Clinical Insights: October 27, 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

    Veklury® (remdesivir) Injection – New Drug Approval – October 22, 2020 – The U.S. Food and Drug Administration approved the antiviral drug Veklury® (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury® should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury® is the first treatment for COVID-19 to receive FDA approval. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    No new update.

    New/Updated Drug Shortage

    October 27, 2020

    October 23, 2020

    October 22, 2020

    October 21, 2020

    October 20, 2020

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Advocates Welcome Down Syndrome Guidance for Adults – October 26, 2020 – “I think it’s very important that these guidelines are finally coming out, because we haven’t had anything like this for our family doctors, and they need this to better understand what Down syndrome is all about today.” Karen Gaffney, 42, president of the Karen Gaffney Foundation, is an outspoken advocate pushing for more medical research to improve the lives of people like her who are living with Down syndrome. She was part of the focus group that helped prioritize medical issues for the new evidence-based clinical guidelines released recently on medical care of adults with Down syndrome in JAMA, The Journal of the American Medical Association. <Read More>

    Women Pharmacist Day Shines Spotlight on Achievements of ‘Superstar’ Women Pharmacy Leaders – October 23, 2020 – On Women Pharmacist Day on October 12, a panel discussion webcast consisting of leading women in pharmacy, hosted by Pharmacy Times® in partnership with the Pharmacist Moms Group, discussed the importance of recognizing the impact of women on the pharmacy landscape and the history of women in the field. Suzanne Soliman, PharmD, BCMAS, is the founder of the Pharmacist Moms Group and established Women Pharmacist Day in 2018. On her group’s Facebook page, she hosted an event to announce the winners of the Woman Pharmacist of the Year award and the Independent Woman Pharmacist of the Year award, sponsored by First Financial Bank. <Read More>

    Walmart Files Lawsuit Seeking to Prove Its Pharmacists are Not Responsible for Opioid Crisis – October 22, 2020 – Walmart filed a lawsuit against the federal government asking a court to clarify that the company and its pharmacists were not responsible for the distribution of improper opioid prescriptions. The retailer said the suit is in response to threats of legal action by the Department of Justice and Drug Enforcement Agency to hold Walmart pharmacists responsible, in part, for the opioid crisis, according to a press release from Walmart (WMT). A spokesperson for the DEA said the agency does not comment on ongoing litigation, and the DOJ did not immediately return a request for comment. <Read More>

    Pharmacy Technicians Gear up to Immunize – October 22, 2020 – As pharmacists prepare for a surge in demand during this year’s flu season and the anticipated release of a COVID-19 vaccine, many state boards of pharmacy are engaged in discussions around allowing pharmacy technicians to participate in immunization administration, according to Ryan Burke, PharmD, director of professional affairs at the Pharmacy Technician Certification Board (PTCB). “Several chain pharmacies are the driving force behind advocacy efforts in some states, arguing that pharmacy technicians will be critical to meeting the demand,” Burke said. <Read More>

    AHA Releases New CPR/ECC Guidelines – October 22, 2020 – The American Heart Association has released its updated 2020 guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. The seven-part series was published through the journal Circulation on October 21. The 2020 guidelines “reflect the latest global resuscitation science and treatment recommendations derived from the 2020 International Consensus on CPR and ECC with Treatment Recommendations,” the AHA said in announcing the release. The AHA guideline is considered the gold standard of clinical recommendations in the practice of resuscitation science. <Read More>

    HHS Issues Guidance on Administration of Vaccinations, COVID-19 Tests by Pharmacy Technicians, Interns – October 22, 2020 – In a recent guidance issued by the Department of Health and Human Services (HHS) under the Public Readiness and Emergency Preparedness Act (PREP Act), qualified pharmacy technicians and state-authorized pharmacy interns are authorized to administer childhood vaccines, coronavirus disease 2019 (COVID-19) vaccines upon availability, and COVID-19 tests. The guidance clarifies that the pharmacy intern should be authorized by the state or board of pharmacy in the state in which the practical pharmacy internship is taking place. However, this state authorization does not need to be a license or registration with the state board of pharmacy. The HHS guidance also clarifies that pharmacy technicians and state-authorized pharmacy interns must be supervised by a qualified pharmacist when administering vaccines under this authorization. <Read More>

