Clinical Insights: November 17, 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

    Sutab® (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets – New Drug Approval – November 10, 2020 – Sebela Pharmaceuticals® announced that the U.S. Food and Drug Administration (FDA) approved Sutab® (sodium sulfate, magnesium sulfate, and potassium chloride) tablets. Sutab®, a sulfate-based tablet preparation for colonoscopy, was developed and will be marketed by Braintree Laboratories, the makers of Suprep® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution—the market leader in branded colonoscopy preparations. Sutab® gives patients and physicians an alternative to liquid-based colonoscopy preparations. Braintree, a leader in gastroenterology, is part of Sebela Pharmaceuticals. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    BrilintaTM (ticagrelor) Tablets – New Approved Indication – November 5, 2020 – AstraZeneca’s BrilintaTM (ticagrelor) has been approved in the US to reduce the risk of stroke, a leading cause of disability and death worldwide, in patients with acute ischemic stroke (National Institutes of Health Stroke Scale score ≤5) or high-risk transient ischaemic attack (TIA). The approval by the US Food and Drug Administration (FDA) was based on positive results from the THALES Phase III trial that showed aspirin plus BrilintaTM 90mg significantly reduced the rate of the composite of stroke and death compared to aspirin alone in patients with acute ischaemic stroke or TIA. The decision follows the Priority Review designation granted by the FDA in July 2020. <Read More>

    Keytruda® (pembrolizumab) for Injection – New Approved Indication – November 13, 2020 –  Merck announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda®, Merck’s anti-PD-1 therapy, in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-approved test. The approval is based on results from the Phase 3 KEYNOTE-355 trial, where Keytruda® in combination with chemotherapy – paclitaxel (pac), paclitaxel protein-bound (commonly known as nab-paclitaxel) or gemcitabine (gem) and carboplatin (carbo) – significantly reduced the risk of disease progression or death by 35% for patients whose tumors express PD-L1 (CPS ≥10) versus the same chemotherapy regimens alone (HR=0.65 [95% CI, 0.49, 0.86]; p=0.0012). <Read More>

    New/Updated Drug Shortage

    November 16, 2020

    November 13, 2020

    November 12, 2020

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    Taytulla® (norethindrone acetate/ethinyl estradiol and Ferrous Fumarate), 1 mg/20 mcg – New Generic Approval – November 9, 2020 – Xiromed LLC, the New Jersey-based generic division of Insud Pharmaceuticals, announced the FDA approval of Gemmily™ (Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules), 1 mg/20 mcg, a therapeutically equivalent generic version of Taytulla®.  Xiromed is the first generic to Taytulla® approved in the United States.  Commercialization activities for Gemmily™ will begin immediately. Xiromed CEO, Narasimhan Mani commented, “The launch of this first-to-market generic is an important milestone for Xiromed, demonstrating the  strength of our development pipeline, and further establishing our position as a leading generic pharmaceutical company in the women’s health segment.  The Xiromed team is excited to offer this first generic product, furthering our commitment to providing high quality generics to patients in the US.” <Read More>

    Clinical and Pharmacy New

    US Rheumatologists Reluctant to Switch to Biosimilars for Patients Doing Well on a Reference Product – November 16, 2020 – Although half of US rheumatologists have patients for which nonmedical switching has been suggested, only 35% were likely to switch patients with rheumatoid arthritis doing well on a reference product to a biosimilar. While US rheumatologists understand and accept biosimilars, they are hesitant to switch patients doing well on a reference to a biosimilar, according to the results of a new survey published in Rheumatology. A 19-question online survey was conducted from May 6, 2019, to June 1, 2019, with the purpose of evaluating the perceptions of biosimilars among US rheumatologists who prescribe tumor necrosis factor α (TNFα) inhibitors. <Read More>

    New Resource Explores Ways Pharmacists Lead Smoking Cessation Efforts – November 16, 2020 – “There are a lot of people who need this service and doctors just don’t have time to go through all the things we go through to help people be successful,” said Julie Stewart, PharmD, who has been practicing at the pharmacy for over 15 years. Word is out that pharmacists are in a perfect position to help patients quit tobacco. In January of this year, the Surgeon General released the first report on smoking cessation in 30 years, highlighting the important role pharmacists play in cessation efforts. <Read More>

    Remote Monitoring Helps Pharmacists ID Irregular Heart Rhythms, Enables Diabetic Pts to Maintain Glycemic Control – November 13, 2020 – Two studies presented at the American College of Clinical Pharmacy’s 2020 Virtual annual meeting point to the power of mobile technology in helping patients with medication-induced heart problems and with diabetes. The first project demonstrated that community pharmacists can make use of mobile electrocardiogram (ECG) monitors to detect heart conduction abnormalities in their patients and alert prescribing physicians. In a pilot study of 53 patients enrolled at three community pharmacies in Iowa, pharmacists used 30-second ECG measures recorded on a mobile device to study patients’ QTc intervals, the length of time from when the heart starts to contract to when it finishes relaxing. All patients were taking medications known to be associated with prolonging the QTc interval, which can cause a rapid heart rate resulting in fainting, seizures or sudden death. <Read More>

