Adverse reaction risk: the provenance

This week I documented the provenance of our Adverse Reaction Risk archetype – it has been a long & memorable journey from the first iteration in 2006 through to its publication in the international openEHR CKM last November 2015.

In the beginning was Sam Heard‘s original archetype – created way back in 2006 when Ocean Informatics had a .biz email address and before any collaboration – just the initial thoughts of one individual.


This was uploaded to the International openEHR CKM in July 2008.


In 2008 this archetype had its first collaborative review. The results of this were collated and as Editor I revised this archetype significantly to include the review feedback PLUS input from a number of publications available from NHS England, FDA and TGA  drug reporting requirements and the ICH-E2B publications. This was uploaded at the end of August 2009.

In late 2010, Australia’s National eHealth Transition Authority (NEHTA) forked the archetype and brought it into the NEHTA CKM environment and ran a series of 5 archetype reviews during the period through to June 2011. The resulting archetype formed the basis for the adverse reaction data elements in the initial PCEHR CDA documents which are currently being transmitted from Australian primary care clinical systems into the PCEHR (now rebadged as ‘My Health Record‘).

NEHTA starts.jpg

In 2012, there was another review round carried out in the international CKM.

The results from that 2012 review, the outcomes from the June 2011 NEHTA archetype and publications from HL7’s FHIR resource and RMIMs were amalgamated by Ian McNicoll in June 2014 to form a new archetype – initial called ‘Adverse Reaction (AllergyIntolerance)‘ and later, the ‘Adverse Reaction (FHIR/openEHR)’ archetype – with the intent of conducting a series of joint FHIR & openEHR community review of the combined model and at the end of the process generating a FHIR resource AND an openEHR archetype with matching, clinically verified content.hl7.jpg

In August 2014 the first joint openEHR/FHIR review was carried out, with myself (@omowizard, AU, openEHR), Ian McNicoll (@ianmcnicoll, UK, openEHR), Graham Grieve (@GrahameGrieve, AU, FHIR) & Russ Leftwich (@DocOnFHIR, USA, HL7 Patient Care/FHIR) as editors. Nasjonal IKT forked the archetype into the Norwegian CKM at the conclusion of that process.


There was a subsequent joint review between openEHR & FHIR that followed, only rather than the few weeks I had anticipated, we had to wait until the FHIR community completed a full FHIR ballot. This blew out the review period to 7 months for our work.


This really highlights the need to separate the ballot/review process for clinical artefacts like FHIR resources and archetypes from balloting process of complete technical standard or specification within a typical standards organisation. If we use this same glacially slow process for the governance of clinical artefacts then it will take decades to achieve high quality shared clinical models.

And one HL7 participant contacted me and said it would be impossible for them to respond to the archetype review in less than 6 months. <facepalm here>. Just for perspective, our typical review round is open for 2 weeks and it takes anywhere from 10 minutes to 30 minutes for most participants to record their contribution.

But we waited… and fed the FHIR ballot comments back into the next archetype iteration. There were not that many! And then we sent it out for the next review – and this time the Norwegian CKM community participated as well. The Norwegian CKM team (led by Silje Ljosland Bakke, @siljelb, & John Tore Valand, @Jtvaland) translated the archetype into Norwegian &  ran a slightly shorter review period, contributing the collective feedback into the international review.

We did this simultaneous review across the FHIR, international and Norwegian communities twice – once in July 2015 and another in November 2015. One of these reviews resulted in the renaming of the archeytpe  concept to ‘Adverse reaction risk’.


At the end of the November 2015 review round, the editors found that there was a consensus reached amongst the participants. In the international CKM we removed the FHIR-specific components and published the content of the ‘Adverse reaction risk’ archetype. The publication status of original archetype was simultaneously changed in the CKM  to rejected – this rejected archetype remains in the international CKM as part of the provenance/audit trail for the published archetype.


The Norwegian CKM has now taken that international archetype and published it within their CKM and under their own governance. The archetypes are semantically aligned.

The FHIR resource has evolved in keeping with the archetype changes. To be completed honest I’m not sure if the final, published openEHR archetype has been reflected back into the latest FHIR resource, but there is no doubt that there certainly the great majority of the two artefacts are aligned due to the joint review process.


