Clinical Insights: November 4, 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

    Bronchitol® (mannitol) Inhalation Powder – New Drug Approval – October 30, 2020 – Chiesi USA, Inc., the U.S. affiliate of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), received U.S. Food and Drug Administration (FDA) approval of Bronchitol® (mannitol) inhalation powder. BronchitolÒ is the first and only inhaled dry powder indicated as add-on maintenance therapy to improve pulmonary function in cystic fibrosis (CF) patients 18 years of age and older. It provides a compact, portable option to CF patients. Bronchitol® was developed by Pharmaxis Ltd., and Chiesi is now its exclusive distributor in the United States and 11 other countries. <Read More>

    SkliceTM (ivermectin) 0.5% Topical Lotion – New OTC Drug Approval – October 27, 2020 – The U.S. Food and Drug Administration approved a lotion to treat head lice for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA initially approved SkliceTM (ivermectin) lotion, 0.5% for the treatment of head lice infestation in patients 6 months of age and older as a prescription drug in February 2012. <Read More> 

    EysuvisTM (loteprednol etabonate) Ophthalmic Suspension – New Drug Approval – October 26, 2020 – Kala Pharmaceuticals, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that the U.S. Food and Drug Administration (FDA) has approved EysuvisTM (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    No new update.

    New/Updated Drug Shortage

    November 03, 2020

    November 02, 2020

    October 30, 2020

    October 28, 2020

    October 27, 2020

    New Drug Recall and Safety Alerts

    Metformin HCl ER 500mg Tablets by Nostrum Laboratories, Inc. – New Drug Recall – November 2, 2020 – Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 500 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 500 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September, 2020. <Read More>

    Paroex® (chlorhexidine gluconate) by Sunstar Americas – New Drug Recall – October 28, 2020 – Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 – 9/30/22 to the consumer level. This product may be contaminated with the bacteria Burkholderia lata. Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported to SAI related to this recall. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Audit: PBMs Paying Pharmacies Differently; CVS Caremark Says That’s Normal Business – November 1, 2020 – An audit performed for the Arkansas Insurance Department of the state’s three dominant pharmacy benefit managers found different-sized pharmacies were paid different amounts for the same drugs last year, though in most arrangements it wasn’t considered significant, and that at least two of the PBMs charged pharmacies “clawback” fees. <Read More>

    ASTRO Releases New Clinical Guidelines for Use of Radiation Therapy in Locally Advanced Rectal Cancer – October 30, 2020 – The updated guidelines outlined indications and best practices for pelvic radiation treatments, as well as the integration of radiation with chemotherapy and surgery for patients with stage II to III disease. New clinical guidelines from the American Society for Radiation Oncology (ASTRO) published in Practical Radiation Oncology provided guidance for physicians who use radiation therapy to treat patients with locally advanced rectal cancer. The updated guidelines, which replace ASTRO’s 2016 guidance for rectal cancer, outlined indications and best practices for pelvic radiation treatments, as well as the integration of radiation with chemotherapy and surgery for patients with stage II to III disease. <Read More>

    Clinical Practice Guidelines on Chronic Myeloid Leukemia (NCCN, 2020) – October 30, 2020 – In October 2020, the National Comprehensive Cancer Network (NCCN) released an updated version of its clinical practice guidelines on chronic myeloid leukemia (CML), including on diagnosis and workup, management of chronic-phase CML (CP-CML), and CML management during pregnancy and breastfeeding. <Read More>

    Pharmacists Should Consider Pharmacokinetics – October 30, 2020 – Although generic drugs can be interchangeable with brand name medications and equally therapeutic, some patients may experience clinical discomfort or new adverse effects when switching to a generic option. This discomfort is caused by pharmacokinetic variability of the active substance, according to an article published in the June edition of Clinical Pharmacokinetics, but does not necessarily warrant a change in the regulatory approach to evaluating bioequivalencies of generic drugs. “A demonstration of bioequivalence is the cornerstone of generic drug approval,” the authors wrote. Bioequivalency is defined as 2 pharmaceutically comparable drug products with statistical proof of bioavailability. Despite strict requirements to demonstrate bioequivalency, the authors noted that several aspects of the regulatory approach have been questioned. <Read More>

