The Medication Shield technology, which was developed thanks to a partnership between public and private sector, provides considerable help for pharmacovigilance experts in analyzing adverse drug reaction (ADR) reports. In this article, Dr. Clement Goehrs, Co-Founder and CEO of Synapse Medicine, reveals how the project was developed.
The Medication Shield in three words :
Safety : because it allows collective protection to reinforce individual protection.
Responsiveness : because it is crucial to respond quickly when it comes to the management of pharmacovigilance risks.
Collaboration : A partnership between the public and private sectors is essential to provide the best possible solutions regarding public health issues.
A response to the need expressed by the pharmacovigilance system
Most ADRs are identified before a drug is even marketed, during the clinical phase. However, and despite all the precautions taken during these studies, not all ADRs can be identified. This is due to the fact that clinical studies are often conducted on a small group of people, which does not represent the entire population in terms of age, medical characteristics, etc.
This is why risk management plans and pharmacovigilance actions are systematically deployed when a drug is marketed. These pharmacovigilance systems, supervised by the Regional Pharmacovigilance Centers (CRPVs) and by the National Agency for the Safety of Medicines and Health Products (ANSM), can detect ADRs that might not have been identified earlier, during the clinical trial phases. This is made possible by analyzing data collected via the online reporting portal (signalement.social-sante.gouv.fr), which allows healthcare professionals and individuals to report any ADRs they experienced following the use of a drug.
Analyzing these reports allows to take, if necessary, measures to ensure patients' safety, such as adding new restrictions of use, or more rarely, withdrawing the drug from the market. Pharmacovigilance systems, therefore, involve significant data collection that must be sorted and analyzed quickly.
The Medication Shield: a unique technology to improve the monitoring of ADR reports
The Medication Shield project was born out of the ambition to answer a simple question: can new data science technologies help pharmacovigilance systems in their data analysis?
To answer this issue, our Medical Director, Dr. Louis Létinier, worked hand in hand with the ANSM, the CRPVs network, and Bordeaux’s University Hospital to develop a tool capable of improving data analysis. This tool, named "Medication Shield" because of its role as a collective shield, analyzes and prioritizes ADR reports in real-time to allow pharmacovigilance teams to focus their attention on the most severe cases. The aim here is to ensure responsiveness in the event of an unexpected situation following the marketing of a drug.
How does it work?
This technology is based on algorithms that analyze data obtained through the online ADR reporting portal (www.signalement.social-sante.gouv.fr). It performs a first sorting of the data, codes them according to an international classification (based on the Medical Dictionary for Regulated Activities, MedDRA), and filters them by severity. The information obtained is transmitted to the CRPVs, which then benefit from an easier data reading.
This tool is integrated between the stages of online reporting and processing by the CRPVs, to fluidify the analysis process and allow pharmacovigilance teams to focus their efforts on the most severe cases.
Our ambition is to deploy this technology within all CRPVs in France to support ADR reports monitoring at the national level. The algorithms of this technology have already been evaluated within university hospitals and are the subject of a scientific paper that is being published.
A project made possible thanks to the unprecedented collaboration between pharmacologists and experts in machine learning
One of the most innovative aspects of this technology, which also represents the foundation of Synapse Medicine's creation, is bringing together many different expertises to the same place. Indeed, this technology requires expertise in machine learning but also a great understanding of pharmacology data. These are expertises that do not usually meet on the same project!
What role does the general public play within the pharmacovigilance system?
Each individual can contribute to the smooth running of the pharmacovigilance system by reporting any worrying ADRs that have not already been mentioned by a doctor. You should not hesitate to participate in this preventive action by reporting worrying symptoms: in doing so, we all help to strengthen our collective protection!
For more information related to the Medication Shield and its integration within the pharmacovigilance system in France, click here.