Artificial intelligence, medications, pharmacogenomics, and ethics.

Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing various scientific and clinical disciplines including pharmacogenomics (PGx) by enabling the analysis of complex datasets and the development of predictive models. The integration of AI and ML with PGx has the potential to provide more precise, data-driven insights into new drug targets, drug efficacy, drug selection, and risk of adverse events. While significant effort to develop and validate these tools remain, ongoing advancements in AI technologies, coupled with improvements in data quality and depth is anticipated to drive the transition of these tools into clinical practice and delivery of individualized treatments and improved patient outcomes.

Characterization of Research Support of Genome Editing Technologies and Transition to Clinical Trials.

Genome editing technologies have become widely used research tools. To assess the rate of growth with respect to federal funding of gene editing projects, we analyzed publicly available data retrieved from the NIH RePORTER and Clinicaltrials.gov databases.

Pharmacogenetic testing in primary care could bolster depression treatment: A value proposition.

Pharmacogenetic testing could reduce the time to identify a safe and effective medication for depression; however, it is underutilized in practice. Major depression constitutes the most common mental disorder in the US, and while antidepressant therapy can help, the current trial -and error approach can require patients to endure multiple medication trials before finding one that is effective. Tailoring the fit of pharmacogenetic testing with prescribers' needs across a variety of settings could help to establish a generalizable value proposition to improve likelihood of adoption.

Assessment of the current status of real-world pharmacogenomic testing: informed consent, patient education, and related practices.

The practice of informed consent (IC) for pharmacogenomic testing in clinical settings varies, and there is currently no consensus on which elements of IC to provide to patients. This study aims to assess current IC practices for pharmacogenomic testing. An online survey was developed and sent to health providers at institutions that offer clinical germline pharmacogenomic testing to assess current IC practices.

The Critical Role of Pharmacists in the Clinical Delivery of Pharmacogenetics in the U.S.

Since the rebirth of pharmacogenomics (PGx) in the 1990s and 2000s, with new discoveries of genetic variation underlying adverse drug response and new analytical technologies such as sequencing and microarrays, there has been much interest in the clinical application of PGx testing. The early involvement of pharmacists in clinical studies and the establishment of organizations to support the dissemination of information about PGx variants have naturally resulted in leaders in clinical implementation. This paper presents an overview of the evolving role of pharmacists, and discusses potential challenges and future paths, primarily focused in the U.

Expanding Family Health History to Include Family Medication History.

The collection of family health history (FHH) is an essential component of clinical practice and an important piece of data for patient risk assessment. However, family history data have generally been limited to diseases and have not included medication history. Family history was a key component of early pharmacogenetic research, confirming the role of genes in drug response.

A Mixed-Methods Protocol to Identify Best Practices for Implementing Pharmacogenetic Testing in Clinical Settings.

Using a patient's genetic information to inform medication prescriptions can be clinically effective; however, the practice has not been widely implemented. Health systems need guidance on how to engage with providers to improve pharmacogenetic test utilization. Approaches from the field of implementation science may shed light on the complex factors affecting pharmacogenetic test use in real-world settings and areas to target to improve utilization.

A Systematic Review of the Scope of Study of mHealth Interventions for Wellness and Related Challenges in Pediatric and Young Adult Populations.

Background: Despite the purported advantages and potential efficacy of mHealth interventions to promote wellness in children, adolescents, and young adults, it is not clear what areas have been explored and the challenges reported in the biomedical literature.

Methods: We conducted a scoping review of publications between 2015 and 2019.

Results: We identified 54 papers that met our inclusion criteria.

Revisiting Secondary Information Related to Pharmacogenetic Testing.

Incidental or secondary findings have been a major part of the discussion of genomic medicine research and clinical applications. For pharmacogenetic (PGx) testing, secondary findings arise due to the pleiotropic effects of pharmacogenes, often related to their endogenous functions. Unlike the guidelines that have been developed for whole exome or genome sequencing applications for management of secondary findings (though slightly different from PGx testing in that these refer to detection of variants in multiple genes, some with clinical significance and actionability), no corresponding guidelines have been developed for PGx clinical laboratories.

Evaluating Primary Care Providers' Readiness for Delivering Genetic and Genomic Services to Underserved Populations.

Introduction: Increased genomics knowledge and access are advancing precision medicine and care delivery. With the translation of precision medicine across health care, genetics and genomics will play a greater role in primary care services. Health disparities and inadequate representation of racial and ethnically diverse groups threaten equitable access for those historically underserved.

Independent Community Pharmacists' Experience in Offering Pharmacogenetic Testing.

Objective: This study assessed pharmacist experiences with delivering pharmacogenetic (PGx) testing in independent community pharmacies.

Methods: We conducted a cluster randomized trial of independent community pharmacies in North Carolina randomized to provide either PGx testing as a standalone service or integrated into medication therapy management (MTM) services. Surveys and pharmacist data about the delivery of PGx testing were collected.

Delivery of Pharmacogenetic Testing with or without Medication Therapy Management in a Community Pharmacy Setting.

