Collaborative drug therapy modification (CDTM): Facilitators, barriers, and perceptions of individual pharmacist participation in Georgia.

BACKGROUND: Georgia Board of Pharmacy (BOP) regulations permit pharmacists to engage in collaborative drug therapy modification (CDTM) with physicians, allowing them to perform patient assessments, adjust pharmacotherapy, and order laboratory tests. Pharmacist-led CDTM can positively affect health outcomes leading to reduced healthcare expenditures. CDTM is underutilized, with < 1% of Georgia pharmacists holding an active license to practice CDTM. OBJECTIVE(S): The objective of this study was to examine CDTM licensed pharmacists' perceptions of facilitators and barriers in providing CDTM. METHODS: Georgia-licensed CDTM pharmacists were invited to participate in a 60-minute qualitative interview. Interview questions were developed from electronic survey responses. The interview was designed to elicit information regarding perceived benefits and barriers to CDTM implementation. Guided by the Consolidated Framework for Implementation Research, thematic analysis was applied to identify themes using ATLAS.ti software to code. Themes were described qualitatively and prevalence of each was reported. RESULTS: Nine interviews were conducted, and data saturation was achieved at interview 6. After resolution of discrepancies, 100% coding agreement was reached among 2 independent researchers. Nine themes were identified, and each was categorized as a facilitator or barrier to establishing pharmacist-led CDTM in Georgia. Themes associated with facilitating were (prevalence %) (1) practice autonomy (100), (2) personal attributes (100), (3) having support (100), and (4) institutional logistics (88). Barrier themes included issues concerning (5) the Georgia BOP (100), (6) pharmacist autonomy (88), (7) lack of provider status (88), (8) institutional restrictions (75), and (9) personal development (e.g., confidence) (22). CONCLUSION: Facilitators to the establishment of pharmacist-led CDTM exist and pharmacists can capitalize on these to create successful CDTM programs. Barriers are varied, and it may be difficult to systematically address individual barriers such as pharmacist autonomy and personal development. Barriers associated with institutional restrictions, the Georgia BOP, and lack of provider status can likely be removed or addressed by policy.

Community pharmacists' naloxone counseling: A theory-informed qualitative study.

BACKGROUND: Opioid-related overdose (ORO) deaths have reached a record high in the United States. Naloxone is an opioid antagonist that can rapidly reverse an opioid overdose. Pharmacists are in an ideal position to provide naloxone and related counseling, given their accessibility and expertise. However, minimal research is available on community pharmacists' naloxone counseling. OBJECTIVES: The aim of this study was to investigate Georgia community pharmacists' naloxone counseling as well as explore their attitudes, subjective norms, and perceived behavioral control toward counseling. METHODS: Semi-structured telephone interviews were conducted to elicit pharmacists' beliefs and practices regarding naloxone counseling. The interviews were guided by open-ended questions based on the theory of planned behavior (TPB). Thematic analysis was performed to identify the modal salient beliefs expressed by the pharmacists. The Consolidated Criteria for Reporting Qualitative Research was used to report the study findings. RESULTS: A total of 12 community pharmacists participated. Pharmacists held mixed attitudes toward naloxone counseling. While they recognized it as a vital part of their profession to prevent ORO deaths, they also expressed concerns about offending patients. Regarding normative beliefs, pharmacists identified several groups, including regulatory agencies (e.g., Board of Pharmacy, CDC), managers, news/media, patients, and doctors, influencing their provision of naloxone counseling. Facilitators to counseling included receiving naloxone training and having access to counseling guidelines and resources. Reimbursement issues, high costs of naloxone, and lack of patient awareness were the most commonly cited barriers. Pharmacists reported participating in counseling and providing information on identifying signs of opioid overdose and administering naloxone. CONCLUSIONS: The TPB is a useful framework for understanding community pharmacists' beliefs and practices regarding naloxone counseling. Capitalizing on facilitators and targeting barriers related to pharmacists' reimbursement issues, high costs of naloxone, and increasing patients' awareness of naloxone use and benefits may enhance pharmacists' naloxone counseling.

A Scoping Review for Debate-Style Journal Clubs in Health Professional Education.

