Inaugural Expert Council Meeting @ EMA London, 25/6/2015 WP1: epSOS use cases and Conceptual Framework epSOS Problems & EMA Solutions Ida Fortino (REGLOMB; ida_fortino@regione.lombardia.it ) Marcello Melgara (LISPA; marcello.melgara@cnt.lispa.it) Anna Gawronska-Blaszczyk (ILiM, GS1; Anna.Gawronska-Blaszczyk@gs1pl.org > William Goossen (NEN, Results 4 Care; wgoossen@results4care.nl ) Giorgio Cangioli (HL7; giorgio.cangioli@gmail.com )

WP1 Objectives To investigate how far we are, considering the actual standards as we have IDPM and the ISO TS 16791 developments, in defining the minimal set of attributes of a medicinal product as well as of a pharmaceutical product needed to unambiguously identify such a product To investigate how standards can be combined to do so To learn from the epSOS use cases To look for intermediate solutions (e.g. EMA Art. 57 db) To define a number of use cases that may identify complementary identification needs.

epSOS ePrescription Use Case: eP/eD - 1 A citizen, while abroad (Country B), needs to retrieve an eP generated in his Country of Affiliation (Country A) The Pharmacist from Country B can request the List of Valid Prescriptions, select with the citizen which one has to be dispensed, dispense all (or part) of the prescribed medications. If needed and allowed, perform a generic substitution One or more eDispensation documents are returned to Country A, to allow the (partial) fulfilment of the eP. epSOS eP Pilots: Spain, Italy, Sweden, Finland, Denmark, Greece, Hungary, Croatia in Pre-production EC Guidelines on eP address this Use Case

epSOS ePrescription Use Case: eP/eD - 2 In Scope: Electronic Prescriptions Medicinal products for human use Community pharmacies Substitution of commercial packaging Out of the Scope Narcotics/Galenics/Treatment/procedure/clinical test prescription Reimbursement management Specific and complicated topics like narcotics and sealed prescriptions Hospital pharmacies and drug administration

epSOS conceptual model Substitution: When allowed, it is limited to: the change of brand name The change of package size If allowed in the Country: change of strength, with special instructions from the Pharmacist

epSOS conceptual model Based on HL7 CDA R2 Level 3 / Level 1 In the Country of Residence: ePrescription to DESCRIBE the prescribed Pharmaceutical Product In special cases (e.g. when substitution is not allowed) the Medicinal Product is identified In the Country of Treatment: ePrescription translated in local language, to allow to the Pharmacist to IDENTIFY the Medicinal Product to be dispensed eDispensation created to describe and identify the dispensed medicinal product

epSOS eP structure and contents eP / eD built as a compromise among Physicians requirements Pharmacist requirements EU Directives / National laws Availability of datasets in National ePs Availability of structured and coded data for the datasets

epSOS eP pending issues - 1 Most of the epSOS issues can be summarised as: Inadequate way of identifying Active Ingredients with ATC Unavailability of coded data in the Member States to describe the pharmaceutical product characteristics Unavailability of structured / coded information to describe special / complex pharmaceutical products … Inadequate model to cover all products Some evolutions: Short term solutions by EXPAND Master Value Set Catalogue 2.0 released by EXPAND New version of all Code Systems Revision of EDQM based Value Sets

Gaps between epSOS eP and EC eP Guidelines The following Required Sections are optional in epSOS: Dose regimen The regimen governing the dose quantity per single administration, the dose frequency, the route of administration and/or speed of administration (in the event of intravenous administration). Duration of treatment Start and/or stop time of treatment Directions for use Details about the directions for use of the prescribed medicinal product, such as ‘with food’ or ‘before a meal’) and any cautionary advice for correct use of the prescribed drug by the patient Roadmap from EC Guidelines Assess adoptability of EMA Art. 57 Database Consider ISO IDMP as a viable medium/long term solution

epSOS and EMA Art. 57 database For eP Sustainability epSOS positively considered EMA Art.57 Database It provides the adequate level of structured and coded information It establishes a process which motivates (obliges) stakeholder to provide requested data at registration phase It makes feasible architectural solutions for a European pharmacopoeia eHN and EC DG-CONNECT asked to assess the possibility to adopt as an intermediate solution: Analysed the structure, data elements and adopted code systems / Value Sets Compared with epSOS eP datasets and Master Value Set Catalogue Made hypotheses on possible ways of adopting EMA Art.57 DB Decision on alternatives to be taken by MS / eHN / eHN Joint Action and EMA, facilitated by EXPAND

epSOS and EMA Art. 57 database

epSOS and EMA Art. 57 database The elements of interest for this analysis are the vocabularies: Substance names Pharmaceutical form Route of administration ATC codes Units of measurement Units of presentation And the fields: Package description Medicinal product name Medicinal product invented name Product generic name Pharmaceutical Form Route of administration(s) Active ingredient(s), Adjuvant(s) Strength of active ingredient(s)/adjuvant(s)

epSOS and EMA Art. 57 database Two possible approaches to overcome issues identified in the epSOS using information and services provided through the ART 57 DB The adoption of the ART 57 Db information for filling the epSOS data structure: i.e. communicate the detailed and complete information on the prescribed product (medication description) (openMedicine D1.1, § 4.2.4.1) The development of services to access the ART 57 database, to resolve the identification of the Pharmaceutical Products cross-borders. (openMedicine D1.1, § 4.2.4.2)

epSOS and EMA Art. 57 database The adoption of the ART 57 Db information for filling the epSOS data structure: i.e. communicate the detailed and complete information on the prescribed product (medication description) Country A MUST have available the full structured / coded information The NCPeH MUST be able to treat a modified eP CDA and in Country B the Portal MUST be able to display the received information

epSOS and EMA Art. 57 database The development of services to access the ART 57 database, to resolve the identification of the Pharmaceutical Products cross-borders. Country A MUST be able to transfer the (e.g.) market authorisation code of a product that can be dispensed Minor changes are needed to the eP CDA (product code already in) Country B MUST make a call to the EMA Art. 57 DB to get the list of Medicinal Product equivalent to the identified one in Country A

epSOS and EMA Art. 57 database: next steps Results of the analysis have been returned to EXPAND, Semantic Maintenance Shop, to formalise, together with the other Maintenance Shops , the feedback to DG Connect / DG-Santé – CEF and eHealth Network (eHN) It will be proposed to include the report on adoptability of EMA Art.57 to eHN November meeting The decision should include the alternatives: Plan NOW the develop services to retrieve info from Art.57 db WAIT for a full adoption of ISO IDMP (planned for 2018) In parallel. openMedicine should proceed with its activities to define the long term solution

Conclusion There is still a lot to be done in openMedicine and on International Standards The roadmap for a full adoption by Member States and Agencies of ISO IDMP is non adequate to allow to start CEF eP/eD services The intermediate solution of adopting EMA Art.57 DB is compatible from a “technical” point of view MS and Agencies should assess if any of the proposed solutions are compatible with the National roadmaps EMA should assess if the development of the services to retrieve info from Art. 57 db is affordable in the short future, or planned together with the adoption of ISO IDMP by 2018

Questions to Experts Do you believe Countries are ready to transfer coded data for the optional sections, made compulsory in EC Guidelines? Dose regimen Duration of treatment Directions for use Are Countries ready to go for an intermediate solution based on current EMA Art. 57 database? Which of the two solution is viable in the short future? The adoption of the ART 57 Db information for filling the epSOS data structure: i.e. communicate the detailed and complete information on the prescribed product (medication description) The usage of the ART 57 services for resolving the identification of the Pharmaceutical Products cross-borders.