Clinical Insights: March 2, 2021

    Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace. Contact us to learn more.

    New Drug Approval

    Nulibry™ (fosdenopterin) Injection – New Drug Approval – February 26, 2021 – The U.S. Food and Drug Administration approved Nulibry™ (fosdenopterin) for injection to reduce the risk of death due to Molybdenum Cofactor Deficiency Type A, a rare, genetic,  metabolic disorder that typically presents in the first few days of life, causing intractable seizures, brain injury and death. <Read More>

    Pepaxto® (melphalan flufenamide) Injection – New Drug Approval – February 26, 2021 – Oncopeptides AB (publ), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, announced that the U.S. Food and Drug Administration, FDA, has approved Pepaxto® (melphalan flufenamide, also known as melflufen), in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. <Read More> 

    Amondys 45 (casimersen) – New Drug Approval – February 25, 2021 – The U.S. Food and Drug Administration granted approval for Amondys 45™ (casimersen) 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 45 skipping (Exons are pieces of DNA that provide information for making proteins in a person’s genome). The agency approved Amondys 45 based on an increase in dystrophin (a protein that helps keep muscle cells intact) production in skeletal muscle observed in patients treated with the therapy. This is the first 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 45 skipping. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Imfinzi® (durvalumab) – Indication Withdrawal – February 22, 2021 – AstraZeneca announced the voluntary withdrawal of the Imfinzi® (durvalumab) indication in the US for previously treated adult patients with locally advanced or metastatic bladder cancer. This decision was made in consultation with the Food and Drug Administration (FDA). In May 2017, Imfinzi® was granted accelerated approval in the US based on promising tumour response rates and duration of response data from Study 1108, a Phase I/II trial that evaluated the safety and efficacy of Imfinzi in advanced solid tumours, including previously treated bladder cancer. Continued approval was contingent on results from the DANUBE Phase III trial in the 1st-line metastatic bladder cancer setting, which did not meet its primary endpoints in 2020. The withdrawal is aligned with FDA guidance for evaluating indications with accelerated approvals that did not meet post-marketing requirements, as part of a broader industry-wide evaluation. This withdrawal does not impact the indication outside the US and does not impact other approved Imfinzi® indications within or outside the US. <Read More>

    New/Updated Drug Shortage

    March 01, 2021

    February 26, 2021

    February 25, 2021

    February 24, 2021

    February 23, 2021

    February 22, 2021

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    NCCN Issues Guidelines for Biosimilar Use – March 1, 2021 – A new set of guidelines for the use of biosimilars from the National Comprehensive Cancer Network (NCCN) addresses challenges of stocking biosimilars, dealing with procurement errors, and obtaining payer authorizations. It also advises health care providers to lobby for more liberal payer policies, stating that current payer preferences threaten the long-term existence of biosimilars. “We strongly recommend against single-source mandates of biosimilar products by insurance companies for a variety of patient safety and operational reasons,” the NCCN wrote. <Read More>

    American Pharmacists Association Commends Executive Order to Support Pharmaceutical Supply Chains – March 1, 2021 – On February 24, President Biden signed an Executive Order on America’s Supply Chains that details plans to establish more resilient, diverse, and secure supply chains for the greater economic prosperity and national security of the country. The executive order also addressed this need within the pharmaceutical industry, stipulating that the Department of Health and Human Services would work with the appropriate pharmacy agencies to submit a report that will identify risks in the pharmaceutical supply chain, specifically related to finished drug products, active pharmaceutical ingredients (API), and critical safety items, such as personal protective equipment (PPE). The order additionally clarified the need for the inclusion of policy recommendations in the report so that the Biden administration could identify actions to address any identified risks. The American Pharmacists Association (APhA) commended President Biden’s signing of the executive order in a press release, noting that adequate drug supply would be critical to ensuring pharmacists’ ability to provide care to patients during the COVID-19 pandemic. <Read More>

    FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine – February 27, 2021 – The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older. <Read More> 

    International Panel Updates Waldenström Macroglobulinemia Treatment Recommendations – February 27, 2021 – Criteria for the treatment of Waldenström macroglobulinemia (WM) were recently updated by an international consensus panel, following the panel’s formation and initial discussion at the 10th annual International Workshops for Waldenström Macroglobulinemia (IWWM) in 2018. After 2 subsequent teleconferences in June 2019 and January 2020, the updates were finalized and published in The Lancet Haematology. WM is a rare form of non-Hodgkin lymphoma, and treatment options have evolved in recent years. Members of the consensus panel were chosen based on their expertise in the rare disease and their participation in discussions at the 10th annual IWWM conference. The review includes recommendations for treatment and clinical trial enrollment, as well as potential priorities for future clinical trials. <Read More>

