Clinical Insights: November 23, 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

    Voxzogo™ (vosoritide) Injection – New Drug Approval – November 19, 2021 – The U.S. Food and Drug Administration approved Voxzogo™ (vosoritide) injection to improve growth in children five years of age and older with achondroplasia and open epiphyses (growth plates), meaning these children still have the potential to grow. Achondroplasia is the most common form of dwarfism. “The approval fulfills an unmet medical need for more than 10,000 children in the United States and underscores the FDA’s commitment to help make new therapies available for rare diseases,” said Theresa Kehoe, M.D., director of the Division of General Endocrinology in the FDA’s Center for Drug Evaluation and Research. “With this action, children with short stature due to achondroplasia have a treatment option that targets the underlying cause of their short stature.” <Read More>

    New Indication/Dosage/Formulation Approval

    No new update.

    New/Updated Drug Shortage

    November 18, 2021

    November 17, 2021

    November 16, 2021

    November 15, 2021

    New Drug Recall and Safety Alerts

    Certain Sterile Products by SterRx, LLC – New Voluntary Recall – November 15, 2021 – SterRx, LLC announced the voluntary nationwide recall of approximately 240 lots within their expiry period due to equipment and process issues that could lead to a lack of sterility assurance for products intended to be sterile. To date, SterRx, LLC has not received reports of any product complaints or adverse events associated with this issue. SterRx, LLC has initiated this voluntary recall to the hospital pharmacy level out of an abundance of caution. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    NICE Draft Guidelines Recommend Dapagliflozin for Chronic Kidney Disease – November 22, 2021 – Dapagliflozin is to be recommended for treating patients with chronic kidney disease (CKD) under draft NICE guidance currently out for consultation. It has been estimated that around 91,000 people in England will be eligible for treatment under the plans. In the draft guidance published this month, NICE recommends consideration of the SGLT2 inhibitors as an add-on to standard care with ACE inhibitors or angiotensin receptor blockers (unless these are not tolerated) in people with: 1) an estimated glomerular filtration rate (eGFR) of 25 ml/min/1.73 m2 to 75 ml/min/1.73 m2 and a urine albumin-to-creatinine ratio (uACR) of 22.6 mg/mmol or more or 2) a uACR of 3 mg/mmol or more and type 2 diabetes. <Read More>

    Neurologists’ Group Issues New Treatment Guidelines for Early Parkinson’s – November 19, 2021 – Guidelines for treating movement problems in people in the early stages of Parkinson’s disease have been updated. The new treatment recommendations from the American Academy of Neurology (AAN) focus on dopaminergic medications, which increase dopamine levels or mimic dopamine effects. Parkinson’s is a movement disorder that occurs when nerve cells in the brain fail to produce enough dopamine. The new guideline updates treatment recommendations published in 2002. <Read More>

    Humana Adds Albertsons Pharmacies to Medicare Part D Network – November 19, 2021 – A Nov. 18 agreement between Humana and Albertsons Cos. adds Safeway, Jewel-Osco and Albertsons pharmacies among others to the payer’s preferred cost-sharing network. The move gives Medicare Part D members access to over 11,000 total locations through Humana’s network. Albertsons Cos. locations will join the network  Jan. 1. <Read More>

    CDC Expands Eligibility for COVID-19 Booster Shots to All Adults – November 19, 2021 – CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) expanded recommendations for booster shots to include all adults ages 18 years and older who received a Pfizer-BioNTech or Moderna vaccine at least six months after their second dose. The Food and Drug Administration’s (FDA) authorization and CDC’s recommendation for use are critical next steps forward in our country’s booster program – a program which will help provide increased protection against COVID-19 disease and death. <Read More>

    Neurologists’ Group Issues Guidance to Families on Controversial Alzheimer’s Drug – November 18, 2021 – Neurologists must make sure Alzheimer’s patients and their families understand that the controversial drug aducanumab does not restore mental function, the American Academy of Neurology (AAN) said in new position statement that includes ethical guidelines. “Aducanumab is not a cure for Alzheimer’s disease, yet since it has been approved by the [U.S. Food and Drug Administration], patients are asking their doctors if this is an option for them,” said statement author Dr. Winston Chiong, an associate professor at the University of California San Francisco and member of the AAN’s Ethics, Law and Humanities Committee. <Read More>

