Clinical Insights: May 25, 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

    Rybrevant™ (amivantamab-vmjw) Injection – New Drug Approval – May 21, 2021 – The U.S. Food and Drug Administration approved Rybrevant™ (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The FDA also approved the Guardant360™ CDx (Guardant Health Inc.) as a companion diagnostic for Rybrevantä. “Advances in precision oncology continue to facilitate drug development, allowing diseases like lung cancer to be subset into biomarker-defined populations appropriate for targeted therapies,” said Julia Beaver, M.D., chief of medical oncology in the FDA’s Oncology Center of Excellence and acting deputy director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “With this approval, for the first time, patients with non-small cell lung cancer with EGFR exon 20 insertion mutations will have a targeted treatment option.” <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    No new update.

    New/Updated Drug Shortage

    May 21, 2021

    May 20, 2021

    May 19, 2021

    May 18, 2021

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Data Show Finerenone May Delay Onset of Atrial Fibrillation in Patients with Chronic Kidney Disease, Diabetes – May 24, 2021 – The new data show that patients were able to benefit from finerenone treatment regardless of AFib history, which indicates that finerenone can reduce the rate of new-onset AFib. Patients with chronic kidney disease and type 2 diabetes (T2D) administered the nodel treatment finerenone were found approximately 30% less likely to develop atrial fibrillation (AFib) than those taking a placebo, according to data presented at the American College of Cardiology’s 70th Annual Scientific Session. Results from the FIDELIO-DKD trial released in 2020 showed that the nonsteroidal, selective mineralocorticoid receptor antagonist met its primary endpoint of a significant benefit in a composite of sustained decrease in kidney function, kidney failure, and renal death. The new data show that patients were able to benefit from finerenone treatment regardless of AFib history, which indicates that finerenone can reduce the rate of new-onset AFib, according to the study. <Read More>

    Mathematical Model of the Brain May Identify Gene Changes Responsible for Cognitive Decline in Aging – May 24, 2021 – A new mathematical model described in eLife suggests there are key similarities between Alzheimer disease and healthy aging. According to the study authors, this model provides insights into the multiscale biological alterations in the elderly and neurodegenerative brain, which have important implications for identifying treatment targets for Alzheimer disease. The researchers developed this mathematical model using a wide range of biological data, including both microscopic information from gene activity and macroscopic information about the brain’s burden of toxic proteins (tau and amyloid), its neuronal function, cerebrovascular flow, metabolism, and tissue structure from molecular PET and MRI scans. <Read More>

    New Guidance for Managing DOAC-Related Bleeding – May 24, 2021 – A new resource from the Anticoagulation Forum provides guidance on bleeding related to direct oral anticoagulants (DOACs), highlighting areas where pharmacists and other clinicians can promote stewardship of these agents and develop systematic approaches to facilitate ordering, delivery, administration and management of reversal agents. The resource “provides distilled, evidence-based guidance on appropriately identifying patients [who] might need reversal, and how to effectively manage those patients depending on which anticoagulant they take,” said Allison Burnett, PharmD, CACP, an antithrombosis stewardship pharmacist at the University of New Mexico Health Sciences Center, in Albuquerque, and the president-elect of the Anticoagulation Forum, a group of anticoagulant service providers in North America. <Read More>  

    Vast Majority of Pharmacists Surveyed are Fully Vaccinated Against COVID-19 – May 24, 2021 – A nationwide survey of pharmacists has found that 88% of respondents are fully vaccinated against COVID-19, and that more than 9 in 10 (92%) said they plan to or have already been vaccinated. An overwhelming percentage of pharmacists (98%) also said they were comfortable addressing vaccine confidence and vaccine hesitancy concerns with their patients and other individuals. The survey continues to demonstrate the growing confidence of pharmacists in the effectiveness and safety of the vaccines, and in their ability to talk to their patients about the vaccines. <Read More>

    Not so Different: How Pharmacists can Help Boost Biosimilar Uptake – May 23, 2021 – As the US biosimilar industry continues to expand, physicians, payers, and pharmaceutical companies have been at the forefront of the discussion on how to increase biosimilar uptake and education efforts. However, pharmacists also have a role to play in sharing information and encouraging uptake. The lack of interchangeability designations for US biosimilars prevents pharmacists from being able to switch out costly originator drugs with more affordable biosimilars. They must get approval from a physician first. There are other ways, though, that pharmacists can help uptake efforts. <Read More>

