Clinical Insights: June 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 

    ZepzelcaTM (lurbinectedin) Injection – New Drug Approval – June 15, 2020 – PharmaMar announced, along with Jazz Pharmaceuticals plc, that the U.S. Food and Drug Administration (FDA) has approved ZepzelcaTM (lurbinectedin) for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression, after platinum-based chemotherapy. Lurbinectedin was approved under “Accelerated Approval” based on Overall Response Rate (ORR) and Duration of Response (DoR). <Read More>

    Tivicay® (dolutegravir) Tablets and Tivicay PD® (dolutegravir) Tablets for Suspension – New Drug Approval – June 12, 2020 – The U.S. Food and Drug Administration approved Tivicay® (dolutegravir) tablets and Tivicay PD® (dolutegravir) tablets for suspension to treat HIV-1 infection in pediatric patients at least four weeks old and weighing at least 3 kg (6.61 pounds) in combination with other antiretroviral treatments. <Read More> 

    SemgleeTM (insulin glargine) Injection New Biosimilar Approval June 11, 2020 – Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Semglee™ (insulin glargine injection), in vial and pre-filled pen presentations, to control high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes. Semglee has an identical amino acid sequence to Sanofi’s Lantus® and is approved for the same indications. <Read More> 

    UpliznaTM (inebilizumab-cdon) Injection – New Drug Approval June 11, 2020 – Viela Bio announced that the U.S. Food and Drug Administration (FDA) has approved UpliznaTM (inebilizumab-cdon) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive as a twice-a-year maintenance regimen following initial doses. Approximately 80% of all patients with NMOSD test positive for anti-AQP4 antibodies. <Read More>

    NyvepriaTM (pegfilgrastim-apgf) Injection – New Biosimilar Approval – June 11, 2020 – Pfizer Inc. announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nyvepria™ (pegfilgrastim-apgf), a biosimilar to Neulasta® (pegfilgrastim). NyvepriaTM is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. <Read More> 

    New Formulation Approval

    No new update.

    New Indication Approval

    No new update.

    New Drug Shortage

    June 15, 2020

    New Drug Recall and Safety Alerts

    Metformin Extended-Release Products by Lupin – New Drug Recall – June 11, 2020 – Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg, lot G901203 to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall. <Read More>

    New Generic Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Flu Vaccine Coverage Linked to Reduced Antibiotic Prescribing – June 15, 2020 – New data suggest that influenza vaccines may reduce overall and inappropriate antibiotic use by decreasing the burden of influenza-like illness commonly mistreated with antibiotics, as well as preventing secondary bacterial infections, according to research from the Center for Disease Dynamics, Economics & Policy, Johns Hopkins University, and the University of Maryland School of Medicine. <Read More>

    Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine – June 15, 2020 – The U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible. The agency determined that the legal criteria for issuing an EUA are no longer met. <Read More> 

    Pharmacies Prepare For Possible Surge In Flu Vaccinations This Season – June 15, 2020 – Pharmacies are preparing for what is expected to be a surge in flu vaccinations this year as Americans are putting a greater focus on staying healthy amid the coronavirus pandemic. “Flu vaccines are widely recommended for the CDC every year, and pharmacies play an important role in providing convenient access to flu shots and other vaccinations to protect patients and their loved ones against vaccine preventable illness,” Tasha Polster, vice president of pharmacy quality, compliance and safety at Walgreens, told Drug Topics®. “This is even more important during the pandemic to help reduce the overall burden of respiratory illnesses, protecting vulnerable populations and the health care system.” <Read More> 

    Coronavirus (COVID-19) Update: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use – June 15, 2020 – The U.S. Food and Drug Administration is warning health care providers about a newly discovered potential drug interaction related to the investigational antiviral drug remdesivir, which has received emergency use authorization for the treatment of hospitalized COVID-19 patients with severe disease. <Read More> 

    ASTRO Reveals First Cervical Cancer Guidelines – June 12, 2020 – This week, the American Society for Radiation Oncology (ASTRO) released its first clinical guidelines for using radiation therapy to treat patients who have non-metastatic cervical cancer. The guidelines, published in Practical Radiation Oncology, discuss best practices for using external-beam radiation therapy (EBRT) and brachytherapy in both post-operative and “definitive” settings. <Read More> 

    How Pharmacies Can Improve Reimbursement for Oncology Drugs – June 12, 2020 – Pharmacists can play a role in the drug reimbursement process for oncology products, which are among the most expensive of all pharmaceuticals. Pharmacy leaders who spoke with OncologyLive® said they can assist with revenue cycle management process, working with the billing and finance teams if any payment is denied and ensuring therapies have prior authorization from private payers. <Read More> 

    Advanced Androgen Blockage in Nonmetastatic Castration-Resistant Prostate Cancer: An Indirect Comparison of Apalutamide and Enzalutamide – Beyond the Abstract – June 12, 2020 – There has been a rapid evolution of the nonmetastatic castrate-resistant prostate cancer (nmCRPC) disease space. Up until 2018, there were no interventions with proven benefit in this disease space. Most patients simply continued androgen deprivation therapy (ADT) until the development of metastases while some attempted secondary hormonal manipulations. <Read More> 

