Effect of Metformin Use on Vitamin B12 Deficiency Over Time (EMBER): A Real-World Evidence Database Study.

OBJECTIVE: To examine the extent to which metformin increases the risk of vitamin B12 deficiency and borderline deficiency over time in participants with type 2 diabetes mellitus (T2DM). METHODS: Using the All of Us database, adults aged ≥18 years with T2DM and a documented history of metformin use were included for the evaluation of B12 deficiency. Those with B12 deficiency before metformin use were excluded. Adjusted logistic regression models were used to evaluate the association between metformin use and long-term metformin use (≥4 years) and the risk of B12 deficiency. We conducted a subgroup analysis comparing differences in borderline B12 deficiency in metformin and non-metformin users. RESULTS: Of 36 740 participants with T2DM, 6221 (16.9%) had documented metformin use. The mean age of metformin users was 65.3 years. B12 deficiency was confirmed in 464 (7.5%) metformin users, and 1919 of 30 519 participants (6.3%) did not use metformin. Metformin users had a 4.7% increased risk of developing B12 deficiency compared with nonmetformin users (P = .44). Each additional year of metformin use was associated with 5% increased likelihood of deficiency (P < .05). Metformin use for ≥4 years resulted in a 41.0% increased odds of B12 deficiency, compared with those who used <4 years of metformin (P < .05). Metformin use increased the odds of borderline B12 deficiency by 27.0% (P < .05). CONCLUSION: Long-term metformin use was associated with an increased risk of B12 deficiency in patients with T2DM, with compounding risk over time.

Using machine learning to develop a clinical prediction model for SSRI-associated bleeding: a feasibility study.

INTRODUCTION: Adverse drug events (ADEs) are associated with poor outcomes and increased costs but may be prevented with prediction tools. With the National Institute of Health All of Us (AoU) database, we employed machine learning (ML) to predict selective serotonin reuptake inhibitor (SSRI)-associated bleeding. METHODS: The AoU program, beginning in 05/2018, continues to recruit ≥ 18 years old individuals across the United States. Participants completed surveys and consented to contribute electronic health record (EHR) for research. Using the EHR, we determined participants who were exposed to SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vortioxetine). Features (n = 88) were selected with clinicians' input and comprised sociodemographic, lifestyle, comorbidities, and medication use information. We identified bleeding events with validated EHR algorithms and applied logistic regression, decision tree, random forest, and extreme gradient boost to predict bleeding during SSRI exposure. We assessed model performance with area under the receiver operating characteristic curve statistic (AUC) and defined clinically significant features as resulting in > 0.01 decline in AUC after removal from the model, in three of four ML models. RESULTS: There were 10,362 participants exposed to SSRIs, with 9.6% experiencing a bleeding event during SSRI exposure. For each SSRI, performance across all four ML models was relatively consistent. AUCs from the best models ranged 0.632-0.698. Clinically significant features included health literacy for escitalopram, and bleeding history and socioeconomic status for all SSRIs. CONCLUSIONS: We demonstrated feasibility of predicting ADEs using ML. Incorporating genomic features and drug interactions with deep learning models may improve ADE prediction.

Pharmacist-Managed Refill Service Impacts on Clinician Workload and Medication Interventions in a Federally Qualified Health Center.

INTRODUCTION: Increasing administrative workload is linked with lower quality of patient care and physician burnout. Conversely, models involving pharmacists can positively impact patient care and physician well-being. Research has consistently demonstrated that pharmacist-physician collaboration can improve outcomes for chronic diagnoses. Pharmacist-managed refill services may improve provider workload measures and clinical outcomes. METHODS: This was an evaluation of a pharmacist-managed refill service at a Federally Qualified Health Center (FQHC). Under collaborative practice agreement, pharmacists addressed refill requests and recommended interventions. Data analysis evaluated effectiveness of the model, including clinical interventions, and involved descriptive statistics and qualitative approaches. RESULTS: Average patient age was 55.5 years old and 53.1% were female. Turnaround time was within 48 h for 87.8% of refill encounters. During an average of 3.2 h per week, pharmacists addressed 9.2% (n = 1683 individual requests in 1255 indirect patient encounters) of the total clinic refill requests during the 1-year study period. In 453 of these encounters (36.1%), pharmacists recommended a total of 642 interventions. 64.8% of these were need for appointment (n = 211) or labs (n = 205). Drug therapy problems and medication list discrepancies were identified in 12.6% (n = 81) and 11.9% (n = 76) of encounters, respectively. DISCUSSION AND CONCLUSIONS: The results of this study are consistent with previous literature demonstrating the value of interprofessional collaboration. Pharmacists addressed refills in an efficient, clinically effective manner in an FQHC setting. This may positively impact primary care provider workload, patients' medication persistence, and clinical care.