The archetype that has finally been published started with the brain dump of a single clinical informatician. At this point in its journey this archetype alone has been shaped by:

  • 13 review rounds
  • 221 review contributions
  • 92 unique individuals
  • 16 countries (top 3 being AU, NO & US)

This has been a very significant block of international work. Getting any kind of consensus on such a clinically significant artefact across different jurisdictions, standards organisations and diverse requirements has not been easy. But we have experienced a great generosity of spirit from all who contributed their time, expertise and enthusiasm to capture an open specification for a single piece of clinical knowledge that can be re-used by others, and potentially improved even more over time.

This is what the published Adverse reaction risk archetype looks like today:


The detail and thought behind each data element and example is significant. Yet we know it is not perfect, nor ‘finished’.

No doubt we will identify new requirements or need to modify it. This journey will then start its next phase…

If you have identified additional requirements… If you disagree with the model…  then register and contribute to the community effort now by registering on the international CKM and make a change request or start a discussion thread.



The unknown substance conundrum…

Is it safe and sensible to record that a patient has had an adverse/allergic reaction to an unknown substance?

This is a question that is causing quite a stir in the HL7 Patient Care email list and I have no doubt that it will be a hot topic in the current FHIR/openEHR Adverse Reaction archetype review. Some are advocating to record a reaction without offering a possible causal substance.

I think we can all agree that it makes absolute sense to record the DIAGNOSIS of an obviously <allergic manifestation> (eg urticaria) to an unknown substance as “<allergic manifestation> of unknown origin”. I think most can comfortably agree with that statement.

Now for the controversial bit…

However while a patient can have a reaction to an unknown substance, I will assert that it does NOT make sense to record an ADVERSE REACTION manifestation to an unidentified substance. I am certainly not denying that a clinician who observes a rash that is clearly of allergic origin, such as an urticaria, will absolutely be thinking in terms of ‘this is clearly of allergic origin and I must investigate further to identify the substance’. This is clearly good clinical practice. However, as clinicians, I am suggesting that sometimes we need to differentiate between what we observe or think from what we might record in a health record at the same given point in time .

In all my years of clinical practice, I cannot remember any paper record where I have ever seen ‘urticaria’ or ‘anaphylaxis’ entered into the Allergy List without a proposed substance being associated. I can see absolutely no reason why we should start doing this for electronic health records.

Both the substance and the manifestation are required to enable a clinician to avoid future exposures in future clinical care. That is the logic behind the existence of the ubiquitous Adverse Reaction or Allergy List.

Until one or more causal substances is postulated and/or confirmed, an isolated clinical manifestation of urticaria or anaphylaxis is, in reality, just a simple (maybe allergy-related) sign, symptom or diagnosis of unknown cause. The act of recording a reaction to ‘nothing’ or ‘unknown substance’ adds no absolutely no value to the Adverse Reaction or Allergy List as it cannot trigger any decision support by a clinical system.

I think I can also safely assert that all clinicians ideally want to be able to prevent a future reaction for their patient, especially in the situation where the substance may not be identifiable at the time of the reaction. This is a key clinical activity that we need to be able to record clearly in EHRs – we cannot afford for an identified allergic reaction to be ‘lost’ in the health record before we can identify the substance.

To that end, the HL7 Patient Care approach has been to record a Reaction Event in the absence of a Substance, while the openEHR approach has been to record the manifestation as part of the health record – symptoms, signs, test results, diagnosis etc, of unknown origin. However for both, a clear imperative is that the clinician can able to flag that this patient has an unresolved puzzle: that there has been a known allergic reaction that may cause future harm if the cause is not identified.

So collectively we need to determine a way for this outstanding health puzzle to be tracked and not lost in the depths of a long ago consultation note. This aligns with the design of Lawrence Weed’s Problem Oriented Medical Records (POMR). In HL7, this approach is captured in their concept of ‘Concern Tracker’, and in the draft Contsys standard (ISO 13940) it is known as a ‘Health Issue Thread’. openEHR needs to develop EVALUATION archetype/s that will support this abstract concepts and support the POMR approach.