OBJECTIVES: The objectives of this scoping review are to (1) describe the available literature regarding the utility of the debate-style journal club for health professional learners on literature evaluation skills and (2) report the themes found within debate-style journal club research and assessments in the context of professional education. FINDINGS: A total of 27 articles written in the English language were included in this scoping review. Published evaluations of debate-style journal clubs have been predominantly based in the pharmacy profession (48%, n = 13), but are reported in other health professions, such as medicine (22%, n = 6), dentistry (15%, n = 4), nursing (7%, n = 2), occupational therapy (4%, n = 1), and physical therapy (4%, n = 1), as well. The skills assessed in these studies often included critical literature evaluation, application of literature to patient care, critical thinking, knowledge retention, use of supporting literature, and debate-specific skills. Learners typically reported better understanding and application of the literature, and enjoying the experience more than traditional journal clubs, but note the increased assessor and learner time requirement for debating. Pharmacy learner-specific articles more often utilized a traditional, team-based debate format, incorporated grading rubrics for skill assessment and debate performance, and included a grading component for the debate in the course. SUMMARY: Debate-style journal clubs are well-received by learners but require an additional time commitment. Debate platforms, format, rubric use and validation, and outcome assessment vary across published reports.

Pharmacists' naloxone services beyond community pharmacy settings: A systematic review.

BACKGROUND: Pharmacists' provision of naloxone services in community pharmacy settings is well-recognized. Recently, studies describing pharmacists' naloxone services in settings other than community pharmacies have emerged in the literature. There is a need to synthesize evidence from these studies to evaluate the scope and impact of pharmacists' naloxone services beyond community pharmacy settings. OBJECTIVES: The objectives of this systematic review were to a) identify pharmacists' naloxone services and their outcomes, and b) examine knowledge, attitudes, and barriers (KAB) related to naloxone service provision in non-community pharmacy settings. METHODS: Eligible studies were identified using PubMed, Web of Science, and CINAHL. Inclusion criteria were as follows: peer-reviewed empirical research conducted in the U.S. from January 2010 through February 2022; published in English; and addressed a) pharmacists' naloxone services and/or b) KAB related to the implementation of naloxone services. PRISMA guidelines were used to report this study. RESULTS: Seventy-six studies were identified. The majority were non-randomized and observational; only two used a randomized controlled (RCT) design. Most studies were conducted in veterans affairs (30%) and academic medical centers (21%). Sample sizes ranged from n = 10 to 217,469, and the majority reported sample sizes <100. Pharmacists' naloxone services involved clinical staff education, utilization of screening tools to identify at-risk patients, naloxone prescribing and overdose education and naloxone dispensing (OEND). Outcomes of implementing naloxone services included improved naloxone knowledge, positive attitudes, increased OEND, and overdose reversals. Pharmacists cited inadequate training, time constraints, reimbursement issues, and stigma as barriers that hindered naloxone service implementation. CONCLUSION: This systematic review found robust evidence regarding pharmacist-based naloxone services beyond community pharmacy settings. Future programs should use targeted approaches to help pharmacists overcome barriers and enhance naloxone services. Additional research is needed to evaluate pharmacist naloxone services by using rigorous methodologies (e.g., larger sample sizes, RCT designs).

Distribution of age, sex, race, and ethnicity in COVID-19 clinical drug trials in the United States: A review.

BACKGROUND: COVID-19 quickly overwhelmed the world, but disproportionately affects certain communities, particularly minority groups. Despite overrepresentation among COVID-19 cases and death, minority groups were underrepresented in some of the early COVID-19 clinical trials. OBJECTIVE: To assess and compare the demographic characteristics of COVID-19 clinical trial participants to national COVID-19 data. METHODS: PubMed was searched from December 1, 2019 to November 24, 2020, for randomized controlled trials evaluating a pharmacologic treatment for COVID-19 patients from one or more U.S. sites written in the English language following the PRISMA checklist. Descriptive statistics were calculated to characterize patient demographics enrolled in the included clinical trials, as well as for comparison with national COVID-19 data. RESULTS: A total of 4472 records were identified, of which 16 studies were included. The median number of participants was higher in studies of nonhospitalized patients compared to those of hospitalized patients (n = 452 [range 20-1062] vs n = 243 [152-2795]). Ten (63%) studies reported mean or median ages of 50 years or older among all study arms. Males comprised more than half of the study cohort in ten (63%) studies. Race and ethnicity were reported separately in four (25%) studies but were combined when reported in five (31%) studies, while six (38%) reported only race or ethnicity. Proportional representation based on age, sex, race, and ethnicity was evident in some trials, but not in others, when compared to national data. CONCLUSION: Overall, participants often did not reflect the actual population with COVID-19 and demographic characteristics were inconsistently reported.