Sociodemographic characteristics differ across routine adult vaccine cohorts: An All of Us descriptive study.

BACKGROUND: The National Institutes of Health All of Us (AoU) Research Program is currently building a database of 1million+ adult subjects. With it, we describe the characteristics of those with documented vaccinations. OBJECTIVES: To describe the sociodemographic, health status, and lifestyle factors associated with vaccinations. METHODS: This is a retrospective study involving data from the AoU program (R2020Q4R2, N = 315,297). Five vaccine cohorts [influenza, hepatitis B (HBV), pneumococcal <65 years old, pneumococcal ≥65 years old, and human papillomavirus (HPV)] were generated based on vaccination history. The influenza cohort comprised participants with documented influenza vaccinations in electronic health records (EHRs) from September 2017 to May 2018. Other vaccine cohorts comprised participants with ≥1 lifetime record(s) of vaccination documented in the EHR by December 2018. The vaccine cohorts were compared to the overall AoU cohort. Descriptive statistics were generated using EHR- and survey-based sociodemographic, health, and lifestyle information. The SAMBA (0.9.0) R package was utilized to adjust for EHR selection and outcome misclassification biases to infer sources of disparity for pneumococcal vaccinations in older adults. RESULTS: Cohort counts were as follows: influenza (n = 15,346), HBV (n = 6323), pneumococcal <65 (n = 15,217), pneumococcal ≥65 (n = 15,100), and HPV (n = 2125). All vaccine cohorts had higher proportions of White and non-Hispanic/Latino participants compared to the overall AoU cohort. The largest differences were found in pneumococcal age ≥65, with 80.2% White participants compared to 52.9% in the overall study population. Multivariable analysis revealed that race/ethnic disparities in pneumococcal vaccination among older adults were explained by biological sex, income, health insurance, and education-related variables. CONCLUSION: Racial, ethnic, education, and income characteristics differ across the vaccine cohorts among AoU participants. These findings inform future utilization of large health databases in vaccine epidemiology research and emphasize the need for more targeted interventions that address differences in vaccine uptake.

The U.S. Travel Health Pharmacists' Role in a Post-COVID-19 Pandemic Era.

Background: Many countries have enforced strict regulations on travel since the emergence of the SARS-CoV-2 (COVID-19) pandemic in December 2019. However, with the development of several vaccines and tests to help identify it, international travel has mostly resumed in the United States (US). Community pharmacists have long been highly accessible to the public and are capable of providing travel health services and are in an optimal position to provide COVID-19 patient care services to those who are now starting to travel again. Objectives: (1) To discuss how the COVID-19 pandemic has changed the practice of travel health and pharmacist provided travel health services in the US and (2) to discuss the incorporation COVID-19 prevention measures, as well as telehealth and other technologies, into travel health care services. Methods: A literature review was undertaken utilizing the following search engines and internet websites: PubMed, Google Scholar, Centers for Disease Control Prevention (CDC), World Health Organization (WHO), and the United States Department of Health and Human Services to identify published articles on pharmacist and pharmacy-based travel health services and patient care in the US during the COVID-19 pandemic. Results: The COVID-19 pandemic has changed many country's entry requirements which may now include COVID-19 vaccination, testing, and/or masking requirements in country. Telehealth and other technological advancements may further aid the practice of travel health by increasing patient access to care. Conclusions: Community pharmacists should consider incorporating COVID-19 vaccination and testing services in their travel health practices in order to meet country-specific COVID-19 entry requirements. Further, pharmacists should consider utilizing telehealth and other technologies to increase access to care while further limiting the potential spread and impact of COVID-19.

Health Disparities in Pharmacy Practice Within the Community: Let's Brainstorm for Solutions.

