Clinical Insights: April 9, 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

    Sevenfact® (coagulation factor VIIa [recombinant]-jncw) – New Drug Approval – April 1, 2020 – The U.S. Food and Drug Administration approved Sevenfact® [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies). Sevenfact® contains an active ingredient expressed in genetically engineered rabbits. <Read More>

    New Formulation Approval

    Triferic AVNU® (ferric pyrophosphate citrate) – New Formulation Approval – March 27, 2020 – Rockwell Medical, Inc, a biopharmaceutical company dedicated to transforming anemia management and improving outcomes for patients around the world, announced that the U.S. Food and Drug Administration (“FDA”) has approved its New Drug Application (“NDA”) for its intravenous formulation of Triferic®, Triferic AVNU®. With this approval, Triferic AVNU® joins Triferic Dialysate® as the only FDA-approved products indicated to replace iron and maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. <Read More>

    New Indication Approval

    Imfinzi® (durvalumab) – New Indication Approval – March 30, 2020 – AstraZeneca’s Imfinzi® (durvalumab) has been approved in the US as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care (SoC) chemotherapies, etoposide plus either carboplatin or cisplatin (platinum-etoposide). The approval by the Food and Drug Administration was based on positive results from the Phase III CASPIAN trial showing Imfinzi in combination with SoC platinum-etoposide demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus SoC alone. <Read More>

    Taltz® (ixekizumab) – New Expanded Indication Approval – March 30, 2020 – Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Taltz® (ixekizumab) injection, 80 mg/mL for the treatment of pediatric patients (ages 6 to under 18) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Psoriasis affects nearly 8 million people in the U.S. Many people living with psoriasis develop symptoms during childhood. <Read More>

    New Drug Shortage

    April 3, 2020

    April 2, 2020

    April 1, 2020

    New Drug Recall and Safety Alerts

    Ranitidine in all Formulations – Expanded Drug Withdrawal – April 1, 2020 – The U.S. Food and Drug Administration announced that it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S. <Read More>

    New Generic Approval and Launch

    Nexium® (esomeprazole) – First-time Generic Approval – March 27, 2020 – Cipla Limited announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Esomeprazole for Oral Suspension 10mg, 20mg and 40mg from the United States Food and Drug Administration (US FDA). Cipla is the first company to file for the 10mg strength. <Read More>

    COVID-19 News

    APhA Coronavirus Watch: CDC Releases Guidance for Pharmacies and Providing Immunizations During Pandemic – April 6, 2020 – On an April 2, 2020, APhA webinar, a CDC representative announced that the agency would release guidance for pharmacists and pharmacy staff as they navigate the COVID-19 pandemic. Lisa M. Koonin, DrPH, MN, MPH, who serves as a senior advisor in support of the CDC 2019 Novel Coronavirus (nCoV) Response, told webinar attendees that the guidance is intended to assist pharmacies on how best to provide care for patients without COVID-related disruptions. CDC recognizes that pharmacies are a vital part of the health care system, Koonin said, and ensuring continuously functioning pharmacies during the pandemic is important for communities, patients, and the nation. “I know that pharmacy staff are doing everything they can to serve patients, and I want to express my appreciation and gratitude for that,” Koonin said. <Read More> 

    APhA Warns Pharmacists and Patients About COVID-19 Test and Product Scams – April 6, 2020 – The American Pharmacists Association (APhA) cautions pharmacists and the public to be wary of fraudulent COVID-19 products and scams being offered online or through other channels during the pandemic. APhA today issued guidance to protect pharmacists and patients from frauds and scams. APhA’s new guidance highlights red flags that should raise concern and provides tips on how to avoid COVID-19 fraud and scams, including encouraging patients and pharmacy personnel to only buy through known and trusted suppliers. <Read More>

    Roundup: Chinese Medical Experts Urge U.S. to Adopt National Guidelines for COVID-19 Treatment – April 6, 2020 – One of China’s leading physicians who helped lead the battle against COVID-19 in Wuhan, China’s COVID-19 epicenter, advised American physicians that controlling the virus requires a coordinated effort from the top on down, a system many American officials and physicians are also clamoring for. “American physicians should have national guidelines for the treatment of COVID-19,” urged Dr. Bin Cao, a respiratory expert and vice president of China-Japan Friendship Hospital (CJFH) in Beijing on a conference call with American physicians early this week. <Read More> 

