Clinical Insights: April 27, 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

    Jemperli™ (dostarlimab-gxly) Injection – New Drug Approval – April 22, 2021 – GlaxoSmithKline plc announced that the US Food and Drug Administration (FDA) has approved Jemperli™ (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody, based on the company’s Biologics License Application. Dostarlimab is indicated for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that have progressed on or following prior treatment with a platinum-containing regimen. This indication is approved under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Ragwitek™ (ragweed pollen allergen extract) – New Approved Indication – April 19, 2021 – ALK, a global, research-driven pharmaceutical company that focuses on the diagnosis and treatment of allergies, announced that the U.S. Food and Drug Administration (FDA) approved Ragwitek™ (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use for the treatment of short ragweed pollen-induced allergic rhinitis in persons ages five through 65. Ragwitek was first launched for adult use in the U.S. and Canada in 2014 and was approved in nine European countries and Russia in late 2017. <Read More>

    Opdivo™ (nivolumab) Injection – New Approved Indication – April 16, 2021 – Bristol Myers Squibb announced that Opdivo™ (nivolumab) (injection for intravenous use), in combination with fluoropyrimidine- and platinum-containing chemotherapy, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, regardless of PD-L1 expression status.1 The approval is based on the Phase 3 CheckMate -649 trial evaluating Opdivo in combination with mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin), compared to chemotherapy (mFOLFOX6 or CapeOX) alone. <Read More>

    New/Updated Drug Shortage

    April 26, 2021

    April 23, 2021

    April 22, 2021

    April 21, 2021

    April 20, 2021

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    AHA Offers Guidance for CVD Risk in Breast, Prostate Cancer – April 26, 2021 – In a scientific statement issued by the American Heart Association and published online April 26 in Circulation: Genomic and Precision Medicine, recommendations are presented for cardiovascular disease (CVD) management in patients with breast and prostate cancer receiving hormone therapy. Tochi M. Okwuosa, D.O., from the Rush University Medical Center in Chicago, and colleagues describe the CVD risks associated with hormone treatment for breast and prostate cancer and provide an evidence-based approach to detect and prevent adverse cardiovascular outcomes. <Read More>

    Help Patients Prevent and Manage Seasonal Allergies – April 26, 2021 – Face mask usage may help, and pharmacists can provide other education and guidance about safe and proper use of nonprescription medications. Spring allergies, also known as hay fever, cause uncomfortable symptoms, such as headaches, itchy or watery eyes, nasal congestion, and repetitive sneezing. Allergy symptoms can interfere with an individual’s productivity at school or work, as well as overall quality of life, because of difficulty concentrating and fatigue due to sleep disturbance. More than 24.4 million individuals—19.2 million adults and 5.2 million under the age of 18 years—in the United States experience varying degrees of seasonal allergies, according to the most recent data from the CDC. The CDC also indicates that seasonal allergies account for an estimated 12 million visits to primary care providers annually. <Read More>

    Technology Connects Community Pharmacies to Patients for At-Home COVID-19 Vaccine Administration – April 26, 2021 – A new service connects community pharmacies with health care systems to support the delivery of health care products and services through crowdsourcing. Telemedicine and on-demand delivery services have advanced exponentially since the start of the COVID-19 pandemic, but this trend toward companies looking to ease patients’ health care access started even before the pandemic. Derrick Miles had observed this trend while working as a health care executive and took action in January 2018 to investigate the potential for a health care delivery service. <Read More>

    Lessons Learned: Pharmacy Purchasing During a Pandemic – April 26, 2021 – Pharmacies cannot prevent shortages, particularly with the complexities of treating COVID-19; however, they can strengthen their ability to prepare their organization to respond to those complexities. Prescription drug shortages are an ongoing, complex issue and pharmacy buyers are accustomed to finding ways to mitigate them in a normal state. However, according to several pharmacy buyers who participated in a McKesson Buyer’s University™ webinar, trying to source during the pandemic was unlike anything they’ve ever seen before. <Read More>

