trillium ii · 12/30/2017 · the deliverable specifies the interoperable fhir artefacts that...

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TRILLIUM II Reinforcing the Bridges and Scaling up EU/US Cooperation on Patient Summary

WP2

D2.5 v2017-12-30 Allergies and Intolerances: data sets, information structures,

value sets and tools-WP2-T2.4-SPMS

30.12.2017

Project title: Grant Agreement: Call identifier:

Trillium Bridge II - Reinforcing the Bridges and Scaling up EU/US Cooperation on Patient Summary 727745 H2020-SC1-2016-CNECT

Dissemination level: Public This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 727745

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Deliverable description

Number and name

of deliverable:

D2.5 v2017-12-30 Allergies and Intolerances - data sets, information structures,

value sets and tools-WP2-T2.4-SPMS

Publishable

summary:

The Project Trillium-II amplifies the EU/US cooperation that begn with Trillium

Bridge (2013-2015), in order to promote the adoption of the International Patient

Summary (IPS), supported by the use of standards.

Work Package 2 (WP2) of Trillium II defines the contents required in the I P S for

emergency and unplanned care, building up the standardized components, assets

and tools needed for this goal.

In this Work Package, task 2.4 produces the “Allergies/Intolerances ”components of

the International Patient Summary. The Allergies components of a Patient Summary

comprehends the information regarding a aptient’s allergies or intolerances, that is

vital to an healthcare professional. provide a better healthcare care to the patient.

This document - “D2.5: Allergies and Intolerances components for the Patient

Summary”, is the main deliverable from this task.

The deliverable specifies the interoperable FHIR artefacts that represent the

components “Allergies and Intolerances”, in an IPS. These artefacts include machine-

processable FHIR resource profiles, as well as the FHIR Value Set resources, which

select the standardized vocabularies supporting the content.

The component uses the base standard FHIR STU3 and reference terminologies to

represent Allergies and Intolerances in a meaningful way.

In addition, the deliverable provides one example for each component. All these

artefacts are accessible online and the deliverable provides the links to access them.

Status: Final Version: 1.0 Last update: 2017.12.30

Deadline: 2017.12.31

Actual delivery: 2017.12.30

Lead beneficiary: SPMS

Contact: Anabela Santos - [email protected]

Ruben Botelho – [email protected]

Contributors: Alexander Berler, Gnomon François Macary, Phast Kai U. Heitmann, HL7 Giorgio Cangioli HL7

Editors: Anabela Santos and Ruben Botelho, PT

mailto:[email protected]

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Statement of originality

This deliverable contains original unpublished work except where clearly indicated otherwise.

Acknowledgement of previously published material and of the work of others has been made through

appropriate citation, quotation or both.

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Change History

Version Date Author Organization Description

0.01 20171010 Anabela Santos SPMS Structure draft

0.02 20171127 Anabela Santos, Ruben Botelho

SPMS Refinement of the strucuture draft, further content and inputs from working materails


SPMS Refinements to the data set and incorporation of more data to the deliverable.

0.04 20171213 Anabela Santos SPMS Incorporation of inputs from HL7.


SPMS Refinements of the data set, incorporation of more content, FHIR Profiling.


SPMS First final draft version.


SPMS Incorporation of Giorgio and Kai inputs, adjustement of the data set, update of FHIR profiles, delivering more text content


SPMS Updating and creating new tables for FHIR resources profiles, value sets and Art-Décor dataset for Allergies or Intolerances. Reviewing content and inserting more information.


SPMS Refinement of the document.

1.0 20171230 Alexander Berler Gnomon Quality Review of the Document

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Table of Contents

1 Introduction ........................................................................................................................................... 8

2 Dependencies upon Other Trillium II Deliverables ................................................................................ 8

2.1. D2.1 Patient Summary Services: Gap Analysis ........................................................................................... 8

2.2. D2.2. Configuration Canvas for Patient Summary Component Libraries .............................................. 9

3 External Sources Considered ................................................................................................................. 9

3.1 HL7 International/CEN TC251 International Patient Summary (IPS) ........................................................... 9

3.1.1 Artefacts produzed by IPS for Allergies/Intolerances................................................................ 9

3.1.2 Comparison of scopes between IPS and Trillium II for Allergies/Intolerances ....................... 10

3.1.3. The Portuguese Catalogue of Allergies and Other Adverse Events (CPARA) ........................................ 10

4 Base Standards .................................................................................................................................... 10

4.1. FHIR Resources and Profiles ..................................................................................................................... 10

