The role of consortia and societies in implementing pharmacogenomics or pharmacogenetic testings in routine clinic


The implementation of pharmacogenomics/pharmacogenetics (PGx) into routine clinical practice is becoming more common nowadays because of the availability of clinical guidelines describing the utilization of pharmacogenetics test results to optimize drug and dose selection to enable safer, with more benefit and cost-effective treatment (1). Research in PGx started many decades ago but the implementation of the PGx in the clinic has started to emerge in last ten years as a result of various initiative taken up by the PGx associations. The genotyping methods are broadly classified into reactive and pre-emptive clinical genotyping (2). Many medical institutes have ensured the reactive utilization of PGx tests for high risk drugs or costly drugs as and when required, however, the sparing use of the PGx not only increases the cost but also not effective when there is a need to prescribe the medication urgently. ...................................................................................................................................................................................The pre-emptive translation of the PGx research has always remained a challenge, but the effort of implementation will bring more knowledge in this field and will add more information by improving the solution strategy of many PGx implementation related issues. In the recent years, initiatives of PGx implementation have been started in Europe, United States (US), and Asia. Twenty-seven different institutions in the US are involved in many programs for implementation of pharmacogenomics and few of these initiatives have been running for more than 10 years. In the year 2007, establishment of the Electronic Medical Records and Genomics (eMERGE) Network was initiated by a huge network of several consortia. Later these consortia and the Pharmacogenomics Research Network (PGRN) initiated eMERGE-PGx study for testing genetic variation in 82 pharmacogenes with targeted sequencing and 5639 samples sequenced from nine eMERGE sites until February 2015 (3, 4). ........................................................................................ References:............................................................. 1. Relling MV, Evans WE. Pharmacogenomics in the clinic. Nature. 2015;526(7573):343-50. 2. Arwood MJ, Chumnumwat S, Cavallari LH, Nutescu EA, Duarte JD. Implementing pharmacogenomics at your institution: establishment and overcoming implementation challenges. Clinical and translational science. 2016;9(5):233. 3. Gottesman O, Kuivaniemi H, Tromp G, Faucett WA, Li R, Manolio TA, et al. The electronic medical records and genomics (eMERGE) network: past, present, and future. Genetics in Medicine. 2013;15(10):761. 4. Bush WS, Crosslin DR, Owusu?Obeng A, Wallace J, Almoguera B, Basford MA, et al. Genetic variation among 82 pharmacogenes: the PGRNseq data from the eMERGE network. Clinical Pharmacology & Therapeutics. 2016;100(2):160-9.

Posted On:27/12/2019




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To achieve this aim, a prospective, block-randomized, controlled clinical trial (PREemptive Pharmacogenomic testing for prevention of Adverse drug REactions; PREPARE) has been implemented across seven European countries. The cost effectiveness and the outcome of patients will be investigated in this unique multigene, multidrug study (6). In Asia, the Southeast Asian Pharmacogenomics Research Network (SEAPharm) is established by 5 countries (Indonesia, Taiwan, Korea,Malaysia, and Thailand) for strengthening the PGx research. The main aim of this network is to support PGx implementation among various communities within and beyond the region (7, 8).---------------------------------------------------------References:---------------------------- 6. van der Wouden CH, Cambon-Thomsen A, Cecchin E, Cheung KC, Davila-Fajardo CL, Deneer VH, et al. Implementing Pharmacogenomics in Europe: Design and Implementation Strategy of the Ubiquitous Pharmacogenomics Consortium. Clinical pharmacology and therapeutics. 2017;101(3):341-58. 7. Chumnumwat S, Lu ZH, Sukasem C, Winther MD, Capule FR, Abdul Hamid AA, et al. Southeast Asian Pharmacogenomics Research Network (SEAPharm): Current Status and Perspectives. Public Health Genomics. 2019. 8. Krebs K, Milani L. Translating pharmacogenomics into clinical decisions: do not let the perfect be the enemy of the good. Human Genomics. 2019;13(1):39.

PM Team
27/12/2019


In addition to the various region-specific consortia, expert groups for example Clinical Pharmacogenetics Implementation Consortium (CPIC) and Association for Molecular Pathology (AMP) have published various standardization recommendations for the laboratory genetic testing, reporting and terminology in order to place an efficient process for ordering the genetic tests and reporting structure of results to the clinicians and patients.

PM Team
27/12/2019


The Clinical Pharmacogenetics Implementation Consortium (CPIC) is an international consortium comprised of volunteers and staff, with the aim of facilitating the utilization of PGx tests for patient care. The CPIC generates and curates peer-reviewed, updatable, evidence-based, and detailed gene/drug clinical practice guidance documents. CPIC guidelines helps clinicians to understand how the available genetic test results are ought to be used for optimization of drug therapy. The CPIC guidelines are evaluated regularly and updated accordingly. Renowned institutions such as BJC healthcare, Boston Children’s hospital, Erasmus MC are implementing the CPIC guidelines as a part of program to facilitate the use of genetic tests to guide prescribing for patients in clinical care settings. Further, the databases such as PharmGKB, PharmVar, ClinGen, and ClinVar have been important resources for nomenclatures of pharmacogenetic alleles and variants (9).--------------------------------------------------------------------------- References: 9. Caudle KE, Keeling NJ, Klein TE, Whirl-Carrillo M, Pratt VM, Hoffman JM. Standardization can accelerate the adoption of pharmacogenomics: current status and the path forward. Pharmacogenomics. 2018;19(10):847-60.

PM Team
27/12/2019


It is also important to mention the roles of various national pharmaceutical societies in the implementation of the PGx into routine clinical practices. Many studies have been carried out in the Western countries to check models for implementing the PGx at the community level and proposed that the pharmacist and the pharmacotherapy personnel could provide support PGx care along with physicians. In UK, the National Genetics Education and Development Centre and Royal Pharmaceutical Society met to identify pharmacists’ role as the provider of the services related to PGx and recognised the role of pharmacists in providing the pharmacogenetics care to the public. Therefore, together with various consortia, the pharmaceutical/pharmacological societies are playing a crucial role in implementing the PGx in routine clinical practice.

PM Team
27/12/2019