).
- C. After a drug reaches phase III testing it is considered an accepted drug and will not be recalled.
- D. The pharmaceutical company weighs the benefits of the drug with the severity of adverse effects.
Correct Answer: B
Rationale: When a new and unexpected adverse effect occurs, especially one of a serious nature, it is reported to the drug company who reports it to the FDA immediately. When a large number of people begin using the drug in phase III studies, it is not unusual to identify adverse effects not previously noted. It would be both unprofessional and inaccurate to imply that pharmaceutical companies put profit ahead of patient concern because lawsuits would remove any potential profit if a drug proves harmful. The FDA is responsible for weighing risk versus benefit in deciding whether to allow the drug to move to the next phase of testing. Drugs found to have serious adverse effects can be removed from the market at any time.
Which of the following legislative acts allowed the Food and Drug Administration (FDA) to tighten control over the quality of drugs and required that safety and efficacy standards be established?
- A. Pure Food and Drug Act of 1906
- B. Federal Food, Drug, and Cosmetic Act of 1938
- C. Durham Humphrey Amendment of 1951
- D. Kefauver-Harris Act of 1962
Correct Answer: D
Rationale: The Kefauver-Harris Act was the result of the use of the 1960s drug thalidomide (Thalomid). The public concern led to the legislation that gave the FDA regulatory control over testing and evaluating of drugs and allowed it to set standards for efficacy and safety. The Pure Food and Drug Act required labeling to eliminate false claims. The Federal Food, Drug, and Cosmetic Act gave the FDA the power to enforce standards for testing drug toxicity and monitoring labeling. The Durham-Humphrey Amendment enforced prescriptions for distribution.
Monitoring of a patient on gabapentin to treat seizures includes:
- A. Routine therapeutic drug levels every 3 to 4 months
- B. Assessing for dermatologic reactions, including Steven's Johnson
- C. Routine serum electrolytes, especially in hot weather
- D. Recording seizure frequency, duration, and severity
Correct Answer: D
Rationale: Monitoring seizure activity is key to assessing gabapentin efficacy.
NSAIDs should be avoided in which group(s) of patients?
- A. Kidney disease
- B. Myocardial infarction
- C. Irritable bowel syndrome
- D. All of the above
Correct Answer: D
Rationale: NSAIDs can worsen kidney function, increase cardiovascular risk, and exacerbate GI conditions, making them risky for all listed groups.
Which of the following glucocorticosteroids are used for cerebral oedema:
- A. Triamcinolon
- B. Prednisolon
- C. Prednison
- D. Dexamethasone
Correct Answer: D
Rationale: Dexamethasone is favored for cerebral edema due to its strong anti-inflammatory properties and low mineralocorticoid activity.