4.2. Reference Terminologies for Value Sets .................................................................................................. 11

4.3. Other terminologies ................................................................................................................................. 11

4.3.1 Medical Dictionary for Regulatory Activities- MedDRA ......................................................................... 11

4.3.2. World Health Organization’s Adverse Reaction Terminology (WHO ART)............................................ 11

4.3.3.The Portuguese Catalog of Allergies and Other Adverse Reactions (CPARA) ........................................ 11

5 Tools .................................................................................................................................................... 12

5.1. ART-DÉCOR for Dataset, Associated Semantics, Value Sets and Mappings ............................................. 12

5.2. Forge for profiling FHIR Resource ............................................................................................................. 12

5.3. Simplifier.net for storage of Profiles and assembly of Implementation Guide ........................................ 12

6 Information Model .............................................................................................................................. 12

6.1. Guidelines for including Statements on Allergies and Intolerances in a Patient Summary ..................... 12

6.2. Allergies and Intolerances dataset for a Patient Summary ...................................................................... 13

6.2.1. Rationale for buiding the dataset .......................................................................................................... 13

6.2.2. Overview of the dataset ........................................................................................................................ 13

6.2.3. Detailed view of the of the Allergies and Intolerances dataset ............................................................ 14

6.2.3.1. Detailed view of the of the core “Allergies and Intolerances” dataset .............................................. 15

6.3. Associated Semantics ............................................................................................................................... 17

7 Technical Specifications ....................................................................................................................... 18

7.1. Implementing allergies or datasets in FHIR .............................................................................................. 18

7.1.2. FHIR Resource Profiles for the Allergies and Intolerances dataset ....................................................... 19

7.1.3. Value Set for Allergies and Intolerances ............................................................................................... 19

8 Examples .............................................................................................................................................. 19

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8.1. Allergies .................................................................................................................................................... 19

9 Open and Closed Issues ....................................................................................................................... 20

9.1. Representing allergies to excipients in FHIR STU3 ................................................................................... 20

9.2. Representing criticality or severity in FHIR STU3 ..................................................................................... 21

10 Recommendations ............................................................................................................................... 21

11 Index of Value Sets .............................................................................................................................. 21

12 Glossary ............................................................................................................................................... 22

List of Tables

Table 1. IPS artefacts used as input to D2.5

Table 2. Resource profiles built on FHIR STU3 by D2.5

Table 3. Data Element Optionality Code

Table 4. Data Element Cardinality Code

Table 5. Semantics for Allergies and Intolerances dataset

Table 6. FHIR STU3 resources mapped to and constrained by the Allergy and Intolerances dataset

Table 7. Resource profiles on FHIR STU3 for Allergies and Intolerances

Table 8. Value Sets for Allergies and Intolerances

List of figures

Figure 1: High level view of the Allergies and Intolerances dataset

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Executive Summary

The Project Trillium-II amplifies the EU/US cooperation that begn with Trillium Bridge (2013-2015), in order

to promote the adoption of the International Patient Summary (IPS), supported by the use of standards.

Work Package 2 (WP2) of Trillium II defines the contents required in the I P S for emergency and unplanned

care, building up the standardized components, assets and tools needed for this goal.

In this Work Package, task 2.4 produces the “Allergies/Intolerances ”components of the International

Patient Summary. The Allergies components of a Patient Summary comprehends the information regarding

a aptient’s allergies or intolerances, that is vital to an healthcare professional. provide a better healthcare

care to the patient.

This document - “D2.5: Allergies and Intolerances components for the Patient Summary”, is the main

deliverable from this task.

The deliverable specifies the interoperable FHIR artefacts that represent the components “Allergies and

Intolerances”, in an IPS. These artefacts include machine-processable FHIR resource profiles, as well as the

FHIR Value Set resources, which select the standardized vocabularies supporting the content.

The component uses the base standard FHIR STU3 and reference terminologies to represent Allergies and

Intolerances in a meaningful way.

In addition, the deliverable provides one example for each component. All these artefacts are accessible

online and the deliverable provides the links to access them.

Deliverable 2.5: Allergies and Intolerances

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1 Introduction

The World Allergy Organization (WAO) estimates that allergies are present in 30 to 40% of the human

population, turning them a global public health problem. The prevalence and incidence continue to rise, while

societies become more affluent and urbanizedturning increasingly more important to recognize and register

these entities. A standardized register will promote the flow of this vital information between Eletronic

Health Record (EHR) systems.