    Study: Pediatric Adherence to Drugs Treating Severe Asthma is About 57% – February 27, 2021 – Late-breaking data presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2021 Virtual Sessions showed an inconsistent—and even seasonally-influenced—pattern of pediatric patient adherence to controller therapy for severe asthma. The research, presented by William Anderson, MD, of the Children’s Hospital Colorado and University of Colorado School of Medicine, showed a near 50% adherence to controller therapy among pediatric severe asthma patients who were remotely monitored for their care via a Propeller Health device. <Read More>

    American Pharmacists Association Comment on Authorization of Janssen Vaccine: We are Ready to Continue this Work – February 27, 2021 – Statement from Scott J. Knoer, MS, PharmD, FASHP, executive vice president and CEO of the American Pharmacists Association, upon the Food and Drug Administration’s (FDA) decision to authorize emergency use of Janssen Biotech’s COVID-19 vaccine:  “Since the first COVID-19 vaccines were authorized more than two months ago, hundreds of thousands of trained and trusted pharmacists, student pharmacists and pharmacy technicians have been willing, ready and able to administer the vaccine to individuals across the country. With this newly authorized COVID vaccine, in addition to the growing supply of currently authorized vaccines, more pharmacists will be able to do their part as vaccinators and vital members of the immunization neighborhood, thereby increasing access to these vital tools. We welcome the FDA’s authorization of the Janssen vaccine. The addition of another safe and effective vaccine to our toolbox means that we are another step closer to our goal of vaccinating everyone we can as quickly as possible, and controlling this terrible pandemic.” <Read More>

    Mankato Hy-Vee Incorrectly Dilutes Vaccines, Administers To 62 Patients – February 26, 2021 – A Hy-Vee pharmacy in Mankato, MN incorrectly diluted doses of the Pfizer COVID-19 vaccine, a mix-up which has impacted 62 of their patients. According to the pharmacy, two staff members at the Riverfront Hy-Vee used vaccines mixed with a sterile water injection diluent instead of the saline diluent provided by Pfizer. <Read More>

    No Evidence Vaccines Impact Fertility – February 26, 2021 – The American College of Obstetricians and Gynecologists, the American Society for Reproductive Medicine and the Society for Maternal-Fetal Medicine released a statement assuring patients that there’s no evidence that the approved COVID-19 vaccines can impact the capacity to conceive children. Although there’s limited research on the matter since clinical trials did not specifically study fertility, no related issues have been reported among thousands of trial participants. In fact, some of them got pregnant. Initial studies on animals for the Moderna vaccine showed no impact on female reproduction or fetal development either. And although detecting fertility issues can take time, as of Jan. 20, fertility loss has not been found to be a side effect among millions who have already received the vaccines after authorization, according to the Centers for Disease Control and Prevention. <Read More>

    Step Therapy Helps Manage Dry Eye Disease – February 26, 2021 – Dry Eye Disease (DED), also known as keratoconjunctivitis sicca, is a common condition that occurs when tears don’t provide adequate lubrication for a patient’s eyes. Epidemiologic information about DED is limited due to lack of a standardized definition as well as diagnostic criteria. DED is often overlooked by clinicians and patients, even though it affects individuals of all ages. Americans, on average, spend $783 per year to manage DED. There are various signs and symptoms that can suggest DDE, such as decreased tear meniscus, fluctuating vision, mucus discharge, ocular irritation, plugged meibomian glands, or redness, according to American Academy of Ophthalmology (AAO) guidelines. Identifying and treating DDE is important to prevent compromised results from cataract, corneal, or refractive surgeries; discomfort; or visual disabilities. <Read More>

    The Role of Telehealth in Oncology Pharmacy is Increasingly Important – February 26, 2021 – Technology can help drastically improve disease monitoring, management, and diagnoses, according to clinical pharmacists. Wearable technology and apps for monitoring health and wellness have increased in popularity, and virtual health services are demonstrating that telehealth can be just as effective as in-person visits with pharmacists. Experts on digital health care at the virtual 2020 American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting and Exhibition presented data and information on evolving health technology in 2 sessions. They illustrated how pharmacists could use this technology in oncology. <Read More>

