Assessment of adverse drug reactions in psychiatric inpatients with the AMSP drug safety program: Methods and first results for tricyclic antidepressants and SSRI
R. Grohmann et al., Assessment of adverse drug reactions in psychiatric inpatients with the AMSP drug safety program: Methods and first results for tricyclic antidepressants and SSRI, PHARMACOPS, 32(1), 1999, pp. 21-28
The AMSP (Arzneimittelsicherheit in der Psychiatrie) study is a new program
for continuous assessment of adverse drug reactions (ADR) in psychiatric i
npatients under naturalistic conditions of routine clinical treatment. It i
s based on the preceding drug surveillance study AMUP (Arzneimitteluberwach
ung in der Psychiatrie). Currently, 29 hospitals are participating in the s
tudy. This paper reports on the methods of the AMSP study and the first fin
dings on the comparative risks of tricyclic antidepressants (TCA) and selec
tive serotonin reuptake inhibitors (SSRI). Data assessment is restricted to
"severe" ADR as defined in the study protocol. Drug use is estimated from
reference day data. From 1993 to 1997, 896 cases of severe ADR were observe
d in 48,564 patients (1.84%). SSRI and the new substances mirtazapine and v
enlafaxine were increasingly used as antidepressants (AD), but TCA were sti
ll the most common AD in 1997 (52.1% of all AD patients). Similar rates of
ADR were observed for SSRI and TCA (1.7% and 1.5%, respectively, for all ca
ses, 0.9% and 1.0%, respectively, only for cases rated as probable). Howeve
r, different types of ADR occurred with the two AD subgroups; whereas toxic
delirium and increased liver enzymes were the most frequent ADR related to
TCA, nondelirious psychic and neurologic ADR predominated with SSRI. The d
uration of inpatient treatment was considerably longer in patients who expe
rienced an ADR due to TCA or SSRI than in those who did not. The AMSP study
promises to contribute greatly to drug safety by providing the relative fr
equencies of severe ADR from a large-scale database and by improving our kn
owledge of ADR.