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.

Investigating the methods and characteristics of the trafficking of performance and image enhancing drugs in Australia.

INTRODUCTION: Using case law, the aims of this study were to document the methods for trafficking of performance and image-enhancing drugs (PIED) into Australia, and the characteristics of individuals and groups involved. METHODS: Data was collected from judges' sentencing comments. Searches were conducted using the Australasian Legal Information Institute database across all states in Australia, for the period of January 2010 to December 2021. After removing duplicates and cases which did not meet the inclusion criteria, 31 cases were included in the analysis. RESULTS: Across the 31 cases, 37 individuals were named as being involved in the supply and/or trafficking of PIEDs, with three cases involving an unknown number of individuals. One case named four actors involved in the supply and/or trafficking of PIEDs, three cases involved three actors, four cases involved two actors and 17 cases involved one actor. In 20 of the 31 cases, individuals operated alone. Over half (19 of the 37) of the individuals were health professionals. The majority (n = 17) of cases involved prescription as the method of acquisition, while seven cases involved the importation of PIEDs. DISCUSSION AND CONCLUSION: The small number of cases identified, with the majority involving only a single actor, and half of the cases involving those in the medical profession. The findings suggest that discrete occurrences of trafficking involves individuals or small groups that do not appear to be linked to large-scale networks or networks involving the supply and trafficking of other illicit substances.

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.

Advancing Public Health through Community Pharmacy Practice.

The overarching goal of public health is to advance the health of individuals, communities, and populations [...].

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.

Multilevel network interventions: Goals, actions, and outcomes.

COVID-19 has resulted in dramatic and widespread social network interventions across the globe, with public health measures such as distancing and isolation key epidemiological responses to minimize transmission. Because these measures affect social interactions between people, the networked structure of daily lives is changed. Such largescale changes to social structures, present simultaneously across many different societies and touching many different people, give renewed significance to the conceptualization of social network interventions. As social network researchers, we need a framework for understanding and describing network interventions consistent with the COVID-19 experience, one that builds on past work but able to cast interventions across a broad societal framework. In this theoretical paper, we extend the conceptualization of social network interventions in these directions. We follow Valente (2012) with a tripartite categorization of interventions but add a multilevel dimension to capture hierarchical aspects that are a key feature of any society and implicit in any network. This multilevel dimension distinguishes goals, actions, and outcomes at different levels, from individuals to the whole of the society. We illustrate this extended taxonomy with a range of COVID-19 public health measures of different types and at multiple levels, and then show how past network intervention research in other domains can also be framed in this way. We discuss what counts as an effective network, an effective intervention, plausible causality, and careful selection and evaluation, as central to a full theory of network interventions.

Beyond Contraception: Pharmacist Roles to Support Maternal Health.

While contraception prescribing by pharmacists has seen rapid growth in recent years, pharmacist-provided services that can impact maternal health encompass more than just contraception. Each phase of maternal health-preconception, pregnancy, and post-pregnancy-has unique needs, and pharmacists are well equipped to provide services to meet those needs and are more accessible than other healthcare providers. While pharmacist-provided maternal health services may lead to significant savings to the healthcare system, additional research to more fully capture the value of pharmacist-provided maternal health services is needed. Robust implementation of a pharmacist-provided maternal health services program will require partnerships between providers, payers, and pharmacists. Infant and maternal mortality, preterm birth, and unintended pregnancies are significant public health issues, and pharmacists should be seen as a capable workforce who can provide needed maternal health care and serve as a gateway into the healthcare system for those capable of pregnancy.

Birth Control Use and Access Including Pharmacist-Prescribed Contraception Services during COVID-19.

The COVID-19 pandemic influenced health care with effects on contraception access emerging. The study objectives were to analyze pandemic impacts on birth control (BC) use and access; and evaluate perceptions of pharmacist-prescribed BC. A 50-item survey was distributed by 31 Michigan community pharmacies to women aged 18-45 over a three-month period. The survey link was also posted on two websites. 147 surveys were analyzed. Respondents were 29 ± 7.9 years old, primarily white (77%) and straight (81%). Fifty-eight percent of respondents used prescription BC, mostly to prevent pregnancy (84%) with oral pills (76%) being the most common formulation. Some BC users (25%) were worried about BC access and 27% had difficulty taking BC regularly. Half of the respondents (50%) would likely use pharmacist-prescribed BC if available, with advantages being more convenient than visiting a doctor's office (71%) and easier access (69%). The major concern about pharmacist-prescribed BC was women not receiving PAP smears and screenings (61%). Respondents reported high confidence (72%) in pharmacist-prescribed BC and believe it would help prevent unintended pregnancies (69%). Some respondents experienced altered BC use and access. Half of the respondents supported pharmacist-prescribed BC. Pharmacist-prescribed BC could help solve pandemic-related access problems.