    Not So Different: What’s Stopping Physicians From Prescribing Biosimilars? – April 25, 2021 – In March 2021, the National Comprehensive Cancer Network’s (NCCN) Oncology Research Program, in partnership with Pfizer, announced 10 research projects that will receive funding to develop innovative ways to improve biosimilar adoption in the oncology space. For this Not So Different series, The Center for Biosimilars® is spotlighting 3 projects to improve perception of biosimilars, promote biosimilars as a therapy choice, and encourage payers to prefer biosimilar use. In this second part, we spoke with Muhammad Shaalan Beg, MD, director of GI Medical Oncology at UT Southwestern Medical Center. Dr Beg discussed how his project titled “Developing a Clinical Decision Support Tool for Biosimilar Use in Oncology” will make it easier for physicians to choose biosimilars for their patients. <Read More>

    Hospice Patients Getting Fewer Opioids for Pain Relief – April 25, 2021 – Overzealous enforcement of opioid guidelines has led to a significant decrease in opioid prescribing to terminally ill patients being admitted to hospice care, according to a new study that found some dying patients may have had their pain undertreated. The study, led by researchers at the Oregon State University College of Pharmacy, looked at prescription records for over 2,600 patients discharged from hospitals to hospice care from 2010 to 2018. Nearly 60% of the patients had a cancer diagnosis. In 2010, researchers say about 91% of the patients were receiving opioids for pain at discharge to hospice. But by 2018, only 79% were getting opioid medication. <Read More>

    Researchers Review Practice Guidelines for Biologics in Psoriasis – April 24, 2021 – Guidelines on the use of biologic drugs in patients with psoriasis were mostly seen as having medium-to-high quality; however, investigators said that more work needs to be done to ensure applicability to clinical practice. The quality of clinical practice guidelines (CPGs) for biologic medications used to treat psoriasis was determined to be medium to high; however, more attention needs to be paid to guideline development applicability, according to a recent analysis. The systematic literature review, published in the Journal of Dermatological Treatment, is one of the first pieces of evidence evaluating biologic therapy recommendations in psoriasis CPGs, showing that despite near consistency, several domains in the guidelines need improvement. <Read More>

    FDA, CDC Lift Pause on Johnson & Johnson COVID-19 Vaccine – April 24, 2021 – Shortly after the Advisory Committee on Immunization Practices (ACIP) made its recommendation about lifting the pause for the Johnson & Johnson (Janssen) COVID-19 vaccine, the FDA and CDC determined that use of the vaccine should resume. In a statement, the two agencies said: 1) Use of the J&J COVID-19 vaccine should be resumed in the United States, 2) The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19, and 3) The FDA has determined that the available data show the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older. <Read More>

    FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients – April 23, 221 – The U.S. Food and Drug Administration authorized marketing of a new device indicated for use in patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion. The Neurolutions IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) is a Brain-Computer-Interface (BCI) device that assists in rehabilitation for stroke patients with upper extremity—or hand, wrist and arm—disability. <Read More>

    Study: Targeted Interventions Improve Bronchiolitis Management in Infants – April 23, 2021 – Medications and management processes known to be ineffective or harmful in infants with bronchiolitis were tossed in favor of targeted interventions in hospitals, resulting in improvements in bronchiolitis care. A recent study found that hospitals that followed guidelines to cease use of certain therapies and management strategies in favor of targeted interventions saw improvements in the care of infants with bronchiolitis, the most common respiratory condition affecting infants. The international, multicenter cluster randomized clinical trial (RCT), published in JAMA Pediatrics, is the first RCT to report whether targeted interventions are effective at improving bronchiolitis management. It is also one of the first to outline the effects of deimplementation of unnecessary care in acute care settings. <Read More>

    Are You Maximizing Your Home Infusion Pharmacy’s Reimbursements? – April 23, 2021 – Home infusion pharmacy clinicians can help to make the most of reimbursement opportunities and minimize risk in payor audit with basic understanding of key reimbursement concepts including pricing, contracting, prior authorizations (PAs), and billing for waste, said Ryan Garst, PharmD, MBA, the senior director of clinical services for the National Home Infusion Association (NHIA), in a session at the organization’s 2021 virtual annual conference. “Resist the temptation to dismiss these topics by thinking ‘we have a revenue cycle team that handles all that,’” Dr. Garst said. “When clinicians don’t know the basics of how services are reimbursed, it can have a significant impact on both patient care and financial outcomes.” <Read More>

