Clinical Insights: August 18, 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

    EnspryngTM (satralizumab-mwge) Injection – New Drug Approval – August 17, 2020 – The U.S. Food and Drug Administration has approved EnspryngTM (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody – patients who are anti-aquaporin-4 or AQP4 antibody-positive. NMOSD is a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Enspryng is the third approved treatment for the disorder. <Read More>

    ViltepsoTM (viltolarsen) Injection – New Drug Approval – August 12, 2020 – The U.S. Food and Drug Administration granted accelerated approval to ViltepsoTM (viltolarsen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This is the second FDA-approved targeted treatment for patients with this type of mutation. Approximately 8% of patients with DMD have a mutation that is amenable to exon 53 skipping. <Read More>

    New Formulation Approval

    No new update.

    New Indication Approval

    No new update.

    New Drug Shortage

    August 17, 2020

    August 12, 2020

    August 11, 2020 

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    Ciprodex® (ciprofloxacin/dexamethasone) – First-Time Generic Approval – August 11, 2020 – Dr. Reddy’s Laboratories Ltd. (along with its subsidiaries together referred to as “Dr. Reddy’s”) announced the launch of Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, USP, a therapeutic equivalent generic version of Ciprodex® (ciprofloxacin 0.3% and dexamethasone 0.1%) Otic Suspension, approved by the U.S. Food and Drug Administration (USFDA). <Read More>

    Clinical and Pharmacy News

    Oncology Practices Adapt Tech, Other Tools to COVID-19 – August 17, 2020 – Agility. Flexibility. A can-do attitude to adapt to the unexpected. These are some attributes community oncology practices have needed to survive during the COVID-19 pandemic, which has put renewed emphasis on the importance of nimble and responsive leadership in dealing with crises, according to medical experts who were panelists on the virtual 2020 Community Oncology Alliance Conference’s Cancer v. COVID session. <Read More>

    Website Shines Light on Diversion During COVID-19 – August 17, 2020 – COVID-19–era arrests for thefts of personal protective equipment (PPE) and respiratory support equipment, hydroxychloroquine and opioids from health care facilities are beginning to surface in the United States, according to the developers of HealthcareDiversion.org, a nonprofit website aimed at shining light on the diversion problem. <Read More>

    Restore Hope Through Pharmacy Services – August 17, 2020 – Millions of Americans have suffered financially and mentally during the COVID-19 pandemic. At least 27 million have lost their health coverage since it began, according to the Congressional Budget Office. In a recent survey conducted by the Commonwealth Fund and SQL Server Reporting Services, more than 40% of respondents said that they are experiencing health insurance insecurity through lack of insurance, loss of insurance, or worrying about the potential to lose insurance. About 20% of these people will not be able to participate in alternative health coverage, such as Medicaid or subsidized health plans through the Affordable Care Act…Fortunately, pharmacists, can step in to help restore what coronavirus has broken by supporting patients who cannot afford medications and have lost their insurance coverage. <Read More>

    Best Cancer Tests Don’t Reach All Who Need Them – August 17, 2020 – Patients with non-small cell lung cancer (NSCLC) who received a companion diagnostic as part of their initial treatment had a 3-fold greater survival benefit than those who were not tested—yet some patients still don’t get tested. That is what authors found in a study published July 6, 2020, in The Oncologist. The investigators, who reported the study was the largest real-world study of its kind, said it confirms the frustration that surrounds precision medicine in cancer care. <Read More>

    Should We Screen all Adolescent Girls and Women for Anxiety? – August 17, 2020 – Anxiety disorders are the most common mental illnesses, affecting up to 40% of women and 20% of men in the course of their lifetimes. Women and adolescent girls are at particularly high risk for the development of anxiety disorders, due to differences in their brain chemistry, psychosocial contributors such as childhood sexual abuse, as well as the hormonal effects of estrogen and progesterone. Since anxiety disorders are so common among women and girls, could early detection lead to improved outcomes? <Read More>

    ACP, AAFP Release New Guideline for Treatment of Non-Low Back Pain – August 17, 2020 – The American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP) released a new clinical guideline recommending that physicians treat acute pain from non-low back musculoskeletal injuries with topical NSAIDs, with or without menthol gel, as first-line therapy. The new, evidence-based, joint guideline was published in Annals of Internal Medicine. <Read More> 

    New Clinical Practice Guidelines on Optimal Management of Patients with COPD – August 17, 2020 – A subcommittee of the American Thoracic Society Assembly in Sleep and Respiratory Neurobiology has released new clinical practice guidelines to help advise clinicians on the optimal management of patients with chronic obstructive pulmonary disease (COPD) and chronic hypercapnia. Hypercapnia is the buildup of carbon dioxide in the bloodstream. The guidelines, published online in the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine, is titled “Long-Term Non-Invasive Ventilation in Chronic Stable Hypercapnic Chronic Obstructive Pulmonary Disease: An Official American Thoracic Society Guideline.” <Read More> 

    Maximizing Adherence Packaging for Patient Health and Pharmacy Growth – August 17, 2020 – Independent and community pharmacists can now invest in technologies that result in more efficient practices, improved quality of care, and increased margins. The environment may be right for your pharmacy. In the last few years, competitors in e-commerce have entered the health care market by offering clinical and non-clinical products and services, including medication adherence packaging and free delivery. <Read More> 

    Keeping the Cold Chain Strong During COVID-19 – August 17, 2020 – Pharmaceutical manufacturers and accreditors will scrutinize cold-chain packaging and processes more closely in the COVID-19 and post-COVID eras, according to Jon Pritchett, PharmD, the pharmacy program director at the Accreditation Commission for Health Care (ACHC), in Cary, N.C. Some manufacturers already go so far as to show specialty pharmacies the precise package materials and packout configurations they’ve validated to optimize temperature integrity of high-value medications and ensure patient safety, Dr. Pritchett added. “They even state the size of cooling packs and how to layer them in the box to maintain temperature for specific medications for set time periods,” he said. <Read More> 

    Multiple Sclerosis Drug May Block HIV Infection – August 17, 2020 – A new study suggests that an immunosuppressive drug that treats multiple sclerosis (MS) may also be effective protecting against HIV infection. Fingolimod (Gilenya), which is approved by the FDA to treat MS flare-ups, may also block HIV and reduce the latent reservoir, according to a study by researchers at the George Washington University (GW) and published in PLOS Pathogens. <Read More> 

    Prepare the Pharmacy for the Next Crisis – August 17, 2020 – Many pharmacies may have prepared standard downtime procedures but may not have given much thought to developing a crisis continuity plan. The purpose of continuity planning is to ensure that dispensing operations continue, that pharmacy information systems’ data remain protected and accessible, and that telecommunications to support critical organization function during and after business interruption. Interruptions can occur for various reasons, such as earthquakes, fires, flooding, hurricanes, pandemics, power loss, tornadoes, and wildfires. Devising a crisis continuity plan can enable pharmacies to continue to provide patient care, ensure staff safety, and maintain financial viability after a disaster. The coronavirus disease 2019 (COVID-19) pandemic and the resulting business closures brought about by the shutdown have highlighted this need to plan for all health care–related essential businesses. <Read More> 

    The Case for Medication-Assisted Treatment: An Ethical Priority – August 16, 2020 – Substance use disorder (SUD), including opioid use disorder (OUD), impacts a significant proportion of the American population—20.3 million people (7.4%) of all Americans aged 12 years or older had a SUD in the past year.1 Of these, 2 million people had an OUD with either heroin and/or misuse of prescription pain relievers. Yet, while medication-assisted treatment (MAT) with methadone, buprenorphine, or naltrexone for OUD is the most efficacious, evidenced-based treatment that is recommended by the National Institute of Health, Substance Abuse and Mental Health Services Administration (SAMHSA), and the World Health Organization, only 11% of patients with an OUD are prescribed approved treatment. <Read More> 

    Therapies for Influenza: Examining the Therapeutic Benefits and Reductions in Influenza-Related Complications – August 16, 2020 – Influenza treatment was a timely topic discussed during the 2020 virtual Directions in Pharmacy® conference. Rupal Mansukhani, PharmD, FAPhA, CTTS, presented a review of antiviral therapies to improve patient outcomes and reduce influenza-related complications. Dr Mansukhani began the discussion with a summary of influenza epidemiology, etiology, and pathophysiology. …Dr Mansukhani then discussed antiviral treatment recommendations, which stress initiating treatment early (i.e., not waiting for laboratory confirmation). Testing for influenza depends on access to testing and the clinical status of the patient, as a negative result does not preclude a patient from treatment, and false positives and/or negatives may occur. <Read More>

    Beset by Coronavirus, Health Authorities Brace for Influenza Season – August 14, 2020 – The approaching influenza season threatens to overwhelm hospitals swamped by COVID-19 patients, prompting increased efforts to get people vaccinated against influenza. To reduce the pressure, drugmakers including AstraZeneca, GlaxoSmithKline, and Sanofi are making approximately 200 million influenza vaccine doses this year for shipment to doctors, hospitals and pharmacies, up 13% from last year and a record, according to CDC. The federal government is also launching a campaign encouraging people to get the seasonal influenza vaccine, while drugmakers and pharmacies explore new measures to ensure more people get vaccinated, such as offering influenza vaccination curbside. <Read More> 

    Stay Up to Date on Alzheimer Research – August 14, 2020 – More than 5 million people in the United States have Alzheimer disease (AD), and that number is expected to triple by 2050. Although AD is the third-leading cause of death in those 65 years and older, just $900 million is dedicated to research. In 2020, the annual cost of AD and other forms of dementia is estimated at $350 billion. All drugs approved by the FDA to treat AD are symptomatic therapies that work on the acetylcholine or glutamate neurotransmitters. The standard medical treatment for AD includes cholinesterase inhibitors and a partial N-methyl-D-aspartate antagonist that ameliorate cognitive and memory deficits. There are no treatments that delay, prevent, or stop disease progression. <Read More> 

    Pharmacy and Telehealth: An Interprofessional Model at a Student-led Free Clinic – August 14, 2020 – Coronavirus disease 2019 (COVID-19) has changed the way patient-centered care is delivered and has challenged providers to identify alternate means of connecting with patients. At Rosalind Franklin University of Medicine and Science (RFUMS), an interprofessional team of faculty and students have taken the initiative to provide patient care through telehealth at the university’s student-led free clinic. The purpose of this article is to demonstrate how clinical pharmacy services can be integrated in an interprofessional (IP) telehealth clinic. <Read More> 

    COVID-19 Spurs Renewed Crisis in OUD Patients – August 13, 2020 – Opioid use disorder (OUD) has become an epidemic within the COVID-19 pandemic, a panel of public health experts said during a webinar organized by the Association of Schools and Programs of Public Health. Without adequate access to treatment, relapse rates among patients with OUD are surging. And when these patients do get access to opioids, their lowered tolerance places them at risk for overdoses, the experts noted during the webinar. <Read More> 

    Digital Tools Can Minimize Guesswork – August 13, 2020 – Thank to advanced health care, pharmaceuticals, and technology enabled providers, people are living longer than ever before. As a result, health systems are expected to manage larger numbers of patients, many of whom live with chronic and complex conditions that may require multiple medication therapies. This situation becomes even more challenging with the additional need to manage medication adherence within the aging population. Given these challenges, pharmacists have an opportunity to expand their traditional responsibilities to drive patient engagement with the help of digital tools. <Read More> 

    Use of Antiemetics in Cancer Patients: ASCO Guideline Update – August 13, 2020 – American Society of Clinical Oncology (ASCO) has updated its guidelines on Antiemetics in cancer patients. The guidelines published in the Journal of Clinical Oncology include new anticancer agents, antiemetics, and antiemetic regimens and provide recommendations on the use of dexamethasone as a prophylactic antiemetic in patients receiving checkpoint inhibitors (CPIs). The guidelines will primarily address medical and radiation oncologists, oncology nurses, nurse practitioners, physician assistants, oncology pharmacists, and patients with cancer. <Read More>

    Five Essential Truths to Treating Dry Eye Disease – August 13, 2020 – Dry eye disease is ubiquitous across all of eye care. The condition affects the quality of routine vision exams, contact lens fittings, and ophthalmic surgical outcomes…All too often, doctors were managing dry eye disease based solely on their own clinical experiences and anecdotal information. Additionally, some eyecare providers had not changed their practice patterns as dry eye disease diagnostics and treatment options evolved. Many physicians clamored for guidance to give them direction for care and, ultimately, better outcomes for patients. <Read More>

    New Treatment Regimens Show Early Efficacy Against Drug-Resistant TB – August 13, 2020 – New treatment regimens for multidrug-resistant tuberculosis (MDR-TB) have shown early effectiveness in 85 percent of patients in a cohort that included many people with serious comorbidities that would have excluded them from clinical trials, according to the results of a new international study. The results, based on observational data from a diverse cohort of patients in 17 countries, underscore the need for expanded access to the recently developed TB medicines bedaquiline and delamanid. By contrast, the historical standard of care, still in use in much of the world, has approximately 60 percent treatment efficacy globally. <Read More> 

    Feed the Patient, Fuel the Savings – August 13, 2020 – A new analysis conducted by the American Society for Parenteral and Enteral Nutrition (ASPEN) shows that appropriate nutrition support can save an estimated $580 million in annual Medicare spending. “With evidence from this study, [providers], payors and policymakers must recognize that nutrition support is a linchpin to [providing] high-quality, cost-effective care,” said critical care and nutrition support pharmacist Angela Bingham, PharmD, an associate professor of clinical pharmacy at the University of the Sciences, Philadelphia College of Pharmacy, who was not involved in the research. <Read More> 

    One-Third of Physicians Order Thyroid Ultrasounds Unsupported by Clinical Guidelines – August 13, 2020 – About one-third of physicians order thyroid ultrasounds in situations not supported by clinical guidelines, according to a study published Wednesday. Researchers said enhanced recommendations and patient discussions are needed to remedy the problem. That’s the takeaway from Michigan Medicine clinicians, who surveyed more than 600 surgeons, endocrinologists and primary care physicians involved in thyroid cancer care. When presented with different patient scenarios, 33% said they utilized ultrasound for reasons not backed up by consensus protocols, such as the Choosing Wisely Campaign. <Read More> 

    NACDS to CMS: Fix Pharmacy Reimbursement Rate Calculations for Drug Discount Cards – August 13, 2020 – NACDS is urging the Centers for Medicare & Medicaid Services (CMS) to change how pharmacy reimbursement rates are calculated for drug discount cards. In its letter to CMS, NACDS said that states are using data from third-party prescription drug discount transactions “in a way that is inconsistent with federal law and policy, and that drives down reimbursement to pharmacies for prescriptions that they fill in the Medicaid program,” NACDS said in a news release. Without a remedy, NACDS said pharmacies may be financially unable to continue to accept third-party discount cards. <Read More> 

    Study Finds BAM15 as Potential Treatment for Obesity – August 12, 2020 – A new study shows the first evidence that a chemical compound, BAM15, which acts as an energy uncoupler, could be an effective drug for treating obesity and related diseases. Researchers at Pennington Biomedical Research Center in Baton Rouge, Louisiana, noted that global spending on obesity and related illnesses is more than $150 billion a year. “Despite this, only a handful of medications are currently FDA-approved for obesity treatment, and the people who take these drugs rarely achieve long-term weight loss,” John Kirwan, PhD, executive director of the Pennington Biomedical Research Center, said in a press release. “Halting the obesity epidemic requires new, more effective medications. This research represents a very promising step in the discovery process.” <Read More> 

    ASH Releases New Guidelines on Treating Newly Diagnosed AML in Older Adults – August 12, 2020 – The American Society of Hematology (ASH) recently released new guidelines to aid older patients who are newly diagnosed with acute myeloid leukemia (AML), as well as their health care providers in making care decisions. The guidelines, developed in partnership with the McMaster GRADE Centre, are based on systematic reviews of all available evidence. The recommendations were developed on the basis that throughout a patient’s disease course, optimal care includes ongoing discussions between clinicians and their patients, continuously examining goals of care, and the corresponding risk-benefit balance of treatment. <Read More> 

