ADVERSE DRUG REACTIONS OF PSYCOPHARMACS

• Published in: Psychiatria Danubina Vol. 22; no. 3; p. 441
• Main Authors: Tomić, Siniša, Leventić, Jelena, Bagatin, Krešimir, Žeželić, Saša, Macolić Šarinić, Viola, Krnić, Darko, Arapović, Selma, Mirošević Skvrce, Nikica
• Format: Paper
• Language: English
• Published: Medicinska naklada 29-10-2010
• Subjects: adverse drug reaction; psycopharmacs; safe use of medicinal products; seriousness
• ISSN: 0353-5053; 1849-0867

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.
Subjects and 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.
Conclusion: 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.