    SPBMs: Impact on Accessibility & Affordability of Gene Therapies for Rare and Orphan Diseases – April 23, 2021 – Expensive new gene therapies for rare diseases that aim to cure1 by correcting the underlying genetic abnormalities are also causing sticker shock among the nation’s self-insured employers, payers, and plan sponsors. The first shot across the bow came in 2013 when a cure for hepatitis C cost $85,000 for a 24-week course, which prompted a battle between manufacturers all vying for their own therapies. Since then, payers have learned valuable lessons and are preparing for the introduction of other ultra-high-cost therapies that now reside in drug manufacturer pipelines with a handful recently launched into the marketplace. <Read More>

    Strategies for Optimizing Molecular Testing in Non–Small Cell Lung Cancer – April 23, 2021 – As genomic profiling becomes more and more essential as part of clinical decision making, clinicians are challenged to stay abreast of advancements in this space to improve patient outcomes and advance the field of precision oncology. The advent of next-generation sequencing (NGS) has been a key driver in treatment advances and improved outcomes for patients with non–small cell lung cancer (NSCLC). However, implementation of universal molecular testing for patient populations who may benefit the most has been somewhat limited, with long turnaround times and lack of adequate tissue noted as 2 of the main causes. <Read More>

    Streptococcal Pharyngitis is a Seasonal Concern – April 23, 2021 – Pharmacists and other clinicians share responsibility for relieving symptoms, preventing transmission, and avoiding complications. Pharyngitis, an inflammation of the back of the throat, can be bacterial or viral. Streptococcal pharyngitis, commonly referred to as strep throat, is caused by Streptococcus pyogenes, group A β-hemolytic Streptococci (GAS). GAS is responsible for fewer pharyngitis cases than viruses are (adults: 5%-15%, children: 20%-30%). Strep throat spreads through direct contact with respiratory fluids and has an incubation period of 2 to 5 days. Its prevalence increases during the winter and early spring, accounting for 1% to 2% of all ambulatory care visits in the United States. <Read More>

    Why do Hospitals Struggle With Adhering to National COPD Care Guidelines? – April 23, 2021 – Investigators explored common challenges cited by hospital staff as barriers to implementation and adherence with national guidelines for managing chronic obstructive pulmonary disease (COPD). In a recent study, investigators found 8 prominent barriers preventing emergency departments (ED) from adhering to national guidelines for treating, discharging, and referring patients with chronic obstructive pulmonary disease (COPD). “The contribution of all clinicians towards the preferential implementation of COPD guidelines in practice is indispensable to prevent readmission of patients within the ED,” wrote the authors. <Read More>

    Updated Guidance for Cancer Patients During Covid-19 may Help Improve Outcomes – April 23, 2021 – New recommendations may provide reassurance for patients and their care teams, while uniquely positioning healthcare providers to help communicate this critical information to vulnerable populations. The Covid-19 pandemic has caused a significant disruption in cancer care due to missed screenings, biopsies and surgeries that further delayed diagnoses for certain cancers. Now with vaccinations underway, updated guidance has been issued regarding cancer patients and Covid-19 vaccinations – these will bring us closer to addressing the effects that the pandemic has had on cancer care. As the leading cause of cancer-related deaths among both men and women in the US, lung cancer outcomes, in particular, have been heavily affected by Covid-19 worldwide. <Read More>

    SGLT2 Inhibitors Changed the Treatment Paradigm for T2D, Have Implications for Managed Care – April 23, 2021 – While the introduction of sodium glucose co-transporter 2 (SGLT2) inhibitors has benefitted patients with type 2 diabetes and impacted guidelines globally, these expensive therapies have managed care implications, explained Richard E. Pratley, MD, of AdventHealth Diabetes Institute and Johns Hopkins University School of Medicine. The treatment paradigm for type 2 diabetes (T2D) is increasingly complex as the introduction of sodium glucose co-transporter 2 (SGLT2) inhibitors has impacted guidelines for managing the disease and managed care in general, said Richard E. Pratley, MD, the Samuel E. Crockett Chair in Diabetes Research and medical director of the AdventHealth Diabetes Institute, and adjunct professor of medicine at the Johns Hopkins University School of Medicine, during his presentation at the National Association of Managed Care Physicians Virtual Spring Managed Care Forum. <Read More>

