Clinical Insights: October 20, 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

    InmazebTM (atoltivimab, maftivimab, and odesivimab-ebgn) Injection – New Drug Approval – October 14, 2020 – The U.S. Food and Drug Administration approved InmazebTM (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients. Zaire ebolavirus, commonly known as Ebola virus, is one of four Ebolavirus species that can cause a potentially fatal human disease. Ebola virus is transmitted through direct contact with blood, body fluids and tissues of infected people or wild animals, as well as with surfaces and materials, such as bedding and clothing, contaminated with these fluids. Individuals who provide care for people with Ebola virus, including health care workers who do not use correct infection control precautions, are at the highest risk for infection. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    No new update.

    New/Updated Drug Shortage

    October 16, 2020

    October 14, 2020

    October 13, 2020

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    Monurol® (Fosfomycin Tromethamine) Granules – First-Time Generic Approval and Launch – October 6, 2020 – Xiromed LLC announced the approval and launch of Fosfomycin Tromethamine Granules for Oral Solution, the first AA-rated generic version of Monurol® approved by the U.S. Food and Drug Administration. Monurol® (fosfomycin tromethamine) granules for oral solution is a prescription antibiotic approved to treat uncomplicated urinary tract infections (UTI) in women caused by certain types of bacteria.  Annual market sales for Monurol for the twelve month period ending August, 2020 were $34 million, according to IQVIA™. <Read More>

    Clinical and Pharmacy News

    NCPA’s 2020 Digest Report Highlights Critical Role of Independent Community Pharmacies  – October 19, 2020 – In 2019, the independent community pharmacy industry represented 35% of all retail pharmacies in the United States with a $73.7 billion marketplace, according to the National Community Pharmacists Association (NCPA)’s recently released 2020 NCPA Digest. The NCPA Digest is released to provide an annual overview of the independent community pharmacy industry. Additionally, it details the wide variety of services offered by independent community pharmacies. “The NCPA Digest report details the many indispensable services patients are able to access at their neighborhood pharmacies, and also some of the pressures they face that can make it difficult to keep their doors open,” said NCPA CEO B. Douglas Hoey, RPh, MBA, in a press release. “The opportunities and challenges alike have been magnified by the coronavirus pandemic, but as we look to the development of vaccines and overcoming the virus, the importance of community pharmacy has never been clearer.” <Read More>

    Guidelines for MCL Set to Change Due to COVID-19 – October 17, 2020 – Guidelines are available to help summarize the best treatment for patients with mantle cell lymphoma (MCL) across various stages based on the greatest level of evidence available and the most up-to-date data. However, ahead of the eighth annual Society of Hematologic Oncology (SOHO) Meeting, Robert Marcus, MA, FRCP, FRCPath, chair of the MCL session, said, “The landscape has completely changed as a consequence of COVID[-19].” <Read More>

    NIH Launches Adaptive Phase 3 Clinical Trial to Test Immune Modulator Drugs in COVID-19 Patients – October 16, 2020 – The National Institutes of Health has launched an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19. Some COVID-19 patients experience an immune response in which the immune system unleashes excessive amounts of proteins that trigger inflammation — called a “cytokine storm” — that can lead to acute respiratory distress syndrome, multiple organ failure and other life-threatening complications. <Read More> 

    Feds Planning Now to Get Coronavirus Shots to Nursing Homes – October 16, 2020 – Federal health officials on Friday unveiled a plan to get yet-to-be-approved coronavirus vaccines to nursing home residents free of charge, enlisting two national pharmacy chains to help. Such a vaccine is not yet available. The distribution program is contingent on the Food and Drug Administration authorizing a vaccine, which does not appear to be imminent. While one nursing home industry group endorsed the administration’s effort, another one was guarded in its reaction. <Read More>

    The Dx of ADHD – October 15, 2020 – Attention-deficit/hyperactivity disorder (ADHD) was first recognized over 100 years ago, but the diagnostic criteria has changed over the years. Here’s a look at the latest guidance for diagnosing ADHD. The condition we now refer to as attention-deficit/hyperactivity disorder (ADHD) was first recognized in England in 1902 by eminent physician Dr George Still (eg, Still’s Disease = Juvenile Rheumatoid Arthritis). Dr Still identified and reported in the journal Lancet several boys who seemed normal physically and intellectually but who struggled with symptoms of “restlessness, inattention, and hyper-arousal.” The cause was then unknown. <Read More>

