Modelling Adverse reaction event report to regulatory bodies

Good morning openEHR community,

I’m currently exploring the design of a potential OpenEHR template for an Adverse reaction event report to regulatory bodies. This report is intended to contain a comprehensive range of information, including specific details about the adverse reaction, patient information (age, weight and height), clinical management details and medication details.

In structuring this template, I plan to principally utilize the Adverse reaction risk archetype (openEHR-EHR-EVALUATION.adverse_reaction_risk.v2), the Adverse reaction event archetype (openEHR-EHR-CLUSTER.adverse_reaction_event.v1) and include additional data as required by Health Authorities.

I am particularly interested in how to persist specific details about the medication associated with the adverse reaction event. These details may include Batch ID, dose, frequency, administration date and administration route. In this way, after reviewing the available archetypes, I couldn’t locate a “Substance details” cluster within the Adverse reaction event archetype, as observed in the Adverse reaction monitoring archetype (openEHR-EHR-OBSERVATION.adverse_reaction_monitoring.v1).

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?

I would really appreciate any insights or experiences from the community regarding modeling Adverse event Report to regulatory bodies (I think that there could be similarities with the UK Yellow Card scheme).

Thank you in advance.
Best regards,
David H

Hello David.

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:

Many thanks for your detailed response. I appreciate your input of potential data duplication and the option of referencing the original data. I am eager to hear additional perspectives from the community on this topic.