Lesson 1 of 3 · about 20 min
What goes in, and in what order
A narrative is a short, factual story of the case. A reviewer should be able to read it and understand who the patient is, what they took, what happened, what was done, and how it ended, without opening the structured fields.
Use this order:
- Source and patient: who reported it, and the patient's age and sex
- Relevant medical history and risk factors
- Suspect drug: indication, dose, route, start date, and any concomitant medicines
- The event: onset, first signs, and how it developed, in time order
- Investigations and findings, with dates and units
- Treatment given and action taken with the suspect drug
- Dechallenge and rechallenge, if any
- Outcome at the time of the report
- The reporter's causality opinion, and the company opinion if one exists
Write in the third person and past tense. Use dates or days relative to the drug start. Avoid abbreviations your reader may not know, and spell out units. Keep to what the source says. If something is unknown, write that it is unknown instead of leaving it out.
Worked example
A physician reported that a 64-year-old female patient with type 2 diabetes started drug X 10 mg orally once daily for hypertension on 03 March. On 09 March, six days later, she developed a generalised itchy rash. She was seen on 10 March, drug X was stopped, and she was given cetirizine. The rash improved over the next three days and had resolved by 15 March. No rechallenge was done. The physician considered the event related to drug X.