Adverse drug reactions of psycopharmacs.
BACKGROUND
The objective of analysis of ADRs caused by drugs that pertain to the ATC group N (nervous system), as reported to the Croatian Agency for Medicinal Products and Medical Devices for the period from March 2005 to December 2008, was to examine the types of ADRs collected in said period, the profile of reporters and the possible impacts this could have on prescribing this group of medicinal products in the future.


METHODS
A retrospective observational study of ADRs was performed. Drugs causing ADRs were grouped according to the ATC drug classification, and subsequently entered into a database. Data were analyzed in respect of total number, gender, age, type, seriousness, expectedness, outcome, system organ class, suspected drug and reporter.


RESULTS
The findings showed that 15% of all reported ADRs were caused by drugs from the ATC group N. 60% of these were caused by drugs belonging to the ATC subgroups N05 (psycholeptics) and N06A (antidepressants). A significant increase in the percentage of serious ADRs in the examined groups of medicinal products was observed. Analysis of expectedness showed that the share of unexpected ADRs is very high.


CONCLUSIONS
The distribution of reporters is not satisfactory. The Agency, as regulatory authority, cannot undertake certain measures to improve the safe use of medicinal products without having reports. Only reporting of ADRs can result in changes to benefit all patient populations. Our joint aim should be avoiding a great number of ADRs and maintaining overall safe use of medicinal products.
Skvrce
Nikica Mirosević
NM
Agency for Medicinal Products and Medical Devices, Ksaverska cesta 4, Zagreb, Croatia.
Arapović
Selma
S
Krnić
Darko
D
Sarinić
Viola Macolić
VM
Zezelić
Sasa
S
Bagatin
Kresimir
K
Leventić
Jelena
J
Tomić
Sinisa
S
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D017523:Croatia; D056736:Drug Recalls / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D006801:Humans; D011619:Psychotropic Drugs / Q000009:adverse effects* / Q000627:therapeutic use; D012008:Recurrence; D012189:Retrospective Studies
D011619:Psychotropic Drugs