Work Package 2 of the Trillium II Project, covers the baseline use case of emergency and unplanned care, and

builds the standardized components, assets and tools needed for this purpose, using standards.

Within this Work Package, Task 2.4 defines the conditions and scope of integration of allergies and

Intolerances into IPS. The task goals are to build the standardized components that carry these contents,

promoting later on, the integration in EHR systems.

This document – “D2.5: Allergies and Intolerances for the patient summary” is the main deliverable from this

task. The other deliverables of the task are annexed to it: machine-processable artefacts, such as profiles of

resources from the HL7 FHIR standard, semantic value sets based on reference terminologies and coded

examples.

2 Dependencies upon Other Trillium II Deliverables 2.1. D2.1 Patient Summary Services: Gap Analysis

Based on an inventory and a review of the Patient Summary initiatives in Europe and in the Unites States of

America, this deliverable provides an assessment of the topics typically expected in a patient summary, as

well as an inspection of the details in each topic.

It also brings back some open issues regarding some topics in the Allergies realm, to emerge downstream

along the content deliverables. As such, D2.1 is an input to task 2.4 in terms of scope, high-level requirements

and information model regarding the allergies realm.

In Deliverable 2.1, an inventory to allow a gap analysis was conducted. For that purpose, relevant initiatives,

regulations, previous and ongoing projects were assessed, using an inspection of the specifications

documents available, trough a survey.

The survey had two parts:

1. A questionnaire containing relevant questions about Patient Summary specifications, namely the

creation of profiles, policies and deliverables, split up into four main domains:

1.1 Legal

1.2 Organizational

1.3 Future goals

1.4 Additional aspects for Topic Matrix

2. Topic Matrix: a spreadsheet summarizing Patient Summary topics, in order to allow the checking of

details. The matrix was initially determined using the recent HL7 FHIR (STU 3) resource definitions with

manual cleaning-up, to obtain a more functional viewpoint on the topic items.


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The information about allergies or intolerances was present in 93% of the Patient Summaries cases, being

the top priority content in the context of unplanned care.

All responders reported to cover allergies and intolerances. The information is used mostly to mention

information related to pharmaceutical products or focuses on absolute contra-indications in an extra area

(alerts) regarding medication. In a few cases, this topic is summarized under“problems”, or “medical risks”.

Headings like “alerts” are used to subsume allergies and intolerances, along with other alerts. It is

mentioned that allergies and intolerances are almost always recorded by a physician.

The identification of the allergen and the type of reaction, when coded, is reported to be based on SNOMED

CT respectively. Local catalogues of “typical allergic reactions” are in place, some of them with a mapping to

international code systems.

2.2. D2.2. Configuration Canvas for Patient Summary Component Libraries

This deliverable is an input to task 3.4 in terms of technical framework, layout, method, conventions, tools

and framework. In particular, D2.2 has selected the framework of tools to be used to produce the component

library. Conventions, which are common to all content deliverables, are stated in D2.2.

D2.2 provides the template for all content deliverables, including this D2.5 deliverable.

D2.2. is also an input to this deliverable in terms of technical framework and production environment. In

particular, D2.2 selects the framework of tools to be used to produce the component library and sets up the

orchestration of these tools along the various steps of this production.

D2.2. also provides conventions common to all content deliverables, about conformance clauses,

cardinalities, as well as naming and identification conventions. These conventions are applied in chapters 6

and 7 of the current deliverable.

3 External Sources Considered 3.1 HL7 International/CEN TC251 International Patient Summary (IPS) IPS is the most recent source of thoughts for incorporating allergies and intolerances to patient summaries. The artefacts of this project that are used as input to this deliverable are:

• Dataset (business content for allergies)

• Templates, particularly entry-level templates (structured data representing allergies);

• Value sets providing the semantics associated with the data elements of the templates.

3.1.1 Artefacts produzed by IPS for Allergies/Intolerances IPS is the most recent source of thoughts for incorporating allergies and intolerances lists into patient summaries.

