Periodic Reporting for period 1 - WEB-RADR 2 (WEB-RADR 2)
Okres sprawozdawczy: 2018-09-01 do 2020-06-30
The WEB-RADR2 project was set up to build upon the learnings and recommendations from the original WEB-RADR project (WEB-RADR1). Specifically, the objectives of WEB-RADR2 were to expand access to the WEB-RADR platform including mobile application (app) and the reach of the information contained within it through the underlying Application Programme Interfaces (APIs) that deliver its functions. In addition, WEB-RADR2 sought to embed WEB-RADR APIs within electronic healthcare records (EHRs) and conduct a proof of concept pilot with EHR connectivity within the Danish healthcare system to test the integration of the WEB-RADR APIs for submitting ADR reports. To facilitate communication between regulatory and healthcare databases, the two core healthcare terminology owners; ICH (MedDRA) and International Health Terminology Standards Development Organisation (IHTSDO) (SNOMED) aimed to complete two independent bi-directional maps (MedDRA to SNOMED CT and SNOMED CT to MedDRA) on a subset of key pharmacovigilance terms and establish mapping protocols.
Information on WEB-RADR1 and WEB-RADR2 are available: https://web-radr.eu/
Information on WEB-RADR1 and WEB-RADR2 are available: https://web-radr.eu/
The WEB-RADR2 project has been designed around sustainability of the project outputs. All partners involved have committed to sustainability and delivery of models that live on beyond the life of the project and have tangible impact on international pharmacovigilance, now and in the future.
The project has delivered:
• APIs to enable ADR reporting to International National Competent Authorities (NCAs) and EU Member States into existing mobile applications and websites without the need to download a separate app (D3.3 D5.1)
• Ability to output ADR data in either the E2B R2 or R3 standard (D2.1 D2.2 D3.1)
• A successful proof of concept pilot for EHR connectivity within the Danish healthcare system, testing integration of WEB-RADR APIs for submitting ADR reports (D5.2 D5.4 D5.5)
• Controlled access to APIs to deliver trusted regulatory news and data to third party apps and websites (D3.3 D5.1)
• The ability to repurpose the delivered APIs for use by the pharmaceutical industry (D2.3 D2.4 D3.2)
• The ability of healthcare professional reporting from their own electronic healthcare record systems by provision of APIs and supporting terminology mappings (D5.3)
• Enhancement of the clinical experience for healthcare professional through provision of regulatory information back into the healthcare record using the required local terminologies (D5.3)
• The ability for epidemiological research across healthcare databases using agreed and validated terminology mappings (D4.1 D4.2)
• A SNOMED International and ICH/MedDRA agreed maintenance approach for the bi-directional mapping including access, distribution, licencing and map maintenance (D4.3 D4.4)
• An agreed sustainability plan and cost models for the adoption and maintenance of mobile apps for NCAs and industry (D1.5 D3.3)
• An agreed sustainability plan and cost models for the adoption and use of the platform including the new APIs developed (D1.5)
The project has delivered:
• APIs to enable ADR reporting to International National Competent Authorities (NCAs) and EU Member States into existing mobile applications and websites without the need to download a separate app (D3.3 D5.1)
• Ability to output ADR data in either the E2B R2 or R3 standard (D2.1 D2.2 D3.1)
• A successful proof of concept pilot for EHR connectivity within the Danish healthcare system, testing integration of WEB-RADR APIs for submitting ADR reports (D5.2 D5.4 D5.5)
• Controlled access to APIs to deliver trusted regulatory news and data to third party apps and websites (D3.3 D5.1)
• The ability to repurpose the delivered APIs for use by the pharmaceutical industry (D2.3 D2.4 D3.2)
• The ability of healthcare professional reporting from their own electronic healthcare record systems by provision of APIs and supporting terminology mappings (D5.3)
• Enhancement of the clinical experience for healthcare professional through provision of regulatory information back into the healthcare record using the required local terminologies (D5.3)
• The ability for epidemiological research across healthcare databases using agreed and validated terminology mappings (D4.1 D4.2)
• A SNOMED International and ICH/MedDRA agreed maintenance approach for the bi-directional mapping including access, distribution, licencing and map maintenance (D4.3 D4.4)
• An agreed sustainability plan and cost models for the adoption and maintenance of mobile apps for NCAs and industry (D1.5 D3.3)
• An agreed sustainability plan and cost models for the adoption and use of the platform including the new APIs developed (D1.5)
WEB-RADR2 outputs will enable delivery of ground-breaking pharmacovigilance systems by enabling customised user experiences for both reporting and data provision through the use of the different features of the Vigilance Hub and use of APIs to embed functionality into healthcare systems partnered with bi-directional mapping between MedDRA and SNOMED CT.
Work conducted in Report Configuration enabled the configuration of reporting forms through the Vigilance Hub; addition of multiple reporting forms, addition of new questions, configurable report form questions, changing of mandatory questions (where not required for key validations). Through the Vigilance Hub, organisations and future adopters have control of their reporting forms and can tailor questions to their specific needs and requirements, without the need to rely on external developers. The generic single sign on (SSO) solution streamlines the signing in process for patients and healthcare professionals, as the reporter’s login credentials are the same regardless of the platform, they have one account across multiple platforms (app, website). APIs were created and documented to support third party organisations embedding WEB-RADR platform functionality into their own systems, applications and websites. There is opportunity to enhance the impact of the platform by extending its reach into third party systems.
