HomePharmacologyTool estimates risk of driving while on meds – Spanish study

Tool estimates risk of driving while on meds – Spanish study

Researchers from the SABIEN group at the ITACA Institute of the Universitat Politècnica de València (UPV), in collaboration with several partner institutions, have developed a new tool to estimate the risk of using medicines while driving.

Led by Vicente Traver and Salvador Borja and published in the scientific journal Therapeutic Advances in Drug Safety, the research introduces the FMB scale (Mobility and Risk Basis Factor) – a continuous, multi-factorial model that enhances the traditional evaluation based on the DRUID system (Driving under the Influence of Drugs, Alcohol and Medicines), currently the most widely used reference in Europe.

Many medicines can cause drowsiness, dizziness or loss of concentration. However, information about these effects is often scattered and not always easy to interpret, said Salvador Borja Ripoll, the study’s lead author from UPV.

“Until now, the DRUID system has classified medicines into broad categories, but it presents limitations in terms of reproducibility, clinical applicability and its ability to discriminate between medicines with similar profiles.”

New proposal – the FMB scale

To address these limitations, researchers at ITACA developed the FMB scale. This qualitative tool structures key variables related to driving, including adverse effects, their frequency, dosage, treatment phase, and pharmaceutical form.

“The aim is to provide clearer and more useful information for both healthcare professionals and patients. Rather than assigning a single category, the scale combines different factors to generate a continuous index that more accurately reflects risk under real conditions of use,” said Traver, head of the SABIEN-ITACA group and study co-author.

The results show that the scale reproduces the qualitative classification of the DRUID system, while offering greater resolution within each category. This makes it easier to identify relevant differences between medicines and improves assessment in situations close to risk thresholds.

Specifically, the findings demonstrate that the scale not only mirrors the DRUID qualitative classification but also identifies significant differences between medicines within the same category and improves evaluation near the boundaries of risk.

“This scale allows us to distinguish more precisely between medicines that, although they share the same category, do not have the same impact on driving. In addition, it transforms complex information into a clear and practical indicator, facilitating clinical decision-making and improving risk communication between healthcare professionals and patients," added Traver, Professor of Electronic Technology and researcher in the SABIEN-ITACA group at UPV.

Added value of the new tool

Looking ahead, the tool could be integrated into mobile applications, electronic prescribing systems or pharmacy software, helping users make more informed decisions and further enhancing road safety.

The researchers believe that this work represents a methodological advance in the assessment of pharmacological risk while driving by incorporating a structured, transparent and reproducible approach that can contribute to improved clinical practice and to the development of evidence-based road safety strategies.

The research team paid tribute to the late Ferran Mocholí, a researcher at the institute who died several years ago but whose vision and initial proposal were decisive in triggering the origins of this work.

Study details

The FMB scale: a multifactorial metric to assess the driving hazard of medicines beyond the DRUID system

Salvador Borja Ripoll, Vicente Traver, Ferran Mocholí et al.

Published in Sage Journals on 18 March 2026

Abstract

Background
Driving while undergoing pharmacological treatment poses a significant risk to road safety. The Driving under the Influence of Drugs, Alcohol, and Medicines (DRUID) system, currently used to classify medicines according to their impact on driving ability, has important limitations, including the absence of classification for numerous drugs, low reproducibility, and limited clinical applicability.

Objectives
To develop a continuous, multifactorial metric capable of refining the estimation of medication-related driving risk and to assess its preliminary performance compared with the traditional DRUID system.

Design
Methodological development and initial validation study.

Methods
In this study, we propose a new multifactorial risk scale, validated by healthcare professionals and engineers, which integrates key pharmacological and clinical variables. The scale combines six weighted criteria: DRUID category, frequency and severity of adverse reactions, number of driving-related adverse reactions, marketed dose, treatment initiation versus chronic treatment, and pharmaceutical dosage form. Each variable was normalised to a 0–1 scale to ensure comparability. In addition, correction mechanisms were introduced to avoid bias arising from the presence of multiple adverse reactions with unknown frequencies, ensuring robustness to incomplete data.

Results
When applied to different clinically used medicines, the scale showed greater sensitivity and accuracy in discriminating risk compared with the traditional DRUID system, reproducing its qualitative categorisation while providing finer intraclass resolution, particularly for medicines situated near risk thresholds.

Conclusion
This tool offers a more flexible, reproducible, and clinically applicable approach with the potential for integration into e-prescribing, mobile health applications, and community pharmacy support systems, supporting more nuanced and evidence-based clinical decision-making.

 

Sage Journals article – The FMB scale (Restricted access)

 

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