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After an extensive study back in 2013, Datawizard concluded that the key to Patient Empowerment is delivering trusted health information to people in a way that is easily accessible and understandable.
Today, not only has this concept has been widely accepted but it has become a fundamental principle in the development of new patient-centered healthcare services, in particular Digital Health services. This is largely due to the “Dr. Google” phenomenon: when health problems, concerns and questions arise, people’s go-to source for information is Google. However, it’s not easy to validate that the answers you find come from trusted sources.
Therefore, the need persists for citizens, particularly EU citizens, to have easy access to trusted sources of health and medicine information that are up-to-date, certified, easy-to-navigate and easy to understand.
Gravitate Health: Better awareness leads to better health
In this context, the European Commission and EFPIA (European Federation of Pharmaceutical Industries and Associations) released an Innovative Medicine Initiative call for projects (IMI-2019-18-03) in 2019 with the primary goal of improving patient access, understanding and adherence to healthcare information, calling it an integrated Digital Health information project.
Datawizard is very proud to be part of the project selected for this call called GRAVITATE HEALTH, representing a diverse consortium of many stakeholders such as Pharma companies, health and medicine experts, doctors, pharmacists, regulators, standards bodies, academic researchers, psychology/behavioural experts, universities and SMEs with the mission to equip and empower citizens with digital information tools that make them more confident, active, and responsive in their health journey.
Datawizard is the only Italian SME company involved in the project with the crucial role in designing and developing the digital services that help to foster the safe use of medicines for better health outcomes and quality of life.
The team includes 30 partners spread over 13 countries and a wide range of stakeholders. Other Italian partners include the Engage Minds Hub of University Sacro Cuore, Milan, with their leading expert on behavioural psychology and therapy adherence.
Gravitate Health was the only proposal out of many to be selected in Stage 1 of the two-stage process in December 2019 and will submit their Stage 2 statement in early 2020 in collaboration with Pharma Companies from EPFIA.
The Gravitate Health Mission
The principal objective of the project is to demonstrate how the use of an integrated, digital, user-centric health information solution with two-way communication could enable tangible improvements in accessibility and understanding of health information from available trusted sources, starting with the medicinal product information (ePI, SmPC, EPAR), EHR- IPS, and Medicinal compendiums.
The secondary objective is to demonstrate that the improved availability and understanding of health information from trusted sources translates to higher levels of adherence to treatment, safer use of medication, improving pharmacovigilance, better health outcomes and quality of life, and new insights into how use of health information can be optimized to act as effective risk minimization measures.
Gravitate Health’s innovative concept is to focus, not conceal or filter, normative ePI content to the user. It is more than a research project because it will help define how to measure the impact of personalised healthcare on a patient’s life and health outcomes. This is a key component that will help guide the future of health and home-care policies in the EU, which will be increasingly relevant as the demand for healthcare rises due to Europe’s ageing population. Datawizard looks forward to contributing our expertise to such an important initiative.
What happens if you are travelling outside your home country and you run out of your prescription medicine, or your luggage is stolen, or you simply forgot to pack your pills? Anyone who has experienced this knows that it’s not always that easy to find a similar commercial drug product or dosage in the country where you are travelling, or to get authorization for your prescription to be filled. This is because drugs are managed at the national level so in theory, your prescription is only valid in the country where it was issued. The European Commission intends to change this, however it’s not as simple to implement as it may seem.
In Europe today, there are more than 600,000 different medicinal products on the market but on average, the list of authorized medicine products in a single member state rarely exceed 30,000 products. From the standpoint of a patient simply trying to get medicine outside of their home country, this may seem like systemic inefficiency. But medicine is a highly regulated industry and each country has its unique history and legislation that pharma companies must adhere to in order to in order to enter that market. So what would be the first logical step towards a world in which European citizens have safer and easier access to prescription medicine in cross-border use cases? It would certainly be helpful to have a unique ID for each drug product that was designed especially for this emerging international use case, because currently, unique medicine ID’s are distinct for each nation, but not designed to ‘cross the border’.
This is the “raison d’être” of UNICOM, a large EU-funded project with the mission of up-scaling the global univocal identification of medicines, in which Datawizard, the only Italian SME company involved in the project, will lead the activities related to Patient Information Empowerment Apps and support those of Clinical Applications. While the true ‘need’ for this new standard stems from a regulatory context (because National Drug Agencies need an infrastructure for cooperation in order to authorize ‘smart substitutions’ when the drug product that Country B will dispense is slightly different than the one that Country A prescribed), this process of harmonisation could have a significant impact on the efficacy of clinical trials on a large scale and even the future of medicine production and and distribution throughout Europe and worldwide.
One name, a thousands pitfalls
Nowadays, the complex differences and variations in the regulatory-pharmaceutical sectors of the different Member States make it difficult to create a unique and transnational identification system for the various products released in the European market. In this context, a univocal ID is a key starting point for making safe, cross-border ePrescriptions possible. UNICOM’s mission is to kick-start the implementation of ISO IDMP (ID of Medicinal Products) standards in EU Member States drug databases which requires participation and adoption among all National Drug Agencies, The European Medicine Agency and many other relevant stakeholders in the healthcare and medicine domains.
During the project, Datawizard and our team of experts, will lead the exploration of how the implementation of IDMP will provide specific benefits to patient health, how to improve pharmacovigilance activities, how to better support clinical actors (doctors, pharmacists, nurses) with decision support, and how to enable more powerful and effective clinical studies as big data related to medicine will now be easier to harmonize across many countries.
A large Consortium to make a real-world impact
UNICOM has some impressive figures: 48 partners, 19 countries represented, including 26 national Drug and eHealth Agencies, the European Medicine Agency, a range of stakeholders involved through their associations and the USA Food & Drug Administration (FDA) as an Advisory Board Member. Italian partners, beside Datawizard, include the Region of Lombardy (ARIA Spa) and Azienda Ospedaliera Universitaria Federico II Campania.
The UNICOM Innovation Action (Grant Number 875299) kicked off on December 1st 2019 and will run for 4 years. It is a truly challenging activity to coordinate, despite the wide range of qualified partners and stakeholders. But our vision is that once EU-interoperable data on medicines becomes available, the positive impact that follows will have justified the great effort we are investing. The expected results of this implementation include: safer and easier patient mobility in the EU, more efficient regulatory management of medicine, better access and quality of health data for improved pharmacy and clinical decision support, clinical research, patient empowerment and overall public health.