    Study: Medical Marijuana Serves as Potential Therapy for Chronic Itch – May 21, 2021 – Medical marijuana could potentially serve as an effective treatment for debilitating chronic itch, according to a study published in JAMA Dermatology. The study authors said that treating the condition has been difficult until now due to a lack of FDA-approved therapies. “Chronic itch can be an especially difficult condition to treat, with off-label therapeutics often utilized,” said Shawn Kwatra, MD, assistant professor of dermatology at the Johns Hopkins University School of Medicine, in a press release. “With the increased utilization of medical marijuana and our knowledge of the role of the endocannabinoid system—a complex cell-signaling system that regulates a variety of functions in the body—in chronic itch, we decided to try medical marijuana with a patient who failed several therapies and had few options left.” <Read More>

    Four Out of Five Health and Medical Apps Are ‘So Bad They Could Put Patients at Risk’, NHS-Backed Review Finds – May 20, 2021 – Four out of five health apps fail to meet basic quality standards and may even harm patients, an NHS-backed review has found. Only around 20 per cent of smartphone health and medical apps followed clinical guidelines, kept patient data secure, were safe from hackers and were easy to use. But the vast majority which promised to help people with conditions like cancer, obesity or mental health problems fell far below basic standards. The tests, on around 5,000 apps, were carried out by the Organisation for the Review of Care and Health Apps, an independent assessor which evaluates app quality for the NHS. <Read More>

    Administrative Burden of Prescribing Biologics – May 21, 2021 – Prescribing biologics can require a complex approval and claims process. Creating a tiered system based on office workload can help practices understand and allocate staff time. Outsourcing approvals to pharmacies where possible can also streamline the process. With the constant advances in the field of dermatology, biologic therapies are quickly becoming a mainstay in treatment for many dermatology patients. With the increased numbers of biologic therapies utilized on a daily basis, the administrative burden and growing frustrations of patients are becoming evident. There is a need for a more streamlined process with biologic medication approvals, and the collaboration with specialty pharmacies and pharmaceutical companies is essential. The following paper outlines these burdens and proposes a framework in 6 steps for minimizing the administrative burdens in a private practice dermatology clinic. <Read More>

    Addressing Primary and Secondary Prevention of Osteoporosis-Related Fractures – May 21, 2021 – Osteoporosis is a bone disease that develops when bone mineral density (BMD) and bone mass decrease, which can lead to decreased bone strength. Clinical features of postmenopausal osteoporosis include low BMD and deterioration of bone structure, which cause bone fragility and increased fracture risk. Because osteoporosis is an asymptomatic disease, patients often are undiagnosed until they experience a fracture, which may lead to hospitalization. In fact, between 2000 and 2011, there were 4.9 million hospitalizations for osteoporosis-related fractures in women ages 55 and older at a cost of $5.1 billion per year. As a result, screening, diagnosis, and treatment for osteoporosis are crucial. <Read More>

    Immunotherapy Revolutionizes Treatment of ES-SCLC – May 21, 2021 – Addition of atezolizumab and durvalumab to chemotherapy is a win for patients with extensive-stage small cell lung cancer. Small cell lung cancer (SCLC) accounts for approximately 15% of all lung cancer cases, with almost all cases attributed to tobacco smoke exposure. SCLC is generally characterized by an aggressive, rapidly growing disease course with a high rate of metastasis. Although this rapid growth and proliferation translate into higher response rates to chemotherapy and radiation, patients relapse quickly with increased rates of disease progression. <Read More>

    What Other Conditions Can mRNA Take Down? Several, According to Pharmacists – May 21, 2021 – Drugmakers may only be scratching the surface of mRNA, the platform Pfizer and Moderna used to develop the first two COVID-19 vaccines granted emergency use authorization by the FDA. COVID-19 vaccines that use mRNA provide instructions for a cell to make a protein, inciting an immune response to enhance the body’s ability to fight the actual virus, according to Indu Lew, PharmD, the chief pharmacy officer at West Orange, N.J.-based RWJBarnabas Health. Dr. Lew called the future of mRNA vaccines “fascinating and endless,” saying scientists could use the technology to express any protein and “potentially treat any disease.” Jason Baldwin, PharmD, the director of pharmacy at Bayfront Health Brooksville (Fla.), had similar optimism. <Read More>