    New Literature Review Highlights Economic Benefits Associated with Achieving Rheumatoid Arthritis Remission – November 18, 2021 – A new literature review published in Advances in Therapy reported that for patients with rheumatoid arthritis (RA), achieving remission was associated with medical cost savings compared with other disease activity levels Clinical guidelines widely recommend the treat-to-target strategy, which uses clinical remission as the primary therapeutic goal for RA. <Read More>

    AAN: New Guidelines for Motor Symptoms in Early PD Favor Levodopa – November 18, 2021 – In some cases, dopamine agonists or MAO-B inhibitors may be warranted. New guidelines for treating motor symptoms in early Parkinson’s disease (PD) were issued by the American Academy of Neurology (AAN), with a focus on tremor, rigidity, and bradykinesia. The report, published in Neurology, provides recommendations on initial therapy for motor symptoms in early PD “to assist the clinician and patient in choosing between treatment options and to guide counseling, prescribing, and monitoring of efficacy and safety,” wrote guideline lead author Tamara Pringsheim, MD, of the University of Calgary in Alberta, Canada, and co-authors. <Read More>

    US Pharmacy Chain CVS to Close About 10% of Stores – November 18, 2021 – US pharmacy and cosmetics chain CVS announced it will close 900 stores over the next three years, amounting to nearly 10 percent of its locations. The chain will begin shuttering stores in the spring of 2022 and continue at a rate of about 300 closures each year, as it shifts its focus to locations aimed at primary care, prescription drugs and health and wellness services, the company said in a statement. “Our retail stores are fundamental to our strategy and who we are as a company,” the company’s CEO Karen Lynch said. <Read More>

    Pregnant Cannabis Users Turn to ‘Budtenders’ for Advice – November 18, 2021 – Pregnant women are using marijuana more often and are turning to their dispensaries for medical advice instead of healthcare professionals. A new study looked at healthcare workers and legal cannabis dealers’ perceptions of the risks and benefits of cannabis use during pregnancy, published Nov. 15. Daily or near-daily use of marijuana has increased among pregnant women to 3.4 percent in 2017, and past month usage has nearly doubled, to 7 percent, since 2002. Current national guidelines advise women who are pregnant not to use cannabis. It has been linked to a range of birth defects including lower birth weight, still birth and neurodevelopmental issues. <Read More>

    How Pharmacy Graduates Can Prepare for Roles on Primary Care Teams – November 18, 2021 – It is estimated that there will be a shortage of 17,800 to 48,000 primary care physicians in the United States by 2034, according to the Association of American Medical Colleges (AAMC). AAMC states that addressing the shortage will require a multipronged approach, including innovative care delivery, use of technology, and improved use of all health professionals on the care team. In addition to midlevel practitioners, such as physician assistants and advanced registered nurse practitioners, pharmacists are health professionals that can be utilized to close the gaps in care within primary care settings. <Read More>

    Systemic Bias May Prevent Individuals Who Inject Drugs From Receiving PrEP – November 17, 2021 – Systematic biases about individuals who inject drugs—which may impact access to pre-exposure prophylaxis (PrEP)—exist among primary and HIV care providers, according to a study published in AIDS and Behavior. Receipt of PrEP education or prescription relies heavily on a provider’s discretion, which can be subject to social biases, according to the study. The investigators surveyed 370 primary and HIV care providers to ascertain whether a patient’s race, sexual orientation, or injection drug use affected clinical judgment. According to the survey results, clinicians considered those who inject drugs to be less responsible, less safety-conscious, and less likely to be adherent to PrEP. Biases relating to sexual orientation were limited and there was no evidence of bias based on race. <Read More>

