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EAHP INVENTORY OF GOOD PRACTICE INITIATIVES EXAMPLE SUBMISSION 1 LEIDEN CENTRE OF EXCELLENCE COURSE IN PHARMACOGENETICS 1. In which country is the example you would like to provide based in? 2. Please provide a title for the example of a good practice initiative you are providing 3. Please provide the name of the principal hospital and/or region in which the good practice initiative is based 4. Are you able to categorise the area/s of practice from which your good practice initiative is drawn? 5. Please provide a short introduction to the example of a good practice initiative in your country. The Netherlands Leiden Centre Of Excellence Course In Pharmacogenetics Leiden University Medical Center, Netherlands Education Pharmacotherapy (Pharmacogenetics) Pharmacogenetics, promising the end of “one size fits all” drugs and of trial and error in pharmacotherapy, is often predicted to be one of the first clinical applications in the postgenomic era. Yet, while pharmacists are often named as ideal candidates to translate the new pharmacogenetic knowledge to clinical practice many do not feel adequately informed about the possibilities of genetic testing and its applicability to their patients. For this reason an excellence course in pharmacogenetics is organised during three days and can be attended by 15 clinical pharmacists aiming to understand the basic concepts and potential clinical applications of pharmacogenetics to hospital pharmacy practice. Of Genes and Drugs The first part of the course is hosted by the department of Clinical Pharmacy & Toxicology of the Leiden University Medical Center. The course starts with an introduction of the basic principles of genetics and then proceeds to explain how genetic variation may result in variability in drug response. It is concluded that we need pharmacogenetic tests in situations where drug response cannot easily be assessed, treatment delay results in severe consequences, prognosis is poor or side effects are severe. The potential of pharmacogenetics will be illustrated by several drug-gene pairs e.g. tamoxifen and CYP2D6, sunitinib and CYP3A5, ABCB1 and NR1I3, 6mercaptopurine and TPMT, abacavir and HLAB*5701, simvastatin and SLCO1B1, and irinotecan and UGT1A1. In the afternoon of the First day the pros and cons of the available pharmacogenetic assays are discussed and participants will have the opportunity to work with available techniques (Taqman, Pyrosequencing, Amplichip, High Resolution Melting). The first day ends with a webinar demonstrating of the resources available on the Pharmacogenomics Knowledge Base (www.pharmgkb.org) such as dosing guidelines and drug labels, potentially clinically actionable gene-drug associations and genotype-phenotype relationships. Clinical implementation The second day focuses on the clinical implementation of pharmacogenetics. Evidence based pharmacogenetic guidelines created by the Dutch Pharmacogenetics Working Group and the Clinical Pharmacogenetics Implementation Consortium will be presented. Then, challenges for clinical implementation of pharmacogenetics such as required level of evidence and necessity of cost-effectiveness analyses are discussed. Solid scientific evidence for improvement in patient care is required prior to implementing pharmacogenetic testing. Information on cost-effectiveness and costconsequences of pharmacogenetic tests will facilitate implementation. In the afternoon participants may obtain their own CYP2D6 and CYP2C19 genotype using the Amplichip® test. Clopidogrel as case study The third day participants will focus on implementing pharmacogenetics in their own hospital. CYP2C19-clopidogrel is selected as primary gene-drug pair to implement because of the high level of scientific evidence, a recommendation in the label to perform genetic testing and the high number of patients treated with this drug. The course ends with a visit to the department of clinical chemistry of the Erasmus Medical Center. Participants are trained to prepare dosing advices using guidelines and pharmacogenetic websites. Summary 6. Please provide the name of the primary person that EAHP can contact for further information about this good practice initiative 7. Please provide the email address of the primary person that EAHP can contact about this example 8. Please provide the telephone number of the primary person EAHP can contact about this good practice initiative. Although several gene-drug pairs have potential for clinical implementation, the clinical uptake of pharmacogenetics is still low. Centers of excellence can play a role in assisting clinical implementation of pharmacogenetics by organizing pharmacogenetic courses to increase pharmacogenetic knowledge in the field and to create a network of peers facilitating implementation projects. [PROVIDED] [PROVIDED] [PROVIDED]