    Decline in HPV-Related Cervical Cancer May Inform Screening and Vaccination Guidance for Other Tumor Types – May 20, 2021 – Seventeen years of data indicate that HPV-related cervical cancer incidence is declining, but other tumors related to the virus persist. Evidence from a population-based study on the incidence of human papillomavirus (HPV)–related cancers indicate a marked decline in cervical carcinoma, potentially due to clear guidance regarding screening measures and HPV vaccination for vulnerable patient groups. On the other hand, the incidence of other HPV-related cancers without clear screening guidelines are on the rise in both men and women. “In young women, cervical carcinoma is decreasing consistently with screening, and possibly vaccination, at the population level,” lead author Cheng-I Liao, MD, of Kaohsiung Veterans General Hospital in Kaohsiung, Taiwan, said during a presentation of the data during a media briefing leading up to the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting. <Read More>

    Five Ways That Clinical Trials Might Change for Good – May 20, 2021 – When COVID-19 forced Penn Medicine Abramson Cancer Center to scale back its clinical trials last year, investigators there worried about how pandemic restrictions might impede research into the fight against cancer. How could they run trials if patients couldn’t come to the Philadelphia center for treatments, tests, and evaluations? In addition, nearly 90% of its clinical trials temporarily suspended enrollment when the pandemic restrictions began. Then investigators started working with trial participants in ways that seem simple but had not previously been allowed by government regulators or companies that sponsor trials: They shipped research medications to patients, let them get some tests done at their local doctor’s offices rather than at the cancer center, and enrolled some participants remotely rather than by meeting them in person. <Read More>

    Implementing Pharmacogenomics Often Pay Dividends – May 20, 2021 – Pharmacogenomics examines how genes affect the way individuals respond to medications, which can help in selecting the most effective therapy and optimal drug dosage. Pharmacogenomics also ties into precision medicine, which is treating each patient individually. The FDA provides pharmacogenomics information in the labeling of various medications that includes drug exposure and clinical response variability, genetic factors involved in drug metabolism, genotype-specific dosing, mechanisms of drug action, risk for adverse events, and trial design characteristics. Pharmacists can play an important role in pharmacogenomics testing to improve outcomes through medication therapy management (MTM) services. <Read More>

    Affordable Alternatives to Ethanol Lock Therapy – May 20, 2021 – Ethanol lock therapy—the use of dehydrated alcohol in central line catheters to prevent catheter-related bloodstream infections (CRBSIs)—has been used widely for pediatric patients on home parenteral nutrition (PN). But with ethanol locks becoming exponentially more expensive, clinicians are employing creative alternatives, a speaker said at the ASPEN 2021 Nutrition Science and Practice Conference. <Read More>

    HHS Releases New Buprenorphine Practice Guidelines, Relaxing Waiver Requirements – May 20, 2021 – The Department of Health and Human Services (HHS) recently released new practice guidance on buprenorphine administration in an effort to make evidence-based treatment for opioid use disorder more accessible to persons suffering with opioid addiction. According to a related press release issued by HHS, overdose deaths have increased during COVID-19 and are at an all-time high, making treatment accessibility imperative. Generally, in order to prescribe buprenorphine, a medication used for the treatment of opioid use disorder, a practitioner must be separately registered or obtain a waiver from the separate registration requirement. Among other things, the new guidelines remove a long-standing training requirement for obtaining a waiver. Practitioners frequently cite this training requirement as an obstacle to treating patients with opioid use disorder. <Read More>

    Study: Automated Prior Authorization may Lower Costs, Improve Care for Cancer Patients – May 20, 2021 – A new study from researchers at CVS Health finds that an automated prior authorization process may drive lower cost, more efficient cancer care. The research, released for the American Society of Clinical Oncology conference, found that from April to December 2020, 279 prior authorization requests were submitted by a large health system through the Novologix platform, a clinical decision support tool for prior auth. Of those submissions, 83% were automatically approved in real time, according to the study. None of the submissions were ultimately denied, according to the researchers, and those not approved automatically were reviewed via a partnership with the National Comprehensive Cancer Network. <Read More>

