PMID- 25984543
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20150518
LR  - 20200930
IS  - 2319-9644 (Print)
IS  - 2279-042X (Electronic)
IS  - 2279-042X (Linking)
VI  - 4
IP  - 2
DP  - 2015 Apr-Jun
TI  - Identification of possible adverse drug reactions in clinical notes: The case of 
      glucose-lowering medicines.
PG  - 64-72
LID - 10.4103/2279-042X.155753 [doi]
AB  - 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.
FAU - Warrer, Pernille
AU  - Warrer P
AD  - Department of Pharmacy, Section for Social and Clinical Pharmacy, University of 
      Copenhagen, Copenhagen, Denmark.
FAU - Jensen, Peter Bjodstrup
AU  - Jensen PB
AD  - Novo Nordisk Foundation Centre for Protein Research, University of Copenhagen, 
      Copenhagen, Denmark.
FAU - Aagaard, Lise
AU  - Aagaard L
AD  - Department of Public Health, University of Southern Denmark, Odense, Denmark.
FAU - Jensen, Lars Juhl
AU  - Jensen LJ
AD  - Novo Nordisk Foundation Centre for Protein Research, University of Copenhagen, 
      Copenhagen, Denmark.
FAU - Brunak, Soren
AU  - Brunak S
AD  - Department of Systems Biology, Centre for Biological Sequence Analysis, Technical 
      University of Denmark, Kongens Lyngby, Denmark.
FAU - Krag, Malene Hammer
AU  - Krag MH
AD  - Department of Pharmacy, Section for Social and Clinical Pharmacy, University of 
      Copenhagen, Copenhagen, Denmark.
FAU - Rossing, Peter
AU  - Rossing P
AD  - Steno Diabetes Center, Gentofte, Denmark.
FAU - Almdal, Thomas
AU  - Almdal T
AD  - Steno Diabetes Center, Gentofte, Denmark.
FAU - Andersen, Henrik Ullits
AU  - Andersen HU
AD  - Steno Diabetes Center, Gentofte, Denmark.
FAU - Hansen, Ebba Holme
AU  - Hansen EH
AD  - Department of Pharmacy, Section for Social and Clinical Pharmacy, University of 
      Copenhagen, Copenhagen, Denmark.
LA  - eng
PT  - Journal Article
PL  - India
TA  - J Res Pharm Pract
JT  - Journal of research in pharmacy practice
JID - 101614023
PMC - PMC4418138
OTO - NOTNLM
OT  - Adverse drug reactions
OT  - adverse events
OT  - clinical notes
OT  - glucose-lowering medicines
OT  - manual review
COIS- Conflict of Interest: PR is employed at the Steno Diabetes Centre owned by Novo 
      Nordisk, has received fees to institution for consultancy or lectures from 
      Abbott, Astra Zeneca, BMS, Boehringer Ingelheim, Eli Lilly and Novo Nordisk and 
      has shares in Novo Nordisk. HUA is employed at the Steno Diabetes Centre and has 
      received fees to institution for consultancy from Abbott and has shares in Novo 
      Nordisk. TA has shares in Novo Nordisk A/S. PWA, PBJ, LJJ, LAA, SB, MHK, and EHH 
      have no conflicting interests to declare regarding the content of this article.
EDAT- 2015/05/20 06:00
MHDA- 2015/05/20 06:01
PMCR- 2015/04/01
CRDT- 2015/05/19 06:00
PHST- 2015/05/19 06:00 [entrez]
PHST- 2015/05/20 06:00 [pubmed]
PHST- 2015/05/20 06:01 [medline]
PHST- 2015/04/01 00:00 [pmc-release]
AID - JRPP-4-64 [pii]
AID - 10.4103/2279-042X.155753 [doi]
PST - ppublish
SO  - J Res Pharm Pract. 2015 Apr-Jun;4(2):64-72. doi: 10.4103/2279-042X.155753.