Washington Multistate Pharmacy Jurisprudence MPJE Practice Exam

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REMS Requirements may include:

  1. Only development of a MedGuide

  2. Assessments at specific post-marketing intervals such as 18 months, 3 years, and 7 years

  3. A ban on television advertising

  4. An endorsement by healthcare celebrities

The correct answer is: Assessments at specific post-marketing intervals such as 18 months, 3 years, and 7 years

Possible explanation REMS (Risk Evaluation and Mitigation Strategies) requirements are imposed by the FDA to ensure that a medication's benefits outweigh its risks. These requirements may include assessing the drug's safety at specific intervals after it has been approved and placed on the market, which is why option B is correct. Options A, C, and D are incorrect because a MedGuide is just one specific type of REMS requirement and is not exclusive to it. Additionally, while some medications may be subject to a ban on television advertising or may feature endorsements by healthcare celebrities, these are not typical REMS requirements.

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