The artefacts of the IPS project that are used as input to this deliverable are listed in the table below:


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Artefacts Medications

Dataset “Allergies and Intolerances”

Section templates “IPS Allergies and Intolerances Section”

Entry-level templates “IPSEntryAllergyOrIntolerance”

Value sets “Agent”, ”Seriousness”, “Classification ofAllergy Reaction” “Status”, “Clinical Manifestation of Allergy/Intolerance Reaction”

Table 1. IPS artefacts used as input to D2.5

D2.1 helped pointing open issues regarding the Allergies or Intolerances topic, to be further analyzed and

closed by the current D2.5 deliverable:

a) Should there be “Notes” in order to allow a registry of allergies using free text?

b) If the answer to the previous question is yes, should we have notes for all values sets or only for

specific ones, like for example substances or allergy reaction?

c) Should we use the term “Criticality” or “Severity”, or both, when the seriounness of an allergic

reaction is to be stated? Both terms have the goal to issue an alert to a physician, pointing a serious

reaction that can endanger a patient’s life. But can we estimate a risk using what has happened, or

can only register that a serious allergic reaction has occurred?

The outcome of D2.1 is a key input to the content of chapters 6 and 7 of the current deliverable.

3.1.2 Comparison of scopes between IPS and Trillium II for Allergies/Intolerances .. The “IPS AllergiesOrIntolerances section”

3.1.3. The Portuguese Catalogue of Allergies and Other Adverse Events (CPARA) The Portuguese Catalogue of Allergies and Other Adverse Events (CPARA) is a structured registry of allergies

and adverse reactions, implemented in the PT Health System. Inspired in the project epSOS, and using several

value sets related to allergies (epSOSActiveIngredient, epSOSReactionAllergy, etc), it is composed of seven

tables, interconnected and mandatory. Each table contains one domain with information considered vital to

characterize allergies:

- Source of Information

- Date

- Classification of Adverse Reaction

- Allergens, subdivided in Drugs, Food and Other Substances

- Severity

- Status

- Confirmation

The catalogue uses SNOMED CT codes, except for Drugs, that are coded using ATC.

4 Base Standards 4.1. FHIR Resources and Profiles FHIR is the base-standard chosen by the Trillium II project to represent and structure of the content of

International Patient Summary.

This D2.5 deliverable builds Profiles on these Resources from the FHIR standard:


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FHIR Resource Type

List

AllergyIntolerance

Table 2. FHIR resources profiled by D2.5

In addition, the deliverable uses profiles, which are common to all content deliverables for the following

resources: Encounter, Organization, Patient, Practitioner, RelatedPerson.

4.2. Reference Terminologies for Value Sets The Trillium II project has chosen a number of international reference terminologies to carry the semantic

content IPS.

This deliverable uses in particular these reference terminologies:

• SNOMED CT (Systematized Nomenclature of Medicine Clinical Terms): international clinical

terminology, used to codify clinical content, in different contexts (diagnosis, observable entities, etc).

• ATC (Anatomical Therapeutic Chemical Code), used to codify active ingredients, which are molecules

(substances) with therapeutic activity. This classification is adopted by the World Health Organization

(WHO). The drugs are classified in different groups and subgroups (levels), according to the organ or

system upon which they act upon.

4.3. Other terminologies

4.3.1 Medical Dictionary for Regulatory Activities- MedDRA

In the late 1990s, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals

for Human Use (ICH) developed MedDRA, a specific standardised medical terminology for medical products

used by humans. Its major goal is to harmonise and promote the sharing of regulatory information

internationally. MedDRA is available to all for use in the registration, documentation and safety monitoring

of medical products, both before and after a product has been authorised for sale. Products covered by the

scope of MedDRA include pharmaceuticals, biologics, vaccines and drug-device combination products.

Today, its growing use worldwide by regulatory authorities, healthcare professionnals, pharmaceutical

companies, clinical research organisations. https://www.meddra.org/

4.3.2. World Health Organization’s Adverse Reaction Terminology (WHO ART)

The WHO Adverse Drug Reaction Terminology (WHO-ART) was developed and is maintained by the Uppsala

Monitoring Centre, the World Health Organization (WHO) Collaborating Centre for International Drug

Monitoring. WHO-ART is used for coding clinical information related to adverse drug reactions, being a a

four-level hierarchical terminology, beginning at the body system/organ level classes. These classes consist

of broad grouping terms, containing more specific “prefered” terms. WHO also contains commonly used

terms (“included terms”), that act as entry terms for the preferred terms, being updated every threee

months. It’s mainly used by regulatory agencies and pharmaceutical manufacturers. More information

available in: https://www.who-umc.org/whodrug/whodrug-portfolio

4.3.3.The Portuguese Catalog of Allergies and Other Adverse Reactions (CPARA)

The Portuguese Catalog of Allergies and Other Adverse Reactions was inspired on the euopean project epSOS.