    Pain Interventions: Practice Advisory Issued for the Use of Gadolinium-based Contrast Agents – May 20, 2021 – Iodinated contrast agents are necessary when administering pain interventions, such as nerve blocks and other injections, however many patients have hypersensitivity reactions to these agents. In fact, the incidence of hypersensitivity reactions has increased over the past decade as the use of iodinated contrast agents has increased. As a result, many interventional pain physicians are now utilizing gadolinium-based contrast agents (GBCAs) when a patient reports a previous reaction to an iodinated agent. However, GBCAs are not always a safe solution. A 2018 FDA safety communication warned that these agents are retained in the body for months to years and should be used with caution. Potential dangers include nephrogenic systemic fibrosis (NSF), impaired brain function, and other adverse events, including, in some cases, death. <Read More>

    Fidaxomicin, Vancomycin Provide Similar C Difficile Initial Cure, Mortality Rates – May 20, 2021 – A meta-analysis suggest the 2 first-line C diff therapies provide similar outcomes, yet differ in recurrent infection risk. Clostridioides difficile (C difficile) infection therapies fidaxomicin and vancomycin do significantly differ in patient outcomes for initial cure nor mortality, according to findings from a new systematic literature review and meta-analysis. In new data presented at the Making A Difference in Infectious Disease (MAD-ID) 2021 Annual Meeting, a team of Rhode Island-based investigators reported clinical outcome similarities between the 2 agents across patients treated in 3 different randomized, controlled trials. <Read More>

    Oncology Biosimilar Market is Growing – May 20, 2021 – More biosimilars continue to be prescribed, and price competition is improving. Although the United States is behind Europe in terms of biosimilars approved and launched, the FDA is adding more approvals each year—29 since 2014—and 73 additional biosimilar candidates are in clinical trials and/or under FDA review. In the hospital community, financial incentives are heavily weighted in favor of biologic reference products, which means that biosimilars in many cases are not even considered, said Ted Okon, MBA, executive director of the Community Oncology Alliance. He quoted from a January 2021 report from Bernstein Financial Advisory, which used a recent federal drug price disclosure mandate to probe what insurers are paying hospitals for the use of reference biologics. <Read More>

    IV Cephalosporin Three Times a Week Effective in Hemodialysis Patients – May 20, 2021 – Dosing IV cephalosporin three times per week is safe and effective in resolving infection—and preventing reinfection—in patients receiving hemodialysis, according to a study presented at the MAD-ID virtual 2021 annual meeting (poster A04). The researchers wanted to know whether this dosing schedule would provide adequate therapeutic drug concentrations to prevent infections, while avoiding supratherapeutic drug levels. <Read More>

    Targeting Stewardship Efforts in the Emergency Department – May 20, 2021 – Antimicrobial stewardship efforts focused on the emergency department (ED) have the potential to decrease antibiotic resistance and improve antibiotic and antifungal use and outcomes, according to Nicole Acquisto, PharmD, an emergency medicine clinical pharmacy specialist at the University of Rochester Medical Center (URMC), in New York. The ED is a target-rich but challenging environment for antimicrobial stewardship. “Antibiotics are the fourth-largest drug class used in the ED as of 2016—which is improved over 2010 when they were the second-largest drug class used,” Acquisto said, citing the National Hospital Ambulatory Medical Care Survey. <Read More>

    Tip of the Week: Promoting Patient Adherence to Medications – May 20, 2021 – It is important for pharmacists to understand the relationship between medication adherence and patient outcomes. This is not the first nor will it be the last thing you read about patient adherence to drug therapy. Assuring, or at least promoting or facilitating, adherence to medications is one of the most salient unmet needs in health care and is a true calling to the pharmacy profession. Therefore, it is useful to examine attempts to promote patient adherence in everyday practice and also within the context of specific value-added services led by pharmacists. It is that much more important for us to understand the relationship between medication adherence and patient outcomes. <Read More>

    Hypertension May Double Heart Risk for Women in Middle Age – May 19, 2021 – Women in their early 40s with mild hypertension, elevated blood pressure, may be twice as likely as those with normal blood pressure to have a heart attack or unstable angina in their 50s, a new study suggests. While men are more likely than women to have hypertension in their early 40s, damage to arteries appears to begin at lower blood pressures in women. If confirmed, the findings imply that there should be a lower threshold for starting antihypertensive treatment in women. <Read More>

