Clinical Insights: September 28, 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

    Opzelura™ (ruxolitinib) Cream – New Drug Approval – September 21, 2021 – Incyte announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Opzelura™ is the first and only topical formulation of a JAK inhibitor approved in the United States. Research shows dysregulation of the JAK-STAT pathway contributes to key features of AD such as itch, inflammation and skin barrier dysfunction. <Read More>

    Tivdak™ (tisotumab vedotin-tftv) Lyophilized Powder for Injection – New Drug Approval – September 20, 2021 – The Food and Drug Administration granted accelerated approval to tisotumab vedotin-tftv (Tivdak™, Seagen Inc.), a tissue factor-directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Approval was based on innovaTV 204, an open-label, multicenter, single-arm clinical trial (NCT03438396). Efficacy was evaluated in 101 patients with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen. Sixty-nine percent of patients had received bevacizumab as part of prior systemic therapy. Patients received tisotumab vedotin-tftv 2 mg/kg every 3 weeks until disease progression or unacceptable toxicity. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Repatha® (evolocumab) Injection – New Approved Expanded Indication – September 24, 2021 – FDA has approved Repatha® (evolocumab) injection as an add-on treatment to diet alone or together with certain other therapies for patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH). Repatha® works to reduce low-density lipoprotein cholesterol (LDL-C), known colloquially as “bad cholesterol.” FDA previously approved Repatha® to reduce the risk of certain complications of cardiovascular disease in adults. The drug was also previously approved as an add-on therapy to reduce LDL-C cholesterol levels in adults with HeFH and patients with HoFH based on studies in adults and pediatric patients aged 13 and older. <Read More>

    Jakafi® (ruxolitinib) – New Approved Indication – September 22, 2021 – Incyte announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi® (ruxolitinib) for treatment of chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. “GVHD is the leading cause of morbidity and mortality in patients following an allogeneic stem cell transplant, yet there historically have been limited treatment options available beyond first-line systemic therapies,” stated Steven Stein, M.D., Chief Medical Officer, Incyte. “Incyte is proud to have contributed to the overall scientific understanding of GVHD through our REACH program, which has led to important treatment advances on behalf of patients and the medical community, including the approval of Jakafi® for certain people who develop chronic GVHD.” <Read More>

    Cabometyx® (cabozantinib) Tablets – New Approved Indication – September 17, 2021 – Exelixis, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Cabometyx® (cabozantinib) for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor (VEGFR)-targeted therapy and who are radioactive iodine-refractory or ineligible. The FDA granted Breakthrough Therapy designation and Priority Review to Cabometyx® and its approval comes more than two months ahead of the Prescription Drug User Fee Act (PDUFA) target action date of December 4, 2021. DTC is the most common type of thyroid cancer in the U.S., and patients who are resistant to radioactive iodine treatment face a poor prognosis.  <Read More>

     

    New/Updated Drug Shortage

    September 27, 2021

    September 24, 2021

    September 23, 2021

    September 22, 2021

    September 21, 2021

    September 20, 2021

    New Drug Recall and Safety Alerts

    Glucagon® Emergency Kit by Eli Lilly and Company – New Voluntary Recall – September 26, 2021 – Eli Lilly and Company is voluntarily recalling lot D239382D, Expiration April 2022, of Glucagon Emergency Kit for Low Blood Sugar (Glucagon® for Injection, 1 mg per vial; Diluent for Glucagon®, 1 mL syringe), to the consumer/user level. Lilly is recalling lot D239382D to the patient level because of a product complaint reporting that the vial of Glucagon® was in liquid form instead of the powder form. The firm’s investigation indicates that the liquid in this Glucagon® vial could be related to the manufacturing process. The use of the liquid form of this product may fail to treat severe low blood sugar due to loss of potency. <Read More>

    Cefazolin Injection Products by IntegraDose Compounding Services, LLC – New Voluntary Recall – September 20, 2021 – Minneapolis, Minnesota, IntegraDose Compounding Services is voluntarily recalling nine lots of cefazolin 2 gram in 20 mL syringe for injection and two lots of cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection due to a lack of sterility assurance resulting from compounding in a newly installed biologic safety cabinet without completing dynamic smoke study testing. <Read More>

