Evaluation of pharmacogenomic information in drug labeling: a case study from Jordan.

Background: Pharmacogenomics (PGx) examines how genetic variations influence individual responses to medications, enabling more precise drug and dose selection. Drug labeling communicates PGx information to healthcare providers. However, in many countries, including Jordan, PGx integration into clinical practice remains limited.

Objective: This study aimed to evaluate the availability of PGx labeling in medications approved by the Jordan Food and Drug Administration (JFDA). It also compared PGx labeling in Jordan with that in drug labels from the United States and Hungary.

Methods: A manual review of drug leaflets was conducted using the JFDA online database between July and September 2024. Drugs were categorized based on the presence or absence of PGx information. Data were then compared with the U.S. FDA's PGx Biomarker Table and the Hungarian National Institute of Pharmacy's SmPCs.

Results: Among 75 reviewed JFDA-approved drugs, only 15 (20%) included complete PGx information. Neurology (50%), psychiatry (26.7%), and oncology (25%) had the highest representation, while cardiology (10%) and urology (0%) were underrepresented. Compared to the USA and Hungary, PGx labeling in Jordan was markedly limited.

Conclusion: The findings show a significant gap in PGx labeling in Jordan, emphasizing the need for regulatory updates to support personalized medicine.