Clinical Utility of Applying PGx and Deprescribing-Based Decision Support in Polypharmacy

Polypharmacy is a necessary and important aspect of drug treatment; however, it becomes a challenge when the medication risks outweigh the benefits for an individual patient. Drug–drug interactions and the introduction of prescribing cascades are common features of polypharmacy, which can lead to ineffectiveness and increased risk of adverse drug reactions (ADR). Genes encoding CYP450 isozymes and other drug-related biomarkers have attracted considerable attention as targets for pharmacogenetic (PGx) testing due to their impact on drug metabolism and response. This Special Issue is devoted to explore the status and initiatives taken to circumvent ineffectiveness and to improve medication safety for polypharmacy patients. Specific areas include drug–drug interactions and consequences thereof in therapeutic management, including PK- and PD-profiling; the application of PGx-based guidance and/or decision tools for drug–gene and drug–drug gene interactions; medication reviews; development and application of deprescribing tools; and drivers and barriers to overcome for successful implementation in the healthcare system

EQUITABLE PHARMACOGENETIC TESTING IMPLEMENTATION FOR RURAL AND UNDERSERVED POPULATIONS

Pharmacogenetic testing has potential to transform healthcare, yet implementation strategies have been limited to major academic medical centers serving metropolitan communities and large health systems. In contrast, rural, community-based health systems are slow to implement these advances, threatening to exacerbate existing healthcare disparities for rural populations. A majority of Montanans live in rural areas, with unique challenges in providing access to pharmacogenetics. We have established partnerships with three clinical sites who serve rural, underserved populations including American Indian, pediatric, and low socioeconomic status patients. We conducted a needs assessment for pharmacogenetic testing implementation by interviewing 48 key stakeholders. Interview questions were centered around participants opinions regarding pharmacogenetics and their perceived barriers and facilitators for implementation of testing. A codebook was created by analysis and organization of common themes. Positive opinions on using pharmacogenetics to guide therapy were common. Perceived benefits included reduced time to symptom management, fewer adverse events, and improved adherence. Concerns expressed in similar studies based in larger medical centers were also present, including conflicts with reimbursement and test turnaround time. Unique concerns for vulnerable, underserved populations included equitable access based on socioeconomic status and sensitivity to culture and historical injustices, particularly for tribal people. Participants were enthusiastic about using telehealth to implement pharmacogenetics in these communities. This will provide an innovative strategy for pharmacogenetic testing and consultations. Participants were eager to implement testing in their facilities. Many concerns can be mitigated with a strategic implementation plan targeted for underserved patients. Our model will implement pharmacogenetics using a telehealth delivery model centered at the University of Montana with outreach to rural health systems and providers. This has the potential to expand as new health innovations are translated into practice. Future work in this area will involve assisting partner sites with implementation efforts and measuring clinical outcomes related to testing services. Our study will help overcome the unique challenges in delivering pharmacogenetics to rural and underserved communities and we aim to provide a model for states with similar patient populations. Our goal is to pave the way for equitable access to pharmacogenetics for all

Pharmacy Practice and Administration

The scope of the Special Issue is research and reviews on evaluations of current practice, innovations in medication management, developments in therapeutics, and pharmaceutical science research that informs and improves practice and administration, as well as the social and administrative pharmacy. We will mainly feature original research, reviews, short reports, and clinical studies, but also case reports, descriptive/how-to, and commentary submissions for consideration

Understanding exposure to pharmacogenetically actionable opioids in primary care

Indiana University-Purdue University Indianapolis (IUPUI)Pharmacogenetic testing has the potential to improve pain management through addressing wide interindividual variations in responses to pharmacogenetically actionable opioids, ultimately decreasing costly adverse drug effects and improving responses to these medications. A recent review of pharmacogenomics in the nursing literature highlighted the need for nurses to more fully embrace the burgeoning field of pharmacogenomics in nursing research, clinical practice, and education. Despite the promise of pharmacogenetic testing, significant challenges exist for evaluating outcomes related to its implementation, including oversimplification of medication exposure, the complexity of patients' clinical profiles, and the characteristics of healthcare contexts in which medications are prescribed. A better understanding of these challenges could enhance the assessment and documentation of the benefits of pharmacogenetic testing in guiding opioid therapies. This dissertation is intended to address the challenges of evaluating outcomes of pharmacogenetic testing implementation and the need for nurses to lead pharmacogenomic-related research. The dissertation purpose was to advance the sciences of nursing, pain management, and pharmacogenomics through the development of a typology of common patterns of medication exposure to known pharmacogenetically actionable opioids (codeine & tramadol). A qualitative, person-oriented approach was used to retrospectively analyze six months of electronic health record and pharmacogenotype data in 30 underserved adult patients. An overarching typology with eight groups of patients that had one of five opioid prescription patterns (singular, episodic, switching, sustained, or multiplex) and one of three types of medical emphasis of care (pain, comorbidities, or both) were identified. This typology consisted of a description of multiple common patterns that compare and contrast salient factors of exposure and the emphasis of why individuals were seeking care. Furthermore, in an aggregate descriptive analysis evaluating key clinical profile factors, these patients had complex medical histories, extensive healthcare utilization, and experienced significant polypharmacy. These findings can aid in addressing challenges related to the implementation of pharmacogenetic testing in clinical practice and point to ways in which nurses can take the lead in pharmacogenomics research. Findings also provide a foundation for future studies aimed at developing medication exposure measures to capture its dynamic nature and identifying and tailoring interventions in this population