    White House COVID-19 Coordinator: Don’t Go to Grocery Store or Pharmacy Unless Essential – April 5, 2020 – It’s come to this – the White House is now advising everyone not to head to the grocery store or pharmacy in the coming two weeks. “The next two weeks are extraordinarily important,” White House coronavirus response coordinator Deborah Birx said Saturday at a press conference. “This is the moment to not be going to the grocery store, not going to the pharmacy, but doing everything you can to keep your family and your friends safe.” <Read More> 

    CDC Launches New Weekly COVID-19 Surveillance Report – April 3, 2020 – CDC is modifying existing surveillance systems to track COVID-19, and posted the first of what will be a weekly surveillance report called, “COVIDView.” The report, updated each Friday, will summarize and interpret key indicators, including information related to COVID-19 outpatient visits, emergency department visits, and hospitalizations and deaths, as well as laboratory data. <Read More> 

    Coronavirus (COVID-19) Update: FDA Coordinates National Effort to Develop Blood-Related Therapies for COVID-19 – April 3, 2020 – The U.S. Food and Drug Administration continues to play a critical role in accelerating medical countermeasures to treat and prevent COVID-19. As part of the response to this pandemic, the agency is taking the lead on a national effort to facilitate the development of, and access to, two investigational therapies derived from human blood. These are called convalescent plasma and hyperimmune globulin and are antibody-rich blood products made from blood donated by people who have recovered from the virus. The products can be administered to individuals diagnosed with COVID-19. There are some limited data to suggest that convalescent plasma and hyperimmune globulin may have benefit in the COVID-19 illness. This is why evaluation of these therapies in the context of a clinical trial and expanded access program is so important. <Read More> 

    FDA Clears a Path for 5 Rapid SARS-CoV-2 Test – April 2, 2020 – After a month of missteps by U.S. officials during the earliest phase of the coronavirus outbreak, including the CDC releasing a flawed SARs CoV-2 test and an unwillingness to use validated assays from abroad, the FDA has used its emergency use authorization (EUA) process to clear five new rapid SARS-CoV-2 tests. <Read More> 

    Coronavirus (COVID-19) Update: FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic – April 2, 2020 – As part of the U.S. Food and Drug Administration’s ongoing commitment to fight the Coronavirus Disease 2019 (COVID-19) pandemic, today the agency issued guidance for immediate implementation to address the urgent and immediate need for blood and blood components. The COVID-19 pandemic has caused unprecedented challenges to the U.S. blood supply. Donor centers have experienced a dramatic reduction in donations due to the implementation of social distancing and the cancellation of blood drives. <Read More> 

    New Guidelines on Caring for ICU Patients with COVID-19 – April 1, 2020 – An international team including McMaster University researchers has come together to issue guidelines for health-care workers treating intensive care unit (ICU) patients with COVID-19. The Surviving Sepsis Campaign COVID-19 panel has released 54 recommendations on such topics as infection control, laboratory diagnosis and specimens, the dynamics of blood flow support, ventilation support, and COVID-19 therapy. <Read More> 

    NABP Supports Boards of Pharmacy to Expedite Emergency Licensure for Pharmacists and Pharmacy Technicians – April 1, 2020 – The National Association of Boards of Pharmacy® (NABP®) is assisting its member boards of pharmacy in expediting emergency and temporary licensure requests for licensed pharmacists and pharmacy technicians through its new program, NABP Passport. Developed in response to coronavirus disease 2019 (COVID-19), NABP Passport facilitates temporary authorization for pharmacists and pharmacy technicians to practice in another state. Available at no cost to individuals and boards of pharmacy, the program reduces the burden on those who are being relied upon to provide an increased level of patient care during the pandemic. Pharmacists and pharmacy technicians who submit requests for emergency licensure to states where they do not currently have a license go through a screening process that includes licensure verification and a search of the NABP Clearinghouse for disciplinary history. Requests are screened within a few business days and, once approved, pharmacists and pharmacy technicians receive an NABP Passport with “COVID-19” authorization that allows them to practice in participating states under an emergency declaration. <Read More>

    ISMP Launches COVID-19 Safety Alerts – March 31, 2020 – The Institute for Safe Medication Practices had just published the first in a series of Acute Care Safety Alert! newsletters focused entirely on COVID-19, and Michael R. Cohen, MS, RPh, the president of ISMP, was energized. “It’s unbelievable,” he told Pharmacy Practice News in a telephone interview. In a little more than a week, the ISMP staff had put together a five-page, tightly packed document covering COVID-19-related topics ranging from the safe use of metered-dose inhaler (MDI) common canister protocols to safeguarding limited supplies of investigational COVID-19 treatments, such as hydroxychloroquine and chloroquine, in the face of growing demand and possibly inappropriate use. <Read More>