    Strategies to Accelerate Diagnosis and Treatment ff Rare Cardiovascular Diseases – February 26, 2021 – The current landscape for patients with rare cardiovascular disease has shifted. Using genome sequencing Yale physician-scientists have begun to elucidate the pathophysiology of genetic disorders and develop treatment guidelines and recommendations. With these advanced diagnostic tools, our team of international experts can offer clinical diagnosis, genetic testing, and risk assessment for patients. <Read More> 

    FDA Allows Pfizer Vaccines to be Stored at Higher Temperatures – February 26, 2021 – The FDA said it will allow Pfizer’s COVID-19 vaccine to be stored and transported at temperatures found in typical pharmaceutical freezers instead of requiring them to be stored at ultralow temperatures that require specialty freezers. Allowing the vaccine to be stored and moved at lower temperatures will ease the burden for vaccination sites having to get special cold storage equipment and should help get the vaccine to more sites, said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. <Read More>

    Pharmacy’s Role in Addressing COVID-19 Vaccine Inequities – February 26, 2021 – Early experiences with COVID-19 vaccine distribution have exposed racial and ethnic disparities in access to health care in America—disparities that were already exposed by the pandemic itself. Reports from all over the country and national data show that the distribution rates of COVID-19 vaccination are much lower among Black and Latinx Americans than whites. In response, several health systems have taken steps to better reach these underserved populations. Whether it’s providing transportation to vaccination sites or conducting registration drives for people with limited access to the internet, these pharmacist-coordinated efforts show the profession is willing to do its part. <Read More>

    Reducing the Disposal of Unused, Expensive Injectable Medications Requires Changes in the Way the U.S. Produces, Administers, and Pays for Drugs – February 25, 2021 – Every year, significant amounts of drugs left over and unused from single-dose vials are discarded, but because of the way drugs are priced and paid for in the United States, the cost of the discarded amount cannot be recouped, says a new congressionally mandated report from the National Academies of Sciences, Engineering, and Medicine. Many of these drugs are among the most expensive drugs on the market, including those for treating cancer, macular degeneration, and rheumatoid arthritis. While the report asserts there is little recoverable economic value to discarded drugs from single-dose vials, it highlights several opportunities to reduce inefficiencies that could lead to a reduction in discarded drugs. <Read More>

    Decrease in Peanut Allergy Among Infants After Guideline Changes – February 25, 2021 – Changes to food allergy guidelines has led to a 16 percent decrease in peanut allergy among infants, according to new study. The research, led by the Murdoch Children’s Research Institute (MCRI) and to be presented at the American Academy of Allergy, Asthma & Immunology Virtual Annual Meeting this Sunday, also found a significant increase in parents introducing peanut into their babies’ diet since the guideline changes. <Read More>

    Strategic Planning for Pharmacy Emergency Preparedness and Response Activities – February 25, 2021 – Pharmacy professionals have been highly responsive as frontline healthcare workers in response to the COVID-19 pandemic. Yet challenges remain in fully expanding pharmacists’ ability to provide the best optimum patient care and overall population health interventions as well as ensure healthcare worker and public health safety. Pharmacy organizations have produced guidelines and advisories to guide workflow and optimize services during this pandemic, yet there still exists a gap in further integration of pharmacists into public health and safety initiatives. Investigators have further sought to make further leaps in this area in development of the Pharmacy Emergency Preparedness and Response (PEPR) Framework. <Read More>

    Guideline for Reducing Opioid Use Post-Surgery Leads to High Pain Management Satisfaction and Disposal Rates – February 25, 2021 – A prescribing guideline tailored to patients’ specific needs reduced the number of opioid pills prescribed after major surgery with researchers reporting a greater than 90 percent patient satisfaction rate with pain management and the highest compliance rate to date with appropriate disposal of leftover pills. The study was selected for the 2020 New England Surgical Society Program and published as an “article in press” on the website of the Journal of the American College of Surgeons (JACS) in advance of print. <Read More>

    Goodbye to a Hero, Mentor, and Friend – February 25, 2021 – A true pharmacy icon, Dr. Joseph A. Oddis, left the Earth this week. He began his life of service to pharmacy and its patients as a young man, going on to become the CEO of ASHP for 37 years and the recipient of the profession’s most distinguished accolades, including the Remington Medal and Hugo Schaefer Award. Over the course of his long career, Dr. Oddis touched every crevice and contour of pharmacy practice as we know it, and in doing so made an untold impact on the lives of millions of patients under pharmacists’ care. <Read More>

