Author Question: The client receiving a newly released medication is experiencing adverse effects. Why does the nurse ... (Read 59 times)

appyboo · **on:** Jul 23, 2018

The client receiving a newly released medication is experiencing adverse effects. Why does the nurse report these adverse effects as part of the postmarketing surveillance stage of the drug approval process?

1. The clinical trials are continuing to collect new data.
2. Individual client response is compared with the clinical trial data.
3. The efficacy of the drug is determined for new drugs.
4. Harmful effects in the larger population continue to be monitored.

Question 2

Which statements regarding the preclinical research stage of drug development are true?

1. Most drugs do not proceed past the preclinical stage because they are found to be too toxic or just ineffective.
2. At the end of the preclinical research stage, client variability is determined and potential drug-to-drug interactions are examined.
3. The preclinical stage of research involves extensive testing on animals in the laboratory to determine if the drug will cause harm to humans.
4. Preclinical research results are always inconclusive.
5. The Food and Drug Administration (FDA) is responsible for extensive testing for safety before the pharmaceutical company can begin the preclinical research stage of development.

l.stuut · **Reply #1 on:** Jul 23, 2018

Answer to Question 1

Correct Answer: 4
Rationale 1: The clinical trials end before the drug is released for use by the general public.
Rationale 2: The client's response is not compared with previous clinical trials.
Rationale 3: The efficacy for the drug is not evaluated via the adverse effects.
Rationale 4: Some harmful effects are subtle, take longer to appear, and are not identified until the drug is prescribed to a large number of people; thus, postmarketing surveillance for harmful effects must be reported.
Global Rationale: The nurse reports the adverse effects because some harmful effects are subtle, take longer to appear, and are not identified until the drug is prescribed to a large number of people; thus, postmarketing surveillance for harmful effects must be reported. The clinical trials end before the drug is released for use by the general public. The client's response is not compared with previous clinical trials. The efficacy for the drug is not evaluated via the adverse effects.

Answer to Question 2

Correct Answer: 1,3,4
Rationale 1: Most drugs do not proceed past the preclinical research stage of development because they are found to be either too toxic or just ineffective.
Rationale 2: Client variability and potential drug-to-drug interactions are examined in Phase 3 of the clinical investigation process after Food and Drug Administration (FDA) approval.
Rationale 3: The preclinical stage of development involves extensive testing on human, microbial cells, and animals to determine drug action and to predict whether the drug will cause harm to humans.
Rationale 4: Because lab tests cannot accurately predict human response to a drug, these results are always inconclusive.
Rationale 5: This extensive testing is done by the pharmaceutical company in the preclinical research stage of drug development, not the FDA.
Global Rationale: The true statements include: most drugs do not proceed past the preclinical research stage of development because they are found to be either too toxic or just ineffective; the preclinical stage of developmentinvolves extensive testing on human, microbial cells, and animals to determine drug action and to predict whether the drug will cause harm to humans; and because lab tests cannot accurately predict human response to a drug, these results are always inconclusive. Client variability and potential drug-to-drug interactions are examined in Phase 3 of the clinical investigation process after Food and Drug Administration (FDA) approval. Extensive testing is done by the pharmaceutical company in the preclinical research stage of drug development, not the FDA.