A Descriptive Analysis of Direct Oral Anticoagulant Drugs Dosing Errors Based on Spontaneous Reports from the EudraVigilance Database

Direct oral anticoagulant drugs (DOACs) interfere with the coagulation process, thus improving patient care for those who require anticoagulant treatment. This study presents a descriptive analysis of adverse reactions (ADRs) attributed to DOAC dosage errors (overdose, underdose, and improper dose)....

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Main Authors: Claudiu Morgovan (Author), Carmen Maximiliana Dobrea (Author), Adriana Aurelia Chis (Author), Anca Maria Juncan (Author), Anca Maria Arseniu (Author), Luca Liviu Rus (Author), Felicia Gabriela Gligor (Author), Simona Alexandrina Ardelean (Author), Laurentiu Stoicescu (Author), Steliana Ghibu (Author), Adina Frum (Author)
Format: Book
Published: MDPI AG, 2023-03-01T00:00:00Z.
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042 |a dc 
100 1 0 |a Claudiu Morgovan  |e author 
700 1 0 |a Carmen Maximiliana Dobrea  |e author 
700 1 0 |a Adriana Aurelia Chis  |e author 
700 1 0 |a Anca Maria Juncan  |e author 
700 1 0 |a Anca Maria Arseniu  |e author 
700 1 0 |a Luca Liviu Rus  |e author 
700 1 0 |a Felicia Gabriela Gligor  |e author 
700 1 0 |a Simona Alexandrina Ardelean  |e author 
700 1 0 |a Laurentiu Stoicescu  |e author 
700 1 0 |a Steliana Ghibu  |e author 
700 1 0 |a Adina Frum  |e author 
245 0 0 |a A Descriptive Analysis of Direct Oral Anticoagulant Drugs Dosing Errors Based on Spontaneous Reports from the EudraVigilance Database 
260 |b MDPI AG,   |c 2023-03-01T00:00:00Z. 
500 |a 10.3390/ph16030455 
500 |a 1424-8247 
520 |a Direct oral anticoagulant drugs (DOACs) interfere with the coagulation process, thus improving patient care for those who require anticoagulant treatment. This study presents a descriptive analysis of adverse reactions (ADRs) attributed to DOAC dosage errors (overdose, underdose, and improper dose). The analysis was performed based on the Individual Case Safety Reports from the EudraVigilance (EV) database. Results show that data reported for rivaroxaban, apixaban, edoxaban, and dabigatran are mostly regarding underdosing (51.56%) compared to overdosing (18.54%). The most dosage error reports were identified for rivaroxaban (54.02%), followed by apixaban (33.61%). Dabigatran and edoxaban had similar percentages (6.26% and 6.11%, respectively) regarding dosage error reports. Since coagulation issues can become life-threatening events, and factors such as advanced age and renal failure can influence the pharmacokinetics of drugs, the correct usage of DOACs is of utmost importance for the management and prevention of venous thromboembolism. Thus, the collaboration and the complementarity of knowledge of physicians and pharmacists may offer a reliable solution for DOAC dose management and improve patient care. 
546 |a EN 
690 |a DOACs 
690 |a EudraVigilance 
690 |a dosage errors 
690 |a underdose 
690 |a overdose 
690 |a safety profile 
690 |a Medicine 
690 |a R 
690 |a Pharmacy and materia medica 
690 |a RS1-441 
655 7 |a article  |2 local 
786 0 |n Pharmaceuticals, Vol 16, Iss 3, p 455 (2023) 
787 0 |n https://www.mdpi.com/1424-8247/16/3/455 
787 0 |n https://doaj.org/toc/1424-8247 
856 4 1 |u https://doaj.org/article/ba59d5a963694b66b559a6bb856d30eb  |z Connect to this object online.