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.
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.
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