Evaluation of Kosovo pharmacists’ knowledge of tamoxifen-induced psychiatric disorders in comparison with reported side effects in the WHO pharmacovigilance database

ABSTRACT

Background: Tamoxifen is a widely prescribed selective estrogen receptor modulator (SERM) used for the treatment and prevention of hormone receptor-positive breast cancer. While tamoxifen has proven effective in lowering the chance of cancer recurrence, current data point to a possible link between tamoxifen treatment and unfavorable psychological consequences. Objective: In this study, the World Health Organization (WHO) pharmacovigilance database will be analyzed to determine the frequency and kind of psychiatric disorders linked to the use of the tamoxifen as well as Kosovo pharmacists’ awareness of these reported adverse effects. Methods: The WHO pharmacovigilance database, VigiBase, was queried for adverse drug reaction reports related to tamoxifen use between 1978 and 2022. A cross-sectional survey of 70 community pharmacies operating in Kosovo was conducted as part of the data collection between January 1 and March 1, 2023, with the goal of comparison. Results: The search of VigiBase yielded a total of 1746 reported cases of psychiatric disorders. The data were further classified based on the type of psychiatric adverse effect, including depressive disorders, anxiety disorders, cognitive impairment, and other psychiatric symptoms. Depressive disorders were the most frequently reported adverse event, accounting for 30% of the cases. Anxiety disorders and sleeps disorders were also prevalent, comprising 11% and 7% of the reported cases, respectively. Other psychiatric symptoms such as mood swings, insomnia, and confusion were observed in 32% of the cases. In Kosovo, 30% of pharmacist’s linked tamoxifen with depression, 25% with anxiety, 56% with sleep disorders, 53% insomnia, and 18% confusion. Conclusions: Based on the WHO pharmacovigilance database and knowledge of Kosovo pharmacists for these documented adverse effects, this study analyzes tamoxifen-induced psychiatric disorders... (AU)