    New Generic/Biosimilar Approval and Launch

    Byooviz™ (ranibizumab-nuna) Intravitreal Injection – New Biosimilar Approval – September 17, 2021 – The U.S. Food and Drug Administration approved Byooviz™ (ranibizumab-nuna) as the first biosimilar to Lucentis® (ranibizumab injection) for the treatment of several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD), a leading cause of vision loss and blindness for Americans aged 65 years and older. Byooviz™ is also approved to treat macular edema (fluid build-up) following retinal vein occlusion (blockage of veins in the retina) and myopic choroidal neovascularization, a vision-threatening complication of myopia (nearsightedness). <Read More>

    Clinical and Pharmacy News

    DEA Issues Public Safety Alert on Sharp Increase in Fake Prescription Pills Containing Fentanyl and Meth – September 27, 2021 – The Drug Enforcement Administration issued a Public Safety Alert warning Americans of the alarming increase in the lethality and availability of fake prescription pills containing fentanyl and methamphetamine. DEA’s Public Safety Alert, the first in six years, seeks to raise public awareness of a significant nationwide surge in counterfeit pills that are mass-produced by criminal drug networks in labs, deceptively marketed as legitimate prescription pills, and are killing unsuspecting Americans at an unprecedented rate. <Read More>

    Call the Shots on Travel Vaccines – September 27, 2021 – As COVID-19 pandemic-related restrictions loosen and international travel reopens, pharmacists are in an optimal position to provide patients with information about travel vaccines. Being vaccinated protects both travelers and the individuals with whom they come in contact during their time abroad and their return home. Many countries have a range of recommended, required, and routine vaccines for travelers. Yet results of a survey of 1254 individuals departing the United States for international destinations found that up to 80% of respondents did not have a health consultation before traveling. The most common reason for declining a pretravel evaluation was a “lack of concern about health problems related to the trip,” according to the survey results. <Read More>

    New Generics Are Less Available in Medicare Insurance Plans, Report Shows – September 27, 2021 – The results of a new report from the Association for Accessible Medicines showed that generic prescriptions are less available to patients with Medicare Part D plans than to those with commercial insurance plans. Generic medications are an important option to improve health care access and reduce medical costs for patients, especially older adults who often have chronic conditions or take multiple medications. Generics saved the national health care system $313 billion in 2019 alone and close to $2.2 trillion over the past decade, according to the report. In 2020, 72 first generics were approved, increasing market competition and helping lower costs for many patients, according to the report. <Read More>  

    Fourth Circuit Hears Customer Privacy Class Action Suit Against Walgreens – September 27, 2021 – The Fourth Circuit heard arguments on Wednesday over whether Walgreens violated customers’ privacy by sharing prescription information through a third-party vendor. “Residents of the State of South Carolina who patronize Walgreens’ pharmacies do so without explicitly or impliedly agreeing to sacrifice their well-established common law privacy rights “at the corner of happy and healthy,” began the underlying class-action lawsuit against the company in February 2019. A three-judge panel on Wednesday heard arguments from both sides. <Read More>

    FDA Takes Steps Aimed at Improving Quality, Safety and Efficacy of Sunscreens – September 24, 2021 – The U.S. Food and Drug Administration took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs. In the short term, these new authorities essentially preserve status quo marketing conditions for these sunscreens. However, the agency proposed revisions and updates to those requirements related to maximum sun protection factor (SPF) values, active ingredients, broad spectrum requirements, and product labeling, among other provisions. <Read More>  

    Increase in Black Pharmacists Comes Almost Entirely From Black Women, According to New Data – September 24, 2021 – Health care providers often hear that patients want to receive care from someone who looks like them. In the medical sphere, a growing body of research even supports the claim that this leads to better care, but the majority of physicians are not representative of certain minority groups. Researchers wanted to find out if other fields of health care, such as pharmacy and dentistry, had similar underrepresentation by race, ethnicity, and sex. They published their results in JAMA Network Open. While there were increases in Black and Hispanic women in these occupations according to the findings, and even larger increases among white and Asian women, the study found no improvement in the representation of Black and Hispanic men in pharmacy and dentistry. <Read More>

    The Challenges in Launching Alaska’s First Pharmacy School – September 24, 2021 – After years of discussion and planning, a partnership between the University of Alaska Anchorage and Idaho State University (ISU) was solidified and the first pharmacy school in Alaska was established in 2016. Prior to this partnership, Alaska was the only state in the country without a pharmacy school. Not only that, but the state also had long experienced a high turnover of pharmacists as well as an overall shortage of health care providers in general. Pharmacists from outside of Alaska often did not remain and pre-pharmacy students leaving the state for pharmacy education often did not return. <Read More>  