    Detect Adverse Events and Medication Errors Using Technology – May 19, 2021 – Digital tools can help pharmacists and other health care providers ensure effective and safe drug use. Technology has changed the practice of pharmacy. Many systems are now part of an ever-increasingly interfaced or integrated health care system allowing the electronic exchange of prescriptions from electronic health records (EHRs) to the pharmacy information system and bidirectional data exchange for many items, such as lab results and test information. With meaningful use of automated distribution cabinet databases, EHR efforts, electronic data exchange, and smart pump technology, the availability of data to use for addressing and preventing adverse medication events has grown. Use of these systems has allowed a data-rich environment to store and retrieve reporting. Mining data is becoming easier and can be used as a tool to identify adverse medication events or potential events. <Read More>

    The Rise in Formulary Exclusions – May 19, 2021 – PBMs say exclusions are important for negotiating lower prices on behalf of health plans and members. Some payer and provider groups say they interfere with patient access to medicines. Formulary exclusions — a decision by a PBM not to include a drug on its list of covered drugs, called a formulary — are not new, but they are increasingly in the spotlight, partly because the PBM industry is increasingly consolidated. CVS Caremark, Express Scripts and OptumRx, the three largest PBMs, collectively process about 3 out of every 4 U.S. prescriptions. Attention to exclusions has grown as the number of drugs excluded from the national formularies of the three PBMs has risen. In 2014, CVS Caremark and Express Scripts excluded a relative handful of medications — 134 between them. By 2020, the three largest PBMs combined excluded 1,195 medications. According to a tally by Adam Fein, Ph.D., a drug pricing and distribution expert, 1,343 drugs are excluded from 2021 formularies of the three major PBMs. <Read More>

    Pharmacy Students Help Develop Automated Syringe-Filling Technology – May 19, 2021 – The technology demonstrates the important role students can play in pushing the pharmaceutical industry forward. Pharmacy students at the University of South Carolina (USC) have partnered with researchers and engineers to develop an innovative, automated syringe-filling system. According to USC, the product can complete this task with small-batch products, which is known to be challenging for workers to do by hand. The technology demonstrates the important role students can play in pushing the pharmaceutical industry forward. The system was designed by pharmacy and engineering students, who partnered with researchers and were led by mechanical engineering professor Ramy Harik, PhD. <Read More>

    The Link Between Insomnia and Mental Illness – May 19, 2021 – Mental Illness and insomnia are highly interconnected, with the incidence of psychiatric illness in patients with insomnia near 50%. Cognitive-behavioral therapy for insomnia (CBT-I) is safe and effective. Studies suggest benefits persist long-term. Providers are of CBT-I are few. Digital, self-guided versions of CBT-I can help to bridge this gap. Insomnia rates have continued to rise throughout the pandemic, contributing to increasing rates of depression and anxiety, as well as worsening symptoms of other severe mental illnesses. Defined as chronic sleep onset and/or sleep continuity problems associated with impaired daytime functioning, insomnia has a bidirectional relationship with mental health issues. <Read More>

    Triple-Drug Therapy Safely Cuts Serious Asthma Flares – May 19, 2021 – Researchers have found that the inclusion of a third drug to commonly used dual-drug inhalers can reduce asthma exacerbations and improve control over the disease in children, adolescents, and adults with moderate-to-severe asthma…Dual-drug inhalers used to treat asthma typically contain an inhaled corticosteroid (ICS) to reduce inflammation, as well as a long-acting beta-adrenoceptor agonist (LABA) that acts as a bronchodilator. High-certainty evidence showed that the inclusion of a third drug to ICS-LABA combination therapy, known as a long-acting muscarinic antagonist (LAMA), reduced severe asthma exacerbations and slightly improved asthma control without an increase in adverse events. Previously, the benefits and harms of adding a LAMA to ICS-LABA therapy for asthma treatment were unclear and based off of only 1300 patients – mainly adults – leading to weak recommendations in treatment guidelines. <Read More>