In epSOS, value sets regarding allergies were developed, using the code system SNOMED CT and ATC for

https://www.meddra.org/

https://www.who-umc.org/whodrug/whodrug-portfolio


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drugs. CPARA v1.0 was the first structured registry to be implemented in PT National Health System, back in

2013, using a national code system, because Portugal wasn’t yet a part of IHTSDO community, the entity

responsible to develop and maintain the international terminology.

CPARA is composed of seven tables, each one containing a domain with a list of terms, considered vital to

characterize these entities. Their filling is mandatory, being regulated by law. In 2015, the version 3.0 of the

catalogue provided an update and also brought SNOMED CT as the code system, keeping the same

structure. The version 3.1.1, dated September 2017,has expanded the number of terms, mantaing SNOMED

CT as the reference terminology. The catalogue is avalilable in the Clinical Terminologies Centre (CTC):

http://www.ctc.min-saude.pt/

5 Tools This section builds on top of section 3 “Orchestration of tools” of deliverable D2.2, and derives the choices

made to the actual content of D2.5: Allergies and Intolerances.

5.1. ART-DÉCOR for Dataset, Associated Semantics, Value Sets and Mappings

The tool ART-DECOR is used to define the content “Allergies and Intolerances” of the PS and to capture the related business requirements. The features of the tool used for these steps are:

• “Dataset”: development of the reference model and underlying concepts;

• “Scenario”: to describe the dynamic usage of each content in the context of “unplanned care”.

Scenario is a layer of the dataset, and provides the cardinalities and conformance clauses.

• “Value sets”: to select the semantics associated with coded concepts of each of these contents.

Art-Decor is used again downstream to map the FHIR profiles registered in Simplifier.net back to the datasets

in Art-decor, and to the associated value sets.

5.2. Forge for profiling FHIR Resource

Forge authoring tool is used to transpose the information model into a set of related FHIR resource profiles.

5.3. Simplifier.net for storage of Profiles and assembly of Implementation Guide The Simplifier.net registry is used to publish the FHIR resource profiles, and to assemble the set of FHIR

resource profiles together with server capabilities, into a FHIR implementation guide.

6 Information Model

This section builds on top of section 3 “Orchestration of tools” of deliverable D2.2.

6.1. Guidelines for including Statements on Allergies and Intolerances in a Patient Summary

Focus on Allergies registry

As established by the overall topic matrix annexed to deliverable D2.1, the allergies and intolerances are the

top priority the International Patient Summary. It is expected that this information appears as coded, and

not free text, as it happens in most of the patient summaries nowadays. On the other hand, it should provide

not only the allergen or the agent of intolerance, but also the information of the source of information, the

severity, the kind of reaction, the status or the confirmation. The focus is in a structured registry of the event,

in order to be able to provide information vital to patient’s safety.

http://www.ctc.min-saude.pt/


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Registering the data

The information about allergies is often written in free text and not coded, using “notes”, where it can be captured. The data contained can, thus, be variable and referring to different items. When the information is coded, is focused mainly in the agents or allergens that cause the allergic reaction, instead of the condition of the allergy it self. For example, “intolerance or allergy agent: penicillin”, instead of “ Allergy to Penicillin”. On the other hand, only more recent systems capture information on “Intolerance”.

Most systems use local codes, and only a few report using the standard SNOMED CT. Allergic reactions are also mostly recorded using local value sets and “pick” lists. Qualified Allergies and Intolerances reports:

Each report of an Allergy and Intolerance is about one allergen, one specific kind of allergic reaction. This

report must be able to specify who made the notification and when. The source of information is vital, since

the quality of data can be infered based on who provided it. If the source is a medical doctor specialized in

allergies, the degree of confidence is much stronger than if is the patient him/her self. For example, it is not

uncommon to find “Allergy to Penicilin” registered in a patient’s record, and the patient is actually taking a

penicillin derivative.

Allergies and unplanned care:

The patient summary is build to support unplanned care, providing thus information that is both summarized

but vital for a healthcare provider that meets the patient for the first time. Allergy to drugs must be

registered, such as the agent, to assure patient’s safety. On the other hand, the severity of the allergic

reaction is also important. Based on that, we can assume that a next encounter with the allergen may convey

a higher or a lower risk to the patient. A higher risk may even be translated in a life-threatening event.

6.2. Allergies and Intolerances dataset for a Patient Summary

6.2.1. Rationale for buiding the dataset

The Allergies/Intolerances components of the International Patient Summary are a list of qualified

statements, each of which describing an allergy or intolerance identified in a given period of time. The

statement includes the available details about the allergic reaction. Alternatively, the list may be limited to

a single statement expressing “Not Known allergies”, meaning that there is no information available about

allergies, or the allergies are unknown. Anyway, the final result is that there are no allergies registered to

for that patient.