    FMI Helps Launch Coalition for PBM Reform – September 24, 2021 – FMI-The Food Industry Association has allied with five other industry organizations to form a watchdog group monitoring pharmacy benefit managers (PBMs). Called the Coalition for PBM Reform, the group aims to bring more transparency to what its members say are anticompetitive and “opaque” business practices by PBMs. The coalition — whose participants include doctors, pharmacy, retail, health care and small-business groups and patient advocates — cite “underwater” reimbursements, patient steering and other questionable PBM practices as restricting patient access and hiking costs. <Read More>  

    CDC Guidelines on STIs Update Some ‘Old Questions’ – September 24, 2021 – The recently-released and long-awaited guidelines on screening for sexually transmitted infections (STIs) from the Centers for Disease Control and Prevention (CDC) introduce some new ways of approaching some common questions you’re probably used to asking your patients. Michael S. Policar, MD, MPH, who is professor emeritus, obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, School of Medicine, addressed attendees of the North American Menopause Society (NAMS) meeting being held this week in Washington, DC, and said that some of the old questions about sexual partners, such as, “do you have sex with men, women or both,” have now been replaced with “are you currently have sex of any kind, oral, vaginal, or anal, with anyone?”1 Also, asking patients if they are having sex with another person, and if so, what kinds of sexual contact do they have, and how they met their partners are important questions to discuss. <Read More>

    Innovative Technology Helps Manage Chronic Conditions – September 24, 2021 – Digital health tools improve patient outcomes while expanding career opportunities for pharmacists. The COVID-19 pandemic has put a strain on the health care system globally, particularly affecting patients with chronic conditions. Many patients with disease states such as chronic obstructive pulmonary disease, diabetes, and hypertension are at high risk of contracting severe COVID-19, so it is especially important for this population to have access to medication therapy management (MTM) services to improve health outcomes. Evidence shows that implementing innovative pharmacist-led MTM services using technology tools such as telehealth during COVID-19 can help patients effectively manage chronic conditions. Aspen RxHealth and Tabula Rasa HealthCare (TRHC) are both innovative platforms for delivering MTM services. <Read More>

    Studies Show More COVID-19 Cases in Areas Without School Masking Policies – September 24, 2021 – The CDC released three studies in the Morbidity and Mortality Weekly Report (MMWR) that highlight the importance of using layered prevention strategies including universal masking to stop the spread and minimize disruptions to school operations for safe in-person education. These studies found that school districts without a universal masking policy in place were more likely to have COVID-19 outbreaks. Nationwide, counties without masking requirements saw the number of pediatric COVID-19 cases increase nearly twice as quickly during this same period. <Read More>

    Walgreens Boots Alliance Makes Majority Investment in Shields Health Solutions – September 23, 2021 – Walgreens Boots Alliance Inc. (WBA) and Shields Health Solutions announced that WBA, through its wholly owned subsidiary, Walgreen Co., is making a majority investment in Shields. WBA’s investment signifies another step the company is taking to accelerate innovative health care models for future growth, providing a platform to further develop health-system partnerships and coordinate care for those with complex chronic conditions. The approximately $970 million investment will support the continued growth of Shields’ health-system–based specialty pharmacy strategy, and builds on a minority equity investment that WBA announced in July 2019. The new investment gives WBA approximately 71% ownership of Shields, with an option to acquire the remaining equity interests in the future. Shields’ other equity holders also will have the option to require WBA to purchase the remaining equity interests, under the agreement. <Read More>

    Man Punches Nurse in the Face Multiple Times After His Wife is Vaccinated for COVID-19 – September 23, 2021 – Police are looking for a man in Canada they say punched a nurse in the face multiple times, knocking her to the ground after she administered a COVID-19 vaccine to his wife without his permission. On Monday, around 9:15 a.m., a man walked into a pharmacy in Sherbrooke, a city in southern Quebec, and accused a nurse in her 40s, who police have not named, of vaccinating his wife, Sherbrooke police spokesman Martin Carrier told CNN. “Right at the beginning, the suspect was very angry, very aggressive, he asked the nurse why she vaccinated his wife without approval, without his consent,” Carrier said. “And he punched her right in the face multiple times so the nurse didn’t have the time to defend or explain herself … and she fell to the ground and the suspect left running out of the drugstore.” <Read More>

