Adverse drug reactions (ADRs) are a major burden to our healthcare and economic systems. In Europe alone, approximately 197,000 annual deaths can be attributed to ADRs. The regular use of five or more medications at the same time (polypharmacy), the coexistence of two or more long-term medical conditions or diseases (comorbidity), and genetic diversity have a significant effect on drug efficacy and consequently, raise the incidence and severity of ADRs.
Aiming to increase overall drug treatment safety, the international team of the EU research project SafePolyMed seeks to provide physicians and pharmacists with innovative tools to define, assess and manage drug interactions, especially the so-called drug-drug-gene interactions (DDGIs).
Overall, the envisioned tools will not only empower healthcare providers but will also educate patients and citizens on how to adequately and safely manage their drug treatments.
SafePolyMed will gather, combine and analyse the electronic health records and genotype data of over 1 million individuals. Genome-wide genotype data, demographic data, underlying health conditions, and polypharmacy will all be combined in regression analyses.
The development of an evidence-based risk scoring system using machine learning (ML) on large real-world datasets enables physicians to identify patients at risk, taking into consideration polypharmacy, multimorbidity, genetic variations as well as demographic and disease-related factors. More personalised and effective decisions will be thereby made possible.
Patient Reported Outcome Measures
Since most adverse drug effects occur during the time a patient is not within the structures of the health care system, a citizen-science approach to empower patients to better understand, recognise and report individual safety outcomes is needed. SafePolyMed aims to develop and validate patient-reported outcome measures (PROMs) in collaboration with patient organisations and other stakeholders using the Delphi consensus process. The developed PROMs will be implemented in the medication management center (MMC) and will be further validated in clinical case studies.
Medication Management Center (MMC)
To ensure interoperability within Europe’s national health systems, SafePolyMed will integrate several advanced modules on patient safety and empowerment in a sustainable, comprehensive knowledge hub - a medication management center (MMC). In doing so, SafePolyMed will provide standardised interfaces across regions and countries in Europe.
Model-based Precision Dosing
Safety and efficacy of drug therapy can be affected by multiple factors, and even the administration of standard drugs at therapeutic doses can lead to dose-related adverse drugs reactions (ADRs). SafePolyMed will apply rigorously validated mathematical models to real-world data in order to make individualized treatment based on patient-related factors possible.
Clinical Case Study
Real-world usage of the medication management tool developed in the previous phase will be examined in a clinical case study, involving four sites in four European countries and serving as a “proof-of-principle”. The primary objective is to assess the feasibility of using the developed tool to empower EU citizens to improve drug safety. Secondly, the study aims to verify whether the tool is able to accurately identify patients at risk of experiencing adverse drugs reactions.