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Gap analysis between Article 57(2) of EC Regulation and the epSOS eP

Gap analysis between Article 57(2) of EC Regulation and the epSOS eP. Giorgio Cangioli , HL7 International Foundation Paolo Alcini , European Medicines Agency Member States authorities and Competence Centres Engagement Workshop . Luxembourg, 21st April, 2015. Table of Contents.

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Gap analysis between Article 57(2) of EC Regulation and the epSOS eP

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  1. Gap analysis between Article 57(2) of EC Regulation and the epSOSeP Giorgio Cangioli, HL7 International Foundation Paolo Alcini, EuropeanMedicinesAgency Member States authorities and Competence CentresEngagement Workshop. Luxembourg, 21st April, 2015

  2. Table of Contents • The context • The epSOS experience.. • …what’s happening now… (EXPAND, openMedicine,..) • …the EMA Art. 57 Database • How Art. 57 Db can help the cross-border eP • The epSOS Art. 57 Gap Analysis • Proposed approaches • Conclusions

  3. The Context The epSOS project, its “children” (EXPAND, openMedicine) and the EMA Art. 57 database

  4. The epSOS experience • The epSOS project piloted the cross-country exchange of medications information in several use cases: • ePrescription / eDispensation • Patient Summary • Healthcare Encounter Report • Medication Related Overview • Without a common European Drug Nomenclature (like RxNorm in US) drugs have been “identified” in epSOS using a set of attributes (ingredients, strengths, form code, route of administration, …) that describe them

  5. The epSOS experience • Those data are conveyed using epSOS defined CDA extensions, based on standard models, relying on commonly available coding systems: ATC (for substances) , EDQM (form code, route of administration, …),… • Several shortages have been however experienced in epSOS: • Capability of providing structured and coded information (particularly for multiactive ingredients products) • Mapping issues with local codes • Concepts in EDQM which countries cannot map nor translate to • Suitability of the ATC code system for the identification of the active ingredients (ATC is not conceived for that) • Management of the “complex” packages • Display of the received information (e.g. non physical units: tablets, puffs,…=> Unit of Presentation) • …….

  6. …what’s happening now… • The EXPAND Thematic Network [2014-2015] (http://www.expandproject.eu) has taken over most of the issues identified in epSOS and some mitigation actions has been agreed for facilitating the prosecution of the pilot, leaving however the most relevant topics to the openMedicine project • The openMedicine Coordination & Support Action (http://www.open-medicine.eu) [2015-2016] aims to • Contribute towards and enhance the safety and continuity of cross-border (and also national level) healthcare through interoperable ePrescriptions • Develop concrete solutions to: “The challenge in ePrescription is how medicines can be communicated in the cross border setting.”

  7. Then ? • EXPAND provided solutions for short term eP pilots • openMedicine is looking for long term comprehensive answers (based on the ISO IDMP Identificationof MedicinalProductsstandards) • What can be done in the medium term for improving the eP interoperability ?

  8. Fundamental questions from epSOS FROM EPSOS: Can the EMA work, undertaken because of the pharmacovigilance legislation, contribute towards improving interoperability of databases and safety and interoperability of ePrescriptions? YES «It – could – work!»

  9. How the Art. 57 DB can help the cross-border eP epSOS vs Art. 57 Gap analysis, Proposed approaches

  10. ...the Article 57 Database (governance) • The submission of data on medicines by marketing-authorisation holders is a legal requirement introduced by the Article 57(2) of Regulation (EU) No 1235/2010 (2010 pharmacovigilance legislation) NCAs & EC grant/ amend Marketing Authorisations of Medicinal Products following evaluation and approval of product information 15 days from initial marketing authorisations 30 days from variation of marketing authorisations Article 57 Database • Article 57 database contains regulated information on Medicinal Products in Europe

