Clinical Insights: October 19, 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

    Tavneos™ (avacopan) – New Orphan Drug Approval – October 8, 2021 – ChemoCentryx, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Tavneos (avacopan), an orally administered selective complement 5a receptor inhibitor, as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (also known as ANCA-associated vasculitis or ANCA vasculitis), specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA vasculitis), in combination with standard therapy. ANCA-associated vasculitis is a systemic autoimmune disease in which over-activation of the complement system further activates neutrophils, leading to inflammation and eventual destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is often fatal if not treated. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Tecentriq® (atezolizumab) Injection – New Indication Approval – October 15, 2021 – The Food and Drug Administration approved atezolizumab (Tecentriq®, Genentech, Inc.) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test. The FDA also approved the VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems, Inc.) as a companion diagnostic device to select patients with NSCLC for adjuvant treatment with Tecentriq®. <Read More>

    Keytruda® (pembrolizumab) for Injection – New Indication Approval – October 13, 2021 – The Food and Drug Administration approved pembrolizumab (Keytruda®, Merck) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test. FDA also granted regular approval to pembrolizumab as a single agent for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. In June 2018, FDA had granted accelerated approval to this indication with the companion diagnostic, PD-L1 IHC 22C3 pharmDx (Dako North America Inc.). <Read More>

    Verzenio® (abemaciclib) Tablets – New Indication Approval – October 13, 2021 – The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company’s Verzenio® (abemaciclib), in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test. Ki-67 is a marker of cellular proliferation. Verzenio® is the first and only CDK4/6 inhibitor approved for this patient population. <Read More>

    Dextenza® (dexamethasone) Ophthalmic Insert – New Indication Approval – October 7, 2021 – Ocular Therapeutix, a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced the U.S. Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (sNDA) to broaden the Dextenza® label to add an additional indication for the treatment of ocular itching associated with allergic conjunctivitis. With the approval, Dextenza® is the first, FDA-approved, physician-administered intracanalicular insert capable of delivering a preservative-free drug for the treatment of ocular itching associated with allergic conjunctivitis with a single administration for up to 30 days. Dextenza® originally received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery, followed by an expansion of the label to also include the treatment of ocular inflammation following ophthalmic surgery in June 2019. <Read More>

    New/Updated Drug Shortage

    October 18, 2201

    October 15, 2021

    October 13, 2021

    October 12, 2021

    New Drug Recall and Safety Alerts

    Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets by  Lupin Pharmaceuticals, Inc. – New Voluntary Recall – October 14, 2021 – Lupin Pharmaceuticals Inc. is voluntarily recalling the below-mentioned batches of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level. As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan. Although Lupin has received no reports of illness that appear to relate to this issue, the company, out of an abundance of caution, is recalling all batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the US. Lupin discontinued the marketing of Irbesartan and Irbesartan and HCTZ tabs in Jan 2021. <Read More>

    Lidocaine HCl Topical Solution 4% by Teligent Pharma, Inc. – New Voluntary Recall – October 12, 2021 – Buena, NJ, Teligent Pharma, Inc. is voluntarily recalling the five lots of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle listed in the table below to the user level. The product is being recalled because the firms testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 18-month stability timepoint. Risk Statement: Use of the super potent product would result in a higher than intended lidocaine dose above that intended. An increased lidocaine dose could lead to the development of local anesthetic systemic toxicity depending on the duration of the treatment and the specific patient. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    A Pharmacist’s Personal Experience: Breaking Down Stigma to Improve Outcomes in ADHD – October 18, 2021 – Misconceptions about the diagnosis of attention-deficit hyperactivity disorder reduce the credibility of health care providers and delay or prevent treatment for patients suffering from this condition. “Mom, is having ADHD something I should be sad or worry about?” my 9 year old son asked one day when I picked him up after school. In that moment, my mind raced to hundreds of possible situations that could have prompted this question. My husband and I have always been open and honest with him about his diagnosis and included him in discussions about his treatment, including his feelings on efficacy and adverse effects. We have done our best to avoid and address social stigmas associated with attention-deficit hyperactivity disorder (ADHD) and provide him with meaningful responses to address situations. <Read More>

    Pharmacists Must Digitize Business Now to Keep Up With Changing Patient Needs – October 18, 2021 – The COVID-19 pandemic and the rapid digital adoption of mobile devices have changed the role of the community pharmacist. Remember the big, boxy, snail-slow computers from the early days? If you had told me back then that someday, the processing power on those computers would fit into the palm of my hand, I probably wouldn’t have believed you. But as modern pharmacists, we know that our patients and their needs have changed. Now they do everything on their phones and if we want to keep up—if we want to keep new patients coming through our doors—we must adapt our business to the new reality. <Read More>