6.2.2. Overview of the dataset

The figure below shows the Allergies and Intolerances dataset. The concepts in this dataset are organized as

a tree structure. Optionality/cardinalities of each concept are not shown on this high-level view.

Details of each concept, as well as usage constraints and cardinalities are showed on the detailed view in

section 6.2.3.

The top element “Allergies/Intolerances ” represents an homogeneous list of Allergies or Intolerances

statements:


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Figure 1: High-level view of the Allergies dataset

6.2.3. Detailed view of the of the Allergies and Intolerances dataset

In the detailed view of the dataset, we provide the hierarchy of data set elements. In the detailed view, the

following codes for Data Element Optionality Constraints and Data Element Cardinalities have been used.

Optionality Description

M The data element is mandatory. It shall be provided with actual data in all cases

R The data element is required. It shall be provided, but may be empty in case there is no data available for it

C The data element is conditional. It shall be provided if the associated condition is verified.

O The data element is optional. It may or may not be provided.

Table 3. Data Element Optionality Code


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Cardinalities Interpretation

[0..1] Zero or one occurrence of the data element

[0..*] Zero or more occurrence of the data element

[1..1] Exactly one occurrence of the data element

[1..*] One or more occurrence of the data element

[1..n] At least one occurrence and not more than n for the data element

Table 4. Data Element Cardinality Code

6.2.3.1. Detailed view of the of the core “Allergies and Intolerances” dataset

Allergies and intolerances 1..1 R 1

List of allergies and intolerances

Allergies and Intolerances 1..* R 6

Source of Information 0..1 R 9

Type of information source about the allergy, e.g. patient, caregiver, nurse etc.

Type (Code) 1..1 R 10

The Type of the source of information

• Patient

• Medical doctor

• Allergy - specialty

• Healthcare professional

• Caregiver

• Legal guardian

• Nurse

• Provider of history other than subject

• Relative

• Description (Text) 0..1 R 11

The description of the source of information code

Seriousness (Code) 1..1 R 26

Identification of the degree of severity of the allergic reaction.

• high

• low

• unable-to-assess

• Assertion Date (Date) 0..1 16

The date in witch the allergy or intolerance is registered

Onset 0..1 17

The year in witch the allergy or intolerance has occured

From (Date) 0..1 18

Until (Date) 0..1 19

Status 0..1 8

Allergy/intolerance status


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Code (Code) 1..1 R 14

Allergy/intolerance status code

Description (Text) 0..1 R 15

Description of the allergy/intolerance status

Classification 0..1 22

Allergy/Intolerance Classification (allergy/intolerance)


• Drug allergy

• Drug intolerance

• Food allergy

• Food intolerance

• Allergy to substance

• Intolerance

• No known allergies

• Description (Text) 0..1 34

Diagnosis 1..* C 23

A (coded) diagnosis of the allergy/intolerance, e.g. lactose intolerance, penicillin allergy

o 1..* R Else

o Description (Text) 0..1 R 25


Code systems that provide codes relating the diagnostic data about allergies. For example, ICD10 CM, SNOMED CT, etc

Agent 1..* C 30

The type of alergen (food, drug or substance) that triggers the allergy or intolerance reaction

o 1..* R Else

o

Type (Code) 0..1 R 2

• Drug

• Food

• Substance

•


• Apple - dietary

• Aspartame

• Carrot, etc


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Clinical Manifestation of the Allergy/Intolerance Reaction 0..* 4

The clinical manifestation of reaction to an allergen


• . Urticaria

• . Dry eyes, etc.

•

Severity (Code) 0..1 R 35

The degree of severity of the allergic reaction

• . Severe

• . Mild


6.3. Associated Semantics

The table below lists the semantics for the codable items of the dataset:

Item Value set/open semantics

Source

Severity Indicating allergy seriousness

SNOMED CT

Status Code representing the status of Allergies and Intolerances

SNOMED CT

Classification Code representing a type of Allergies and Intolerances

SNOMED CT

Diagnosis Code representing the allergy to a substance, drug or food.

SNOMED CT, ICD 10-CM

Agent Code representing the allergen

ATC, SNOMED CT

Clinical Manifestation of the Allergy/Intolerance reaction

Clinical manifestation of the allergy and intolerance

SNOMED CT

Table 5. Semantics for Allergies and Intolerances dataset


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7 Technical Specifications

7.1. Implementing allergies or datasets in FHIR

Allergies and Intolerances dataset are implemented in FHIR by profiling allergies resource. As FHIR resources

contain mandatory elements in addition to those that have been identified in the dataset, these mandatory

elements are included in the profiles.