Pharmacogenomics

This Special Issue focuses on the current state of pharmacogenomics (PGx) and the extensive translational process, including the identification of functionally important PGx variation; the characterization of PGx haplotypes and metabolizer statuses, their clinical interpretation, clinical decision support, and the incorporation of PGx into clinical care

Precision Medicine

This colligated Special Issue of Pharmaceutics on Precision Medicine: Applied Concepts of Pharmacogenomics in Patients with Various Diseases and Polypharmacy offers to the reader a series of articles that describe the concept of Precision Medicine, discuss its implementation process and limitations, demonstrate its value by illustrating some clinical cases, and open the door to new and more sophisticated techniques and applications

How real-world data can facilitate the development of precision medicine treatment in psychiatry

Precision medicine has the ambition to improve treatment response and clinical outcomes through patient stratification, and holds great potential in mental disorders. However, several important factors are needed to transform current practice into a “precision psychiatry” framework. Most important are (1) the generation of accessible large real-world training and test data including genomic data integrated from multiple sources, (2) the development and validation of advanced analytical tools for stratification and prediction, and (3) the development of clinically useful management platforms for patient monitoring that can be integrated into healthcare systems in real-life settings. This narrative review summarizes strategies for obtaining the key elements – well-powered samples from large biobanks, integrated with electronic health records and health registry data using novel artificial intelligence algorithms – to predict outcomes in severe mental disorders and translate these models into clinical management and treatment approaches. Key elements are massive mental health data and novel artificial intelligence algorithms. For the clinical translation of these strategies, we discuss a precision medicine platform for improved management of mental disorders. We include use cases to illustrate how precision medicine interventions could be brought into psychiatry to improve the clinical outcomes of mental disorders

Payer Perspectives On Preemptive Pharmacogenetic Testing

Purpose: As preemptive pharmacogenetics expands in the academic healthcare setting, further study is needed to assess the views of additional stakeholders in the marketplace on this technology and the barriers and facilitators to their uptake. The purpose of this study is to investigate the perspectives and opinions about coverage policies for preemptive pharmacogenetic testing of third-party payers. Methods: A qualitative study utilizing a blended inductive and directed approach was conducted. A screener survey determined interview eligibility as well as demographic data. Semi-structured interviews were conducted with payers from organizations of varying structure and beneficiary populations. Meaning units and codes were used for each interview and aggregated to identify the subthemes and major themes. Results: A total of 14 payers were interviewed, covering 122,000,000 million lives, or almost 40% of the U.S. population. Positive and negative opinions were noted. Most positive opinions were prefaced with a position that pharmacogenetics held great potential for the healthcare system, but that full implementation was several years away. The work of the Clinical Pharmacogenetics Implementation Consortium (CPIC) and the Pharmacogenomics Research Network (PGRN) was viefavorably. However, this would not drive policy decisions. Negative opinions came from a concern of the lack of data that would make these tests actionable for a payer from a policy development point of view. Concerns about the cost of testing large numbers of people was mentioned frequently, as well as the inability to predict when a patient or physician would use the data from a test or potential cost savings from the technology. Discussion: Preemptive pharmacogenetic testing remains a cautious pursuit for many payers. Lacking clinical outcomes data, the inability to evaluate the economic benefits from testing, and high costs are a few central concerns. Real-world implementations from academic institutions and the work of CPIC were seen as promising endeavors. The research community of pharmacogenetic advocates should review this study and focus their efforts on providing the data needed to guide informed policy decision making with regard to pharmacogenetic testing

Tackling overprescribing

Long overdue with a lot to d