Writing the Narrative

Part of Pharmacovigilance and Drug Safety (PV) Training: Coding and the Narrative.

About 2 minutes. Free, in your language, no account needed.

Who you are writing for

A reader who was not there, has not seen the case, may read it years from now, and needs to understand what happened without reading the whole file.

It is not a summary of the fields above it. It is the account that makes the fields make sense.

What it contains

• The patient in brief: age, sex, relevant medical history
• The product: what, how much, for what, since when
• What else the person was taking
• What happened, in order, with dates
• What was done about it
• What happened after the product was stopped, if it was
• The outcome
• Alternative explanations considered

Chronological, always

The single most useful property of a narrative is that events appear in the order they happened. A reader assessing causality is reading for sequence. A narrative that opens with the outcome and works backwards makes that assessment harder for no benefit.

Neutral language

Describe, do not argue. "The patient developed a rash three days after the first dose, which resolved four days after the product was stopped" is a narrative. "The rash was clearly caused by the product" is an assessment, and assessments belong in the assessment fields.

Say what is unknown

A narrative that quietly omits what nobody established reads as complete. A reader cannot tell the difference between a fact that was checked and a fact that was never sought.

"The reporter was unable to confirm whether the product was restarted" is more useful than silence.

Length follows the case

A narrative long enough to carry the sequence and no longer. A three page account of a mild non-serious event wastes a reviewer's attention, which is finite and is needed elsewhere.