Comparing cytochrome P450 pharmacogenetic information available on United States drug labels and European Union Summaries of Product Characteristics

Reis-Pardal, Joana; Rodrigues, Armanda; Rodrigues, Elsa; Fernández-Llimós, Fernando

doi:10.1038/tpj.2016.40

Cited by 11 publications

(6 citation statements)

References 36 publications

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“…In accordance with findings from other countries [14,16,17,22], CYP2D6 was the most frequently mentioned biomarker in the Swiss DLs. This cytochrome P450 enzyme is known for its genetic variability with about 100 different alleles [23] resulting in the phenotypes of poor, intermediate, normal, and ultra-rapid metabolizer (UM) with a prevalence of 0.4-5.4%, 0.4-11%, 67-90%, and 1-21%, respectively [24].…”

Section: Discussionsupporting

confidence: 88%

“…In contrast to most previous studies analyzing the DLs for PGx information by reviewers reading the DLs [ 11 , 14 ], we applied an automated search by NLP. Of the total hit sentences identified by NLP, 43% contained PGx-relevant information.…”

Section: Discussionmentioning

confidence: 99%

“…Several groups have compared the information on PGx in DLs authorized by different agencies [11][12][13][14]. In the United States, the Food and Drug Administration (FDA) approves the DLs, and provides a table of pharmacogenomic biomarkers in DLs [15].…”

Section: Introductionmentioning

confidence: 99%

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Pharmacogenetic information in Swiss drug labels – a systematic analysis

et al. 2020

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Implementation of pharmacogenetics (PGx) and individualization of drug therapy is supposed to obviate adverse drug reactions or therapy failure. Health care professionals (HCPs) use drug labels (DLs) as reliable information about drugs. We analyzed the Swiss DLs to give an overview on the currently available PGx instructions. We screened 4306 DLs applying natural language processing focusing on drug metabolism (pharmacokinetics) and we assigned PGx levels following the classification system of PharmGKB. From 5979 hits, 2564 were classified as PGx-relevant affecting 167 substances. 55% (n = 93) were classified as “actionable PGx”. Frequently, PGx information appeared in the pharmacokinetics section and in DLs of the anatomic group “nervous system”. Unstandardized wording, appearance of PGx information in different sections and unclear instructions challenge HCPs to identify and interpret PGx information and translate it into practice. HCPs need harmonization and standardization of PGx information in DLs to personalize drug therapies and tailor pharmaceutical care.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionmentioning

confidence: 99%

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Pharmacogenetic information in Swiss drug labels – a systematic analysis

et al. 2020

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“…Nevertheless, our study reveals the fact that SmPCs are not standardized and do not necessarily contain up to date information. A review of the literature shows that this is not a local problem peculiar to some countries such as Turkey, and is, in fact, a global problem [24][25][26][27]. SmPCs are suggested as useful and effective tools for disclosing PGx [28].…”

Section: Discussionmentioning

confidence: 99%

Variability of pharmacogenomic information in drug labels approved by different agencies and its ethical implications

ner

Ekmekçi

Kurtoglu

2020

Preprint

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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.

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“…Territorial differences in drug label content of PGx biomarker information depending on responsible approval agencies do exist. For example, it is well known that cytochrome P450 pharmacogenetic information included in US FDA drug labels present significantly more specific pharmacogenetic information than analogous EU SmPCs [9].…”

Section: Discussionmentioning

confidence: 99%

Pharmacogenomic biomarker information differences between drug labels in the United States and Hungary: implementation from medical practitioner view

et al. 2019

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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.

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Comparing cytochrome P450 pharmacogenetic information available on United States drug labels and European Union Summaries of Product Characteristics

Cited by 11 publications

References 36 publications

Pharmacogenetic information in Swiss drug labels – a systematic analysis

Pharmacogenetic information in Swiss drug labels – a systematic analysis

Variability of pharmacogenomic information in drug labels approved by different agencies and its ethical implications

Pharmacogenomic biomarker information differences between drug labels in the United States and Hungary: implementation from medical practitioner view

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