Clinical Insights: April 16, 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

    Koselugo® (selumetinib) – New Drug Approval – April 10, 2020 – The U.S. Food and Drug Administration approved Koselugo® (selumetinib) for the treatment of pediatric patients, 2 years of age and older, with neurofibromatosis type 1 (NF1), a genetic disorder of the nervous system causing tumors to grow on nerves. Koselugo® is the first drug approved by the FDA to treat this debilitating, progressive and often disfiguring rare disease that typically begins early in life. <Read More>

    New Formulation Approval

    No new update

    New Indication Approval

    Reblozyl® (luspatercept-aamt) – New Indication Approval ­– April 3, 2020 – Bristol Myers Squibb and Acceleron Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Reblozyl® (luspatercept-aamt), the first and only erythroid maturation agent (EMA), for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T). Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia. <Read More>

    New Drug Shortage

    April 13, 2020

     

    April 10, 2020

     

    April 09, 2020

     

    April 08, 2020 

     

    April 07, 2020

    New Drug Recall and Safety Alerts

    No new update

    New Generic Approval and Launch

    Proventil® HFA (albuterol sulfate) Metered Dose Inhaler – New Generic Approval – April 8, 2020 – The U.S. Food and Drug Administration approved the first generic of Proventil® HFA (albuterol sulfate) Metered Dose Inhaler, 90 mcg/Inhalation, for the treatment or prevention of bronchospasm in patients four years of age and older who have reversible obstructive airway disease, as well as the prevention of exercise-induced bronchospasm in this age group. <Read More>

    COVID-19 News

    Pharmacists Respond to COVID-19: An Army of Experts Needed – April 9, 2020 – Infectious diseases (ID) pharmacists and antibiotic stewardship programs (ASP) provide potent weapons for combating COVID-19 in hospitalized patients. However, an “army of experts” is needed to win the battle. We describe selected examples of how non-ID clinical pharmacists are stepping up to do whatever it takes to care for COVID-19 patients at The Ohio State University Wexner Medical Center. <Read More>

     APhA Developing Training Program for Pharmacists at COVID-19 Testing Sites – April 9, 2020 – A steering group for the American Pharmacists Association (APhA) is in the process of creating a nasopharyngeal swab training program for pharmacists to continue their efforts in combatting the coronavirus disease 2019 (COVID-19). Michael Klepser, PharmD, FCCP, FIDP is not only a part of this group, but was also a potential carrier of the virus himself. <Read More>

     Pharmacy Groups Praise HHS Guidance Allowing Pharmacists to Provide COVID-19 Testing – April 9, 2020 – A coalition of national and local pharmacy organizations is praising the Department of Health and Human Services’ (HHS) decision to allow licensed pharmacists to order and administer COVID-19 tests during the new coronavirus disease pandemic. “Pharmacists, in partnership with other healthcare providers, are well positioned to aid COVID-19 testing expansion. Pharmacists are trusted healthcare professionals with established relationships with their patients,” HHS said in an April 8 guidance. <Read More>

    ASHP Survey: Mask Shortages Common – April 7, 2020 – Four out of 10 U.S. hospitals and health systems (42%) are experiencing moderate to major disruptions in medical mask supplies, an increase of 17 percentage points from two weeks ago, according to Round 2 of ASHP’s biweekly member survey on the status of medical supplies during the COVID-19 pandemic. Those reporting serious disruptions have either had to go without masks or used alternatives “with mixed or poor results,” according to the survey, which included responses from 382 member hospitals and health systems. <Read More>

     Demand for Ventilator Drugs ‘Unprecedented’ – April 7, 2020 – he danger that there won’t be enough medications to facilitate mechanical ventilation in COVID-19 patients is sharply rising just as coronavirus infections surge in hotspots around the nation, according to a new Vizient analysis of 13 critical sedatives, opioids and paralytic drugs. “What we’re seeing right now is an unprecedented demand for these medications, and we’re not at an apex yet from what our data are showing,” said Dan Kistner, PharmD, the group vice president of pharmacy solutions at Vizient Inc. <Read More>

