The MedeA (Medicina Personalizada Aplicada, Applied Personalised Medicine) Initiative is a genuine personalized medicine (PM) clinical implementation programme. It is based on an analysis of each patient’s individual pharmacogenetic biomarkers, drug-drug interactions and clinical data evaluated in an e-health strategy. This information is fed into a software system called Personalized oriented Prescription System (PoPS). It acts as a clinical decision support tool (CDST) for the clinician and suggests the best drug or drug combination and dose for the individual patient.
MedeA is part of a regional Spanish PM strategy, which integrates pharmacogenetic data, biomarker analyses and other relevant health data from the Electronic Medical Record (EMR) system. The aim is to develop a PoPS for individualised drug prescription in regular clinical practice by assessing and analysing genetic information and other variables from the EMR with artificial intelligence algorithms.
Thus, a reduction of adverse effects and a significant improvement of quality of life for the patients is expected. In addition to the benefit for the patients, the implementation of the MedeA initiative is expected to contribute to the sustainability of the Health System. The project will be implemented for all patients of the Public Health System in the Spanish region of Extremadura. The most innovative feature of MedeA is that all the pharmacogenetic information, along with other relevant data and artificial intelligence tools in the e-health context, are available in the software systems used in the EMR of the regional Health System.
In the context of MedeA, a pre-emptive genotyping study takes place that analyses gene variations with known pharmacogenetic significance. These are pharmacodynamics and pharmacokinetic biomarkers (the metabolic genotypes CYP2D6, CYP2C9 and CYP2C19), all recommended by Drug Regulatory Agencies and covering the majority of drugs used in clinical practice. Initially, the MedeA Initiative will cover a cohort of 3000/5000 patients for the study. It is currently being implemented (2017-2023) with a total budget of 5.465.747 €. Before this ongoing study, a pilot study with 804 patients in Primary Health Care in the Extremadura Health Care Services (SES) had been conducted during 2012-2017, with promising results: The relationship found between an increase in the use of health services by individuals with less common metabolizing phenotypes (i.e. poor metabolizers) highlighted the connection between these metabolic states and hospitalizations.
© Adrián LLerena, UNIV EXTREMADURA-SES
The ongoing MedeA Initiative is divided into four Technological Challenges:
- Ch01: PoPS: Development of a Personalized oriented Prescription System (CDSS Clinical Decision Support System);
- Ch02: SiGEN: Development of a set-up for laboratory analysis of pharmacogenetic biomarkers;
- Ch03: PePS: Development of a stratification system for patients and/or healthy volunteers participating in clinical research/trials;
- Ch04: SeRAM: Development of tools for clinical evaluation and detection of adverse reactions during daily life based on biosensors (IoT).
The PoPS will include recommendations given by the European and Spanish regulatory drugs agencies (EMA and AEMPS) as well as other international consortiums (e.g. PharmGKB, CPIC, DPWG) regarding selection of genomic biomarkers.
This e-health innovation programme involves private companies in its development, by using Innovative Public Procurement to promote R&D&I in companies and within the framework of the Open Innovation Model promoted by the Extremadura Health Care Services and the Spanish Ministry of Science and Innovation (MICINN). It is currently being developed at the Clinical Research Center of the Extremadura University Institute for Biomedical Research (INUBE), where a Pharmacogenetics and Personalized Medicine Unit was established. The project is currently managed by the Health Care Service (SES, Servicio Extremeño de Salud), in close contact with health care professionals and patient associations.
MedeA will protect privacy, following the RGPD-LOPDGDD (European General Data Protection Regulation adapted to the Spain framework) for the storage and handling of genetic samples and data, as well as all intellectual property rights emanating from the project.
This initiative would be applicable to any health care setting developing an automated personalised prescription system promoting drug safety and efficacy. It is conceptualized as a proof of concept for PM implementation and could be taken up by other European health care services, contributing to their sustainability and improving the treatment of patients.