New Drugs: Faricimab-svoa (Vabysmo) for Macular Degeneration and Diabetic Macular Edema and Omidenepag Isopropyl (Omlonti) for Glaucoma and Ocular Hypertension.

Two drugs are covered in this quarterly column. Faricimab-svoa (Vabysmo) for Macular Degeneration and Diabetic Macular Edema and Omidenepag Isopropyl (Omlonti) for Glaucoma and Ocular Hypertension.

Assessing Information Gaps Associated with Initial Pediatric Study Plans for New Oncology Drug and Biological Products.

The Research Acceleration for Cure and Equity (RACE) for Children Act requires sponsors to submit a Pediatric Study Plan (PSP) with a proposed pediatric investigation of new molecularly targeted drugs and biologics that are intended for treatment of adult cancers, and whose target is relevant to pediatric cancer or provide a justification for a plan to request a deferral or waiver of the required investigation. A landscape analysis was performed to identify trends in information gaps associated with a sponsor's first initial PSP (iPSP) submission for oncologic new molecular entities received in 2021. Comments sent to sponsors by the US Food and Drug Administration (FDA) during the review process of each evaluated iPSP were categorized using nine flags relating to different portions of the PSP.

Provider survey of the roles of clinical pharmacists in primary care in a Federally Qualified Health Center versus an Accountable Care Organization.

Background: Healthcare providers at primary care Federally Qualified Healthcare Centers (FQHC) and an Accountable Care Organizations (ACO) collaborated with clinical pharmacists in providing patient care utilizing the comprehensive medication management (CMM) framework. The intention of CMM was to generate more time for providers to see patients, and to improve overall patient quality of life.

Objectives: The purpose of this study was to survey the providers' views of clinical pharmacy services, and to compare and contrast the shared-visit model in rural FQHCs and an ACO collaborative practice agreement model in a mid-sized metropolitan area.

New Drug: Tirzepatide (Mounjaro).

Type 2 diabetes mellitus (T2DM) is the most common form of diabetes and is a chronic and progressive illness. Millions of Americans have T2DM and many patients do not achieve the recommended blood glucose levels. Glucagon-like peptide 1 (GLP-1) based therapy is an established treatment for the management of T2DM and is recommended early in the treatment algorithm.

Drug- and patient-related factors are the strongest predictors of endocrine therapy adherence in breast cancer patients.

Purpose: Medication non-adherence to treatment regimens can severely impact the mortality of patients afflicted with breast cancer.The purpose of this study was to identify factors that contribute to non-adherence to endocrine therapy in breast cancer treatment plans.

Methods: Thirty-two women with a breast cancer diagnosis were surveyed by pharmacists and pharmacy students to identify the patient- related factors (e.

The Report of the 2018-2019 Professional Affairs Standing Committee: The Role of Educators in Pharmacy Practice Transformation.

The 2018-2019 Professional Affairs Committee examined the potential roles and needs of clinical educators (faculty and preceptors) in leading transformation in pharmacy practice. The committee was charged to (1) discuss the potential roles and responsibilities of faculty and preceptors leading transformation and enhanced patient care services in pharmacy practice; (2) describe factors, including clinician well-being and resilience, which may influence faculty and preceptor involvement in practice transformation and the enhancement of patient care services; and (3) recommend how the efforts and successes of faculty and preceptors involved in pharmacy practice transformation can be replicated and recognized as well as identify the types of continuing professional development (CPD) that should be available to enable the influence and implementation of patient care services. This report provides a framework for addressing the committee charges by examining the roles of advocacy, collaboration, continuing professional development, and clinician resilience and well-being.

Effect of Aromatase Inhibition (Exemestane) on Urine Concentration of Osteoprotegerin in Healthy Postmenopausal Women.

This pilot study examined how exemestane (an aromatase inhibitor [AI]) affected osteoprotegerin (OPG) urine concentrations in postmenopausal women. Exemestane (25 mg, single dose) was given to 14 disease-free women past menopause in this nonrandomized, open-label study. Before dosing, urine specimens were gathered.

Exemestane may be less detrimental than letrozole to bone health in women homozygous for the UGT2B17*2 gene deletion.

Purpose: UGT2B17 gene deletion (UGT2B17*2) has been reported to affect bone health as well as the pharmacokinetics of aromatase inhibitor (AI) drugs such as exemestane. The goal of this study was to assess associations between UGT2B17 gene deletion and bone health prior to and after 24 months of AI treatment in postmenopausal women with hormone receptor positive (HR+) breast cancer.

Methods: Bone health in women with HR+ breast cancer enrolled on the prospective randomized Exemestane and Letrozole Pharmacogenetics (ELPh) trial was determined by measuring bone turnover markers (BTM) and bone mineral density (BMD) pre-treatment and after 3 BTM and 24 BMD months of treatment with either the steroidal AI exemestane or the nonsteroidal AI letrozole.

Descriptive Analysis of Acceptance by Prescribers and Economic Benefit of Pharmacist Recommended Interventions in a Critical Care Unit.

Background: Pharmacist clinical intervention is defined as the action that identifies and prevents medication-related problems and optimizes patient's medication therapy in cooperation with other healthcare professionals. Types of clinical interventions may vary, but each is patient specific. Few studies have focused on clinical pharmacists interventions in a critical care setting at a rural hospital.

Influence of Transporter Polymorphisms on Drug Disposition and Response: A Perspective From the International Transporter Consortium.

