WG 6 «Pharmacy & Medication» Current activities Porto, Wednesday 11th June 2014

ACTIVE WORK ITEMS (AS FROM KARUIZAWA)

Precently published document ISO TS Health informatics — Requirements for international machine- readable coding of medicinal product package identifiers (this is closely linked to IDMP, which has been published by end 2012)

Current document in Revision process ISO TR (Health informatics -- Functional characteristics of prescriber support systems) – Addresses CPOE – Partial overlap with MPD – Requires an update, in particular if widely used – Resolution to move to revision ISO/TS (Health informatics -- Electronic reporting of adverse drug reactions) – In the context of adverse event reporting, meeting specific requirements in Korea – Some overlap with the ICSR series; built on ICH E2B Technical Specification, which has been revised in the mean time – Recommendation will be provided by Korean delegation at Berlin meeting

Work items launched prior 2013 prEN ISO/CD Health informatics- Requirements for electronic prescriptions – Project Lead: Frits Elferink prEN ISO/DTS Health Informatics - Business requirements for the exchange of structured dose instructions for medicinal products – Project Lead: Scott Robertson

Work items launched during 2013 prEN ISO/DTS Health Informatics - Requirements for Medicinal Product Dictionaries prEN ISO/DTS Health Informatics - Requirements for a record of the Dispense of a Medicinal Product prEN ISO/NP Health informatics — Data elements and structures for identification of extemporeanous and magistral (compound) pharmaceutical preparations without marketing authorisation

New work items ballotted early 2014 prEN ISO/DTR Health informatics – Identification of medicinal products (IDMP) – Core principles for Maintenance of Identifiers and Terms prEN ISO/DTS Health informatics – Identification of medicinal products (IDMP) – Implementation Guide for ISO for Data Elements and Structures for the Unique Identification and Exchange of Regulated Information on Substances

Ballots to be opened shortly prEN ISO/CD Health informatics- Requirements for electronic prescriptions

Future Work Items IDMP implementation guides for 11615, 11616, (11240 – no IG planned) ICH eCTD ( Electronic Common Technical Document ) Immunisation file for LMIC (?)

HORIZON 2020

From EU H2020 Work Programme , Chapter 8. Health, demographic change and wellbeing PHC* # 34: eHealth Interoperability i.common reference information model for eHealth deployment; can competing / overlapping standards coexist? ii.challenge in ePrescription: how medicines can be communicated in the cross border setting? Lack of common data model and common vocabulary for medicinal or pharmaceutical products (!) iii.clinical domain as among the most complex from a semantic point of view; detailed analysis on the advantages and disadvantages, as well as the impact of using SNOMED CT as the core terminology at the EU level is needed *PHC= Personalising Health and Care

What does H2020/PHC #34 ii require? safety and continuity of cross-border treatment + interoperable prescriptions Proposition to be built on existing standards (CEN, ISO, HL7) and involve SDOs Proposition to be built on epSOS (ePrescription) Investigate – Unambiguous definition and description of medicinal and pharmaceutical products, including unique identification. – Handling of substitution These are only extracts from the H2020 call

WG 6 assets and newer work items… …fit in the H2020 requirements – WP 1 «epSOS use cases and conceptual framework” Consider the existing standards (IDMP, etc.) Learn from epSOS Define additional use cases to epSOS – WP 2 A “Identification and Description of Pre-packed Branded Medicinal Products” Formulate proposals for extension / modification of the existing standards Identify and correct where needed different interpretations given in different countries to the same elements / concepts Identify concepts not yet included in the actual standards WP in blue: WG 6 is involved

WG 6 assets and newer work items… …fit in the H2020 requirements – WP 2 B «Identification and description of other medicinal products” inventory of additional prescription and administration related issues will be made descriptive and identifying attributes defined as complementary to the existing infostructure Have substitution in mind – WP 2 C “Other descriptive needs, product administration and alternative treatments” Validate the concepts listed in WP1 on applicability to new use cases Investigate applicability of the concepts defined in WP2A and WP2B Investigate what attributes are needed for reverse identification of a product

WG 6 assets and newer work items… …fit in the H2020 requirements – WP 3 «Substitution of prescribed medicinal products” Provide a concise framework and approach for analysing the substitution challenge Collect hard evidence on this in MSs Analyse the information collected, identify core cross-border issues Develop and validate concrete solution proposals – WP 4 “Validation, Recommendations and Roadmap” – WP 5 “Communication and Liaison» – WP 6 «Coordination and Management»

Relations between work items IDMPePrescript.MPDCompoundDispense R ePrescript.(X)XX MPDXX CompoundXXX Dispense RXX(X) H2020XXXXX

H2020 – WG 6 experts proposed William Goossen (WP 1) Christian Hay (WP 2a) Tomas Wennebo (WP 2b) Delphine Carli-Ghabarou (WP 2c) Leonora Grandia (WP 3) Shirin Golyardi (WP 5)

Varia

Roadmap