Modelling Adverse reaction event report to regulatory bodies

[damoca (David Moner)]

Hello David.

@david.hernandez

Considering this, would it be appropriate to include a dedicated section containing the “openEHR-EHR-ACTION.medication.v1” archetype in order to persist specific details about the medication associated with the adverse reaction event?

Exactly, this is how it works. Always remember that the openEHR-EHR-EVALUATION.adverse_reaction_risk.v2 will be contained inside a COMPOSITION, from which you will build the template. And that COMPOSITION can contain other ENTRY archetypes with related information.

In your case, if you are representing a report for each single adverse reaction event, you can use the openEHR-EHR-COMPOSITION.event_summary.v0 archetype as the root of your template, and add to it all the ENTRY archetypes you need.

Now, the advanced/tricky part, and I would like to hear the opinion of others. For sure both the adverse reaction EVALUATION and the medication ACTION are already registered in the CDR, probably through an encounter record. And now you want to communicate it to a regulatory body using a report where you will be duplicating the data. Or you can create a report that references the original data. Which is the best approach?

This is a know grey area that has been discussed several times in the community, buy I feel that we still don’t have a clear response.

More info:

How accurately do we model "copied" data?

openEHR templates will frequently feature data from other repositories. In the context of a clinical referral letter, results may be added in to the narrative of the text and this is itself a copy of the source data from the pathology system. We have to be aware that this data exists and should not be used i.e. query only the source systems. We have to make a decision on how accurately we model this data i.e. as an observations, SNOMED CT codes etc with accurate values. Or do we only store thes…