[Estimation of adverse drug reactions by the evaluation scores of subjective symptoms (complaints) and background of patients. IV. Drug eruptions].
OBJECTIVE
The purpose of this study is to develop, implement, and assess an estimation procedure for preventing adverse drug reaction by subjective symptoms (complaints) of patients. This time, we focused and studied on drug eruptions.


METHODS
We have built a database for CARPIS (Case Reports of Adverse Drug Reaction and Poisoning Information System) since 1987, and the case reports of adverse drug reactions accumulated in the CARPIS database to be total about 20,000. We studied 1473 cases of drug eruptions cumulated in CARPIS database. The evaluation scores were created based on the subjective symptoms and backgrounds of the patients. We estimated 1473 cases using this evaluation scores.


RESULTS
We could estimate 1455 cases (98.8%) in 1473 cases to be drug eruptions using this evaluation scores. The validity of this evaluation scores were sensitivity = 98.8%, specificity = 91.0% and predictive value of positive test = 99.4%. The positive likelihood ratio was 11.0 and negative likelihood ratio was 0.01.


CONCLUSIONS
This study confirmed the validity of our evaluation scores. We reported the evaluation scores about drug-induced liver diseases, drug-induced extra-pyramidal symptoms and drug-induced leukopenia before. In order to apply these evaluation scores to the clinical practice, we prepared an evaluation form for subjective symptoms and backgrounds of the patients with adverse drug reactions.
Fukumoto
H
H
Pharmaceutical Information Center, Faculty of Pharmacy, Meijo University, Nagoya, Japan.
Ohtsu
F
F
Yano
R
R
Inagaki
K
K
Sakakibara
J
J
D016907:Adverse Drug Reaction Reporting Systems; D016208:Databases, Factual; D003875:Drug Eruptions / Q000453:epidemiology; D006801:Humans; D007564:Japan / Q000453:epidemiology; D011237:Predictive Value of Tests