Publication: Prescriber compliance to direct oral anticoagulant labels and impact on outcomes in Thailand
Issued Date
2021-03-01
Resource Type
ISSN
13652125
03065251
03065251
Other identifier(s)
2-s2.0-85090448785
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Mahidol University
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SCOPUS
Bibliographic Citation
British Journal of Clinical Pharmacology. Vol.87, No.3 (2021), 1390-1400
Suggested Citation
Phannita Wattanaruengchai, Surakit Nathisuwan, Wipharak Rattanavipanon, Suvatna Chulavatnatol, Junporn Kongwatcharapong, Phatcharin Mitsuntisuk, Thanaputt Chaiyasothi, Duangkamon Kritsanapipat, Arintaya Phrommintikul, Nathorn Chaiyakunapruk, Khanchit Likittanasombat, Gregory Y.H. Lip Prescriber compliance to direct oral anticoagulant labels and impact on outcomes in Thailand. British Journal of Clinical Pharmacology. Vol.87, No.3 (2021), 1390-1400. doi:10.1111/bcp.14535 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/78438
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Title
Prescriber compliance to direct oral anticoagulant labels and impact on outcomes in Thailand
Abstract
Aims: This study aimed to evaluate the prescriber compliance to the approved labels of direct oral anticoagulants (DOACs) and impact of appropriateness of dosing on clinical outcomes. Methods: A retrospective study was conducted using simple-stratified random sampling of adult patients receiving ≥6 months of DOACs for various indications during 2013–2017 in 10 tertiary care hospitals. Patients were classified into 3 dosing groups including approved dose, underdosing and overdosing based on the Thai Food and Drug Administration-approved labels. Cox proportional hazard models were used to evaluate the impact of different dosings on thromboembolic and bleeding events. Results: From 1200 patients included in the data analysis, prescribing of DOACs was consistent with the approved indications in 1130 cases (94.2%) while 70 patients (5.8%) received DOACs despite having contraindications or with off-label usage. Among 1026 cases of dosing evaluation cohort, 688 patients (67.1%) received approved doses. There were 227 (21.9%) and 110 (10.7%) cases of underdosing and overdosing, respectively. Multivariate analysis showed that underdosing was associated with an increased risk of thromboembolism 3.023 (95% confidence interval [CI]: 1.291–7.080; P =.011) while overdosing was associated with an increased risk of bleeding requiring hospitalization (adjusted hazard ratio, 3.045; 95% CI, 1.501–6.178; P =.002) and Bleeding Academic Research Consortium type 2 or more (adjusted hazard ratio, 2.196; 95% CI, 1.083–4.452; P =.029). Conclusion: Prescribers’ compliance to approved indications were high. However, 1/3 of DOAC prescriptions were inconsistent with approved dosing. Dosing deviation was associated with an increase in adverse clinical outcomes.