Clinical Insights: April 1, 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

    Zeposia® (ozanimod) Capsules – New Drug Approval – March 26, 2020 – Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) approved Zeposia® (ozanimod) 0.92 mg for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Zeposia®, an oral medication taken once daily, is the only approved sphingosine-1-phosphate (S1P) receptor modulator that offers RMS patients an initiation with no genetic test and no label-based first-dose observation required for patients. <Read More>

    New Formulation Approval

    No new update

    New Indication Approval

    Epclusa® (sofosbuvir/velpatasvir) – New Expanded Indication Approval –March 19, 2020 – The U.S. Food and Drug Administration approved a supplemental application for Epclusa (sofosbuvir and velpatasvir) to treat hepatitis C virus (HCV) in children ages 6 years and older or weighing at least 37 pounds (17 kilograms) with any of the six HCV genotypes—or strains—without cirrhosis (liver disease) or with mild cirrhosis. Epclusa in combination with ribavirin is indicated for the treatment of pediatric patients 6 years and older or weighing at least 37 pounds with severe cirrhosis. The FDA previously approved Epclusa to treat HCV in adults. <Read More>

    New Drug Shortage

    March 31, 2020

    March 27, 2020

    March 25, 2020

    March 24, 2020

    New Drug Recall and Safety Alerts

    Phytonadione Injectable Emulsion Ampules by Dr. Reddy’s Laboratories – New Drug Recall – March 26, 2020 – Dr. Reddy’s Laboratories Ltd. (along with its subsidiaries together referred to as “Dr. Reddy’s”) announced that it is voluntarily recalling four lots (ACB902, ACB903, ACB904, ACB905) of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules to the hospital level. The product is being recalled due to product complaints received due to ampules breaking and shattering, upon opening, during compounding. <Read More>

    EpiPen® and EpiPen Jr® Auto-Injectors and Their Authorized Generic Versions by Pfizer, Inc. and Mylan, Inc. – New Safety Alert – March 23, 2020 – In a joint statement, Pfizer, Inc. and Mylan, Inc. issued an alert regarding EpiPen® 0.3 mg and EpiPen Jr® 0.15 mg Auto-Injectors and their authorized generic versions. Administration may be delayed or prevented during an emergency due to: 1) Device failure from spontaneous activation caused by using a sideways force to remove the blue safety release, 2) Device failure from inadvertent or spontaneous activation due to a raised blue safety release, 3) Difficulty removing the device from the carrier tube, 4) Certain identified use errors. <Read More>

    Sandimmune® And Neoral® Blister Packages by Novartis Pharmaceuticals Corporation – New Drug Recall – March 18, 2020 – Novartis Pharmaceuticals Corporation (“Novartis”), in cooperation with the U.S. Consumer Product Safety Commission (“CPSC”) is implementing a CPSC-approved corrective action plan for Sandimmune® (cyclosporine capsules, USP) 100-mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) modified 100-mg soft gelatin capsules 30-count blister packs within expiry distributed in the United States. This action is not a result of any quality or efficacy issues with the medicines for their intended use. <Read More> 

    FDA Approves Label Changes to SGLT2 Inhibitors Regarding Temporary Discontinuation of Medication Before Scheduled Surgery – New Safety Alert – March 17, 2020 – The U.S. Food and Drug Administration has approved safety labeling changes to a specific class of type 2 diabetes medications called sodium glucose co-transporter-2 (SGLT2) inhibitors, which includes canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin. These changes recommend temporary discontinuation of these medications before scheduled surgery. <Read More>

    New Generic Approval and Launch

    Daraprim® (pyrimethamine) – First-time Generic Launch – March 20, 2020 – Dr. Reddy’s Laboratories Ltd. announced the launch of pyrimethamine tablets USP, 25 mg, a therapeutic equivalent and first-wave generic version of Daraprim® (pyrimethamine) tablets, approved by the U.S. Food and Drug Administration (USFDA). This product is the only AB-rated generic version Daraprim® (pyrimethamine) tablets approved by the USFDA. <Read More>


