Asynchronous consult report generation for pharmacogenomic clinical support: Time and motion.

As pharmacogenomic (PGx) testing becomes more commonplace in clinical practice, appropriate application of laboratory data to all relevant medications becomes necessary to maximize PGx value. However, many clinicians lack PGx knowledge and confidence, so prescribers may appreciate clinical support when applying PGx data to a patient's entire medication list. Pharmacists routinely provide PGx consult support, and asynchronous written consults may improve logistical simplicity, but specific process steps and time expectations are less settled. Four pharmacists produced written consult reports for 18 patient cases across three rounds of review. Discussion took place before each of the three rounds to drive consensus in steps, process, and resources used. Time per process step was tracked in the third round. Asynchronous written PGx consult reports generally required less than 30 min to generate if no more than 2 medications had PGx-based guidance, but that time more than doubled when more medications require PGx-based guidance. After three rounds of review, pharmacists found consensus regarding an optimal workflow for generating a PGx consult. Findings from this study may support pharmacist training, practice management, and expectation management for asynchronous written PGx consult development.

COVID-19 host genetic risk study conducted at community pharmacies: Implications for public health, research and pharmacists' scope of practice.

Community pharmacists serve a large, diverse population of patients, resulting in the potential to utilize community pharmacies as recruitment sites for clinical research. Beyond traditional roles as one of the most accessible health care professionals in the US healthcare system, pharmacists have played a major role in the response to the COVID-19 pandemic, administering hundreds of thousands of vaccines and tests. However, less emphasis is placed on the ability to leverage community pharmacies as research-focused partners for clinical studies. In this study, we demonstrate the feasibility and workflow of recruiting study participants from community pharmacies and confirm genetic markers of COVID-19 susceptibility. Specific genetic markers include those associated with COVID-19 infection risk (ACE2, TMEM27, and RAVER1), difficulty breathing (NOTCH4), and hospitalization (OAS3). In addition, collaboration with a clinical laboratory allowed for a more seamless consenting process without substantial training needs or workflow disruption at the community pharmacy site. The COVID-19 pandemic has demonstrated that the expansion of pharmacists' scope of practice is a key factor in managing the population health crisis; this study demonstrates that pharmacies can also advance clinical research studies by serving as sites for patient recruitment from a large, diverse, and ambulatory study population.

Development and Initial Evaluation of an Advanced Pharmacy Practice Experience Readiness Assessment Plan.

Objective. To describe the composition of an advanced pharmacy practice experience (APPE) readiness assessment plan (APPE-RAP) along with initial findings following retrospective application to a cohort of students.Methods. The APPE-RAP uses existing summative assessment data within the ExamSoft platform on six skills and 12 ability-based outcomes from the pre-APPE curriculum. Thresholds were created to sort students into three readiness categories for skills and knowledge, determine overall readiness, and identify need for curricular review. Students that completed their third professional year in spring 2021 served as the pilot cohort. The APPE-RAP was applied after the cohort progressed to APPEs to analyze appropriateness of categorization and revise the plan before full implementation.Results. The APPE-RAP was applied to 131 students that progressed to APPEs in spring 2021. Overall, 87.9% were APPE ready for all skills and aggregate knowledge. Two skills met criteria for curricular review. Seven students (5.3%) were categorized as red on at least one skill after one remediation attempt. Nine students (7%) were categorized as red on an aggregate knowledge-based ability-based outcomes (ABO) evaluation. Four students (3.1%) did not pass one of their first two experiential rotations. Using a red categorization on aggregate knowledge as a risk indicator identified APPE failure with 94% specificity and a 98% negative predictive value.Conclusion. Existing assessment data may be leveraged to identify assessment targets to help quantify APPE readiness. Further research is warranted to identify additional assessment thresholds that enhance quantification of APPE readiness as well as the impact of focused remediation on attainment of APPE readiness.

Viability of Virtual Skills-based Assessments Focused on Communication.