    FDA Must Revisit Major Drug Compounding Policy, Judge Rules – September 22, 2021 – A federal judge dealt the U.S. Food and Drug Administration’s oversight of compounding pharmacies a blow by finding a memorandum of understanding with states governing how the companies’ drugs are sold interstate was improperly developed. U.S. District Judge Christopher Cooper in Washington, D.C., on Tuesday ruled that the FDA in developing the policy failed to consider the economic impact on small pharmacies that prepare compounded drugs for individual patients that are not approved by the FDA. <Read More>  

    Central Fill Pharmacy Market: Pressure on Pharmacies to Reduce Medication Errors Propels the Global Market – September 22, 2021 – Central fill pharmacies have gained attention in the past couple of years, as these are the source of specialty drugs. This is one of the key factors driving the global central fill pharmacy market. Moreover, increase in the geriatric population and pressure on pharmacies to reduce medication errors propels the global central fill pharmacy market. Increase in shift toward automation, which helps reduce labor cost, augments the global market. Rise in focus on minimizing human intervention in packaging, counting, and filling pharmaceuticals boosts the growth of the global central fill pharmacy market. Moreover, the ability to get real-time inventory data and possibility to track the usage and optimizing the inventory are a few other benefits of adopting a central fill pharmacy model. <Read More>

    Methamphetamine-Involved Overdose Deaths Nearly Tripled Between 2015 to 2019, NIH Study Finds – September 22, 2021 – Overdose deaths involving methamphetamine nearly tripled from 2015 to 2019 among people ages 18-64 in the United States, according to a study by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health. The number of people who reported using methamphetamine during this time did not increase as steeply, but the analysis found that populations with methamphetamine use disorder have become more diverse. Published in JAMA Psychiatry, the study suggests that increases in higher-risk patterns of methamphetamine use, such as increases in methamphetamine use disorder, frequent use, and use of other drugs at the same time, may be contributing to the rise in overdose deaths. <Read More>  

    Help Patients Combat Dry Eye – September 22, 2021 – With new FDA-approved treatments available for dry eye and other therapeutic agents being developed, health care experts continue to emphasize that this condition should not be taken lightly by patients or overlooked by health care professionals. During a Pharmacy Times webcast, experts discussed several topics related to dry eye, including OTC and prescription treatment options and how to advise patients on proper use…Nijm started the conversation by explaining that dry eye disease is an imbalance in homeostasis, or a disruption in homeostasis of the tear film, that usually occurs because of inflammation. The condition causes an inflammatory waterfall that results in the symptoms that patients often experience. <Read More>  

    Pandemic Sends Moms into Crisis Mode – September 22, 2021 – COVID-19 may change how stress for women in the pharmacy profession is viewed. It is hard enough to be a mom and a pharmacist outside of a pandemic. Crazy schedules, including late nights and holiday and weekend work, have always been an issue. But now women in pharmacy can factor in increased anxiety about sending kids back to the classroom, vaccination responsibilities, virtual learning, and working with at-risk populations, which is sending many into crisis mode. What can we do to help each other during this pandemic, and can it be a turning point regarding how our profession and maybe even society value motherhood? <Read More>

    Senate Dems Try to Mend Fences Over Drug Price Reform Divide as Moderates Seek Slimmed-Down Proposal – September 22, 2021 – Top Senate Democrats are seeking to assuage concerns from moderates over the extent of their drug price reforms, as senators want more input from pharma over how far to go with giving Medicare the power to negotiate lower drug prices. Moderate Democrats have expressed major concerns with the party’s effort to give Medicare sweeping authority to negotiate for lower drug prices and force manufacturers to apply those prices to commercial plans. Talks over drug price reforms have heated up as Congress moves toward voting this fall on a $3.5 trillion infrastructure package expected to include such legislation. <Read More>  

    Opioid Spending in Comp Continues to Decline – September 22, 2021 – Workers compensation pharmacy costs continued to decline during the COVID-19 pandemic due to a steady reduction in opioid use, according to data released Wednesday by CompPharma LLC…Workers comp opioid spending has gone down over 62% since 2016, according to data collected through CompPharma’s surveys, which also found that total workers comp pharmacy costs have decreased by 38% over the past decade. <Read More>