    Influential Group Recommends That Pharmacists Receive Priority Access to COVID-19 Vaccine  – October 15, 2020 – A special committee of the National Academies of Science, Engineering, and Medicine (NASEM) tasked with developing a framework on the allocation and distribution of the COVID-19 vaccine agreed that pharmacists should be in the first group to be vaccinated. In a draft framework, pharmacists were placed on tier 2, behind physicians, nurses, and other providers. APhA and other pharmacy organizations urged the elevation of pharmacists to the top tier of “phase 1,” citing pharmacists’ exposure to COVID-19 as frontline health care workers who have served continuously throughout the pandemic across practice settings. The letter urged the inclusion of pharmacists in all practice settings. <Read More>

    Celebrate and Advocate for the Pharmacy Profession – October 15, 2020 – If anything has demonstrated the need and value of expanded access to community-based care, it’s been the coronavirus disease 2019 (COVID-19) pandemic. Over the past several weeks, the passage of new legislation has highlighted the pharmacists’ value to their communities. At the time of this publication, the US Department of Health & Human Services has authorized all state-licensed pharmacists the ability to administer pediatric immunizations, as well as COVID-19 vaccines once they are available. This is a significant step forward for the profession, as pharmacists will play a critical role in immunization efforts amid the COVID-19 response. However, for a long time, industry headwinds have impeded pharmacists’ ability to practice at the top of their licenses. As pharmacists begin to step into the role of clinicians, legislation should ensure that they are also compensated fairly for doing so. <Read More>

    Help Patients Using Opioids Avoid Stigma – October 15, 2020 – In February 2020, Netflix released a documentary series depicting the early years of what is now known as the opioid epidemic. The Pharmacist follows a journey that is familiar to many working in pharmacies across the United States. The story is told through the eyes of Louisiana pharmacist Dan Schneider, who begins noticing increased opioid use, misuse, and the first mass opioid–dispensing clinics now commonly referred to as pill mills. Like many who work in community pharmacy, he wants to do something to halt its spread but feels powerless to make an impact… Perhaps no other health care workers have been exposed to this epidemic more frequently than pharmacists and pharmacy technicians (techs). Like the fictional Schneider, they are on the front lines and are placed almost daily in situations where they desire to do “something” but lack the ability to directly help. Because of the frequency of these encounters, pharmacists and techs often suffer from something known as compassion fatigue, the phenomenon when a care provider experiences secondary trauma from caring for someone else, which can affect job satisfaction and morale and result in decreased empathy for patients. <Read More>

    Gender Gap Still Exists in Pharmacist Leadership – October 15, 2020 – To fully understand the leadership achievements of women in pharmacy, it is important to highlight those who set the stage for the profession. Elizabeth Gooking Greenleaf, the first female pharmacist in the United States, opened an apothecary shop in Boston, Massachusetts, in 1727. Mary Corinna Putnam Jacobi was the first woman to graduate from a school of pharmacy, receiving her degree from the New York College of Pharmacy in 1863…Despite those first big steps, gender gaps exist today in pharmacy leadership positions, even though a majority of pharmacy school graduates are women. Female pharmacists play a critical role in advancing the pharmacy profession through leadership. <Read More>

    When Shorter May Not Be Better: Pseudomonas Infection in Hematopoietic Stem Cell Transplant Recipients – October 14, 2020 – Recent literature continues to suggest that shorter duration of antibiotics and stepdown to highly bioavailable oral agents may be appropriate for the treatment of gram-negative infections, in particular bacteremia. It is not clear, however, which patients may be poor candidates for shorter durations. There has been some general acceptance that Pseudomonas infections may require more aggressive therapy; many prior studies have focused primarily on relatively uncomplicated Enterobacterales infections. A randomized multicenter trial by Yahav, et al. found that a 7-day course was noninferior to a 14-day course in patients hospitalized with gram-negative bacteremia, but this included a small proportion of Pseudomonas infections, with 28 patients (9%) in the short 7-day arm and 20 (7%) in the longer 14-day arm. In addition, the number of immunocompromised patients was limited. Hematopoietic stem cell transplant (HSCT) recipients accounted for less than 2% of the total patients. <Read More>

