Clinical Insights: November 10, 2020

    Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place. Contact us to learn more.

    New Drug Approval

    SesquientTM (fosphenytoin sodium) Injection – New Drug Approval – November 5, 2020 – Sedor Pharmaceuticals, LLC announced that the U.S. Food and Drug Administration (FDA) has approved SesquientTM (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients. According to Neurocritical Care Society Guidelines, status epilepticus, which is classified as a single epileptic seizure lasting more than five minutes or two or more seizures within a five-minute period, must be treated quickly since irreversible brain damage or death may result if cessation of seizure is not achieved within 60 minutes of onset. Ready-to-dilute and room temperature stable, SesquientTM is the only FDA-approved fosphenytoin that allows point-of-care storage, as well as fast and efficient administration in emergency rooms, intensive care units, first responder vehicles, and long-term care facilities, where serial seizures such as status epilepticus are most commonly treated. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    No new update.

    New/Updated Drug Shortage

    November 10, 2020

    November 09, 2020

    November 06, 2020

    New Drug Recall and Safety Alerts

    Chlorhexidine Gluconate Oral Rinse USP, 0.12% by Lohxa LLC – New Drug Recall – November 9, 2020 – Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an expiration date from 01/31/21 – 03/31/21 (see specific lots below) to the consumer level. This product is sourced and repackaged from Sunstar Americas Inc. who has notified us the product may be contaminated with the bacteria Burkholderia lata. <Read More>

    New Generic/Biosimilar Approval and Launch

    Tirosint® (levothyroxine) – First-time Authorized Generic Approval – November 3, 2020 – Lannett Company, Inc. announced that it has commenced the launch of the authorized generic of Tirosint® (Levothyroxine Sodium Capsules USP). Lannett entered into an exclusive U.S. distribution agreement with IBSA Institut Biochimique SA, a global pharmaceutical company headquartered in Switzerland. Under the agreement, Lannett will primarily provide sales, marketing and distribution support for the product, for which it will receive a share of the profits. Other financial terms were not disclosed. <Read More>

    Clinical and Pharmacy New

    Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19 – November 9, 2020 – The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions. <Read More>

    FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development – November 9, 2020 – Throughout my career as a cancer doctor and medical researcher, I have been concerned about and have sought to address issues related to health care disparities. One important step that researchers and medical product sponsors can take to confront health care disparities is to make sure that clinical trials for medical products are more inclusive of multiple populations. We have seen these health care disparities, for example, during our fight against COVID-19, as certain segments of the population (e.g., older adults, pregnant women, children, and racial and ethnic minorities) are affected in different ways. This difference in impact illustrates why we must encourage developers of any medical product such as treatments or vaccines for COVID-19 – as well as medical products more broadly – to endeavor to include diverse populations to understand their risks or benefits across all groups. <Read More>

    New RA Guideline Emphasizes Maximizing Methotrexate and Biologics, Minimizing Steroids – November 6, 2020 – The American College of Rheumatology (ACR) will preview its 2020 Guideline for the Management of Rheumatoid Arthritis (RA) at ACR Convergence, the ACR’s annual meeting. The comprehensive, clinical recommendations for pharmacologic treatment of RA includes important updates to the previous guideline released in 2015. <Read More>

    Methotrexate Use Linked to Greater Tuberculosis Risks – November 6, 2020 – Tuberculosis screening among patients receiving methotrexate in high-risk areas is a greatly unmet need in public healthcare. In a new assessment presented at the American College of Rheumatology (ACR) Convergence 2020, investigators from North America reported that methotrexate—a staple of rheumatic disease care and a driver of cell-mediated immunity interruption—was associated with greater regional tuberculosis cases. <Read More>

    FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults – November 6, 2020 – The U.S. Food and Drug Administration permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The device provides gentle vibration through touch based on an analysis of heart rate and motion during sleep. <Read More>

    Coronavirus (COVID-19) Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection – November 6, 2020 – The U.S. Food and Drug Administration authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells. The FDA issued an emergency use authorization (EUA) for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which specifically detects this type of antibody. <Read More> 

    What’s Ahead? Pharmacy Technology Will Drive Patient Care – November 6, 2020 – Pharmacies across all care settings, from retail chain and community pharmacies to hospitals, health systems, and long-term care facilities, are tasked with keeping their patients healthy and adherent while facing pressure from payers on reimbursement rates, compressing margins, and the need to stay compliant. Supporting these pharmacies and finding new ways to help them improve the care they deliver—while reducing costs and improving efficiency—has been a key focus for 2020 and will continue into next year. <Read More>

    American Pharmacists Association Begins Recruiting for New 2021 Executive Residency Program – November 5, 2020 – The American Pharmacists Association (APhA) is expanding career opportunities for pharmacists by growing its portfolio of postgraduate training programs. Building on the success of the APhA Foundation Executive Fellowship in Association Management & Leadership, which is funded by the Knowlton Center for Pharmacist-Based Health Solutions and provides broad association management and executive training, APhA will also begin recruiting for a new 2021–2022 Executive Residency program. “We’re instituting these new positions and growing this program for several reasons. First, we want to offer pharmacists opportunities to advance their careers and gain insights and prospects for leadership. At the same time, we are engaging pharmacists in the success of APhA’s strategies, with the current and future needs of the profession in mind,” said Scott J. Knoer, MS, PharmD, FASHP, APhA Executive Vice President and CEO. <Read More>

    Algorithm Reduces Use of Riskier Antibiotics for UTIs – November 5, 2020 – One paradox about antibiotics is that, broadly speaking, the more we use them, the less they continue to work. The Darwinian process of bacteria growing resistant to antibiotics means that, when the drugs don’t work, we can no longer treat infections, leading to groups like the World Health Organization warning about our ability to control major public health threats. Because of its ubiquity, one topic that’s particularly concerning is urinary tract infections (UTIs), which affect half of all women and add almost $4 billion a year in unnecessary health-care costs. <Read More>