    AAP Offers Interim Guidance for Pediatric Practice Safety Guidelines – October 21, 2020 – As more children return to the pediatric office, the need to create safety protocols is imperative. The American Academy of Pediatrics (AAP) has created guidance for developing them. The American Academy of Pediatrics has updated their interim guidance for testing children for COVID-19, infection control, and personal protective equipment (PPE) protocols. The guidance also stresses that understanding of the disease is constantly changing and the guidance may continue changing in the future. <Read More>

    Key Updates and Limitations of Guidelines to Treat Asthma – October 21, 2020 – Recent updates to the Global Initiative for Asthma (GINA) and the European Respiratory Society/American Thoracic Society (ERS/ARS) guidelines have renewed focus on treating severe asthma. During 2 panels at CHEST 2020, experts discussed key updates, limitations of the guidelines, and more. In the first session, Anne Reihman, MD, of the Division of Pulmonary and Critical Care Sciences at the University of Colorado, highlighted anti–interleukin (IL)-5 treatment failure when treating severe asthma. There are currently 3 FDA-approved drugs to treat the IL-5 inflammatory pathway: mepolizumab, reslizumab, and benralizumab. <Read More>

    Pharmacists Are Front-line Educators of Patients During COVID-19 Pandemic – October 21, 2020 – Since the start of the coronavirus disease 2019 (COVID-19) pandemic, Amy Kallo, a PharmD student at Midwestern University, worked as a pharmacy intern at a CVS in Chicago. According to Kallo, working at a pharmacy during the pandemic helped to solidify her understanding of the role of pharmacists as educators in their communities. “We are definitely the front line to educate patients,” Kallo said…Yet, during the COVID-19 pandemic, Kallo explained that her understanding of the role of the retail pharmacist became clearer than ever before. <Read More>

    Keeping Up With Pharmacists’ Changing Scope of Practice Amid COVID-19 – October 21, 2020 – A panel discussion at the Academy of Managed Care Pharmacy Nexus 2020 meeting examined the changes in the health care landscape occurring due to the coronavirus disease 2019 (COVID-19) pandemic, particularly around pharmacists’ scope of practice, and which changes are likely to persist after the pandemic. Margaret Scott, MS, MPH, RPh, associate principal at Avalere Health, began by saying that COVID-19 is a topic that needs no introduction, as it has affected everyone in some way. She outlined the myriad of changes that the health care industry has witnessed in the months since the pandemic, including an influx of Medicaid enrollment due to unemployment, disruptions to both new and ongoing health care treatment, a shift in policy focus away from drug pricing, and the increased awareness of social determinants of health. <Read More>

    Succeeding in Value-Based Payment Requires Engaging Pharmacists From Health Plans and Systems – October 21, 2020 – Pharmacists have an important role to play in the success of value-based payment models, according to panelists who discussed their health plan’s value initiatives at the Academy of Managed Care Pharmacy Nexus 2020 meeting. Showing a slide of the ever-increasing proportion of gross domestic product spent on health care, Joseph Albright, PharmD, manager of clinical pharmacy programs at Blue Cross Blue Shield North Carolina (BCBSNC), said that the question of sustainability is now more of a reality. We need to bend the cost curve, considering the growing field of high-priced drugs, and the solution is a transition away from fee-for-service (FFS) payment toward paying for value and results. <Read More>

    New Practice Guidelines Aim to Reduce Harmful Consequences of Schizophrenia – October 21, 2020 – A new set of evidence-based practice guidelines for the treatment of patients with schizophrenia has been released by the American Psychiatric Association, with the goal of reducing the significant consequences the disorder has on individuals. Here, Laura J. Fochtmann, MD, MBI, a member of the practice guidelines writing group, shares some insights into the guidelines and how they may impact clinical practice, and discusses future research needs related to schizophrenia. <Read More>