    What’s Needed to Make Nudges Work in Health Care – February 25, 2021 – Sometimes, relatively small changes to the design of the clinical environment or how information is framed are all that’s needed to make big improvements to patient outcomes and transform care delivery. There’s an emerging field of study on these changes—which are known as nudges—that already has produced a host of best practice recommendations. An article published in the AMA Journal of Ethics® (@JournalofEthics) describes how to design and implement nudges using a systematic approach. The article—written by Joseph D. Harrison, a clinical psychology doctoral student at Philadelphia College of Osteopathic Medicine, and Mitesh Patel, MD, director of the Penn Medicine Nudge Unit, one of the world’s first behavioral design teams embedded within a health system—also lays out how to do it safely and effectively. <Read More>

    The Impact of COVID-19 on Pharmacy Management and Compliance – February 25, 2021 – Pharmacy leaders have leveraged their experience, their role in interdisciplinary teams, and technology to quickly reinvent approaches to manage long-standing issues exacerbated by the pandemic. The coronavirus disease 2019 (COVID-19) pandemic not only introduced rapid-fire changes to care delivery, but it also exposed the health care system’s weak links. We learned just how fragile the current health care infrastructure is as frontline pharmacy staff and leaders were forced to navigate new medication and supply shortages as well as rapidly adapt to this once-in-a-century global public health emergency. <Read More>

    Kentucky Compounding Pharmacy Forfeits $1.8M for Illegal Drug Distribution Scheme – February 25, 2021 – Nicholasville, Ky.-based compounding pharmacy Tailor Made Compounding on Feb. 24 forfeited nearly $1.8 million and was sentenced to three years of probation for illegal distribution of prescription drugs, according to the U.S. Department of Justice. The compounding pharmacy’s owner, Jeremy Delk, was sentenced to three years of probation, including four months of home incarceration, and 100 hours of community service. He also was ordered to pay a $20,000 fine and is prohibited from participating in a business involving the distribution of prescription drugs. <Read More>

    Pfizer and BioNTech Initiate a Study as Part of Broad Development Plan to Evaluate COVID-19 Booster and New Vaccine Variants – February 25, 2021 – Pfizer Inc. and BioNTech SE announced they have begun an evaluation of the safety and immunogenicity of a third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the circulating and potential newly emerging SARS-CoV-2 variants. The study will draw upon participants from the Phase 1 study in the United States who will be offered the opportunity to receive a 30 µg booster of the current vaccine 6 to 12 months after receiving their initial two-dose regimen. The study is part of the Companies’ clinical development strategy to determine the effectiveness of a third dose against evolving variants. <Read More>

    Sylvant® (siltuximab) Recommended by the National Comprehensive Cancer Network® (NCCN®) as the Preferred Treatment Option for Patients with Idiopathic Multicentric Castleman Disease (iMCD) Regardless of Histopathologic Subtype – February 25, 2021 – EUSA Pharma (UK) Limited, a global biopharmaceutical company focused on oncology and rare diseases, announced that the National Comprehensive Cancer Network® (NCCN®) has updated their Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas to include siltuximab (Sylvant®) as the preferred primary treatment for patients with human immunodeficiency virus–negative [HIV(-)] and human herpesvirus 8–negative [HHV-8(-)] multicentric Castleman disease (MCD), also known as idiopathic multicentric Castleman disease (iMCD), regardless of histopathologic subtype. Siltuximab is currently approved in more than 40 countries worldwide for the treatment of all histopathologic subtypes of iMCD, a rare, life-threatening and debilitating orphan condition of the lymph nodes and related tissues. The update is based on a 2020 publication which demonstrated that there is insufficient evidence to guide treatment based solely on lymph node histopathologic subtype. <Read More>

    Models for Pharmacists Practicing at the Top of Their License – February 25, 2021 – Clinical pharmacists practicing at the top of their license have the opportunity to close provider shortage gaps and improve the quality of patient care, whether in health-system or specialty pharmacy settings. But complying with state regulations governing scope of practice is critical, said several experts during the American College of Clinical Pharmacy 2020 virtual meeting. Pharmacists from New Mexico, North Carolina and Illinois highlighted the evolution of advanced practice models in their states, services covered, the unique roles advanced practice pharmacists perform, and current and future challenges to the model. <Read More>