     Safety Concerns Pause Clinical Trials for J&J, Eli Lilly Coronavirus Drugs – October 14, 2020 – Johnson & Johnson (J&J) on Monday announced that it has paused dosing in all of its clinical trials on its experimental coronavirus vaccine to investigate an “unexplained illness in a study participant.” Separately, NIH on Tuesday announced that it has paused a clinical trial on Eli Lilly’s experimental coronavirus treatment due to potential safety issues. The announcements came as U.S. officials as of Wednesday morning reported a total of 7,894,900 cases of the novel coronavirus since the country’s epidemic began—up from 7,840,388 cases reported as of Tuesday. <Read More>

    Let’s Ban the Term ‘Pharmacy Technician’ – October 14, 2020 – I had the privilege a few years ago to be the program director for a Centers for Medicare & Medicaid Services demonstration project that sought to pay pharmacies for incorporating care management functions into pharmacy workflow in coordination with primary care across hundreds of pharmacies for a per-member, per-month payment. These days, such types of programs and arrangements with payers are commonplace with medical providers but are only now reaching the shores of community pharmacy practice… Pharmacies should ban the term and title pharmacy technician. Technicians put pills in bottles. A pharmacy’s staff requires much more. The term is also unbecoming and misrepresents their value to the pharmacy. At Community Care of North Carolina, we had pharmacy program assistants, formerly called techs, help take medication histories and coordinate communications between care team members for care management functions. Other pharmacies should pivot too. <Read More>

     Differences Between the Flu and COVID-19 – October 13, 2020 – The annual flu season is about to be in full swing. In the United States, flu season falls between October and March each year, with December, January and February seeing the highest number of flu cases. While the yearly onset of sore throats, runny noses and body aches related to the flu is to be expected to some extent, this year, the COVID-19 pandemic is thrown into the mix…Are your symptoms consistent with influenza? Or are they indicators you’ve been exposed to COVID-19? We’ll break down the differences between symptoms of the flu and COVID-19 as well as what other similarities and differences exist between the two viral diseases so you’re as prepared as possible heading into flu season. <Read More>

    A Tribute to the Unsung Heroes: Pharmacists – October 13, 2020 – Pharmacists are getting increased recognition as they continue to serve on the front lines of the COVID-19 epidemic. They are innovating quickly to offer accessible healthcare, counseling, and COVID-19 resources to their local communities. Local pharmacists see more patients on a daily basis than any other healthcare provider, and that’s particularly true in the wake of COVID-19. Pharmacies play a critical role in providing patients and customers with access to care, products and services they need.  TV screens and other point of care tactics installed within the pharmacy educate consumers and encourage them to speak with their pharmacist, a reliable source of counseling and information for general health and wellness concerns, as well as COVID-19. <Read More>

     Bridging the Gap Between Medical and Pharmacy Benefits – October 13, 2020 – Those of us who work in health care are well aware of the unsustainable trajectory of national health care spending. Health care expenditures in the United States grew 4.6% to $3.6 trillion in 2018, representing $11,172 per person. Spending for 2019-2028 is projected to grow at an average annual rate of 5.4%, reaching an estimated $6.2 trillion by 2028…While these figures provide a broad picture of what is happening in health care spending, it is important to drill down to the individual patient to understand what these rising costs mean to patient care. The underlying concern is that as the cost of care continues to escalate, barriers to quality care will increase accordingly, especially for patients with complex conditions. A major barrier obstructing access to care for many of these patients is the disconnect between medical benefits and pharmacy benefits. These 2 entities, which are critical to the health and welfare of the patient, operate independently with virtually no collaboration on behalf of the patient. Unless we start to think about medical and pharmacy benefits in a new way that puts patients’ needs first, population groups that are already underserved could have even more difficulty accessing care as costs increase. <Read More>

    340B in the News

    Hospitals Denied Full Court Review in Lawsuit Over 340B Cuts – October 19, 2020 – Hospitals suing HHS over a policy that will cut Medicare outpatient drug payments by nearly 30 percent at 340B hospitals failed to persuade a full appeals court to rehear the case, according to court documents published by Bloomberg Law.  The U.S. Court of Appeals for the District of Columbia Circuit denied the hospitals’ motion for en banc, or full court, review Oct. 16. A three-judge panel for the appeals court ruled in July that cuts to the payment rate for drugs purchased under the 340B program are legal. The judges said that the lower HHS drug reimbursement rate “rests on a reasonable interpretation of the Medicare statute.” The denied petition for a full court review means the three-judge panel’s decision is upheld. <Read More>