Objective To evaluate faculty and student perceptions of and performance on virtual skills-based assessments focused on communication compared to in-person assessments.Methods In spring 2020, virtual skills-based assessments were conducted. After all assessments were completed, two 12-item questionnaires, one for students and one for the faculty members who conducted the assessment, were designed to assess perceptions of virtual skills-based assessments. The surveys were distributed via an online platform to second- and third-year (P2 and P3) pharmacy students and to faculty who had participated in a virtual skills-based assessment. Scores from the spring 2020 virtual skills-based assessment were compared to scores on the in-person skills-based assessment that took place in spring 2019.Results Of the 19 faculty and 279 students invited to participate, 18 (94.7%) faculty and 241 (86.4%) students responded. The majority of faculty (88.9%) and students (63.5%) perceived the virtual skills-based assessments to be effective at simulating an interaction. However, only 33.3% of faculty and 28.6% of students preferred the virtual environment. There was not a significant difference in student performance between in-person and virtual assessments for patient consultation and SOAP note skills.Conclusion Providing sufficient formative and summative feedback to pharmacy students is a challenge, particularly in the context of skills-based assessments. Students and faculty reported that the virtual assessment provided an opportunity for an appropriate assessment of student communication skills. However, a strong preference for using virtual skills-based assessments in the future was not observed.

Engaging pharmacogenomics in pain management and opioid selection.

Opioid misuse and mismanagement has been a public health crisis for several years. Pharmacogenomics (PGx) has been proposed as another tool to enhance opioid selection and optimization, with recent studies demonstrating successful implementation and outcomes. However, broad engagement with PGx for opioid management is presently limited. The purpose of this article is to highlight a series of barriers to PGx implementation within the specific context of opioid management. Areas of advancement needed for more robust pharmacogenomic engagement with opioids will be discussed, including clinical and economic research needs, education and training needs, policy and public health considerations, as well as legal and ethical issues. Continuing efforts to address these issues may help to further operationalize PGx toward improving opioid use.

Pharmacogenomics in the United States Community Pharmacy Setting: The Clopidogrel-CYP2C19 Example.

Pharmacogenomics (PGx) is expanding across health-care practice settings, including the community pharmacy. In the United States, models of implementation of PGx in the community pharmacy have described independent services and those layered on to medication therapy management. The drug-gene pair of clopidogrel-CYP2C19 has been a focus of implementation of PGx in community pharmacy and serves as an example of the evolution of the application of drug-gene interaction information to help optimize drug therapy. Expanded information related to this drug-gene pair has been provided by the US Food and Drug Administration and clinical PGx guidelines have and continue to be updated to support clinical decision-making. Most recently direct-to-consumer (DTC) PGx has resulted in patient generated sample collection and submission to a genetic testing-related company for analysis, with reporting of genotype and related phenotype information directly to the patient without a health-care professional guiding or even being involved in the process. The DTC testing approach needs to be considered in the development or modification of PGx service models in the community pharmacy setting. The example of clopidogrel-CYP2C19 is discussed and current models of PGx implementation in the community pharmacy in the United States are presented. New approaches to PGx services are offered as implementation continues to evolve and may now include DTC information.

Retrospective evaluation of preconception care opportunities in a chain community pharmacy setting.

OBJECTIVES: Certain prescription medications should be avoided during pregnancy to reduce the risk of fetal harm. Identification of these medications to minimize exposure may be achieved through the integration of preconception care recommendations into medication therapy management (MTM) services. The primary objective of this study was to identify missed opportunities for pharmacists to provide preconception care support related to medications associated with adverse pregnancy outcomes for reproductive-aged women who received MTM consultations at a regional supermarket pharmacy chain. Secondary objectives examined the concurrent use of prenatal vitamins, folic acid, or hormonal contraception in patients receiving medications associated with adverse pregnancy outcomes. METHODS: The study examined all MTM and prescription drug claims submitted by a regional chain of supermarket pharmacies from January 1, 2018 to June 30, 2019, to identify female patients aged 15-45 years who received MTM services. Prescription claims were cross-referenced to determine which of these patients also received medications associated with adverse pregnancy outcomes. To identify patients with long-term use of opioids and nonsteroidal anti-inflammatory drugs, a restriction based on days supplied was then applied. RESULTS: Of the 2020 female patients who received MTM services and filled at least 1 prescription during the study period, 731 (36.2%) were found to have received at least 1 medication associated with adverse pregnancy outcomes for the minimal days' threshold. Of these, 509 (69.6%) lacked evidence of concurrent prescription contraception, and 74 (10.1%) had a concurrent prescription for folic acid or prenatal vitamins. CONCLUSION: The use of medications associated with adverse pregnancy outcomes was widespread in this sample of reproductive-aged women. The findings of this study indicate the need for additional research to investigate the implementation of targeted MTM interventions to build standard workflow processes and facilitate pharmacists' management of this critical clinical issue.