Lessons learned from a formative study evaluating student pharmacists' experience with a case-based learning "choose your own adventure" activity.

BACKGROUND: A case-based learning "Choose Your Own Adventure" (CBL-CYOA) activity was designed to support students in learning to identify drug-related problems and make clinical decisions related to drug therapy management. The purpose of this study was to describe student pharmacists' experiences in order to understand, from their perspective, which design features of the CBL-CYOA activity were valued as useful for developing clinical decision-making skills in an Applied Pharmacy Practice I course. However, several limitations with various features of study design minimized the usefulness of results. IMPACT: In retrospect, methodological limitations with both the survey and focus group designs negatively impacted the interpretation of results in this study. RECOMMENDATIONS: Attention to thoughtful survey development with better alignment to the purpose of the study and neutral questions may produce more useful results. Further, additional focus groups and a purposeful sampling strategy may add to increasing the credibility of the findings in this study. DISCUSSION: Overall, formative studies like this one have the potential to produce insights into how innovative instructional designs operate in real-world contexts. They also have the capacity to output results that provide an evidence base for refining and improving those designs. We hope that our reflections in this paper may be useful to other educators and researchers working to plan similar projects in the future.

Clinical Severity on Hospital Admission for COVID-19: An Analysis of Social Determinants of Health From an Early Hot Spot in the Southeastern U.S.

INTRODUCTION: Disparities in COVID-19 infection, illness severity, hospitalization, and death are often attributed to age and comorbidities, which fails to recognize the contribution of social, environmental, and financial factors on health. The purpose of this study was to examine relationships between social determinants of health (SDOH) and COVID-19 severity. METHODS: This multicenter retrospective study included adult patients hospitalized with COVID-19 in Southwest Georgia, U.S. The primary outcome was the severity of illness among patients on hospital admission for COVID-19. To characterize the effect of biological and genetic factors combined with SDOH on COVID-19, we used a multilevel analysis to examine patient-level and ZIP code-level data to determine the risk of COVID-19 illness severity at admission. RESULTS: Of 392 patients included, 65% presented with moderate or severe COVID-19 compared to 35% with critical disease. Compared to moderate or severe COVID-19, increasing levels of Charlson Comorbidity Index (OR 1.15, 95% CI 1.07-1.24), tobacco use (OR 1.85, 95% CI 1.10-3.11), and unemployment or retired versus employed (OR 1.91, 95% CI 1.04-3.50 and OR 2.17, 95% CI 1.17-4.02, respectively) were associated with increased odds of critical COVID-19 in bivariate models. In the multi-level model, ZIP codes with a higher percentage of Black or African American residents (OR 0.94, 95% CI 0.91-0.97) were associated with decreased odds of critical COVID-19. CONCLUSION: Differences in SDOH did not lead to significantly higher odds of presenting with severe COVID-19 when accounting for patient-level and ZIP code-level variables.

A Scoping Review Evaluating the Effect of SGLT-2 Inhibitors on Insulin Dose Requirements in Insulin-Dependent Patients With Type 2 Diabetes.