    Researchers Simplify and Streamline Guidelines for Managing Knee Osteoarthritis – October 29, 2020 – The burden of knee osteoarthritis is set to continue to increase around the world. Aging populations and rising levels of obesity, combined with an absence of a cure for the disease, will lead to an increased strain on health-care systems. Due to this, there is a focus on how to best manage the disease…Facing such complexities, health-care providers turn to clinical practice guidelines to help inform the decision-making process. But according to a research team from the Universities of Oxford, Southampton, Liège, Oulu, Maryland, Oslo and Boston, the complexities for clinicians don’t end there. <Read More>

    The Expanding Roles of Genetic Counselors in Specialty Pharmacy Management – October 29, 2020 – Traditionally, the role of genetic counselors has been dedicated to caring for patients and families affected by genetic conditions. Today, genetic counselors apply their molecular and clinical expertise in diverse roles, many delivered via telehealth. Recent rapid advances in gene-based therapies represent additional roles for genetic counselors throughout the health care system, including collaborations with pharmacy professionals. Here’s a look at some evolving changes and potential future shifts in how genetic counselors and pharmacists collaborate. <Read More>

    Seven Best Practices for Pharmacies Managing Short-Dated Inventory – October 28, 2020 – As with any perishable item, short-dated drugs are more prone to the risk of destruction if they are not managed appropriately.  These medications should be approached differently to help ensure that the product is used for its original intended purpose – to treat patients.  Whether stock is aging on the shelf, a short-dated discount becomes available, or there is limited supply in the market, pharmacy teams are often faced with having to procure & manage short-dated inventory.  How effectively and proficiently this is done can be the difference between dollars saved or dollars lost within the hospital pharmacy’s budget. <Read More> 

    Clinical Insights: Palforzia® is the First FDA-approved Treatment of Peanut Allergy – October 28, 2020 – In January 2017, the National Institute of Allergy and Infectious Diseases (NIAID) published an addendum guideline to prevent peanut allergy in the United States. It is for pediatricians to introduce peanut based on patient risk levels: assessment from previous egg allergy history and/or eczema. The summary includes guidelines with 3 different categories based on the child’s risk level and when to introduce peanut to their diet… The exact mechanism of action of Palforzia® [Peanut (Arachis hypogaea) allergen Powder-dnfp] is not known. It is a peanut protein in a form of powder made from defatted peanut flour. Allergic reactions to peanut occur when the body’s immune system recognizes peanut allergen as harmful, which produces allergic reactions, such as hives, swelling, redness, digestive problems, or even dangerous reactions such as anaphylaxis. Palforzia is thought to work as an oral immunotherapy in which the body is slowly exposed to a small amount of allergen with increased dosing exposure over a long period of time. <Read More>

    U.S. Pharmacies Attract New Flu Shot Customers as Coronavirus Surges – October 28, 2020 – Walmart Inc, Walgreens Boots Alliance Inc, CVS Health Corp and Rite Aid Corp have told Reuters demand for flu shots at their U.S. pharmacies is up sharply – in some cases double from last year – as people try to protect themselves from influenza in the midst of a worsening COVID-19 pandemic. The pharmacies are giving millions more flu shots than they have in past years, filling a gap from COVID-19 wary consumers who are avoiding the doctor’s office. The gains represent millions of dollars in potential profit. <Read More>

    Antibody Treatments are Promising—But There’s 3 Key Reasons to be Cautious of the Hype – October 27, 2020 – Antibody treatments for Covid-19 have shown promising results in early clinical trials, but the treatments likely will be in short supply if they’re authorized for use in the United States, leading to questions about where and how the limited supply of treatments should be allocated. <Read More>

