Periodic Reporting for period 2 - UNICOM (Up-scaling the global univocal identification of medicines)
Période du rapport: 2021-06-01 au 2022-11-30
The accurate identification of medicinal products anywhere in a health system context is a worldwide patient safety issue. It necessitates a collaborative solution. Despite 20 years of efforts by the global health standardisation community, there is a persistent need for agreed and implementable standardised medicinal product attributes, code systems, implementation guides and data exchange infrastructures. The International Organization for Standardization's (ISO) suite of IDMP (Identification of Medicinal Products) standards for accurate identification along the full life cycle of drugs was conceived to meet this challenge.
IDMP standards are to be used to describe and identify medicinal products, their ingredients, and their packages so that the information can be safely recorded, coded, and exchanged between regional, national, and international stakeholders. Receiving IDMP-compliant data helps regulatory bodies by facilitating and substantially improving regulatory processes around authorising medical products,managing their full life cycle, and rendering global pharmacovigilance and risk management procedures faster and more reliable. In the clinical domain, IDMP compliant data will support improving processes related to (cross-border) prescription exchange, dispensation reporting, or the reconciliation of medicinal products prescribed by independent healthcare professionals treating the same patient.
The UNICOM project's main goal is to enhance and implement the ISO IDMP standards for the univocal identification of medicinal products across participating Member States and stakeholders engaged in the life-cycle data management of medicinal products. As a four-and-a-half year trans-Atlantic semantic interoperability project with a consortium of over forty European and American partners, UNICOM is well situated to provide the collaborative platform needed for such an ambitious goal. UNICOM integrates diverse perspectives and coordinates activities by bringing together multiple stakeholders, such as standard development organisations, national medicines authorities, pharmaceutical industry, national eHealth authorities, medicinal products database providers, cross-border healthcare services, healthcare professionals, patient advocacy groups, and others, into one European Innovation Action focused on IDMP implementation.
IDMP standards are to be used to describe and identify medicinal products, their ingredients, and their packages so that the information can be safely recorded, coded, and exchanged between regional, national, and international stakeholders. Receiving IDMP-compliant data helps regulatory bodies by facilitating and substantially improving regulatory processes around authorising medical products,managing their full life cycle, and rendering global pharmacovigilance and risk management procedures faster and more reliable. In the clinical domain, IDMP compliant data will support improving processes related to (cross-border) prescription exchange, dispensation reporting, or the reconciliation of medicinal products prescribed by independent healthcare professionals treating the same patient.
The UNICOM project's main goal is to enhance and implement the ISO IDMP standards for the univocal identification of medicinal products across participating Member States and stakeholders engaged in the life-cycle data management of medicinal products. As a four-and-a-half year trans-Atlantic semantic interoperability project with a consortium of over forty European and American partners, UNICOM is well situated to provide the collaborative platform needed for such an ambitious goal. UNICOM integrates diverse perspectives and coordinates activities by bringing together multiple stakeholders, such as standard development organisations, national medicines authorities, pharmaceutical industry, national eHealth authorities, medicinal products database providers, cross-border healthcare services, healthcare professionals, patient advocacy groups, and others, into one European Innovation Action focused on IDMP implementation.
Over the second reporting period, UNICOM has achieved its second milestone: Guide of common rules for data migration as a basis for legacy data migration. UNICOM has strongly supported further development and implementation of the European Substance Registration System, which is now being hosted and maintained by EMA, guaranteeing its sustainability and strategic use by the Substance Validation Group. Concerning the IDMP compliant application forms under the "Product Life Cycle" project, UNICOM is working closely with EMA in their continued development of the project. The first User acceptance test was completed, resulting in an initial go-live of the Variation Applications forms. Additionally, UNCOM has continued to help expand knowledge of IDMP-related standards and terminologies across stakeholders in the medicinal product community via regular community of expertise webinars. The UNICOM publication “IDMP in a capsule” explaining the role of IDMP standards in the life cycle stages of medicinal products has been disseminated to a wide audience while being available in multiple languages.
Knowledge sharing has been key for the implementation of IDMP at the 11 participating National Competent Authorities (NCAs). Through different workshops, NCAs have shared their experiences with implementing IDMP in their systems and addressed a broad range of associated questions. The UNICOM FHIR IDMP Server (UFIS) was created with the collaboration of various NCA and enabled them to test the EMA implementation guide and identify challenges. UFIS has around 300 medicinal products and will be used for the UNICOM pilots.