    Pharmacy Group Warns Over Anti-Competitive Partnership – November 5, 2020 – If you’re taking prescription medication and if you have Medicare Part D Drug coverage, you know how expensive it’s become. But according to the National Community Pharmacists Association, which calls itself the “voice for independent pharmacy” for 21,000 pharmacies across the United States, a pending partnership between two pharmacy benefit managers (PBM’s) — Express-Scripts and Prime Therapeutics “will squash local pharmacies and ultimately limit consumer choices.” <Read More>

    The BCG Shortage: What’s Being Done—And What You Can Do – November 4, 2020 – In this interview, Seth P. Lerner, MD, discusses current recommendations for managing patients during the BCG shortage, what the FDA is doing to resolve the problem, and a SWOG trial testing a new strain of BCG. The non–muscle invasive bladder cancer treatment BCG remains in short supply, with Merck currently serving as the sole supplier of the medication in the US. In this interview, Seth P. Lerner, MD, discusses current recommendations for managing patients during this shortage, what the FDA is doing to resolve the problem, and a SWOG trial testing a new strain of BCG. <Read More>

    Experts Lead Call to Action for Doctors to Heed Guidelines on Diabetes Care – November 4, 2020 – Large clinical trials involving patients with type 2 diabetes at high cardiovascular risk have led to remarkable advances in our understanding of the effectiveness of two types of diabetes drugs – GLP-1 receptor agonists and SGLT2 inhibitors – to reduce high blood sugar and reduce adverse health events related to the heart and kidney disease. But only a small proportion of patients with diabetes and cardiovascular disease are currently treated with these medications. Moreover, cardiologists very rarely prescribe these potentially life-saving drugs. <Read More>

    New Migraine Drugs Target Triptan Contraindication Population – November 4, 2020 – Migraines are a chronic neurobiological condition that are among the most common disabling health conditions affecting people worldwide. This disorder peaks in prevalence between 25 and 55 years of age and the patient population is approximately 75% female. The current acute migraines treatments have shown efficacy and safety, however, approximately one-third of people do not respond, cannot use these options due to contraindications, or report dissatisfaction in therapy. Triptans are considered the gold standard for the acute treatment of moderate to severe migraine, with strong evidence in support of their efficacy. <Read More>

    USPSTF Updates Recommendation for Earlier Colorectal Cancer Screening – November 4, 2020 – The United States Preventive Services Task Force (USPSTF) now recommends that colorectal cancer (CRC) screening begin 5 years earlier, at age 45 versus age 50, according to new draft guidelines. The grade B recommendation, which endorses screening for CRC in adults aged 45 to 49 years, also lists the noninvasive CRC screening test Cologuard as a recommended screening method for all average-risk adults between the ages of 45 years and 75 years. CRC screening for adults aged 50 years to 75 years remains a grade A recommendation. <Read More>

    Countering COVID-19’s Thromboinflammation – November 4, 2020 – Even before Yale New Haven Hospital, in Connecticut, started receiving an influx of COVID-19 patients this spring, staff there heard from colleagues in New York City about some unexpected complications from the causative virus. Chief among them was multisystem inflammatory syndrome (MIS). The syndrome, characterized by fever, systemic inflammation and organ dysfunction (Ann Intern Med 2020 Jul 29. doi: 10.7326/L20-0882), also can lead to vascular damage. <Read More>

    Hydroxyurea Adherence Linked to Low Opioid Use in Sickle Cell Patients – November 4, 2020 – Findings from a new study showed a negative correlation between hydroxyurea adherence and risk of receiving a prescription for strong opioids among patients with sickle cell disease. Current practice guidelines recommend opioid analgesics due to the recurrent pain crises experienced by these patients. However, hydroxyurea has long demonstrated benefit in reducing these crises. Nevertheless, there has been limited research assessing hydroxyurea adherence and opioid use among this population. <Read More>

    Americans Have Almost Doubled Spending on Specialty Drugs From Pharmacies, Study Finds – November 4, 2020 – Between 2010 and 2017, Americans nearly doubled spending on specialty drugs purchased at pharmacies or by mail after accounting for rebates, according to a study cited by STAT. Seven things to know about the study, as reported by STAT: 1) Specialty drugs made up 38 percent of retail and mail-order prescription spending in 2017, up from 20 percent in 2010. Spending tripled for Medicare Part D beneficiaries and more than doubled for those with private insurance, according to the study, which was published in Health Affairs. <Read More>

    Pharmacy Chains Report Higher Than Usual Demand for Flu Vaccines – November 4, 2020 – Americans are taking the advice of US health care leaders, pharmacists, and others by getting flu vaccinations in record numbers this fall. CVS Health pharmacy staff have already administered more influenza vaccinations than the 9 million flu vaccines it gave during the entire previous flu season, a spokesperson told Bloomberg. Plus, CVS expects to double that number by the end of this season, the spokesperson said. <Read More>

    340B in the News

    Community Health Center Alliance Sues California to Preserve 340B Drug Pricing Program – November 6, 2020 – The Community Health Center Alliance for Patient Access (CHCAPA) filed a lawsuit in federal court contesting California’s plan to exclude the pharmacy benefit from Medicaid managed care, which would prevent community health centers from benefitting from the  Federal 340B Drug Pricing Program. The CHCAPA contends eliminating the benefit would “strike a major financial blow” to health centers providing care to low-income communities and would divert the funds Congress intended to help these centers serve the communities. <Read More>