Clinical Insights: September 14, 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

    No new update.

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    No new update.

    New/Updated Drug Shortage

    September 10, 2021

    September 09, 2021

    September 08, 2021

    New Drug Recall and Safety Alerts

    Firvanq® (Vancomycin Hydrochloride for Oral Solution), Vancomycin 50 mg/mL Kit by Azurity Pharmaceuticals, Inc. – New Voluntary Recall – September 8, 2021 – Azurity Pharmaceuticals, Inc. (“Azurity”) is voluntarily recalling one lot of Firvanq® (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit (“Firvanq®”) to the consumer level, as some products in the affected lot have been found to incorrectly contain a First Omeprazole (FIRST-PPI) diluent instead of the Firvanq® diluent bottle. Risk Statement: Vancomycin may not be completely solubilized in the FIRST-PPI diluent which could lead to doses above or below those recommended in the label. <Read More>

    Aminosyn II 15%, An Amino Acid Injection, Sulfite Free IV Solution by ICU Medical – New Voluntary Recall – September 3, 2021 – ICU Medical, Inc. is voluntarily recalling one lot (2,112 units) of Aminosyn II, 15%, An Amino Acid Injection, Sulfite Free intravenous (IV) solution  to the hospital/user level due to the presence of visible particulate matter identified as fibers, hair, and proteinaceous material along with other particles. ICU Medical became aware of this issue while inspecting retain samples as part of routine process. Administration of a drug product that contains particulate matter could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to end-organ damage or death. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Ovarian Cancer Treatment Update and Pharmacists’ Role – September 13, 2021 – New targeted therapies known as PARP inhibitors (PARPis) used to treat patients with advanced ovarian cancer are transforming the treatment landscape through precision medicine. Pharmacists can play a key role in treating patients with ovarian cancer through counseling, drug information consults, and adherence. September is Ovarian Cancer Awareness Month and an important time to educate patients about the latest treatments and research. New targeted therapies known as PARP inhibitors (PARPis) used to treat patients with advanced ovarian cancer are transforming the treatment landscape through precision medicine. <Read More>

    How PBMs Can Help Rein in Drug Spending – September 13, 2021 – Formulary changes, utilization management, and a lack of transparency upset a lot of members, which hides a lot of good things that pharmacy benefit managers do. Pharmacy benefit managers (PBMs) are hired by employers or organizations to act as the middleman between drug manufacturers and pharmacies. They essentially seek to bring together the entire pharmacy supply chain, while helping to improve patient outcomes through clinical and cost-saving programs The United States spent an estimated sum of approximately $500 billion on medications in 2019. This number combines all insurance types as well as cash-paying patients. This is a $200 billion increase over the past 10 years. There is no telling what this number would be without PBMs. <Read More>

    HHS Announces the Availability of $25.5 Billion in COVID-19 Provider Funding – September 10, 2021 – The Biden-Harris Administration announced that the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), is making $25.5 billion in new funding available for health care providers affected by the COVID-19 pandemic. This funding includes $8.5 billion in American Rescue Plan (ARP) resources for providers who serve rural Medicaid, Children’s Health Insurance Program (CHIP), or Medicare patients, and an additional $17 billion for Provider Relief Fund (PRF) Phase 4 for a broad range of providers who can document revenue loss and expenses associated with the pandemic. <Read More>

    FDA Will Follow the Science on COVID-19 Vaccines for Young Children – September 10, 2021 – As schools around the country are re-opening for in-person learning and families are returning to their busy school year schedules, we know many parents are anxious about the pandemic and protecting their children. Many parents have questions about COVID-19 and when vaccines will be available for children younger than 12 years of age. Many of our team at the FDA are parents and grandparents themselves, and our team shares the same concerns as many in our country about protecting our loved ones from COVID-19. We are therefore also eager to see COVID-19 vaccines available for young children. We also know that we all share the interest in making sure this process is done with safety at top of mind. <Read More>