Advances in genomic technologies have led to a wealth of information identifying genetic polymorphisms in membrane transporters, specifically how these polymorphisms affect drug disposition and response. This review describes the current perspective of the International Transporter Consortium (ITC) on clinically important polymorphisms in membrane transporters. ITC suggests that, in addition to previously recommended polymorphisms in ABCG2 (BCRP) and SLCO1B1 (OATP1B1), polymorphisms in the emerging transporter, SLC22A1 (OCT1), be considered during drug development.

Impact of the OATP1B1 c.521T>C single nucleotide polymorphism on the pharmacokinetics of exemestane in healthy post-menopausal female volunteers.

What Is Known And Objective: OATP1B1 mediates the transport of a diverse range of amphiphilic organic compounds that include bile acids, steroid conjugates and hormones. This retrospective pharmacogenetic study was conducted to assess the impact of the OATP1B1 c.521T>C single nucleotide polymorphism (SNP) on the pharmacokinetics of the steroidal aromatase inhibitor drug exemestane in healthy volunteers.

COX2 induction: a mechanism of endocrine breast cancer resistance?

Purpose: Urine prostaglandin E2 (PGE2) levels have shown to be a risk factor of breast cancer, and the use of nonsteroidal anti-inflammatory drugs (NSAIDs) is known to be beneficial in preventing breast cancer risk and/or recurrence with or without aromatase inhibitors. We hypothesized that the use of an aromatase inhibitor triggers the activation of the inflammatory pathway via release of PGE2.

Methods: A single oral 25 mg dose of an aromatase inhibitor (exemestane) was given to 14 healthy postmenopausal female volunteers.

Clinical Interpretation of Urine Drug Tests: What Clinicians Need to Know About Urine Drug Screens.

Urine drug testing is frequently used in clinical, employment, educational, and legal settings and misinterpretation of test results can result in significant adverse consequences for the individual who is being tested. Advances in drug testing technology combined with a rise in the number of novel misused substances present challenges to clinicians to appropriately interpret urine drug test results. Authors searched PubMed and Google Scholar to identify published literature written in English between 1946 and 2016, using urine drug test, screen, false-positive, false-negative, abuse, and individual drugs of abuse as key words.

Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial.

Background: In polypharmacy patients under home health management, pharmacogenetic testing coupled with guidance from a clinical decision support tool (CDST) on reducing drug, gene, and cumulative interaction risk may provide valuable insights in prescription drug treatment, reducing re-hospitalization and emergency department (ED) visits. We assessed the clinical impact of pharmacogenetic profiling integrating binary and cumulative drug and gene interaction warnings on home health polypharmacy patients.

Methods And Findings: This prospective, open-label, randomized controlled trial was conducted at one hospital-based home health agency between February 2015 and February 2016.

Time-kill Kinetics of a Novel Antimicrobial Silver Wound Gel Against Select Wound Pathogens.

Unlabelled: New treatments are needed as infection risk associated with diabetic, venous, and pressure ulcers are becoming more prevalent as comorbidities of obesity, aging, and major disease. Postsurgical, burn, and immunocompromised patients are also at an increased risk of wounds and infection. Silver has been utilized in treating various wounds associated with infections and, although highly effective, caution is required for use beyond 2 weeks due to potential silver cytotoxicity.

Impact of UGT2B17 Gene Deletion on the Pharmacokinetics of 17-Hydroexemestane in Healthy Volunteers.

Exemestane is an aromatase inhibitor drug used for the treatment of hormone-dependent breast cancer. 17-Hydroexemestane, the major and biologically active metabolite of exemestane in humans, is eliminated via glucuronidation by the polymorphic UGT2B17 phase II drug-metabolizing enzyme. Previous microsomal studies have shown that UGT2B17 gene deletion affects the intrinsic hepatic clearances of 17-hydroexemestane in vitro.

Glacial Acetic Acid Adverse Events: Case Reports and Review of the Literature.

Glacial acetic acid is a dangerous chemical that has been associated with several adverse drug events involving patients over recent years. When diluted to the proper concentration, acetic acid solutions have a variety of medicinal uses. Unfortunately, despite warnings, the improper dilution of concentrated glacial acetic acid has resulted in severe burns and other related morbidities.

Antileukemic Efficacy of Continuous vs Discontinuous Dexamethasone in Murine Models of Acute Lymphoblastic Leukemia.

Osteonecrosis is one of the most common, serious, toxicities resulting from the treatment of acute lymphoblastic leukemia. In recent years, pediatric acute lymphoblastic leukemia clinical trials have used discontinuous rather than continuous dosing of dexamethasone in an effort to reduce the incidence of osteonecrosis. However, it is not known whether discontinuous dosing would compromise antileukemic efficacy of glucocorticoids.

Characterization of the effects of heat stress on the DNA-intercalating dye EvaGreen for potential use with the joint biological agent identification and diagnostic system.

Although advances in real-time polymerase chain reaction (PCR) technology and equipment have facilitated field research, only a limited selection of reagents do not require cold storage. This study explored the temperature stability of the commercially available DNA-intercalating dye EvaGreen after exposure to a spectrum of temperatures for 176 days by analyzing quantification cycle (Cq) and end fluorescence levels during amplification of the invA gene of Salmonella typhimurium. To further characterize potential dye stability, the effects of small differences in dye volume were examined and dye samples were subjected to an Air Force deployment to the Middle East.

Treatments for methamphetamine abuse: a literature review for the clinician.

Methamphetamine (METH) use and dependence is a serious public health concern with implications across multiple areas from societal impact to burden on psychiatric and medical resources. An estimated 8% of admissions to substance abuse treatment programs are related to stimulants with METH/amphetamine abuse. To date, effective pharmacotherapy options to enhance abstinence have not been identified.