OBJECTIVE: Assess evidence describing the effect of Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors on total daily insulin (TDI) requirements in insulin-dependent patients with type 2 diabetes. DATA SOURCES: A scoping review was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Protocols and Scoping Reviews (PRISMA-ScR) guidelines. The search was conducted in PubMed; citation mapping was completed in Web of Science. Filters for human studies, English language, and a publication date, from January 1, 2005 to April 12, 2021, were applied. STUDY SELECTION AND DATA EXTRACTION: Studies assessing insulin dose requirements with concurrent use of an SGLT2 inhibitor for patients with type 2 diabetes were included. DATA SYNTHESIS: Sixteen studies were included and demonstrated that addition of an SGLT2 inhibitor typically reduced TDI requirements. Insulin reductions were often statistically significant, occurring in studies evaluating (1) within subjects who received SGLT2 inhibitors, and (2) between subjects receiving SGLT2 inhibitors versus placebo. Compared with placebo, insulin dose reduction ranged from -0.72 to -19.2 units. However, studies were relatively small, not designed to assess TDI change, and some utilized fixed dose insulin protocols or empiric insulin dose reductions. CONCLUSIONS: Lowering insulin requirements may have benefits, such as decreased hypoglycemia risk, insulin resistance, and cost. Addition of an SGLT2 inhibitor may modestly reduce TDI requirements for patients with type 2 diabetes. Evidence indicating SGLT2 inhibitor use reduces TDI may lead to additional implementation in practice and inform future research. Further research is needed to clarify insulin type (i.e., basal or prandial) and degree of TDI reduction expected with addition of an SGLT2 inhibitor.

Evaluation of quality measure attainment with pharmacist-delivered Medicare annual wellness visits.

BACKGROUND: Medicare is required to fully cover annual wellness visits (AWVs) to increase access to preventive care. As health care converts to pay for performance models, clinical quality measures have increasing importance. Few studies have investigated the effect of pharmacist-delivered AWVs on clinical quality measure attainment in a rural family medicine (FM) clinic setting. OBJECTIVES: The primary objective of this study was to evaluate attainment of clinical quality measures for pharmacist-delivered AWVs compared with physician-delivered AWVs (usual care). Secondary objectives included assessment of the number and type of drug therapy problems (DTPs) identified by pharmacists during AWVs. METHODS: This single-center retrospective cohort study was conducted within an FM clinic located in southwest Georgia. Two cohorts were created according to the provider of AWVs during 2017: pharmacist or physician-usual care. Data on quality measure eligibility, attainment, and DTPs (for the pharmacist group only) were collected through electronic chart review. Descriptive statistics were used to characterize variables, and chi-square (or Fisher exact where appropriate) tests to compare the proportion of clinical quality measures attained between groups. RESULTS: Among 334 delivered AWVs, pharmacists performed 68.6%. Approximately 62% of pharmacist and usual care visits were female with mean ages of 72 (SD +/- 9.1) and 62 (SD +/- 13.9) years, respectively. Pharmacist-delivered AWVs had statistically significant greater quality measure attainment in the following categories: advance care planning, osteoporosis cardiovascular screenings, and Tdap vaccinations compared with usual care (P < 0.05). Usual care had statistically significant greater quality measure attainment for diabetes screening. Seventy-five DTPs were identified in the pharmacist group, with the majority being related to adherence (39%). CONCLUSION: Pharmacist-delivered AWVs had greater quality measure attainment in several areas than usual care. Furthermore, increased quality measure attainment may assist in meeting benchmarks set by payers to ensure ongoing reimbursement of these services.

Team feedback: A missing piece of the interprofessional education puzzle.

INTRODUCTION: The ambulatory care practice model has long embraced interprofessional collaboration, well before it was formalized by the Interprofessional Education Collaborative. Establishing a mechanism to gather insight from other members of the interprofessional team may facilitate further development of interprofessional education (IPE). COMMENTARY: There is limited evidence investigating non-pharmacy trainees and medical provider perceptions of advanced pharmacy practice experience (APPE) student involvement in IPE. Most available evidence evaluates the satisfaction of non-pharmacy trainees and other health care professionals with APPE student recommendations. IMPLICATIONS: Emphasis on IPE, such as formalizing feedback from other health care professionals during experiential rotations, may assist preceptors in adapting interactions, strengthening interprofessional collaborations, and ensuring that students are valued team members who contribute to providing quality patient care.

Diagnostic Utility of a Ferritin-to-Procalcitonin Ratio to Differentiate Patients With COVID-19 From Those With Bacterial Pneumonia: A Multicenter Study.