    COVID-19 News

    Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19 – March 31, 2020 – As part of the Trump Administration’s all-hands-on-deck approach across public, academic and private sectors to combat the COVID-19 pandemic, the U.S. Food and Drug Administration stood up a new program to expedite the development of potentially safe and effective life-saving treatments. <Read More>

    Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19 – March 30, 2020 – The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed. <Read More>

    FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation – March 30, 2020  On Friday, the President signed into law a $2 trillion emergency relief bill that will continue to aid the response efforts and ease the economic impact of COVID-19. The legislation will help all of us at the FDA deliver support and guidance to protect and promote public health during this unprecedented pandemic. <Read More>

    Coronavirus (COVID-19) Update: FDA Takes Further Steps to Help Mitigate Supply Interruptions of Food and Medical Products – March 28, 2020 – During this COVID-19 pandemic, the FDA is working around the clock to make sure that Americans have access to safe food and medical products. The agency is continuously examining the global supply chain to identify any concerns and assess the availability of the products Americans need most. We are also partnering with the Federal Emergency Management Agency (FEMA) on supply chain issues, including importation of needed medical products to support the U.S. response. <Read More>

    CDC Statement on COVID-19 Apple App – March 27, 2020 – Apple Inc. – in partnership with the White House Coronavirus Task Force and the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention (CDC) – released an app and website that guides Americans through a series of questions about their health and exposure to determine if they should seek care for COVID-19 symptoms.  The tool provides CDC recommendations on next steps including guidance on social distancing and self-isolating, how to closely monitor symptoms, recommendations on testing, and when to contact a medical provider. <Read More> 

    APhA Coronavirus Watch: Senate Passes Coronavirus Legislation Without Provider Status – March 27, 2020 – Despite intense lobbying by a coalition of pharmacy stakeholders, the U.S. Senate on Wednesday, March 25, 2020, passed a coronavirus legislative package that did not include pharmacist provider status language. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the third legislative package in response to COVID-19, is aimed at mitigating the economic effects of the pandemic. <Read More>

    Boards of Pharmacy Nationwide Respond to COVID-19 Pandemic – March 27, 2020 – In response to the nationwide COVID-19 emergency, state boards of pharmacy across the country are authorizing waivers of specific provisions of pharmacy laws and implementing policies to address potential staffing shortages and emergency dispensing of pharmaceuticals. <Read More> 

    FDA Letter to Stakeholders: Do Not Use Chloroquine Phosphate Intended for Fish as Treatment for COVID-19 in Humans – March 27, 2020 – The FDA’s Center for Veterinary Medicine has recently become aware that some consumers may mistake chloroquine phosphate used to treat disease in aquarium fish for FDA-approved drugs (used to treat malaria and certain other conditions in humans) that are being studied as a COVID-19 treatment for humans.  Unfortunately, we have learned that one person in the United States has died after he and his wife reportedly took chloroquine used to treat their fish in an attempt to prevent COVID-19; his wife also became very ill.  <Read More>

    Coronavirus (COVID-19) Update: FDA Takes Action to Help Increase U.S. Supply of Ventilators and Respirators for Protection of Health Care Workers, Patients– March 27, 2020 – The U.S. Food and Drug Administration took action to help increase the supply of ventilators, ventilator tubing connectors, and ventilator accessories, as well as filtering facepiece respirators (FFRs) due to shortages during COVID-19, as part of our commitment to ease burdens on the health care system during this pandemic. <Read More> 

    New Challenges, Planning for Pandemics Within Specialty Pharmacy – March 26, 2020 – As cases of coronavirus disease 2019 (COVID-19) continue to increase around the world, all industries are acting quickly to help prevent the spread of the disease and ensure continuity of business. Many companies in the United States, especially in areas near significant identified outbreaks, have moved to entirely remote workforce solutions. In countries where the virus has spread at a near uncontrollable rate, such as Italy, one of the critical businesses continuing to operate with staff onsite are pharmacies that treat patients in need. <Read More>

