NR-565 Week 1 Discussion: Pharmacogenomics (Original Post, Peer Response)

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NR-565 Week 1 Discussion: Pharmacogenomics (Original Post, Peer Response) NR565 week 1 discussion Professor and class, Before initiating abacavir, an anti-retroviral, for a newly diagnosed HIV p ... ositive patient the nurse practitioner orders HLA-B*5701 allele genetic testing. The test confirms that the patient carries the HLA-B*5701 allele. The HLA-B*5701 is genetic testing used to determine the potential risk for severe side effects from the antiviral medication abacavir (De Spiegelaere et al., 2015). The HLA-B gene has an impact on how the immune system responds and recognizes various pathogens while mediating hypersensitivity reactions (De Spiegelaere et al., 2015). If a copy of the HLA-B*5701 is positive, it determines there is at least one copy of the allele. This test is run by obtaining a sample of the patient's saliva or blood. Abacavir is a nucleoside reverse transcriptase inhibitor used as an antiretroviral therapy in HIV patients (De Spiegelaere et al., 2015). Due to this drug having a hypersensitive reaction to patients that are HLA-B*5701 carriers, the FDA has recommended all providers pre- screen their patients before prescribing this medication in the treatment of HIV patients (De Spiegelaere et al., 2015). In this scenario, the patient carries the HLA-B*5701 allele; therefore, they should not be prescribed abacavir. The side effects of a patient receiving abacavir that test positive for the HLA-B*5701 allele can be fatal (De Spiegelaere et al., 2015). Additionally, they may exhibit symptoms that include a fever, rash, vomiting, and shortness of breath (De Spiegelaere et al., 2015). A patient is prescribed antiplatelet therapy (clopidogrel) following an acute myocardial infarction (MI). Six months later, the patient suffers another acute MI. The patient has been adherent to therapy and the nurse practitioner suspects that clopidrogel may have been ineffective. How might genetic testing have been beneficial in this case? For the last ten years, I have been working in the cardiac Cath Lab. Antiplatelet therapy is a crucial aspect of positive patient outcomes. Plavix (clopidogrel) is an antiplatelet drug that inhibits the ability of platelets from sticking together, preventing clot formation. Plavix has been a gold standard for patients that receive coronary interventions. If a patient has another cardiac event, we use P2Y12 blood samples to determine if the patient is responsive to Plavix. When a patient is resistant to Plavix, it generally means the CYP2C19 gene is nonfunctional (Moon et.al., 2018). When the CYP2C19 gene is nonfunctional, it cannot convert Plavix to its active form (Moon et.al., 2018). In this scenario, pre-genetic testing could have determined if Plavix would have been an effective Antiplatelet therapy for this patient. Unfortunately, patients that have genetic variants of CYP2C19 have an increased risk for developing a major cardiac event, stroke, and death (Moon et.al., 2018). Identify 2 limitations of pharmacogenomics testing. Explain. Two limitations of pharmacogenetics testing are the lack of genetic knowledge and cost- effectiveness evidence (Krebs, & Milani, 2019). Many providers do not order genetic testing for their patients due to a lack of understanding. Providers are not aware of the amount of pharmacogenomic-guided medications that patients are exposed to. One Vanderbilt study found that out of the 52,000 individuals that were surveyed, 65% were exposed to pharmacogenomic-guided drugs (Krebs, & Milani, 2019). Furthermore, the age of healthcare providers varies dramatically. Those who graduated more than ten years ago had minimal training on genetic testing (Krebs, & Milani, 2019). Additionally, due to increased discoveries and advances in technology, it has made it challenging to stay up to date with the latest information. Providers may order genetic testing; however, few know how to implement results into clinical action. Another considerable barrier to implementing genetic testing is the lack of data that shows the cost savings of gene testing and cost-effectiveness on clinical outcomes. If there were more evidence-based practice studies showing profitability, it would promote the necessity of further genetic testing. Identify 2 ethical concerns of using pharmacogenomics testing. Explain The first ethical concern in implementing pharmacogenetics testing is determining who