Periodic Reporting for period 3 - UNICOM (Up-scaling the global univocal identification of medicines)
Okres sprawozdawczy: 2022-12-01 do 2024-05-31
UNICOM project’s main objective is to accelerate and scale up the implementation of the suite of standards of the International Organization for Standardization for the Identification of Medicinal Products (ISO IDMP) throughout the healthcare ecosystem.
Critical issues arising from the inaccurate identification of medicinal products can be solved with the use of ISO IDMP standards. Some examples are drug falsification, dangerous drug-drug interactions, and challenges in helping physicians and pharmacists make substitution decisions and effective ePrescription (eP), eDispensation (eD), and Patient summary (PS) cross-border and improved pharmacovigilance.
The use of IDMP ensures that any medicine, and what it contains, can be accurately identified anywhere in Europe and indeed globally. Unique identification is the foundation and the core of an interoperable and dynamic ecosystem dedicated to better patient safety and better healthcare for all. The ISO IDMP standards cover the core identifiers for a medicinal product, notably a common format for the Medicinal Product Identifier (MPID), the Medicinal Product Package Identifier (PCID), and for a global Pharmaceutical Product Identifier (PhPID). By focusing on the development, testing, implementation, and dissemination of IDMP standards, UNICOM has played a significant role in supporting regulatory purposes, global pharmacovigilance, and the advancement of cross-border digital health services such as eP, eD, and the international PS.
Critical issues arising from the inaccurate identification of medicinal products can be solved with the use of ISO IDMP standards. Some examples are drug falsification, dangerous drug-drug interactions, and challenges in helping physicians and pharmacists make substitution decisions and effective ePrescription (eP), eDispensation (eD), and Patient summary (PS) cross-border and improved pharmacovigilance.
The use of IDMP ensures that any medicine, and what it contains, can be accurately identified anywhere in Europe and indeed globally. Unique identification is the foundation and the core of an interoperable and dynamic ecosystem dedicated to better patient safety and better healthcare for all. The ISO IDMP standards cover the core identifiers for a medicinal product, notably a common format for the Medicinal Product Identifier (MPID), the Medicinal Product Package Identifier (PCID), and for a global Pharmaceutical Product Identifier (PhPID). By focusing on the development, testing, implementation, and dissemination of IDMP standards, UNICOM has played a significant role in supporting regulatory purposes, global pharmacovigilance, and the advancement of cross-border digital health services such as eP, eD, and the international PS.
In collaboration with the European Medicines Agency (EMA), UNICOM has driven the implementation of the EMA Product Lifecycle Management (PLM) Portal. This platform enables users to submit electronic application forms (eAFs), access SPOR Product Management Services (PMS), and manage electronic Product Information (ePI). These efforts are sustained by the EMA EU Implementation Guide (IG). While the variation form for centrally authorised products is already live, the form for nationally authorised products will be available soon.
The European Substance Registration System (EU-SRS) provides structured, ISO IDMP-compliant data on substances, ensuring unique and standardised coding. Developed alongside the EMA, national medicine authorities, and international partners like the FDA and NCATS, EU-SRS is now maintained by the EMA. Several guides, including the "Data Cleansing Manual SVG," ensure smooth implementation and sustainability for national medicines authorities.
Significant progress has been made by 11 National Competent Authorities (NCAs) participating in the project, as they work to develop IDMP-compliant national databases. This has been achieved either by upgrading existing systems or building new ones from scratch. Their shared experiences and best practices have been documented and made publicly accessible.
UNICOM has worked closely with the eHealth Network (eHN) and MyHealth@EU to promote ISO IDMP in cross-border services like ePrescriptions, eDispensations (eD), and Patient Summaries. This collaboration helped improve guidelines for these services and incorporate recommendations for adopting ISO IDMP and EMA SPOR data models. Two change proposals were co-developed and accepted by EU Member States.
UNICOM also worked with the European Directorate for the Quality of Medicines (EDQM) and WHO’s Uppsala Monitoring Centre (WHO-UMC) to create standards for the global Pharmaceutical Product Identifier (PhPID). Although PhPID was not a direct deliverable of the project, progress was made using structured data elements based on EMA's SPOR terminology.
UNICOM created sample IDMP-format product databases to help partners learn, including developing the UNICOM IDMP server for piloting. This server follows the Minimum Attributes list and includes APIs to access the data, allowing IDMP-compliant data to be tested in a sandbox environment. The project also developed an Implementation Guide (IG) with FHIR profiles and examples, which can be tested using the UNICOM Testing Toolbox. Technical assets, like the Database and FHIR Guide, will be passed on to the Xt-EHR project to ensure sustainability. In addition, feedback on UNICOM outputs will be collected and refined by IHE, which will be balloted and published as a set of global digital health specifications. European (UNICOM) specific requirements will be released as an HL7 FHIR IG (EU realm) and an IHE Volume-4 addendum. This work will continue through the XpanDH project and the EHRxF Standards and Policy Hub.
UNICOM developed two mobile apps—one for patients and one for healthcare providers (pharmacists and physicians). These apps, integrated with the UNICOM IDMP database, help identify equivalent medicinal products while traveling. Managed by Datawizard, the apps are expected to expand their medicine database, support more countries and languages, and add drug interaction features.
Lastly,UNICOM built a transatlantic Community of Expertise (CoE) through monthly webinars since June 2020. These webinars, covering key IDMP implementation topics, are available to the public on the UNICOM website and YouTube channel. UNICOM National Competent Authorities (NCAS) also hosted webinars for non-participating NCAs to share knowledge on IDMP implementation. Additionally, the "IDMP in a Capsule" handbook, available in multiple languages, explains IDMP standards in a user friendly way. A course titled "Identification of Medicinal Products for End Users and Suppliers" was also developed. This nine-module course, featuring webinars and presentations by experts, is hosted by the iHD Academy.
