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

Eva K. Kempers Orcid Logo, Chantal Visser, Jamilla Goedegebuur, Qingui Chen, Mette Søgaard, Anne Gulbech Ording, Carline van den Dries, Denise Abbel, Sarah Aldridge, Kate J. Lifford, Johanneke E. A. Portielje, Melchior C. Nierman, Annelies Boetes‐Draisma, Sjef J. C. M. van de Leur, Frederikus A. Klok, Eric C. T. Geijteman, Marieke J. H. A. Kruip, Suzanne C. Cannegieter

Pharmacoepidemiology and Drug Safety, Volume: 34, Issue: 6, Start page: e70158

Swansea University Author: Sarah Aldridge

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DOI (Published version): 10.1002/pds.70158

Abstract

Background: In 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. Objectives: To validate different methods of constructing VKA tre...

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Published in: Pharmacoepidemiology and Drug Safety
ISSN: 1053-8569 1099-1557
Published: Wiley 2025
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URI: https://cronfa.swan.ac.uk/Record/cronfa69540
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Objectives: To 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. Methods: Data 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&#x2010;based VKA treatment episodes, the ratio of VKA&#x2010;exposed person&#x2010;time based on dispensings vs. INR measurements, and the number of dispensing&#x2010;based episodes. 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spelling 2025-05-20T13:38:05.5882189 v2 69540 2025-05-20 Determining Drug Exposure Based on Medication Dispensing Data: A Validation Study of Vitamin K Antagonist Treatment Episodes Against INR Records a42ee8ba1ff8174d5bb62d2d95364b90 Sarah Aldridge Sarah Aldridge true false 2025-05-20 MEDS Background: In 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. Objectives: To 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. Methods: Data 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. Results: Depending 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. Conclusion: Fixed 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. Journal Article Pharmacoepidemiology and Drug Safety 34 6 e70158 Wiley 1053-8569 1099-1557 acenocoumarol, anticoagulants, epidemiologic methods, pharmacoepidemiology, phenprocoumon 1 6 2025 2025-06-01 10.1002/pds.70158 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University Another institution paid the OA fee 2025-05-20T13:38:05.5882189 2025-05-20T13:31:09.9534223 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Health Data Science Eva K. Kempers 0000-0001-9458-8674 1 Chantal Visser 2 Jamilla Goedegebuur 3 Qingui Chen 4 Mette Søgaard 5 Anne Gulbech Ording 6 Carline van den Dries 7 Denise Abbel 8 Sarah Aldridge 9 Kate J. Lifford 10 Johanneke E. A. Portielje 11 Melchior C. Nierman 12 Annelies Boetes‐Draisma 13 Sjef J. C. M. van de Leur 14 Frederikus A. Klok 15 Eric C. T. Geijteman 16 Marieke J. H. A. Kruip 17 Suzanne C. Cannegieter 18 69540__34318__e9f34c8825e44e069cddb93f70ef3659.pdf pds.70158.pdf 2025-05-20T13:31:09.9444371 Output 2167678 application/pdf Version of Record true © 2025 The Author(s). This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License (CC BY-NC). true eng http://creativecommons.org/licenses/by-nc/4.0/
title Determining Drug Exposure Based on Medication Dispensing Data: A Validation Study of Vitamin K Antagonist Treatment Episodes Against INR Records
spellingShingle Determining Drug Exposure Based on Medication Dispensing Data: A Validation Study of Vitamin K Antagonist Treatment Episodes Against INR Records
Sarah Aldridge
title_short Determining Drug Exposure Based on Medication Dispensing Data: A Validation Study of Vitamin K Antagonist Treatment Episodes Against INR Records
title_full Determining Drug Exposure Based on Medication Dispensing Data: A Validation Study of Vitamin K Antagonist Treatment Episodes Against INR Records
title_fullStr Determining Drug Exposure Based on Medication Dispensing Data: A Validation Study of Vitamin K Antagonist Treatment Episodes Against INR Records
title_full_unstemmed Determining Drug Exposure Based on Medication Dispensing Data: A Validation Study of Vitamin K Antagonist Treatment Episodes Against INR Records
title_sort Determining Drug Exposure Based on Medication Dispensing Data: A Validation Study of Vitamin K Antagonist Treatment Episodes Against INR Records
author_id_str_mv a42ee8ba1ff8174d5bb62d2d95364b90
author_id_fullname_str_mv a42ee8ba1ff8174d5bb62d2d95364b90_***_Sarah Aldridge
author Sarah Aldridge
author2 Eva K. Kempers
Chantal Visser
Jamilla Goedegebuur
Qingui Chen
Mette Søgaard
Anne Gulbech Ording
Carline van den Dries
Denise Abbel
Sarah Aldridge
Kate J. Lifford
Johanneke E. A. Portielje
Melchior C. Nierman
Annelies Boetes‐Draisma
Sjef J. C. M. van de Leur
Frederikus A. Klok
Eric C. T. Geijteman
Marieke J. H. A. Kruip
Suzanne C. Cannegieter
format Journal article
container_title Pharmacoepidemiology and Drug Safety
container_volume 34
container_issue 6
container_start_page e70158
publishDate 2025
institution Swansea University
issn 1053-8569
1099-1557
doi_str_mv 10.1002/pds.70158
publisher Wiley
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Health Data Science{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Health Data Science
document_store_str 1
active_str 0
description Background: In 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. Objectives: To 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. Methods: Data 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. Results: Depending 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. Conclusion: Fixed 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.
published_date 2025-06-01T05:30:21Z
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score 11.096068

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