Retrospective analysis of the frequency and recognition of adverse drug reactions by means of automatically recorded laboratory signals.
OBJECTIVE
To estimate the frequency of adverse drug reactions (ADRs) identified through the use of automatic signals generated from laboratory data (ALS) in hospitalised patients. To determine the frequency of spontaneous recognition of these ADRs by the attending physicians and to assess the potential value of ALS for detection of ADRs.


METHODS
Laboratory results of patients hospitalised in a nine bed medical ward were automatically recorded over a period of 17 months. Values exceeding defined boundaries were used as ALS. Charts of every third patient were analysed retrospectively with regard to adverse drug related reactions and causality was evaluated as well as whether the ADR had been recognised during the period of hospitalisation.


RESULTS
The charts and ALS of 98 patients were analysed. In 18 cases a drug-related adverse reaction was probable. Awareness to the reaction by the treating physicians was evident in 6 out of these 18 ADRs. Approximately 80% of the ADRs were considered predictable. Three ADRs were regarded as serious.


CONCLUSIONS
Adverse drug reactions are common and often preventable. Only one third of ADRs which could have been detected through ALS were recognised by the attending physicians. An increased doctor's awareness of the frequency of drug related abnormal laboratory results by means of ALS is likely to increase the recognition rate of ADRs and might help to prevent them.
Tegeder
I
I
Department of Experimental and Clinical Pharmacology and Toxicology University Erlangen/Nürnberg, Universitätsstrasse 22, 91054 Erlangen, Germany.
Levy
M
M
Muth-Selbach
U
U
Oelkers
R
R
Neumann
F
F
Dormann
H
H
Azaz-Livshits
T
T
Criegee-Rieck
M
M
Schneider
H T
HT
Hahn
E
E
Brune
K
K
Geisslinger
G
G
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000410:Alanine Transaminase / Q000097:blood / Q000187:drug effects; D001219:Aspartate Aminotransferases / Q000097:blood / Q000187:drug effects; D015415:Biomarkers / Q000097:blood / Q000652:urine; D016903:Drug Monitoring / Q000379:methods / Q000706:statistics & numerical data*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006403:Hematologic Tests; D006801:Humans; D007668:Kidney / Q000187:drug effects / Q000201:enzymology / Q000473:pathology; D007674:Kidney Diseases / Q000188:drug therapy / Q000201:enzymology / Q000652:urine; D008099:Liver / Q000187:drug effects / Q000201:enzymology / Q000473:pathology; D008107:Liver Diseases / Q000097:blood / Q000188:drug therapy / Q000201:enzymology; D008297:Male; D008499:Medical Records / Q000706:statistics & numerical data*; D008875:Middle Aged; D010819:Physician's Role; D012189:Retrospective Studies
D015415:Biomarkers; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase