Rates of which phenomenon cannot be established from FAEMS reports?

• A. Occurrence
• B. Frequency
• C. Prevalence
• D. Incidence

Answer: (A)

The main idea is that spontaneous reporting systems like FAEMS collect reports of adverse events, but they don’t provide reliable denominators. To calculate a rate, you need both a numer and a defined population at risk (or exposure data) over a specific time. FAEMS can tell you that an adverse event has been reported, i.e., that occurrence has been observed within the system, but it cannot tell you how often that event happens in the broader population. Underreporting, reporting biases, and missing exposure data mean true rates—such as incidence or prevalence—cannot be established from FAEMS alone. To determine population-based rates, you’d need active surveillance or studies with known exposure numbers and a defined population.