Assessing the Validity and Reliability of the Pharmacist Interprofessional Competencies Tool.

Objective. To determine the validity and reliability of the Pharmacist Interprofessional Competencies Tool (PICT). Methods. Faculty members at Ferris State University, College of Pharmacy developed the PICT, which has five interprofessional criterion (collaboration, ownership, respect, engagement, and application) and four competency levels (unacceptable, novice, competent, and proficient) to assess the interprofessional competencies of pharmacy students. Fourteen pharmacy faculty members were trained in how to use the PICT and then used it to assess students' behaviors in four to six video-recorded interprofessional education (IPE) learning activities. A subset of these faculty members evaluated the video-recorded IPE learning activities using two other previously validated interprofessional assessment tools. Psychometric analysis of the PICT, including internal consistency and inter-rater reliability, was conducted, along with a correlation analysis and factor analysis, and the results were compared to those from the other validated assessment tools. Results. The overall rating of the internal consistency of the PICT was excellent and item-total correlations of the individual criterion were fair to good, with the exception of the respect criterion. The PICT demonstrated excellent overall inter-rater reliability, and individual criterion rated as fair to excellent with the exception of the respect criterion. Specific dimensions of the PICT showed high convergence with previously validated interprofessional assessment tools. Conclusion. The PICT exhibited overall validity and reliability as an assessment tool for measuring the interprofessional competencies of pharmacy students. In establishing the overall validity and reliability of the assessment tool, the respect criterion was not proved to be reliable or valid. Additional training and slight modifications to the PICT and associated IPE learning activities are planned to assist with longitudinal assessment of student performance across the curriculum.

An initial environmental scan of APPE readiness assessment.

INTRODUCTION: Standards 2016 require schools/colleges of pharmacy (s/cop) to assess students' readiness to enter advanced pharmacy practice experiences (APPEs). However, literature describing how schools are meeting this standard is limited. The purpose of this study was to conduct an environmental scan to describe how s/cop assess student readiness to enter APPEs. METHODS: A web-based survey was distributed to assessment leads at United States s/cop, regardless of accreditation status. Respondents answered questions related to their current approach to assessing student APPE readiness, existence of intentional assessment plans, competencies used, assessment methods, benchmarks, and remediation strategies. Aggregate data were analyzed using descriptive statistics. RESULTS: Fifty-two S/COP (36.1%) responded. The majority (90.1%) were fully accredited schools. Most respondents have an intentional APPE readiness plan (73.5%), although the duration since implementation varied. There was no consensus among schools on which competencies informed APPE readiness with 67.3% listing Center for the Advancement of Pharmacy Education (CAPE) 2013 outcomes, 61.2% Guidance for Standards 2016 Appendix A, 53.1% pre-APPE domains (Standards 2007), and 30.6% Entrustable Professional Activities. Twenty-eight S/COP (57.1%) reported having individual student-level data to assess student APPE readiness. The most common methods for validating student APPE readiness were preceptor (48.9%) and student (44.9%) surveys. CONCLUSIONS: This environmental scan begins to identify trends in how S/COP is approaching the assessment of student readiness to begin APPEs. Further research is needed to identify best practices and practical methods to ensure compliance with current accreditation standards.

Pharmacogenomics: A Practical Primer for Senior Care Pharmacists.

Pharmacogenomics (PGx), the study of how an individual's genetic makeup affects his or her response to drugs, is a fast-growing field that gives health care providers a valuable tool to help safely and effectively manage medication. However, few providers have experience in applying the results of PGx tests to their practices, and this can lead to disregarding the data or unnecessarily modifying medication regimens. Pharmacists are uniquely positioned to become wellversed in the interpretation of PGx data, critically evaluating the "green-yellow-red" result categories that seemingly signal "go, caution, stop" regarding the use of a particular medication. Pharmacists also can evaluate genotype and phenotype information, commonly included in PGx laboratory reports, to optimize therapy. Using a case-based approach, this primer is intended to provide consultant pharmacists with practical direction to aid in PGx interpretation that will provide contextappropriate recommendations that contributes to positive patient outcomes.

