Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure
Аутори
Stević, IvanaJanković, Slobodan M.
Milošević-Georgiev, Andrijana
Marinković, Valentina
Lakić, Dragana
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
Serious hematological adverse drug reactions (HADRs) may lead to or prolong hospitalization
and even cause death. The aim of this study was to determine the regulatory factors associated
with HADRs caused by drugs that were authorized up to July 2023 by the European Medicines
Agency (EMA) and to evaluate the frequency of HADRs. Using a cross-sectional approach, the type
and frequency of HADRs were collected from the Summaries of Product Characteristics of Drugs
Authorized by the EMA and analyzed within proprietary, nonproprietary, and biosimilar/biological
frameworks. Multivariate statistical analysis was used to investigate the associations of generic
status, biosimilar status, conditional approval, exceptional circumstances, accelerated assessment,
orphan drug status, years on the market, administration route, and inclusion on the Essential
Medicines List (EML) with HADRs. In total, 54.78% of proprietary drugs were associated with HADRs
at any frequency, while anemia, leuco...penia, and thrombocytopenia were observed in approximately
36% of the patients. The predictors of any HADR, anemia, and thrombocytopenia of any frequency
are generic status, biosimilar status, and inclusion on the EML, while the only protective factor is the
administration route. Biosimilars and their originator biologicals have similar frequencies of HADRs;
the only exception is somatropin. Knowledge of the regulatory factors associated with HADRs could
help clinicians address monitoring issues when new drugs are introduced for the treatment of patients.
Кључне речи:
Hematological adverse drug reaction / Regulatory factors / Centralized procedureИзвор:
Scientific Reports, 2024, 14, 1, 9074-Издавач:
- Nature Portfolio
Финансирање / пројекти:
- Министарство науке, технолошког развоја и иновација Републике Србије, институционално финансирање - 200161 (Универзитет у Београду, Фармацеутски факултет) (RS-MESTD-inst-2020-200161)
- Фармаколошка анализа ефеката биолошки активних супстанци на изоловане глатке мишиће гастроинтестиналног и урогениталног тракта човека (RS-MESTD-Basic Research (BR or ON)-175007)
- Министарство науке, технолошког развоја и иновација Републике Србије, институционално финансирање - 200111 (Универзитет у Крагујевцу, Медицински факултет) (RS-MESTD-inst-2020-200111)
Институција/група
PharmacyTY - JOUR AU - Stević, Ivana AU - Janković, Slobodan M. AU - Milošević-Georgiev, Andrijana AU - Marinković, Valentina AU - Lakić, Dragana PY - 2024 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/5618 AB - Serious hematological adverse drug reactions (HADRs) may lead to or prolong hospitalization and even cause death. The aim of this study was to determine the regulatory factors associated with HADRs caused by drugs that were authorized up to July 2023 by the European Medicines Agency (EMA) and to evaluate the frequency of HADRs. Using a cross-sectional approach, the type and frequency of HADRs were collected from the Summaries of Product Characteristics of Drugs Authorized by the EMA and analyzed within proprietary, nonproprietary, and biosimilar/biological frameworks. Multivariate statistical analysis was used to investigate the associations of generic status, biosimilar status, conditional approval, exceptional circumstances, accelerated assessment, orphan drug status, years on the market, administration route, and inclusion on the Essential Medicines List (EML) with HADRs. In total, 54.78% of proprietary drugs were associated with HADRs at any frequency, while anemia, leucopenia, and thrombocytopenia were observed in approximately 36% of the patients. The predictors of any HADR, anemia, and thrombocytopenia of any frequency are generic status, biosimilar status, and inclusion on the EML, while the only protective factor is the administration route. Biosimilars and their originator biologicals have similar frequencies of HADRs; the only exception is somatropin. Knowledge of the regulatory factors associated with HADRs could help clinicians address monitoring issues when new drugs are introduced for the treatment of patients. PB - Nature Portfolio T2 - Scientific Reports T1 - Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure VL - 14 IS - 1 SP - 9074 DO - 10.1038/s41598-024-59710-3 ER -
@article{ author = "Stević, Ivana and Janković, Slobodan M. and Milošević-Georgiev, Andrijana and Marinković, Valentina and Lakić, Dragana", year = "2024", abstract = "Serious hematological adverse drug reactions (HADRs) may lead to or prolong hospitalization and even cause death. The aim of this study was to determine the regulatory factors associated with HADRs caused by drugs that were authorized up to July 2023 by the European Medicines Agency (EMA) and to evaluate the frequency of HADRs. Using a cross-sectional approach, the type and frequency of HADRs were collected from the Summaries of Product Characteristics of Drugs Authorized by the EMA and analyzed within proprietary, nonproprietary, and biosimilar/biological frameworks. Multivariate statistical analysis was used to investigate the associations of generic status, biosimilar status, conditional approval, exceptional circumstances, accelerated assessment, orphan drug status, years on the market, administration route, and inclusion on the Essential Medicines List (EML) with HADRs. In total, 54.78% of proprietary drugs were associated with HADRs at any frequency, while anemia, leucopenia, and thrombocytopenia were observed in approximately 36% of the patients. The predictors of any HADR, anemia, and thrombocytopenia of any frequency are generic status, biosimilar status, and inclusion on the EML, while the only protective factor is the administration route. Biosimilars and their originator biologicals have similar frequencies of HADRs; the only exception is somatropin. Knowledge of the regulatory factors associated with HADRs could help clinicians address monitoring issues when new drugs are introduced for the treatment of patients.", publisher = "Nature Portfolio", journal = "Scientific Reports", title = "Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure", volume = "14", number = "1", pages = "9074", doi = "10.1038/s41598-024-59710-3" }
Stević, I., Janković, S. M., Milošević-Georgiev, A., Marinković, V.,& Lakić, D.. (2024). Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure. in Scientific Reports Nature Portfolio., 14(1), 9074. https://doi.org/10.1038/s41598-024-59710-3
Stević I, Janković SM, Milošević-Georgiev A, Marinković V, Lakić D. Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure. in Scientific Reports. 2024;14(1):9074. doi:10.1038/s41598-024-59710-3 .
Stević, Ivana, Janković, Slobodan M., Milošević-Georgiev, Andrijana, Marinković, Valentina, Lakić, Dragana, "Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure" in Scientific Reports, 14, no. 1 (2024):9074, https://doi.org/10.1038/s41598-024-59710-3 . .