    APhA Statement on HHS Secretary’s Drug Pricing Plan – September 10, 2021 – The American Pharmacists Association (APhA) made the following statement on the comprehensive plan to lower drug prices that U.S. Department of Health and Human Services Secretary Xavier Becerra released. Secretary Becerra was tasked with developing the report in a July 2021 executive order. “APhA thanks HHS for several of the recommendations contained in the report on lowering drug prices. We are pleased to see that Secretary Becerra heard APhA’s recommendation to require pharmacy benefit managers (PBMs) operate in a more transparent manner. PBMs currently do business behind a curtain, and pharmacy knows firsthand how that secrecy allows them to line their pockets at the expense of patients, pharmacies, and the health care system. <Read More>

    Acne Care for Transgender Patients – September 10, 2021 – For transmasculine patients undergoing testosterone therapy, acne is more than a transient adverse effect (AE), said Howa Yeung, MD, MSc, an assistant professor of dermatology at Emory University School of Medicine in Atlanta, Georgia. Many patients require topical and oral treatments that could include isotretinoin, which creates unique challenges in this population. “For transgender and gender-diverse patients who start gender-affirming hormone therapy, oftentimes their skin also reacts to changes in hormone levels,” Yeung said. For transmasculine patients, he said, testosterone injections often increase skin oiliness, fueling acne development, usually during the first 6 months of therapy. “Clinicians presumed that the body essentially gets used to the testosterone and acne subsides after 1 to 2 years. It’s almost considered a transient [AE], a rite of passage.” <Read More>

    Beyond COVID-19: The Future of Pharmacy Techs as Immunizers – September 10, 2021 – With COVID-19 vaccination clinics still operating and booster doses on the horizon, there continues to be a need for pharmacy technicians as immunizers well into the future. If there’s a positive aspect of the COVID-19 pandemic, it might be the fact that pharmacy technicians across the nation readily volunteered to fulfil the “all hands on deck” need for immunizers. It is from this call that an immediate-need vaccine administration skillset was planted for the pharmacy technician workforce. When we step back to define the role of a pharmacy technician, administering immunizations is not a typical skillset unless the technician practices in Idaho, Rhode Island, or Utah. <Read More>

    EANO, ESMO Release Joint Guidelines for Brain Metastases Treatment – September 10, 2021 – The European Association of Neuro-Oncology (EANO) and the European Society for Medical Oncology (ESMO) have released joint guidelines and recommendations for the diagnosis, treatment, and follow-up of parenchymal brain metastases (BM). BMs cause neurological symptoms, such as epileptic seizures, headaches, and motor deficits, within weeks of onset. Many of the signs depend on the location of the BM, and cerebellar BMs typically can cause rapid neurological deterioration. The screening of individuals is recommended at the time of diagnosis of some cancers, such as lung cancer, metastatic human epidermal growth factor receptor 2, stage IV melanoma, and triple-negative breast cancer. <Read More>

    The Generic Drugs Industry Responds to COVID-19 – September 10, 2021 – Add generic drug shortages to the long list of practice challenges that have emerged during the COVID-19 pandemic, according to several industry experts. From the beginning, the pandemic threatened to trigger a huge disruption in the generic drug industry’s worldwide operations. “There were very big concerns about how our industry would be impacted, particularly when certain countries were closed off to the rest of the world,” said Erik Komendant, the vice president for federal government affairs at the Association for Accessible Medicines (AAM), the organization that represents the generic industry. “The challenge initially was that everyone was shutting down,” Mr. Komendant said. “And when the world basically shut down air transportation, it required our members to reroute their supply chains and distribution.” <Read More>

    Outdated Rule Increases Medicare’s Costs for Generic Drugs by $26 Billion a Year – September 10, 2021 – Public outcry about the shockingly high cost of brand-name drugs and a demand for new laws to rein in the cost of these medicines has persisted for years. But more than 90% of all prescriptions — almost 4 billion a year — are filled with generic drugs. Little attention has been paid to how much insurance companies, pharmacy benefit managers, and pharmacies charge to fill these generic prescriptions. Yet the difference between the highest and lowest price being charged for the same generic drug is so large that many billions of dollars could be saved each year by having prescriptions filled at the lowest-cost pharmacies. <Read More>

