Blockchain Applications in the Pharmaceutical Industry.

Methods: We utilized a 4D framework using ease of implementation, novelty, necessity, and fit of the overall industry to examine the adoption of blockchain technology in the pharmaceutical industry. Based on the 2D framework of difficulty and novelty as driving factors for the development of foundational technologies in the world of business by Iansiti and Lakhani, each application was ranked and scored for the best potential implementation. The potential applications proposed in this paper can be grouped into two main categories. The first category, management, includes best-use cases, such as health records, clinical trials, and inventory systems. The second category, monitoring, highlights cases, such as pharmaceutical products, preventing counterfeits, optimizing supply chains, and addressing prescription misuse and abuse. Results: Each application was ranked by the four metrics in the framework, giving the greatest weight to necessity and ease of implementation. Using the highlighted methodology earlier, the applications for best implementation include Prescription Drug Misuse and Abuse Prevention, Prevention of Counterfeits, Clinical Trial Outcomes, and Smart Contracts. Conclusion: Blockchain technology offers a new and promising solution to the pharmaceutical industry's needs. To promote the most appropriate use, each application of blockchain technology must fit within the framework of necessity, ease of implementation, familiarity amongst stakeholders, and fit of the overall industry. By using the extended framework proposed by Iansiti and Lakhani, we show how blockchain, in all these domains, shows promise to improve pharmaceutical industry performance.

Use of Sodium-Glucose Cotransporter-2 Inhibitor for Diabetes Management in Patients Following Kidney Transplantation.

Objective: To evaluate data sources pertaining to the safety and efficacy of sodium-glucose cotransporter-2 (SGLT2) inhibitor use for diabetes management in patients following kidney transplantation. Data Sources: A literature search was conducted through PubMed (1966-January 2023), EMBASE (1973-January 2023), and clinicaltrials.gov databases using the search terms kidney transplantation, diabetes mellitus, and SGLT2 inhibitor or empagliflozin, dapagliflozin, and canagliflozin. Study Selection and Data Extraction: Studies evaluating human kidney transplant recipients (KTR) receiving SGLT2 inhibitors treatment and published in the English language were included. Eight case series or retrospective analyses, 4 prospective observational studies, and 1 randomized controlled trial were identified. Data Synthesis: Available literature provides evidence that the addition of SGLT2 inhibitors may provide modest benefits on glycemic control, body weight, and serum uric acid levels in certain KTR. Various studies and case reports found that incidence of urinary tract infections was low, but still present. Overall, there are limited data on mortality and graft survival; however, one study reported a benefit of SGLT2 inhibitor use in KTR relative to these outcomes. Conclusions: The current literature evaluated demonstrates that there may be benefit to the addition of SGLT2 inhibitors for diabetes management in select KTR. However, the limited evidence within a large diverse population and extended duration of treatment makes it difficult to definitively identify the true efficacy and safety of SGLT2 inhibitor use in this population.

Examination of the Effectiveness of Direct Oral Anticoagulants in Comparison to Warfarin in an Obese Population.

Background: While commonly prescribed today, direct oral anticoagulants (DOACs) have historically been avoided in patients with class III obesity or a weight >120 kg due to limited literature regarding the efficacy and safety in this population. Objective: The overall objective was to examine the effectiveness of DOACs compared to warfarin in a population with obesity. Methods: Patients with a diagnosis of venous thromboembolism (VTE) or atrial fibrillation and a body mass index (BMI) ≥35 kg/m2 from August 1, 2015, to August 1, 2020, were included in this retrospective cohort study. Patients receiving a DOAC were matched in a 1:2 ratio to warfarin. The primary outcome was a composite of stroke or recurrent VTE. Secondary outcomes included the individual components of the primary outcome, hospitalization for bleed, and the primary outcome in patients with a BMI ≥40 kg/m2. Results: A total of 162 patients were included, with 54 and 108 in the DOAC and warfarin groups, respectively. Baseline BMI was similar between groups (45.7 kg/m2 for DOACs vs 43.8 kg/m2 for warfarin), with approximately 70% of patients having a BMI ≥40 kg/m2. The primary outcome occurred in 1 patient (1.9%) in the DOAC group and 2 patients (1.9%) in the warfarin group. The DOAC group had a higher, nonsignificant incidence of bleeding (5.6% vs 0.9%, P = 0.11). There was no difference between groups in incidence of deep vein thrombosis (DVT), pulmonary embolism (PE), or stroke in patients with a BMI ≥40 kg/m2. Conclusion: DOACs may be as efficacious as warfarin in the prevention of stroke or recurrent VTE in patients with a BMI of ≥35 kg/m2. Prospective, randomized trials are warranted to further assess the efficacy and safety of DOACs in this population.

Assessing the Impact of Comprehensive Medication Management on Achievement of the Quadruple Aim.