    New Guidelines Released for Managing COVID-19 Patients – March 26, 2020 – Whether or not to use corticosteroids in a critically ill patient with COVID-19 is just one of the topics the Surviving Sepsis Campaign tackled in its new recommendations for managing critically ill patients with COVID-19. This recommendation will be of particular interest to infectious disease physicians and critical care pharmacists, according to lead author Waleed Alhazzani, MD, MSc, an associate professor in the Division of Critical Care, Department of Medicine, McMaster University, in Hamilton, Ontario. <Read More>

    Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency – March 26, 2020 – The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including n95 respirators) for health care professionals during this pandemic. <Read More>

    Q&A for Consumers: Hand Sanitizers and COVID-19 – March 26, 2020 – The best way to prevent the spread of infections and decrease the risk of getting sick is by washing your hands with plain soap and water, advises the Centers for Disease Control and Prevention (CDC). Washing hands often with soap and water for at least 20 seconds is essential, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not available, CDC recommends consumers use an alcohol-based hand sanitizer that contains at least 60% alcohol. <Read More>

    Interim CDC Recs to Preserve PPE Supplies  – March 25, 2020  As concern over shortages of personal protective equipment (PPE) at U.S. hospitals grows, the CDC has updated interim recommendations for health care professionals (HCPs) managing the COVID-19 outbreak. The information highlights recommendations for HCPs working in health care facilities, as well as providing strategies to address shortages of key supplies. <Read More>

    FDA Efforts to Connect Manufacturers and Health Care Entities: The FDA, Department of Veterans Affairs, National Institutes of Health, and America Makes Form a COVID-19 response Public-Private Partnership – March 25, 2020 – FDA recognizes that many stakeholders are interested in designing and producing 3D printed devices during the COVID-19 public health emergency. We are also aware that stakeholders often do not know what device designs to choose or how much to print. In light of this and as part of our effort to protect the public to the extent possible, FDA is facilitating information-sharing regarding the use of 3D printing and other advanced manufacturing technologies in the context of personal protective equipment (PPE) and other medical device parts. <Read More> 

    ASHP Makes Recommendations for Pharmacy Readiness for COVID-19 – March 24, 2020 – As millions of Americans stay at home to avoid contracting SARS-CoV-2, the nation’s health care workers are going back to their hospitals and clinics each day to care for the mounting cases of infected patients. Having enough health care providers to meet that challenge is a major concern. The American Hospital Association estimated that almost 5 million patients might require hospitalization, almost 2 million of them in an ICU. <Read More>

    NICE Publishes First Set of Coronavirus Clinical Guidelines – March 23, 2020 – The first of a series of new “rapid” clinical guidelines for staff working during the Covid-19 outbreak have been released by the National Institute for Health and Care Excellence (NICE). <Read More>

    Coronavirus (COVID-19) Update: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators – March 22, 2020 – The U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing. “The FDA’s new actions will mean America can make more ventilators during this crisis,” said Health and Human Services Secretary Alex Azar. <Read More>

    Coronavirus (COVID-19) Update: FDA Provides Update on Patient Access to Certain REMS Drugs During COVID-19 Public Health Emergency – March 22, 2020 – As part of the U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus pandemic (COVID-19), the agency issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time. “The FDA recognizes that during the COVID-19 public health emergency, the completion of some REMS-required laboratory testing or imaging studies may be difficult because patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. <Read More>

    Are Warnings Against NSAIDs in COVID-19 Warranted? – March 18, 2020 – The European Medicines Agency (EMA) says there is currently “no scientific evidence” that nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, could worsen coronavirus disease. EMA adds that it “is monitoring the situation closely and will review any new information that becomes available on this issue in the context of the pandemic.” <Read More>

