The potential impact of pharmacogenetic testing on medication adherence

Haga, Susanne B.; LaPointe, Nancy M. Allen

doi:10.1038/tpj.2013.33

Cited by 61 publications

(37 citation statements)

References 27 publications

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“…Thus, analysis of particular genetic variants through PGx testing may help optimize pharmaceutical therapy by identifying patients with these polymorphisms and better informing the selection of the proper drug and dosage and reducing risk of ADRs. The substantial healthcare costs associated with ADRs [5–8], the increasing use of prescription drugs in the USA [9] and other potential benefits of PGx testing such as increased medication adherence [10,11] provide further support for the use of PGx testing to personalize care.…”

Section: Introductionmentioning

confidence: 99%

Pilot Study of Pharmacist-Assisted Delivery of Pharmacogenetic Testing in a Primary Care Setting

et al. 2014

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Aim To describe the rationale and design of a pilot program to implement and evaluate pharmacogenetic (PGx) testing in a primary care setting. Study rationale Several factors have impeded the uptake of PGx testing, including lack of provider knowledge and challenges with operationalizing PGx testing in a clinical practice setting. Study design We plan to compare two strategies for the implementation of PGx testing: a pharmacist-initiated testing arm compared with a physician-initiated PGx testing arm. Providers in both groups will be required to attend an introduction to PGx seminar. Anticipated results We anticipate that providers in the pharmacist-initiated group will be more likely to order PGx testing than providers in the physician-initiated group. Conclusion Overall, we aim to generate data that will inform an effective delivery model for PGx testing and to facilitate a seamless integration of PGx testing in primary care practices.

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Section: Introductionmentioning

confidence: 99%

Pilot Study of Pharmacist-Assisted Delivery of Pharmacogenetic Testing in a Primary Care Setting

et al. 2014

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“…It becomes part of their personal medical history to be shared with healthcare professionals. If the use of a patient's pharmacogenetic information improves their chance of a good clinical response, or reduces their side effects and improves tolerability, then the patient is more likely to take their medication, with compliance being crucial to positive treatment outcomes [11]. It seems inevitable that pharmacogenetics and its core role in personalized medicine will become the standard of care in the future.…”

Section: Editorialmentioning

confidence: 99%

Proposed FDA Regulation of Clinical Laboratories and Clinical Implementation of Pharmacogenetics

Massey¹

2017

PPIJ

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Submit Manuscript | http://medcraveonline.com of very different attributes among the different types of genetic tests. An understanding of the differences between these tests allows one to stratify them according to the degree of scientific evidence supporting their utility, as well as the degree of risk they pose to public safety.It is in the interest of public safety that any test that is used to make medical decisions be accurate and FDA is justifiably concerned regarding the potential harm an inaccurate genetic test result could cause. The draft guidance outlining FDA's proposed regulatory framework for oversight of LDTs acknowledges that the risks posed by the wide varieties of LDTs varies greatly, and the proposed regulatory framework is based on the degree of risk that a particular LDT presents, i.e. a risk-based approach [1]. This is a well-reasoned approach that is consistent with FDA's responsibilities to protect the public health while the regulatory framework is being developed and implemented, without denying access to this information to patients during this implementation period. While there are a wide range of risk levels associated within any of the classes of genetic tests, it is generally recognized that genetic tests that diagnose a disease or risk of disease, especially if the disease is potentially life-threatening, pose a greater risk to the public due to a false result because of the harmful actions that may be taken, or beneficial actions which may not be taken, based on the inaccurate test result (e.g. inaccurate ovarian cancer diagnosis leading to unneeded major medical procedures [2] misdiagnosis and lack of care in the case of a false negative result for HER2 breast cancer [3] etc.). In contrast, genetic information that can help inform the patient (and healthcare provider) about their genetic predisposition for an array of drug metabolizing enzymes poses much less risk, as it does not result in unnecessary treatment, does not put the patient at risk of undergoing unnecessary medical treatment, or just as troubling, does not result in the patient not receiving treatment due to false negative misdiagnosis. These differences in the potential harm that can result from inaccurate test results makes pharmacogenetic tests much safer, from a public health standpoint, than the above-mentioned genetic tests for cancer (disease) diagnosis.In an FDA assessment of any LDT, the potential benefit of the test must also be taken into account so that the relative risk or risk-benefit relationship can be considered in the context of current medical practice. The clinical benefit of pharmacogenetics is explicitly stated by FDA on its own website, where a list of pharmacogenetic markers that appear in the FDA-approved prescribing information of over 100 drugs is posted [4]. FDA provides information that suggests that adverse drug reactions are the 4th leading cause of death in the US, cost the nation billions of dollars annually, and that the majority of these adverse drug reactions have a genetic basis...

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“…A study has shown that pharmacogenetic testing may serve as another tool to boost patients' confi dence in the safety and effi cacy of prescribed medications (Haga and LaPointe 2013 ). It has a positive impact on medication-taking behavior and reduces non-compliance which is well-known in patients with chronic conditions, and is associated with signifi cant morbidity, mortality and health-care costs.…”

Section: Role Of Patientsmentioning

confidence: 99%

Textbook of Personalized Medicine

Jain¹

2015

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The potential impact of pharmacogenetic testing on medication adherence

Cited by 61 publications

References 27 publications

Pilot Study of Pharmacist-Assisted Delivery of Pharmacogenetic Testing in a Primary Care Setting

Pilot Study of Pharmacist-Assisted Delivery of Pharmacogenetic Testing in a Primary Care Setting

Proposed FDA Regulation of Clinical Laboratories and Clinical Implementation of Pharmacogenetics

Textbook of Personalized Medicine

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