Objective: The delivery of pharmacogenetic (PGx) testing has primarily been through clinical and hospital settings. We conducted a study to explore the feasibility of delivering PGx testing through community pharmacies, a less-studied setting.

Methods: We conducted a cluster randomized trial of community pharmacies in North Carolina through two approaches: the provision of PGx testing alone or PGx testing with medication therapy management (MTM).

The Potential Benefit of Expedited Development and Approval Programs in Precision Medicine.

Background: Increased understanding of the molecular causes of disease has begun to fulfill the promise of precision medicine with the development of targeted drugs, particularly for serious diseases with unmet needs. The drug approval regulatory process is a critical component to the continued growth of precision medicine drugs and devices. To facilitate the development and approval process of drugs for serious unmet needs, four expedited approval programs have been developed in the US: priority review, accelerated approval, fast track, and breakthrough therapy programs.

Individualizing pharmacogenomic test results in the context of the microbiome.

The field of pharmacogenetic testing was hailed as one of the early successful clinical applications arising from the personalized (or precision) medicine revolution. Substantial progress has been made to identify genes and genetic variants involved in drug response and establish clinical implementation programs. Yet, drug response is a complex trait and recent work has highlighted the key role played by the gut microbiome.

Toward digital-based interventions for medication adherence and safety.

Introduction: Adherence to the prescribed use of medications is a major problem for many patients. Whether intentional or unintentional, the failure to take medications as prescribed results in an array of health problems, hospitalizations, and increased health expenditures.

Areas Covered: The paper reviews the different types of interventions to promote the appropriate use of medications from provider-based to digital-based interventions.

The enduring importance of family health history in the era of genomic medicine and risk assessment.

Improving disease risk prediction and tailoring preventive interventions to patient risk factors is one of the primary goals of precision medicine. Family health history is the traditional approach to quickly gather genetic and environmental data relevant to the patient. While the utility of family health history is well-documented, its utilization is variable, in part due to lack of patient and provider knowledge and incomplete or inaccurate data.

Promoting Wellness Through Mobile Health Technology in a College Student Population: Protocol Development and Pilot Study.

Background: The health and well-being of college students has garnered widespread attention and concern in recent years. At the same time, the expansion and evaluation of digital technologies has grown in recent years for different target populations.

Objective: This protocol aims to describe a pilot feasibility study on wearables to assess student interest and to gather baseline data from college freshmen, for the academic year 2019 to 2020.

Pharmacogenomic Testing In Pediatrics: Navigating The Ethical, Social, And Legal Challenges.

For the past several years, the implementation of pharmacogenetic (PGx) testing has become widespread in several centers and clinical practice settings. PGx testing may be ordered at the point-of-care when treatment is needed or in advance of treatment for future use. The potential benefits of PGx testing are not limited to adult patients, as children are increasingly using medications more often and at earlier ages.

Awareness of family health history in a predominantly young adult population.

Family health history (FHH) is a key predictor of health risk and is universally important in preventive care. However, patients may not be aware of the importance of FHH, and thus, may fail to accurately or completely share FHH with health providers, thereby limiting its utility. In this study, we conducted an online survey of 294 young adults and employees based at a US university setting regarding their knowledge, sharing behaviors, and perceived importance of FHH, and use of electronic clinical tools to document and update FHH.

A stepwise approach to implementing pharmacogenetic testing in the primary care setting.

Pharmacogenetic testing can help identify primary care patients at increased risk for medication toxicity, poor response or treatment failure and inform drug therapy. While testing availability is increasing, providers are unprepared to routinely use pharmacogenetic testing for clinical decision-making. Practice-based resources are needed to overcome implementation barriers for pharmacogenetic testing in primary care.

Clinical Utilization of Pharmacogenetics in Psychiatry - Perspectives of Pharmacists, Genetic Counselors, Implementation Science, Clinicians, and Industry.

Introduction: The use of pharmacogenomic (PGx) testing to guide decisions and improve patient outcomes has increased in recent years. PGx testing represents a decision support tool that may inform dosing, increase the likelihood of treatment response, and identify patients at risk for medication side effects.

Methods: This is a narrative review of utilization of PGx testing in psychiatry from stakeholders including, pharmacists, genetic counselors, implementation scientists, industry, and clinicians.

Access to Genetic Counselors in the Southern United States.

The expansion of genetic and genomic testing across medical specialties and the changing workforce demographics of certified genetic counselors (CGCs) have led to concerns of a workforce shortage. We assessed the number of genetic counselors working in the Southern United States-a rural and medically underserved region-using various online and professional resources. We identified 683 practicing genetic counselors across the Southern U.

Pharmacogenomics courses in pharmacy school curricula.

The appropriate use and integration of pharmacogenetic (PGx) testing will pivot on provider preparation and training. Pharmacists have been recognized as one of the key providers in the delivery of PGx testing and as such, professional organizations have recommended inclusion of PGx content in pharmacy curricula. We reviewed the curriculum of 132 US pharmacy schools for information about PGx courses.