Technological Advances, Precision Medicine and Regulatory Improvements in Drug Safety and Pharmacy Support

Dear Colleagues,

Advances in drug safety and pharmacy support have evolved rapidly due to regulatory improvements, technological innovation and a deeper understanding of pharmacology. These advances aim to ensure the safety, efficacy and availability of medicines while reducing the risks associated with drug use. Key developments here revolve around the topics of pharmacovigilance and real-world data, precision medicine, therapeutic drug monitoring (TDM), and artificial intelligence and machine learning in drug safety. Furthermore, regulatory authorities, such as the FDA and EMA, have been enhancing their post-marketing surveillance systems.

The future of drug safety and pharmacy support is bright, with technological advances, tailored pharmacotherapy and regulatory improvements continuing to have a significant impact. From AI-driven safety monitoring to precision medicine, these innovations help ensure that drugs are used safely and effectively, ultimately improving patient outcomes.

This Special Issue aims to bring together experts to share cutting-edge research or reviews on drug safety and pharmacy support. All types of clinical studies that improve patient care and management, including (but not limited to) those on pharmacovigilance, precision medicine, therapeutic drug monitoring (TDM), regulatory improvements and post-marketing surveillance, and artificial intelligence and machine learning in drug safety, are welcome.

We look forward to receiving your contributions.

Prof. Dr. Janko Samardžić
Guest Editor

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• drug safety
• pharmacovigilance
• precision medicine
• therapeutic drug monitoring
• post-marketing surveillance
• artificial intelligence
• machine learning
• clinical pharmacology

Title: Five-Year Trends in SSRI and Benzodiazepine Consumption: A Precision Medicine Approach to Comparative Analysis between Serbia and European Countries
Authors: Janko Samardzic; Filip Simovic; Kristina Sekanic; Milica Radosavljevic
Affiliation: Institute of Pharmacology Clinical Pharmacology and Toxicology, Faculty of Medicine University of Belgrade, Belgrade, Serbia
Abstract: Selective serotonin reuptake inhibitors (SSRIs) and benzodiazepines (BZs) are the most commonly prescribed medications for anxiety, though their widespread use extends beyond clinical therapy into non-medical use and abuse. This dual use raises concerns, particularly in countries like Serbia, where SSRIs and BZs, including diazepam, oxazepam, lorazepam, bromazepam, prazepam, alprazolam, escitalopram, and sertraline, are frequently prescribed. The growing trend in medication consumption demands a closer look at prescribing patterns, especially in the context of precision medicine, which aims to tailor treatments based on individual characteristics such as genetics, environment, and lifestyle. This study investigates the five-year trend in SSRIs and BZs consumption in Serbia from 2018 to 2022, comparing these trends with data from 12 other European countries. By analyzing medication consumption through a precision medicine approach, we can better understand the underlying factors influencing prescribing practices and assess the potential for individualized treatment strategies. Methods: Data on drug sales for human medicine from the Agency for Medicine and Medical Devices of Serbia (ALIMS) were used for the analysis of consumption in the period 2018-2022. The study followed the ATC/DDD methodology recommended by the World Health Organization (WHO). Data on drug consumption in other 12 European countries were obtained from the representative national registers, while GDP per capita data were sourced from the Eurostat database. Statistical analysis of the data involved using Student's t-test and Spearman's rank correlation test. Results: From 2018 to 2021, sertraline was the best-selling drug in this group, but with a statistically significant decrease (R²=0.7948, p=0.042), while escitalopram showed a statistically significant increase (p=0.006) and became the best-selling drug in the SSRI group in 2022. Group consumption of SSRI drugs fluctuated from 2018 to 2022, with the highest values in 2020, but these changes were not statistically significant (p=0.6223). Among 12 European countries, 8 demonstrated higher consumption rates than Serbia in 2019 and 2020, with the remaining 4 showing lower rates. Notably, Iceland has the highest consumption of SSRIs, with consumption rates exceeding those in Serbia by 300% and 280%. In contrast, Latvia has the lowest consumption among the selected European countries, at 57% and 55% lower rates than Serbia. Additionally, a positive correlation was observed between antidepressant consumption and GDP per capita. In a period of 5 years, bromazepam was the most commonly prescribed BZ with a statistically significant increase (R2=0.36, p