    Removing One Barrier to Opioid Use Disorder Treatment – February 25, 2021 – On January 14, 2021, the Department of Health and Human Services (HHS) submitted notice to the Federal Register that it would issue practice guidelines that exempt physicians from the requirement to apply for a waiver to prescribe buprenorphine to treat opioid use disorder (OUD) in up to 30 patients at one time. This exemption has been placed on hold by the Biden administration and may require legislative change to implement. An exemption to the X-waiver has the potential to help reverse the morbidity and mortality associated with the opioid overdose epidemic, although without accompanying changes and attention it will not be enough. <Read More>

    Study Shows Opioid Use Among US Patients With Knee Osteoarthritis Costs 14 Billion Dollars in Societal Costs – February 25, 2021 – Although guidelines do not recommend use of opioids to manage pain for individuals with knee osteoarthritis, a recent study published early online in Arthritis Care & Research, an official journal of the American College of Rheumatology and the Association of Rheumatology Professionals, estimates that 858,000 Americans use opioids such as tramadol and oxycodone for their knee pain, equating to $14 billion in lifetime opioid-related societal costs, or nearly $0.5 billion annually. <Read More>

    Harris Addresses Vaccine Hesitancy in DC Pharmacy Visit – February 25, 2021 – Vice President Kamala Harris on Thursday visited a local pharmacy in Washington, DC, to highlight the Biden administration’s retail pharmacy vaccination program and combat vaccine hesitancy. Harris stressed the importance of all Americans, particularly those in communities of color hesitant about getting the vaccine, signing up for it as soon as it becomes available. The vice president spoke to a woman who was at the pharmacy receiving her second dose of the Moderna Covid-19 vaccine. After getting the shot, the woman told Harris she was looking forward to being able to see her 5-year-old great grandson. <Read More>

    NCCN Releases Guidelines for Pediatric Nephroblastoma Treatment – February 24, 2021 – The National Comprehensive Cancer Network (NCCN) recently published new guidelines for the treatment of pediatric patients with nephroblastoma (Wilms tumor), the first ever set of guidelines published in the United States for children with a solid tumor, according to a press release from the organization. The purpose of the guidelines is to maximize the benefits of treatment for nephroblastoma while limiting the toxicities associated with treatment. Considering the rarity of the disease, the NCCN guidelines can provide crucial information for oncologists who treat patients with nephroblastoma. <Read More>

    New Treatments Aim to Increase Survival Rate – February 24, 2021 – Cancer staging systems for squamous cell carcinoma have helped improve dermatologists’ ability to accurately stage the cancer, according to one expert. Cutaneous squamous cell carcinoma (cSCC) appears to be far surpassing melanoma as a cause of skin cancer– related death. Each year, more than 15,000 individuals in the United States die of cSCC, which is more than twice the number of deaths related to melanoma. This concerning statistic has captured the attention of the industry and investigators, who are developing new ways to assess squamous cell carcinoma risk and better treat the disease. <Read More>

    FDA Guidance Allows Fast Updates of COVID-19 Vaccines – February 24, 2021 – The FDA has issued guidelines allowing for faster development of updated coronavirus vaccines, based on previously approved shots that have been tweaked to combat emerging variants of the SARS-CoV-2 virus. There is evidence that some of the emerging strains, particularly one that has emerged in South Africa, could be more resistant to vaccines developed to combat earlier versions of the virus. Changes in the “Spike” protein targeted by nearly all the vaccines approved or in development could also lead to more infectious variants, such as the strain that emerged in Kent and is now prevalent across most of the UK. As the virus is constantly evolving, there is need a to quickly develop and approve updated vaccines to neutralise new versions of the virus that may be able to evade the immune response from older vaccines. <Read More>

    Doctors Treat Female UTIs With Wrong Antibiotics Nearly Half the Time, Study Finds – February 24, 2021 – At least 50% of adult women report having at least one urinary tract infection in their lives, according to the World Health Organization, making that painful disorder one of the most common and collectively expensive types of infection in the world. A 2011 report by WHO found UTIs contributed to over 8 million office visits and over 1 million hospitalizations, for an overall annual cost of over $1 billion. Now, a new study has found that doctors gave the wrong antibiotics to nearly half of 670,400 people diagnosed with a UTI. In addition, over three-quarters of those women received antibiotic prescriptions for longer than medically necessary. Long treatment durations — surpassing clinical guidelines — were more common in rural than urban areas, according to the study published Wednesday in the journal Infection Control & Hospital Epidemiology of The Society for Healthcare Epidemiology of America. <Read More>