    Clinical and Pharmacy News

    Updated ADHD Clinical Practice Guidelines – March 26, 2020 – “It has been 8 years since The American Academy of Pediatrics (AAP) updated the Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents was last revised,” explains Mark L. Wolraich, MD, FAAP. With the AAP typically reviewing guidelines every 3 years to either reaffirm or revise them, and psychiatric diagnostic criteria for ADHD revised in the DSM-5 during this interval, The AAP recently updated the guideline, which was originally published in 2000 and later revised in 2011 alongside an accompanying process of care algorithm (PoCA). <Read More> 

    FDA Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes – March 26, 2020 – As our society becomes more global, it has become increasingly clear that the U.S. Food and Drug Administration needs to take a more collaborative approach to our drug approval process. Today, drugs that are approved by the FDA to be marketed in the United States are developed both in and out of the United States. Of the 46,391 participants in the clinical trials that supported the 48 novel drugs approved by the FDA in 2019, 60% of the participants were located outside the U.S., showing the international nature of drug development. <Read More> 

    Andexanet Checks Bleeding in ICrH Patients – March 26, 2020 – Findings from a new study of patients with spontaneous intracranial hemorrhage (ICrH) receiving a factor Xa (FXa) inhibitor found that andexanet alfa (Andexxa, Portola) halted bleeding in 79% of patients within 12 hours of administration. <Read More>

    Apixaban Shows Advantage in Real-World VTE Study – March 25, 2020 – Data from more than 14,000 patients with active cancer and venous thromboembolism (VTE) indicate that apixaban is safer and more effective in preventing VTE than low-molecular-weight heparin (LMWH) in this high-risk patient population. <Read More>

    New WHO Recommendations to Prevent Tuberculosis Aim to Save Millions of Lives – March 24, 2020 – New World Health Organization (WHO) guidance will help countries accelerate efforts to stop people with tuberculosis (TB) infection becoming sick with TB by giving them preventive treatment. <Read More> 

    Novel Agent Checks Hemolytic Anemia–Causing Disorder – March 24, 2020 – An investigational monoclonal antibody called sutimlimab was found to be effective in controlling the hemolytic anemia that characterizes cold agglutinin disease (CAD) in a pivotal phase 3 trial. <Read More>

    Total-Dose Infusion of Iron Safely Increases Hemoglobin in IDA Patients – March 24, 2020 – A total dose infusion (TDI) protocol of iron sucrose, administered by pharmacists, successfully increased serum hemoglobin for hospital inpatients with iron deficiency anemia (IDA) with minimal adverse events, according to a new retrospective study. <Read More>

    Insulin Gains New Pathway to Increased Competition – March 23, 2020 – Today is a historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway. This regulatory transition, mandated by Congress and implemented by the FDA, is incredibly important for patients. For the first time, a pathway will be open for products that are proposed as biosimilar to, or interchangeable with, the transitioned products. <Read More> 

    Drug Price Growth Expected to Slow in US and Worldwide: Report – March 23, 2020 – The prices of US brand-name drugs grew more slowly from 2014–2019 than during the previous 5 years, and the slowdown is expected to continue through 2024, according to the ninth annual report on global medicine usage and sales from the IQVIA Institute for Human Data Science. <Read More>

    A Message to Asthma Sufferers About a Shortage of Albuterol Metered Dose Inhalers – March 20, 2020 – The American College of Allergy, Asthma and Immunology – Certain areas of the country are experiencing shortages of albuterol inhalers. The shortage will probably spread throughout the U.S., although it is not a production problem. The shortage is occurring because of the increased use of albuterol inhalers in hospitals for COVID-19 and suspected COVID-19 patients to help with respiratory issues. <Read More>


    340B in the News

    Coronavirus: HRSA Issues Guidance Outlining Flexibility to 340B Providers – March 25, 2020 – The Health Resources and Services Administration’s (HRSA) Office of Pharmacy Affairs (OPA) has created a COVID-19 Resources page on its website providing information for 340B drug pricing program stakeholders. In particular, the guidance addresses flexibility that HRSA may afford to providers participating in the 340B program (covered entities) related to program compliance, eligibility, and registration during the COVID-19 public health emergency. <Read More>