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      Physicians’ Attitudes and Ethical Obligations to Pharmacogenetic Testing

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          Abstract

          Introduction

          Despite the increased utilization of pharmacogenetic (PGt) testing to guide drug therapy, little is known about the ethical challenges posed by the use of these genetic tools.

          Methods

          This cross-sectional study aimed to address ethical issues related to ancillary genetic information, consent forms, and potential confidentiality breaches from physicians’ perspectives. A questionnaire was administered to all practicing physicians working in KAUH.

          Results

          Almost 49% and 65% of physicians were willing to recommend PGt testing for adult and pediatric patients, respectively. The findings showed that physicians attitudes towards the clinical utility of PGt testing became more preceptive. The majority (73.7%) indicated that PGt testing should not be treated as other routine laboratory tests. The finding also focused on potential conflicts regarding ancillary genetic information, in which 78.8% indicated that they would like to preserve the confidentiality and privacy of the patients and only 14.4% of physicians did not feel obligated to let patients know about any future risk that might be uncovered using PGt testing. The findings showed that collecting both verbal and written consents was imperative prior to testing. Seriousness and predictability of the diseases were reported to be legitimate circumstances that allow disclosure of genetic information.

          Discussion

          Unless the field of PGt testing addresses the ethical challenges that might be encountered during PGt treatment, these issues might influence its acceptance in routine clinical settings. Establishing a minimal set of ethical standards may help emphasize the role of physicians and thus facilitate the implementation of PGt tests.

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          Most cited references31

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          Cytochrome P450 2C9 polymorphisms: a comprehensive review of the in-vitro and human data.

          The discovery of six distinct polymorphisms in the genetic sequence encoding for the cytochrome P450 2C9 (CYP2C9) protein has stimulated numerous investigations in an attempt to characterize their population distribution and metabolic activity. Since the CYP2C9*1, *2 and *3 alleles were discovered first, they have undergone more thorough investigation than the recently identified *4, *5 and *6 alleles. Population distribution data suggest that the variant *2 and *3 alleles are present in approximately 35% of Caucasian individuals; however, these alleles are significantly less prevalent in African-American and Asian populations. In-vitro data have consistently demonstrated that the CYP2C9*2 and *3 alleles are associated with significant reductions in intrinsic clearance of a variety of 2C9 substrates compared with CYP2C9*1; however, the degree of these reductions appear to be highly substrate-dependent. In addition, multiple in-vivo investigations and clinical case reports have associated genotypes expressing the CYP2C9*2 and *3 alleles with significant reductions in both the metabolism and daily dose requirements of selected CYP2C9 substrates. Individuals expressing these variant genotypes also appear to be significantly more susceptible to adverse events with the narrow therapeutic index agents warfarin and phenytoin, particularly during the initiation of therapy. These findings have subsequently raised numerous questions regarding the potential clinical utility of genotyping for CYP2C9 prior to initiation of therapy with these agents. However, further clinical investigations evaluating the metabolic consequences in individuals expressing the CYP2C9*2, *3, *4, *5, or *6 alleles are required before large-scale clinical genotyping can be recommended.
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            Primary care physicians' knowledge of and experience with pharmacogenetic testing.

            It is anticipated that as the range of drugs for which pharmacogenetic testing becomes available expands, primary care physicians (PCPs) will become major users of these tests. To assess their training, familiarity, and attitudes toward pharmacogenetic testing in order to identify barriers to uptake that may be addressed at this early stage of test use, we conducted a national survey of a sample of PCPs. Respondents were mostly white (79%), based primarily in community-based primary care (81%) and almost evenly divided between family medicine and internal medicine. The majority of respondents had heard of PGx testing and anticipated that these tests are or would soon become a valuable tool to inform drug response. However, only a minority of respondents (13%) indicated they felt comfortable ordering PGx tests and almost a quarter reported not having any education about pharmacogenetics. Our results indicate that primary care practitioners envision a major role for themselves in the delivery of PGx testing but recognize their lack of adequate knowledge and experience about these tests. Development of effective tools for guiding PCPs in the use of PGx tests should be a high priority. © 2012 John Wiley & Sons A/S.
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              Clinical utility of genetic and genomic services: a position statement of the American College of Medical Genetics and Genomics.

              (2015)
              These recommendations are designed primarily as an educational resource for medical geneticists and other health-care providers to help them provide quality medical genetics services. Adherence to these recommendations does not necessarily ensure a successful medical outcome. These recommendations should not be considered inclusive of all proper procedures and tests or exclusive of other procedures and tests that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, geneticists and other clinicians should apply their own professional judgment to the specific clinical circumstances presented by the individual patient or specimen. It may be prudent, however, to document in the patient's record the rationale for any significant deviation from these recommendations.
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                Author and article information

                Journal
                J Multidiscip Healthc
                J Multidiscip Healthc
                JMDH
                jmulthealth
                Journal of Multidisciplinary Healthcare
                Dove
                1178-2390
                10 March 2020
                2020
                : 13
                : 249-258
                Affiliations
                [1 ]Department of Clinical Pharmacy, Jordan University of Science and Technology , Irbid, Jordan
                [2 ]Department of Basic Medical Sciences, Yarmouk University , Irbid, Jordan
                Author notes
                Correspondence: Suhaib Muflih Department of Clinical Pharmacy, Jordan University of Science and Technology , Irbid22110, JordanTel +962-79-7868603 Email smmuflih@just.edu.jo
                Author information
                http://orcid.org/0000-0002-6214-3168
                http://orcid.org/0000-0003-4001-5058
                http://orcid.org/0000-0002-2919-1280
                http://orcid.org/0000-0002-2808-5099
                Article
                245369
                10.2147/JMDH.S245369
                7071873
                32210569
                0506c5ca-64a9-4c5a-b30b-aaff0eb6f0c1
                © 2020 Muflih et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                : 09 January 2020
                : 27 February 2020
                Page count
                Tables: 4, References: 40, Pages: 10
                Categories
                Original Research

                Medicine
                pgt testing,ethical issues,physicians,informed consent form,ancillary information
                Medicine
                pgt testing, ethical issues, physicians, informed consent form, ancillary information

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