According to typical FHIR profiling conventions, non-mandatory FHIR elements which do not have

correspondence in the present dataset are omitted (cardinality 0…0) in profiles.

7.1.1. FHIR Resources for the Allergies and Intolerance dataset item

FHIR Resource Date element Profiling constraints/ extension

Allergy and Intolerance List

- AllergyIntolerance AllergyIntolerance

- - Source of Information AllergyIntolerance Asserter

- - - Type AllergyIntolerance Code One slice of CodeableConcept.coding (SNOMED CT)

- - - Description AllergyIntolerance Description

- - Seriousness AllergyIntolerance Criticality Value set: high | low |

unable-to-assess Min = 1

- - Onset AllergyIntolerance Onset

- - - From Datetime Date

- - - Until Datetime Date

- - Status AllergyIntolerance Verification Status

- - - Code AllergyIntolerance Code One slice of CodeableConcept.coding (SNOMED CT)


- - Classifications



- - Diagnosis AllergyIntolerance Diagnosis Min = 1 if any Agent present

- - - Code AllergyIntolerance Code One slice of CodeableConcept.coding (SNOMED CT, ICD10 CM/PCS, etc)


- - Agent AllergyIntolerance Agent Min = 1 if any Diagnosis present

- - - Type Value set: Food | Drug | Substance

- - - Code AllergyIntolerance Code One slice of CodeableConcept.coding (SNOMED CT or ATC)


- - Type of Allergy/Reaction AllergyIntolerance Reaction



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- - - Severity AllergyIntolerance Severity Value set: Severe | Mild


Table 6. FHIR STU3 resources mapped to and constrained by the Allergies and Intolerances dataset

7.1.2. FHIR Resource Profiles for the Allergies and Intolerances dataset

The table below references the resource profiles built on FHIR STU3, for allergies and intolerances.

FHIR STU3 resource Profile

Link to online specification

AllergyIntolerance https://simplifier.net/TrilliumII/AllergyIntolerance-summary-TrilliumII

List List-ofAllergies

https://simplifier.net/TrilliumII/ListofAllergies-summary-TrilliumII

Table 7. Resource profiles on FHIR STU3 for Allergies and Intolerances

7.1.3. Value Set for Allergies and Intolerances

The value sets are built and managed in ART-DECOR. The list below provides direct links to the value sets on

the ART-DECOR platform, as well as the link of the Value Set resources.

Name ART-DÉCOR Value Set

Allergy Intolerance Information Source

https://art-decor.org/art-decor/decor-valuesets--trilm2-?id=2.16.840.1.113883.3.1937.777.19.11.4

Allergy Intolerance Substances


Allergy Severity FHIR https://art-decor.org/art-decor/decor-valuesets--trilm2-?id=2.16.840.1.113883.4.642.3.125

Table 8. Value Sets for Allergies and Intolerances

8 Examples 8.1. Allergies

Dataset item Value Additional information - Source of Information - -Type Allergy - specialty - Seriousness High - Assertion Date 02-05-2013 - Onset - - From 2012 Year - Status

- - Code 55561003 SNOMED CT

https://simplifier.net/TrilliumII/AllergyIntolerance-summary-TrilliumII

https://simplifier.net/TrilliumII/AllergyIntolerance-summary-TrilliumII







https://art-decor.org/art-decor/decor-valuesets--trilm2-?id=2.16.840.1.113883.4.642.3.125

https://art-decor.org/art-decor/decor-valuesets--trilm2-?id=2.16.840.1.113883.4.642.3.125


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- - Description Active

- Classifications - - Code 414285001 SNOMED CT

- - Description Food Allergy - Agent - - Type Food - - Code 256319004 SNOMED CT - - Description Carrot - Type of Allergy/Reaction - - Code 1985008 SNOMED CT - - Severity Severe - - Description Vomitus

Table 9. Example of dataset values for food allergic reaction

bDataset item Value Additional information - Source of Information - -Type Healthcare professional - Seriousness High - Assertion Date 02-08-2012 - Onset - - From 2010 Year - Status

- - Code 55561003 SNOMED CT - - Description Active

- Classifications - - Code 59037007 SNOMED CT

- - Description Drug intolerance - Agent - - Type Drug - - Code N02BE01 ATC - - Description Paracetamol - Type of Allergy/Reaction - - Code 126485001 SNOMED CT - - Severity Severe - - Description Urticaria