    Physician Practice: Why it’s not one Size Fits all – May 19, 2021 – Physicians have many choices of practice settings and modes, and a bit of experimentation is advisable before deciding on the setting that best suits you.  “Don’t just jump right into private practice if you are unsure of it,” advises Zhudi M. Jasser, MD, a Phoenix internist and governing council chair of the AMA Private Practice Physicians Section (AMA-PPPS). “It may be good to go work for somebody or work for an institution, and then realize what a lack of control has done for you.” Dr. Jasser is a staunch supporter of the private practice model, though it may not suit every doctor’s personality, he said during an AMA webinar hosted by the AMA Organized Medical Staff Section. The webinar offered physicians’ firsthand advice on the pros and cons of different practice modes. <Read More>

    Dupixent™ Reduces Asthma Exacerbations in Younger Children – May 19, 2021 – The monoclonal antibody dupilumab (Dupixent™, Sanofi/Regeneron) significantly reduced exacerbations in children ages 6 to 11 years with uncontrolled moderate to severe asthma, according to research presented at the ATS 2021 International Conference (abstract A1204). In the multicenter, double-blind VOYAGE trial, investigators enrolled 408 children ages 6 to 11 with uncontrolled moderate to severe asthma. The researchers performed prespecified primary analyses in two groups in the study… <Read More>

    Quantifying ED Physician Time Saved by Clinical Pharmacists – May 19, 2021 – The emergency department (ED) presents many challenges related to the selection, dosing, administration, and monitoring of medications. The American College of Emergency Physicians considers the role of pharmacists in the ED critical to ensure efficient, safe, and effective medication use. Pharmacists should serve as well-integrated members of the ED multidisciplinary team and actively participate in patient care decisions to optimize pharmacotherapy for patients. Since pharmacists are unable to generate revenue by billing for their services in most states, quantifying cost avoidance is a common modality to demonstrate the monetary value of clinical pharmacy services. <Read More>

    Combination Immunotherapy Provides Potential Benefits in Controlling, Reducing HIV – May 19, 2021 – A combination immunotherapy of interleukin-21 (IL-21) and interferon alpha (IFN-alpha) in combination with antiretroviral therapy (ART) is effective in generating highly functional natural killer (NK) cells that can help control and reduce simian immunodeficiency virus (SIV) in animal models, according to a study published in Nature Communications. The investigators said this finding is critical for developing additional treatment options to control HIV/AIDS. ART is currently the leading treatment for HIV/AIDS, capable of reducing the virus to undetectable levels. However, ART is not a cure, and it is hampered by issues such as cost, adherence to medication treatment plan, and social stigma, according to the study. <Read More>

    Community Pharmacy Evolves to Provide Direct Patient Care – May 19, 2021 – Collaboration with academic centers expands clinical services to help support health care goals. The community pharmacy is often the first place where patients, residents, and even future students of the profession meet with a pharmacist. Pharmacists play a prominent role in communities nationwide. More than 62,000 community pharmacy locations serve as the front door to the profession …This affects how pharmacies operate and propels them to broaden their focus from a business perspective and public health standpoint. As pharmacists seek new ways to maximize their impact and roles in providing health care services to the public, the need to expand clinical services has become readily apparent. <Read More>

    Reaching Patient-Centered Medical Home Accreditation in Pediatrics – May 18, 2021 – For WVU Medicine Children’s, achieving patient-centered medical home accreditation was a marathon, not a sprint. The organization, whose Pediatric and Adolescent Group Practice got the nod from the National Committee for Quality Assurance in April 2021, said although it more than is worth it, the work for PCMH recognition can sometimes be a slog. “The buy-in is very, very, very important and valuable in this process because it is a team that gets you there,” Janani Narumanchi, MD, WVU Medicine Children’s medical director and the PCMH initiative’s physician champion, said in an interview with PatientEngagementHIT. “Because there were times the momentum gets lost. In the beginning, you are very enthusiastic. When you’re seeing the finish line, you’re enthusiastic. It comes up. Enthusiasm comes all the way back up. But in the middle, when it’s just the daily mundane paperwork and stuff, sometimes the steam goes out.” <Read More>

    House Committee Uncovers How Humiraä’s Price Spiked by 470% as AbbVie Execs Cashed Bonuses Tied to the Hikes – May 18, 2021 – Prior to the House Committee on Oversight’s grilling of AbbVie CEO Richard Gonzalez on Tuesday, the committee staff released a 57-page report following a two year investigation into how and why the company spiked the price of Humiraä (adalimumab) and made it the highest-grossing drug of all time. While the committee investigation and public lashing aren’t likely to do actual damage to AbbVie’s bottom line or bring new Humira biosimilar competition before 2023 in the US, the report digs into how AbbVie used more than two dozen price increases, shadow pricing with Amgen’s blockbuster Enbrelä, and patent thickets to block competition while amassing more than $170 billion in net revenue from Humiraä since 2003. <Read More>