    The National Association of Specialty Pharmacy Announces 2020 Annual Meeting & Expo Virtual Experience – June 12, 2020 – The National Association of Specialty Pharmacy (NASP), a nonprofit organization representing all specialty pharmacy industry stakeholders, announces that this year’s Annual Meeting & Expo will be transitioning to a virtual conference EXPERIENCE. Utilizing innovation and cutting-edge technology, our Annual Meeting Virtual Experience allows you to safely enhance your knowledge, earn required CPE credits to satisfy your annual state licensure requirements, share best practices, foster partnerships and synergies and celebrate what is special about specialty pharmacy all from the comfort of your own home or office at a significant discount. <Read More>

    Pharmacists Play Valuable Role in Addressing Social Determinants of Health – June 11, 2020 – Through screening and interventions that target medication adherence and reduce medical spend, pharmacists can help influence outcomes associated with social determinants of health (SDOH), according to a live broadcast session from the 2020 Pharmacy Quality Alliance Annual Meeting. <Read More>

    A Novel Collaborative Tuberculosis Care Model – June 11, 2020 – Although latent tuberculosis infection (LTBI) is a curable condition, research indicates that treatment completion rates are inconsistent. “Inconsistent rates of treatment completion are oftentimes due to the duration of LTBI treatment and medication-related side effects,” explains Bernadette Jakeman, PharmD, PhC, BCPS, AAHIVP. To determine whether a collaborative care model could be effective in the treatment of LTBI, Dr. Jakeman and colleagues conducted a prospective pilot study in collaboration with community pharmacies and the New Mexico Department of Health, and published their results in Preventing Chronic Disease. <Read More> 

    Are You Ready to Standardize 4 Safety? – June 11, 2020 – The massive national interprofessional effort to release agreed-upon standardized concentrations for most medication doses is nearing completion. Standardize 4 Safety (S4S), an initiative funded by the FDA and led by ASHP, released its first set of standardized concentrations, for adult continuous infusions, in October 2016. The next set, for pediatric continuous infusions, has been in the comment and review period for almost a year, and a final release is expected before summer of 2020, according to Michael Ganio, PharmD, ASHP’s director of pharmacy practice and quality. <Read More> 

    FDA Issues Guidance on Prescription Drug Sample Distribution During COVID-19 – June 11, 2020 – On June 8, 2020, the Food and Drug Administration (FDA or Agency) issued temporary guidance to address concerns related to distribution of drug samples during the COVID-19 public health emergency.1 Under an exercise of enforcement discretion, the FDA has declared it will not enforce certain requirements of the Prescription Drug Marketing Act of 1987 (PDMA) and its implementing regulations during the pandemic with respect to the distribution of drug samples by mail or common carrier. Specifically, the FDA has expressed a willingness to allow drug samples to be shipped directly to patients’ homes and to allow for alternative forms of receipt and verification. <Read More> 

    NABP Issues Nearly 50,000 Temporary Licenses for Pharmacists, Techs – June 11, 2020 – The National Association of Boards of Pharmacy (NABP) has issued nearly 50,000 “passports”, or temporary licenses, for pharmacists and pharmacy technicians. “Launched in response to the [coronavirus disease 2019 (COVID-19)] crisis, this new service supports member state boards of pharmacy in processing requests for temporary and emergency licensure to pharmacists and pharmacy technicians,” NABP said in an email sent to Drug Topics®. <Read More> 

    Hospital Pharmacists Face Challenges in Reducing Antibiotic Overuse – June 10, 2020 – Antibiotics pose a conundrum: These drugs are crucial for destroying or slowing certain types of bacteria, but concern about overuse in hospitals and inappropriate prescribing practices fuels debate about the complex relationship between antibiotic use and antimicrobial resistance. “Pharmacists play a pivotal role in antimicrobial stewardship in an organization, and it’s really around a multidisciplinary approach and a coordinated effort, with the goal to improve and measure appropriate use of antibiotics,” said Onisis Stefas, PharmD, MBA, vice president and chief pharmacy officer at Northwell Health in New York. <Read More>

    Centralized Anticoagulation Hub Appears Promising for VA – June 10, 2020 – A pilot program by the Department of Veterans Affairs to provide pharmacist-directed, centralized anticoagulation services is helping streamline care for patients in some rural areas and free up time for clinicians in regional VA centers to manage other patients. <Read More>

    Communication Is Key During Pandemic Management – June 10, 2020 – A well-executed communication approach has been key to coping with the first wave of the pandemic, experts said during a recent webinar hosted by the Institute for Safe Medication Practices (ISMP) and ECRI, an organization that focuses on  health care safety, quality and cost-effectiveness. <Read More> 

    AGA Releases New Guidelines for Probiotic Use in Gastroenterology – June 10, 2020 – The American Gastroenterology Association (AGA) has released new guidelines calling for the use of certain probiotics in some circumstances, while recommending against their use for other situations. <Read More>