Precision Pharmacotherapy: Integrating Pharmacogenomics into Clinical Pharmacy Practice.

Precision pharmacotherapy encompasses the use of therapeutic drug monitoring; evaluation of liver and renal function, genomics, and environmental and lifestyle exposures; and analysis of other unique patient or disease characteristics to guide drug selection and dosing. This paper articulates real-world clinical applications of precision pharmacotherapy, focusing exclusively on the emerging field of clinical pharmacogenomics. This field is evolving rapidly, and clinical pharmacists now play an invaluable role in the clinical implementation, education, and research applications of pharmacogenomics. This paper provides an overview of the evolution of pharmacogenomics in clinical pharmacy practice, together with recommendations on how the American College of Clinical Pharmacy (ACCP) can support the advancement of clinical pharmacogenomics implementation, education, and research. Commonalities among successful clinical pharmacogenomics implementation and education programs are identified, with recommendations for how ACCP can leverage and advance these common themes. Opportunities are also provided to support the research needed to move the practice and application of pharmacogenomics forward.

Highlighting a gap in student pharmacist training: Intraprofessional education with pharmacy technicians.

INTRODUCTION: The Accreditation Council for Pharmacy Education (ACPE) Accreditation Standards suggest integration and inclusion of interprofessional education in doctor of pharmacy programs. Although not directly mentioned by these Standards, intraprofessional education between student pharmacists and student pharmacy technicians may provide valuable preparation for comradery in practice. COMMENTARY: Given the prevalence of collaboration between pharmacists and pharmacy technicians in pharmacy practice, lack of intraprofessional education could be a vital gap in current programs. There have been previous calls within academic pharmacy and from key stakeholder groups for greater involvement of the profession in the training and education of pharmacy technicians, yet literature is sparse on successful models. This commentary includes a discussion of why intraprofessional training is vital, a brief commentary on example intraprofessional activities, as well as strategies for collaboration. IMPLICATIONS: A series of questions with the intention of evoking further conversations and awareness within academic pharmacy completes the commentary.

Interprofessional education through a telehealth team based learning exercise focused on pharmacogenomics.

BACKGROUND: Traditional interprofessional educational (IPE) exercises are those where learning exists "about, from, and with" trainees in two or more professions in order to prepare health sciences professionals to work on interprofessional teams. One emerging difficulty with IPE is the paucity of health profession students at single institutions, and the geographic and financial constraints of multi-institutional collaboration. INTERPROFESSIONAL EDUCATION ACTIVITY: To circumvent these barriers, we developed a multi-institution telehealth team-based learning (TBL) event between medical and pharmacy students on the topic of pharmacogenomics (PGx). Using a validated pre-post survey design, student attitudes and perceptions were measured before and after an educational intervention designed to simulate interprofessional telehealth collaboration. The survey results showed significant improvement across all areas of student attitudes toward interprofessional collaboration. Also, medical student PGx confidence increased substantially during the exercise even though the only PGx instruction they received was from pharmacy students. DISCUSSION: These data demonstrate that learning exists "about, from, and with" trainees in other professions, even if they do not physically train in the same location. Free tools are available to create virtual interactions between students on different campuses, and telehealth exercises using these tools are a valid way to conduct IPE across different campuses. The instructional experience does not need to be identical for all participants in the IPE event; rather, tailoring the educational experience to each group of students provides opportunities for inter-student teaching.

Pharmacist-Provided Pharmacogenetic Point-of-Care Testing Consultation Service: A Time and Motion Study.

