Document Type : Original Article
Authors
- . Pernille Warrer 1
- . Peter Bjødstrup Jensen 2
- . Lise Aagaard 3
- . Lars Juhl Jensen 4
- . Søren Brunak 5
- . Malene Hammer Krag 1
- . Peter Rossing 6
- . Thomas Almdal 6
- . Henrik Ullits Andersen 6
- . Ebba Holme Hansen 1
1 Department of Pharmacy, Section for Social and Clinical Pharmacy, University of Copenhagen, Copenhagen, Denmark
2 Novo Nordisk Foundation Centre for Protein Research, University of Copenhagen, Copenhagen, Denmark
3 Department of Public Health, University of Southern Denmark, Odense, Denmark
4 2 Novo Nordisk Foundation Centre for Protein Research, University of Copenhagen, Copenhagen, Denmark
5 Department of Systems Biology, Centre for Biological Sequence Analysis, Technical University of Denmark, Kongens Lyngby, Denmark
6 Steno Diabetes Center, Gentofte, Denmark
Abstract
Objective: Through manual review of clinical notes for patients with type 2 diabetes
mellitus attending a Danish diabetes center, the aim of the study was to identify adverse drug
reactions(ADRs) associated with three classes of glucose‑lowering medicines: “Combinations
of oral blood‑glucose lowering medicines” (A10BD), “dipeptidyl peptidase‑4 (DDP‑4)
inhibitors” (A10BH), and “other blood glucose lowering medicines” (A10BX). Specifically,
we aimed to describe the potential of clinical notes to identify new ADRs and to evaluate
if sufficient information can be obtained for causality assessment.
Methods: For observed adverse events (AEs) we extracted time to onset, outcome, and
suspected medicine(s). AEs were assessed according to World Health Organization-Uppsala
Monitoring Centre causality criteria and analyzed with respect to suspected medicines, type
of ADR (system organ class), seriousness and labeling status.
Findings: A total of 207 patients were included in the study leading to the identification
of 163 AEs. 14% were categorized as certain, 60% as probable/likely, and 26% as possible.
15 (9%) ADRs were unlabeled of which two were serious: peripheral edema associated with
sitagliptin and stomach ulcer associated with liraglutide. Of the unlabeled ADRs, 13 (87%)
were associated with “other blood glucose lowering medications,” the remaining 2 (13%)
with “DDP‑4 inhibitors.”
Conclusion: Clinical notes could potentially reveal unlabeled ADRs associated with
prescribed medicines and sufficient information is generally available for causality assessment.
However, manual review of clinical notes is too time-consuming for routine use and hence
there is a need for developing information technology (IT) tools for automatic screening
of patient records with the purpose to detect information about potentially serious and
unlabeled ADRs.
Keywords
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