TY  - 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 . .

TY  - GEN
AU  - Stević, Ivana
AU  - Janković, Slobodan M
AU  - Petrović, Nemanja
AU  - Čanak-Baltić, Nataša
AU  - Lakić, Dragana
PY  - 2022
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/5623
AB  - Drug-induced disorder „can result from unanticipated or anticipated drug effects“ (1).
The prevalence of hematological adverse drug reactions (ADR) in chemotherapeutics is
expected to be high; for non-chemotherapeutics, there is insufficient epidemiological data,
although a spontaneous reporting system is mandatory in a drug's life cycle (2-6). ADR is
considered to be the fifth cause of death, with the hospitalization rate caused by ADR estimated
to be between 0.9-7.9% (7-8), while one study suggests that about „10 to 20% of hospitalized
patients will experience ADRs during their stay“ (9). Frequency data on hospital admissions
due to hematological ADR vary between studies, e.g., 9% (7) up to 26.5% (10).
The study by Abu et al. categorized major ADR types based on system disorders, where
hematologic ADR encountered 9.9-15.2% of ADRs (9). The same study estimated costs per
ADR from 65.00 to 12,129.90 USD, whereas costs were generally lower when the micro-
costing approach was used (9).
A cost-of-illness (COI) study should be performed to precisely determine the costs
generated by ADR. COI studies measure the economic burden of an illness on society, health
insurance funds, or patients. Jefferson et al. (2000) defined “the aim of COI studies is
descriptive: to itemize, value, and sum the costs of a particular problem with the aim of giving
an idea of its economic burden“ (11). There are different methods of conducting this type of
study, such as prevalence‐based, incidence‐based, or econometric approaches, with again
different approaches (e.g., prospective, retrospective; top-down, bottom-up…) or with different
perspectives of COI studies (such as societal, health care system, third-party payer) (11).
However, micro-costing studies represent the gold standard for conducting COI studies (12).
Only a few cost drivers of HADR have been proven to date, e.g., prolonged in-hospital stay,
costs of using drugs, and transfusion costs (13-14).
T1  - Non-oncological drug-induced blood disorders: a cost of illness study using the microcosting Methodology - study plan
ER  - 

@misc{
author = "Stević, Ivana and Janković, Slobodan M and Petrović, Nemanja and Čanak-Baltić, Nataša and Lakić, Dragana",
year = "2022",
abstract = "Drug-induced disorder „can result from unanticipated or anticipated drug effects“ (1).
The prevalence of hematological adverse drug reactions (ADR) in chemotherapeutics is
expected to be high; for non-chemotherapeutics, there is insufficient epidemiological data,
although a spontaneous reporting system is mandatory in a drug's life cycle (2-6). ADR is
considered to be the fifth cause of death, with the hospitalization rate caused by ADR estimated
to be between 0.9-7.9% (7-8), while one study suggests that about „10 to 20% of hospitalized
patients will experience ADRs during their stay“ (9). Frequency data on hospital admissions
due to hematological ADR vary between studies, e.g., 9% (7) up to 26.5% (10).
The study by Abu et al. categorized major ADR types based on system disorders, where
hematologic ADR encountered 9.9-15.2% of ADRs (9). The same study estimated costs per
ADR from 65.00 to 12,129.90 USD, whereas costs were generally lower when the micro-
costing approach was used (9).
A cost-of-illness (COI) study should be performed to precisely determine the costs
generated by ADR. COI studies measure the economic burden of an illness on society, health
insurance funds, or patients. Jefferson et al. (2000) defined “the aim of COI studies is
descriptive: to itemize, value, and sum the costs of a particular problem with the aim of giving
an idea of its economic burden“ (11). There are different methods of conducting this type of
study, such as prevalence‐based, incidence‐based, or econometric approaches, with again
different approaches (e.g., prospective, retrospective; top-down, bottom-up…) or with different
perspectives of COI studies (such as societal, health care system, third-party payer) (11).
However, micro-costing studies represent the gold standard for conducting COI studies (12).
Only a few cost drivers of HADR have been proven to date, e.g., prolonged in-hospital stay,
costs of using drugs, and transfusion costs (13-14).",
title = "Non-oncological drug-induced blood disorders: a cost of illness study using the microcosting Methodology - study plan"
}

Stević, I., Janković, S. M., Petrović, N., Čanak-Baltić, N.,& Lakić, D.. (2022). Non-oncological drug-induced blood disorders: a cost of illness study using the microcosting Methodology - study plan. .

Stević I, Janković SM, Petrović N, Čanak-Baltić N, Lakić D. Non-oncological drug-induced blood disorders: a cost of illness study using the microcosting Methodology - study plan. 2022;..

Stević, Ivana, Janković, Slobodan M, Petrović, Nemanja, Čanak-Baltić, Nataša, Lakić, Dragana, "Non-oncological drug-induced blood disorders: a cost of illness study using the microcosting Methodology - study plan" (2022).