Identification of possible adverse drug reactions in clinical notes: The case of glucose-lowering medicines
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 l...
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doaj-a879d7ae208f40ecbd3642f40c2237a92020-11-24T21:51:16ZengWolters Kluwer Medknow PublicationsJournal of Research in Pharmacy Practice2319-96442279-042X2015-01-0142647210.4103/2279-042X.155753Identification of possible adverse drug reactions in clinical notes: The case of glucose-lowering medicinesPernille WarrerPeter Bjødstrup JensenLise AagaardLars Juhl JensenSøren BrunakMalene Hammer KragPeter RossingThomas AlmdalHenrik Ullits AndersenEbba Holme HansenObjective: 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.http://www.jrpp.net/article.asp?issn=2319-9644;year=2015;volume=4;issue=2;spage=64;epage=72;aulast=WarrerAdverse drug reactions; adverse events; clinical notes; glucose-lowering medicines; manual review |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Pernille Warrer Peter Bjødstrup Jensen Lise Aagaard Lars Juhl Jensen Søren Brunak Malene Hammer Krag Peter Rossing Thomas Almdal Henrik Ullits Andersen Ebba Holme Hansen |
spellingShingle |
Pernille Warrer Peter Bjødstrup Jensen Lise Aagaard Lars Juhl Jensen Søren Brunak Malene Hammer Krag Peter Rossing Thomas Almdal Henrik Ullits Andersen Ebba Holme Hansen Identification of possible adverse drug reactions in clinical notes: The case of glucose-lowering medicines Journal of Research in Pharmacy Practice Adverse drug reactions; adverse events; clinical notes; glucose-lowering medicines; manual review |
author_facet |
Pernille Warrer Peter Bjødstrup Jensen Lise Aagaard Lars Juhl Jensen Søren Brunak Malene Hammer Krag Peter Rossing Thomas Almdal Henrik Ullits Andersen Ebba Holme Hansen |
author_sort |
Pernille Warrer |
title |
Identification of possible adverse drug reactions in clinical notes: The case of glucose-lowering medicines |
title_short |
Identification of possible adverse drug reactions in clinical notes: The case of glucose-lowering medicines |
title_full |
Identification of possible adverse drug reactions in clinical notes: The case of glucose-lowering medicines |
title_fullStr |
Identification of possible adverse drug reactions in clinical notes: The case of glucose-lowering medicines |
title_full_unstemmed |
Identification of possible adverse drug reactions in clinical notes: The case of glucose-lowering medicines |
title_sort |
identification of possible adverse drug reactions in clinical notes: the case of glucose-lowering medicines |
publisher |
Wolters Kluwer Medknow Publications |
series |
Journal of Research in Pharmacy Practice |
issn |
2319-9644 2279-042X |
publishDate |
2015-01-01 |
description |
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. |
topic |
Adverse drug reactions; adverse events; clinical notes; glucose-lowering medicines; manual review |
url |
http://www.jrpp.net/article.asp?issn=2319-9644;year=2015;volume=4;issue=2;spage=64;epage=72;aulast=Warrer |
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