  11. …the Article 57 Database (Content) • Structured Medicinal Product Information: • P1: MAH (Legal Entity) • P2: QPPV • P3: PhV Enquiries • P4: PSMF • P5: Authorisation country code • P6: Authorisation procedure • P7: Authorisation status • P8: Authorisation number • P9: Authorisation date • P10: MRP/DCP/EU number • P11: Date of withdrawal/revocation/suspension • P12: Package description • P13: Orphan drug designation • P14: Comments (e.g. paediatric use) • P15: Medicinal product name • P16: Medicinal product invented name • P17: Product generic name • P18: Product company name • P19: Product strength name • P20: Product form name • P21: Pharmaceutical Form • P22: Route of administration(s) • P23: Active ingredient(s), Adjuvant(s) • P24: Excipients • P25: Medical device(s) • P26: Strength of active ingredient(s)/adjuvant(s) • P27: Therapeutic Indication(s) • P28: ATC code • P29: Medicinal Product type/Legal Basis • Unstructured Medicinal Product Information: • P30: Summary of Medicinal Product Characteristics • Substance controlled terminology: • S1: Substance names • S2: Substance Translations • S3: Substance synonyms • S4: Substance class • S5: Reference source • S6: International Codes Multilanguage • Reference controlled terminology: • R1: Pharmaceutical form • R2: Route of Administration • R3: ATC codes • R4: Units of Measurement (UCUM) • R5: Units of presentation • R6: Reference source • Organisation controlled terminology: • O1: MAH (Legal Entity) details • O2: QPPV • O3: PhV Enquiries • O4: PhV System Master File

  12. …the Article 57 Database (Content) Article 57 Database Brand name 1 XEVPRM Format XEVPRM Format Brand name 2 Abstract composition codes represents the Pharmaceutical Product independently from its commercial form, identified as Non Proprietary Medicinal  Preparation

  13. Art. 57 Vs epSOS gap Analysis • The project team performed a gap analysis with the perspective of supporting the epSOS use cases using the EMA “facilities” • Data models comparison • Vocabulary comparison

  14. Art. 57 Vs epSOS gap Analysis • Data Model • Information available in the EMA database is substantially a superset of what is required by epSOS • the only exception concern the type of outer package, coded in epSOS and providedas general description in the EMA DB. • Not a criticalissue

  15. Art. 57 Vs epSOS gap Analysis • Vocabulary • The adoption of some XEVMPD (eXtendedEudraVigilance Medicinal Product Dictionary) vocabularies may resolve most of the epSOS known issues (e.g. the identification of the active ingredients) • Substance names • Pharmaceutical form • Route of Administration • ATC codes • Units of Measurement • Units of Presentation

  16. Art. 57 Vs epSOS gap Analisys • Main gaps are • Differentversions of adopted code system: WHO ATC, EDQM (European Directorate for the Quality of Medicines) • Usage of EMA specific code system extensions (mainly for EDQM) (i.e. pre-adoption of concepts not yet included in the official release) • Different approach on the management of the units of measure, both based on UCUM (Unified Code for Units of Measure) • Notation : case sensitive Vs case insensitive • Adopted Logic : prefix and unit (e.g. ‘m’ and ‘g’ as separate fields) Vs pre-coordinated unit (e.g. mg) • Usage context: specific (strength denominator; strength numerator) Vs broad scope (any field where units are used) • EMA provides suitable vocabularies, currently not foreseen in epSOS (ingredients (non ATC); unit of presentations)

  17. Possible approaches • Two possible - not mutually exclusive - approaches have been identified: • Use the ART 57(2) Database for filling the epSOS data structure: i.e. communicate the detailed and complete information on the prescribed product (medication description) • Use the ART 57 services for resolving the identification of the Products cross-borders. • No constrains have been specified about how each country will determine and provide this information in the issued cross-border ePrescription. For example: • determined by the prescriber as part of the information available in the local drug DB; • assigned when the prescription is transmitted outside the national borders by a software component on the basis of the data present in the prescription; • ….

  18. Filling the epSOS elements using the Art 57 data Amoxicillin and clavulanic acid, 875 mg/125 mg, Tablets, Oral; 20 tablets; …. The patient receives a prescription for ‘Pharmacillo’from her Italian doctor…. … she then travels to Greece where she wants to redeem the prescription… 18 (*) Medicinal product names are fictional and for illustrative purposes only..