    Sepsis Week: Pharmacists’ Have a Critical Impact on the Treatment of Sepsis – September 22, 2021 – Several studies have shown that a pharmacist’s presence on a sepsis team has a statistically significant impact on patient outcomes, with pharmacists taking on several roles during patient management. Sepsis is a life-threatening infection that can quickly lead to tissue damage, organ failure, and even death. An estimated 18 to 31 million cases occur globally every year with 850,000 occurring in the United States. With the mortality rate of sepsis at up to 30%, it is the leading cause of death for patients in the ICU. Sepsis can arise from any source of infection, with 2 of the most common sources being pneumonia and urinary tract infection. The rapid progression of sepsis makes it imperative to diagnose and start goal-oriented treatments as soon as possible. It has been shown that patient survival rate decreases by 7.6% for every hour that antimicrobial therapy is delayed. <Read More>

    FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations – September 22, 2021 – The U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in: 1) individuals 65 years of age and older; 2) individuals 18 through 64 years of age at high risk of severe COVID-19; and  3) individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19. <Read More>  

    Build a Successful Hospital Pharmacy Analytics Program – September 21, 2021 – A robust hospital pharmacy analytics program can improve drug utilization and advance patient care delivery. In a webinar by Becton Dickinson held on June 16, 2021, pharmacy leaders discussed the critical elements of high-performing pharmacy analytics programs and how hospital pharmacy departments can grow them to drive operational, clinical, and financial decisions.  Joe Lassiter, PharmD, MS, president of The Robertson Group, LLC, based in Portland, Oregon, kicked off the presentation by underscoring the need for pharmacy analytics. “In 2019, [the American Society of Health-System Pharmacists] launched the Practice Advancement Initiative, or PAI, 2030 as a continuation of [its] Practice Model Initiative to guide and ensure that practitioners and leaders [‘meet the demands of future practice and patient care delivery models’],” Lassiter explained. <Read More>

    Specialty Pharmacists Improve HIV Prophylaxis in the ED – September 21, 2021 – Integrated health-system specialty pharmacy services in the emergency department (ED) can enhance care for HIV post-exposure prophylaxis (PEP) patients, according to a study presented at the virtual ASHP 2021 Specialty Pharmacy Conference. The initiative used electronic health record (EHR) alerts to prompt the specialty pharmacy interventions. It resulted in better access to PEP therapy, more consistent post-discharge follow-up care and several financial gains, including a boost in revenue from retained PEP prescriptions, reported Daniel Jude, PharmD, a clinical pharmacy specialist at North Memorial Health, in Robbinsdale, Minn., and lead author of the study. <Read More>  

    Florida Authorizes Use of Automated Dispensing Systems – September 21, 2021 – New legislation allows community pharmacies to improve medication access in an outpatient setting. For years, the state of Florida has authorized the use of automated pharmacy dispensing systems to provide medication to patients residing in hospice settings, long-term care facilities, and prisons. To improve medication access in other outpatient settings, Governor Ron DeSantis recently signed legislation into law that gives community pharmacies authorization to use these systems. Automated dispensing has the potential to alleviate the access-related issues of a high prescription-volume location, as well as in rural areas that may not have community pharmacies nearby. <Read More>  

    Increasing Patient Adherence to Oral Chemotherapy – September 21, 2021 – With more than 115 oral agents approved by the FDA to manage different types of cancer, oral oncolytics “have solidified their place in cancer treatment,” a pharmacist said at the virtual 2021 ASHP Specialty Pharmacy Conference. However, patients must remain adherent to these therapies to maximize their effectiveness, and that’s where a collaborative effort between clinical and specialty pharmacists can have a significant impact. There are many barriers to adherence, such as low health literacy, complex administration instructions, challenging adverse effects and high out-of-pocket costs, said Eve Segal, PharmD, BCOP, the lead clinical pharmacist at the University of Washington Medical Center/Seattle Cancer Care Alliance, during a clinical gems session. <Read More>

    CVS Pharmacy Sues PBM Startup Capital Rx, Calls Noncompete Clause ‘Unenforceable’ – September 21, 2021 – CVS Pharmacy has filed suit against startup pharmacy benefit manager Capital Rx, claiming the PBM’s noncompete clause is preventing an employee from coming to work for the pharmacy giant. Suresh Yarlagadda, M.D., joined Capital Rx in May 2021 and was unaware of the noncompete clause as it was “buried in a document” he signed upon joining the company, according to the lawsuit. According to the clause, Yarlagadda was barred from joining a company “that provides technology or services related to pharmacy benefits or pharmacy data services, excluding an operating business delivering medical insurance or medical health plans.” <Read More>