    Most Women Receive Inappropriate Treatment for Urinary Tract Infections – February 24, 2021 – Nearly half of women with uncomplicated urinary tract infections received the wrong antibiotics and almost three-quarters received prescriptions for longer than necessary, with inappropriately long treatment durations more common in rural areas, according to a study of private insurance claims data published in Infection Control & Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America. <Read More>

     CDC Adds Cetirizine as Therapy for Anaphylaxis After Covid-19 Vaccination – February 24, 2021 – TerSera Therapeutics has announced the addition of cetirizine as adjunctive therapy to the Centers for Disease Control and Prevention (CDC) guidelines titled ‘Interim considerations: preparing for the potential management of anaphylaxis after Covid-19 vaccination’. The latest development is in addition to the CDC’s guidelines titled ‘General Best Practice Guidelines for Immunization’, which recommends the use of a cetirizine 10mg IV as adjunctive therapy for emergency management of anaphylaxis on vaccinating adults. <Read More>

    Medication Assistance Supports Patients and Pharmacy Alike – February 24, 2021 – Financial toxicity to patients battling cancer is well documented within the oncology community. Novel cancer drug therapies are continually released and accrue an increasing number of FDA-approved indications, bringing with them increasingly unaffordable out-of-pocket costs for the patients. At the same time, pharmacy directors are under increasing pressure to reduce their annual drug spend. The increase in drug costs is not a new phenomenon. However, the cost of individual cancer therapy now frequently exceeds 6 digits. Often, patients with cancer also face having to quit their jobs, apply for disability payments, and deplete their savings, which can lead to bankruptcy. The coronavirus disease 2019 (COVID-19) pandemic has added additional financial distress, with many patients with cancer losing their jobs and employer-sponsored health benefits when they can still work. These financial pressures can cause patients to self-discontinue their lifesaving therapies or, at a minimum, leave them grappling with enormous medical debt. <Read More>

    What Causes Nausea? 12 Common Causes – February 23, 2021 – Several conditions can cause nausea, including stress, anxiety, infections, motion sickness, and many more. Occasional temporary nausea is also common but typically not cause for concern. Nausea is a sensation that makes a person feel they need to vomit. Sometimes, individuals with nausea do vomit, but not always. In this article, we explore what triggers nausea, including a list of 12 common causes. We will also discuss some of these conditions in more detail and describe their symptoms and treatments. <Read More>

    Understanding the QTc – February 23, 2021 – Psychiatrists prescribe medications that increase the risk of Torsades de Pointes (TdP), a potentially fatal polymorphic ventricular tachycardia that arises during abnormal ventricular repolarization. Prolongation of the corrected QT-interval (QTc) on the 12-lead electrocardiogram (ECG) is a primary marker of TdP risk and a major drug safety benchmark used by the US Food and Drug Administration (FDA). Psychiatrists must be aware of risk factors that increase risk of TdP and feel comfortable performing individual risk-benefit analyses when prescribing a medication with known risk. This includes basic proficiency in ECG interpretation, including recognition and measurement of relevant intervals and application of appropriate corrections for heart rate (HR) and QRS duration. <Read More> 

    Hospitals Hone COVID-19 Vaccine Cold Chain Strategies – February 23, 2021 – Hospitals are key participants in COVID-19 vaccine distribution. But the facilities still face many challenges, including storage of vaccines at compliant temperatures, unpredictable deliveries and, most recently, a shortage of specialized syringes needed to stretch doses of the Pfizer-BioNTech vaccine. Through it all, pharmacists are adjusting workflow to ensure the Pfizer and Moderna vaccines are administered as efficiently as possible. Northwell Health, a network of 23 hospitals and nearly 800 outpatient facilities in New York, is a case in point. “We don’t know week to week what we’ll get,” said Onisis Stefas, PharmD, MBA, Northwell’s vice president and chief pharmacy officer. <Read More>

