Ketorolac as a risk signal in nonsteroidal anti-inflammatory drug utilization: an ecological pharmacoepidemiological study

Background. Although clinical guidelines prioritize oral administration of nonsteroidal anti-inflammatory drugs (NSAIDs), the distribution of administration routes across Russian regions has not been quantitatively characterized. Market concentration indices and cost decomposition have scarcely been used in Russian studies of drug utilization.

Objective: To quantify the regional consumption of systemic NSAIDs in the retail sector of the pharmaceutical market in the Samara Region for 2023–2025 and to compare the structural position of ketorolac with published European pharmacoepidemiological data.

Material and methods. A retrospective regional study on the drug utilization was conducted using anonymized sales data on systemic NSAIDs from the pharmacy retail sector in the Samara Region for the years 2023–2025. The data source was the AlphaRM database. Consumption volume was calculated in defined daily doses (DDD) according to the WHO ATC/DDD index, accounting for administration route; consumption intensity was expressed as DDD per 1,000 inhabitants per day (DDD/1,000 inhabitants/day, DID). Additional analyses included the drug utilization 90% (DU90) segment, market concentration indicators (Herfindahl–Hirschman Index, HHI), cumulative share of the three leading molecules (concentration ratio of top-3 firms, CR3), and budget burden structure. The resulting indicators were compared against findings from European NSAID utilization studies.

Results. Total consumption of systemic NSAIDs in the Samara Region was 40.1 DID in 2023 and 43.1 DID in 2025, comparable to Nordic reference values. Ketorolac consistently ranked among the top three molecules in the DU90 segment throughout 2023–2025, accounting for an average of approximately 6.1 DID and 14.7% of total DDD volume. This structural position of ketorolac substantially exceeded values reported in European sources, with moderate market concentration (HHI<0.15, stable CR3 values).

Conclusion. While the overall consumption of systemic NSAIDs in the Samara Region is comparable to European countries, the structural position of ketorolac in the regional retail segment substantially exceeds the published reference values. Due to ketorolac's restricted regulatory status, these findings should be regarded as a population-level signal that requires further confirmation through an assessment of individual prescriptions and clinical outcomes. The methods employed in this study can be applied to other regions of the Russian Federation.

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