    Pain Patients Worried About CDC Expanding Opioid Guideline – April 23, 2021 – “These guidelines have been a disaster for people with chronic pain.” “The guideline is flat out wrong on facts, wrong on science and wrong on medical ethics.” “The CDC has no qualifications or authority to develop pain management guidelines, especially those pertaining to opioid therapy.” Those are just a few of the comments we received from nearly 4,200 pain patients and healthcare providers who participated in PNN’s survey on impending changes to the CDC’s opioid prescribing guideline. “It has been misunderstood, misapplied, bastardized and weaponized to use against chronic pain patients,” is how one pain sufferer put it. People obviously have strong opinions about the CDC guideline. Can it be changed and made more effective? Or should the entire guideline be thrown out? <Read More>

    Overcoming the Unique Hurdles to Biosimilar Uptake in Oncology – April 23, 2021 – With the costs of biologic drugs increasing, biosimilars have emerged as an attractive option for containing costs and expanding access to treatment. However, some barriers to wider uptake still need to be addressed, according to a presentation at the National Association of Managed Care Physicians Virtual Spring Managed Care Forum. Sanjiv S. Agarwala, MD, professor of medicine at Temple University, explained that biologics have revolutionized the treatment of serious conditions, including cancer, over the past few decades. However, costs are a pressing issue for all providers and biologics are a major culprit, accounting for half of Medicare’s drug spending in 2018. <Read More>

    Development of Biosimilar and Interchangeable Biological Products During the COVID-19 Pandemic: What the ANDA Guidance Left Unsaid – April 23, 2021 – There has been much discussion about FDA’s recently-issued guidance regarding the development and review of abbreviated new drug applications (“ANDAs”) during the COVID-19 pandemic. The guidance, “Development of Abbreviated New Drug Applications During the COVID-19 Pandemic—Questions and Answers” (“COVID Q&A Guidance”), also leaves much unsaid. Notably, the guidance stops short of extending the Agency’s thinking on the articulated scientific and regulatory principles from small molecule generics to follow-on biological products, i.e., biosimilar and interchangeable biological products. There may be good reason for this: the biosimilars pathway differs from the ANDA pathway in a number of important ways, and the treatment of the two product categories by FDA has justifiably been separate in most cases. As we explain below, however, the COVID Q&A Guidance’s “case-by-case” approach to 180-day exclusivity for generics should be flexible enough to apply to first interchangeable exclusivity for interchangeable biosimilar products, too. <Read More> 

    Understanding Specialty Pharmacy (Part 2): The Patient Journey – April 23, 2021 – You’ve gone to the same pharmacy for 20 years and now you are prescribed a new medication for a likely scary condition or disease that you cannot pick up from your neighborhood pharmacy…Now, consider the journey a specialty patient will follow to ultimately receive their medication. The journey is often complicated from the very beginning, as most specialty medications treat complex disease states that are hard to diagnose. This means that patients are often tired and frustrated before they even have a diagnosis, let alone a filled prescription. Once these patients have seen a specialist, endured the testing and appointments required to get an accurate diagnosis, and received a prescription, they are more than ready to begin their treatment. Unfortunately, however, this typically is not the end of the complicated journey. <Read More>

    Mandatory Biosimilar Switching Pays Off for Canada – April 22, 2021 – For Alberta and Green Shield Canada, savings are beginning to add up from switching initiatives for multiple reference biologics. Recognizing the swift upward march of biologics prices and the savings potential of biosimilars, which are cheaper versions of original brand biologics, various entities in Canada have imposed switching policies to get patients off costly reference drugs. They have been successful thus far, officials reported at the recent Festival of Biologics USA. In December 2019, the Canadian province of Alberta initiated mandatory biosimilar switching for patients enrolled in government drug plans for individuals without private coverage, seniors, and low-income groups. <Read More>

    ASHP, APhA Express Support for New Bill Expanding Medicare Patients’ Access to Pharmacists – April 22, 2021 – The American Society of Health-System Pharmacists (ASHP) and the American Pharmacists Association (APhA) are both expressing support for the Pharmacy and Medically Underserved Area Enhancement Act, which would allow pharmacists to deliver Medicare Part B services to Medicare patients in underserved communities, according to a press release…The legislation does not expand scope of practice, but instead brings Medicare rules in alignment with existing responsibilities already granted to pharmacists through various credentialing and privileging programs. <Read More>

