Assessment of adverse drug reactions in psychiatric hospitals

Abstract

A system for monitoring adverse drug reactions (ADR) in psychiatric inpatients was introduced in psychiatric hospitals in the FRG in May 1979. It consists of intensive drug monitoring (IDM) and a so-called "organized spontaneous reporting system" (OSR). ADR are rated separately according to impact on therapy and probability of causal relationship. With IDM all ADR (Grades I-III) are assessed in a randomly selected sample of inpatients. With OSR only ADR leading to discontinuation of the drugs in question (= ADR Grade III) are assessed. In 406 drug-treated inpatients monitored by IDM in the psychiatric hospitals of Berlin and Munich from May 1979 to Dec. 1981, ADR were observed in 60,4%. In 15% of IDM-patients ADR led to discontinuation of the drugs in question; with OSR the relative frequency of these Grade III ADR was 9,0% in 5096 patients monitored throughout the entire period. Life-threatening events were observed in 1,2% of patients undergoing IDM as well as 1.2% of those undergoing OSR. The most frequently observed ADR by IDM were sedation, extrapyramidal signs, disturbances of the autonomic nervous system and increase in transaminases, and by OSR Parkinsonism, akathisia, sedation, toxic delirium and increased transaminases. The relative frequency of Grade III ADR was similar for neuroleptics and antidepressants (5,4% and 5,3% in OSR); a very low relative frequency of ADR Grade III was found for tranquilizers and hypnotics (0,7% and 0,2%). Methodological aspects of this drug monitoring system are discussed in the light of current literature.

Acute Delirious Syndromes due to Psychotropic Drugs

“…There was no difference in risk far male or female patients in tbis study, while other authors found a preponderance of men (I) or women (2). As to age groups, there was a tendency towards the more elderly patients in the ADR group which is consistent with other reports (1,2,4,5); nevertheless, as 45 % of our patients were under 50 years, age cannot be estimated as a very important factor. Although delirium due to psychotropic drugs seems to show symptoms that are not as severe as seen in delirium tremens (3), almost three quarters of our patients showed vegetative symptoms.…”

“…Methods and first results of this study have been published earlier (4,9). From May 1979 to December 1983, alt inpatients of the Oepartment of Psychiatry in Munich treated with psychotropic drugs have been continually monitored by the methods of the Drug Monitoring system.…”

Hyperglycemia Associated with Antipsychotic Treatment in a Multicenter Drug Safety Project

“…The probability rating is based on criteria described earlier [12]: ± Grade 1, possible: ADR not known, or time course or dosage unusual for imputed drug, or alternative explanation for ADR more probable. ± Grade 2, probable: ADR known with drug in question, time course and dosage in accordance with previous experience, alternative explanation less probable.…”

Letter to the Editor

“…Relative frequencies that were based on "probable" and "definite" cases only, have been published by Grohmann et al (1). They are much lower.…”

“…Dear Sir, This letter refers to the article entitled "Adverse drug reactions -an epidemiological study at psychiatric hospitals" by Schmidt et al (1).…”