Abstract
Pharmacogenomic biomarker availability of Hungarian Summaries of Product Characteristics (SmPC) was assembled and compared with the information in US Food and Drug Administration (FDA) drug labels of the same active substance (July 2019). The level of action of these biomarkers was assessed from The Pharmacogenomics Knowledgebase database. From the identified 264 FDA approved drugs with pharmacogenomic biomarkers in drug label, 195 are available in Hungary. From them, 165 drugs include pharmacogenomic data disposing 222 biomarkers. Most of them are metabolizing enzymes (46%) and pharmacological targets (41%). The most frequent therapeutic area is oncology (37%), followed by infectious diseases (12%) and psychiatry (9%) (p < 0.00001). Most common biomarkers in Hungarian SmPCs are CYP2D6, CYP2C19, estrogen and progesterone hormone receptor (ESR, PGS). Importantly, US labels present more specific pharmacogenomic subheadings, the level of action has a different prominence, and offer more applicable dose modifications than Hungarians (5% vs 3%). However, Hungarian SmPCs are at 9 oncology drugs stricter than FDA, testing is obligatory before treatment. Out of the biomarkers available in US drug labels, 62 are missing completely from Hungarian SmPCs (p < 0.00001). Most of these belong to oncology (42%) and in case of 11% of missing biomarkers testing is required before treatment. In conclusion, more factual, clear, clinically relevant pharmacogenomic information in Hungarian SmPCs would reinforce implementation of pharmacogenetics. Underpinning future perspective is to support regulatory stakeholders to enhance inclusion of pharmacogenomic biomarkers into Hungarian drug labels and consequently enhance personalized medicine in Hungary.
Highlights
Pharmacogenomics (PGx) is one of the precision medicine (PM) tools to be applied to maximize treatment effectiveness, Supplementary information The online version of this article contains supplementary material, which is available to authorized users.Department of Primary Health Care, Medical School, University of Pécs, H-7623 Pécs, Rákóczi u 2, HungaryDoctoral School of Health Sciences, Faculty of Health Sciences, University of Pécs, H-7621 Pécs, Vörösmarty u 4, HungaryInstitute of Sport Sciences and Physical Education, University of Pécs, H-7624 Pécs, Ifjúság útja 6, Hungary while limit the drug toxicity by differentiating responders from nonresponders to medications, based on an individual’s genetic constitution [1]
PGx information is partially present in drug label of 20 (10%), completely missing from drug label of 30 (15%) available active ingredients in Hungary compared with US Food and Drug Administration (FDA) (Table 1, italic and bold, respectively)
In order to be able to compare the level of action of PGx biomarkers between Hungary and the United States, we extracted the information from the Hungarian Summaries of Product Characteristics (SmPC) for US FDA approved drugs available in Hungary and compared with the level of action available on The Pharmacogenomics Knowledgebase (Table 3)
Summary
Pharmacogenomic biomarker information differences between drug labels in the United States and Hungary:. Information on PGx biomarkers and laboratory testing provides the resource for practicing medical doctors to apply personalized medicine in clinic [4]. The drug labeling for some, but not all, of the products includes specific actions to be taken based on the PGx biomarker information. (1) Provide an evaluation of current status of PGx biomarker information present in Hungarian drug labels. We assessed PGx level of action categories according to PharmGKb® [7] of the doctor targeted section of Hungarian drug label as (1) testing required, (2) testing recommended, (3) actionable with dosing info, (4) actionable, and (5) informative. Statistical analyses were performed applying Microsoft® Excel® for Mac® 2011 and IBM® SPSS® Statistics Version for Mac (SPSS Inc., Chicago, IL, USA)
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