engleski

Implementation of pharmacogenomics in product information

Although there is ample scientific evidence on the importance of genetic predisposition in the development of drug side effects, the implementation of this knowledge in clinical practice lags significantly behind. This paper analyzes the level of application of pharmacogenomics(PGx) in product information (PI) approved by national procedures in the EU. The analysis includes those nationally approved drugs in Croatia for which there are published guidelines which include pharmacogenetic data. A total of 265 marketing authorizations were analyzed. Most of the data included in PI were for information only, while the most common PGx biomarkers were genes encoding CYP P450. Analysis according to the Anatomical-therapeutic-chemical classification revealed that most substances are related to the nervous system. The conclusion states that the information in the PI should be more precise in terms of instructions in which cases testing is indicated. At the same time, it should contain effective recommendations for the use of the drug according to the results of PGx testing.

pharmacogenomics ; gene polymorphism ; drug side effects ; product information ; cytochrome P450 (CYP)

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