The AbbVie e-PV pilot demonstrated that the WEB-RADR platform could be tailored to meet the needs of pharmaceutical companies. Through the requirements gathering and validation processes the project developed a better understanding of the adoption process and different company requirements. The work undertaken has a significant impact for adopters who wish to use the WEB-RADR platform to support studies, patient support programmes and disease programmes, and deliver educational and risk minimisation materials. The ability to use data provisioned through APIs, and the capability to deliver approved content to users of the platform could both reduce costs and increase the impact of the activities.
The Med Safety App is seen as a trusted, recognisable ADR reporting tool that transcends language barriers. It brings consistency and standardisation to reporting whilst enabling countries to tailor the App. The Med Safety App has been a successful tool in raising awareness of pharmacovigilance more broadly; it is available in multiple languages, supported by the World Health Organization (WHO) and Uppsala Monitoring Centre (UMC), and is connected to UMC’s Vigi-tools supporting global pharmacovigilance.
The bi-directional maps (MedDRA to SNOMED CT and SNOMED CT) are essential for interoperability between clinical and regulatory systems. The bi-directional mappings were completed on a subset of key pharmacovigilance terms proving that bi-directional maps can be produced in a quality assured manner and maintained into the future. The mapping work will facilitate the interoperability of SNOMED CT encoded EHR data to with regulatory data coded in MedDRA. There has been significant interest from external organisations who have volunteered to participate in the alpha review of the maps. It is anticipated that the bi-directional maps created can better facilitate epidemiological studies between databases encoded in different terminologies, leading to more robust assessments of the real-world impact of medicines. Additionally, the maps provide the potential for use in digital development and innovation in clinical trials with research of electronic health records, and in the use of real-world evidence.
The DKMA pilot was successful and has proven that EHR connectivity is feasible and ADR reports can be successfully submitted via the WEB-RADR API from a Danish system. This result paves the way for future connectivity with other IT-system providers and highlights the exploitable potential of the APIs developed. The proof of concept has potential for significant pharmacovigilance impact; HCPs will have the functionality to report ADRs directly from the local IT system without the need for such costly system integration as would previously have been required. This will not only improve the quality and the number of ADR reports but reduce data entry time and increase data quality and quantity.
Work conducted in Report Configuration enabled the configuration of reporting forms through the Vigilance Hub; addition of multiple reporting forms, addition of new questions, configurable report form questions, changing of mandatory questions (where not required for key validations). Through the Vigilance Hub, organisations and future adopters have control of their reporting forms and can tailor questions to their specific needs and requirements, without the need to rely on external developers. The generic single sign on (SSO) solution streamlines the signing in process for patients and healthcare professionals, as the reporter’s login credentials are the same regardless of the platform, they have one account across multiple platforms (app, website). APIs were created and documented to support third party organisations embedding WEB-RADR platform functionality into their own systems, applications and websites. There is opportunity to enhance the impact of the platform by extending its reach into third party systems.
The AbbVie e-PV pilot demonstrated that the WEB-RADR platform could be tailored to meet the needs of pharmaceutical companies. Through the requirements gathering and validation processes the project developed a better understanding of the adoption process and different company requirements. The work undertaken has a significant impact for adopters who wish to use the WEB-RADR platform to support studies, patient support programmes and disease programmes, and deliver educational and risk minimisation materials. The ability to use data provisioned through APIs, and the capability to deliver approved content to users of the platform could both reduce costs and increase the impact of the activities.
The Med Safety App is seen as a trusted, recognisable ADR reporting tool that transcends language barriers. It brings consistency and standardisation to reporting whilst enabling countries to tailor the App. The Med Safety App has been a successful tool in raising awareness of pharmacovigilance more broadly; it is available in multiple languages, supported by the World Health Organization (WHO) and Uppsala Monitoring Centre (UMC), and is connected to UMC’s Vigi-tools supporting global pharmacovigilance.
The bi-directional maps (MedDRA to SNOMED CT and SNOMED CT) are essential for interoperability between clinical and regulatory systems. The bi-directional mappings were completed on a subset of key pharmacovigilance terms proving that bi-directional maps can be produced in a quality assured manner and maintained into the future. The mapping work will facilitate the interoperability of SNOMED CT encoded EHR data to with regulatory data coded in MedDRA. There has been significant interest from external organisations who have volunteered to participate in the alpha review of the maps. It is anticipated that the bi-directional maps created can better facilitate epidemiological studies between databases encoded in different terminologies, leading to more robust assessments of the real-world impact of medicines. Additionally, the maps provide the potential for use in digital development and innovation in clinical trials with research of electronic health records, and in the use of real-world evidence.
The DKMA pilot was successful and has proven that EHR connectivity is feasible and ADR reports can be successfully submitted via the WEB-RADR API from a Danish system. This result paves the way for future connectivity with other IT-system providers and highlights the exploitable potential of the APIs developed. The proof of concept has potential for significant pharmacovigilance impact; HCPs will have the functionality to report ADRs directly from the local IT system without the need for such costly system integration as would previously have been required. This will not only improve the quality and the number of ADR reports but reduce data entry time and increase data quality and quantity.