The European Substance Registration System (EU-SRS) provides structured, ISO IDMP-compliant data on substances, ensuring unique and standardised coding. Developed alongside the EMA, national medicine authorities, and international partners like the FDA and NCATS, EU-SRS is now maintained by the EMA. Several guides, including the "Data Cleansing Manual SVG," ensure smooth implementation and sustainability for national medicines authorities.
Significant progress has been made by 11 National Competent Authorities (NCAs) participating in the project, as they work to develop IDMP-compliant national databases. This has been achieved either by upgrading existing systems or building new ones from scratch. Their shared experiences and best practices have been documented and made publicly accessible.
UNICOM has worked closely with the eHealth Network (eHN) and MyHealth@EU to promote ISO IDMP in cross-border services like ePrescriptions, eDispensations (eD), and Patient Summaries. This collaboration helped improve guidelines for these services and incorporate recommendations for adopting ISO IDMP and EMA SPOR data models. Two change proposals were co-developed and accepted by EU Member States.
UNICOM also worked with the European Directorate for the Quality of Medicines (EDQM) and WHO’s Uppsala Monitoring Centre (WHO-UMC) to create standards for the global Pharmaceutical Product Identifier (PhPID). Although PhPID was not a direct deliverable of the project, progress was made using structured data elements based on EMA's SPOR terminology.
UNICOM created sample IDMP-format product databases to help partners learn, including developing the UNICOM IDMP server for piloting. This server follows the Minimum Attributes list and includes APIs to access the data, allowing IDMP-compliant data to be tested in a sandbox environment. The project also developed an Implementation Guide (IG) with FHIR profiles and examples, which can be tested using the UNICOM Testing Toolbox. Technical assets, like the Database and FHIR Guide, will be passed on to the Xt-EHR project to ensure sustainability. In addition, feedback on UNICOM outputs will be collected and refined by IHE, which will be balloted and published as a set of global digital health specifications. European (UNICOM) specific requirements will be released as an HL7 FHIR IG (EU realm) and an IHE Volume-4 addendum. This work will continue through the XpanDH project and the EHRxF Standards and Policy Hub.
UNICOM developed two mobile apps—one for patients and one for healthcare providers (pharmacists and physicians). These apps, integrated with the UNICOM IDMP database, help identify equivalent medicinal products while traveling. Managed by Datawizard, the apps are expected to expand their medicine database, support more countries and languages, and add drug interaction features.
Lastly,UNICOM built a transatlantic Community of Expertise (CoE) through monthly webinars since June 2020. These webinars, covering key IDMP implementation topics, are available to the public on the UNICOM website and YouTube channel. UNICOM National Competent Authorities (NCAS) also hosted webinars for non-participating NCAs to share knowledge on IDMP implementation. Additionally, the "IDMP in a Capsule" handbook, available in multiple languages, explains IDMP standards in a user friendly way. A course titled "Identification of Medicinal Products for End Users and Suppliers" was also developed. This nine-module course, featuring webinars and presentations by experts, is hosted by the iHD Academy.
The UNICOM project advances the adoption of ISO IDMP (Identification of Medicinal Products) standards across Europe. These standards provide a harmonised framework for the accurate identification and exchange of medicinal product information across regulatory, clinical, and cross-border healthcare domains, thus improving data interoperability, pharmacovigilance, and patient safety. IDMP enables more effective pharmacovigilance, leading to earlier detection of safety signals and a reduction in ADRs. Earlier detection of safety signals through improved pharmacovigilance can reduce ADR-related hospitalisations, leading to significant healthcare savings and improved patient outcomes. This is particularly relevant for cross-border healthcare, where varying data standards have historically hindered the effectiveness of pharmacovigilance systems.
Beyond enhancing patient safety, IDMP supports digitalising healthcare services, such as ePrescriptions and eHealth programs. The pharmaceutical industry also benefits, as standardised data streamlines regulatory processes, accelerates new therapies' time-to-market and improves post-marketing surveillance. These advances are vital for personalised medicine, where rapid and accurate product identification enables tailored treatments.
UNICOM’s work aligns closely with broader European Union policies, such as the European Health Data Space (EHDS) regulation, which will require Members State to use standardized Electronic Health Records (EHR)systems electronic prescription and dispensation records which conform to the European EHR Exchange Format. The regulation emphasizes making healthcare data findable, accessible, interoperable, and reusable (FAIR). The IDMP standards are key to achieving these goals, ensuring that medicinal product data can be easily shared and utilized across the EU and beyond.
Beyond enhancing patient safety, IDMP supports digitalising healthcare services, such as ePrescriptions and eHealth programs. The pharmaceutical industry also benefits, as standardised data streamlines regulatory processes, accelerates new therapies' time-to-market and improves post-marketing surveillance. These advances are vital for personalised medicine, where rapid and accurate product identification enables tailored treatments.
UNICOM’s work aligns closely with broader European Union policies, such as the European Health Data Space (EHDS) regulation, which will require Members State to use standardized Electronic Health Records (EHR)systems electronic prescription and dispensation records which conform to the European EHR Exchange Format. The regulation emphasizes making healthcare data findable, accessible, interoperable, and reusable (FAIR). The IDMP standards are key to achieving these goals, ensuring that medicinal product data can be easily shared and utilized across the EU and beyond.