Implementation of pharmacogenomics in product information

Abstract

Aim: The aim of our study was to analyse the level of implementation of pharmacogenomics (PGx) in product information (PI) of medicinal products approved through national procedures in the EU. Materials & methods: In the analysis, we included nationally approved medicinal products in Croatia if guidelines for relevant substances were published. Results: Overall, 265 marketing authorizations were analyzed. The majority of data included in PI was only informative, while the most frequent PGx biomarkers were genes which code CYP P450. Analysis according to the Anatomical Therapeutic Chemical classification revealed that most substances belonged to the nervous system. Conclusion: Although hindrances in implementation are anticipated, PI should be more specific in terms of when the testing is indicated and should include actionable recommendations according to the results of PGx testing.