title: Implementing Pharmacogenomics in Europe: Design and Implementation Strategy of the Ubiquitous Pharmacogenomics Consortium.
abstract: Despite scientific and clinical advances in the field of pharmacogenomics (PGx), application into routine care remains limited. Opportunely, several implementation studies and programs have been initiated over recent years. This article presents an overview of these studies and identifies current research gaps. Importantly, one such gap is the undetermined collective clinical utility of implementing a panel of PGx-markers into routine care, because the evidence base is currently limited to specific, individual drug-gene pairs. The Ubiquitous Pharmacogenomics (U-PGx) Consortium, which has been funded by the European Commission's Horizon-2020 program, aims to address this unmet need. In a prospective, block-randomized, controlled clinical study (PREemptive Pharmacogenomic testing for prevention of Adverse drug REactions [PREPARE]), pre-emptive genotyping of a panel of clinically relevant PGx-markers, for which guidelines are available, will be implemented across healthcare institutions in seven European countries. The impact on patient outcomes and cost-effectiveness will be investigated. The program is unique in its multicenter, multigene, multidrug, multi-ethnic, and multihealthcare system approach.
authors.affiliation: Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: C H
authors.initials: CH
authors.lastname: van der Wouden
authors.affiliation: UMR Inserm U1027 and Université de Toulouse III Paul Sabatier, Toulouse, France.
authors.forename: A
authors.initials: A
authors.lastname: Cambon-Thomsen
authors.affiliation: Experimental and Clinical Pharmacology, Centro di Riferimento Oncologico, National Cancer Institute, Aviano, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Cecchin
authors.affiliation: Royal Dutch Pharmacists Association (KNMP), The Hague, The Netherlands.
authors.forename: K C
authors.initials: KC
authors.lastname: Cheung
authors.affiliation: Department of Clinical Pharmacy, Granada University Hospital, Institute for Biomedical Research, Granada, Spain.
authors.forename: C L
authors.initials: CL
authors.lastname: Dávila-Fajardo
authors.affiliation: Department of Clinical Pharmacy, St Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: V H
authors.initials: VH
authors.lastname: Deneer
authors.affiliation: Pharmacogenetics Laboratory, Institute of Biochemistry, Faculty of Medicine, University of Ljubljana, Slovenia.
authors.forename: V
authors.initials: V
authors.lastname: Dolžan
authors.affiliation: Department of Physiology and Pharmacology, Section of Pharmacogenetics, Karolinska Institutet, Stockholm, Sweden.
authors.forename: M
authors.initials: M
authors.lastname: Ingelman-Sundberg
authors.affiliation: Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
authors.forename: S
authors.initials: S
authors.lastname: Jönsson
authors.affiliation: Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
authors.forename: M O
authors.initials: MO
authors.lastname: Karlsson
authors.affiliation: Center for Clinical Genetics, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: Kriek
authors.affiliation: The Golden Helix Foundation, London, United Kingdom.
authors.forename: C
authors.initials: C
authors.lastname: Mitropoulou
authors.affiliation: University of Patras, School of Health Sciences, Department of Pharmacy, University Campus, Rion, Patras, Greece.
authors.forename: G P
authors.initials: GP
authors.lastname: Patrinos
authors.affiliation: Department of Molecular and Clinical Pharmacology, Royal Liverpool University Hospital and University of Liverpool, Liverpool, United Kingdom.
authors.forename: M
authors.initials: M
authors.lastname: Pirmohamed
authors.affiliation: Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Vienna, Austria.
authors.forename: M
authors.initials: M
authors.lastname: Samwald
authors.affiliation: Dr. Margarete Fischer-Bosch Institute of Clinical Pharmacology, Stuttgart, Germany and University of Tübingen, Tübingen, Germany.
authors.forename: E
authors.initials: E
authors.lastname: Schaeffeler
authors.affiliation: Dr. Margarete Fischer-Bosch Institute of Clinical Pharmacology, Stuttgart, Germany and University of Tübingen, Tübingen, Germany.|Department of Clinical Pharmacology, University Hospital Tübingen, Tübingen, Germany.|Department of Pharmacy and Biochemistry, University of Tübingen, Tübingen, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Schwab
authors.affiliation: Bio.logis Center for Human Genetics, Frankfurt am Main, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Steinberger
authors.affiliation: Research Division, Federal Institute for Drugs and Medical Devices, Bonn, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Stingl
authors.affiliation: Division of Nephrology and Dialysis, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
authors.forename: G
authors.initials: G
authors.lastname: Sunder-Plassmann
authors.affiliation: Experimental and Clinical Pharmacology, Centro di Riferimento Oncologico, National Cancer Institute, Aviano, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Toffoli
authors.affiliation: Department of Molecular and Clinical Pharmacology, Royal Liverpool University Hospital and University of Liverpool, Liverpool, United Kingdom.
authors.forename: R M
authors.initials: RM
authors.lastname: Turner
authors.affiliation: Royal Dutch Pharmacists Association (KNMP), The Hague, The Netherlands.
authors.forename: M H
authors.initials: MH
authors.lastname: van Rhenen
authors.affiliation: Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: J J
authors.initials: JJ
authors.lastname: Swen
authors.affiliation: Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: H-J
authors.initials: HJ
authors.lastname: Guchelaar
mesh_terms: D015415:Biomarkers; D003362:Cost-Benefit Analysis; D057286:Electronic Health Records / Q000458:organization & administration; D005060:Europe; D005838:Genotype; D006801:Humans; D000071185:Pharmacogenomic Testing / Q000191:economics / Q000379:methods* / Q000706:statistics & numerical data* / Q000639:trends; D017410:Practice Guidelines as Topic; D057285:Precision Medicine / Q000379:methods; D011446:Prospective Studies; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers