Clinical Insights: July 21, 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 

    No new update.

    New Formulation Approval

    No new update.

    New Indication Approval

    Botox® (onabotulinumtoxinA) – New Expanded Indication Approval – July 9, 2020 – Allergan, an AbbVie company, announced that the U.S. Food and Drug Administration (FDA) approved a supplemental Biologics License Application (sBLA) that supports expanded use of Botox® for the treatment of spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy. <Read More> 

    Dysport® (abobotulinumtoxinA) – New Expanded Indication Approval – July 9, 2020 – Ipsen Biopharmaceuticals announced that the United States Food and Drug Administration (FDA) has approved the expanded use of Dysport® (abobotulinumtoxinA) in pediatric patients. When Dysport was first FDA-approved in 2016 for pediatric lower limb spasticity, Ipsen was granted Orphan Drug exclusivity for pediatric patients whose lower limb spasticity was caused by cerebral palsy (CP). <Read More>

    New Drug Shortage

    July 20, 2020

    July 16, 2020

    July 15, 2020 

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Shingles Vaccine Becoming Increasingly Common Among Older Adults – July 20, 2020 – Shingles vaccination among adults has increased substantially over the past 10 years, according to a new National Center for Health Statistics (NCHS) data briefing…Data from the 2008-2018 National Health Interview Survey were used in the analysis. The survey showed that shingles vaccination among adults aged 60 years and older increased from just 6.7% in 2008 to 34.5% in 2018. The shingles vaccine was significantly more common in the West-North-Central region of the United States, with a 42.8% vaccination rate for adults over age 60. The East-South-Central region had a 26.3% vaccination rate. <Read More> 

    Introducing New Guidelines on the Treatment of Drug-resistant Tuberculosis – July 20, 2020 – To build capacity and assist countries in the operationalization of the latest WHO policy guidance on the treatment of multidrug- and extensively drug-resistant tuberculosis (M/XDR-TB), WHO and its Collaborating Centre for the Introduction of New Drugs and Regimens for the Treatment of M/XDR-TB with the support of the Green Light Committee for the WHO European Region (rGLC/Europe) conducted a training for health professionals. <Read More> 

    Chronic Insomnia May Require Intervention – July 20, 2020 – About 30% to 50% of adults are estimated to experience insomnia at some point in their lifetime, and 20% are known to experience persistent insomnia. Pharmacists can offer medication therapy management (MTM) for the various treatments. Insomnia is a condition that can cause a number of problems, such as absenteeism. Individuals experiencing insomnia are about 2 times more likely to be absent from their work compared with good sleepers. The disorder can be caused by anxiety, depression, medication adverse effects (AEs), periodic limb movement disorder, and restless leg syndrome, among other factors. As clinicians, it is crucial to identify the underlying causes of insomnia to eliminate or minimize such factors. <Read More>

    Medication Therapy Management, Immunizations as Advanced Career Options – July 20, 2020 – As pharmacy technicians are taking on more roles that require advanced skill sets, medication therapy management (MTM) and immunizations/vaccinations are among the most important, according to a session presented at the first annual National Pharmacy Technician Association’s virtual Pharmacy Technician Student Summit. <Read More> 

    Pharmacy Technician Certification Board (PTCB) Announces New Certificate Programs in Hazardous Drug Management and Billing and Reimbursement – July 20, 2020 – The Pharmacy Technician Certification Board (PTCB), the nation’s leading credentialing organization for pharmacy technicians, has introduced two new Assessment-Based Certificate Programs, one in Hazardous Drug Management and another in Billing and Reimbursement. The new certificates recognize PTCB Certified Pharmacy Technicians (CPhTs) with specialized knowledge and will count toward becoming an Advanced Certified Pharmacy Technician (CPhT-Adv). <Read More> 

    Coronavirus (COVID-19) Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing – July 18, 2020 – The U.S. Food and Drug Administration reissued an emergency use authorization (EUA) to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples. Sample pooling is an important public health tool because it allows for more people to be tested quickly using fewer testing resources. Sample pooling does this by allowing multiple people – in this case four individuals – to be tested at once. <Read More> 

    How Embedded Pharmacists Can Improve Correctional Health Care – July 17, 2020 – Primary care physicians (PCPs) working in an institution in North Carolina face many of the same problems common to practices throughout the country. They care for an aging patient population and address the challenges associated with multiple comorbidities and complicated therapeutic regimens. The difference, though, is these physicians work exclusively with patients who are incarcerated. To improve outcomes in incarcerated populations, embedded pharmacists have become part of the care team. <Read More> 

    Why Biosimilar Approval Applications Break Down – July 17, 2020 – Developing biosimilars is not an easy process. Exact details of the manufacturing process are typically not available from the reference manufacturer. Further, minute variations in product quality can be magnified as biosimilar production moves through its various stages. For these reasons, biosimilar developers often run into complications when seeking approval from regulatory authorities. <Read More> 

    New Clinical Practice Guidelines Recommend Varenicline Over the Patch for Adult Smokers – June 17, 2020 – The American Thoracic Society’s (ATS) new clinical practice guideline on treatment for tobacco dependence in adults addresses how clinicians may deal with patients’ reluctance to quit, according to a press release. Published in the American Journal of Respiratory and Critical Care Medicine, the latest ATS practice guideline maintains the first principle of clinical practice, that “all patients who use tobacco should receive treatment for their dependence, and not simply be encouraged to stop.” <Read More> 

    FDA Publishes New Clinical Guidelines For Cancer Treatment – June 17, 2020 – US Food and Drug Administration published guidelines for clinical trials of cancer treatment. It set criteria for individuals to be tested. They focused on minimum age consideration in cancer clinical trials of Pediatric patients. Two centers of FDA, Drug Evaluation and Research, and Biologics Evaluation and Research, worked together. They laid stress on including children and those with severe health conditions in cancer trials. This strategy is though against the usual usage of data quality and ethical considerations. <Read More> 

    Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report – July 17, 2020 – Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death. In this controlled, open-label trial comparing a range of possible treatments in patients who were hospitalized with Covid-19, we randomly assigned patients to receive oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days or to receive usual care alone. The primary outcome was 28-day mortality. Here, we report the preliminary results of this comparison. <Read More> 

    The Face of Retail Pharmacy Operations During COVID-19 – July 17, 2020 – Following the global spread of coronavirus disease 2019 (COVID-19), the lives of many people, both domestically and internationally, has dramatically changed from what was once considered to be normal. These activities have been significantly affected to the point that people are becoming fearful of certain practices and behaviors that were once considered standard and have since become restricted or banned entirely. The extensive impact of the pandemic has been felt across many communities across the United States. This can also be said for an industry that many Americans depend, which is their pharmacy services. <Read More>

    The Role of Professionalism in the Lives of Pharmacy Technician Students – July 16, 2020 – At the National Pharmacy Technician Association’s virtual Pharmacy Technician Student Summit, Jamie McGuire, the pharmacy technician program director, discussed the role of professionalism in the lives of pharmacy technician students. McGuire defined professionalism through some quotes from others, such as Frank Tyger, a columnist and cartoonist for the Trenton Times, who wrote, “Professionalism is knowing how to do it, when to do it, and doing it,” as well as, “Professionalism means consistency of quality.” <Read More> 

    Study: Health Care Providers Need More Knowledge About Medicinal Cannabis Use in Oncology – July 16, 2020 – Patients with cancer use cannabis to manage their symptoms related to their diagnosis and clinical treatments. With medicinal cannabis research in its infancy, many health care providers are unsure how to provide accurate counseling and appropriate treatment to their patients. Current Oncology published a study in its May 2020 issue indicating the lack of knowledge about cannabis recommendations along with notable barriers among health care professionals regarding direct patient care. These investigators identified monitoring patients’ cannabis use, prescribing an accurate dose or strain, and insufficient research as significant barriers. <Read More> 

    COVID-19 Impact on Pharmacy Benefit Management Services Market Growth, Competitive Landscape, Future Trends, Size Projection, Key Insights and Industry Dynamics By 2024 – July 16, 2020 – The pharmacy benefit management services market is likely to grow at a 5.8% CAGR between 2019 2024, according to the recent report by Market Research Future (MRFR). Pharmacy benefit management services will help a patient in availing various medical facilities. This allows insurance companies as well as their beneficiaries in insurance claim methods and acts as a bridge between them. Besides, it helps to connect drug companies, pharmacies, drug wholesalers, members, and employers for the finest possible outcome with regards to healthcare claims as well as other services. <Read More>

    National Lipid Association Gives Statement on Dyslipidemia Genetic Testing – July 15, 2020 – The National Lipid Association (NLA) has released a new scientific statement on the role of genetic testing in dyslipidemia. The statement, authored by a team of US- and Canada-based investigators, provides clinicians a guidance on navigating genetic testing counseling—from its benefits and risks, to what patients may be most eligible or interested. <Read More>

    NCPA Launches “Essential” Campaign to Shed Light on COVID-19 Relief Package Pitfalls – July 15, 2020 – The next novel coronavirus disease 2019 (COVID-19) national relief package should ensure hazard pay for pharmacists, allow pharmacist-administered tests and vaccines, and deem pharmacists “essential” workers, according to the National Community Pharmacists Association (NCPA). The organization launched its “Essential” campaign on July 15, which aims to rally pharmacists and other small business owners to pressure Congress to include several key provisions in the next package of COVID-19 relief. <Read More> 

    Hospitals Stock up on COVID-19 Drugs to Prepare for Second Wave in Fall – July 14, 2020 – U.S. hospitals are stocking up on drugs for treating COVID-19 in an effort to avoid another scramble for critical medications should a second wave of the virus threaten new drug shortages. Hospitals in New York and other areas that faced large numbers of COVID-19 patients earlier this year bought and used large amounts of drugs. <Read More>

    Oral Arguments in U.S. Supreme Court PBM Case Get a New Date – July 14, 2020 – After a pandemic-related delay, we know now when Rutledge v. Pharmaceutical Care Management Association (PCMA) will have its day in court. Oral arguments in the case will be heard on October 6, 2020. Rulings typically come several months after oral arguments. It is still unknown whether arguments will be held in person or virtually. The case was filed by Arkansas Attorney General (AG) Leslie Rutledge. PCMA is the professional association that represents PBMs. <Read More>

    APhA Coronavirus Watch: Trump Decision to Withdraw From WHO Prompts Pharmacy Response – July 14, 2020 – Frontline pharmacists who are caring for patients rely heavily on the World Health Organization (WHO), said APhA and the International Pharmaceutical Federation (FIP) in a July 8, 2020, statement. The statement urges the United States to reconsider its withdrawal from the global health organization. <Read More> 

    Andexxa Enters Guidelines for Bleeding on Oral Anticoagulation – July 14, 2020 – Recently-approved treatments prompted an update to American College of Cardiology (ACC) guidance on managing bleeding in patients on oral anticoagulation. New guidance included the consideration of bleeding on newer oral anticoagulants, such as the factor Xa inhibitor betrixaban (Bevyxxa) approved by the FDA in 2017. In addition, the updated ACC Expert Consensus Decision Pathway (ECDP) — published online Tuesday in the Journal of the American College of Cardiology — endorses andexanet alfa (Andexxa), approved in 2018, as a factor Xa inhibitor reversal strategy. <Read More> 

    Social Determinants of Health: Tackle Disparities From the Pharmacy – July 14, 2020 – Enhanced pharmacy services such as home delivery, curbside services, and expanded personal patient outreach create opportunities to address social determinants of health during the pandemic. Nonmedical issues are requiring pharmacists’ attention in increasingly urgent ways, especially in light of the coronavirus disease 2019 (COVID-19) pandemic. A greater focus on social determinants of health (SDOH) may lead to a much more comprehensive approach to treating patients in the pharmacy and ultimately drive improved outcomes. Overall health is often determined by social and economic issues, and understanding how these factors affect patients is key to identifying and addressing SDOH in the pharmacy setting. <Read More>

    340B in the News

    HRSA Eliminates Delay in Use of 340B Drugs in New Hospital Clinic Locations – July 15, 2020 – The Health Resources and Services Administration (HRSA) has issued guidance eliminating a longstanding enforcement position that delayed the ability of hospitals participating in the 340B drug pricing program to use 340B-purchased drugs in new outpatient clinics for as long as nearly two years. HRSA issued the policy in new FAQs on HRSA’s Office of Pharmacy Affairs website and through FAQs issued by Apexus, HRSA’s contractor. <Read More>