    The Role of Imaging and Genomic Testing in Prostate Cancer Therapy – September 10, 2021 – Results from the VISION trial announced at the 2021 American Society of Clinical Oncology Annual Meeting signaled an exciting future for precision medicine in prostate cancer. The results showed that theranostic lutetium 177-PSMA-617 (LuPSMA) significantly improved radiographic progression-free survival and overall survival when compared with best standard of care alone in patients given a diagnosis of prostate-specific membrane antigen (PSMA) –positive, metastatic, castrate-resistant prostate cancer (mCRPC) who had progressed after chemotherapy and hormone therapy. Further, treatment with LuPSMA revealed no unexpected or concerning safety signals. Together, these findings heralded possibilities both for the target population and for other men given the diagnosis of advanced prostate cancer. <Read More>

    HHS Releases Report to Address High Drug Prices – September 10, 2021 – The Department of Health and Human Services (HHS) released a report, “Comprehensive Plan for Addressing High Drug Prices,” on Sept. 9 in response to the July 9 executive order on competition in the American economy (executive order 14036). The proposal seeks to foster innovation, increase competition to reduce drug spending in the health care system, and improve patients’ access to affordable medications. The report outlines both legislative and administrative actions to lower drug pricing. <Read More>

    Hospital-at-Home Gains Traction – September 9, 2021 – Before November 2020, the biggest obstacle to delivering hospital-level care to acutely ill patients at home was a rule restricting Medicare fee-for-service payments to brick-and-mortar hospitals. But with U.S. COVID-19 cases rising again at year-end, the Centers for Medicare & Medicaid Services (CMS) issued a waiver that effectively gave qualified hospitals the flexibility to provide acute home care to Medicare patients and get paid for it as if they were occupying a hospital bed. Community-acquired pneumonia, heart failure, asthma and chronic obstructive pulmonary disease were among the more than 60 acute conditions that CMS considered treatable at home. <Read More>

    PQA and CPF Lead National Initiative to Prioritize Pharmacy Measure Concepts – September 9, 2021 – Pharmacists and pharmacy teams, now more than ever, are a critical part of the health care delivery system. As community pharmacies continue to innovate and provide important services to patients, they need the proper tools to demonstrate their value. Quality measures are essential for this purpose, allowing pharmacies to monitor progress and drive improvement, while quantifying their impact on patients’ health and welfare. However, there currently is a dearth of standard pharmacy measures to support this need. <Read More>

    More Than 40% of US Counties are Pharmacy Deserts – September 9, 2021 – In more than 40 percent of U.S. counties, residents must drive more than 15 minutes to reach a pharmacy, according to a report released Sept. 9 by telemedicine and pharmacy discount company GoodRx. The report estimated that over 41 million Americans live in a pharmacy desert. GoodRx identified pharmacy deserts by comparing the average driving distance to the closest pharmacy to the average time it takes to drive 10 miles in a rural area (about 15 minutes) based on the Department of Agriculture’s definition of food deserts. <Read More>

    The Role of Pharmacists and Prescription Monitoring Programs in Stemming the Opioid Epidemic – September 9, 2021 – The opioid crisis continues to be a public health threat. According to the Centers for Disease Control and Prevention, 70.6% of all overdose deaths are attributed to opioids. COVID-19 has fueled a spike in the cases of opioid overdose across the nation.2 Various strategies to combat the crisis include the use of prescription monitoring programs (PMPs), increasing naloxone accessibility, opioid prescribing policies, provision of funding for treatment, and needle exchanges. PMPs are the most widely used, having been adopted by 49 states. Literature agrees that pharmacists are best suited to play a key role in the opioid epidemic because of their accessibility, education, and their unique relationship with patients. <Read More>

    Some Doctors are Prescribing Ivermectin for COVID-19-That Doesn’t Mean You Should Take it – September 9, 2021 – Despite FDA guidelines urging against the practice, some doctors are prescribing ivermectin to prevent or treat COVID-19 infections. These formulations are not the same as ivermectin products intended for livestock or pets. Ivermectin is approved to treat several types of parasitic infections in humans but is not approved for or authorized for COVID-19. The CDC, FDA, and AMA all advise against its use against COVID-19 because there is no evidence it works. There are groups of physicians and other healthcare professionals who insist ivermectin is effective against COVID-19, despite other physicians and researchers saying that this research is flawed or shows little or no benefit. <Read More>

