Clinical Insights: April 24, 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

    TukysaTM (tucatinib) – New Drug Approval – April 17, 2020 – As part of Project Orbis, the U.S. Food and Drug Administration approved TukysaTM (tucatinib) in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery, or has spread to other parts of the body, including the brain, and who have received one or more prior treatments. <Read More> 

    PemazyreTM (pemigatinib) – New Drug Approval – April 17, 2020 – The U.S. Food and Drug Administration granted accelerated approval to PemazyreTM (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma. “This approval demonstrates that while we continue to focus our efforts on addressing the COVID-19 pandemic, the FDA remains committed to the important work of reviewing treatments for patients with cancer and other serious conditions,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. <Read More>

    JelmytoTM (mitomycin gel) – New Drug Approval – April 15, 2020 – The U.S. Food and Drug Administration approved JelmytoTM (mitomycin gel), the first therapy to treat low-grade upper tract urothelial cancer (UTUC). Urothelial cancer is a cancer of the lining of the urinary system…“This is the first approval specifically for patients with low-grade UTUC and provides an option for some patients who may otherwise require a nephroureterectomy,” said Pazdur. “Due to substantial treatment challenges associated with the complex anatomy of the upper urinary tract, many patients need to be treated with radical surgery – usually complete removal of the affected kidney, ureter and bladder cuff. JelmytoTM gives patients, for the first time, an alternative treatment option for low-grade UTUC.” <Read More>

    New Formulation Approval

    No new update

    New Indication Approval

    Braftovi® (encorafenib) – New Indication Approval – April 8, 2020 – Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Braftovi® (encorafenib) in combination with cetuximab (marketed as Erbitux®) for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy. The approval is based on results from the BEACON CRC trial, the only Phase 3 trial to specifically study patients with previously treated metastatic CRC with a BRAFV600E mutation. <Read More>

    New Drug Shortage

    April 20, 2020

     

    April 15, 2020

     

    April 14, 2020

     

    April 13, 2020

    New Drug Recall and Safety Alerts

    Ketorolac Tromethamine Injection by Fresenius Kabi – New Drug Recall – April 20, 2020 – Fresenius Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter composed of the following elements: carbon, silicon, oxygen and polyamides. Particulate matter was found in eight reserve sample vials. <Read More> 

    Ceftazidime Injection by B. Braun Medical Inc. – New Drug Recall – April 20, 2020 – Braun Medical Inc. (B. Braun) is voluntarily recalling one (1) lot of 2g Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container to the hospital/user level.. During stability testing of Batch H8J812, test results were found to exceed the specification limits for High Molecular Weight Polymers (HMWP) at the nineteen (19) month [82 week] stability interval. <Read More> 

    Tetracycline Tablets by Avet Pharmaceuticals – New Drug Recall – April 16, 2020 – Avet Pharmaceuticals Inc. (“Avet”), based in East Brunswick, New Jersey, is initiating a voluntary recall of certain lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles to the consumer/user level…These drug products are manufactured by Avet Pharmaceuticals Labs Inc. and distributed under the Heritage Pharmaceuticals Inc. label. The voluntary recall is being initiated due to low out of specification dissolution test results. <Read More>

    Nizatidine Oral Solution by Amneal Pharmaceuticals – New Drug Recall – April 15, 2020 – Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. The three recalled lots are identified in the table below. Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA. <Read More>

     

    FDA Schedule Change

    Epidiolex® (cannabidiol) Oral Solution – FDA Schedule Change – April 6, 2020 – GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid platform, along with its U.S. subsidiary Greenwich Biosciences, Inc., announced that it has received notification from the United States Drug Enforcement Administration (DEA) confirming that Epidiolex® (cannabidiol) is no longer subject to the Controlled Substances Act (CSA).  This change takes effect immediately. <Read More>

    New Generic Approval and Launch

    No new update

    COVID-19 News

    Expert U.S. Panel Develops NIH Treatment Guidelines for COVID-19 – April 21, 2020 – A panel of U.S. physicians, statisticians, and other experts has developed treatment guidelines for coronavirus disease 2019 (COVID-19). These guidelines, intended for healthcare providers, are based on published and preliminary data and the clinical expertise of the panelists, many of whom are frontline clinicians caring for patients during the rapidly evolving pandemic. The guidelines are posted online (covid19treatmentguidelines.nih.gov) and will be updated often as new data are published in peer-reviewed scientific literature and other authoritative information emerges. <Read More>

