Arizona MPJE (Pharmacy Jurisprudence) Practice Exam

Which significant regulation was established by the Kefauver-Harris Drug Amendment?

1. Adverse event reporting and informed consent for clinical trials

2. Importation of opium

3. Mandatory placebo use in trials

4. Pharmacy technician certification

The correct answer is: Adverse event reporting and informed consent for clinical trials

The Kefauver-Harris Drug Amendment, enacted in 1962, introduced significant changes to the way drugs were evaluated for safety and effectiveness. One key aspect of this amendment was the requirement for drug manufacturers to provide evidence of both safety and efficacy before a drug could be approved for use. The amendment also established the necessity for informed consent from participants in clinical trials, which means that individuals involved in research studies need to be fully informed about the potential risks and benefits before agreeing to participate. Furthermore, it put in place provisions for the reporting of adverse drug reactions, ensuring that any negative effects observed during clinical use are documented and addressed. While the other options presented may involve important regulations in pharmacy and healthcare practice, they do not represent the core aspects introduced by the Kefauver-Harris Drug Amendment. The regulation of opium importation, placebo use in clinical trials, and certification for pharmacy technicians are not central features of this landmark legislation. Thus, the requirement for adverse event reporting and the mandate for informed consent are the most significant and directly aligned with the provisions of the Kefauver-Harris Drug Amendment.