Evaluation of current regulation and guidelines of pharmacogenomic drug labels; opportunities for improvements.

Shekhani R1, Steinacher L2, Swen JJ1,3, Ingelman-Sundberg M2.

Author information

1: Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands.
2: Department of Physiology and Pharmacology, Section of Pharmacogenetics, Karolinska Institutet, Biomedicum 5B, SE-171 77, Stockholm, Sweden.
3: Leiden Network for Personalised Therapeutics, Leiden, The Netherlands.

Abstract

Pharmacogenomic drug labels in summary of product characteristics (SmPCs) provide an instrument for clinical implementation of pharmacogenomics. We compared pharmacogenomic guidance by CPIC, DPWG, FDA, and by the European agencies EMA, CBG-MEB and FIDMD, collectively assigned as EMA/FM. Out of 54 drugs with an actionable gene-drug interaction in the CPIC and DPWG guidelines, only 50 % had actionable pharmacogenomic information in the SmPCs and the agencies were in agreement in only 18 % of the cases. We further compared 450 additional drugs, lacking CPIC or DPWG guidance, and found 126 actionable gene-drug labels by FDA and/or EMA/FM. Based on these 126 drugs in addition to the 54 above the consensus of actionable pharmacogenomic labelling between FDA and EMA/FM was only 54 %. In conclusion, guidelines provided by CPIC/DPWG are only partly implemented into the SmPCs and the implementation of pharmacogenomic drug labels into the clinics would strongly gain from a higher extent of consensus between agencies.