Variability of pharmacogenomic information in drug labels approved by
different agencies and its ethical implications
Abstract
Rationale, aims and objectives: 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
important for the personalization of medications because genetic
differences may affect both drug efficacy and safety. Providing adequate
PGx to patients has ethical implications. 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. 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 recommended”, “actionable”,
and “informative”. Results: There are 381 drugs listed in PharmGKB
drug label annotations and 278 of these have biomarkers. A total of 242
(63.52%) drugs are approved and available in Turkey. Of these, 207
(54.33%) 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 a significant effect on the efficacy and the
safety of drugs. Conclusion: These findings suggest an urgent need for
the standardization of pharmacogenomics information globally because it
may not only affect the efficacy and safety of medications but also
essential ethical rules regarding patient rights.