The adoption of IDMP in eHealth services has been furthered by defining the guidelines for cross-border interoperability and semantic specifications related to ePrescription/eDispensation(eP/eD) and Patient Summary (PS). Moreover, to support UNICOM pilots, the T6.1 database defines and creates a smart substitution component for integrating eD systems for cross-border use. Cooperation between UNICOM and eHDSI eP cluster resulted in the approval of several change proposals to adopt IDMP and enrich eP/eD and PS. Preproduction test for MyHealth@EU will start in 2023 in synergy with UNICOM pilots. Regarding the use of IDMP in personalised medicine, polypharmacy on a cohort of older adults at the Federico II University Hospital was studied, identifying the polymorphic pharmacogenes that could be responsible for drug-gene interactions. These results are instrumental for clinical pilots in UNICOM. For Medicinal Product Dictionaries (MPDs), the implementation guidance for identifying medicinal products in medicinal products dictionaries has been created. Following the initial socioeconomic impact assessment and cost-benefit analysis framework, an interim report on data collection elaborated on foreseen costs and benefits through different methodologies.
The project management, scientific, and technical coordination offices ensured that the underlying cross-project technical coordination processes were fully functional, including submitting 32 deliverables. In addition to the publishing of regular news items and continued social media engagement, outreach efforts, in accordance with the project's communication and exploitation strategy, included the creation of the UNICOM Newsletter, community of expertise webinars, large consortium meetings, best-practice workshops on ISO IDMP for non-participating NCAs, trans-Atlantic cooperation workshops, and several events focused on the specific use cases of different stakeholders.
Knowledge sharing has been key for the implementation of IDMP at the 11 participating National Competent Authorities (NCAs). Through different workshops, NCAs have shared their experiences with implementing IDMP in their systems and addressed a broad range of associated questions. The UNICOM FHIR IDMP Server (UFIS) was created with the collaboration of various NCA and enabled them to test the EMA implementation guide and identify challenges. UFIS has around 300 medicinal products and will be used for the UNICOM pilots.
The adoption of IDMP in eHealth services has been furthered by defining the guidelines for cross-border interoperability and semantic specifications related to ePrescription/eDispensation(eP/eD) and Patient Summary (PS). Moreover, to support UNICOM pilots, the T6.1 database defines and creates a smart substitution component for integrating eD systems for cross-border use. Cooperation between UNICOM and eHDSI eP cluster resulted in the approval of several change proposals to adopt IDMP and enrich eP/eD and PS. Preproduction test for MyHealth@EU will start in 2023 in synergy with UNICOM pilots. Regarding the use of IDMP in personalised medicine, polypharmacy on a cohort of older adults at the Federico II University Hospital was studied, identifying the polymorphic pharmacogenes that could be responsible for drug-gene interactions. These results are instrumental for clinical pilots in UNICOM. For Medicinal Product Dictionaries (MPDs), the implementation guidance for identifying medicinal products in medicinal products dictionaries has been created. Following the initial socioeconomic impact assessment and cost-benefit analysis framework, an interim report on data collection elaborated on foreseen costs and benefits through different methodologies.
The project management, scientific, and technical coordination offices ensured that the underlying cross-project technical coordination processes were fully functional, including submitting 32 deliverables. In addition to the publishing of regular news items and continued social media engagement, outreach efforts, in accordance with the project's communication and exploitation strategy, included the creation of the UNICOM Newsletter, community of expertise webinars, large consortium meetings, best-practice workshops on ISO IDMP for non-participating NCAs, trans-Atlantic cooperation workshops, and several events focused on the specific use cases of different stakeholders.
UNICOM, an Innovation Action, develops, implements, tests and pilots an IDMP-based infrastructure supporting semantic interoperability along the medicines data value chain and across national agencies and EMA, all of which entails significant progress beyond the current status quo. This will facilitate faster and better pharmacovigilance reporting, create economic efficiency gains for industry and service providers, and facilitate the use case of ePrescription/eDispensation in cross-border settings. It will improve safe, reliable recording of medicinal product information in clinical documents (e.g. Patient Summaries, health records) and enable safer communication with and empowerment of patients. It will improve reuse of medication related data for public health and medical research as well as create new synergies across regulatory, healthcare, public health, and scientific domains.
More specifically, by the end of the project, UNICOM will have piloted IDMP compliant data feeds to and among National Competent Authorities for Medicinal Products, eHealth organisations, and medicinal product dictionary providers. ISO IDMP enhanced eHealth Pilot Services at national and cross border level with selected patients are planned to demonstrate the project´s impacts. Continued outreach to Member States outside the UNICOM consortium will push for IDMP implementation across the global medicinal product community.
More specifically, by the end of the project, UNICOM will have piloted IDMP compliant data feeds to and among National Competent Authorities for Medicinal Products, eHealth organisations, and medicinal product dictionary providers. ISO IDMP enhanced eHealth Pilot Services at national and cross border level with selected patients are planned to demonstrate the project´s impacts. Continued outreach to Member States outside the UNICOM consortium will push for IDMP implementation across the global medicinal product community.