Pharmacovigilance in the Geriatric Population: Analysis of Risk Management Plans for Medicinal Products in Russia in 2024

INTRODUCTION. Geriatric patients are the fastest growing demographic group, accounting for over half of all medicinal product users. Pharmacovigilance in this population is influenced by age-related physiological changes and social factors. Risk management plans (RMPs), developed by marketing authorisation holders, play a preventive role in managing the risks associated with the use of medicinal products in elderly patients.
AIM. This study aimed to evaluate the completeness of information on the geriatric group within target populations in RMPs for medicinal products launched in the Russian pharmaceutical market in 2024.
MATERIALS AND METHODS. This study analysed 110 RMPs for medicinal products potentially applicable to geriatric populations, submitted to the Scientific Centre for Expert Evaluation of Medicinal Products between January and December 2024. All the documents included full modules and sections.
RESULTS. The analysis revealed critical gaps in RMPs data for geriatric populations, including the epidemiology of indication(s) and target population(s) (these data were missing in 52.0% of cases); clinical trial exposure (patients over 60 years were excluded from clinical trials in 47.3% of cases); populations not studied in clinical trials (these data were unreported in 63.6% of cases); post-authorisation experience in elderly or senile patients (these data were missing in 83.6% of cases); and potential harm from overdose (risk warnings were absent in 96.4% of cases). There were no additional risk minimisation measures for emphasising the considerations for medicinal product use in the geriatric population in the analysed documents.
CONCLUSIONS. When drafting RMPs, marketing authorisation holders and medicinal product developers do not pay sufficient attention to geriatric populations and often underestimate the risks associated with medicinal product use in elderly and senile patients. The issues associated with the use of medicinal products in geriatric patients can be mitigated through rigorous risk management practices applied during pharmacotherapy. The parties concerned should consider this when drafting the summary of medicinal product characteristics and the patient information leaflet, labelling the medicinal product, and selecting the package size.

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