    HHS Partners with Chain and Independent Pharmacies to Increase Access to Future COVID-19 Vaccines – November 13, 2020 – Nineteen pharmacies have partnered with the Department of Health and Human Services for consumer access to a COVID-19 vaccine when one becomes available. The program covers approximately 60% of pharmacies throughout the 50 states, the District of Columbia, Puerto Rico and the U.S. Virgin Islands. Through the partnerships with network administrators, independent pharmacies and regional chains will also be part of the federal pharmacy program, further increasing access to a vaccine across the country – particularly in traditionally underserved areas, HHS said. <Read More>

    New Guidelines for Community-Acquired Pneumonia – November 13, 2020 – According to Mark H Sawyer, MD, and professor of clinical pediatrics at the University of California San Diego School of Medicine and Rady Children’s Hospital in San Diego, we should see updates to the guidelines for community-acquired pneumonia (CAP) in 2021. In his session from the virtual 2020 American Academy of Pediatrics National Conference & Exhibition, Sawyer reviewed the present guidelines and discussed the newest approaches to CAP. A summary of the guidelines recommends hospitalization of infants (3-6 months) for hypoxia and known Staphylococcus aureus. Use of pulse oximetry is useful to guide severity and is available in the clinic setting, notes Sawyer. Blood cultures, a complete blood count (CBC), and chest x-ray (CXR) have not proven to be helpful in the outpatient setting but does assist in the diagnosis for inpatients. <Read More>

    Pharmacy Compliance: What Do You Need to Know? – November 13, 2020 – Pharmacies in the United States face substantial compliance burdens. From the Centers for Medicare and Medicaid Services (CMS) to the Drug Enforcement Administration (DEA), multiple federal agencies have oversight of pharmacies, and they diligently enforce pharmacies’ compliance obligations. As a result, pharmacies need to make compliance a priority. This should be a top-down effort, and compliance policies and procedures should address all aspects of a pharmacy’s operations—from drug ordering to insurance billing, and from receiving prescriptions to dispensing prescription medications. Oversights in any facet can lead to compliance violations, and these violations can in turn lead to federal law enforcement investigations. <Read More>

    First-Ever Guidelines for Pediatric Opioid Prescribing Released by APSA – November 12, 2020 – Opioids are useful for pain management following surgery and other major procedures, but until now there had been no recommendations guiding safe use of opioids in children. American Pediatric Surgical Association (APSA) has established first-ever guidelines for pediatric opioid prescribing. Dr. Kelley-Quon and her colleagues have outlined 20 guidelines for safer pain management in children and adolescents. <Read More>

    Pfizer’s COVID Vaccine Looks Promising, But Big Hurdles Remain – November 12, 2020 – Early COVID-19 vaccine trial results announced by Pfizer this week caused hopes to soar for a swift end to the pandemic that has killed more than 242,000 and infected more than 10 million in the United States alone. But even if the preliminary results released Monday pan out, it will still take many months to produce enough of the vaccine to inoculate everyone in the United States, experts warn. The health care industry will also face special distribution challenges related to this particular vaccine, which must be maintained in extremely cold storage and delivered in a two-shot regimen. <Read More>

    Cardinal Health Partners with CDC to Support Vaccine Access for Pharmacies – November 11, 2020 – Cardinal Health has reached an agreement with the Centers for Disease Control and Prevention (CDC) to act as a network administrator in Phase 2 of the Federal Pharmacy Partnership Strategy for COVID-19, which will enable retail independent, small chains and long-term care pharmacy customers to participate in the vaccination effort. The COVID-19 vaccine will be distributed by the CDC’s central distributor. <Read More> 

    Updated HIV Primary Care Guidelines – November 11, 2020 – Persons with HIV are living longer thanks to antiretroviral therapies (ART) and therefore updated primary care recommendations are needed as the HIV population ages, according to updated clinical guidelines published in Clinical Infectious Diseases. Investigators from around the United States outlined optimal medical care and desired medical outcomes for persons with HIV, so that they can live to a near expected lifespan. Advances in ART have made this possible, they said, leading to an update of the 2013 HIV Primary Care Guidelines from the HIV Medicine Association (HIVMA) of the Infectious Diseases Society of America (IDSA). <Read More>

    A Bright Future for Hospital Pharmacy – November 11, 2020 – For hospital pharmacies, the coronavirus disease 2019 (COVID-19) pandemic sparked an abrupt and intensive reevaluation of nearly every aspect of their operations, from the logistics of drug procurement to the relationships that are so critical to delivering quality care. As difficult as it may be to imagine today, the pandemic eventually will be under control. Exactly how and when that will happen is unknown. But now is the time for pharmacies to determine what changes to keep as they move forward—and to ensure they have the right partners to support a bright future. <Read More>