    Health Systems Still Fighting for Specialty Access – September 21, 2021 – Health systems continue to make significant inroads into the specialty pharmacy market, with more than two-thirds of multihospital systems launching programs in a recent five-year period. But despite those gains, the sector still faces major roadblocks, including a lack of access to limited distribution drugs (LDDs) and payor contracts, according to ASHP’s inaugural National Survey of Health-System Specialty Pharmacy Practice. <Read More>   

    Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S. – September 21, 2021 – Johnson & Johnson announced new data reinforcing the strong and long-lasting protection of its COVID-19 vaccine. New data also showed that protection against COVID-19 increases when a booster shot of the Johnson & Johnson vaccine is administered. The safety profile of the vaccine remained consistent and was generally well-tolerated when administered as a booster…Additional data show a booster increases protection 94 percent protection in the U.S. with booster given at two months Four-fold increase in antibodies when given at two months 12-fold increase in antibodies when booster given at six months. <Read More>  

    Multiple Sclerosis Treatment Guidelines – September 20, 2021 – Multiple sclerosis (MS) is a chronic autoimmune disease. It causes the immune system to react abnormally, attacking the central nervous system, which is made up of the brain, spinal cord, and optic nerve. There are a number of treatment options that can help reduce symptoms of MS, including medications and stem cell therapy. Different people may experience a variety of different symptoms of MS. They may also experience symptoms that vary in severity. Some people may have mild symptoms that are easily manageable, while others may have severe symptoms that can cause serious problems. <Read More>  

    Federal Mandates for COVID-19 Mean Enhanced Inventory, Scheduling: What Pharmacists Need to Know – September 20, 2021 – Pharmacists will need to make sure they have the necessary personal protective equipment in place to meet increased clinic activity and while keeping an eye on levels of flu vaccines and tests. President Biden’s announcement of the most comprehensive, mandated COVID-19 vaccine and testing program to date has the health care community taking notice and starting to plan. For pharmacists, these directives offer both challenges and opportunities for their practices…The pathway to success lies in having robust inventory, scheduling, reporting, and community communications systems in place. <Read More>  

    As COVID-19 Continues to Surge, Turn to 503Bs for Help – September 20, 2021 – Integrating these facilities into the pharmacy supply chain strategy has become key for hospitals during the pandemic. In the era of COVID-19, health system pharmacy leaders are struggling to keep up with the scores of demands on their resources and time. With coronavirus-related emergency department visits and hospitals admissions reminiscent of 2020, especially across the South and Southwest, pharmacy leaders are looking for effective and, in some cases, alternative solutions to help them just make it through a busy week. 503B outsourcing facilities are proving to be crucial partners to health-system and hospital pharmacies in helping to mitigate drug shortages and the impact on patients during the COVID-19 Delta variant surge this summer. <Read More>

    HHS Report Reiterates Biden Administration Support for Wide-Ranging Action to Address Drug Prices – September 20, 2021 – On September 9, 2021, the Department of Health and Human Services (“HHS”) released its widely anticipated “Comprehensive Plan for Addressing High Drug Prices.”  The HHS report supports far-reaching legislative and administrative actions. These include changes that would allow the government to negotiate drug prices, limit price increases to the rate of inflation, prohibit “pay-for-delay” agreements, expedite generic and biosimilar drug approvals, restructure cost sharing and reimbursements in Medicare, and tether Medicare payments to patient outcomes. HHS’s proposed initiatives would have substantial impacts not only on drug prices, but also on innovation and antitrust policy relevant to the pharmaceutical industry. <Read More>    

    Early Treatment With ACE Inhibitors Improves Cardiac Outcomes of Patients With Becker Muscular Dystrophy – September 20, 2021 – There is no consensus on when to introduce cardioprotective treatment in patients with Becker muscular dystrophy (BMD), and practice varies widely. A new study published in the Journal of Neuromuscular Diseases concludes that starting treatment with an ACE inhibitor as soon as cardiac function drops below the lower limit of the normal range reduces the risk of patients developing severe cardiomyopathy and heart failure, which are common outcomes in BMD. <Read More>   