Nonoptimized medication regimens cost patients and payors in the United States more than $528 billion in additional health care expenses each year. Comprehensive medication management is a patient-centered approach to medication optimization delivered by a clinical pharmacist working with the patient, physicians, and other members of the health care team. Comprehensive medication management ensures medications are assessed for appropriateness, effectiveness, and safety given the patient's clinical status, comorbidities, and other medications, as well as the patient's ability to take the medications as intended and adhere to the regimen. This article reviews the growing body of literature demonstrating the value of comprehensive medication management in achieving the quadruple aim of health care: better care, reduced health care costs, an improved patient experience, and provider well-being.

A user-centered, learning asthma smartphone application for patients and providers.

PROBLEM: Smartphone applications are an increasingly useful part of patients' self-management of chronic health conditions. Asthma is a common chronic health condition for which good self-management by patients is very helpful in maintaining stability. User-centered design and intelligent systems that learn are steps forward in building applications that are more effective in providing quality care that is scalable and tailored to each patient. METHODS: A literature and application store search to review historic and current asthma smart phone applications. User-centered design is a methodology that involves all stakeholders of a proposed system from the beginning of the design phase to the end of installation. One aspect of this user-centered approach involved conducting focus groups with patients and health care providers to determine what features they desire for use in applications and create a model to build smart infrastructure for a learning health care system. A simple prototype for an asthma smartphone application is designed and built with basic functionality. OUTCOMES: Only one publication in the literature review of asthma smartphone applications describes both user-centered design and intelligent learning systems. The authors have presented a set of user-desired attributes for a smart health care application and a possible data flow diagram of information for a learning system. A prototype simple user-centered designed asthma smartphone application that better assists patients in their care illustrates the value of the proposed architecture. DISCUSSION: Our user-centered approach helped design and implement a learning prototype smart phone application to help patients better manage their asthma and provide information to clinical care providers. While popular in other industries, user-centered design has had slow adoption in the health care area. However, the popularity of this approach is increasing and will hopefully result in mobile application that better meets the needs of both patients and their care providers.

Semaglutide once-weekly: improved efficacy with a new safety warning.

INTRODUCTION: Semaglutide once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) injection has been approved as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus (T2DM). Areas Covered: The safety and efficacy of the semaglutide once-weekly injection are reviewed using results from preliminary pharmacology studies and later-phase randomized control trials (RCTs) and meta-analyses. Semaglutide once-weekly is compared to placebo and active comparators for T2DM in the SUSTAIN clinical trial series, with outcomes of: glycemic control, weight loss, major adverse cardiovascular events, and adverse effects. Risk for diabetic retinopathy complications (DRCs) is reviewed in detail, due to significantly higher risk for DRCs seen in SUSTAIN 6. SUSTAIN 6 is the first instance of a GLP-1 RA demonstrating significantly increased risk for DRCs. Semaglutide's current regulatory approvals, practice considerations, and cost-effectiveness compared to similar therapies are also considered. Expert Commentary: Semaglutide demonstrates high glycemic efficacy and favorable safety profile, and reduces the risk for cardiovascular events. Mild to moderate gastrointestinal events and retinopathy complications were more common with semaglutide compared to placebo, though serious adverse events were similar to controls and infrequent. Improved clinical efficacy should be carefully weighed against the risk for GI and retinopathy complications.

A structured mentoring program to develop junior faculty into successful co-coordinators of a large multi-instructor pathophysiology course.

BACKGROUND AND PURPOSE: To develop and implement a system for junior clinical faculty to become successful course coordinators with the use of a mentoring program and ensure that student performance and satisfaction are maintained at a high level. EDUCATIONAL ACTIVITY AND SETTING: For five years, first-time faculty discussion group leaders in a required large (>225 students) multi-instructor pathophysiology course opted into a structured mentoring program for course coordination in the subsequent year. Program categories included course material development, exam and quiz management, discussion group management, and communication among students, faculty, and staff. FINDINGS: Mentors' previous coordination experience ranged from a few years to over a decade. Faculty participants included three second-year faculty. Each participant successfully undertook a full co-coordinator role the following year. Subsequently, each then became a lead mentor the following year for new participants. Exam quality/reliability statistics were sustained at a high level, course evaluations and student performance improved throughout the program, and all mentor/mentee reflections demonstrated a positive and impactful experience. DISCUSSION AND SUMMARY: Course coordination can be a small percentage of clinical faculty workload, yet is a significant time commitment. Pharmacy resident certificate or new faculty academy programs often do not include course coordination, which is a vital, higher level function/role. Structured mentoring early in professional career of junior faculty aids in the assumption of pedagogical leadership roles, while also developing mentoring skills of mid-level faculty.

Higher Referrals for Diabetes Education in a Medical Home Model of Care.

