Received: 18.05.2026
Accepted: 18.08.2026
Published online: 21.08.2026
UDC: 615.2/.065(574)
DOI: 10.53511/pharmkaz.2026.4.7
ANALYSIS OF SPONTANEOUS ADVERSE DRUG REACTION REPORTS AND APPROACHES TO PHARMACOVIGILANCE QUALITY ASSESSMENT IN THE REPUBLIC OF KAZAKHSTAN IN 2025
Nagiyeva N.Sh.1, Kadyrbayeva G.M.1, Zhurynova A.O.1, Ablayeva D.S.2, Kozhanova K.K.1
1Kazakh National Medical University named after S.D. Asfendiyarov, Almaty, Kazakhstan
2 “Turlan Medical” LLP, Shymkent, Kazakhstan
Introduction: Spontaneous reports are a key source for detecting medicine safety signals. However, absolute report counts do not represent the population incidence of adverse reactions and cannot be used to directly compare the safety of individual medicines. Assessing report structure and data completeness is therefore important for improving pharmacovigilance practice.
Objective: To describe the structure of publicly available aggregated adverse drug reaction reports in the Republic of Kazakhstan in 2025 and to identify measures that, within the limits of the available data, can be used to assess the characteristics and quality of the reporting dataset.
Materials and Methods: A retrospective descriptive study was conducted using publicly available monthly reports of the National Center for Expertise of Medicines and Medical Devices for January-December 2025. The aggregated dataset comprised 2,971 reports and was described by reporting source, region, Anatomical Therapeutic Chemical (ATC) groups, pharmaceutical organization, medicine manufacturer, and outcome. Because individual case-level data were unavailable, independent deduplication and exclusion of invalid individual case safety reports (ICSRs) could not be performed; analyses were limited to counts and percentages.
Results: Of 2,971 reports, 2,232 (75.1%) originated from healthcare organizations, 724 (24.4%) from pharmaceutical companies, and 15 (0.5%) through the DariKZ channel. ATC groups J01 and J04 accounted for 948 (31.9%) and 729 (24.5%) reports, respectively. Manufacturer information was missing in 766 reports (25.8%), and outcome information was missing in 761 (25.6%). Report counts varied across regions, but no standardization by population, hospitalizations, or medicine exposure was performed.
Discussion: The available aggregated data support description of report volume, structure, and completeness of selected fields, but they do not allow estimation of adverse reaction incidence, comparative medicine safety, or the overall quality of the national pharmacovigilance system. Process indicators such as reporting timeliness, ICSR clinical completeness, expectedness, and seriousness according to international criteria require individual case-level data.
Conclusion: Analysis of the 2025 open monitoring data characterized the structure of spontaneous reports and identified substantial missingness in manufacturer and outcome information. Measures derived from aggregated data should be interpreted as descriptive and reporting-data-quality measures. Comprehensive pharmacovigilance system assessment requires standardized denominators and structural, process, and outcome indicators based on individual ICSRs.
Keywords: pharmacovigilance, spontaneous reporting, adverse drug reactions, ICSR, medicines, data quality, ATC classification, Republic of Kazakhstan.
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