Clinical Insights: September 8, 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

    Onureg® (azacitidine) Tablets – New Drug Approval – September 1, 2020 – The Food and Drug Administration approved azacitidine tablets (Onureg®, Celgene Corporation) for continued treatment of patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. <Read More>

    Xaracoll® (bupivacaine hydrochloride) Implant – New Drug Approval – August 31, 2020 – Innocoll Holdings Limited, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, announced that the US Food and Drug Administration (FDA) has approved Xaracoll® for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair, a painful and commonly-performed surgery. Xaracoll® is a unique, non-injectable drug-device combination in the form of a fully bioresorbable collagen implant containing bupivacaine hydrochloride. Xaracoll® is placed directly into the surgical site during surgery and, after placement, releases bupivacaine immediately and over time. <Read More> 

    Sogroya® (somapacitan-beco) Injection – New Drug Approval – August 28, 2020 – The U.S. Food and Drug Administration approved Sogroya® (somapacitan) for adults with growth hormone deficiency. Sogroya® is the first human growth hormone (hGH) therapy that adult patients only take once a week by injection under the skin; other FDA-approved hGH formulations for adults with growth hormone deficiency must be administered daily. <Read More>

    New Formulation Approval

    No new update.

    New Indication Approval

    No new update.

    New Drug Shortage

    September 08, 2020

    September 01, 2020

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Community Pharmacists Make a Difference With Immunizations – September 7, 2020 – There are many areas of patient care where pharmacists can have a direct impact, yet a number of them do not have the confidence or understand the potential magnitude of that impact. If pharmacists want to continue to move the profession forward, seeking provider opportunities, they must gain that confidence and help stakeholders understand the important roles they play. These include conducting diabetes or point-of-care testing, but it is immunizations that provide the clearest snapshot. <Read More> 

    ADA’s Updated 2020 Guidance On Pharmacologic Treatment Of Adults With Type 2 Diabetes – September 5, 2020 – The American Diabetes Association (ADA) has updated the guidance on pharmacologic treatment of adults with type 2 diabetes which has been published in the Annals of Internal Medicine. This will provide clinicians, patients, researchers, payers, and other interested parties with evidence-based recommendations for the diagnosis and management of diabetes. <Read More> 

    New Clinical Practice Guidelines on AML in Older Adults – September 5, 2020 – The American Society of Hematology (ASH) published new guidelines to help older adults with acute myeloid leukemia (AML) and their health care providers make critical care decisions, including if and how to proceed with cancer treatment and the need for blood transfusions for those in hospice care. Each year, nearly 20,000 people receive a diagnosis of AML. The disease generally develops in older people; the median age of diagnosis is 68. As the Baby Boomer generation ages and the average demographic age in the United States increases, evidence-based recommendations for the optimal treatment of older adults with AML take on greater urgency and importance. <Read More> 

    Drug Class, Type of Pharmacy Influence Medication Substitution – September 4, 2020 – The use of generic medications has been found to conserve financial resources and often increase patient adherence. However, the rates of substitution can vary based on several factors, including drug class, the number of prescriptions a patient has, and the type of pharmacy dispensing the medication. Investigators conducted a cross-sectional analysis of data and quantified generic substitution rates for 26 drug classes, according to findings published in Therapeutic Innovation & Regulatory Science. <Read More> 

    Managing Oral Oncolytics During the COVID-19 Pandemic – September 4, 2020 – The coronavirus disease 2019 (COVID-19) pandemic has significantly altered how health care professionals treat patients on oral therapies and manage their care, with many strategies for treatment shifting to minimize the potential exposure to the virus for the vulnerable patient population. In a Pharmacy Times® webcast, Katie Culos, PharmD, BCOP, a specialist in cellular therapy and hematology at Vanderbilt University Medical Center in Nashville, Tennessee, led a discussion with Katherine Lin, PharmD, BCPS, BCOP, of PANTHERx Rare Pharmacy in Pittsburgh, Pennsylvania, about the management of oral oncolytics during the COVID-19 pandemic, considering the many policies and procedures that have been implemented by providers for cancer care. <Read More> 

    APhA, 12 Other Pharmacy Organizations Call for Tier 1 Priority Status for Pharmacists in Planning for the COVID-19 Vaccine – September 4, 2020 – The American Pharmacists Association and 12 other pharmacy organizations told a special committee of the National Academies of Science, Engineering and Medicine (NASEM) that pharmacists should be given tier 1 priority status in the allocation and distribution of COVID-19 vaccine(s). “Pharmacies and pharmacists in all practice settings are essential front-line health care providers and have been providing COVID-19 and related patient care since the coronavirus first appeared in the United States,” the group said. “We are proud of the tremendous critical efforts that our members have undertaken to help our nation respond to the pandemic.” <Read More> 

