Pharmacogenomic information from CPIC and DPWG guidelines and its application on drug labels

Abstract

There are several hurdles to overcome before implementing pharmacogenomics (PGx) in precision medicine. One of the hurdles is unawareness of PGx by clinicians due to insufficient pharmacogenomic information on drug labels. Therefore, it might be important to implement PGx that reflects pharmacogenomic information on drug labels, standard of prescription for clinicians. This study aimed to evaluate the level at which PGx was being used in clinical practice by comparing the Clinical Pharmacogenetics Implementation Consortium and Dutch Pharmacogenetics Working Group guidelines and drug labels of the US Food and Drug Administration (FDA) and the Korea Ministry of Food and Drug Safety (MFDS). Two PGx guidelines and drugs labels were scrutinized, and the concordance of the pharmacogenomic information between guidelines and drug labels was confirmed. The concordance of the label between FDA and MFDS was analyzed. In FDA labels, the number of concordant drug with guidelines was 24, while 13 drugs were concordant with MFDS labels. The number of drugs categorized as contraindication, change dose, and biomarker testing required was 7, 12 and 12 for the FDA and 8, 5 and 4 for the MFDS, respectively. The pharmacogenomic information of 9 drugs approved by both FDA and MFDS was identical. In conclusion, pharmacogenomic information on clinical implementation guidelines was limited on both FDA and MFDS labels because of various reasons including the characteristics of the guidelines and the drug labels. Therefore, more effort from pharmaceutical companies, academia and regulatory affairs needs to be made to implement pharmacogenomic information on drug labels.

Keywords: Drug Labeling; Guideline; Korea Ministry of Food and Drug Safety; Pharmacogenomics; United States Food and Drug Administration.

Figure 1. Selection of drugs for comparison between the pharmacogenomics guidelines and drug labels of the regulatory affairs.

CPIC, Clinical Pharmacogenetics Implementation Consortium; DPWG, Dutch Pharmacogenetics Working Group; FDA, US Food and Drug Administration; MFDS, Korea Ministry of Food and Drug Safety.

Figure 2. Classification of drugs listed in the CPIC and DPWG guidelines by (A) the anatomical therapeutic chemical code and (B) pharmacogenomics related genes.

Drug categories classified as “This is not a gene-drug interaction” on the DPWG guideline. CPIC, Clinical Pharmacogenetics Implementation Consortium; DPWG, Dutch Pharmacogenetics Working Group.

Figure 3. Concordance between the pharmacogenomic information in the guidelines and on the drug labels (A) pie chart showing the ratio of the concordance and discordance of the FDA and MFDS (B) bar chart representing the number of concordant drugs categorized by indication (C) bar chart representing the number of concordant drugs categorized by the anatomical therapeutic chemical code.

FDA, US Food and Drug Administration; MFDS, Korea Ministry of Food and Drug Safety.