    The Decline of Child Antipsychotic Medications – November 10, 2020 – According to a Rutgers study, despite significant decline in antipsychotic use in privately insured children since 2009, doctors continue to prescribe antipsychotic medication off-label for conditions not approved by the US Food and Drug Administration. These conditions include conduct disorder, attention-deficit/hyperactivity disorder, anxiety, and depression. “We lack information on the effectiveness and safety of antipsychotics for treating those conditions in young children,” lead author Greta Bushnell, PhD, MSPH, a member of the Rutgers Institute for Health, Health Care Policy and Aging Research and an assistant professor at Rutgers School of Public Health, said to the press. <Read More>

    DMARDs Increase Likelihood of Osteopenia and Osteoporosis in Scleroderma – November 10, 2020 – Non-corticosteroid immunosuppressant use and long duration of disease increase the likelihood of patients with systemic scleroderma being diagnosed with osteopenia and osteoporosis, according to researchers reporting at the annual meeting of the American College of Rheumatology on Friday. The researchers, led by Lorinda Chung, director of the Scleroderma Program at Stanford School of Medicine, found that more than 40% of 348 adult systemic scleroderma patients attending its Rheumatologic Dermatology Clinic from January 2006 to March 2016 had a diagnosis of osteopenia/osteoporosis (41.4%; 95% CI: 36.2%, 46.6%). <Read More>

    Why ‘Pharmacy Benefit Managers’ are Hurting You and Your Local Pharmacy – November 10, 2020 – So, just who are ‘Pharmacy Benefit Managers’ or ‘PBM’s as they’re more commonly known. They’re the quiet middlemen that stand between drug manufacturers and your local pharmacy and even though you’ve never heard of them, they know all about YOU. Pharmacy Benefit Managers were originally created to assist the healthcare industry by acting as a liaison between parties and administering costs and procedures that actually helped everyone. But over the years they have morphed into a super powerful group of organizations that now dictate how much YOU as a consumer pay for your prescription drugs. <Read More>

    340B in the News

    To Keep Drug Costs Down and Fairness Up, Stop the Abuses of 340B – November 17, 2020 – Alas, hospitals and pharmacies are abusing a federal program meant to help low-income patients.  New research from consulting firm Berkeley Research Group reports that these bad actors are lining their own pockets with discounts on prescription drugs at the expense of millions of disadvantaged American patients. This exploitative behavior is unacceptable under any circumstances, especially now in the midst of twin medical and economic crises. Our lawmakers mustn’t let this abuse continue. <Read More>

    Spanberger Leads Bipartisan Effort to Save 340B Drug Pricing Program – November 15, 2020 – Seventh District Congresswoman Abigail Spanberger is leading a bipartisan effort to defend the foundational 340B Drug Pricing Program from changes that would lead to significant increases in the cost of prescription medications for Virginia healthcare providers… Spanberger wrote a letter supported by 216 House colleagues urging HHS Secretary Alex Azar to take immediate action to prevent Kalderos and pharmaceutical companies from changing the 340B program from a discount to a rebate model. The healthcare providers that benefit from 340B discounts– and who could be facing significant price increases if the change goes through– include Federally Qualified Health Centers, Ryan White HIV/AIDS clinics, rural hospitals, children’s hospitals, and safety-net hospitals that serve low-income Americans. <Read More>

    The Affordable Care Act at Risk: American Health Policy at a Crossroads – November 11, 2020 – We are at a major crossroads in U.S. health policy. The direction for American health care in 2021 and beyond will depend in large part on events that are unfolding now, and that will come to fruition in the first half of 2021. Foremost among those events are the U.S. Supreme Court’s decision on the validity of the Patient Protection and Affordable Care Act (ACA), which the Court is considering now and will hand down in the first half of 2021, and the final results of the general elections to determine the political dynamic in the Congress come January 2021…Whatever policy direction the future brings, however, one thing is certain: Developments in the next few months will result in a big wave of follow-on litigation in 2021 and beyond. Lawsuits against the Department of Health and Human Services (HHS) and CMS have already become the “new normal,” with the courts being asked to rule on issues ranging from site neutrality to transparency regulations to 340B cuts to Medicaid work requirements, and much more. <Read More>

    Five Issues Hospitals Want Biden to Tackle in his First 100 Days – November 10, 2020 – Former Vice President Joe Biden is beginning his transition to power as the novel coronavirus is breaking somber records in the U.S. — and hospitals in some areas find themselves stretched to the brink once again. Bolstering the federal response to the pandemic is the sector’s No.1 ask for the incoming president…The new administration should reverse Trump-era policies that have cut back on funding for facilities serving a large proportion of low-income or vulnerable patients, Feldpush said. That includes cuts to outpatient clinic visits and Part B drug payments to hospitals in the 340B drug pricing program. Biden’s CMS administrator could reverse the 340B rate cut of 23%, but Biden himself hasn’t mentioned it as a priority, according to consulting firm PwC. <Read More>