ArticleExploratory research in clinical and social pharmacy2025
Off-label prescribing of tamsulosin: A nationwide retrospective study combining prescription and regulatory data.
Article in Exploratory research in clinical and social pharmacy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Off-label use of medicines raises important safety and regulatory concerns. Tamsulosin, an alpha-1 adrenergic receptor blocker originally approved for benign prostatic hyperplasia (BPH) in men, is also prescribed beyond licensed indications. Aim: This study aimed to describe national on-label and off-label prescribing patterns of tamsulosin in Hungary using insurance and regulatory data. Methods: We conducted a retrospective, cross-sectional descriptive analysis of two national datasets: the National Health Insurance Fund (NEAK) database of reimbursed prescriptions (2019-2023) and the National Institute of Pharmacy and Nutrition (NNGYK) records of off-label authorisations (2009-2023). Prescriptions were analyzed by sex and International Classification of Diseases 10th Revision (ICD-10) codes. Results: A total of 906,011 prescriptions were linked to 214 ICD-10 codes; 805 entries lacked identifiable codes. Of these, 888,830 (98.1 %) were for men and 17,181 (1.9 %) for women. Female prescriptions most frequently carried codes for ureteral stones (2805; 16.3 %), dysuria (1872; 10.9 %), urinary retention (1722; 10.0 %), and kidney stones (1498; 8.7 %). Notably, 2845 prescriptions (16.6 %) in women were linked to prostate-related codes, suggesting coding errors. NNGYK approved eight individual off-label requests, mainly for urological indications. Conclusions: Off-label tamsulosin prescribing in Hungary is relatively infrequent but concentrated in women. These findings highlight the importance of pharmacovigilance, clinician awareness, and further research to clarify its therapeutic role in non-BPH indications.
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