Up-scaling the global univocal identification of medicines

Informations projet

UNICOM

N° de convention de subvention: 875299

DOI

10.3030/875299

Projet clôturé

Date de signature de la CE 11 Novembre 2019

Date de début 1 Decembre 2019

Date de fin 31 Mai 2024

Financé au titre de

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coût total

€ 20 730 965,50

Contribution de l’UE

€ 18 994 883,50

Coordonné par

EMPIRICA GESELLSCHAFT FUR KOMMUNIKATIONS UND TECHNOLOGIEFORSCHUNG MBH
Germany

CORDIS fournit des liens vers les livrables publics et les publications des projets HORIZON.

Les liens vers les livrables et les publications des projets du 7e PC, ainsi que les liens vers certains types de résultats spécifiques tels que les jeux de données et les logiciels, sont récupérés dynamiquement sur OpenAIRE .

Livrables

Documents, reports (61)

Technical specifications to cross-border services
EU-SRS Data Management Plan
Cost-benefit analysis incl. spill-over effects
Technical helpdesk, testing operation manuals and release management governance
Guidelines to implement IDMP in National eHealth Services
Acceptance test report of the implemented changes and extensions
IDMP ICSR-Clinical Systems Connectivity
Gap and requirements analysis for CESP Dataset Module providing the IDMP compliant application dataset
Gap-Analysis report on CTS
Documentation to hand-over the EU-SRS to a maintenance organization
Guidance of GDPR compliance incl. templates model contract term

M18, M40

Report on link between IDMP and Pharmacotherapeutic Groups
Report on education and certification programs
Estonia: Progress report on implementation

M14, M26, M38, M54

Results of Personalised Medicine Pilot
Procedures for use of IDMP in Personalised Medicine
Gap analysis about existing and new standards and profiles
Requirements for a new ISO logical model [platform independent]
Guidelines for cross-border semantic interoperability, V1; V2

M18, M54

Finland: Progress report on implementation

M14, M26, M38, M54

Belgium: Progress report on implementation

M14, M26, M38, M54

Sweden: Progress report on implementatio

M14, M26, M38, M54

Landscape Analysis, Gap Analysis and Forecast Assessment for Use of IDMP in Big Health Data Projects
An analysis of the IDMP MPID provided compared to that needed in MPD for clinical care and for secondary uses
Austria: Progress report on implementation

M14, M26, M38, M54

Norway: Progress report on implementation

M14, M24; M38, M54

Proof of Concept demonstrator report
Report on MPD & IDMP data-focused pilot for eRx & dispensing
Assessment framework socio-economic impact
ISO IDMP Handbook
Croatia: Progress report on implementation

M14, M26, M38, M54

Spain: Progress report on implementation

M14, M26, M38, M54

Review report of the GDPR and other legal requirements
Application of IDMP in Drug Labelling and Drug Information, in Clinical Decision Support and in QA of Clinical Data
Common minimum data set that needs to be implemented in the national NCA and eHealth solution
Ireland: Progress report on implementation

M14, M26, M38, M54

Pilot deployment report, V1; V2

M36, M54

Guidelines for Cross-Border ePrescription / eDispensation V1; V2

M12, M54

Piloting Strategy definition
Guidance document on how MPDs should map to substance data
Dissemination approach & communication strategy
Liaison with EC, MSs and stakeholders annual report

M12, M24, M36, M54

Portugal: Progress report on implementation

M14, M26, M38, M54

IDMP Implementation guidance for pharmacy system suppliers (focus on patient medication list)
IDMP Implementation guidance to EHR and eRx system suppliers (focus on patient medication list)

IDMP Implementation guidance to EHR and eRx system suppliers ( focus on patient medication list)

IDMP Coding Principles and Guidance for ICSRs
Report on testing profiles, projectathons IDMP-rel. data exchange
Business Requirements Specifications for IDMP adoption in eHealth Services, V1

M6, M54

Educational material on IDMP for end users of prescribing and dispensing systems and their suppliers on IDMP
Implementation guidance for IDMP in MPD
UNICOM business plan and sustainability strategy
Protocol and Statistical Analysis Plan for Proof of Concept Studies
Best-practice ISO IDMP workshops according to needs of the NCAs

M18, M36, M48

Annual Report on Dissemination

M12, M24, M36, M54

Member State Readiness report V1; V2

M42, M54

Training and communication material
Semantic Specifications, V1; V2

M21, M54

Interim report on cost-benefit data collection
Final report, incl. guidance of EU and MS on application of GDPR
Endorsed Implementation Plan for Substance Management
Germany: Progress report on implementation

M14, M26, M38, M54

Other (3)