BACKGROUND: There is an urgent need for accurate, rapid, inexpensive biomarkers that can differentiate coronavirus disease 2019 (COVID-19) from bacterial pneumonia. We assess the role of the ferritin-to-procalcitonin (F/P) ratio to classify pneumonia cases into those due to COVID-19 vs those due to bacterial pathogens. METHODS: This multicenter case-control study compared patients with COVID-19 with those with bacterial pneumonia, admitted between March 1 and May 31, 2020. Patients with COVID-19 and bacterial pneumonia co-infection were excluded. The F/P in patients with COVID-19 vs with bacterial pneumonia were compared. Receiver operating characteristic curve analysis determined the sensitivity and specificity of various cutoff F/P values for COVID-19 vs bacterial pneumonia. RESULTS: A total of 242 COVID-19 pneumonia cases and 34 bacterial pneumonia controls were included. Patients with COVID-19 pneumonia had a lower mean age (57.1 vs 64.4 years; P = .02) and a higher body mass index (30.74 vs 27.15 kg/m2; P = .02) compared with patients with bacterial pneumonia. Cases and controls had a similar proportion of women (47% vs 53%; P = .5), and COVID-19 patients had a higher prevalence of diabetes mellitus (32.6% vs 12%; P = .01). The median F/P was significantly higher in patients with COVID-19 (4037.5) compared with the F/P in bacterial pneumonia (802; P < .001). An F/P ≥877, used to diagnose COVID-19, resulted in a sensitivity of 85% and a specificity of 56%, with a positive predictive value of 93.2% and a likelihood ratio of 1.92. In multivariable analyses, an F/P ≥877 was associated with greater odds of identifying a COVID-19 case (odds ratio, 11.27; 95% CI, 4-31.2; P < .001). CONCLUSIONS: An F/P ≥877 increases the likelihood of COVID-19 pneumonia compared with bacterial pneumonia.

Pharmacist-Led Annual Wellness Visits: A Review.

OBJECTIVE: To summarize findings of pharmacist involvement with Medicare Annual Wellness Visits (AWV), including the number of pharmacist interventions, patient/provider satisfaction, and billing models. DATA SOURCES: A literature search was conducted using PubMed, ScienceDirect College Edition Journals Collection-Health and Life Sciences, Cochrane Library, CINAHL, Medline, and Academic Search Complete, including dates between January 01, 2011, and November 05, 2018. STUDY SELECTION: Search was limited to full-text, peer-reviewed articles, published in English which were relevant based on identification of a pharmacist's role in AWV. Search terms included "Medicare annual wellness visits" and "Pharmacists." DATA EXTRACTION: A data extraction tool was used to collect study authors, year published, study design, description of intervention, objectives, primary outcome measures, model of care, clinic setting, location, results, number of patients, and overall effect. RESULTS: Of the 139 returned citations, 11 met inclusion criteria. Of the practice settings, 7 (72.72%) utilized a collaborative practice agreement for conducting AWV. Six (54.54%) of the studies measured financial outcomes, 3 (27.27%) measured satisfaction of students/patients/physicians, 2 (18.18%) measured clinical outcomes, and finally 4 (36.36%) measured number and types of interventions. Review revealed that 6 (54.54%) articles had more medication-related interventions than nonmedication-related interventions. Studies evaluating finances as it relates to AWVs had various findings including 38% return on investment, higher reimbursement for pharmacist-led visits, and an increase in revenue. CONCLUSION: In a variety of outpatient health centers, AWV were conducted by pharmacists, had a positive impact on patient care, and had high satisfaction rates between patients and physicians.

Diagnostic utility of a Ferritin-to-Procalcitonin Ratio to differentiate patients with COVID-19 from those with Bacterial Pneumonia: A multicenter study.

