The application of an institutional clinical data warehouse to the assessment of adverse drug reactions (ADRs). Evaluation of aminoglycoside and cephalosporin associated nephrotoxicity.
OBJECTIVE
To apply an institutional clinical data warehouse (CDW) to the assessment of adverse drug reactions (ADRs) and demonstrate its utility through a specific example.


METHODS
We modeled the process for assessing ADRs through retrospective cohort design by using CDW at the Osaka University Hospital as follows: 1) We defined a drug X, an adverse drug reaction (ADR) Y, and a laboratory measurement Z to assess Y during a given study period; 2) we excluded those whose Z value exceeded the defined criteria or were not available at the inception of the cohort; 3) we divided the patients into two groups based on exposure or non-exposure to X; 4) we matched the patient characteristics between the two groups through stratification and randomization; and 5) we compared the frequency of patients who presented Y during the study period between the two groups. Aminoglycoside and Cephalosporin associated nephrotoxicity in pediatric inpatients was used as an example to demonstrate the usefulness of this approach.


RESULTS
Our evaluation indicates that there is an increased risk of nephrotoxicity for pediatric inpatients who were prescribed cephalosporin either alone or in combination with aminoglycoside; further, aminoglycoside tends to increase the cephalosporin-associated nephrotoxicity.


CONCLUSIONS
Our findings are consistent with those drawn from other studies, indicating that the method of applying an institutional CDW is useful for assessing ADRs.
Zhang
Q
Q
Department of Integrated Medicine, Medical Informatics, Graduated School of Medicine, Osaka University, 2-15 Yamada Oka, Suita City, Osaka 565-0871, Japan.
Matsumura
Y
Y
Teratani
T
T
Yoshimoto
S
S
Mineno
T
T
Nakagawa
K
K
Nagahama
M
M
Kuwata
S
S
Takeda
H
H
D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D000617:Aminoglycosides / Q000009:adverse effects*; D000900:Anti-Bacterial Agents / Q000009:adverse effects*; D002511:Cephalosporins / Q000009:adverse effects*; D002648:Child; D019992:Databases as Topic; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008962:Models, Theoretical; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors
D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D002511:Cephalosporins