    Tip of the Week: Managers Have the Power, Responsibility to Mitigate Workers’ Emotional Exhaustion – November 17, 2021 – Burnout is receiving greater attention in the pharmacy field and throughout the health care community. Practitioner burnout can impact not only their own wellbeing but also has ramifications for patient care. A recent management tip discussed the use of a professional sabbatical to provide pharmacists with time to rest and recharge. However, sabbatical leave may not be an option for many managers, and more conventional and typically accessible methods are needed. Those experiencing burnout are dealing with a more complex issue than simply being overworked. Burnout actually consists of 3 components: emotional exhaustion, depersonalization, and a low sense of personal accomplishment. It is important for managers to assess their working conditions and the culture of the workplace to determine which types of burnout staff may be experiencing. <Read More>

    Infectious Disease Society of America Issues Guidelines for PPE use – November 17, 2021 – The Infectious Disease Society of America issued eight guidelines for healthcare workers using PPE when working with COVID-19 patients. The guidelines, published Nov. 17 in Clinical Infectious Diseases, are evidence-based recommendations from a multidisciplinary panel on PPE usage in conventional, contingency and crisis settings. Recommendations are labeled as “strong” or “conditional,” as indicated by the usage of “recommend” and “suggest” respectively. The panel acknowledged knowledge gaps in instances of insufficient evidence and made no recommendation. <Read More>

    Americas Report Surge in Drug-Resistant Infections Due to Misuse of Antimicrobials During Pandemic – November 17, 2021 – Countries in the Americas are reporting surges in drug-resistant infections that are likely due to the unprecedented misuse of antimicrobial drugs in the treatment of COVID-19, warned the Pan American Health Organization (PAHO) Director, Dr. Carissa F. Etienne, during a media briefing. “Throughout this pandemic, we have taken the power of antimicrobials for granted,” the Director said on the eve of World Antimicrobial Awareness Week. “And while it may be months or even years until we see the full impact of their misuse and overuse, we cannot afford to wait to take action.” Data shows that more than 90% of hospitalized COVID patients in the Americas were given an antimicrobial, while only 7% required these drugs to treat a secondary infection. <Read More>

    Addressing COVID-19 Vaccination Hesitation as a Pharmacist – November 17, 2021 – Pharmacists have not always been at the forefront of immunization administration, but our history of involvement may go back further than one realizes. Two centuries ago, the world was battling a different faceless foe of viral origin: smallpox. During this time of turmoil lies the beginning of pharmacists taking on the additional responsibility of vaccination. Since that time, we have come a long way in the frequency and scope of our immunization involvement. Community pharmacists have been routinely administering various vaccines since 1994 when formalized training became available. What this amounts to is that we were ready to take on our role in immunizing when the COVID-19 vaccines became available; however, our biggest benefit with the vaccine may not be the administration, but rather the counseling we can offer patients. <Read More>

    Long Story Short: Cellulitis can be Treated in Less Than a Week – November 16, 2021 – Duration of therapy may be just 5 to 6 days for patients without risk factors for complications. Cellulitis develops because of pathogen entry through breaks in the skin barrier and can range from mild to severe, depending on the extent of skin layer involvement. The condition is most common in older patients with fragile skin or patients with impaired local host defenses, such as diabetes, obesity, or venous insufficiency or lymphedema.1 In the United States, cellulitis diagnosis leads to 2.3 million emergency department visits and accounts for 10% of infectious diseases–related hospitalizations annually. <Read More>

    Is ADHD Overdiagnosed and Overtreated? – November 16, 2021 – A large 2021 study reports evidence of ADHD overdiagnosis, with the authors noting that people with other conditions may sometimes receive an ADHD diagnosis instead. Other data suggest that children who are among the youngest in their class may be more likely to receive an ADHD diagnosis. Their relative immaturity and resulting behavioral problems may seem like symptoms of ADHD when they are, in fact, due to age. A person’s views about ADHD overdiagnosis may depend on personal experience and bias. There is a large movement among people who oppose psychiatry to discredit the notion of ADHD. Conversely, ADHD advocates may lobby for earlier and more frequent diagnoses. <Read More>