IMPORTANCE: There is a need to develop tools to differentiate COVID-19 from bacterial pneumonia at the time of clinical presentation before diagnostic testing is available. OBJECTIVE: To determine if the Ferritin-to-Procalcitonin ratio (F/P) can be used to differentiate COVID-19 from bacterial pneumonia. DESIGN: This case-control study compared patients with either COVID-19 or bacterial pneumonia, admitted between March 1 and May 31, 2020. Patients with COVID-19 and bacterial pneumonia co-infection were excluded. SETTING: A multicenter study conducted at three hospitals that included UCHealth and Phoebe Putney Memorial Hospital in the United States, and Yichang Central People's Hospital in China. PARTICIPANTS: A total of 242 cases with COVID-19 infection and 34 controls with bacterial pneumonia. MAIN OUTCOMES AND MEASURES: The F/P in patients with COVID-19 or with bacterial pneumonia were compared. Receiver operating characteristic analysis determined the sensitivity and specificity of various cut-off F/P values for the diagnosis of COVID-19 versus bacterial pneumonia. RESULTS: Patients with COVID-19 pneumonia had a lower mean age (57.11 vs 64.4 years, p=0.02) and a higher BMI (30.74 vs 27.15 kg/m 2 , p=0.02) compared to patients with bacterial pneumonia. Cases and controls had a similar proportion of women (47% vs 53%, p=0.5) and COVID-19 patients had a higher prevalence of diabetes mellitus (32.6% vs 12%, p=0.01). The median F/P was significantly higher in patients with COVID-19 (4037.5) compared to the F/P in bacterial pneumonia (802, p<0.001). An F/P ≥ 877 used to diagnose COVID-19 resulted in a sensitivity of 85% and a specificity of 56%, with a positive predictive value of 93.2%, and a likelihood ratio of 1.92. In multivariable analyses, an F/P ≥ 877 was associated with greater odds of identifying a COVID-19 case (OR: 11.27, CI: 4-31.2, p<0.001). CONCLUSIONS AND RELEVANCE: An F/P ≥ 877 increases the likelihood of COVID-19 pneumonia compared to bacterial pneumonia. Further research is needed to determine if obtaining ferritin and procalcitonin simultaneously at the time of clinical presentation has improved diagnostic value. Additional questions include whether an increased F/P and/or serial F/P associates with COVID-19 disease severity or outcomes.

Countermeasures to Coronavirus Disease 2019: Are Immunomodulators Rational Treatment Options-A Critical Review of the Evidence.

Severe acute respiratory syndrome coronavirus 2 is associated with higher concentrations of proinflammatory cytokines that lead to lung damage, respiratory failure, and resultant increased mortality. Immunomodulatory therapy has the potential to inhibit cytokines and quell the immune dysregulation. Controversial data found improved oxygenation after treatment with tocilizumab, an interleukin-6 inhibitor, sparking a wave of interest and resultant clinical trials evaluating immunomodulatory therapies. The purpose of this article is to assess potential proinflammatory targets and review the safety and efficacy of immunomodulatory therapies in managing patients with acute respiratory distress syndrome associated with coronavirus disease 2019.

Neuropsychiatric Symptoms in Dementia: Considerations for Pharmacotherapy in the USA.

Dementia affects all domains of cognition. The relentless progression of the disease after diagnosis is associated with a 98% incidence of neuropsychiatric symptoms (NPS) at some point in the disease, including depression, psychosis, agitation, aggression, apathy, sleep disturbances, and disinhibition. These symptoms can be severe and lead to excess morbidity and mortality. The purpose of this article was to describe current literature on the medication management of NPS of dementia and highlight approaches to and concerns about the pharmacological treatment of NPS in the USA. Guidelines and expert opinion favor nonpharmacologic management of NPS as first-line management. Unfortunately, lack of adequate caregiver training and a high failure rate eventually result in the use of psychotropic agents in patients with dementia. Various psychotropic medications have been studied, although how they should be used in the management of NPS remains unclear. A systematic approach to evaluation, treatment, and monitoring, along with careful documentation and evidenced-based agent and dose selection, is likely to reduce risk and improve patient outcomes. Considerations should be given to the NPS presentation, including type, frequency, and severity, when weighing the risks and benefits of initiating, continuing, or discontinuing psychotropic management. Use of antidepressants, sedative/hypnotics, antipsychotics, and antiepileptic agents should include a clear and documented analysis of risk and benefit in a given patient with dementia.