Background: With recent advances in pharmacogenomics (PGx) comes the potential to customize medication use based on genetic data. Support for PGx has found practical limitations in terms of workflow and turnaround time of a test. However, with the expansion of point-of-care testing (POCT) in pharmacy practice models comes opportunity for PGx testing in the pharmacy setting. Objective: The purpose of this study is to quantify the amount of time spent during each step of a PGx POCT encounter in a community pharmacy setting. Methods: A time and motion study was conducted using a mock community pharmacy space for a simulated PGx-focused encounter to manage antiplatelet therapy following hospital discharge. PGx POCT was conducted using the Spartan RX instrument. Simulated patient encounters were divided into 7 categories. Time spent in each step, as well as total time spent, was tracked. Results: A total of 54 simulated PGx POCT encounters took place with an average time of 9.49 minutes (SD ± 1.38 minutes). Instrument run time adds 60 minutes to the total time required to obtain a result. Duties that could be performed by an appropriately trained pharmacy technician totaled 6.86 minutes. Conclusions: PGx POCT would require 9.49 minutes of pharmacy staff hands-on time for the encounter, which could be reduced to 2.64 minutes of pharmacist time with appropriate pharmacy technician involvement. Time requirements for PGx POCT are similar to that of community pharmacy-based immunizations. Future studies could explore how practice could change if PGx testing were routinely performed in the pharmacy.

Commentary: Should Pharmacogenomic Evidence Be Considered in Clinical Decision Making? Focus on Select Cardiovascular Drugs.

Despite advances in technology and guidelines from the Clinical Pharmacogenetics Implementation Consortium (CPIC) that focus on how to use pharmacogene test results, hurdles remain that have delayed the widespread application of pharmacogenomics in clinical practice. These hurdles include a lack of prospective randomized controlled trials to address the utility of pharmacogenomics on clinical outcomes, what the clinical algorithm for pharmacogenomics should be, and whether pharmacogenomics is cost-effective. However, the implementation of clinical practice guidelines, such as those from professional organizations, is commonplace and often termed the application of evidence-based medicine. Here, we draw an analogy between the evidence supporting many commonly cited clinical practice guidelines and U.S. Food and Drug Administration-approved labeling recommendations and the evidence supporting recommendations from CPIC. Although many clinical practice guideline recommendations are supported by the results of randomized controlled clinical trials, we cite examples of common clinical practices that are supported by levels and types of evidence similar to the evidence supporting many of the CPIC recommendations. Specifically, we discuss clinical recommendations for guidance related to drug-drug interactions, drug-gene interactions, therapeutic range selection, and dosage adjustments based on patient-specific factors within the context of a select set of cardiovascular therapeutic topics.

Use of targeted medication reviews to deliver preconception care: A demonstration project.

OBJECTIVES: To demonstrate the ability of a statewide network of community pharmacists to provide preconception care services with the use of targeted medication reviews (TMRs). Community pharmacists are well qualified and well positioned to assist in this public health priority; however, there are no documented case studies of pharmacists providing preconception care with the use of TMRs. METHODS: Through the demonstration project, pharmacists provided educational TMRs focused on 3 elements of preconception care to women aged 15 to 45 years enrolled in a nonprofit managed care plan: (1) medications that may cause fetal harm (category D/X); (2) folic acid use; and (3) immunizations. TMRs were generated and released to the individual pharmacy where that patient had prescriptions filled. Any practicing pharmacist in Ohio participating in the medication therapy management platform with a patient in the sample received a TMR notification. The pharmacists documented and billed for the service through this commercially available platform. RESULTS: Nineteen weeks after implementation of the TMRs, 1149 individual pharmacists from 818 different pharmacies had completed at least 1 TMR. Pharmacists completed 33% of all TMR opportunities with a 65% success rate. CONCLUSION: Establishing new services that were focused on preconception care resulted in rapid integration into existing medication therapy management processes in hundreds of pharmacies across Ohio. These results may help to provide justification for additional payers to reimburse for similar services. Through demonstrating the impact on preconception care, the role of the community pharmacist may continue to expand to include provision of additional preventive care services following the model developed in this initiative.

Provision of Clinical Preventive Services by Community Pharmacists.

Community pharmacists are highly accessible health care professionals, providing opportunities for partnerships with other health care and public health professionals to expand the population's access to clinical preventive services. To document examples of the community pharmacist's role in providing clinical preventive services to the general population, we conducted PubMed searches using the key word "community pharmacy" and key words from the US Preventive Services Task Force recommendations rated A or B. We present 4 descriptive summaries of clinical preventive services that can be offered by community pharmacists. Community pharmacists can provide clinical preventive services such as providing education, conducting screenings, and making referrals to improve population health.