    Postpandemic Future Is Bright for Technicians – April 22, 2021 – Tapping techs as immunizers opens up greater visibility and new source of health care labor. A silver lining can be found in every cloud, according to the proverbial phrase. Although the coronavirus disease 2019 (COVID-19) pandemic can hardly be called a mere cloud, it has opened up opportunities in the pharmacy profession that are likely to continue even after the pandemic has abated. Techs have become an integral part of the COVID-19 vaccination effort. Prior to the pandemic, techs were not relied upon frequently as vaccine immunizers. However, once the US Department of Health & Human Services (HHS) expanded the roles of techs to administer vaccines to the public, a previously untapped source of health care labor capital was unleashed. <Read More>

    COVID-19 Pandemic Causes Dramatic Shifts in Prescription Drug Spending – April 22, 2021 – The COVID-19 pandemic heavily influenced U.S. spending for prescription drugs in 2020, according to ASHP’s National Trends in Prescription Drug Expenditures and Projections for 2021 (Am J Health Syst Pharm 2021 Apr 21 doi:10.1093/ajhp/zxab160). Shifts in care related to the pandemic will be a significant driver of drug expenditures in 2021, along with uptake in the use of biosimilars, a large pipeline of new cancer drugs and increased approvals of specialty medications.
    Prescription drug spending in 2020 grew at a moderate rate of 4.9% to $535.3 billion. Increased use drove the growth, which accounted for 2.9% of the total increase, according to the report. Spending on new drugs accounted for 1.8% of the increase, and price changes accounted for 0.3%. <Read More>

    Updates in Renal Cell Carcinoma Management – April 22, 2021 – Renal cell carcinoma (RCC) is the ninth most common neoplasm in the United States and accounts for approximately 3.8% of all new cancer diagnoses. RCC originates from the kidney cortex and accounts for 85% of all renal tumors. The median age of diagnosis for this disease is 64 years, with a gender disparity toward men at a notable 1.7-fold increased risk of RCC development compared with females. Older age, male sex, and African American and Hispanic ethnicities are nonmodifiable risk factors for the development of RCC, with obesity, smoking, poor diet, alcohol consumption, and hypertension identified as the leading modifiable risk factors. <Read More>

    Pharmacy Technician Role Expands – April 22, 2021 – The COVID-19 pandemic has resulted in more opportunities for health care professionals, and pharmacy technicians are no exception. Changes and growth within the health care industry have always been a part of the journey within the pharmacy profession. The pandemic has meant many changes on the testing and vaccination fronts, which gives techs who want to expand their responsibilities and roles a leg-up in helping protect their communities alongside their pharmacist partners. Federal and state waivers are paving the way for techs to help combat COVID-19. <Read More>

    Proper Treatment of UTIs Often Eludes Nursing Homes, Hospitals – April 21, 2021 – When nursing home (NH) residents are hospitalized, they are often treated for urinary tract infections (UTIs) at the hospital before they’re sent back to the NH. That can cause a disconnect when it comes to treatment, according to a retrospective cohort study in the American Journal of Infection Control (AJIC). “A variety of guidelines are used with NH residents and hospitalized patients for many common diagnoses and treatments,” conclude investigators with the University of Michigan-Flint, School of Nursing. “However, data on hospital use of guidelines specifically designed for NH residents is lacking.” <Read More>

    Expanding the Role of the Pharmacist in the Wake of COVID-19 – April 21, 2021 – Community pharmacists should consider leaning on their specialty pharmacist peers, where available, as we continue to navigate the new, more virtual normal and attempt to expand these types of services in the future. The past year has been unlike any year in recent history, as the world has been consumed with a pandemic most people could not have even fathomed. Damage has been done in so many areas, in so many subsectors of the world’s population, affecting health and mortality, as well as social and financial impacts and everything in between. As a society, we hope to have a light at the end of this long and arduous tunnel, with COVID-19 vaccines becoming more readily available by the day and testing being more streamlined and available than ever before. Throughout the COVID-19 pandemic, health care workers have often been lauded for their heroic efforts in helping the United States battle this virus to the best of its ability. <Read More>

