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M-12: Pharmacogenomics in Drug Labeling and Guidelines: An International Perspective

Poster Presenter

Christina Salama

Pharmacy Student
Saint John's University
United States

Objectives

Pharmacogenomics’ (PGx) translation into clinical care differs in pace of implementation and acceptance worldwide. The objective of this study is to assess the difference in prescribing information (PI) and PGx guidelines of international medical agencies based on actionability and testing.

Method

Utilizing the PharmGKB website, the PI of all non-antineoplastic drugs approved by the FDA, EMA, HCSC and PMDA were compared in terms of inclusion of PGx information and its level of action. A similar comparison was conducted with the dosing guidelines published by CPIC, DPWG, CPNDS. Co-Author Ruchira Kasbekar

Results

A total of 273 drugs have been annotated under the drug labeling section on the PharmGKB website, of those 189 are non-antineoplastic drugs which were included in the analysis. Drugs were subclassified into 10 groups based on therapeutic area. The level of action in the different drug labels have been classified as informative PGx, testing recommended, testing required, and actionable PGx. Any given drug can have a combination of such recommendations. The FDA has the highest number of drug labels that included testing required or testing recommended for genetic biomarkers prior to administration with 15% compared to the EMA, HCSC and PMDA with only 5%, 6% and 0.6%, respectively. Under the actionable drug labels, the FDA has 47 %, while the EMA, HCSC, and PMDA has 8%, 25%, and 14%, respectively. While under the informative drug labels, the FDA continues to have the highest number of medications with 25% compared to the EMA, HCSC and PMDA with 14%, 6%, 4%, respectively. The PGx information within the labels was not always consistent among the PI’s approved by the different international medical agencies. While comparing PIs for inclusion of the PGx information, it was noted that up to 13% of drugs did not have PGx information within the FDA approved labels but was present in at least one other PI approved by another international agency. The gap was more significant in the EMA, HCSC, and PMDA, having 73%, 63% and 81.4%, respectively. As for the dosing guidelines, a total of 79 drugs have been annotated under the dosing guideline section of the PharmGKB website, of those 71 are non-antineoplastic drugs which were included in this analysis. A comparison of availability of drug dosing guidelines published by CPIC, DPWG, CPNDS and others was conducted. The DPWG has the highest number of dosing guideline published with 69%. While CPIC, CPNDS and other professional societies had 55%, 6% and 3% respectively.

Conclusion

The results from this study reveal that while PGx is being incorporated into many of the PIs and dosing guidelines, there is a lack of uniformity and consistency among the international regulatory agencies and the dosing guidelines. Findings from this analysis demonstrate a significant gap within the medical agencies which would reflect poorly on drug therapy and global patient care. As a result, both patients and clinicians may be subject to certain challenges in healthcare delivery leading to inconsistent efficacy and safety outcomes while prescribing and receiving medications across the world. A general trend that can be observed with the regulatory agencies is that the FDA has incorporated the highest number of PGx information in their approved PI’s. While the Dutch Pharmacogenetics Working Group (DPWG) dosing guideline has published more recommendations than any other professional society across the global. This analysis used PharmGKB to gather the data, as such a possible limitation in the methodology is the possibility of missing drugs with PGx information as well as the need to translate to the English language many of the labels available. The observed variation and discrepancy among the regulatory agencies and PGx published dosing guidelines may be due to the infrastructure, policy and culture available internationally. This could also be limited and specific to the different ethnicities which currently only live in that section of the world. As we move forward toward globalization of healthcare, it becomes imperative to uniformly guide the management of many relevant disease states with precise drug treatment and predictive outcomes thus providing global precision medicine.