    Clinical Practice Recommendations Published For Immunotherapy to Treat Breast Cancer – October 16, 2021 – The Society for Immunotherapy of Cancer published clinical practice guidelines for treating patients with breast cancer using immunotherapy. The Society for Immunotherapy of Cancer (SITC) recently published the first clinical practice guidelines focusing on immunotherapy as treatment for patients with breast cancer utilizing a panel of leaders in immunotherapy and breast oncology along with patient advocates and breast cancer survivors. “Immunotherapy is now offering some patients with breast cancer clinically meaningful benefit in early-stage and advanced disease,” Jennifer Litton, MD, chair of the SITC Breast Cancer Immunotherapy Guideline Expert Panel, said in a press release. “It is important for clinicians and patients to understand that immunotherapy is very different from traditional breast cancer treatments, and this new guideline offers the expert guidance needed to safely consider these treatments.” <Read More>

    Buprenorphine Misuse Decreased Among U.S. Adults With Opioid Use Disorder From 2015-2019 – October 15, 2021 – Data from a nationally representative survey indicate that in 2019, nearly three-fourths of U.S. adults reporting buprenorphine use did not misuse the medication in the past 12 months. In addition, buprenorphine misuse among people with opioid use disorder trended downward between 2015-2019, despite increases in the number of people receiving buprenorphine treatment. The study, published in JAMA Network Open, was conducted by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, and the Centers for Disease Control and Prevention. <Read More>

    Six Execs Share the Dangers of Pharmacy Burnout – October 15, 2021 – Pharmacy staff members across the country are reporting unprecedented levels of burnout, an issue that could not only negatively affect employees’ mental health, but also patient safety.  Here, six pharmacy leaders from health systems across the country detail the negative effects of pharmacy burnout. Burnout can happen in any profession, but in the healthcare workforce it not only results in decreased productivity and higher rates of turnover, it can also lead to medication errors and increased patient harm. Although the prevalence and effects of burnout in physicians and nurses have been well-researched, this is a relatively new area of study in pharmacy staff. <Read More>

    Pharmacists Get the Call To Help With COVID-19 Rx – October 14, 2021 – The Department of Health and Human Services’ recent decision to allow licensed pharmacists to order and administer selected COVID-19 therapeutics was welcomed by ASHP and other professional groups that had been pushing for the policy change. But in many facilities, the change just codified something that pharmacists have been doing throughout the pandemic. Whether it’s administering monoclonal antibodies (mAbs) or other COVID-19 therapeutics, front-line pharmacists have been stepping in for medical staffs overwhelmed by surging COVID-19 caseloads. <Read More>

    New Guidelines Include Updates for CLE Treatment, Management – October 14, 2021 – An international group of researchers devised updated guidelines on the management and treatment of cutaneous lupus erythematosus (CLE). In a recently published Journal of Autoimmunity article, researchers from across America, Asia, and Europe outlined an evidence- and consensus-based guideline to provide dermatologists and rheumatologists with practical recommendations for diagnosis, treatment, and long-term management of cutaneous lupus erythematosus (CLE). The guidelines are based on a checklist established by the international Reporting Items for Practice Guidelines in Healthcare (RIGHT) Working Group. Specifically, the standards agreed upon by at least 80% of the 32 voting physicians include the statements that evaluation of systemic involvement is needed to exclude systemic lupus erythematosus (SLE) prior to diagnosing CLE and that patients with CLE require education and long-term follow-up. <Read More>

    What is the Ideal Duration of Daptomycin and Ceftaroline Combination Therapy for MRSA Bacteremia? – October 14, 2021 – Staphylococcus aureus is the leading cause of bloodstream infections worldwide, associated with a high incidence of metastatic infections such as infective endocarditis and osteomyelitis. The Infectious Diseases Society of America clinical guidelines for the management of MRSA infections endorse the use of vancomycin or daptomycin as standard therapy for MRSA bacteremia. However, recent studies have shown that a combination of standard therapy plus an antistaphylococcal β-lactam (eg, nafcillin, cefazolin) may enhance bactericidal activity and improve outcomes, such as reduced duration of bacteremia, recurrence, and mortality in patients with persistent MRSA bacteremia. Proposed mechanisms include β-lactam-induced reduction in cell wall cross-linking, allowing increased daptomycin and vancomycin binding and β-lactam synergy with cationic host defense peptides against MRSA. <Read More>