    Pharmacists Help Weigh Cardiac Risks of Hydroxychloroquine – April 20, 2020 – There have been warnings against the indiscriminate use of hydroxychloroquine in COVID-19 patients, given the lack of peer-reviewed efficacy data. But there’s another concern: the cardiotoxities attributed to the medication. Given that hydroxychloroquine often is prescribed in conjunction with azithromycin, which carries its own potential heart risks (N Engl J Med 2012;366[20]:1881-1890), many providers are unsure how to proceed. That’s where pharmacists can help, according to Marianne Pop, PharmD, BCPS, a clinical assistant professor and an emergency medicine clinical pharmacist at the University of Illinois College of Pharmacy in Rockford. Whether it’s managing potential side effects of hydroxychloroquine or reviewing the patient’s medication history for any other agents that might exacerbate cardiovascular problems, pharmacists can be valuable contributors, she noted. <Read More> 

    NCPA Survey: Independent Pharmacies Report Financial Strain from COVID-19 Pandemic – April 20, 2020 – Independent pharmacies are being overwhelmingly impacted by the coronavirus disease 2019 (COVID-19) pandemic, according to results from a survey conducted by NCPA. Eighty-eight percent of community pharmacy owners reported intentions to apply for COVID-19 federal aid, such as provisions from the CARES Act, that has been made available for small businesses, according to the survey. The survey, which gauged pharmacy economic health during the COVID-19 pandemic, received a total of 511 responses from independent pharmacy owners and managers across the country from April 9 through April 14, 2020. <Read More> 

    Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19 – April 17, 2020 – A federal court has entered a temporary injunction against the Genesis II Church of Health and Healing (Genesis) and four individuals associated with the entity requiring them to immediately stop distributing its “Miracle Mineral Solution” (MMS), an unproven and potentially harmful treatment offered for sale to treat Coronavirus, which includes Coronavirus Disease 2019 (COVID-19) and many other diseases. In granting the government’s request for relief, the court found that the United States has demonstrated that Genesis and the associated individuals named in the injunction are violating the Federal Food, Drug, and Cosmetic Act (FD&C) by unlawfully distributing MMS, an unapproved new drug and misbranded drug. When combined with the included activator MMS has a chlorine dioxide content equivalent to industrial bleach. The court also found that there is a danger that the defendants will continue violating the law without the temporary restraining order. <Read More>

    CDC Issues Updated Guidance for Pharmacies During the COVID-19 Pandemic – April 16, 2020 – The CDC recently published an updated guidance for pharmacies during the coronavirus disease 2019 (COVID-19) pandemic, based on the most recent information regarding safety practices and precautions for the disease. The CDC explained that these guidelines should be applied to all staff in pharmacies so that it is possible to minimize risks to the health of staff and customers and to ensure that pharmacies are able to continuously stay open to support public health. There were 4 major changes made from previous guidelines in the following areas: <Read More>

    IDSA: No Recommendations for COVID-19 Treatment for Now, ‘Knowledge Gaps’ Cited – April 14, 2020 – There is currently insufficient evidence to recommend any particular medication for treatment of COVID-19, an expert panel of the Infectious Diseases Society of America (IDSA) has concluded. Many pharmacologic therapies are being used or considered for the treatment of patients with COVID-19. Given the rapidly emerging literature on treatment, the IDSA convened the panel to develop interim evidence-based guidelines to support clinicians in making decisions about treatment and management of patients with COVID-19. This is a “living document” that represents the best understanding to date on the treatment of patients with COVID-19, and it will be updated frequently as new information becomes available, IDSA member Rajesh Gandhi, MD, from Harvard Medical School and the Massachusetts General Hospital, Boston, said today during a media briefing. <Read More>

    NIH Begins Clinical Trial of Hydroxychloroquine for COVID-19 – April 13, 2020 – Hydroxychloroquine, an experimental therapy for coronavirus disease 2019 (COVID-19), is being investigated in a clinical trial led by the National Institutes of Health (NIH), according to the agency. The trial, which will evaluate the drug’s safety and efficacy in patients hospitalized with COVID-19, has begun with its first participants now enrolled in Tennessee. <Read More> 

    Ivermectin Intended for Animals: Letter to Stakeholders – Do Not Use in Humans as a Treatment for COVID-19 – April 10, 2020 – The FDA’s Center for Veterinary Medicine has recently become aware of increased public visibility of the antiparasitic drug ivermectin after the announcement of a research article that described the effect of ivermectin on SARS-CoV-2 in a laboratory setting. The Antiviral Research pre-publication paper, “The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro”  documents how SARS-CoV-2 (the virus that causes COVID-19) responded to ivermectin when exposed in a petri dish. These types of laboratory studies are commonly used at an early stage of drug development. No ivermectin was administered to humans in this study. Additional testing is needed to determine whether ivermectin might be appropriate to prevent or treat coronavirus or COVID-19. <Read More>

    Clinical and Pharmacy News

    American Thoracic Society Issues New Guidelines for COPD Treatments – April 23, 2020 – New official guidelines have been published by the American Thoracic Society (ATS) for the treatment of chronic obstructive pulmonary disease (COPD). Among the new recommendations, the combination of long-acting beta two agonists (LABA) and long-acting muscarinic antagonists (LAMA) is recommended over either therapy alone to treat people with COPD who have shortness of breath or exercise intolerance. <Read More> 

