Abstract:The PGx level given in drug labels provides information on availability of PGBM testing. Higher PGx levels, based on better evidence of usefulness of PGBM testing, provide a route to broader test coverage.
“…It turned out that PGx levels in US labels were strongly associated with coverage of testing of pharmacogenomics biomarkers, with almost all labels with “Testing Required” having insurance coverage. Notably, in Japan, all labels listed as “Testing Required” were covered by the National Health Insurance …”
Section: Discussionmentioning
confidence: 99%
“…An example is the translational pharmacogenomic programme led by St Jude Children's Research Hospital (St Jude, Memphis, TN, USA), where PG4KDS is a project aimed at evaluating PGx test results in children and selectively choosing the tests that have strong evidence and closely linking them to drug response, in order to incorporate them into patient medical records . Although other such initiatives are already in place, albeit only in countries with very high HDI, further collaborations and communications between PGx experts and healthcare professionals are needed. “[Need] practice guidelines from physician organizations, i.e.…”
Section: Discussionmentioning
confidence: 99%
“…Since then, there have been major initiatives to push PGx forward especially relating to developing clinical guidelines that are accessible and understandable by clinicians, and integration of PGx clinical decision support (CDS) into the electronic medical records (EMRs) . For instance, the Clinical Pharmacogenetics Implementation Consortium (CPIC) of the Pharmacogenomics Knowledgebase (PharmGKB) and the Dutch Pharmacogenetics Working Group have already contributed to guidelines and clinical annotation levels of evidence covering 100 gene–drug interactions, translating known genetic laboratory test results into concrete clinical decision‐making regarding drug prescribing . In addition, in 2015, the EU funded a large PGx implementation study that takes into consideration the large diversity of healthcare systems and languages of citizens across Europe …”
Section: Introductionmentioning
confidence: 99%
“…3,6 For instance, the Clinical Pharmacogenetics Implementation Consortium (CPIC) of the Pharmacogenomics Knowledgebase (PharmGKB) and the Dutch Pharmacogenetics Working Group have already contributed to guidelines and clinical annotation levels of evidence covering 100 gene-drug interactions, translating known genetic laboratory test results into concrete clinical decision-making regarding drug prescribing. [7][8][9][10][11] In addition, in 2015, the EU funded a large PGx implementation study that takes into consideration the large diversity of healthcare systems and languages of citizens across Europe. 12 Despite these efforts, PGx clinical implementation may still be facing different challenges in different parts of the world.…”
Aims
Eight years ago, a paper‐based survey was administered during the World Pharma 2010 meeting, asking about the challenges of implementing pharmacogenetics (PGx) in clinical practice. The data collected at the time gave an idea about the progress of this implementation and what still needs to be done. Since then, although there have been major initiatives to push PGx forward, PGx clinical implementation may still be facing different challenges in different parts of the world. Our aim was therefore to distribute a follow‐up international survey in electronic format to elucidate an overview on the current stage of implementation, acceptance and challenges of PGx in academic institutions around the world.
Methods
This is an online anonymous LimeSurvey‐based study launched on 11 November 2018. Survey questions were adapted from the initially published manuscript in 2010. An extensive web search for worldwide scientists potentially involved in PGx research resulted in a total of 1973 names. Countries were grouped based on the Human Development Index.
Results
There were 204 respondents from 43 countries. Despite the wide availability of PGx tests, the consistently positive attitude towards their applications and advances in the field, progress of the clinical implementation of PGx still faces many challenges all around the globe.
Conclusions
Clinical implementation of PGx started over a decade ago but there is a gap in progress around the globe and discrepancies between the challenges reported by different countries, despite some challenges being universal. Further studies on ways to overcome these challenges are warranted.
“…It turned out that PGx levels in US labels were strongly associated with coverage of testing of pharmacogenomics biomarkers, with almost all labels with “Testing Required” having insurance coverage. Notably, in Japan, all labels listed as “Testing Required” were covered by the National Health Insurance …”
Section: Discussionmentioning
confidence: 99%
“…An example is the translational pharmacogenomic programme led by St Jude Children's Research Hospital (St Jude, Memphis, TN, USA), where PG4KDS is a project aimed at evaluating PGx test results in children and selectively choosing the tests that have strong evidence and closely linking them to drug response, in order to incorporate them into patient medical records . Although other such initiatives are already in place, albeit only in countries with very high HDI, further collaborations and communications between PGx experts and healthcare professionals are needed. “[Need] practice guidelines from physician organizations, i.e.…”
Section: Discussionmentioning
confidence: 99%
“…Since then, there have been major initiatives to push PGx forward especially relating to developing clinical guidelines that are accessible and understandable by clinicians, and integration of PGx clinical decision support (CDS) into the electronic medical records (EMRs) . For instance, the Clinical Pharmacogenetics Implementation Consortium (CPIC) of the Pharmacogenomics Knowledgebase (PharmGKB) and the Dutch Pharmacogenetics Working Group have already contributed to guidelines and clinical annotation levels of evidence covering 100 gene–drug interactions, translating known genetic laboratory test results into concrete clinical decision‐making regarding drug prescribing . In addition, in 2015, the EU funded a large PGx implementation study that takes into consideration the large diversity of healthcare systems and languages of citizens across Europe …”
Section: Introductionmentioning
confidence: 99%
“…3,6 For instance, the Clinical Pharmacogenetics Implementation Consortium (CPIC) of the Pharmacogenomics Knowledgebase (PharmGKB) and the Dutch Pharmacogenetics Working Group have already contributed to guidelines and clinical annotation levels of evidence covering 100 gene-drug interactions, translating known genetic laboratory test results into concrete clinical decision-making regarding drug prescribing. [7][8][9][10][11] In addition, in 2015, the EU funded a large PGx implementation study that takes into consideration the large diversity of healthcare systems and languages of citizens across Europe. 12 Despite these efforts, PGx clinical implementation may still be facing different challenges in different parts of the world.…”
Aims
Eight years ago, a paper‐based survey was administered during the World Pharma 2010 meeting, asking about the challenges of implementing pharmacogenetics (PGx) in clinical practice. The data collected at the time gave an idea about the progress of this implementation and what still needs to be done. Since then, although there have been major initiatives to push PGx forward, PGx clinical implementation may still be facing different challenges in different parts of the world. Our aim was therefore to distribute a follow‐up international survey in electronic format to elucidate an overview on the current stage of implementation, acceptance and challenges of PGx in academic institutions around the world.
Methods
This is an online anonymous LimeSurvey‐based study launched on 11 November 2018. Survey questions were adapted from the initially published manuscript in 2010. An extensive web search for worldwide scientists potentially involved in PGx research resulted in a total of 1973 names. Countries were grouped based on the Human Development Index.
Results
There were 204 respondents from 43 countries. Despite the wide availability of PGx tests, the consistently positive attitude towards their applications and advances in the field, progress of the clinical implementation of PGx still faces many challenges all around the globe.
Conclusions
Clinical implementation of PGx started over a decade ago but there is a gap in progress around the globe and discrepancies between the challenges reported by different countries, despite some challenges being universal. Further studies on ways to overcome these challenges are warranted.
“…Other sections such as indications, dosage/use and contraindications rarely provide PGx information. In contrast to the study of Shimazawa et al [ 21 ], we did not prioritize one section per DL, but we analyzed all sections mentioning PGx information.…”
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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