P R E S E N T E D B Y V A D A P E R K I N S , U S F D A

UPDATE: ISO 20443/20451

ISO IDMP

• ISO 20443 • Lead editor: Vada Perkins • Co-editors: Andrew Marr, Paolo Alcini

• ISO 20451 • Lead editor: Vada Perkins, • Co-editor: Leonora Grandia

HL7/XML Review: Lise Stevens, Christian Kravogel, Myron Finseth, Panagiotis Telonis

ISO 20451/20443: MEDICINAL PRODUCT IDENTIFICATION: KEY ITEMS

• Conformance/Cardinality • “Business Rules”

• ISO core (not region specific) • UML Models • HL7/XML Code Snippets • Editorial (ISO rules-syntax, proofing)

• Additional language for clarification

ACCOMPANYING NOTE FOR ISO 20443 AND 20451 DRAFT TECHNICAL SPECIFICATIONS

• Further harmonisation steps will be required in order

to align the style and presentation with the other work items that constitute the Draft Technical Specifications (implementation guides) for the suite of ISO IDMP standards.

• It is the intention of ISO TC 215-WG 6, to address all

harmonisation steps during the corresponding ballot cycles, comment reconciliation, document revision, and finalisation of the corresponding draft technical specifications.

ITEMS TO BE ADDRESSED

• Items to be addressed during the development and finalization of the documents as part of the ballot reconciliation and prior to official publication include the following:

• Consistency in the way examples and values allowed are expressed throughout

the DTS IDMP documents upon completion of the ballot and subsequent ballot reconciliation.

• Consistency in cross-referenced and repeated sections. • Further refinements to ensure consistency of terminology and definitions. • Refinement of HL7 SPL/CPM messaging and example(s) based on ballot

comments and reconciliation. • *Finalize conformance (e.g., mandatory, optional, conditional) following ballot

review and reconciliation. • Finalize cardinality following ballot review and reconciliation. Further editorial review/revisions based on the agreed upon comment

reconciliation. Update of the UML models to correspond to the agreed upon cardinality

identified within the suite of IDMP standards and corresponding Technical Specifications.

CONFORMANCE TERMINOLOGY AND CONTEXT AS IT RELATES TO THE ISO IDMP STANDARDS AND CORRESPONDING TECHNICAL SPECIFICATIONS

• Mandatory: Defining elements necessary for the unique identification of medicinal products per the ISO IDMP standards/technical specifications.

• Optional: When listed at the category level (e.g., specified substance),

optional corresponds to ISO categories or data elements that are not absolutely necessary for the unique identification of medicinal/pharmaceutical products according to the ISO IDMP standards/technical specifications. Regional implementation of the ISO IDMP standards/technical specifications may elevate the optional conformance categories to ‘mandatory’ per jurisdictional requirements.

• Conditional: Conditional applies to the ‘within category’ data elements,

as applicable, when there are alternatives data sources for a given data element(s) to identify a medicinal/pharmaceutical product. Regional implementation of the ISO IDMP standards/technical specifications may elevate the conditional conformance categories to ‘mandatory’ per jurisdictional requirements.

IMPORTANT!

• All regional/jurisdictional guidance/implementation guides must conform to the suite of ISO IDMP standards and corresponding Technical Specifications.

OID, DATA TYPE, AND BUSINESS RULES REFERENCES

• Omitted from the DTS documents. • Regional/jurisdictional implementation

guides/guidance shall determine the applicable business rules and OIDs relevant to their regional requirements.

• Data types and other corresponding message exchange items are to be referred to HL7. • An appropriate HL7 point of reference will be included in

the IDMP standards and corresponding TS documents once established with HL7.

HL7/XML CODE SNIPPETS

• HL7 SPL(R7) and HL7 CPM (R3) balloted in June 2015 • Recirculation ballot in process

• Official publication by end of 2015 • Review/revision of all code snippets to be inline with

the most current SPL/CPM releases

20443/20451 WG DISCUSSION

• ISO TS documents to supplement the standards • Not “stand alone” documents • Discussions with ISO CS on “bundling” the ISO IDMP standards,

corresponding TS documents and corresponding HL7 standards • ISO CS to provide language to describe the intended

audience for the standards/technical specifications

DISCUSSIONS DURING 20443/20451

• ISO Business Process/Rules • Identified within the ISO 11615/11616 standards • MPID/PCID • BAID1/BAID 2 • Identification of appropriate examples

• Many presentations of medicinal products • Narrow to 2-3 full examples: Fully worked example given in

Annex E in Standard, brought up to date with changes introduced in the Implementation Guide

• Add reference to supply chain identification standard (e.g. reference to CEN ISO TS 16791, Annex D).

EXAMPLE 1

• Suspension and emulsion for emulsion for injection, with an administration device

EXAMPLE 2

• A product where there is a delivery device, such as a prefilled syringe which is to be defined as both a container and device.

EXAMPLE 3

• A complex packaging type –e.g. bagged solutions with different bag components –EXTRANEAL (Icodextrin 7.5%) Solution for peritoneal dialysis.

EXAMPLE 4

• Solid oral dosage form

EXTRANEAL (ICODEXTRIN 7.5%)

• In the UK there are 17 presentations that cover a range of fill volumes, number of units per box, number of bags, with different connectors. • In the UK, these could be defined as one MPID but multiple

PCIDs. • In France they are all separate MAs hence multiple MPIDs

each with one PCID.

TIMELINE (PROPOSED)

• 20443/20451 • Disposition/Revisions/DTS Ballot: 18 March 2016

• 11615/11616 • Disposition/Revisions/DIS Ballot: 18` March 2016

• Rationale: • Sufficient time required to address all comments with all

delegations prior to ballot • Allows for both the standards and technical specifications

to be collectively balloted and officially published. • Ensures consistency across documents

SPL CODE SNIPPETS

COLOURED SPL CODE SNIPPETS

SCHEMA SNIPPET IN XEVPRM

ADD SPL SCHEMA

• Add an overview on which SPL elements are applicable for IDMP and which not.

SPL CODE SNIPPETS