    Pharmacologic Recommendations for Supportive Care After Hematopoietic Cell Transplant – June 10, 2020 – Approximately 23,000 hematopoietic cell transplants (HCTs) are performed in the United States annually for the treatment of malignant and nonmalignant diseases. The most common malignant indications for HCT include multiple myeloma, non-Hodgkin lymphoma (NHL), and acute myelogenous leukemia (AML)… Pharmacologic supportive care can decrease complications associated with GVHD, immunosuppression, and infections. Recommendations for supportive care differ by transplantation source and patient risk factors. Pharmacologic options consist of immunosuppressive therapy for GVHD prophylaxis, colony-stimulating factors (CSFs) for myelosuppression, and antimicrobial prophylaxis for infections. <Read More> 

    Pharmacies Can Take Steps to Protect Against Cyberattacks – June 10, 2020 – When it comes to cybersecurity threats related to the Health Insurance Portability and Accountability Act (HIPAA), pharmacists are in a unique and rather unenviable position. Joey Mattingly, PharmD, PhD, MBA, an associate professor and vice chair of academic affairs of Pharmaceutical Health Services Research at the University of Maryland School of Pharmacy in Baltimore, teaches a pharmacy management course that examines practical implications of HIPAA. Like all businesses, pharmacies are susceptible to cyberattacks, he said, so it is important to have an information security plan that covers everything from training to what to do if a breach occurs. <Read More> 

    Updated AACE/ACE Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis: What Do Clinicians Need to Know? – June 9, 2020 – In collaboration with the American College of Endocrinology (ACE), the American Association of Clinical Endocrinologists (AACE) has released a 2020 update to the clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis. These guidelines were published in Endocrine Practice. <Read More>

    IDSA Provides Suggestions to Further Improve Medicare/Medicaid Sepsis Core Measure – June 9, 2020 – Although the Infectious Diseases Society of America (IDSA) commends the Centers for Medicare & Medicaid Services (CMS) for emphasizing the importance of improving sepsis management and outcomes with the implementation of the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1), IDSA has outlined several recommendations aimed at reducing the risk for unintended consequences of SEP-1 in a position paper published in Clinical Infectious Diseases. <Read More>

    CMS Issues New Guidelines for Resuming Non-Emergency Surgeries as COVID-19 Restrictions Ease – June 9, 2020 – The federal government on Tuesday unveiled a new set of guidelines for the safe resumption of non-emergency health care services, including surgeries and other inpatient procedures. The Centers for Medicare & Medicaid Services (CMS) released the updated recommendations as many states have begun tentatively lifting the strict stay-at-home orders that had been in place since the middle of March. <Read More>

    Opioid Prescriptions After Childbirth Linked to Increased Risk of Overdose, Persistent Use – June 9, 2020 – Women who are prescribed opioids after childbirth have an increased risk of persistent opioid use or other serious opioid-related events, including overdose, in their first year postpartum, according to a new study by Vanderbilt University Medical Center researchers. This is true regardless of whether the woman had a vaginal delivery or a cesarean section. <Read More> 

    U.S. News & World Report and Pharmacy Times® Reveal This Year’s Top-Recommended Health Products – June 9, 2020 – U.S. News & World Report, the global authority in rankings and consumer advice, and Pharmacy Times®, the leading multimedia pharmacy network for pharmacists, released the top-recommended health products for 2020. As integral members of the health care team, pharmacists serve as a valuable resource for patients and caregivers. Excedrin became the No. 1 pick among pharmacists for treating headaches, and Delsym products remained favorites for cough relief in adults and children. <Read More> 

    Global Oncology Pharmacists Face Restricted Access to Essential PPE Items, UCI Study Finds – June 8, 2020 – Oncology pharmacy practitioners around the globe are fighting to provide cancer patients high quality cancer care with increasingly limited and sometimes restricted personal protective equipment supply as well as impaired access to essential anticancer medication, according to University of California, Irvine-led study. <Read More>

    340B in the News 

    COVID-19: 340B Update: HRSA Updates Guidance Granting New HOPD Flexibility – June 10, 2020 – As health care providers continue to grapple with the evolving impact of COVID-19, the Health Resources and Services Administration (“HRSA”) has updated its COVID-19 guidance for providers participating in the 340B Drug Pricing Program (“340B Program”), also known as covered entities…New hospital outpatient departments (“HOPDs”) may begin using 340B drugs upon converting a location to provider-based without having to wait through the cost report filing and enrollment process (for offsite locations) before beginning to use 340B drugs as has been traditionally required. <Read More>

    HRSA Allows 340B Hospitals New Flexibilities to Use 340B Drugs at Offsite Facilities – June 9, 2020 – The Health Resources and Services Administration (HRSA) announced recently that 340B hospitals may use 340B drugs at certain offsite locations before such locations are reported on hospitals’ most recently filed Medicare cost report and registered in the online 340B database. Hospitals should review and, as necessary, revise written policies and procedures to reflect new eligibility and registration provisions and take steps to ensure compliance with the 340B program “patient definition,” duplicate discount prevention and other applicable 340B Program requirements. <Read More>