Variability of Pharmacogenomics Information in Drug Labels Approved by Different Agencies and its Ethical Implications

Abstract

Aims: The aim of this study was to determine if there are discrepancies among various agency-approved labels for the same active ingredient and where the labels approved by the Turkish Medicines and Medical Devices Agency (TMMDA) stand regarding the inclusion of PGx and discuss these ethical implications. Background: The efficacy and safety of drugs can be improved by rational prescription and personalization of medicine for each patient. Pharmacogenomics information (PGx) in Drug Labels (DL) is one of the important tools for the personalization of medications because genetic differences may affect both drug efficacy and safety. Providing adequate PGx to patients has ethical implications. Objective: The study aims to evaluate PGx in the DLs approved by TMMDA and other national agencies provided by the Pharmacogenomics Knowledgebase. Methods: DL annotations from the Pharmacogenomics Knowledgebase and DLs approved by the TMMDA were analyzed according to information and action levels, which are testing required, testing reconunended, actionable, and informative. Results: There are 381 drugs listed in PharmGKB drug label annotations with pharmacogenomics information, and 278 of these have biomarkers. A total of 242 (63.5%) drugs are approved and available in Turkey. Of these, 207 (85.5%) contain the same information as in or similar to that in the labels approved by the other agencies. The presence and level of information varied among the DLs approved by different agencies. The inconsistencies may have an important effect on the efficacy and the safety of drugs. Conclusion: These findings suggest a need for the standardization of PGx information globally because it may not only affect the efficacy and safety of medications but also essential ethical rules regarding patient rights by violating not sufficiently sharing all available information.