    Cardinal Health to Deliver Drugs to Pharmacies via Drone – November 16, 2021 – Cardinal Health will test the use of drones to expedite its delivery of medications and inhalers to pharmacies, The Wall Street Journal reported. 1) The pharmaceutical distributor partnered with medical product delivery company Zipline International, which will operate the drones. 2) The pilot program will begin in 2022 outside Charlotte, N.C., pending approval from the Federal Aviation Administration. 3) The drones, which look like miniature planes, will be about 6 feet from head to tail and will have 11-foot wingspans, according to the Journal. They will fly 300 to 400 feet above ground and use parachutes to drop shipments into landing areas the width of about two parking spaces. <Read More>

    Health Systems Prove Value in Specialty Care – November 16, 2021 – Compared with other types of specialty pharmacies, those based in health systems have superior access to patients and providers, as well as information in medical records, speakers said during a session at the virtual 2021 ASHP Specialty Pharmacy Conference. These factors can be leveraged to demonstrate value to various stakeholders. “Metrics commonly used to measure specialty pharmacy services today focus mostly on operational requirements,” said Amber Skrtic, PharmD, CSP, AAHIVP, a clinical pharmacist with Trellis Rx at Parkview Health, in Fort Wayne, Ind. “While we perform better on these metrics, they don’t show the full impact of our integrated services. <Read More>

    New Research Finds Disturbing Lack Of Crucial Blood Cancer Medication – November 16, 2021 – New research in the November 2021 issue of JNCCN-;Journal of the National Comprehensive Cancer Network finds fewer than one-third of hospitals had immediate availability of a crucial blood cancer medication called all-trans retinoic acid (ATRA). ATRA is initiated early in the treatment of acute promyelocytic leukemia (APL)-;a form of acute myeloid leukemia (AML), to prevent major bleeding, clotting, and potential death. APL is very treatable and tends to have a better prognosis than other subtypes of AML when treated appropriately. <Read More>

    Pharmacy Benefit Managers are Getting in the way of Affordable Medications – November 16, 2021 – Nevadans who need affordable prescription medications that they can pick up at their neighborhood pharmacy are running up against powerful forces that are elevating drug costs and making it difficult for independent drugstores to even keep their doors open. The harmful actions of pharmacy benefit managers (PBMs), corporate middlemen who have great control over the medicine supply chain, require action from our state and federal elected officials. As a witness to and victim of this anti-consumer environment, let me explain. When I chose to become a pharmacist, I did so because I loved having the ability to make people feel better and help with their health challenges. I looked forward to having my own local pharmacy where I could build relationships with my Nevada community — and help ensure my patients had information about and access to the care that would improve their health and lives. When I finally opened my own pharmacy, it was everything I had imagined. Until it wasn’t. <Read More>

    Pharmacy Chains Defend Actions as Landmark U.S. Opioid Trial Nears its End – November 16, 2021 –  Lawyers for pharmacy chains including CVS and Walgreens argued they were not to blame for the U.S. opioid epidemic, as jurors prepared to consider whether to hold them responsible for the devastation the drug crisis caused in two Ohio counties. Mark Lanier, a lawyer for Lake and Trumbull counties, told a federal jury in Cleveland that a verdict in the case against CVS Health Corp (CVS.N), Walgreens Boots Alliance Inc (WBA.O) and Walmart Inc (WMT.N) would have ramifications across the country. <Read More>

    Long-Term Study of Children With COVID-19 Begins – November 15, 2021 – A large, long-term study of the impacts of COVID-19 on children has enrolled its first participant at the National Institutes of Health’s Clinical Center in Bethesda, Maryland. The study, which is supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will track up to 1,000 children and young adults who previously tested positive for COVID-19 and evaluate the impact of COVID-19 on their physical and mental health over three years. The study is expected to yield a detailed picture of COVID-19’s effects on the overall health of children, their development and immune responses to infection, and their overall quality of life in the years following infection. <Read More>