    AGA Releases New Ulcerative Colitis Guidance – April 22, 2020 – A new set of recommendations for patients with ulcerative colitis (UC) includes a variety of treatment options suitable to treat the disease. A team, led by Joseph D. Feuerstein, MD, Division of Gastroenterology and Center for Inflammatory Bowel Diseases at Beth Israel Deaconess Medical Center, recently released new ulcerative colitis guidelines on behalf of the American Gastroenterology Association (AGA) that address the adult outpatients with moderate to severe ulcerative colitis, as well as the medical management of adult hospitalized patients. <Read More> 

    Location Matters in Statin Treatment Among Veterans with Type 2 Diabetes – April 22, 2020 – Patients with diabetes are more likely to develop cardiovascular disease and events than patients without diabetes. Statin therapy is known to reduce the risk of cardiovascular events, and guidelines recommend them in all patients with diabetes. Despite this, several studies have documented racial and ethnic disparities in statin use. A recent study in the American Journal of Cardiology delved deeper into the subject to determine the joint impact of race and location of residence on statin use among veterans. <Read More> 

    Specialty Pharmacist Certification: The CSP Credential – April 21, 2020 – Is specialty pharmacy certification for you? Specialty pharmacy originated in the era of HIV and post-transplant immunosuppressant treatments requiring specialized pharmacist oversight. Over the past 20 years, the specialty pharmacy channel has been the fastest growing segment of pharmacy practice. It has evolved to accommodate the oversight of high risk and, usually, high cost medications—imperative to the explosion of biologic pharmaceutical agents—due to the added complexity and attention that they require. Consequently, these drug therapies require a higher level of knowledge compared with traditional disease and drug therapies. The Certified Specialty Pharmacist (CSP) credential is designed to validate your professional expertise. It will elevate your status to a specialty pharmacy professional, differentiate you in a competitive job market, position you for handling limited or exclusively distributed drugs, position you to better serve payer requirements, and protect the public by improving health outcomes and medication errors. If a career in specialty pharmacy is your interest, then becoming a CSP could be a worthwhile pursuit. <Read More>

    Biosimilar Knowledge is Essential to Modern Pharmacy – April 20, 2020 – Clinical pharmacists can play an important role in educating consumers about biosimilars, but they need to familiarize themselves with these products, said an expert panel recently.

    “Clinical pharmacists are in a unique position to provide appropriate patient and provider education. There’s also an increased impact by pharmacists in managing the formularies with multiple biosimilars available,” Antony Mato, MD, MSCE, said. To do this, they need to know the difference between different biologics, which represent the fastest growing therapeutic class of drugs. In 2017, an estimated $120.1 billion was spent on biological medicines, up from $76.9 billion in 2013, according to a Forbes analysis. <Read More>

    Study: Carved-In Pharmacy Benefits Reduce Medical Costs – April 17, 2020 – Research has shown that the carve-in model of pharmacy benefits results in lower medical costs. But much of that work has been reported in the “gray literature” of white papers and company reports with little, if any, outside review, according to Patrick Gleason, assistant vice president of health outcomes at Prime Therapeutics. Gleason and his co-authors set out to remedy the iffiness of that gray literature body of research on carve-in pharmacy benefit  with a large study of Cambia Health Solutions self-insured Blues plans in Oregon, Washington, Idaho and Utah. Published online last month in the Journal of Managed Care & Specialty Pharmacy, their study compared about 200,000 people in Cambia plans that had Prime as an integrated “carved-in” PBM with about 125,000 people in Cambia plans with PBMs “carved out,” so medical and pharmacy benefits of the members are were managed separately. <Read More>

    340B in the News 

    Safety Net Hospitals to Congress: Give Us More Targeted Funding, Changes to DSH and 340B to Combat COVID-19 – April 14, 2020 – A group representing safety net hospitals made a list of requests to Congress to shore up their shaky finances to combat COVID-19. America’s Essential Hospitals, which represents safety-net hospitals that primarily rely on Medicaid and disproportionate share payments, sent a letter on Monday to congressional leaders debating the next step in economic stimulus. In addition to more funding, the group pressed for regulatory changes and help for the controversial 340B drug discount program. The group criticized the method that Health and Human Services used to disperse $30 billion in funding to providers because the agency allocated it based on Medicare funding. The process “clearly disadvantages essential hospitals and other providers with below-average Medicare volumes and disproportionately high Medicaid and low-income volumes,” the letter said. “In fact, some of the hospitals caring for the largest influx of COVID-19 patients in hotspots will get minimal funding in the first tranche of emergency fund payments.” <Read More>