    FDA Meets a Court Deadline, But Fails to Protect America’s Kids from E-cigarettes – September 9, 2021 – The Food and Drug Administration issued decisions on new tobacco product applications, addressing the over 6 million unique products and flavor variations submitted for agency review.  Missing from the FDA’s announcement was a decision on a company that has the largest e-cigarette market share – Juul. “How the FDA could fail to make a decision on Juul products is beyond me,” said ATS Tobacco Action Committee Chair Michelle Eakin, PhD. <Read More>

    Insurers Win Suit With PBM Over D&O, E&O Cover – September 9, 2021 – A federal appeals court Wednesday affirmed a lower court ruling in favor of units of Allied World Assurance Company Holdings Ltd., Intact Insurance Group USA LLC and Travelers Cos. Inc. in litigation filed by a prescription benefit manager over their refusal to indemnify it under their errors & omissions and directors & officers liability insurance coverages. <Read More>

    New Options in the Treatment of Patients with Low-Risk Myelodysplastic Syndrome Need to Be Further Studied – September 8, 2021 – For patients with low-risk myelodysplastic syndrome, standardized treatment options are not readily available and dependent on the patient’s specific conditions. For patients with low-risk myelodysplastic syndrome (MDS), standardized treatment options are not readily available and dependent on the patient’s specific conditions. Furthermore, patients with erythropoietin (EPO) failure often do not have a treatment to readily fall back on. Which is why it’s important for more varied studies to occur in the MDS field, according to Uwe Platzbecker, MD. <Read More>

    Time to Heed OIG Guidance on Rx Discounts – September 8, 2021 – Pharmaceutical manufacturers looking to help patients gain access to expensive drug and medical treatments need to tread lightly and heed guidance from the Department of Health and Human Services’ Office of Inspector General (OIG), according to panelists speaking at Informa Connect’s 2021 Compliance Congress for Specialty Products, held virtually. Otherwise, they could be at risk for legal action. <Read More>

    Some Stakeholders Put the “Brakes” on Alzheimer’s Drug – September 8, 2021 – Nearly two months after the FDA’s controversial decision to approve aducanumab (Aduhelmä, Biogen) for the treatment of Alzheimer’s disease, payors are still determining how they will cover the drug, while hospitals and health systems grapple with decisions about which patients, if any, should be offered the amyloid plaque–targeting agent. Meanwhile, two congressional committees—the House Committee on Oversight and Reform and the Committee on Energy and Commerce—have launched an investigation into the approval process and pricing of the drug, which at its highest dose costs over $4,300 per infusion, or about $56,000 annually. <Read More>

    Limiting Screen Time for Young Adults After Concussion Results in Shorter Duration of Symptoms – September 8, 2021 – A clinical trial of 125 young adults shows that those who limited screen time for 48 hours immediately after suffering a concussion had a significantly shorter duration of symptoms than those who were permitted screen time. These findings, published in JAMA Pediatrics, offer the first clinical evidence that restricting time spent at a computer, television or phone screen in the acute period following a concussion can reduce the duration of symptoms. The study supports preliminary clinical recommendations to limit screen time. <Read More>

    Risk of Opioid Overdose Appears Higher in Older Americans, USC Study Indicates – September 8, 2021 – One in 10 adults were at risk of overdose, with older Americans relying on high doses of opioids more than younger adults, researchers found in a national sample of prescription claims. Even with COVID-19 dominating the news, the epidemic of opioid use remains a nationwide threat. While public awareness and efforts to stop addiction and overdoses have intensified, some communities reported higher rates of opioid-related deaths in 2020 than ever before. The extent and burden of opioid prescription drug use has gone largely uninvestigated as most studies have focused on curtailing illegal use. Recent research led by USC School of Pharmacy faculty member Dima M. Qato aims to fill that knowledge gap. The findings — published in Pharmacoepidemiology and Drug Safety — revealed that, although high risk prescription opioid use has declined, nearly 1 in 10 adults were taking opioids that put them at increased risk from an opioid overdose in 2016. <Read More>

