French medication intelligence company Synapse Medicine has rolled-out its Medication Shield technology in collaboration with the regional pharmacovigilance centers (CRPVs) and the French National Agency for Medicines and Health Products Safety (ANSM).
The technology claims to increase the safety of the COVID-19 vaccination campaign in France by managing the adverse drug reactions (ADRs) signals on a reporting portal, which is implemented by the French Ministry of Health.
The reactions are encoded automatically into a standardised international terminology (MedDRA) which ranks them by severity.
Synapse Medicine has been working in collaboration with the health institutions for the last 18 months on the management of pharmacovigilance cases. They have since published an infographic explaining how the Medication Shield technology is integrated into the French pharmacovigilance system.
WHY IT MATTERS
The ANSM has chosen to deploy the Medication Shield on a national level in response to the vaccination programme, which requires rapid analysis from pharmacovigilance centres.
Designed as a time-effective solution, this systematic collation of reports will allow pharmacovigilance to benefit from a faster reading of data linked to ADR reports, consequently allowing them to focus their attention on the more pressing cases.
As COVID-19 vaccines were developed in record time, any possible side effects must be reported to ensure better responsiveness. The system will allow monitoring teams from ANSM and CRPVs to analyse reports depending on the level of severity.
The technology ultimately aims to simplify ADR signals processing to allow health authorities to detect them faster after the drug is commercialised and to take corrective measures if needed.
Medication Shield recently enabled France to issue the first pharmacovigilance signal related to hypertension regarding the Pfizer vaccine. A potential signal was also detected regarding the Astrazeneca vaccine, causing several hospitals to pause the vaccination campaign for a few days.
THE LARGER CONTEXT
In 2017, the French Ministry of Health implemented an online reporting portal dedicated to ADR reports, allowing citizens to report any unexpected adverse drug event that has an impact on health.
In January, the NHS announced that they will start recording COVID-19 vaccine ethnicity data, following criticisms for its lack of comprehensive data on the uptake of the vaccine among different ethnic groups.
In November, the UK decided to use AI for COVID-19 vaccine side effects. Software company Genpact UK was paid £1.5 million for an AI tool that processes any adverse reactions to arise from the vaccination.
ON THE RECORD
Dr Clément Goehrs, co-founder and CEO of Synapse Medicine, said: "The Medication Shield acts as a collective shield. It allows pharmacovigilance experts, physicians, and pharmacists to save time during the management of ADR reports and focus their attention on the most severe cases. The major challenge here is to monitor any unexpected events following the COVID-19 vaccination in real-time, and more broadly following the use of any medication."