Health disparity is defined as a type of health difference that is closely linked with social, economic and/or environmental disadvantage. Over the past two decades, major efforts have been undertaken to mitigate health disparities and promote health equity in the United States. Within pharmacy practice, health disparities have also been identified to play a role in influencing pharmacists' practice across various clinical settings. However, well-characterized solutions to address such disparities, particularly within pharmacy practice, are lacking in the literature. Recognizing that a significant amount of work will be necessary to reduce or eliminate health disparities, the University of California, Irvine (UCI) School of Pharmacy and Pharmaceutical Sciences held a webinar in June 2021 to explore pertinent issues related to this topic. During the session, participants were given the opportunity to propose and discuss innovative solutions to overcome health disparities in pharmacy practice. The goal of this perspective article is to distill the essence of the presentations and discussions from this interactive session, and to synthesize ideas for practical solutions that can be translated to practice to address this public health problem.

Pharmacy-Based Travel Health Services in the United States.

The aim of this paper is to review pharmacy laws and regulations, pharmacist training, clinic considerations, and patient care outcomes regarding pharmacy-based travel health services in the United States. Pharmacists and pharmacies in the United States are highly visible and accessible to the public, and have long been regarded as a source for immunization services. As international travel continues to increase and grow in popularity in this country, there is a pressing need for expanded access to preventative health services, including routine and travel vaccinations, as well as medications for prophylaxis or self-treatment of conditions that may be acquired overseas. In the United States, the scope of pharmacy practice continues to expand and incorporate these preventable health services to varying degrees on a state-by-state level. A literature review was undertaken to identify published articles on pharmacist- or pharmacy-based travel health services or care in the United States. The results of this paper show that pharmacists can help to increase access to and awareness of the need for these services to ensure that patients remain healthy while traveling abroad, and that they do not acquire a travel-related disease while on their trip. For those pharmacists interested in starting a travel health service, considerations should be made to ensure that they have the necessary training, education, and skill set in order to provide this specialty level of care, and that their practice setting is optimally designed to facilitate the service. While there is little published work available on pharmacy or pharmacist-provided travel health services in the United States, outcomes from published studies are positive, which further supports the role of the pharmacist in this setting.

Proposal to Reduce Adult Immunization Barriers in California.

Adult vaccination rates in the United States are consistently lower than the National Healthy People 2020 goals. Barriers to adult vaccination include inconsistency of insurance coverage of adult vaccines and difficulty in accessing vaccines. To help address the gap in adult access to vaccines, in 2016 the Department of Health Care Services--which administers the Medi-Cal program (California's version of Medicaid)--implemented the All Plan Letter (APL) 16-009, which requires coverage of recommended adult vaccines as a pharmacy benefit. Adult Medi-Cal patients can now receive the vaccines recommended for their age and underlying health conditions, and they can do so not only at a provider's office but also at local pharmacies, improving access and convenience. This policy brief recommends expanding coverage of all adult vaccines as a pharmacy benefit of all public and commercial insurance plans.

Pharmacists' scope of practice in travel health: cregulations.

OBJECTIVES: The primary objective of this study was to assess pharmacists' authority to provide travel health services in each state and Washington, DC. Secondary objectives were to determine the need for collaborative practice agreements (CPAs), protocols, or prescriptions for this type of pharmacy practice and to identify jurisdictions where pharmacists are able to practice as travel health providers independent of CPAs or individual physician protocols. METHODS: An online survey was developed to assess pharmacists' authority to administer travel immunizations, furnish travel-related medications, and order travel-related laboratory tests. Open-ended items on scope of practice, training requirements, and pending legislation or regulations were also included. The survey was distributed to state pharmacy association executives. A member of the research team searched pharmacy laws to clarify missing or inconsistent responses. Data were analyzed using descriptive statistics. RESULTS: The survey response rate was 76.5% (n = 39). Missing (n = 12) or conflicting (n = 6) response issues were resolved. Thus, data were available for 100% of jurisdictions. In most jurisdictions, pharmacists were able to provide one or more components of this service. In 44 jurisdictions (86.3%), pharmacists were allowed to administer travel immunizations. Twenty-seven jurisdictions (52.9%) allowed pharmacists to furnish travel medications. Pharmacists in 23 jurisdictions (43.1%) could order travel health-related laboratory tests. Pharmacists can practice independently in 1 state, but CPAs or individual physician protocols are required elsewhere. CONCLUSIONS: To the authors' knowledge, this study represents the first national pharmacists' travel health scope-of-practice analysis. While pharmacists in many jurisdictions can provide some components of travel health services, only one, New Mexico, currently allows pharmacists to practice all aspects independently. Thus, pharmacists continue to have an opportunity to expand scope of practice in travel health. Additional research may help to drive increased access to and use of travel health care.