Table 10. Example of dataset values for a drug (paracetamol)

9 Open and Closed Issues 9.1. Representing allergies to excipients in FHIR STU3

Many times, patients are not allergic to an active ingredient, but instead to the excipient: element added to

the active ingredient in order for the human body be able to absorb a drug. Usually, an excipient has no

medicinal properties. Its standard purpose is to streamline the manufacture of the drug product and

ultimately facilitate the physiological absorption of the drug. Excipients might aid in lubricity, flowability,

disintegration, taste, etc. and may confer some form of antimicrobial function.

An excipient must best a) suit the intended dosage form of the drug, b) have organoleptic properties, c) be

conform to the pharmacopeial regulations, d) be easy to source, and e) work effectively. The potential


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toxicity, and the origin of the chemicals, such as other factors, influence the excipient chosen to deliver a

drug. For example, a plant-based excipient might be chosen over another with animal origin (gelatin), to

avoid allergies.

These allergies are frequently underreported, being wrongly mistaken with allergies to the active ingredients

itself. Their representation in a structured format, would be paramount to have a clear distinction of them.

SNOMED CT has a code for “allergy to a drug vehicle” (402593006 | Allergy to drug vehicle) and a code for

“Drug coating (product) (80371006|Drug coating (product)). However, these concepts keep out other

excipients used, for example, to lubricate or to assure the dilution of a drug.

Allergic reactions to excipients contained in drugs are rare but can be severe or confusing. With regard to

generic versus brand drug, often the ingredients are different. One of possible the strategies may involve

to recommend that the physician exercises caution in considering which brand drug or generic was

administered and in listing all medicine components, and not only the active ingredient.

9.2. Representing criticality or severity in FHIR STU3

These items were matter of an ongoing discussion inside the working group. Criticality represents a risk of

the severity of an allergic reaction, based in the present allergen encounter. Severity refers to the

seriousness of the allergic reaction.

The discussion was mainly focused in the possibility or not to foster a risk of severity projected in the future,

based only on the present reaction. To give an example, if a patient has a light allergic reaction today (a

localized rash), that doesn’t mean that in the future, when he encounters the same allergen, the reaction is

only mild and doesn’t endanger patient’s life. Because allergies are an immune-mediated process, the next

encounter with the same allergen may, in fact, turn into a potentially lethal event, depending on the immune

status of the patient, the amount of allergen, and other variables.

The working group felt, however, that this kind of information should be captured, because if a first allergic

reaction is severe, that is a clear indicator that an high risk of a severe posterior allergic reaction. So, it was

proposed that both terms be captured in the data set, but placed in different items. Criticality was substituted

by the term “seriousness”.

10 Recommendations

Promoting the implementation of a structured registry of Allergies and Intolerances is paramount to promote

patient’s safety and the quality of healthcare. The International Patient Summary can boost the

dissemination worldwide of this register and promote good practices. Regular updates of the value sets

should be kept in mind, since these entities keep augmenting at a logarithmic scale.

Another recommendation is the alignment of the Standard terminologies used in IPS for Allergies and

Intolerances with other standards used in this context such as MedDRA (Medical Dictionary for Regulatory

Activities), for example.

11 Index of Value Sets See section 7.1.3.


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12 Glossary Abbreviation Definition IPS International Patient Summary

WAO World Allergy Organization

WP2 Work Package 2

EHR Electronic Health Record

PS Patient Summary

WHO World Health Organization

ATC Anatomical Therapeutic Chemical Code

FHIR Fast Healthcare Interoperability Resource

SNOMED CT Systematized Nomenclature of Medicine Clinical Terms

MedDra Medical Dictionary for Regulatory Activities

STU3 Standard for Trial Use release 3 of the FHIR standard

CEN TC 251 Comité Européen de Normalisation - Technical Committee of Health Informatics

HL7 Health Level Seven

ART-DECOR Advanced Requirement Tooling - Data Elements, Codes, OIDs and Rules

WHO-ART World Health Organization’s Adverse Reaction Terminology

epSOS Smart Open Services for European Patients

PT Portugal

IHTSDO International Health Standards Development Organization

CTC Clinical Terminologies Centre

CPARA Portuguese Catalog of Allergies and Other Adverse Events

ICH International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

trillium ii · 12/30/2017 · the deliverable specifies the interoperable fhir artefacts that...

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