A sustainable EU network of fully trained & skilled substance validation experts able to maintain substance data in a European system
Cleansed substance data for use within the EU regulatory network
Delivery of selected ISO IDMP medicinal product data for crossborder pilots

Demonstrators, pilots, prototypes (11)

Patient-Facing App Ecosystem and Repository
UNICOM User Portal Reference implementation for eP/eD and PS
UNICOM reference test platform (incl. Gazelle, Art Décor)

Technical helpdesk, testing operation manuals and release management governance

Prototype presentation of ISO IDMP compliant datafeeds to eHealth consumers
UNICOM IDMP DB API
Validated, fit-for-purpose European Substance Registration System
UNICOM Smart Substitution component
Demonstration of Patient Empowerment App
Established, implemented processes and procedures for maintenance of substance data in Europe
UNICOM Semantic components
Develop demonstrators, including videos

Publications

Peer reviewed articles (4)

Identification of Drugs Acting as Perpetrators in Common Drug Interactions in a Cohort of Geriatric Patients from Southern Italy and Analysis of the Gene Polymorphisms That Affect Their Interacting Potential

Auteurs: Mauro Cataldi, Camilla Celentano, Leonardo Bencivenga, Michele Arcopinto, Chiara Resnati, Annalaura Manes, Loreta Dodani, Lucia Comnes, Robert Vander Stichele, Dipak Kalra, Giuseppe Rengo, Francesco Giallauria, Ugo Trama, Nicola Ferrara, Antonio Cittadini, Maurizio Taglialatela
Publié dans: Geriatrics, Numéro 8, 2023, Page(s) 84, ISSN 2308-3417
Éditeur: MDPI AG
DOI: 10.3390/geriatrics8050084

Alignment of two standard terminologies for dosage form: RxNorm fromthe National Library of Medicine for the United States and EDQM from theEuropean Directorate for the Quality in Medicines and Healthcarefor Europe

Auteurs: Natalie Karapetian, Robert Vander Stichele, Yuri Quintana
Publié dans: Scientific article published in International Journal of Medical Informatics 104826, Numéro Volume 165, September 2022,, 2022, ISSN 1386-5056
Éditeur: Elsevier BV
DOI: 10.1016/j.ijmedinf.2022.104826

How Granular Can a Dose Form Be Described? Considering EDQM Standard Terms for a Global Terminology

Auteurs: Robert H. Vander Stichele; Joseph Roumier; Dirk van Nimwegen
Publié dans: Applied Sciences; Volume 12; Numéro 9; Pages: 4337, Numéro 2, 2022, ISSN 2078-2489
Éditeur: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/app12094337

How to ensure we can track and trace global use of COVID-19 vaccines?

Auteurs: Robert H. Vander Stichele, Christian Hay, Malin Fladvad, Miriam C.J.M. Sturkenboom, Robert T. Chen
Publié dans: Vaccine, Numéro 39/2, 2021, Page(s) 176-179, ISSN 0264-410X
Éditeur: Elsevier BV
DOI: 10.1016/j.vaccine.2020.11.055

Conference proceedings (3)

Medicinal Product Data Standardisation – Prerequisite for Efficient Data ExchangeBetween Stakeholders and Impact on the (Inter)National Health Systems Medicinal Product Data Standardisation in the Agency for Medicinal Products and Medical Devices(HALMED)

Auteurs: Sanja Grčić Plečko, Maja Fatiga, Dubravka Sudić
Publié dans: eTELEMED 2022 : The Fourteenth International Conference on eHealth, Telemedicine, and Social Medicine, 2022, ISBN 978-1-61208-984-3
Éditeur: international Journal on Advances in Life Sciences

Will The Implementation of ISO/CEN Standards for Global Identification of Medicinal Products (IDMP) Make Any Difference for Pharmaco-Epidemiology?

Auteurs: Robert H. Vander Stichele, MD – University of Ghent Med School, University of Ghent, Belgium, Gent, Oost-Vlaanderen, Belgium Co-Author(s) Miriam C. Sturkenboom, PharmD, PhD, FISPE – prof. dr., University Medical Center Utrecht, Utrecht, Utrecht, Netherlands Carlos Duran – Julius Center for Health Sciences and Primary Care, Department of Data Science & Biostatistics, University Medical Cent
Publié dans: Proceeding of the 2022 ICTH conference in Oslo, Numéro 1123, 2022
Éditeur: ICPE

Identification of Medicinal Products: Providing an Educational Framework

Auteurs: Hans Gille, Robert Stegwee
Publié dans: Proceeding of the pHealth conference Identification of Medicinal Products, Numéro Volume 299: pHealth 2022, 2022, Page(s) 271 - 274
Éditeur: IOS Press
DOI: 10.3233/shti220997