Pharmacogenomics in drug therapy: global regulatory guidelines for managing high-risk drug reactions.

Abstract

Pharmacogenomics is rapidly transforming precision medicine, yet regulatory policies governing its implementation vary widely across countries. This review aims to provide a global perspective on pharmacogenomics guidelines, with a particular focus on high-risk drug reactions such as carbamazepine therapy-induced severe cutaneous adverse reactions. Carbamazepine was selected as a representative example due to its inclusion on the World Health Organization's essential medicines list and its well-documented association with high-risk alleles, which are linked to severe cutaneous adverse reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis-conditions with significant mortality rates. Two databases, Overton and Dimensions, were searched to identify relevant national guidelines and policy documents in English. Countries were identified based on document availability and access to governmental sources. The review revealed that all examined countries recognized genetic variation in carbamazepine response within their guidelines, showing notable consistency. However, religious implications related to pharmacogenomics were largely absent. The findings also indicated a growing global momentum toward integrating pharmacogenomics into healthcare systems, although the depth and scope of regulation differ. The United States stands out for its comprehensive pharmacogenomics policy framework, which extends to clinical and industry settings. Lessons from the U.S. model can inform policy development in other regions, tailored to each country's healthcare infrastructure and cultural context. In conclusion, global harmonization of pharmacogenomics policies is essential to foster international collaboration, enable data sharing, and enhance the safe and equitable implementation of pharmacogenomics in clinical practice.