     340B Update: Ryan White Clinics Sue in Response to Contract Pharmacy Actions as Congress Requests Information on Ways to Improve the 340B Program – October 19, 2020 – Covered entities participating in the 340B Drug Pricing Program (340B Program) continue to grapple with drug manufacturers’ actions to limit contract pharmacy access to 340B pricing. Ryan White clinics recently sued the Department of Health and Human Services (HHS) and Health Resources and Services Administration (HRSA) in federal district court, asking the court to direct the Secretary of HHS to… <Read More> 

    Fierce Pharma Politics—Pushback Escalates After Drug Companies Restrict 340B Drug Discounts – October 19, 2020 – After AstraZeneca’s move to stop selling discounted drugs to safety net providers through contract pharmacies, patient advocates took the drugmaker to task. Outside AZ’s Delaware headquarters, protestors blasted the company’s recent decision to restrict the sale of discounted meds through contract pharmacies under the federally mandated 340B Drug Pricing Program. The program requires companies to discount medicines to hospitals and clinics that serve disadvantaged communities. But AstraZeneca isn’t alone in cracking down on drugs sold under the 340B program. Eli Lilly, Sanofi, Novartis and Merck & Co. have also implemented new restrictions or initiatives, according to reports. In August, seven hospital and pharmacy groups asked (PDF) U.S. Department of Health and Human Services (HHS) secretary Alex Azar to enforce the 340B rules following new moves from the companies. <Read More>

    Health-System Specialty Pharmacies Unite to Advocate for Common Interests – October 16, 2020 – Eight major health systems launched a new nonprofit coalition that will work to share best practices and advocate for their common interests. “We’ve seen there is a need for a platform that specifically addresses and is committed to the concerns of health systems’ specialty pharmacies,” said Tanya Menchi, the executive director of the new Health System Owned Specialty Pharmacy Alliance (HOSP). “That’s why they have come together.” Among members’ key concerns of HOSP are providing patient choice of specialty pharmacy providers and accessing limited distribution medications and payor networks, according to Menchi. The viability and continuance of the 340B program is “obviously another big concern,” she said. <Read More> 

    340B Entities Sue HHS Over Lack of Dispute Resolution Process – October 16, 2020 – Three organizations serving primarily HIV and AIDS patients and who each are also considered “Covered Entities” under the 340B Drug Pricing Program (the Plaintiffs) filed a lawsuit against Department of Health and Human Services (HHS) Secretary Alex Azar and the Administrator of the Health Resources and Services Administration (HRSA) Administrator Thomas Engels (the Defendants) on October 9, 2020, seeking to compel action by their respective agencies. <Read More> 

    PhRMA Slams Proposed Change to Medicaid Line-Extension Definition – October 15, 2020 – In comments recently submitted to the administration, trade group Pharmaceutical Research and Manufactures of America (PhRMA) raised concerns with a number of changes included in the Centers for Medicare & Medicaid Services (CMS) Medicaid proposed rule. Writing on the PhRMA website, Nicole Longo, director of public affairs focusing on Medicare, 340B, importation and more, says we’re diving deeper into CMS’s proposal to vastly expand the types of medicines that would fall under the definition of a “line extension” and how that change threatens future development of needed cures and treatments by establishing a tax on innovation. <Read More>

    Problems Continue with 340B Program – October 13, 2020 – Citizens Against Government Waste has been critical of the 340B drug discount program for several years and has called for it be reformed.  On Thursday, October 8, the Berkeley Research Group (BRG) released a report that demonstrates once again how 340B has been corrupted and is being abused due to unclear legislation, legally questionable guidance, and unwarranted expansion.  The opening statement in the report, “For-Profit Pharmacy Participation in the 340B Program,” could not be better said:   “What started as a well-intentioned effort to provide safety-net providers free or discounted drugs to treat uninsured and vulnerable patients appears to have evolved into a profit-centric corporate initiative that has fundamentally altered the 340B program.” <Read More>