Definition

The frequency of adverse event reports relative to drug exposure, typically expressed as reports per patient-years of exposure or per units sold.

Example

If 100 reports are received and estimated exposure is 1 million patient-years, the reporting rate is 0.0001 or 10 per 100,000 patient-years.

Regulatory source

Signal Detection, Epidemiology

Common mistakes

Interpreting reporting rates as incidence rates. Spontaneous reporting has significant underreporting and cannot establish true incidence.

Inspector question

How do you calculate and use spontaneous reporting rates? What caveats do you apply when interpreting them?

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