  19. Filling the epSOS elements using the Art 57 data • Proposed harmonization tasks • Adopt the XEVMPD substance vocabulary for resolving the known issues about the identification of the active ingredients. • Allow to use the substance ATC code and the active ingredient data as distinct information • Recently approved EXPAND change proposals support this ! • Align the epSOS ATC and EDQM based value sets with the XEVMPD ones • Use the EMA tables of units for generating new value sets to be used in epSOS for filling strengths’ denominators and numerators. • A 1 to 1 relationship between the epSOS and the ART. 57 used units can be defined.

  20. Filling the epSOS elements using the Art 57 data • Constraints for the adoption • Country of Affiliation must have in its local database the coded information contained in Art 57 database for its authorised medicines –or – • Country of Affiliation must perform a callto EMA Art 57 database to retrieve the coded data • Country of Affiliation must upgrade the National Connector • epSOS MVC and MTC have to be upgraded • OpenNCP Semantic Components and Portal and eP scrutiny test tools must be updated • Country of Treatment must have in its local database the coded information contained in Art 57 db for its authorised medicines to fill the eDispensation –or – • Country of Treatment must perform a callto EMA Art 57 database to retrieve the coded data for the eDispensation • Advantage of the adoption • Preparatory to the adoption of ISO IDMP

  21. Cross-borders identification with Art. 57 services Marketing Authorisation MHN: IT 479 6763 Italian name: Pharmacyllo* Authorised by: AIFA Marketing Authorisation MPID: GR 549 6731 Greek name: Cyllaron* Authorised by: ANSM Marketing Authorization Number e.g. IT 479 6763 The patient receives a prescription for ‘Pharmacyllo’from her Italian doctor…. … she then travels to Greece where she wants to redeem the prescription… 21 (*) Medicinal product names are fictional and for illustrative purposes only..

  22. Cross-borders identification with Art. 57 services • The Pharmaceutical Products are resolved cross-borders using the ART 57 services • The country that issues the prescription identifies the product through the national authorization number • The dispensing country queries the Art. 57 services for obtaining which product(s), in that country, fit(s) with the prescribed one. • Proposed harmonization tasks • Introduce the concept of authorization number in the epSOS data set (as mandatory) • This concept is already present in the implemented model adopted in the epSOS extension.

  23. Cross-borders identification with Art. 57 services • Constraints for the adoption • Country of Affiliation who allows only to prescribe by “generics” or by Active Ingredients, must simulate a Dispensation retrieving a registration code of a medicine compliant to the ePrescription –or – • Country of Affiliation must perform a callto EMA Art 57 database to retrieve the registration data (very unlikely…) • Country of Treatment must perform a callto EMA Art 57 database to retrieve the list of medication equivalent to the receive ePrescription (suggested: through the portal) • eDispensation is built using the registration code of the dispensed medicinal • Advantage of the adoption • Limited changes in OpenNCP and MVC are required • No need for coded data in Country A and B • Conceptually, no changes are needed in the portal display, being the Country B medicinals

  24. Conclusions « It – could – work! » (Young Frankenstein, 1974)

  25. Conclusions (1/2) • A medium term solution for improving the EU cross-border eP interoperability based on the Art. 57 Database content and services can be realized. • It covers registered pharmaceutical products • It may evolve towards long terms sustainable future solutions based on IDMP, coherently with the evolution path foreseen by EMA for the Art. 57 and by the openMedicine project. • Two possible - not mutually exclusive - approaches can be thought : • Filling the epSOS elements using the Art 57 data • Resolve the Pharmaceutical Products, cross-borders, using the ART 57 services

  26. Conclusions (2/2) • EMA is currently validating the information received in Art57 database and it is also discussing with MSs on how to ensure good data quality minimising the “a posteriori” validation. • EMA is currently liaising with MSs to check the level of completeness of the data received in Art57 database. • EMA will review the business process and the data workflow during the ISO IDMP implementation to improve data quality at source point

  27. Fundamental questions from epSOS FROM EPSOS: Can the EMA work, undertaken because of the pharmacovigilance legislation, contribute towards improving interoperability of databases and safety and interoperability of ePrescriptions? YES «It – could – work!»

  28. Thank You ! Questions ? • Our questions: • Which solution do Member States prefer the most? • Which Member States are ready for either solutions?

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