    ACP Offers Guidance on Antibiotic Duration for Common Infections – April 21, 2021 – In a Best Practice Advice document issued by the American College of Physicians and published online April 6 in the Annals of Internal Medicine, recommendations are presented for prescribing appropriate and short-duration antibiotic therapy for patients with common bacterial infections. Rachael A. Lee, M.D., M.S.P.H., from the University of Alabama at Birmingham, and colleagues conducted a narrative literature review of published clinical guidelines, systematic reviews, and individual studies that addressed common bacterial infections to describe best practices for appropriate and short-duration antibiotic therapy prescribing. <Read More>

    World of Pharmacy Still Spins, Despite COVID-19 – April 21, 2021 – Technicians and other pharmacy professionals have been focused on the pandemic, but now can turn to what’s next. The world of pharmacy has remained steadfast, with escalating drug costs, the seemingly never-ending opioid crisis, and workforce issues. Pharmacy professionals are continuously working to reduce medical expenses and increase provider access through health care reform. However, drug shortages continue to drive medication costs up, which results in reduced medication adherence. The end of 2019 brought the coronavirus disease 2019 (COVID-19) and forced the pharmaceutical industry to find common ground in 2020. A new normal is beginning to blossom from the struggles of 2020, and 2021 will be about figuring out how best to navigate this challenging new era of pharmacy. <Read More>

    New Analysis Associates Integrated Specialty Pharmacy With Lower Total Cost of Care – April 21, 2021 – Health systems individually have struggled to demonstrate improvements to total cost of care because, without data about patients they do not serve, they cannot define a comparison group. A poster presented at the Academy of Managed Care Pharmacy (AMCP) 2021 virtual meeting highlights a new study that measures the impact of integrated specialty pharmacy on the total cost of health care. Conducted by Shields Health Solutions (SHS) in conjunction with Optum Advisory Services, the study found that risk-adjusted per member per month (PMPM) costs were 13% lower for the intervention group compared to the control group. <Read More>

    How a Pharmacy Merger Will Help People Living With HIV – April 21, 2021 – National HIV-focused pharmacy services organization Avita has merged with three other major pharmacy companies and will move forward with an increased concentration on assisting underserved communities. Avita (officially, Longs Pharmacy Solutions/Avita Pharmacy) completed its merger with Paramount Specialty Pharmacy, PharmBlue, and PharMedQuest in March, resulting in an entity with a “unified focus on vital 340B pharmacy services,” according to an Avita news release. <Read More>

    Survey: Half of Ohio Pharmacists Don’t Have Enough Time to Safely Perform Job – April 21, 2021 – Half of Ohio pharmacists said they do not have adequate time to perform their job safely, with pharmacists who work for retail pharmacy chains or grocery chains being more likely to report this, according to survey results released April 20 by the Ohio Board of Pharmacy. In July, the board collected 4,159 survey responses from pharmacists working in a variety of settings about their workload. The survey found half of respondents said the workload to staff ratio does not allow them to safely and effectively provide for patients. Half also said they did not have time to take breaks during their shifts. <Read More>

    Hematology Pharmacists are the Ultimate Weapon for Treating Cancer – April 21, 2021 – The hematology/oncology pharmacist is in the best position to assist patients and caregivers in understanding how to safely take cancer medications. We often hear that practicing medicine is an art. But developing a treatment plan for hematological cancer turns that art into a science, and trained oncology pharmacists are its ultimate weapon. Patients with cancers of the blood can have various and complex medication needs. Each patient tends to have a unique disorder, and an experienced oncology pharmacy team with knowledgeable experts is essential. <Read More>

    FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines – April 21, 2021 – The U.S. Food and Drug Administration takes its responsibility to ensure medical product quality, safety and effectiveness very seriously. The American public puts its trust in the agency to ensure that all medical products, including COVID-19 vaccines, meet the agency’s standards for quality, safety and effectiveness. As part of our regulatory processes for reviewing all manufacturing facilities, the FDA recently completed an inspection of Emergent BioSolutions, a proposed manufacturing facility for the Johnson & Johnson COVID-19 Vaccine. As Johnson & Johnson announced last month, the FDA has not authorized this facility to manufacture or distribute any of Johnson & Johnson’s COVID-19 Vaccine or components and, to date, no COVID-19 vaccine manufactured at this plant has been distributed for use in the U.S. <Read More>

