Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

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ADRs deemed significant by the pharmacist shall be reported to the FDA's _____________.

  1. FDA Online Reporting

  2. Medwatch program

  3. Safety Recall Center

  4. Drug Enforcement Agency

The correct answer is: Medwatch program

The MedWatch program is the FDA's safety information and adverse event reporting system, making it the appropriate channel for pharmacists to report significant adverse drug reactions (ADRs). MedWatch serves as a way for healthcare professionals, including pharmacists, to communicate serious problems that they experience with pharmaceuticals, dietary supplements, and other medical products, thereby contributing to the FDA's mission of protecting public health. This program allows for timely dissemination of important safety information to healthcare providers and the public, facilitating improved patient safety and better-informed clinical decisions. The other options do not serve the specific function of reporting ADRs. For instance, FDA Online Reporting is a general reference and does not directly correlate with the structured system for adverse event reporting. The Safety Recall Center deals with product recalls rather than individual ADRs. The Drug Enforcement Agency primarily focuses on the regulation and enforcement related to controlled substances and does not handle ADR reporting. Therefore, the MedWatch program is the clear and correct choice for reporting significant ADRs.