    Reports: Drug Manufacturers and Middlemen Both Responsible for Rising Consumer Costs – May 18, 2021 – The world of prescription drug pricing can be bewildering — intentionally so, some critics of the industry claim. Whether that’s true or not, several reports this year show that the supply chain’s alchemy of list prices, rebates and net prices hurts consumers. And a U.S. Senate report says drugmakers and middlemen share the blame. The media often breathlessly report increases in list prices of more-expensive, brand-name drugs. “Big drugmakers just raised their prices on 500 prescription drugs,” read the headline of a January story by CBS News, for example. But the story didn’t mention that government payers, insurance companies and the middlemen they hire usually pay far less than the list price. As Johnson & Johnson owner Janssen Pharmaceuticals reported, the net cost of its branded drugs actually fell by 14.4% since 2016. <Read More>

    Vancomycin and the Move to AUC-Based Dosing – May 18, 2021 – Dosing practices for vancomycin remain notoriously uneven, which is one of the reasons why updated 2020 guidelines on the antibiotic are still so important to heed, several ID experts told Pharmacy Practice News. The guidelines represent a significant change in practice (Pharmacotherapy 2020;40[4]:363-367). Under the new recommendations, dosing vancomycin using trough-only monitoring—as has been the standard for the past decade—is no longer recommended. Instead, a more individualized approach is urged, using the 24-hour area under the curve to minimum inhibitory concentration ratio (AUC24:MIC). <Read More>

    Could a Mobile Cleanroom be a Solution for Your Pharmacy? – May 18, 2021 – Between 2018 and 2020, the Smilow Cancer Network of Yale New Haven Health underwent a major expansion, which included adding new cleanrooms and expanding existing ones at several locations within the network of 14 cancer centers and the flagship Smilow Cancer Hospital…The solution? A mobile cleanroom. Several vendors, including Germfree and Cleanroom Design LLC, offer a variety of temporary cleanroom options, with some literally on wheels and able to be parked outside a facility for as long as a facility needs them, and other modular options that can be built off-site and configured for a variety of sizes and layouts before delivery to your institution. <Read More>

    Public Opioid Policy May Interfere with Hospice Patients’ Pain Management – May 17, 2021 – Public policy intended to reduce opioid abuse and addiction appear to have the unintended consequence of limiting hospice patients’ access to these often necessary pain management drugs. Misapplication of current U.S. Centers for Disease Control & Prevention (CDC) guidelines for opioid prescribing is a likely contributor to this problem. Recent research spearheaded by the Oregon State University (OSU) College of Pharmacy examined the medical records of 2,500 hospital patients who were discharged to hospice between 2010 and 2018. Findings indicate that opioid prescriptions for hospice patients are on a downward trend (a 12% decline), while the use of less powerful, non-opioid medications is rising. Researchers expressed concern that these trends mean that many hospice patients are being under-treated for pain. The findings appeared in the Journal of Pain & Symptom Management. <Read More>

    Smoking, Oxygen Use Linked to Higher Hospitalization Risk in IPF – May 17, 2021 – While receiving treatment at specialized centers lowers the risk of hospitalization among patients with idiopathic pulmonary fibrosis (IPF), being a former smoker and requiring oxygen therapy are both associated with a higher likelihood of hospitalization. These are some of the findings of multiple studies that Boehringer Ingelheim will present about the management of pulmonary fibrosis associated with interstitial lung disease (IPF-ILD) at the 2021 American Thoracic Society (ATS) International Conference, held online, May 14–19. <Read More>

    Algorithm Drives More Appropriate PN Use in Children – May 17, 2021 – Focusing on patient safety and engaging front-line dietitians in the development of an algorithm for appropriate use of pediatric parenteral nutrition allowed Seattle Children’s Hospital to achieve a significant, sustained reduction in PN usage and reduced the likelihood that PN contributed to central line–associated bloodstream infections (CLABSIs). After implementing a four-step quality improvement project on appropriate initiation, weaning and discontinuation of PN at the hospital, the number of PN orders written per day declined from an average of 45 to 32, said Amber Pulido, PharmD, BCPS, BCNSP, a parenteral nutrition program pharmacist at the medical center. <Read More>

