Aggregate Does Not Mean Unimportant

Part of Pharmacovigilance and Drug Safety (PV) Training: What Does Not Expedite.

About 1 minutes. Free, in your language, no account needed.

The reports that change labels

It is easy to treat the expedited case as the real work and the aggregate report as paperwork. The history of the field does not support that.

Most label changes, most risk minimization measures and most withdrawals come from the accumulated picture, not from a single dramatic case. The individual report is rarely conclusive on its own. Thirty of them, against a known denominator, can be.

What an authority does with it

A regulator reading a periodic report is deciding whether the balance of benefit and risk is still acceptable on the current terms. The possible outcomes include leaving the product alone, changing the label, requiring additional studies, restricting the indication, or suspending the authorization.

That decision is made on what the report contains.

Frequency changes are the quiet finding

The event everyone knows about, occurring more often than the label says, is a real finding and an easy one to overlook, because nothing in it is new. A listed reaction occurring at three times the listed frequency is a change in the product's risk profile even though no new event has appeared.

This is the kind of thing only an aggregate view can show.

The cumulative view

A periodic report covers an interval, and it also carries a cumulative position. An event occurring twice in the interval may be occurring for the eleventh time overall, and the interval view alone would make it look trivial.

Anyone reading only the current interval is reading half the report.