An Empirical Comparison of the Profiles of Security Threat Group Offenders with General Offenders.

Datasets of offender attributes, both pre-custody and in-custody, were provided by the Correctional Service of Canada with the goal of exploring whether Security Threat Group (STG) offenders (informally, gang members of various kinds) differ in any systematic way from other offenders. For pre-custody attributes, we show that the entire offender population varies along two almost independent axes, one associated with affinity for violence, and the other with affinity for substance abuse. Within this structure, STG offenders are characteristically less extreme, in either direction, than the general offender population. For approximately two dozen attributes, STG offenders, as a group, tend to have higher values; for a few, they tend to have lower values. For in-custody attributes, the entire offender population forms a triangular structure whose vertices represent: passivity; violence and troublemaking; and involvement in programs leading to partial release. The differences between the STG offender population and the general offender population are small. An offender who is placed at the high end of the propensity for violence axis and/or the high end of the substance abuse axis based on pre-custody attributes is much more likely to be involved in incidents, grievances, and violence while in custody. This may have implications for risk stratification of incoming offenders.

Opioid use disorder: Calling pharmacists to action for better preconception and pregnancy care.

Opioid use disorder (OUD) in women of child-bearing potential is problematic in the United States. This has resulted in increasing risk for adverse maternal outcomes, neonatal abstinence syndrome, fetal and neonatal harm, prolonged hospitalizations, and increased health care costs. Pharmacists in all practice settings have opportunities to provide preconception and pregnancy care to prevent and manage OUD. Given pharmacists' scope of practice and expertise, key roles include assessing patients for OUD; mitigating exposure; educating patients regarding potential infant effects; recommending contraceptive methods and counseling on proper use; ensuring safe breastfeeding with concurrent medications; and linking patients to needed services. Through patient counseling, medication management, and harm reduction interventions, pharmacists can work to combat this public health crisis. To encourage increased uptake of pharmacists into these roles, more needs to be done to reimburse pharmacists for these important services and quantify their impact on patient and population health outcomes.

Pharmacy technician-administered immunizations: A five-year review.

In October 2020, the U.S. Department of Health and Human Services (HHS) issued guidance authorizing trained pharmacy technicians in all states to administer immunizations. Given that this action is temporary, it will be necessary for states to adopt their own legislation or regulations to sustain these efforts beyond the coronavirus pandemic. At least 11 different immunization administration training programs have emerged for pharmacy technicians. An increasing number of publications have emerged on pharmacy technician immunization administration, demonstrating the ability to train technicians and have them safely administer immunizations in practice. Supervising pharmacists reported initial hesitancy but strong acceptance of delegating this task after experience in practice. States should look to expand and make permanent the authority of pharmacy technicians to ensure these benefits can continue to be realized after the HHS guidance expires.

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.

Identification of a sex-stratified genetic algorithm for opioid addiction risk.

The opioid epidemic has had a devastating impact on our country, with wide-ranging effects on healthcare, corrections, employment, and social systems. Programs have been put in place for monitoring prescriptions, initiating and expanding medications for opioid use disorder, and harm reduction (i.e., naloxone distribution, needle exchanges). However, opportunities for personalization of opioid therapy based on addiction risk have been limited. The goal of the present study was to develop an objective risk assessment algorithm based on genetic markers that are correlated with opioid use disorder (OUD). A total of 180 single-nucleotide polymorphisms (SNPs) were tested in patients with and without OUD. SNPs selected for testing were associated with opioid metabolism and drug reward pathways based on previous studies. Of the 394 patients recruited, 200 had OUD and 194 served as controls without OUD but with prior opioid exposure. Logistic regression analyses stratified by sex identified ten unique SNPs in females and nine unique SNPs in males that were significantly associated with OUD. A Genetics Opioid Risk Score (GenORs) was calculated by counting the number of OUD risk-associated SNPs/genotypes for each patient. To evaluate the discrimination of the GenORs, a receiver operating characteristic (ROC) curve for each sex was generated and determined to be sensitive and specific. This represents the first published example of a sex-based genetic risk score with potential to predict OUD, and the first OUD algorithm to include opioid-associated pharmacokinetic genes.

Evaluation of an American Sign Language co-curricular training for pharmacy students.