    Does This Supplement Live up to its Hype? – April 21, 2021 – If you’ve been wandering the vitamin and supplement aisle of your local grocery store recently, you may have noticed an “out of stock” sign where the melatonin used to be. That’s because this supplement has become one of America’s most popular sleep aids, and demand spiked last year. According to an article published in Business Insider, US consumers spent more than $825 million on melatonin supplements in 2020—a whopping 42.6% increase in sales compared with 2019. Most of us associate melatonin supplements with insomnia but researchers are looking into new uses for this wildly popular dietary supplement. Recently, this dietary supplement has been promoted not just as a sleep aid, but as a way to prevent or treat certain chronic diseases—and some are even taking it to relieve pandemic-induced stress. But history tells us that what manufacturers claim their supplements can do doesn’t always match up with what they have been proven to do. And, because there is less FDA oversight for dietary supplements compared with OTC or prescription medications, companies could falsely advertise the quantity of melatonin in their product, according to the Business Insider article. <Read More>

    Pharmacy Benefit Manager Bill Passes Florida’s Final Panel Without Side Effects – April 21, 2021 – Legislation to regulate pharmacy benefit managers is on its way to the Florida Senate floor. The Senate Appropriations Committee gave its unanimous support on Wednesday to a bill (SB 390) that would clarify that the Office of Insurance Regulation can audit PBMs, like it does other entities, to examine potential cost-cutting areas. Lawmakers have attempted to add that oversight in the past, but OIR said the statute wasn’t clear enough. PBMs are middlemen between health care plans and pharmacies that are often blamed for rising prescription drug prices. They help determine which drugs insurance plans will cover and negotiate on behalf of insurers to secure discounts from drug manufacturers. When a claim is filed, PBMs collect money from those plans, then pass money to pharmacies through different methods. <Read More>

    FDA Announces New Streamlined Approach to Add Pooled Serial Screening Claims to Certain Authorized Tests for Use in Serial Testing Programs – April 20, 2021 – The U.S. Food and Drug Administration took steps to further facilitate the authorization of molecular tests for screening asymptomatic individuals using pooled anterior nasal respiratory specimens in serial testing programs. The FDA issued an amendment for many molecular diagnostic COVID-19 tests that had received an emergency use authorization (EUA). If a test developer has self-certified it has validated its test for pooling, FDA will add that test to a list of tests that can be used for pooling nasal specimens as part of a serial testing program. <Read More>

    What’s Your White-Bagging Strategy? – April 20, 2021 – It would be an understatement to say that hospital pharmacists are disgruntled with the concepts of white bagging and mandated restricted drug distribution models that commercial payors include in their armamentarium of drug spending control tools. Some pharmacists have prohibited white bagging at their facilities and diligently try to avoid restricted drug distribution, perhaps even closing formularies to those affected products. Is this developing into a standoff between hospital pharmacists and commercial payors? <Read More>

    WhatsApp ‘Prescriptions’ Add to COVID Woes – April 19, 2021 – Even as an acute shortage of beds, medical equipment and doctors, hampers COVID management in Uttar Pradesh, the ‘WhatsApp University’ is doing brisk business in the pandemic. Prescriptions for Covid treatment come dime a dozen on WhatsApp groups, ranging from home remedies to Ayurveda and Unani prescriptions and audio and video advices. None of the remedies are certified or verified but people are lapping them up with an alarming urgency. <Read More>

    Meds-to-Beds Program Meets Challenges of COVID-19 – April 19, 2021 – In retrospect, it may not have been the ideal time for the University of Alabama at Birmingham (UAB) Medical West Hospital to launch a new retail pharmacy and meds-to-beds (M2B) program, right on the cusp of the COVID-19 pandemic. But the joint venture agreement between the 310-bed acute care hospital in Bessemer, Ala., and ShiftRx, the Newberg, Ore.-based ambulatory pharmacy investment and consulting company, was finalized in 2019, and the operational phase was far along in the early months of 2020. <Read More>

    Pharmacy is Ready to Embrace Expanded Roles – April 19, 2021 – There is no doubt that the coronavirus disease 2019 (COVID-19) pandemic has changed the dynamics in most if not all health care settings. COVID-19 screenings, mandatory masks, and temperature checks are now common practices. One of the initial changes in pharmacy was the approval of pharmacists to order and administer COVID-19 testing following a statement on April 8, 2020, from the US Department of Health and Human Services.1 This is the first authorization of its kind for pharmacists to order and administer a test without the approval of or collaboration with a physician. With the addition of testing in many pharmacies, changes in workflow for pharmacists and pharmacy technicians became a necessity. Even in pharmacies that were already performing other clinical services, such as flu or strep testing, the sheer demand for COVID-19 testing forced a drastic and immediate shift in daily workflow functions. <Read More>