should be tested (Korngiebel, Thummel, & Burke, 2017). It is up to the provider to assess each patient appropriately by gathering relevant data. This includes the projected benefits, potential harm, and alternative treatments available to the patient. It is up to the provider to review the scientific data and determine the quality of research. Another ethical concern is obtaining patient consent. Most facilities and laboratories do not require approval for genetic testing (Haga, & Mills, 2016). Depending on the type of gene testing and course of action, an effective treatment may not be available. The American Medical Association’s Code of Ethics requires providers to give accurate medical information to patients to help them make informed decisions about their own care (Haga, & Mills, 2016). This is especially important for those patients that have potential risk for discrimination; for example, the patient in this scenario that has tested positive for HIV. Korngiebel, D. M., Thummel, K. E., & Burke, W. (2017). Implementing Precision Medicine: The Ethical Challenges. Trends in pharmacological sciences, 38(1), 8–14. https://doi.org/10.1016/j.tips.2016.11.007 Haga, S. B., & Mills, R. (2016). A review of consent practices and perspectives for pharmacogenetic testing. Pharmacogenomics, 17(14), 1595–1605. https://doi.org/10.2217/pgs-2016-0039 Krebs, K., & Milani, L. (2019). Translating pharmacogenomics into clinical decisions: do not let the perfect be the enemy of the good. Human genomics, 13(1), 39. https://doi.org/10.1186/s40246-019-0229-z Moon, J. Y., Franchi, F., Rollini, F., Rivas Rios, J. R., Kureti, M., Cavallari, L. H., & Angiolillo, D. J. (2018). Role of genetic testing in patients undergoing percutaneous coronary intervention. Expert review of clinical pharmacology, 11(2), 151–164. https://doi.org/10.1080/17512433.2017.1353909 De Spiegelaere, W., Philippé, J., Vervisch, K., Verhofstede, C., Malatinkova, E., Kiselinova, M., Trypsteen, W., Bonczkowski, P., Vogelaers, D., Callens, S., Ruelle, J., Kabeya, K., De Wit, S., Van Acker, P., Van Sandt, V., Emonds, M. P., Coucke, P., Sermijn, E., & Vandekerckhove, L. (2015). Comparison of methods for in-house screening of HLA-B*57:01 to prevent abacavir hypersensitivity in HIV-1 care. PloS one, 10(4), e0123525. https://doi.org/10.1371/journal.pone.0123525 Marissa, Thanks for sharing your post with us, and I appreciate the inclusion of your work experience. This discussion certainly is in your wheelhouse! As we are learning this week, genetic testing can be a very valuable tool in achieving ideal outcomes for our patients, and, as our discussion pinpoints, avoiding serious adverse effects. I also see cost as a significant limitations; until we are able to prove cost-effectiveness we are going to have trouble getting insurance companies to cover it. This is the aspect of health care that tends to frustrate me; taking a look at this clopidogrel example, I doubt that anyone would argue that paying for the genetic test would cost far less than what the insurance company is going to pay out to cover the treatment needed for a repeat MI. And that's just the tangible costs of care. But, I digress a bit there. As it relates to prescribing, until genetic testing becomes more mainstream (which I do believe is on the horizon), knowing in general which ethnic groups are more likely to have these genetic variations is going to help us prescribe medications more safely. Lezlee Dr. Fankie, I also believe pharmacokinetic testing in on the rise. Therefore, it is up to us as providers to seek out key stakeholders. It's essential that all patients qualify for a genetic test, not just those patients that will be receiving chemo or HIV therapy. Not only will patent's have the best possible outcomes with their medication regimen, but It will also allow providers to develop a more accurate medication regimen. From a cost standpoint, studies have shown that patients who participated in pharmacokinetic testing saved $1035.60 over a year in prescription medications (Krebs, & Milani, 2019). So while it seems like it would be a monetary burden for insurance companies and patients, in the long run, it would save both parties money, and improve the patient's plan of care. Krebs, K., & Milani, L. (2019). Translating pharmacogenomics into clinical decisions: do not let the perfect be the enemy of the good. Human genomics, 13(1), 39. https://doi.org/10.1186/s40246-019-0229-z [Show More]

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