BACKGROUND AND PURPOSE: With a prevalence of about one million d/Deaf and Hard of Hearing (HOH) patients that utilize American Sign Language (ASL) and the strong potential for communication barriers to adversely influence patient care outcomes, strategies must be developed to support health care professionals and students in learning to better care for d/Deaf and HOH patients. The primary objective of this project was to implement and assess a co-curricular course focused on helping student pharmacists become more confident and comfortable in communicating with d/Deaf and HOH patients. EDUCATIONAL ACTIVITY AND SETTING: The co-curricular course (ASL for the Pharmacy Professional) consisted of four 90-min classes, each covering different words/phrases and Deaf cultural competence. Students were taught basic ASL including the alphabet, numbers, vocabulary, and sentence structure. Deaf culture and d/Deaf patient interaction was also covered. Students interacted with a Deaf physician over Skype and with d/Deaf and HOH individuals from the local community. FINDINGS: Pre- and post-surveys that contained an identical set of questions were administered before and after course completion. Surveys assessed confidence and level of comfort of first- and second-professional year student pharmacists surrounding Deaf culture and interacting with d/Deaf and HOH patients. Following the course, students reported significantly improved confidence in communicating with d/Deaf patients directly and with a translator. SUMMARY: Following completion of a co-curricular ASL course, doctor of pharmacy students perceived an increase in confidence in working with d/Deaf and HOH patients. Program logistics were simplified through collaboration with an outside entity.

Patient perceptions of pharmacogenomic testing in the community pharmacy setting.

BACKGROUND: In order to optimize community pharmacist roles and patient outcomes, a better understanding of patient perceptions of pharmacogenomic (PGx) testing may be helpful for successful integration into community pharmacy practice. OBJECTIVE: The objective of this study was to identify patient perceptions related to PGx testing in the community pharmacy setting. METHODS: Semi-structured, face-to-face interviews were conducted with adults ≥18 years of age to gather their perceptions of PGx testing. Interview participants were taking either an antiplatelet agent or a selective serotonin reuptake inhibitor listed in Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines and were patients at one of two community pharmacies in West Michigan. Interview questions were designed to follow the Theory of Planned Behavior and to take into account existing literature on patient perceptions of PGx. Interviews were recorded, transcribed by a third party transcription service, coded by a team of three researchers to identify themes, and analyzed using nVivo qualitative analysis software. RESULTS: A total of 19 interviews were conducted over a period of 16 days in June 2016. Upon preliminary evaluation, four themes related to patient perceptions of PGx testing were consistently observed across multiple interviews: 1) trust, 2) experience, 3) risk/benefit, and 4) clarity. CONCLUSIONS: Semi-structured patient interviews revealed four themes related to PGx testing in the community pharmacy setting. These themes may influence the desire to pursue PGx testing. Future research may seek to identify how community pharmacists can communicate with patients about PGx in the context of these themes to empower patients to make positive health care decisions.

Pharmacist Consult Reports to Support Pharmacogenomics Report Interpretation.

BACKGROUND: The clinical implementation of pharmacogenomics (PGx) has often involved teams that include pharmacists. PGx laboratories often provide baseline information within the laboratory report that is based on Food and Drug Administration and Clinical Pharmacogenomics Implementation Consortium guidance, but information is often provided independent of concurrent disease states or medication use, among other clinical factors. Major challenges to widescale implementation of PGx include lack of physician experience or confidence in interpreting the data. The purpose of this paper is to describe how pharmacists can help further personalize PGx information and identify clinical recommendations for a given patient. METHODS: This work was performed as a secondary objective of a study evaluating genetic biomarkers of opioid addiction risk. This portion of the study utilized a descriptive analysis of pharmacist consult reports that consist of individualized, patient-level clinical recommendations that take into account current medications, current health conditions, and PGx data. A panel of 60 common PGx targets were tested among patients being treated for chronic pain or opioid use disorder (OUD). A pharmacist consult report was generated and compared with standard laboratory reporting of general PGx information. RESULTS: Of the 252 patients, PGx reports for 198 (78.6%) contained red and/or yellow clinical decision support flags for medications with actionable or informative PGx guidance for currently prescribed medications. Pharmacists recommended modifications to current prescriptions for 31 (53%) of the patients with actionable flags and 17 (12%) of the patients with informative flags. Drug classes most commonly included medications for cardiology, depression and anxiety, pain (opioids) and gastrointestinal management. Taken together, 24.2% of the actionable and informative flags had immediate clinical value based on the pharmacist's review. An additional 217 (86%) received one or more clinical recommendations not related to PGx. CONCLUSION: While PGx provides another opportunity for pharmacotherapy personalization, PGx data must be considered within the context of other patient-specific factors. Pharmacists were able to streamline the PGx report flags and identify other pharmacotherapy interventions following application of patient-specific data, thereby developing a brief report of recommendations for the patient's prescriber(s). Engaging clinical pharmacists in the PGx clinical decision process may help to facilitate more widespread PGx implementation.