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; wgoossen@results4care.nl) www.open-medicine.eu TOWARDS A TRANS-ATLANTIC SOLUTION TO UNIVOCALLY IDENTIFY MEDICINAL PRODUCTS USA-EU Workshop FDA White Oak Campus, 10903 New Hampshire Av., Silver Spring, MD is a project funded by the in the context of

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

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

EHRs, communication, profiles, messages Multiple contexts in which the medicinal product is used Example 1: ISO EN 13606-1 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

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

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.

And all other IDMP items….   Table 2 Data elements from the substance standard EN ISO 11238 and implementation guide ISO TS 19844 (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.

Medicinal product DCM under construction

Medicinal product DCM under construction

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.

FDA Example for a removed class for UC http://www.fda.gov/ForIndustry/DataStandards/Structure dProductLabeling/ucm162043.htm SPL Color NCI Thesaurus OID: 2.16.840.1.113883.3.26.1.1 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 2.16.840.1.113883.3.26.1.1

Implementation HL7 v3 (from ICSR IG) XML Snippet for PhPID <code code="4" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" displayName="drugInformation"/> <component typeCode="COMP"> <substanceAdministration classCode="SBADM" moodCode="EVN"> <id root="3c91b4d5-e039-4a7a-9c30-67671b0ef9e4"/> <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="2.16.840.1.113883.3.989.2.1.1.20" displayName="drugInformation"/> <component typeCode="COMP"> <substanceAdministration classCode="SBADM" moodCode="EVN"> <id root="3c91b4d5-e039-4a7a-9c30-67671b0ef9e4"/> <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.

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">

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

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 13606-3 Refererence archetype.