    Communicating with Patients in the Time of COVID-19 – April 7, 2020 – The COVID-19 outbreak has affected every part of our health care system. Pharmacies, just as expected, have showed up in meaningful ways to support their communities. We’re seeing independent community pharmacies compound hand sanitizer and donate the product to medical facilities, local emergency medical services, fire and police departments. Many pharmacies are operating closed-door stores and delivering prescriptions right to their patients’ homes. <Read More>

     COVID-19: Potential Implications for Individuals with Substance Use Disorders – April 6, 2020 – As people across the U.S. and the rest of the world contend with coronavirus disease 2019 (COVID-19), the research community should be alert to the possibility that it could hit some populations with substance use disorders (SUDs) particularly hard. Because it attacks the lungs, the coronavirus that causes COVID-19 could be an especially serious threat to those who smoke tobacco or marijuana or who vape. <Read More>

     Aerosol and Surface Distribution of Severe Acute Respiratory Syndrome Coronavirus 2 in Hospital Wards, Wuhan, China, 2020 – March 2020 – To determine distribution of severe acute respiratory syndrome coronavirus 2 in hospital wards in Wuhan, China, we tested air and surface samples. Contamination was greater in intensive care units than general wards. Virus was widely distributed on floors, computer mice, trash cans, and sickbed handrails and was detected in air ≈4 m from patients. <Read More>

    Clinical and Pharmacy News

    Biosimilar Medicine Group Concerned About Actions Limiting Drug Supply Amid COVID-19 – April 12, 2020 – Aware that travel restrictions and border controls imposed by coronavirus disease 2019 (COVID-19) pose a threat to drug supply, the International Generic and Biosimilar Medicines Association (IGBA) is working to establish priority designations for medicines in air and sea cargo transport. The move is among diverse attempts by private and public institutions recently to secure supplies of drugs and pharmaceuticals amid the dizzying pace of events. <Read More>

     Ten Strategies to Reduce Medication Errors – April 11, 2020 – It’s been 20 years since the Institute of Medicine released its landmark To Err is Human report, but medication errors remain a serious problem in our health care system. Pharmacists are positioned to play a key role in preventing or catching errors that can occur at the various stages of the drug-use process: prescribing, dispensing, and administration. Here are some strategies that can help. <Read More>

     Magellan Rx Management Medical Pharmacy Trend Report Delivers Industry Insights and Forecasting in Notable 10th Edition – April 8, 2020 – Magellan Rx Management, a division of Magellan Health, Inc., released its tenth annual Medical Pharmacy Trend Report™, featuring a comprehensive view of medical benefit drug trends—one of the largest drivers of total specialty drug spend. For 10 years, Magellan Rx has produced the industry’s only detailed trend report that analyzes medical benefit drug claims for trends, data benchmarking, forecasting for significant categories, as well as current medical benefit drug management approaches. <Read More>

    AMCP Files Amicus Brief in US Supreme Court Case Challenging PBMs – April 7, 2020 – The Academy of Managed Care Pharmacy (AMCP) has filed an amicus brief in the United States Supreme Court case Rutledge v. The Pharmaceutical Care Management Association (PCMA), arguing that a ruling in favor of Rutledge would drive up health care costs, and hinder patients’ health outcomes and ability to access affordable medications. The case is scheduled to be heard April 27, 2020. <Read More>

     

    340B in the News

    Brufsky Describes Biosimilar Dilemmas in Clinical Practice – April 12, 2020 – Putting biosimilars to use is more complicated than it appears on the surface, according to Adam M. Brufsky, MD, PhD, professor of medicine and associate chief of the Division of Hematology/Oncology and co-director of the Comprehensive Breast Cancer Center at University of Pittsburgh Department of Medicine…What further complicates the picture, besides the problem of how to administer follow-up injections, is the complexity of the payment landscape. <Read More>