    Tip of the Week: Responsibilities of the Pharmacist-in-Charge – August 12, 2020 – The importance of compliance with employment law and with regulatory agencies cannot be undersold. This week’s Tip of the Week examines a specific court case involving the accountability of a pharmacist-in-charge. In Sternberg vs. California State Board of Pharmacy, an appellate court affirmed a decision by a lower court supporting the California State Board of Pharmacy (Board) that subjected the pharmacist license of the plaintiff to disciplinary action following the discovery of widespread theft of a dangerous drug from the pharmacy by an employee who Andrew Sternberg supervised as the pharmacist-in-charge…Pharmacy managers have significant responsibilities, including responsibility for the persons who report to them, and this is much the case for the pharmacist-in-charge, a legally designated title. Pharmacy managers must maintain close control over operations. In addition, although it is nearly impossible to be absolutely perfect in the hiring process, this case makes a strong argument for taking care in selecting the right personnel. <Read More> 

    Updated Clinical Practice Guidelines for Managing Mucositis Published – August 11, 2020 – Updated clinical practice guidelines for managing mucositis, a very common and often debilitating complication of cancer therapy, was recently published in the journal Cancer. Patients experiencing mucositis often require enteral or parenteral nutrition, consume more opioids, and experience more interruptions to cancer therapy than patients who do not experience mucositis. <Read More> 

    The Price of COVID-19 for Pharmacies – August 11, 2020 – In these unprecedented times, the tentacles of the COVID-19 pandemic seem to be endless, including how it may affect pharmacy benefit plans and the providers who serve the patients using the benefit plans. There is much uncertainty around the development of a vaccine, handling drug shortages, and finding effective drug therapies in treating acutely ill patients. In these circumstances, many pharmacy providers, physicians and health systems are facing a financial crisis. The market has adjusted in an effort to improve patient service through increased mail-order pharmacy and telemedicine, but can we be sure that quality of care has been maintained? <Read More>

    340B in the News

    340B Action Heats Up: New Developments From the Courts, Administration and Drug Makers – August 17, 2020 – In the courts, in the Administration and in drug maker initiatives, action on the Section 340B prescription drug discount program has heated up this summer. The program, known by its section number of the federal Public Health Service Act, has been the subject of a D.C. District Court of Appeals decision upholding a reduction in Medicare reimbursement for certain 340B-purchased drugs, a regulatory proposal to reduce such reimbursement even further, steps by pharmaceutical manufacturers to address perceived compliance issues in the 340B contract pharmacy context, and an agency notice imposing additional 340B registration requirements for nonprofit hospitals. This article provides details on these issues, as well as on President Trump’s recent executive order regarding federally qualified health center prices for insulin and injectable epinephrine. <Read More> 

    Court of Appeals Reverses Hospitals’ Victory in 340B Drug Reimbursement Case – August 13, 2020 – On July 31, 2020, the U.S. Court of Appeals for the District of Columbia Circuit reversed a district court decision that had found unlawful Medicare’s nearly 30 percent rate cut for separately payable outpatient drugs purchased under the 340B program. In a 2-1 decision, the Court of Appeals applied the deferential Chevron doctrine to hold that CMS had reasonably interpreted the Medicare statute to grant it the authority to impose this rate cut on hospitals. Rather than the statutory rate for 340B drugs of Average Sales Price (ASP) plus six percent, the rule directs that hospitals will be paid ASP minus 22.5 percent, a rate cut that will cause hospitals to continue to lose billions of dollars each year in reimbursement. <Read More> 

    Omnicell to Acquire Pharmaceutical Strategy Group’s Leading 340B Software-Enabled Service Business – August 12, 2020 – Omnicell, Inc, a leading provider of medication management solutions and adherence tools for health systems and pharmacies, announced it has entered into a definitive agreement with Pharmaceutical Strategies Group (PSG) to acquire its 340B Link business for total aggregate cash consideration of $225 million, subject to customary adjustments. The acquisition will add a comprehensive and differentiated suite of software-enabled services and solutions used by certain eligible hospitals, health systems, clinics, and entities to manage compliance and capture 340B drug cost savings on outpatient prescriptions filled through the eligible entity’s pharmacy or a contracted pharmacy partner. <Read More>