WG 6 «Pharmacy & Medication»Current activities

Porto, Wednesday 11th June 2014

ACTIVE WORK ITEMS(AS FROM KARUIZAWA)

Precently published document

• ISO TS 16791 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 22790 (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 22224 (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 17253 Health informatics- Requirements for electronic prescriptions – Project Lead: Frits Elferink

• prEN ISO/DTS 17251 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 19256 Health Informatics - Requirements for Medicinal Product Dictionaries

• prEN ISO/DTS 19293 Health Informatics - Requirements for a record of the Dispense of a Medicinal Product

• prEN ISO/NP 19294 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 14872 Health informatics – Identification of medicinal products (IDMP) – Core principles for Maintenance of Identifiers and Terms

• prEN ISO/DTS -19844 Health informatics – Identification of medicinal products (IDMP) – Implementation Guide for ISO 11238 for Data Elements and Structures for the Unique Identification and Exchange of Regulated Information on Substances

Ballots to be opened shortly

• prEN ISO/CD 17253 Health informatics- Requirements for electronic prescriptions

Future Work Items

• IDMP implementation guides for 11615, 11616, 11239 (11240 – no IG planned)

• ICH eCTD (Electronic Common Technical Document)

• Immunisation file for LMIC (?)

HORIZON 2020

From EU H2020

• Work Programme 2014-2015,Chapter 8. Health, demographic change and wellbeing

• PHC* # 34: eHealth Interoperabilityi. 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 itemsIDMP ePrescript. MPD Compound Dispense R

ePrescript. (X) X X

MPD X X

Compound X X X

Dispense R X X (X)

H2020 X X X X X

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

WG meeting Karuizawa

Deadline for sending

Berlin Agenda

WG meeting Berlin

Earliest Ballot post Berlin

Mai19-23

August 22/25

October 6-10

October 20

Roadmap

End of earliest 3months ballot

Deadline for sending SFO

Agenda

WG meeting SFO

Earliest Ballot post SFO

January 21

March 6/9

April 20-24 Mai 4