    ASTRO Issues Clinical Guideline on Radiation Therapy for Rectal Cancer – October 21, 2020 – A new clinical guideline from the American Society for Radiation Oncology (ASTRO) provides guidance for physicians who use radiation therapy to treat patients with locally advanced rectal cancer. Recommendations outline indications and best practices for pelvic radiation treatments, as well as the integration of radiation with chemotherapy and surgery for stage II-III disease. The guideline, which replaces ASTRO’s 2016 guidance for rectal cancer, is published in Practical Radiation Oncology. <Read More> 

    Need for Biosimilar Cooperation Among Hospitals, Infusion Centers, and Payers is Identified – October 21, 2020 – Overcoming biosimilar uptake barriers will take collaboration and policy change by hospitals, infusion clinics, and health plans, presenters said at the Academy of Managed Care Pharmacy Nexus 2020 Virtual conference. Hospitals, infusion centers, and payers all need to take steps to promote biosimilar use in order to overcome current uptake barriers, said presenters from Health First of Florida during the Academy of Managed Care Pharmacy’s Nexus 2020 Virtual conference. <Read More>

    PBM Audits: Proper Mind-set and Responsive Steps – October 21, 2020 – Working with pharmacy benefit managers (PBMs) can be a frustrating experience for pharmacies. The PBM possesses the pharmacy’s money. If the PBM does not pay the pharmacy, the pharmacy is harmed, regardless of whether the PBM has the right to withhold money. This falls under the adage “Possession is 9/10ths of the law”… As PBMs possess the pharmacies’ money, whether PBMs are right or wrong does not matter from a practical standpoint. If they refuse to pay pharmacies, the pharmacies are forced into a precarious position. <Read More>

    Pharmacy Tech Day: Advancing Pharmacy Technician Practice – October 20, 2020 – The year 2020 has been a challenging year for everyone, but especially for healthcare workers on the front lines. Due to this, it’s more important now than ever, that pharmacy technicians practice at the very top of their license. While boards of pharmacy have traditionally limited pharmacy technician practice from performing such tasks like final product verification, administering immunizations to patients, or performing CLIA-waived point of care testing, more and more states are undergoing the process of reviewing, discussing, and in some cases, changing their rules to permit properly trained technicians to perform these and other tasks. To further seize on this trend, NHA has spearheaded an initiative to bring together representatives from some of the biggest pharmacy organizations in the industry. <Read More>

    Tracking Diversion During COVID-19 – October 20, 2020 – Drug diversion may be an unrecognized offshoot of the ongoing COVID-19 pandemic. Security experts cite several high-profile examples, including a pharmacy technician who was charged with the theft of more than 700 hydroxychloroquine tablets and azithromycin from Harbor-UCLA Medical Center in West Carson, Calif., and several other cases of diverted morphine, ventilators, personal protective equipment (PPE) and other key items that are crucial to patient care during the pandemic. <Read More>

    Best Practices for Specialty Pharmacy Management of Multiple Sclerosis – October 20, 2020 – William Trombatt and James Adams of AllianceRx Walgreens Prime discussed specialty pharmacy for people with MS at PBMI Specialty Rx Forum last week. The need for “higher touch” programs is important for people with MS, said Adams. Just over 900,000 people in the U.S. live with multiple sclerosis (MS), according to a study funded by the National Multiple Sclerosis Society and, by some estimates, the average lifetime medical cost is $4.1 million. This disease has the second highest all-cause medical cost for those with chronic conditions. Getting patients into treatment quickly, and keeping them on treatment, is important to decrease the chances of the disease worsening but also to keep costs and healthcare utilization down. <Read More>

    340B in the News

    A Prescription for America’s Drug Pricing Problem? – October 21, 2020 – Sky-high prescription drug costs remains one of the most hotly contested issues in healthcare today. U.S. prescription drug spending exceeds $500 billion a year and is growing at a rate that’s three times faster than inflation, according to a House Ways and Means Committee report… The 340B drug-pricing program, which provides approximately $30 billion in drug discounts annually, is a critical lifeline for getting affordable, life-saving drugs to some of the most vulnerable populations. But the program has recently come under significant pressure because of compliance challenges. Disputes between drug manufacturers, payers (PBMs), contract pharmacies and 340B-eligible providers (covered entities) over duplicate rebates, long-standing poor business practices, and essentially zero trust between the groups have gotten so much attention that even Congress has demanded solutions. <Read More>