    Pharmacy in the Era of Telehealth – April 19, 2021 – Although telehealth existed before the COVID-19 pandemic, its popularity surged in response to social distancing efforts and widespread lockdowns a year ago. Legislators temporarily lifted many barriers to its adoption, allowing expanded use among providers and patients. This begs the question: How will telehealth evolve beyond the pandemic? It’s safe to assume that telehealth won’t completely replace in-person health care. Patients won’t stop visiting their local pharmacies. But pharmacists can learn how to better integrate technology and telepharmacy models to enhance the already quality care they provide. In this issue’s cover story, we dive into the innovative ways pharmacists are doing just that––from remote sterile compounding to secure medication storage and virtual care consults. <Read More>

    340B in the News

    Mom-and-Pop Pharmacies Says State Holding up Their Fed Money – April 24, 2021 – Small mom-and-pop pharmacies are claiming foul after the state is holding up for two years of federal reimbursement dollars. The state had initially agreed last year to move the Medicaid payment model away from more corporate ‘middlemen,’ known as Pharmacy Benefit Managers (PBM). However, after the passing of the state’s budget, that decision was delayed by two years…“In regards to the Pharmacy Benefit Carve Out, I strongly believe that we can protect the 340B providers while implementing the carve-out and supporting independent pharmacies. We are going to have to work together to develop a structure that accomplishes that goal,” said Rivera. <Read More>

    AAMC Asks HHS Secretary to Stop Drug Companies’ Illegal 340B Actions – April 23, 2021 – The AAMC and five other organizations representing hospitals and pharmacists sent a letter on April 20 to Health and Human Services (HHS) Secretary Xavier Becerra, JD, requesting that the HHS immediately take action to prevent six drug companies from refusing to provide hospitals with 340B discounts for drugs dispensed through community pharmacies (also known as “contract pharmacies”). The letter highlighted the importance of community pharmacies and requested that the “HHS immediately and definitively state that these refusals to provide discounts are illegal and take the action Congress specifically prescribed to address this type of situation — impose civil money penalties.” <Read More>

    Advocacy Groups to HHS: Fine Drugmakers That Deny 340B Discounts – April 21, 2021 – Six healthcare organizations sent a letter to HHS April 20 urging the department to prevent drugmakers from refusing to give 340B drug discounts. The six organizations were the American Hospital Association, American Society of Health-System Pharmacists, Children’s Hospital Association, Association of American Medical Colleges, America’s Essential Hospitals and 340B Health. The groups wrote that none of HHS’ efforts have stopped Eli Lilly, Sanofi, AstraZeneca, Novartis, Novo Nordisk or United Therapeutics from refusing to provide “statutorily required” drug discounts to 340B hospitals that are dispensing those prescriptions via community pharmacies. <Read More>

    Boozman Backs Legislation to Protect Arkansas Hospitals Participating in Drug Discount Program – April 20, 2021 – U.S. Senator John Boozman (R-AR) is backing legislation to provide certainty to Arkansas hospitals participating in the 340B drug discount program during the COVID-19 public health emergency. The 340B drug pricing program is providing flexibility to more than 40 Arkansas medical facilities to help lower prescription drug prices. As a result of COVID-19, many hospitals were forced to reduce inpatient hospital admissions of low-income Medicare and Medicaid patients, a critical metric in determining eligibility for the 340B program. <Read More>

    Small Changes to 340B can Make a Big Difference for Struggling Patients – April 19, 2021 – The COVID-19 pandemic has made the issue of healthcare access more urgent than ever. Yet, at a time of deep divisions in Washington, chances for major reform are slim. The Biden administration doesn’t need an ambitious package of reforms to make health care more affordable. Federal officials could instead focus on fixing dysfunctional programs already on the books. A drug discount program known as 340B should be high on their list. Its original goal was to make brand-name drugs more affordable for uninsured and low-income populations. Instead, pharmacies and hospitals have abused 340B discounts to boost their own profit margins. <Read More>