Assessment of Adverse Drug Reactions in Psychiatric Inpatients with the AMSP Drug Safety Program: Methods and First Results for Tricyclic Antidepressants and SSRI

Grohmann, Renate; Rüther, Eckart; Engel, Rolf R.; Hippius, Hanns

doi:10.1055/s-2007-979184

Cited by 52 publications

(52 citation statements)

References 4 publications

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“…The German AMSP database covers some 29 hospitals and has been used to compare ADRs between tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs). Similar rates were found for the two groups but with different reaction profiles (Grohmann et al 1999): toxic delirium was most common with TCAs, whilst nondelirious psychic and neurological symptoms predominated with SSRIs. In Italy researchers using an ADR database for the elderly (covering some 81 hospitals), found moderate alcohol intake to increase the risk of ADRs, especially amongst women (Onder et al 2002).…”

Section: Pharmacoepidemiologysupporting

confidence: 65%

Database use in psychiatric research: An international review

Higgins

Howard²

2005

Eur. J. Psychiat.

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-Objective: Whilst database use for the purposes of audit is well established amongst clinicians, their research potential has yet to be fully realised. This review provides an international perspective on research using databases in psychiatry, considering the advantages and constraints of their use.Method: Large databases used in psychiatric research were identified through a systematic search of MEDLINE and EMBASE databases. The types of research conducted with these databases were then grouped into categories for discussion. A narrative synthesis of results is presented, illustrated with examples.Results: Research identified included pharmacoepidemiology, perinatal, aetiological, suicidology and health service research.Conclusions: Databases have been used to address a range of questions in psychiatry, often by employing linkage between clinical and national administrative databases. The success of such research is not only dependent on appropriate methodology and database design, but also on clinician commitment to data entry. Further exploitation of linkage potential between databases is envisaged, alongside international development of clinical databases designed with the purpose of research in mind.

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Section: Pharmacoepidemiologysupporting

confidence: 65%

Database use in psychiatric research: An international review

Higgins

Howard²

2005

Eur. J. Psychiat.

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“…The methodology has been described elsewhere (6,21,23,24). Currently, more than 35 German, Swiss, Austrian, Hungarian and Belgian sites are participating.…”

Section: Methodsmentioning

confidence: 99%

Off-label Utilization of Antidepressants

Zullino

Schwartz²,

Bilancioni

et al. 2008

Acta Med. (Hradec Kralove, Czech Repub.)

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Summary: While antidepressant prescription rules are established for approved indications by large-scale studies, off-label utilization naturally often lacks the validation by large scientific databases, and is at its best based on expert consensus. The aim of the present survey was to study the prescription habits of hospital psychiatrists with regard to antidepressants, comparing patients treated for depressions and anxiety disorder with patients receiving off-label antidepressant treatment. Methods: Data on drug use for this study were based on 6 reference days from April 1999 to November 2001 in the 98-bed psychiatric hospital of the University of Lausanne, Switzerland. The drug prescriptions of 174 patients were assessed. Results: Whereas the diagnosis did not influence the choice between newer or older antidepressants, patients presenting an anxiety disorder were 4.5 times more likely (p<0.05) and patients with other diagnoses 8 times more likely (p<0.001) to receive an antipsychotic comedication compared to patients whose primary diagnosis was a depressive disorder. Also, patients receiving concomitantly a nonbenzodiazepine hypnotic were less likely to be prescribed an older antidepressant (p<0.05). While patients with anxiety disorder and those with major depression received their antidepressants at comparable doses, patients with an off-label indication were treated preferentially with lower doses. Conclusions: The results of this survey suggest, that the prescribing hospital psychiatrists developed preferences with regard to the choice of the antidepressant class, which they then used for both registered and off-label indications. They then seemed to adapt the dose and the comedication according to the diagnosis, confirming the initial study hypothesis.

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“…Depending on the set up it can reach large populations under observation and at the same time provide denominator data to allow for incidence calculations. The AMSP study in Germany has proven that targeted pharmacovigilance in psychiatry is a valuable tool for the evaluation of ADRs as well as educating clinicians in the field of ADRs (Grohmann et al, 2004). Another study from the UK determined the feasibility of conducting a prospective targeted pharmacovigilance study to monitor adverse drug reactions associated with atypical antipsychotic therapy in children (Rani et al, 2009).…”

Section: Targeted Adr Surveillancementioning

confidence: 99%