    Drug Shortages are an Increasing Risk, Health System Pharmacists Say – February 23, 2021 – Trade restrictions, pandemics and climate change will likely increase the potential for drug shortages, 92 percent of health system pharmacy experts told the American Society of Health-System Pharmacists in its 2021 pharmacy forecast report, released this month. In the report, released Feb. 4 in the American Journal of Health-System Pharmacy, the society said that there was a 36.6 percent increase in drug shortages between 2017 and 2020, with 276 of them in 2020, according to the University of Minnesota’s Center for Infectious Disease Research and Policy. <Read More>

    Revised Guidelines for Breast Thermology Released By The American Academy of Thermology – February 23, 2021 – The American Academy of Thermology is a 501c(3) that promulgates the scientific application of medical thermology.  Every three years reviews and revises peer reviewed Guidelines for medical infrared imaging.  The 2021 revision of the AAT’s Guidelines for Breast Thermography has been released and is available at: https://aathermology.org/organization-2/guidelines/guidelines-for-breast-thermology/. There are significant changes in this revision, including, but not limited to the proper performance and documentation of infrared breast imaging.  Breast Thermography is an adjunctive Breast Thermal Findings Assessment that can have clinical importance in the management of breast health. <Read More>

    New Guidelines Aim to Help Reduce Blood Pressure for Chronic Kidney Disease Patients – February 23, 2021 – A recommendation for more intensive blood pressure management from an influential global nonprofit that publishes clinical practice guidelines in kidney disease could, if followed, benefit nearly 25 million Americans, according to an analysis led by researchers at the Johns Hopkins Bloomberg School of Public Health. The new recommendation from Kidney Disease: Improving Global Outcomes, a global nonprofit that develops evidence-based clinical practice guidelines in kidney disease, is aimed at doctors to help them to reduce blood pressure for chronic kidney disease patients whose systolic blood pressure levels are over 120 mmHg. Blood pressure can be reduced using antihypertensive medications and lifestyle modifications. The analysis indicates that 69.5 percent of chronic kidney disease patients in the United States–a total of 24.5 million people–would meet that criterion. <Read More>

    Study Demonstrates Macrolide-Resistance in S. pneumoniae in the United States Exceeds 25 Percent Threshold Set in Current Community-Acquired Bacterial Pneumonia (CABP) Treatment Guidelines – February 23, 2021 – Nabriva Therapeutics plc, a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced the publication of a study documenting the high rates of macrolide-resistant Streptococcus pneumoniae throughout the United States. The study entitled, A Multicenter Evaluation of the Prevalence and Regional Variation in Macrolide Resistant S. pneumoniae in Ambulatory and Hospitalized Adult Patients in the U.S. was published this month in Open Forum Infectious Diseases (OFID), and demonstrated that macrolide resistance in S. pneumoniae is greater than 25 percent in most regions of the country and 39.5 percent overall. An accompanying editorial, authored by Daniel Musher, M.D., was also published in same issue of OFID. <Read More> 

    IDSA Updates Guidance to Support Use of Tocilizumab for COVID-19 – February 23, 2021 – The Infectious Diseases Society of America has backed the use of tocilizumab for COVID-19. In a change to its clinical guidelines, the IDSA now “suggests” the use of tocilizumab — a common rheumatoid arthritis medication — in addition to standard of care treatment such as steroids among patients hospitalized with progressive severe or critical COVID-19, rather than standard of care treatment alone. <Read More>

    Fauci Says New Guidelines for Vaccinated People Coming ‘Soon’ – February 23, 2021 – As more Americans are vaccinated, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, says new guidelines for vaccinated people will be coming “soon” from the U.S. Centers for Disease Control and Prevention (CDC). “I believe you’re going to be hearing more of the recommendations of how you can relax the stringency of some of the things, particularly when you’re dealing with something like your own personal family when people have been vaccinated,” Fauci told CNN. <Read More>

    Should an Atty Lead HHS? Lawmakers Debate Pros and Cons – February 23, 2021 – U.S. senators diverged Tuesday over the California attorney general’s qualifications to lead the U.S. Department of Health and Human Services, with critics questioning the nominee’s health care credentials and supporters emphasizing his penchant for suing hospitals and drugmakers over controversial pricing practices. The divisions appeared throughout a Senate health committee hearing on President Joe Biden’s nomination of Golden State Attorney General Xavier Becerra as secretary of HHS, a vast agency that spends more than $1 trillion annually and runs much of the federal government’s response to the coronavirus pandemic. “As the attorney general sits before us, I’ll say what I’ve said to him privately: I’m not sold yet,” Sen. Richard Burr, R-N.C., the Committee on Health, Education, Labor and Pensions’ ranking member, said near the start of Tuesday’s hearing. “I’m not sure that you have the necessary skills or experience to do this job at this moment.” <Read More>