    Pharmacies Set Policies to Stop U.S. Hoarding of Potential Coronavirus Treatments – March 26, 2020 – Pharmacies CVS Health and Express Scripts, part of Cigna Corp, are setting up measures to prevent hoarding in the United States of malaria drug hydroxychloroquine and other treatments that are being tried against the new coronavirus. Walgreens Boots Alliance has placed limits on prescriptions of chloroquine, which is also used to fight malaria, and hydroxychloroquine. <Read More>

    Clinical and Pharmacy News

    Biosimilars Market to 2025 – Growing Steady at 24.7% CAGR and Projected to Reach $35.7 Billion – April 6, 2020 – The Global Biosimilars Market size is projected to reach USD 35.7 Billion by 2025 from USD 11.8 Billion in 2020, at a CAGR of 24.7%. This report spread across 184 pages, profiling 20 companies and supported with 132 tables and 46 figures are now available in this research. An exclusive data offered in this report is collected by research and industry experts team. <Read More>

    Opportunities and Considerations for Pharmacists as Medical Science Liaisons – April 5, 2020 – Retail and inpatient careers continue to dominate the pharmacy landscape. Careers in the pharmaceutical industry also can offer pharmacists a different environment to practice in with unique challenges, rewards, and considerations. Numerous pharmaceutical and biotechnology companies offer a variety of positions a pharmacist could fill. Although careers in research and development often come to mind when considering an industry trajectory, there is also a need for pharmaceutical professionals outside the lab. One such role is that of a Medical Science Liaison (MSL). <Read More>

    Review Outlines Challenges of Integrating Biosimilars Into Clinical Practice – April 3, 2020 – The introduction of biosimilars in the US market brings along specific challenges to health system pharmacists, including formulary assessment, implementation, and education of patients and various health system stakeholders, according to a review published in Drugs In Context. Despite the Biologics Price Competition and Innovation Act (BPCIA) being passed in 2009, the US FDA approved its first biosimilar in 2015. As of February 2020, 24 other biosimilars have been approved while only 11 have launched. In comparison, the European Union has had over 50 biosimilars approved since 2006. <Read More>

    Boost in Serum EPA Levels From Prescription Fish Oil Drives Heart Benefits April 3, 2020 – Higher levels of the omega-3 fatty acid eicosapentaenoic acid (EPA) found in the blood—and not a decrease in triglyceride levels as originally thought—appear to explain the reductions in cardiovascular (CV) events and deaths seen among people taking the prescription fish oil, icosapent ethyl (Vascepa, Amarin), according to a study that was presented at the American College of Cardiology’s Annual Scientific Sessions together with the World Congress of Cardiology (ACC.20/WCC), held virtually. <Read More>

    MJH Life Sciences™ Acquires the Pharmacy Benefit Management Institute (PBMI) – April 2, 2020 – MJH Life Sciences™ has announced it has acquired the Pharmacy Benefit Management Institute (PBMI) from Pharmaceutical Strategies Group (PSG). This latest addition to the MJH portfolio broadens its leadership position in managed care at a crucial time for medicine in our country. “Credible information is critical to healthcare professionals during this global pandemic, and education about how it will impact drug benefit management is vital,” said Mike Hennessy Jr., president and CEO of MJH Life Sciences™. “For 25 years, PBMI’s annual meeting has been a driver of change within the marketplace, and as part of our Managed Markets Network, we look forward to growing the conference to make an even bigger impact in the field of managed care.” <Read More>


    340B in the News 

    340B COVID-19 Updates: HRSA COVID-19 Resources and Regulatory Flexibility – March 31, 2020 – As U.S. hospitals and health clinics continue preparing for novel coronavirus (COVID-19) patient surges, federal regulatory agencies are developing resources to help health care providers comply with myriad regulatory requirements. In this context, the U.S. Health Resources and Services Administration (HRSA) recently issued a number of COVID-19 resources aimed at assisting Federal 340B Drug Discount Program (340B Program) covered entities in maintaining 340B Program compliance throughout the COVID-19 outbreak. The latest HRSA COVID-19 resources address a number of issues, including recordkeeping requirements, registration of additional covered entity sites, relaxation of the Group Purchasing Organization (GPO) prohibition, and the delivery of services through telehealth platforms. Further, the COVID-19 resources state HRSA will continue auditing covered entities for 340B Program requirements. However, 340B Program audits will be performed remotely for at least the next several months. <Read More>