    New Highs and Lows for Young Adult Drug Use – September 8, 2021 – Although alcohol, opioid, amphetamine and tobacco use is losing favor with college-age adults, marijuana and hallucinogens appear to be the drugs of choice, according to a new report by the National Institute on Drug Abuse (NIDA). Marijuana use rose among college students over the past five years and remained at historically high levels among same-aged peers who were not in college in 2020, according to survey results from the 2020 Monitoring the Future(MTF) panel study. <Read More>

    AAP Updates Influenza Vaccination Guidance for Children – September 8, 2021 – The American Academy of Pediatrics (AAP) has issued updated guidelines for the prevention and control of influenza in pediatric patients. Routine annual influenza vaccination is recommended for all patients 6 months of age and older who have no medical contraindications. In a new policy statement, the AAP outlined several updates for the 2021-2022 influenza season, including: <Read More>

    Third of Cancer Drugs Without Proven Clinical Benefit Continue to be Recommended for Patients – September 8, 2021 – One third of cancer drugs that received accelerated approval from the US Food and Drug Administration (FDA) continue to be recommended in clinical guidelines after their confirmatory clinical trials fail to show improvement on their primary endpoints, finds a study published by The BMJ…The researchers say clinical guidelines “should better align with the results of post-approval trials of cancer drugs that received accelerated approval.” <Read More>

    PCMA Challenges Disclosure Rules – September 8, 2021 – Prices in American healthcare are difficult to nail down because they are obscured by secret negotiations between payers and providers and, in the case of drugs, pharmaceutical manufacturers. But that is beginning to change. Despite court challenges and uneven compliance, hospitals were forced to start disclosing prices at the beginning of this year. Now, because of rules issued by the Trump administration, it is the PBMs’ turn. The price transparency rule, different parts of which go into effect next year and in 2023, would require disclosure of cost-sharing estimates to plan members, which isn’t controversial, but also the net prices that PBMs pay to drugmakers after discounts and rebates, which is. The U.S. Chamber of Commerce and the Pharmaceutical Care Management Association (PCMA), the PBM industry’s trade group, filed lawsuits challenging the net price disclosures in August. <Read More>

    QAnon Conspiracy Theorists Harass Northwest Side Hospital That Rejected Unproven Ivermectin Treatment for COVID Patient – September 7, 2021 – Employees at AMITA Resurrection Hospital are being targeted by conspiracy theorists because they won’t treat a COVID-19 patient with ivermectin, a drug used for livestock with parasites. Jefferson Park resident Veronica Wolski was hospitalized two weeks ago after contracting COVID-19, according to VICE. She claims she asked a doctor to administer ivermectin and was refused, according to Wolski’s social media posts reviewed by VICE. Ivermectin is a Food-and-Drug-Administration-approved prescription used to treat certain infections caused by parasites. It is not authorized or approved by the FDA for prevention or treatment of COVID-19, and the FDA, Centers for Disease Control and Prevention, American Medical Association and the drug manufacturer have warned against using it to treat COVID-19. <Read More>

    FDA Slaps a Hold on BioMarin’s PKU Gene Therapy – September 7, 2021 – A string of gene therapy clinical trials have been paused due to safety concerns. The most recent is BioMarin Pharmaceutical, which announced that the U.S. Food and Drug Administration (FDA) had placed a clinical hold on its BMN 307 Phearless Phase I/II study. The trial investigates BMN 307, an AAV5-phenylalanine hydroxylase (PAH) gene therapy in adults with phenylketonuria (PKU). Biomarin’s study was paused based on interim safety data from a preclinical, non-GLP pharmacology study that found liver tumors in laboratory animals receiving the therapy. <Read More>

    Five Things to Know About the US Booster Shot Plan – September 7, 2021 – Federal regulators are working to develop a plan to distribute COVID-19 booster shots to the general population amid the spread of the delta variant and studies that suggest the vaccines’ efficacy may wane over time. Five updates on the U.S. booster plan: 1) The U.S. will likely start distributing Pfizer COVID-19 booster shots starting the week of Sept. 20, but Moderna’s will likely take longer, Anthony Fauci, MD, the White House’s chief medical adviser, said Sept. 5, according to CNBC. The FDA and CDC may not have enough time to review data on Moderna’s shot by Sept. 20, Dr. Fauci said. For people who received two doses of Moderna’s vaccine, Dr. Fauci said it’s better to wait for Moderna’s approval rather than getting a Pfizer booster, CNBC reported… <Read More>