    340B in the News

    UCB to restrict 340B discounts to hospitals using community pharmacies – November 23, 2021 – Beginning Dec. 13, global drug company UCB will stop providing 340B discounts to hospitals for drugs dispensed at community-based pharmacies. UCB is now the ninth drug company to restrict 340B pricing for community pharmacies, according to a Nov. 23 news release from 340B Health, an association representing more than 1,400 public and private nonprofit hospitals and health systems participating in the federal drug pricing program, which requires drugmakers to sell their products at a discount to providers who serve low-income communities. <Read More>

    Study: Some Subsidized Medicine Programs Don’t Fulfill Goal – November 19, 2021 – A taxpayer subsidy program intended to help vulnerable people afford medicine isn’t working as intended, according to a new study from the California-based, free-market Pacific Research Institute. The 340B program, named for section 340B of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA). The 340B program aims to provide discounted drugs to boost vulnerable populations’ access to medicine. Participating manufacturers provide qualifying clinics and hospitals discount up to 50% or more of the costs for outpatient drugs, otherwise, their drugs will not be covered by Medicaid. <Read More>

    Commentary: A Danger to Struggling Hospitals – November 19, 2021 – The term “340B” sounds like a savings plan offered to an investor. In reality, it’s a health care program that does have a savings element to it – for both hospitals and patients. 340B is a drug pricing program that lets health systems save millions of dollars on drug costs, increasing access to prescription medicines for community members who need them. But Jonathon Green and Michael Azzolin, in a new GHN Commentary, point out that the indirect effects of the pandemic threaten to cut off many rural hospitals’ use of the 340B program. And those hospitals are the ones that depend on it the most. <Read More>

    340B Program, PAPs Help Ensure Specialty Rx Success – November 16, 2021 – Actively managing participation in the federal 340B Drug Pricing Program and other financial assistance and medication access efforts can help maximize savings and ensure the overall success of specialty pharmacy services, a panel of experts said during the 2021 ASHP Conference for Pharmacy Leaders, held virtually. For example, when the FDA approved the pediatric cystic fibrosis medication elexacaftor-tezacaftor-ivacaftor (Trikaftaâ, Vertex) in June, the specialty pharmacy team at Atrium Health Wake Forest Baptist, in Winston-Salem, N.C., worked with eligible patients and their families to ensure they were completing necessary lab tests and education counseling during clinic visits leading up to the approval so patients would be ready, said Regina Schomberg, PharmD, BCPS, the system director of pharmacy, retail and specialty pharmacy services. <Read More>

    Community Access National Network Releases Fifth Policy Report on 340B Drug Pricing Program – November 16, 2021 – When the 340B Drug Pricing Program was enacted in 1992, there were a few “gaps” between the law’s statutory language and the program’s practical application. Among them was the realization that some covered entities that couldn’t afford to operate their own pharmacy. The Health Resources and Services Administration (HRSA) issued guidance to address the gap… Sounds great, right? Right? Not exactly! Under the 340B program, patients don’t always get their share of the savings from the rebates and discounts. Arguably, it would appear everyone is directly benefiting one way or another from the program and its lucrative revenue stream, except for patients. <Read More>

    As Big Pharma and Hospitals Battle Over Drug Discounts, Patients Miss Out on Millions in Benefits – November 16, 2021 – In early July, as the covid-19 pandemic slammed rural America, the president of a small Kansas hospital sat down on a Friday afternoon and wrote the president of the United States to plead for help. “I do not intend to add to your burden,” said Brian Williams, a retired Army lieutenant colonel and Desert Storm combat veteran. He said his hospital, Labette Health, was “like a war zone,” inundated with unvaccinated patients. A department head had threatened to resign, saying he could not “watch one more body be carried out.” But Williams wasn’t seeking pandemic relief. Instead, he asked President Joe Biden to confront pharmaceutical manufacturers Eli Lilly and Co., Novo Nordisk and others for refusing to honor a federal drug discount program for hospitals and clinics. The program gives Williams millions to pay staff members, ensure remote clinics remain open and provide charity care for patients unable to pay, he said. <Read More>