An Analysis of Medication Adherence in a Large Outpatient Population During the COVID-19 Pandemic Using a Novel Value-Based Pharmacy System.

Background: Adherence to a medication regimen is defined as taking the medication as directed by the prescriber. Adherence is critical to achieve the desired therapeutic outcomes. Medication adherence has not been examined in large outpatient populations since the onset of the COVID-19 pandemic. A novel outpatient value-based pharmacy system (VPS) was used to collect adherence data from a large, outpatient population. The aim of this descriptive study was to analyze the reasons, medication classes, and diagnoses associated with nonadherence. Materials and Methods: Telepharmacist-documented adherence data from a large (n = 6,479) outpatient population that received remote consultation during the COVID-19 pandemic (August 1, 2020-November 28, 2022) were considered for this study. The adherence data were compiled within the VPS. Results: The overall rate of patients reporting at least one incident of nonadherence to their medication regimens was 21.5%. Medications used to treat hypertension, type 2 diabetes, and hyperlipidemia were least adhered to. Statins, beta-2 agonists, and corticosteroids were least adhered to. The most common reasons for nonadherence included knowledge gaps regarding therapy, forgetfulness, and side effects. Discussion: This represents the first descriptive analyses of adherence metrics in a large outpatient population during the COVID-19 pandemic. Polypharmacy, prevalence of diagnosis, and medication side effect profile may have contributed to the results observed. This study demonstrates the ability of a VPS to document key data to better inform the health care team. Elucidating adherence metrics in such populations may allow pharmacists and prescribers to identify subpopulations that require further education and management.

Access to Telepharmacy Services May Reduce Hospital Admissions in Outpatient Populations During the COVID-19 Pandemic.

Introduction: Avoidable hospital admissions put increased pressure on already strained health care resources, causing emotional and financial distress for patients and their families while taxing the health system. Pharmacist involvement in patient care has been shown to improve health care outcomes. Telepharmacy allows for personalized interaction and access to pharmacy services in a flexible format. The primary aim of this report is to explore the impact that access to a personalized telepharmacy service has on the hospital admission rate in an outpatient population before and during the COVID-19 pandemic. Materials and Methods: A retrospective, double-arm cohort study was performed. Hospital admission rates were analyzed in two similarly aged groups; one group (n = 2,242) had access to telepharmacy services through their primary care provider and another group did not (n = 1,540), from 2019 to 2020. Statistical analysis was performed to explore hospitalization rates in both groups. Results: An increase in hospitalization rates was observed in both groups of patients from 2019 to 2020. The patient group that had access to the telepharmacy service demonstrated a reduced rise in hospitalization rates versus the group without access to the telepharmacy service (access group +12.9% vs. nonaccess group +40.2%, p < 0.05, Student's t-test). Discussion: The patient group with access to telepharmacy services demonstrated a reduced increase in hospitalizations versus the group without access in 2020. While this represents a preliminary investigation into the potential impacts of telepharmacy on hospitalization rates, telepharmacy services may have a role in improving patient outcomes and cost savings.

Analysis of Heteroplasmic Variants in the Cardiac Mitochondrial Genome of Individuals with Down Syndrome.

Individuals with Down syndrome (DS, trisomy 21) exhibit a pro-oxidative cellular environment as well as mitochondrial dysfunction. Increased oxidative stress may damage the mitochondrial DNA (mtDNA). The coexistence of mtDNA variants in a cell or tissue (i.e., heteroplasmy) may contribute to mitochondrial dysfunction. Given the evidence on mitochondrial dysfunction and the relatively high incidence of multiorganic disorders associated with DS, we hypothesized that cardiac tissue from subjects with DS may exhibit higher frequencies of mtDNA variants in comparison to cardiac tissue from donors without DS. This study documents the analysis of mtDNA variants in heart tissue samples from donors with (n = 12) and without DS (n = 33) using massively parallel sequencing. Contrary to the original hypothesis, the study's findings suggest that the cardiac mitochondrial genomes from individuals with and without DS exhibit many similarities in terms of (1) total number of mtDNA variants per sample, (2) the frequency of mtDNA variants, (3) the type of mtDNA variants, and (4) the patterns of distribution of mtDNA variants. In both groups of samples, the mtDNA control region showed significantly more heteroplasmic variants in comparison to the number of variants in protein- and RNA-coding genes (P < 1.00×10-4 , ANOVA).

Pharmacokinetics of Chemotherapeutic Drugs in Pediatric Patients With Down Syndrome and Leukemia.

