Antipsychotic drugs are generally registered for treating schizophrenia, psychosis,
mania, and conditions of severe (locomotor) agitation. In common practice, however,
they are prescribed in a wide range of different psychiatric disorders. We conducted
a retrospective, exploratory study to examine off-label use of antipsychotics and
possibly sex differences. We defined antipsychotic use as quasi-label when used in
non-registered disorders that have psychosis as an inherent co-morbidity. When antipsychotics
were prescribed in disorders that are generally not known with psychosis, we defined
this as off-label use. In this study, we combined pharmacy records with data from
general practitioners in order to evaluate the range of diagnoses for which antipsychotic
drugs are used. We focused on sex differences in type of disorder and in prescribed
dosages of antipsychotic drugs. Among 97 male and 95 female antipsychotic users, we
could classify women significantly more often as on-label antipsychotic drug users
compared with men. Most often, this occurred with typical antipsychotic drug treatment.
While female patients used equal dosages for on-label and quasi-/off-label indications,
we found that male patients used significantly lower dosages in quasi-/off-label indications
compared with on-label indications. We suggest elaborate future research on the characteristics
of quasi- and off-label antipsychotic drug use in order to define effective and safe
use of antipsychotic drugs among off-label indications.
Key words
off-label - antipsychotic - sex - diagnosis - dose
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Lolkje TW de Jong - van den Berg, Pharm D, PhD
University of Groningen
Department of Social Pharmacy, Pharmacoepidemiology and Pharmacotherapy
Antonius Deusinglaan 1
9713 AV Groningen
The Netherlands
Telefon: +31 50 3633261
Fax: +31 50 3632772
eMail: l.t.w.de.jong-van.den.Berg@farm.rug.nl