    New European NSTE ACS Guidelines Embrace hs-Troponin, CTA, NOAC Trials – September 3, 2020 – With their first update in 5 years, the European Society of Cardiology (ESC) guidelines for non-ST-segment elevation acute coronary syndromes have incorporated several new concepts plus rethinks related to diagnosis and management. The guidelines were published online in the European Heart Journal to coincide with the virtual ESC Congress 2020. <Read More>

    Make the Most of IV Compounding Robots – September 3, 2020 – Intravenous (IV) chemotherapy compounding robots can yield important operational and safety benefits for health-system pharmacies, including greater productivity and reduced error rates. However, according to experts, reaping those gains requires close observation, careful consideration and ongoing fine-tuning processes. <Read More> 

    Student Debt Continues to Rise for New Pharmacists – September 3, 2020 – Students in the class of 2020 finished pharmacy school with an average debt of $179,514, according to a July 2020 survey from the American Association of Colleges of Pharmacy. The average student debt among pharmacists increased 4% compared with the class of 2019 and has gone up 14% since 2016. Programs for a Doctor of Pharmacy degree, or Pharm.D., typically last four years. <Read More> 

    During this Pandemic, It’s Time to Expand Children’s Access to Vaccines – September 3, 2020 – We need all hands on deck to defeat the resilient coronavirus. Yet several groups in organized medicine are still fighting to deny parents the right to choose where their children get their childhood vaccines — when broader access to protective vaccines is critical for our children to safely attend school or get childcare. Patient choice, access and practitioner collaboration must be our focus. The U.S. Department of Health Human Services recently did a great thing for the American public, announcing a new policy that standardizes access to childhood vaccines across all states and territories. HHS said that during this pandemic, pharmacists may administer certain licensed or authorized vaccines recommended for children ages 3-18, even where state laws and regulations are more restrictive. <Read More> 

    Apixaban: A New Treatment Option for Cancer-Associated VTE – September 3, 2020 – Venous thromboembolism (VTE) is the second-leading cause of death among patients with cancer…Low molecular weight heparin (LMWH) agents have been the standard of practice because of their reduced risk of recurrent VTE compared with oral vitamin K antagonist (VKA). LMWH agents have limitations: cost, renal elimination, and subcutaneous (SQ)–only formulation that makes it less desirable. Factor Xa inhibitors, such as rivaroxaban (Xarelto), edoxaban (Savaysa), and apixaban (Eliquis), are indicated for the treatment of acute VTE and atrial fibrillation. Recent evidence supports the use of edoxaban and rivaroxaban in cancer-associated VTE; however, these 2 agents lead to more major bleeding than LMWH. Apixaban is the latest agent investigated that has a favorable safety and efficacy profile for this patient population. <Read More> 

    COVID-19: What Have We Learned? How Do We Move Forward? – September 3, 2020 – On Jan. 19, a patient who had recently returned from Wuhan, China, walked into an urgent care clinic in Washington state with a cough. The rest is history. The patient was the first one in the United States to be diagnosed with SARS-CoV-2, the virus that causes COVID-19. He was admitted to Providence Regional Medical Center, one of 51 facilities that make up Providence St. Joseph Health, located throughout several western states, Texas and Alaska. Quickly, it became obvious that this was no ordinary infection. <Read More> 

    Report: PBM “Reforms” Leave Biosimilars Out in the Cold – September 2, 2020 – A review of changes in business practices by pharmacy benefit managers (PBMs) states that apparent reforms have been undermined by behind-the-scenes arrangements that locked in outsized profits for these organizations and undermined efforts at greater value for health care consumers and other stakeholders. These practices have stalled placement of biosimilars on formulary and slowed uptake, giving preference to more costly originator drugs, the authors argued. “With few exceptions, biosimilar uptake among PBMs has been slow. Formulary decisions on brand drugs, sometimes touted as innovative cost-saving measures, are often unrelated to clinical value and may be implemented for products without any available comparative evidence of clinical or cost-effectiveness, suggesting that rebates influence them,” the authors wrote. <Read More> 

    Clinical Practice Guidelines on Cardiovascular Disease Risk Reduction in Type 2 Diabetes (ACC, 2020) – September 2, 2020 – In July 2020, the American College of Cardiology (ACC) published clinical recommendations regarding cardiovascular disease risk reduction using sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists (GLP-1RAs) in patients with type 2 diabetes. It is recommended that for patients with type 2 diabetes (T2D) who have or are at very high risk for clinical atherosclerotic cardiovascular disease (ASCVD), heart failure (HF), and/or diabetic kidney disease, a patient-clinician discussion be initiated, at a clinical follow-up visit, regarding the use of a sodium-glucose cotransporter 2 (SGLT2) inhibitor and/or a glucagon-like peptide 1 receptor agonist (GLP-1RA), with demonstrated cardiovascular (CV) benefit. <Read More> 

