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Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster
Gilles Defer1, Sophie Fedrizzi2, Damien Chevanne1
1Neurology Department, Caen University Hospital, Caen, France.
Drug Safety
|October 13, 2020
Summary
A mobile app significantly increased adverse drug reaction (ADR) reporting for multiple sclerosis patients using new medications. This mobile device application (App) offers a more effective method for pharmacovigilance compared to traditional reporting channels.
Area of Science:
- Pharmacovigilance and patient safety
- Digital health interventions
- Multiple sclerosis therapeutics
Background:
- Patient reporting is crucial for pharmacovigilance.
- Mobile applications offer a potential method to enhance patient reporting.
- Evaluating the efficacy of mobile apps in pharmacovigilance is necessary.
Purpose of the Study:
- To determine if a mobile application increases suspected adverse drug reaction (ADR) reporting.
- To compare ADR reporting via a mobile app versus traditional methods (email, phone, website).
- To assess ADR reporting in multiple sclerosis patients initiating first-line disease-modifying drugs.
Main Methods:
- An open, multi-center, cluster-randomized controlled trial (VigipSEP study) was conducted.
- Centers were randomized to either the My eReport France® App (experimental) or traditional reporting (control).
- Hierarchical Poisson regression model used for primary outcome analysis of ADR reports per patient.
Main Results:
- Centers using the mobile app showed a significantly higher mean number of ADR reports per patient (0.47 vs. 0.03, p=0.002).
- Individual-level analysis revealed a 18.6-fold increased relative risk of ADR reports in the experimental arm (p < 0.001).
- The study included 159 patients across 24 centers from April 2017 to April 2019.
Conclusions:
- Mobile app usage significantly enhanced ADR reporting among multiple sclerosis patients on first-line disease-modifying drugs.
- The My eReport France® App proved to be an effective tool for improving pharmacovigilance.
- Digital health tools can improve patient engagement in reporting adverse drug reactions.
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