1. WP1: D 1. 3 openMedicine infostructure WP2: D 2
WP1: D 1.3 openMedicine infostructure WP2: D 2.3 Final data elements (identification and description)
Contact: William Goossen (NEN;
TOWARDS A TRANS-ATLANTIC SOLUTION TO UNIVOCALLY IDENTIFY MEDICINAL PRODUCTS
USA-EU Workshop
FDA White Oak Campus, New Hampshire Av., Silver Spring, MD
is a project funded by the in the context of

2. Overall goal and objectives of D 1.3
initial multi-standards framework
solutions to issues identified in epSOS
attention to factors related to multiple contexts
univocal identification of medicinal products:
identifiers
and descriptive attributes
application context: ePrescription, eDispense, record keeping

3. Development of D 1.3 / D 2.3
Use D 1.1. summary of epSOS results on ePrescription:
No identification of medicinal product
Identifier
Descriptive attributes
Issues with variations in contexts
Legal
Roles of professionals
ICT / eHealth strategies
And more
Methodology:
Systems approach
Identification of contextual factors
Identification of identifiers and of descriptive factors from IDMP
Discussions with various experts

4. EHRs, communication, profiles, messages
Multiple contexts in which the medicinal product is used
Example 1: ISO EN
Compositions
Set of entries comprising a clinical care session or document e.g. test result, letter e.g epSOS sPrescription document
EHR
The electronic health record for one person
Folders
High-level organisation of the EHR e.g. per episode, per clinical speciality
Sections
Clinical headings reflecting the workflow and consultation/reasoning process: e.g. prescription
Clusters
Compound entries, test batteries e.g. blood pressure, full blood count
Elements
Element entries: leaf nodes with values e.g. reason for encounter, body weight
Data values
Date types for instance values e.g. coded terms, measurements with units
Entries
Clinical “statements” about Observations,
Evaluations, and Instructions e.g. which medicine to take

5. ISO TS 19256 Medicinal product dictionary
Holds and uniqely identifies regulated medicinal products within jurisdictions
Localised dictionaries of IDMP based identifiers from industry and regulators

6. Identify the identifiers
Table 1. Core identifying data elements from IDMP for all use cases for all domains.
Source
Data element
EMA article 57 database
Use case
Xborder ePrescription / Dispense / Record keeping
Include/ exclude in DCM
Motivation
ISO 11238
Substance ID
Include
include
Every substance will be identified by this mandatory ID.
ISO 11616
Pharmaceutical Product Identifier PhPID
Every pharmaceutical product will be identified by this mandatory ID.
ISO 11615
Medicinal Product Identifier MPID
Every (regulated) medicinal product will be identified by this mandatory ID.
Packaged Medicinal Product Identifier (PCID)
Every packaged product will be identified by this mandatory ID.

7. And all other IDMP items….
Table 2 Data elements from the substance standard EN ISO and implementation guide ISO TS (FRAGMENT ONLY)
Source ISO IDMP
IDMP data elements
IDMP: Mandatory Should Conditional
EMA article 57 database
Xborder use case
DCM include/ exclude
Motivation
ISO TS 19844
Ingredient M
include
Core concept for the ingredient level of data elements. A substance is any matter that has a discrete existence, irrespective of origin, which may be biological or chemical.
4.1. Specified_Substance
include optional
This one is normally not used in clinical practice, and hence not yet included in the DCM. However, included optional based on expert input.
4.1. Specified_SubstanceGroup
exclude
Valueset 4 categories. Normally not used in clinical practice, could be considered for an extension later?
4.2. Substance_ID
Every substance will be identified by an ID. Once a substance has been defined, a unique identifier that is permanently associated with that substance will be assigned.

8. Medicinal product DCM under construction

9. Medicinal product DCM under construction

10. Identifiers, identifiers, identifiers, codes
Each class in Model needs a unique code (IHTSDO expressed interest in creation)
For several defining characteristics we use controlled concept oriented terminologies, e.g. to be independent of a specific language such as Frisian, Gealic, Ligurian, Pictish, or Zarphatic (or English).
The data go in a specific fields in databases, EHRs and specific tags in e.g HL7 v3 XML or FHIR JSON messages.
This field or tag must be uniquely identified as to not mix it with other data elements
OIDs are required for each controlled vocabulary and for each value set.

11. FDA Example for a removed class for UC
dProductLabeling/ucm htm
SPL Color
NCI Thesaurus OID:
NCI concept code for SPL color: C48556
SPL Acceptable Term
Code
BLACK
C48323
BLUE
C48333
BROWN
C48332
GRAY
C48324
GREEN
C48329
ORANGE
C48331
PINK
C48328
PURPLE
C48327
RED
C48326
TURQUOISE
C48334
WHITE
C48325
YELLOW
C48330
OID

12. Implementation HL7 v3 (from ICSR IG)
XML Snippet for PhPID
<code code="4" codeSystem=" " displayName="drugInformation"/>
<component typeCode="COMP">
<substanceAdministration classCode="SBADM" moodCode="EVN">
<id root="3c91b4d5-e039-4a7a-9c b0ef9e4"/>
<consumable typeCode="CSM">
<instanceOfKind classCode="INST">
<kindOfProduct classCode="MMAT" determinerCode="KIND">
<code code="13456" codeSystem="EU.OID.PHPID" codeSystemVersion="1"/>
<name>Fastaction FlexPen 100 IU/ml Solution for injection</name>
XML Snippet for the MPID
<code code="4" codeSystem=" " displayName="drugInformation"/>
<component typeCode="COMP">
<substanceAdministration classCode="SBADM" moodCode="EVN">
<id root="3c91b4d5-e039-4a7a-9c b0ef9e4"/>
<consumable typeCode="CSM">
<instanceOfKind classCode="INST">
<kindOfProduct classCode="MMAT" determinerCode="KIND">
<code code="GB-XYZ Pharma-13456" codeSystem="EU.OID.MPID" codeSystemVersion="1"/>
<name>Fastaction FlexPen 100 IU/ml Solution for injection</name>
[1] This is a placeholder for the actual OIDs from the organization that gives the instance identifications for PhPID and MPID.

13. Implementation ISO 13606-3: Fragment
archetype (adl_version=1.4)
CEN-EN13606-CLUSTER.Ingredient.v1
concept
[at0000]
language
original_language = <[ISO_639-1::en]> }
ELEMENT[at0003] occurrences matches {1..1} matches { -- substance_ID
value existence matches {0..1} matches {
SIMPLE_TEXT[at0017] occurrences matches {1..1} matches { -- SIMPLE_TEXT
originalText existence matches {0..1} matches {/.*/}
["at0003"] = <
text = <"substance_ID">
description = <"Unique ID of the substance">

14. Conclusions D 1.3 / D 2.3
Appropriate identifiers come from EN ISO IDMP series
Plus “the openMedicine Set of Attributes”
Standards framework => various contexts & issues identified and made manageable
Enable use of IDMP & terminologies in x Border exchange.
DCM Medicinal Product => underpinned from IDMP, art 57 and use cases

15. Ongoing work Ongoing review by experts
Checked against results of D 2.1 & D 2.2. EMA art 57
Determine one unique code for each class in the model
Will have to come from Snomed CT, EMA or other terminologies in pharmacy domain
Identify vocabularies per class that has a concept descriptor data type (CD) to populate.
Assign OIDs for DCM, classes, unique codes and value sets if not available
Finally express the DCM as HL 7 v3 content, e.g. for use in CDA and v3 messages, FHIR and as Refererence archetype.