Building a Case From an Incomplete Report
Part of Pharmacovigilance and Drug Safety (PV) Training: Processing the Case.
About 2 minutes. Free, in your language, no account needed.
Most reports are incomplete
The report you receive will rarely contain everything you need. The work of case processing is assembling a coherent account from partial information without inventing the parts that are missing.
What you are trying to establish
- Who the patient is, in the limited sense that matters: age band, sex, relevant history
- What product, at what dose, for how long, and for what indication
- What happened, when, and in what sequence relative to the product
- What else the person was taking
- What was done and what the outcome was
The sequence is the part most often lost. An event that started before the first dose is a different case from one that started after it, and a report that says only "patient developed a rash" does not tell you which.
Sources you may use
The reporter. The medical records, if provided. The investigator, for a trial case. Published literature about the product. The reference safety information.
Not: your assumption about what usually happens, or what the event probably was.
The line you do not cross
If a reporter says the patient had "a heart problem", you record a heart problem and you ask what kind. You do not record myocardial infarction because that is the most likely heart problem in a person of that age.
This is the single most common way an inexperienced case processor damages a database. The invented specificity is invisible later, because the case reads as though somebody knew.
Record what you did not find
A field left blank and a field actively established as unknown look identical in most systems unless you distinguish them. "Concomitant medications: none reported" and "Concomitant medications: reporter states none" are different facts.