    Immunoglobulin Effective in Treating Myasthenia Gravis – October 27, 2020 – Patients being treated for myasthenia gravis (MG) can successfully transition from intravenous immunoglobulin (IVIG) to subcutaneous immunoglobulin (SCIG) and from SCIG to IVIG, according to a study published in the European Journal of Neurology. Current treatment of MG includes symptomatic and course-modifying therapies that target the immune system, according to the study. IVIG and subcutaneous immunoglobulin (SCIG) are both viable options for chronic therapy. The retrospective study looked at charts of 34 patients with MG between January 2015 and January 2020 who were treated with IVIG/SCIG for at least 6 months. The primary outcome was the mean change in Myasthenia Gravis Impairment Index (MGII) after treatment with IG. Secondary outcomes were the change in pyridostigmine, immunosuppressive medications, and patient‐reported “percentage of normal,” according to the study. <Read More>

    Post-Op Opioid Sparing: Pharmacists Can Help – October 27, 2020 – Opioids continue to be commonly overprescribed after surgery, but stewardship programs focused on multimodal analgesia and clinician education can reduce postoperative opioid use without hampering patient satisfaction, according to a session at the American College of Clinical Pharmacy’s 2020 virtual annual meeting. Multiple studies have demonstrated that opioids commonly go unused after surgery, noted presenter Douglas Oyler, PharmD, an assistant professor in the Department of Pharmacy Practice and Science and the director of the Office of Opioid Safety at the University of Kentucky, in Lexington. <Read More>

    Pharmacy Interns and Techs Who Meet HHS Requirements Can Administer Childhood, COVID-19 Vaccines – October 27, 2020 – The U.S. Department of Health and Human Services (HHS) has released guidance that expands the immunization authorities of state-licensed pharmacy interns and “qualified” pharmacy technicians during the public health emergency. Interns and techs who meet conditions set forth by HHS will not only be allowed to administer ACIP-recommended childhood vaccines (ages 3 to 18) and FDA-authorized or licensed COVID-19 vaccines and tests (ages 3 and older)—including serology tests—but they will also be granted liability coverage for these duties during the public health emergency. <Read More>

    340B in the News

    The U.S. Court of Appeals Denies Rehearing on Cuts to 340B Drug Pricing Program – November 2, 2020 – In a setback to hospitals challenging deep cuts to reimbursement for prescription drugs acquired through the 340B drug pricing program (“340B Program”), the U.S. Court of Appeals for the District of Columbia, on October 19, denied a request to reconsider a decision by three-judge panels of the Court upholding these cuts.  Short of a Supreme Court appeal, this decision effectively ends hospital challenges to these reimbursement reductions, and makes the implementation of additional cuts in 2021 a near inevitability. <Read More>

    Novartis Scales Back Decision to Restrict 340B Drug Sales – October 30, 2020 – Novartis scaled back an earlier move to halt sales of drugs discounted under the 340B program to contract pharmacies. The drugmaker announced that it will still provide discounted drugs to contract pharmacies, but only those facilities within 40 miles of the 340B hospital’s location. Novartis is one of three drug companies that has restricted sales to contract pharmacies, which are third-party entities that dispense 340B drugs on behalf of the participating hospital, prompting a dispute with hospitals over the legality of the moves. <Read More>

    Regulatory and Legislative Actions Are Likely to Continue to Affect 340B Program – October 28, 2020 – Decisions in the Senate will most likely affect protections for covered entities under the 340B program, according to a virtual panel at the National Association of Specialty. Pharmacy 2020 Annual Meeting & Expo Virtual Experience. The panelists explained that these congressional decisions will have implications for the program over the next 2 years. During the session, Peggy Tighe, JD, legislative counsel for Ryan White Clinics for 340B Access and principal at Powers Law Firm; Neil B. Minkoff, MD, founder of FountainHead HealthCare; and Mark Ogunsusi, JD, PharmD, associate at Powers Law Firm, discussed the regulatory and legislative actions currently affecting the 340B program as well as how the upcoming presidential election may further affect the program. <Read More>