Special Case Types — Death, Pregnancy, Overdose, and Device-Related Events

Most of what this module covers applies to every narrative, but a handful of case types carry structural requirements the standard template doesn’t fully capture — and they get read with unusual care precisely because the stakes of getting them wrong are higher. Fatal cases are the clearest example: the narrative needs the stated cause of death, whether an autopsy was performed and what it found if so, and an explicit statement of the temporal relationship between the suspect drug and the death — not left for the reader to infer from the dates elsewhere in the case.

Pregnancy cases need a different kind of precision: exposure timing relative to gestational age or trimester, because teratogenic risk varies enormously across pregnancy, and outcome tracked for both mother and fetus or infant, for as long as follow-up allows. A pregnancy narrative that reports the mother’s outcome but not the infant’s — or vice versa — is incomplete in a way that a routine adverse event narrative missing a comparable detail usually isn’t, because both outcomes are independently reportable and independently important.

Overdose narratives require a distinction that’s easy to skip: intentional versus accidental, and — separately — which effects came from the overdose itself (a predictable, dose-related toxicity) versus any adverse reaction that would have been genuinely unexpected even at a normal dose. Conflating those two collapses information a reviewer specifically needs, since an overdose producing an entirely predictable toxic effect is a very different safety signal from an overdose that also produced something no one would have predicted from the drug’s known profile.

Device-related narratives shift the frame again: alongside the usual clinical picture, the narrative needs the device identifier, a description of what actually malfunctioned or what user error occurred, and — critically — whether the report is really about the device, the associated drug, or both. A combination product where a delivery device failed and caused a dosing error is a fundamentally different kind of case than the same device delivering the correct dose while the patient had an unrelated drug reaction, and the narrative needs to make that distinction unambiguous rather than leaving both possibilities open.