Naslov
Integrating Pharmacogenomics with Pharmacovigilance- Croatian Experience

Autori
Božina, Nada ; Mirošević Skvrce, Nikica ; Macolić Šarinić, Viola

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni

Izvornik
Drug Safety / - , 2015

Skup
15th ISoP Annual Meeting “Cubism in Pharmacovigilance”

Mjesto i datum
Prag, Češka Republika, 27.10.2015. - 30.10.2015

Vrsta sudjelovanja
Predavanje

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
adverse drug reactions; pharmacovigilance; pharmacogenomics

Sažetak
Integrating pharmacogenomics with pharmacovigilance (PhV) have substantial role in searching post- marketing adverse drug reactions (ADR) and in drug development. Information on genetic polymorphisms is valuable when analyzing the causal relationship between drug intake and dose related ADR. To study the possible genetic associations with ADRs, the Croatian Agency for Medicinal Products & Medical Devices (HALMED) has piloted a project to collect DNA and phenotype data of ADR cases using the international standardized phenotypic criteria. Besides the data from spontaneous adverse reaction reporting system, the clinical data routinely recorded in hospital settings provide additional opportunities for identifying and quantifying ADRs. Since 2010 we asked reporters of some ADRs to invite patients to participate in the study. We established biological sample repository in the University Hospital Centre Zagreb, Lab for pharmacogenomics (accredited according to ISO 15189) ; undertake genotyping to identify novel associations or validate findings in cohorts of patients with well-defined phenotypes. HALMED developed a method for informing physicians or pharmacists and their patients about a possible pharmacogenetic involvement in the pathogenesis of the reported ADR and for offering easy access to genotyping. Data on ADRs of statins, anticoagulants, antiepileptics, antipsychotics, immunosuppressants, NSAIDs, tyrosine kinase inhibitors, have been collected and DNAs were genotyped. An anonymized copy of the test results has been used for the interpretation of possible signals. Some study results have been published. PhV centres a valuable starting point for pharmacogenomic studies and may suggest investigations and subsequent individualized pharmacogenetic counseling after a reported ADR.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti

POVEZANOST RADA