    340B in the News

    Most Dollars Spent on Top-Selling Orphan Drugs Don’t go to Treat People With Rare Diseases – March 1, 2021 – For more than 30 years, the U.S. government has encouraged drug companies to develop new treatments for rare diseases that affect fewer than 200,000 Americans, and to see if existing drugs might also be effective for these diseases. This “orphan drug” program has led to new options for patients worldwide, under special rules that give drug companies financial incentives as a way of making up for a potentially small market. But a surprising number of orphan drugs are among the world’s top-selling drugs—including several so-called “partial orphan drugs” approved to treat both rare and common diseases. A new study, led by a team of University of Michigan and Boston University researchers, looks at how much spending on partial orphan drugs actually goes to treat rare diseases… Orphan drugs—including partial orphans of either kind—are also exempt from discounts usually required for drugs sold to hospitals participating in the 340B Drug Pricing Program. That program subsidizes medication costs for providers that serve a disproportionate share of underserved patients. The authors of the new paper suggest a number of policy changes, including eliminating the 340B exemption for orphan-designated drugs and reducing the level of orphan drug incentives for partial orphan drugs. <Read More>

    United States: HHS Advisory Opinion: Drug Manufacturers Must Offer 340B Program Discounts to Contract Pharmacies – March 1, 2021 – In an important development for 340B participating providers (“Covered Entities”), the Department of Health and Human Services (“HHS”) Office of General Counsel (“OGC”) published an Advisory Opinion stating its view that drug manufacturers must honor 340B program discounts under contract pharmacy arrangements. The Advisory Opinion was remarkable in the clarity and forcefulness of HHS’s position that drug manufacturers must offer 340B Program discounts for drugs dispensed to Covered Entity patients at contract pharmacies. This is the latest development in an ongoing dispute involving 340B Covered Entities, drug manufacturers and HHS. Since 1996, HHS guidance has allowed Covered Entities to provide 340B drugs to their patients through contract pharmacies (i.e., retail pharmacies that serve Covered Entity patients). Due to various objections on complex regulatory grounds, drug manufacturers began refusing to ship drugs to contract pharmacies beginning last summer, unilaterally challenging decades of established industry practice and regulatory interpretations by HHS. <Read More>

    Astroturf Campaign Attacks Discount Drug Program for the Poor – February 26, 2021 – An anti-government waste group is helping its Big Pharma funder oppose a discount drug program that doesn’t cost the government a penny. Before that letter was sent, the drug industry got lobbying support from a surprising source. Conservative anti-government spending group Council for Citizens Against Government Waste (CCAGW) sent House lawmakers a counter-letter, urging them not to add their names to the McKinley letter… “It is our understanding you have been asked to sign a letter intended for Health and Human Services Secretary Alex Azar regarding actions several pharmaceutical companies have taken to restrict sales to certain entities that serve 340B patients,” CCAGW wrote. “CCAGW asks that you focus on reforming the 340B program instead of signing a letter that will not solve longstanding problems.” The 340B program does not cost the government or taxpayers anything, so it’s not clear how CCAGW’s work on it fits with its mission of eliminating waste. Sludge asked CCAGW about its work on this issue but did not receive a response. One possibility is that the group is helping its big drug industry donor advance its agenda by lending it an appearance of conservative grassroots support. <Read More>

    From 340B to Price Transparency: Here are 3 Takeaways From Becerra’s Confirmation Hearing – February 23, 2021 – California Attorney General Xavier Becerra, President Joe Biden’s choice to lead the Department of Health and Human Services (HHS), pledged to strictly enforce price transparency violations but was more ambivalent on a feud surrounding the 340B drug discount program. The Senate Health, Education, Labor and Pensions Committee held a confirmation hearing Tuesday on Becerra’s nomination. Becerra will also have a confirmation hearing Wednesday before the Senate Finance Committee, which will vote on whether to send the nomination to the full Senate. While Becerra gave clear answers on his approach to price transparency and the controversial rebate rule, he also demurred on how he would handle a feud surrounding the 340B drug discount program. <Read More>