The adjunctive use of a centralised database in the monitoring of clozapine-related neutropenia.
OBJECTIVE
To assess the effectiveness of centralised routine monitoring of blood counts in subjects receiving clozapine.


METHODS
A cohort study based on a prospective drug exposure database.


METHODS
Patients with schizophrenia in 38 specialised centres across Australia.


METHODS
The time from detection of neutropenia to the interruption of therapy, the time to recovery of the absolute neutrophil count, the eventual outcome of subjects developing neutropenia.


RESULTS
A total of 1500 subjects were registered on the database. Seven subjects developed severe neutropenia (a neutrophil count < 1.5 x 10(9)/L) whilst on therapy. Mean time to cessation of therapy was 1.6 days (range < 1-6 days). Neutrophil counts recovered to normal levels in all subjects after 6.4 days (range < 1-13).


CONCLUSIONS
In the population investigated, the addition of a centralised database to clinical monitoring resulted in very rapid detection of severe neutropenia and an equally rapid cessation of therapy. In the sample investigated, this led to very low morbidity and zero mortality.
Pascoe
Steven J
SJ
Horsham Research Centre, Horsham, West Sussex, UK. steve.pascoe@pharma.novartis.com
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000368:Aged; D003024:Clozapine / Q000009:adverse effects*; D016208:Databases, Factual / Q000706:statistics & numerical data; D016903:Drug Monitoring / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced*; D017891:Pharmacoepidemiology; D013997:Time Factors
D003024:Clozapine