    Specialty Drug Commercialization Process and Considerations – September 7, 2021 – As specialty drugs move through clinical trials and preparations for commercialization begin, significant attention is warranted to this process considering the massive investments that would have been already made in the product up to this point. The specialty pharmacy drug pipeline is a rapidly growing segment of the pharmaceutical industry that primarily focuses on the development of novel, complex, and likely high-cost products. These medications tend to treat disease states that affect smaller patient populations and are often prescribed primarily by specialists. <Read More>

    Building COVID-19 Vaccine Confidence in the Community Pharmacy – September 7, 2021 – In an effort to increase equitable access to COVID-19 vaccination across the United States, the White House launched the Federal Retail Pharmacy Program for COVID-19 Vaccination in February 2021. This program gives eligible individuals the ability to receive COVID-19 vaccinations at more than 40,000 participating pharmacy locations across the nation. Most Americans live within 5 miles of a pharmacy, which makes pharmacies readily accessible in diverse communities and positions them as critical players in the federal COVID-19 vaccination strategy. Americans seeking COVID-19 vaccination may enter the pharmacy with hesitation or questions regarding the available vaccines; therefore, pharmacists can prepare for conversations that can help their community understand the importance of vaccination and support their informed decision to be vaccinated. <Read More>

    PhRMA Battles Biden on Proposal for Medicare to Negotiate Drug Prices – September 7, 2021 – Since President Joe Biden on August 12 proposed to have Medicare negotiate drug prices, the Pharmaceutical Research and Manufacturers of America has been supporting televised ads in opposition while other organizations have been urging consumers to tell their elected officials to support the president’s plan. The Medicare negotiation push with the goal of lowering drug prices is part of a $3.5 trillion budget proposal that narrowly passed the House last month. This advances with a roughly $1 trillion infrastructure bill to the Senate, where it is expected to go through the process of reconciliation without GOP support. <Read More>

    North Dakota, Which Once Lost Its Fight to Regulate PBM Practices, Gets a Rematch – September 7, 2021 – At the U.S. Eighth Circuit Court of Appeals last week, Pharmaceutical Care Management Association (PCMA) and North Dakota delivered oral arguments in litigation over state laws regulating some PBM practices. The proceedings were the latest step in PCMA v Wehbi’s winding path through the courts. The circuit court once sided with the PBM lobbying group, but the U.S. Supreme Court vacated that ruling after it unanimously decided to uphold an Arkansas PBM-regulation law. The North Dakota laws at issue address, among other things, PBMs’ retroactive extraction of certain fees from pharmacies, restrictions on what pharmacists can discuss with their patients, and limitations on pharmacists’ authority to dispense certain drugs. <Read More>

    Predatory Practices Destroying Independent Pharmacies, Survey Finds – September 6, 2021 – A survey of Delaware’s independent community pharmacists on the impact of pharmacy benefit managers reveals predatory practices are potentially devastating these small businesses, said Kathy McGuiness, state auditor, who released the new special report Aug. 27. “Your community pharmacists – who are your first line of defense when you are sick or hurting and need to talk – are struggling to keep their doors open,” said McGuiness, who is a licensed immunizing pharmacist and former small-business owner. “Our survey results show that these prescription drug middlemen, known as PBMs, are strangling these critically important community businesses.” <Read More>

    340B in the News

    AHA: Tax-Exempt Hospitals Gave $105B in Community Benefits Such as Financial Assistance in 2018 – September 10, 2021 – Tax-exempt hospitals provided $105 billion in community benefits that range from financial assistance to erasing medical debt in 2018, a new analysis finds. The analysis released Thursday by the American Hospital Association also showed that hospitals in the 340B drug discount program devoted nearly $68 billion in community benefits the same year. The finding comes as drugmakers have restricted access to 340B products due to concerns that discounts do not benefit the patient. “This analysis demonstrates that improving the health of their communities remains at the heart of the mission of America’s hospitals and health systems,” said AHA President and CEO Rick Pollack in a statement. <Read More>