Triage

Part of Pharmacovigilance and Drug Safety (PV) Training: Intake and Triage.

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

Two questions, in this order

When a report arrives, two questions decide everything that follows:

Is this a valid case? The four criteria from the previous chapter.

Is it serious? Because a serious case carries a short clock and a non-serious case does not.

Everything else can wait a little. These cannot.

Triage is a decision to escalate, not a final assessment

Triage is deliberately fast and deliberately cautious. You are not making the final seriousness determination at intake. You are deciding whether this needs to move now.

If the report is ambiguous about seriousness, treat it as serious for triage purposes and let the full assessment correct it. The cost of a case that moved quickly and turned out to be non-serious is some wasted effort. The cost of the reverse is a missed regulatory deadline.

What to capture before the reporter is gone

A spontaneous reporter is often available once. Before ending that first contact:

• Confirm the product, including strength and formulation if known
• Ask what happened, in their words, and when
• Ask about the outcome and whether the person is still taking the product
• Establish whether the product was stopped and what happened afterwards
• Get contact permission for follow-up

The last one is the one most often forgotten, and it is the one that makes every later question possible.

Do not interrogate

A distressed reporter describing something that happened to their mother is not a data source to be optimized. Ask what you need, in a human order, and be willing to lose a field rather than lose the reporter.