Children with Down syndrome (DS) have a 10- to 30-fold increased risk of developing acute myeloid leukemia or acute lymphoblastic leukemia. Patients with DS and leukemia are treated with the same chemotherapeutic agents as patients without DS. Treatment regimens for pediatric leukemia comprise multiple cytotoxic drugs including methotrexate, doxorubicin, vincristine, cytarabine, and etoposide. There have been reports of increased toxicity, as well as altered therapeutic outcomes in pediatric patients with DS and leukemia. This review is focused on the pharmacokinetics of cytotoxic drugs in pediatric patients with leukemia and DS. The available literature suggests that methotrexate and thioguanine display altered pharmacokinetic parameters in pediatric patients with DS. It has been hypothesized that the variable pharmacokinetics of these drugs may contribute to the increased incidence of treatment-related toxicities seen in DS. Data from a small number of studies suggest that the pharmacokinetics of vincristine, etoposide, doxorubicin, and busulfan are similar between patients with and without DS. Definitive conclusions regarding the pharmacokinetics of cytotoxic drugs in pediatric patients with leukemia and DS are difficult to reach due to limitations in the available studies.

Mitochondrial DNA heteroplasmy in cardiac tissue from individuals with and without coronary artery disease.

The cellular environment associated with coronary artery disease (CAD) can lead to mitochondrial DNA (mtDNA) damage. Mitochondrial variants in some copies of mtDNA (heteroplasmy) and mtDNA content are potential genetic biomarkers for CAD-associated disease states. Massively parallel sequencing and qRT-PCR techniques were used to measure heteroplasmic variants and mtDNA content in heart samples from donors with (n = 8) and without (n = 7) documented CAD. Both groups showed increased numbers of heteroplasmic mtDNA variants in the control region (CR) (p < .0010, ANOVA). The donors with CAD displayed a 41.07% increase in heteroplasmic mtDNA variant number in the CR (p = .043), an 87.50% increase in the number of heteroplasmic mtDNA deletions (p = .12), and a 48.76% increase in the number of heteroplasmic mtDNA single nucleotide variants (p = .029). These data suggest potential trends towards higher cardiac mtDNA heteroplasmy levels in heart samples from donors with CAD.

Analysis of outpatient HER2 testing in New York state using the statewide planning and research cooperative system.

AIM: HER2 testing is necessary in the context of therapy with trastuzumab, pertuzumab, lapatinib and neratinib. There is a paucity of reports describing the utilization rates of HER2 testing in large outpatient populations. METHODS: The Statewide Planning and Research Cooperative System (SPARCS) was used to examine HER2 testing across the state of New York (USA) during the 2012-2016 period. RESULTS: There was a linear increase in HER2 testing (r = 0.91, p = 0.030). There were increases in HER2 testing observed among minorities, including 0.5-fold and 3.5-fold increases in individuals identified as black and Asian, respectively. Major state population centers showed the highest HER2 testing. CONCLUSION: This study establishes a platform to further evaluate clinical utility, outcomes and equity of access for 'precision oncology' testing.

Pharmacotherapeutic Considerations for Individuals with Down Syndrome.

Down syndrome (DS; trisomy 21) is the most common survivable disorder due to aneuploidy. Individuals with DS may experience multiple comorbid health problems including congenital heart defects, endocrine abnormalities, skin and dental problems, seizure disorders, leukemia, dementia, and obesity. These associated conditions may necessitate pharmacotherapeutic management with various drugs. The complex pathobiology of DS may alter drug disposition and drug response in some individuals. For example, reports have documented increased rates of adverse drug reactions in patients with DS treated for leukemia and dementia. Intellectual disability resulting from DS may impact adherence to medication regimens. In this review, we highlight literature focused on pharmacotherapy for individuals with DS. We discuss reports of altered drug disposition or response in patients with DS and explore social factors that may impact medication adherence in the DS setting. Enhanced monitoring during drug therapy in individuals with DS is justified based on reports of altered drug disposition, drug response, and other characteristics present in this population.

Hospital consumer assessment of healthcare providers and systems scores relating to pain following the incorporation of clinical pharmacists into patient education prior to joint replacement surgery.

BACKGROUND: Pharmacist involvement has been shown to improve various aspects of patient care. Patients undergoing knee and hip replacement surgery generally experience post-operative pain and discomfort. Pain control can impact patient satisfaction, as reported by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. OBJECTIVE: The current pilot study aims to measure the potential impact that incorporating pharmacists into preoperative patient education programs has on the response to select HCAHPS questions. METHODS: Patient responses to two select HCAHPS questions related to pain were recorded for a year prior to pharmacist involvement in a comprehensive preoperative patient education program (2012) and a year after pharmacists became actively involved (2013). RESULTS: In all reporting surgical patients, there was a modest 3.68% improvement in mean scores reflecting patient's feelings that hospital staff did "everything they could" to attend to their pain (mean2012=3.66, SD=0.63 versus mean2013=3.80, SD=0.43, p=0.018, Mann-Whitney U test). There was a non-significant 2.98% improvement in scores reflecting the level that pain was "well controlled" (mean2012=3.54, SD=0.651 versus mean2013=3.65, SD=0.554, p=0.069, Mann-Whitney U test) in surgical patients. CONCLUSION: The results suggest comprehensive pharmacist involvement in patient education prior to joint replacement surgery may impact HCAHPS scores related to pain control. While the observed potential improvements were modest, the current results justify larger, multi-institution prospective studies to better elucidate the impact pharmacists can have on pain management in patients undergoing joint replacement.