BACKGROUND: The medical home model has been gaining attention from the health care community as a strategy for improved outcomes for management of chronic disease, including diabetes. The purpose of this study was to compare referrals for diabetes education among patients receiving care from a medical home model versus a traditional practice. METHODS: Data were obtained from a large, university-affiliated primary care patient data registry. All patients (age 18-96 years) with a diagnosis of prediabetes or diabetes and seen by a physician at least twice during 2011 to 2013 were selected for inclusion. Multivariate regression models measuring the association between medical home status and referral to diabetes education were computed before and after adjusting for covariates. RESULTS: A significantly (P < .001) higher percentage of patients in a medical home than without a medical home (23.9% vs 13.5%) received a referral for diabetes education. After adjusting for covariates, medical home patients were 2.7 times more likely to receive a referral for diabetes education (odds ratio, 2.70; 95% confidence interval, 1.69-4.35). CONCLUSION: Patients in a medical home model were more likely to receive referrals for diabetes education than patients in a standard university-affiliated family medicine practice. Future longitudinal designs that match characteristics of patients with a medical home with those of patients without one will provide strong evidence to determine whether referral to diabetes education is a result of the medical home model of care independent of confounding factors.

Buprenorphine Versus Methadone for Opioid Dependence in Pregnancy.

OBJECTIVE: To evaluate maternal and neonatal safety outcomes for methadone and buprenorphine in the obstetric population. DATA SOURCES: A literature search of PubMed (1966 to March 2016) and EMBASE (1973 to March 2016) was completed using the search terms buprenorphine, methadone, pregnancy, opioid, and neonatal abstinence syndrome Priority was given to randomized controlled trials and trials directly comparing buprenorphine and methadone during pregnancy. The bibliographies were reviewed for other relevant articles. STUDY SELECTION AND DATA EXTRACTION: All human studies published in English, that compared methadone and buprenorphine use in pregnancy were evaluated. Because of the limited number of obstetric studies, only 5 critical studies were found. DATA SYNTHESIS: Buprenorphine significantly improved or had similar outcomes to methadone for development of neonatal abstinence syndrome (NAS), percentage of infants requiring treatment for NAS (20%-47% vs 45.5%-57%, respectively), total amount of morphine used to treat NAS (0.472-3.4 vs 1.862-10.4 mg, respectively), duration of NAS (4.1-5.6 vs 5.3-9.9 days, respectively), peak NAS (3.9-11 vs 4.9-12.8 score, respectively), infant hospital stay (6.8-10.6 vs 8.1-17.5 days, respectively), and gestational age at delivery (38.8-39.7 vs 37.9-38.8 weeks, respectively). No difference was found with other neonatal or maternal outcomes. CONCLUSIONS: Both methadone and buprenorphine are effective agents, with improved safety compared with continued nonmedical opioid use during pregnancy. There is evidence to suggest that buprenorphine should be considered as an equivalent option to methadone for use in pregnancy; however, larger studies are still needed to fully evaluate buprenorphine safety and advantages over methadone in the obstetric population.

Review of pharmacotherapy options for the management of obesity.

PURPOSE: To highlight the prevalence and impact of obesity in the United States and provide nurse practitioners (NPs) with an overview of pharmacotherapy options for treatment of overweight and obese individuals. DATA SOURCE: A comprehensive review of the literature was conducted using multiple databases, including PubMed, MEDLINE, and Ovid. Keywords used to obtain relevant articles included obesity and drug, or orlistat, topiramate/phentermine, lorcaserin, bupropion/naltrexone, and liraglutide. CONCLUSIONS: Obesity is a prevalent disease with more than two thirds of Americans being considered overweight and one third being obese. Obesity places patients at an increased risk for many comorbidities that impact patient health as well as public health. There are currently five approved medications for the chronic management of obesity, two of which were approved in 2014. These pharmacological therapies are options to aid weight loss in patients that are obese or those who are overweight with additional risk factors. IMPLICATIONS FOR PRACTICE: NPs can assist patients struggling with their weight. With new pharmacotherapy options, there is an opportunity to add to diet and exercise in order to achieve increased weight loss. A decrease in obesity would potentially alleviate the burden on the healthcare system, both socially and economically, and improve patient quality of life.

Race and referral to diabetes education in primary care patients with prediabetes and diabetes.

PURPOSE: The purpose of the study was to determine whether there are any race-related disparities in the prevalence of provisions for diabetes education in primary care clinics for patients with diabetes and prediabetes. METHODS: A retrospective cross-sectional study of 3967 patients aged 14 to >89 years with prediabetes and diabetes. Medical record data from patient encounters within primary care clinics at a large academic medical health system between July 1, 2008, and July 31, 2013, were used to determine rates of referral for diabetes education by race. Multivariate logistic regression models were used to assess associations between race and referral to diabetes education. Separate regression models were computed for patients who were prediabetic and diabetic. Adjusted models included age, sex, A1C, health care utilization, smoking, and diagnosis for depression, hyperlipidemia, hypertension, vascular disease, and obesity. RESULTS: Compared to that of white patients, a significantly higher prevalence of African American patients with prediabetes were referred to diabetes education, and this association was also observed in patients with diabetes. In fully adjusted models, white patients with prediabetes were significantly less likely to be referred. CONCLUSIONS: Being African American independently increased the likelihood of referral for diabetes education in patients with prediabetes and patients with diabetes. After adjusting for patient comorbidities and risk factors, this association remained significant for patients with prediabetes. Additional research is needed to determine if provider beliefs and attitudes regarding race and diabetes education account for this association.