Evidence map›Paper›PMID 40389391›Full record

ArticlePharmacoepidemiology and drug safety2025

Determining Drug Exposure Based on Medication Dispensing Data: A Validation Study of Vitamin K Antagonist Treatment Episodes Against INR Records.

Eva K Kempers, Chantal Visser, Jamilla Goedegebuur, Qingui Chen, Mette Søgaard, Anne Gulbech Ording, Carline van den Dries, Denise Abbel, Sarah J Aldridge, Kate J Lifford and 8 more

Abstract readValidation Study
In one paragraph

Article in Pharmacoepidemiology and drug safety, 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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1 · What the graph read from it

What it found

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2 · The registry

The trial behind it

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3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

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4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

18 authors.

Eva K KempersDepartment of Hematology, Erasmus MC, Erasmus University Medical Centre Rotterdam, Rotterdam, the Netherlands.ORCID https://orcid.org/0000-0001-9458-8674
Chantal VisserDepartment of Hematology, Erasmus MC, Erasmus University Medical Centre Rotterdam, Rotterdam, the Netherlands.
Jamilla GoedegebuurDepartment of Medicine - Thrombosis and Haemostasis, Leiden University Medical Center, Leiden, the Netherlands.
Qingui ChenDepartment of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands.
Mette SøgaardDanish Center for Health Services Research, Department of Clinical Medicine, Aalborg University Hospital, Aalborg University, Aalborg, Denmark.
Anne Gulbech OrdingDanish Center for Health Services Research, Department of Clinical Medicine, Aalborg University Hospital, Aalborg University, Aalborg, Denmark.
Carline van den DriesDepartment of General Practice & Nursing Science, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
Denise AbbelDepartment of Medicine - Thrombosis and Haemostasis, Leiden University Medical Center, Leiden, the Netherlands.
Sarah J AldridgePopulation Data Science, Swansea University, Swansea, UK.
Kate J LiffordWales Centre for Primary and Emergency Care Research (PRIME Centre Wales), Division of Population Medicine, Cardiff University, Cardiff, UK.
Johanneke E A PortieljeDepartment of Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands.
Melchior C NiermanDepartment of Thrombosis and Anticoagulation, Atalmedial Medical Diagnostic Centers, Amsterdam, the Netherlands.
Annelies Boetes-DraismaThrombosis Service Star-shl, Rotterdam, the Netherlands.
Sjef J C M van de LeurThrombosis Service, Isala Hospital Zwolle, Zwolle, the Netherlands.
Frederikus A KlokDepartment of Medicine - Thrombosis and Haemostasis, Leiden University Medical Center, Leiden, the Netherlands.
Eric C T GeijtemanDepartment of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
Marieke J H A KruipDepartment of Hematology, Erasmus MC, Erasmus University Medical Centre Rotterdam, Rotterdam, the Netherlands.
Suzanne C CannegieterDepartment of Medicine - Thrombosis and Haemostasis, Leiden University Medical Center, Leiden, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn pharmaco-epidemiological studies using vitamin K antagonist (VKA) exposure, constructing treatment episodes based on dispensed prescriptions is challenging, particularly due to the large variability in therapeutic dose.

objectivesTo validate different methods of constructing VKA treatment episodes based on dispensed prescriptions, using VKA exposure based on international normalized ratio (INR) measurements as a reference.

methodsData from five Dutch anticoagulation clinics were linked to VKA dispensing data from Statistics Netherlands. Three random samples of 10 000 VKA users between 2013 and 2019 were used to compare the construction of VKA treatment episodes based on dispensings, applying fixed or dynamic methods, against the reference of exposure based on INR measurements. A total of 60 different methods were validated by computing the percentage of INR measurements occurring outside dispensing-based VKA treatment episodes, the ratio of VKA-exposed person-time based on dispensings vs. INR measurements, and the number of dispensing-based episodes.

resultsDepending on the method used to construct treatment episodes, 14.8%-42.2% of the INR measurements were not covered by a dispensing-based episode. The VKA-exposed person-time ratio ranged between 0.73 and 1.13, and there was substantial variability in the number of dispensing-based episodes. Fixed methods resulted in a lower percentage of INR measurements outside the dispensing-based episodes, a VKA-exposed person-time ratio closer to 1.0, and a lower number of constructed episodes.

conclusionFixed methods performed better than dynamic methods when classifying VKA exposure based on dispensing data. Our findings may guide other researchers working with VKA dispensing data, especially when the tablets dispensed or the prescribed dose are unavailable.

Indexed as

AnticoagulantsDrug PrescriptionsInternational Normalized RatioPharmacoepidemiologyVitamin KAgedAged, 80 and overFemaleHumansMaleMiddle AgedNetherlandsAnticoagulantsVitamin Kacenocoumarolanticoagulantsepidemiologic methodspharmacoepidemiologyphenprocoumon

Identifiers

PMID40389391
PMCPMC12089007

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.