Anthracycline-Related Cardiotoxicity in Patients with Acute Myeloid Leukemia and Down Syndrome: A Literature Review.

Pediatric patients with Down syndrome (DS) are at an increased risk of developing certain cancers. Specifically, patients with DS have a reported 10-20-fold increased risk of developing acute myeloid leukemia (AML). Anthracycline-based treatment regimens achieve good results in patients with DS and AML. It has been proposed that DS status constitutes a risk factor for the cardiotoxicity associated with the use of anthracyclines in the pediatric setting. However, published evidence pointing toward an increased risk of cardiotoxicity in patients with DS is relatively scarce and conflictive. This concise review compiles literature relating to the incidence of anthracycline-related cardiotoxicity in pediatric patients with DS. In general, reports from trials using anthracyclines at the maximum recommended dose showed increases in the incidence of anthracycline-related cardiotoxicity in patients with DS in comparison with trials that used anthracyclines at reduced doses. Evidence from the literature suggests that patients with DS can achieve favorable therapeutic outcomes after receiving treatment with reduced doses of anthracyclines to minimize the potential for cardiotoxicity. Further prospective trials, along with the available evidence, would assist the design of treatment protocols for patients with pediatric leukemias and DS.

Analysis of mtDNA, miR-155 and BACH1 expression in hearts from donors with and without Down syndrome.

Cancer patients with Down syndrome (DS) are at increased risk for anthracycline-related cardiotoxicity. Mitochondrial DNA (mtDNA) alterations in hearts with-DS may contribute to anthracycline-related cardiotoxicity. Cardiac mtDNA and the mtDNA(4977) deletion were quantitated in samples with- (n = 11) and without-DS (n = 31). Samples with-DS showed 30% lower mtDNA (DS(MT-ND1/18Sratio): 1.48 ± 0.72 versus non-DS(MT-ND1/18Sratio): 2.10 ± 1.59; p = 0.647) and 30% higher frequency of the mtDNA(4977) deletion (DS(% frequency mtDNA(4977)) deletion: 0.0086 ± 0.0166 versus non-DS(% frequency mtDNA(4977)) deletion: 0.0066 ± 0.0124, p = 0.514) than samples without-DS. The BACH1 and microRNA-155 (miR-155) genes are located in chromosome 21, and their products have demonstrated roles during oxidative stress. BACH1 and miR-155 expression did not differ in hearts with- and without-DS. An association between BACH1 and miR-155 expression was detected in hearts without-DS, suggesting alterations between BACH1-miR-155 interactions in the DS settings.

Hospital consumer assessment of healthcare providers and systems scores relating to pain following the incorporation of clinical pharmacists into patient education prior to joint replacement surgery

Background: Pharmacist involvement has been shown to improve various aspects of patient care. Patients undergoing knee and hip replacement surgery generally experience post-operative pain and discomfort. Pain control can impact patient satisfaction, as reported by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. Objective: The current pilot study aims to measure the potential impact that incorporating pharmacists into preoperative patient education programs has on the response to select HCAHPS questions. Methods: Patient responses to two select HCAHPS questions related to pain were recorded for a year prior to pharmacist involvement in a comprehensive preoperative patient education program (2012) and a year after pharmacists became actively involved (2013). Results: In all reporting surgical patients, there was a modest 3.68% improvement in mean scores reflecting patient’s feelings that hospital staff did "everything they could" to attend to their pain (mean 2012=3.66, SD=0.63 versus mean 2013=3.80, SD=0.43, p=0.018, Mann-Whitney U test). There was a non-significant 2.98% improvement in scores reflecting the level that pain was "well controlled" (mean2012=3.54, SD=0.651 versus mean2013=3.65, SD=0.554, p=0.069, Mann-Whitney U test) in surgical patients. Conclusion: The results suggest comprehensive pharmacist involvement in patient education prior to joint replacement surgery may impact HCAHPS scores related to pain control. While the observed potential improvements were modest, the current results justify larger, multi-institution prospective studies to better elucidate the impact pharmacists can have on pain management in patients undergoing joint replacement (AU)

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