West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

Which legislation impacts the requirement for patient counseling on medications?

1. Controlled Substances Act of 1970

2. Drug Quality and Security Act of 2013

3. Omnibus Budget Reconciliation Act of 1990 (OBRA 90)

4. Pure Food and Drug Act of 1906

The correct answer is: Controlled Substances Act of 1970

The correct choice is the Omnibus Budget Reconciliation Act of 1990 (OBRA 90). This legislation significantly impacted pharmacy practice by establishing requirements for patient counseling and drug utilization review for Medicaid patients. OBRA 90 specifically mandates that pharmacies must offer counseling to patients upon the dispensing of medications, ensuring that they receive essential information about their prescriptions, which enhances patient understanding and safety. In contrast, the Controlled Substances Act of 1970 primarily focuses on the regulation of drugs and substances that have the potential for abuse, establishing schedules for these substances and their distribution. It does not address patient counseling requirements directly and is more concerned with the legal framework for the prescribing and dispensing of controlled substances. The Drug Quality and Security Act of 2013 addresses issues related to the safety of the drug supply chain but does not specifically mandate patient counseling. The Pure Food and Drug Act of 1906 was one of the first federal laws aimed at regulating food and drug safety. While it laid the groundwork for later consumer protection laws, it does not specifically relate to patient counseling practices. Thus, the focus of OBRA 90 on patient counseling distinctly makes it the relevant legislation for requirements regarding counseling on medications.