    WHO Updates Clinical Care Guidance With Corticosteroid Recommendations – September 2, 2020 – WHO published guidance for clinicians and health care decision-makers on the use of corticosteroids in patients with COVID-19. We recommend systemic corticosteroids for the treatment of patients with severe and critical COVID-19. We suggest not to use corticosteroids in the treatment of patients with non-severe COVID-19 as the treatment brought no benefits, and could even prove harmful. Treatment should be under supervision of a clinician. <Read More> 

    Be Vigilant With Pediatric Populations – September 2, 2020 – Although clinicians associate many patient populations with chronic medication use, drug-drug interactions (DDIs), and polypharmacy, clinicians do not generally recognize the pediatric group as having great risk. Clinicians often reserve vigilance with drug-related issues for critically ill patients or older populations, while mistaking the resilience of childhood as a protective barrier. Although this paradigm may accurately represent some, if not most children, a portion of the pediatric population with chronic conditions requires medication from a variety of drug classes and, consequently, is at an equal or greater risk for adverse drug reactions (ADRs) relative to adults. <Read More> 

    Pharmacists Face Critical Changes to Immunization Practices During the COVID-19 Pandemic – September 2, 2020 – Pharmacists’ ability to provide services has been hindered throughout the coronavirus disease 2019 (COVID-19) pandemic. In a Pharmacy Times’ webcast on immunization practices during the pandemic, thought leaders discussed considerations and best practices regarding the administration of vaccinations. The key opinion leaders in the discussion included Jeff Goad, PharmD, FAphA, FCPhA, FCSHP, of Chapman University School of Pharmacy; Brian Hille, RPh, of Albertsons Companies; Lauren Simko, PharmD, of Pharmacy Development Services; and Suzanne Soliman, PharmD, of Pharmacists Moms™ Group. Hille noted that pharmacists are a critical element of the country’s ability to immunize its citizens. “We, as a profession, provide such a large percentage of the total immunizations across the country, not just flu but others. So, it was really important for us to make sure that we could maintain immunization services during the pandemic,” Hille said. “We never fully stopped providing immunizations, but we definitely slowed down.” <Read More> 

    Telepharmacy in the Time of COVID-19 – September 2, 2020 – In March, with a potential surge in COVID-19 cases on the horizon, the Geisinger Health system realized very early that it needed to make some changes. As the system implemented several initiatives in its clinics and hospital sites, Geisinger’s pharmacy worked aggressively behind the scenes to keep employees safe without compromising patient care. By mid-March, 78% of its specialty pharmacy staff were working from home; only those staff needed to fill and ship orders remained on site. Home-based pharmacists focused on remote order entry and verification, precertification and prior authorizations, and telephone-based assessments and clinical teaching. Clinical pharmacists across the system scheduled video conferencing appointments with their patients and filled in any gaps in care, and inpatient pharmacists moved home whenever possible, implementing virtual rounding with the medical team and patient education sessions using Skype. <Read More> 

    FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs – September 1, 2020 – Since the outset of our discovery of impurities called nitrosamines in some types of drugs more than two years ago, the U.S. Food and Drug Administration has undertaken a thorough investigation in an effort to protect patients. While nitrosamines are common in water and foods, nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. For this reason, the discovery of unexpected nitrosamine impurities in some drug products is a serious concern, and the FDA has been working, in collaboration with regulatory counterparts around the world, to find and remove drugs with unacceptable nitrosamine impurities from the U.S. drug supply. <Read More> 

    FDA Approves First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients – August 31, 2020 – The U.S. Food and Drug Administration approved the MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the users or their caregivers for use by individuals aged 2 to 6 with type 1 diabetes. The 770G System is a first-of-a-kind device for patients aged 2 to 6 years. It is the first legally marketed device that can automatically adjust insulin delivery based on continuous glucose monitor values for this patient population. <Read More> 

    CDC’s Tips® Campaign led One Million U.S. Adults to Quit Smoking During 2012-2018 – August 27, 2020 – Findings from a Centers for Disease Control and Prevention (CDC) study published in Preventing Chronic Disease show that CDC’s Tips From Former Smokers® (Tips®) campaign led more than 1 million U.S. adults to quit smoking and an estimated 16.4 million U.S. adults to attempt to quit smoking during 2012–2018. The 1 million quits (people who stopped smoking for at least a year) and the 16.4 million quit attempts (people who stopped smoking for 1 day or more during a 3-month period) mark a milestone for Tips—the first federally funded anti-smoking ad campaign. <Read More> 