    340B in the News

    Eli Lilly Wants Court to Halt HRSA From Issuing Penalties Over 340B Contract Pharmacy Moves – May 21, 2021 – Eli Lilly is asking a federal court to stop the federal government from imposing any penalties over its decision to restrict sales of 340B-discounted products to contract pharmacies. The request for a preliminary injunction and temporary restraining order filed late Thursday comes less than a week after the Health Resources and Services Administration wrote to Lilly and five other drug companies over the contract pharmacy restrictions. The injunction and order show that drug companies appear likely to fight HRSA’s order to immediately offer 340B-discounted drugs to contract pharmacies, which are third-party entities that dispense drugs on behalf of the 340B covered entities. <Read More>

    HRSA Orders Drug Manufacturers to Pay 340B Contract Pharmacies – May 21, 2021 – The Health Resources and Services Administration (HRSA), which oversees the federal 340B Drug Pricing Program, has directed six drug manufacturers to immediately resume providing 340B discounted pricing to contract pharmacies without restrictions, and warned that they face Civil Monetary Penalties (CMPs) if they do not do so immediately. In letters sent May 17 to the manufacturers—AstraZeneca, Lilly USA, Novartis, Novo Nordisk, Sanofi and United Therapeutics—HRSA acting Administrator Diana Espinosa, MPP, wrote that each manufacturer “must immediately begin offering its covered outpatient drugs at the 340B ceiling price to covered entities through their contract pharmacy arrangements, regardless of whether they purchase through an in-house pharmacy.” She also noted that they must comply with 340B statutory obligations and the 340B program’s CMP final rule, and “credit or refund all covered entities for overcharges that have resulted from (the) policy.” <Read More>

    340B Program: AHF Salutes Biden Administration for Ordering Six Drug Companies to Restore Price Discounts – May 18, 2021 – AIDS Healthcare Foundation (AHF) commended the Biden administration for holding shameless, greedy drug companies accountable for illegally denying price discounts on prescription drugs to nonprofit clinics and hospitals because they were using contract pharmacies. On May 17, the U.S. Health Resources Services Administration (HRSA) sent six letters informing AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, Sanofi and United Therapeutics that they are in direct violation of the statute establishing the 340B Drug Pricing Program. (HRSA press statement on violation letters). “Thousands of non-profit providers depend on the 340B program to keep their doors open to serve vulnerable populations. 340B costs taxpayers nothing and stretches federal programs that strengthen the healthcare safety net, already severely stressed by a system that enriches the for-profit pharmaceutical industry,” said Laura Boudreau, Chief of Operations, Risk Management and Quality Improvement for AHF. “We’re delighted the Biden Administration has shown it will defend the 340B Program that the pharmaceutical industry tries every day to strangle. However, the war is not over. We hope the administration takes the battle to other 340B predators, such as pharmacy benefit managers and private insurance companies that are trying to steal the 340B benefits that support safety net clinics and rural hospitals.” <Read More>

    Eli Lilly Fires Back Against HHS Order to Repay Providers for Violating 340B – May 18, 2021 – Late Thursday, drug manufacturing giant Eli Lilly filed a motion in an Indiana district court to halt 340B-related monetary penalties, scant days after the Biden administration set a June 1 deadline for biopharmaceutical companies to comply with new conditions in the drug discount program and allow hospital contract pharmacies access to discounted drugs. The suit alleges a Monday letter from Diana Espinosa, acting head of the Health Resources and Services Administration, gives “no legal explanation or justification for the arbitrary June 1 deadline.” <Read More>

    Biden Administration Throws Down Its First Gauntlet on 340B – May 18, 2021 – On May 17, 2021, the Biden Administration took its first major action impacting the 340B Drug Discount Program.  In a forceful statement, the Administration made plain its views on a major controversy that has pitted drug manufacturers against 340B covered entities for the past year – proclaiming that drug manufacturers are violating the 340B statute by restricting covered entity access to 340B discounts for drugs dispensed through 340B contract pharmacies. <Read More>