    Pfizer and Biontech Announce Positive Topline Results From Pivotal Trial of Covid-19 Vaccine in Children 5 to 11 Years – September 20, 2021 – Pfizer Inc. and BioNTech SE announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older. The antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 µg doses. The 10 µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age. These are the first results from a pivotal trial of a COVID-19 vaccine in this age group. <Read More>    

    340B in the News

    HRSA Refers Six Drug Manufacturers to OIG for Possible 340B-Related Civil Penalties – September 24, 2021 – On Sept. 22, 2021, the U.S. Health Resources and Services Administration (HRSA) publicly referred six matters involving drug manufacturers to the United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) for possible imposition of civil monetary penalties (CMPs).   HRSA’s referrals stem from the above-referenced manufacturers’ unilateral restriction of 340B drug sales to 340B program-eligible health care providers (Covered Entities) that, among other activities, utilize more than one contract pharmacy partner. HRSA’s referrals to OIG are unprecedented in the 340B Program space and are indicative of a concerted effort by HHS, HRSA and OIG to meaningfully address 340B compliance matters, including ongoing manufacturer sales restrictions in the 340B Program space. However, more importantly, HRSA’s action clearly highlights the need for 340B Program stakeholders to monitor the ever-changing 340B legal landscape. <Read More>  

    Six Drug Companies Could Face Steep Fines for Violating 340B Law – September 24, 2021 – Six major drug companies are facing potential fines for continually violating federal law requiring they provide 340B drug pricing program discounts on eligible drugs at community pharmacies. The Health Resources and Services Administration on Wednesday sent notices to Eli Lilly, AstraZeneca, Novartis, Novo Nordisk, Sanofi and United Therapeutics noting them their cases had been referred to HHS’ Office of Inspector General due to the companies’ ongoing refusals to offer 340B pricing to safety-net providers through community pharmacy partnerships. That refusal is a direct violation of the 340B statute, HRSA said. <Read More>

    Hospitals to CMS: Keep the Inpatient-Only List, Don’t Increase Price Transparency Noncompliance Fee – September 21, 2021 – The American Hospital Association on Sept. 17 submitted its comments on CMS’ Outpatient Prospective Payment System proposed rule for 2022, strongly opposing stiffer penalties for price transparency noncompliance and supporting the agency’s decision to keep the inpatient-only list. CMS unveiled the proposed rule July 19. Below are six key takeaways from the American Hospital Association’s comments: 1) The AHA urged CMS not to finalize the proposed penalty increases for price transparency noncompliance. It asked the agency to “instead focus on aligning the various federal price transparency policies to better serve patients and reduce duplication of effort”…5) The AHA opposed the CMS’ OPPS payment cuts to 340B hospitals, saying “these cuts directly harm 340B hospitals and their ability to care for their patients, contravening Congress’ intent in establishing the 340B program. <Read More>  

    ASHP Among Stakeholders Blasting Actions Against 340B – September 21, 2021 – Merck has fired another salvo in the war over the federal 340B Drug Pricing Program. Last month, the company announced that it was giving 340B-covered entities a deadline of Sept. 1 to provide 340B claims data for all claims originating from contract pharmacies. The manufacturer’s move came despite warnings that requiring such data is prohibited: The Health Resources and Services Administration (HRSA) has said efforts by manufacturers to constrain 340B contract pharmacies violate the 340B statute. <Read More>

    Hospital Groups Push Back Against Stiffer Penalties for Failing to Publish Prices – September 20, 2021 – Hospital industry groups are pushing back against a proposal to jack up fines for health systems that don’t publish their prices, arguing that facilities are putting all their resources behind combating the COVID-19 pandemic. The groups wrote in comments to the 2022 Hospital Outpatient Prospective Payment System (OPPS) rule strongly opposing a proposal to apply fines for noncompliance with a price transparency requirement on a per-bed basis. The current rule fines hospitals $300 a day… Hospital groups also made renewed pleas to CMS to halt continued cuts to the 340B drug discount program and to off-campus hospital clinics to bring Medicare payments in line with physician offices. CMS is proposing to maintain a 22.5% cut to payments for certain drugs discounted under the 340B program, which requires drug companies to offer discounts to safety net providers in exchange for participation in Medicare and Medicaid. The cuts were first proposed by the Trump administration back in 2018, and CMS will continue to exempt rural sole community hospitals, children’s hospitals and certain cancer hospitals. <Read More>