    340B in the News

    AHF Warns Pharma Its Attacks on 340B Drug Program Will Harm Patients – September 8, 2020 – WASHINGTON–(BUSINESS WIRE)–AIDS Healthcare Foundation (AHF) condemns the latest series of attempts by drug manufacturers to undermine an essential part of the healthcare safety net, the 340B Drug Pricing Program. “Make no mistake, the 340B Program is under attack,” said Tracy Jones, AHF senior manager and executive director of the AIDS Task Force of Greater Cleveland, an AHF affiliate. “At a time when safety net providers around the country are struggling to keep their doors open and serve patients in the midst of a pandemic, drug companies are devising new ways to make the costs of drugs more expensive, and to cut safety net providers off from the savings they need to support their services.” <Read More> 

    Sen. Lesser Calls Out Drug Companies Threatening Drug Program – September 5, 2020 – State Senator Matt Lesser (D-Middletown) along with U.S. Senator Richard Blumenthal (D-Conn.), his Middletown legislative colleagues, Representative Sean Scanlon, and Representative Quentin Phipps called out drug companies that are limiting restriction on who can access life saving medication. Senator Matt Lesser specifically called out two companies in particular, Eli Lilly and Sanofi, to put an end to both illegally erecting hurdles for patients to access affordable prescription drugs, such as insulin, from federally qualified health centers (FQHCs) and other health care providers, under the 340B drug-pricing program. <Read More> 

    CMS Eyes Deeper 340B Rate Cuts; Hospitals Cry Foul – September 3, 2020 – Hospitals that serve large numbers of patients who are uninsured or covered by Medicaid and Medicare took another big hit on Aug. 4, when the Centers for Medicare & Medicaid Services (CMS) unveiled a new round of cuts to the federal 340B drug program as part of its 2021 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment System Proposed Rule (CMS-1736-P). <Read More> 

    Eli Lilly Stops Giving 340B Discounts to Contract Pharmacies – September 3, 2020 – Eli Lilly told hospitals Sept. 1 that it will no longer give 340B drug discounts to hospitals that ship the drugs to 340B contract pharmacies instead of dispensing them in house, according to documents obtained by 340B Report, a news site that focuses on the 340B program…Eli Lilly said it will only give 340B discounts to covered entities and their child sites, not to contract pharmacies, as of Sept. 1, as a precaution to avoid duplicate discounts that could be offered at the pharmacies. Covered entities that don’t have an in-house pharmacy can contact Eli Lilly regarding an exception, the company said. <Read More> 

    Florida’s Community Health Centers Call on Congress, HHS and HRSA to Stop Drug Manufacturers from Undermining the 340B Program – September 2, 2020 – The Florida Association of Community Health Centers (FACHC) called on Congress and federal agencies to stop drug manufacturers’ efforts to limit access to affordable medications for uninsured and underinsured populations. The not-for-profit organization released the following statement from its President and CEO, Andrew Behrman: “Drug manufacturers have joined the ranks of pharmacy benefit managers (PBMs) to destroy one of the very best-intended programs from the federal government. They have become increasingly emboldened in recent months by inaction at the national level in how they choose to address perceived slights in the 340B Program. What was designed by Congress to provide up-front discounts to safety net providers for medications that save lives and control chronic conditions (such as asthma, diabetes, and heart disease) is now under attack not only from the middlemen like PBMs who try to scoop out these savings from the safety net and keep them for themselves, but also from the manufacturers. These discounts are, for many Community Health Centers, a lifeline used to keep providing services to the most vulnerable population in the state and across the country. <Read More> 

    What Does Excellence in Oncology Pharmacy Look Like? – September 1, 2020 – Specialty pharmacies are improving health and creating value in the oncology space. Study results have demonstrated that pharmacists are effective partners in improving care, reducing cost, and avoiding drug complications for patients with cancer. Yet what does excellence in oncology pharmacy look like? For any specialty pharmacy program to reach excellence, it must be patient centric, outcomes focused, collaborative, and future oriented…By working with a range of health care stakeholders, specialty pharmacies can affect more than just the individual patient journey. Analyzing pharmacy data and sharing appropriate information can help identify trends, areas for improvement, cost savings, and other opportunities to promote safer, more effective care. Manufacturer partnerships and limited distribution drug programs provide specialty medication and support for patients with extremely rare or complicated conditions. Clinical trial and research programs help advance research, leading to new and improved therapies, and 340B partnerships extend care to uninsured and underinsured populations while providing additional revenue to eligible treatment centers. Support for community-based 501(c)(3) organizations promotes research, peer-to-peer support, and the availability of emergency financial assistance for patients in times of need. <Read More>