    Replacing and Upgrading Automated Dispensing Cabinets – October 14, 2021 – Automated dispensing cabinets (ADCs) provide critical support to hospital staff, but they have a finite life span. Fortunately, health systems can transition to new ADCs at new and existing facilities with minimal disruptions to patient care, as illustrated by a case report presented at Omnicell Illuminate 2021. James L. Besier, PhD, MS, RPh, the pharmacy manager of Shriners Children’s Ohio, in Dayton, described how his hospital transitioned from a stand-alone facility to a “hospital within a hospital” with nearby Dayton Children’s Hospital and used six ADCs to compensate for an 82% reduction in the pharmacy’s physical floor space, from 1,608 to 310 square feet. <Read More>

    Walgreens to Invest Over $5.5 Billion in Health Services Push – October 14, 2021 – Walgreens Boots Alliance Inc (WBA.O) said on Thursday it would take majority stakes in two smaller health care providers for about $5.5 billion, as the second largest U.S. pharmacy chain shifts focus beyond its drugstores. Shares in Walgreens rose nearly 7% to $50.44 in afternoon trading after it reported fourth-quarter results that beat estimates, helped by easing pandemic-related restrictions and COVID-19 vaccine administrations at its stores. The company said it would make a $5.2 billion investment in VillageMD, raising its stake in the primary care provider to 63%. It will also invest $330 million in post-acute and home care provider CareCentrix to take a 55% stake. <Read More>

    How Alternative Funding Programs Can Ease the Cost Burden of Specialty Drugs – October 13, 2021 – Imagine being prescribed a medication for the management of a debilitating chronic condition that costs $6,000 a month. That’s a far cry from a $30 copay…Given the importance and utilization of specialty drugs, how can pharmacy benefits managers (PBMs) help ease the cost burden so that patients can get the medications they need without it being a financial detriment for employers and employees? Before exploring how to make specialty drugs more affordable, it’s important to understand the factors behind their cost. <Read More>

    GERD Occurs in a Range of Severities – October 13, 2021 – Finding relief can be frustrating and takes effort and time for many patients, but pharmacists can help. Heartburn and acid regurgitation are common problems, and almost everyone experiences an episode occasionally after consuming fried foods or alcohol with a hearty meal, or during pregnancy. Some of these symptoms are categorized as functional heartburn or dyspepsia. For some people, acid regurgitation and heartburn become frequent, and they receive a diagnosis of gastroesophageal reflux disease (GERD). In the Western world, about 30% of the population has GERD. For patients, the condition is annoying, often painful and sleep disturbing, and disruptive to quality of life. For practitioners, GERD is time-consuming. For health care systems, it consumes more than its fair share of resources. <Read More>

    How an Online Pharmacy Made Millions Selling Unproven COVID-19 Drugs – October 13, 2021 – Digital pharmacy Ravkoo took advantage of relaxed telehealth and prescribing regulations to fill thousands of prescriptions amid the pandemic, most of which were for unproven COVID-19 treatments promoted by anti-vaccination groups, Time reported Oct. 13. From November 2020 to September 2021, Ravkoo filled at least 340,000 prescriptions, which totaled an estimated $8.5 million in drug costs, according to data The Intercept hacked and published. Nearly half of the prescriptions Ravkoo has filled were for ivermectin or hydroxychloroquine, and another 30 percent were zinc or azithromycin. All four drugs have been touted as COVID-19 cures by anti-vaccination groups, though there is no evidence showing they effectively treat the virus. <Read More>

    Independent Pharmacy Cooperative Issues Public Comment on FTC Notice – October 13, 2021 – The Independent Pharmacy Cooperative (IPC) represents the interests of pharmacist owners, managers, and employees of more than 2600 independent community pharmacies located in all 50 States and the District of Columbia…IPC applauds the Commission’s new policy direction to examine how current business contracting practices harm the public, consumers, the marketplace, and other business – especially small business. This is especially welcoming to see the FTC taking a fresh perspective to understand how in the prescription drug benefit marketplace, the business practices of Pharmacy Benefit Managers (PBM) have proven to be detrimental to the interests of consumers, including business consumers of prescription drug benefit coverage. <Read More>

    APhA Members Unite to Advocate for Pharmacy Patients – October 12, 2021 – APhA members representing 31 states, Puerto Rico, and the District of Columbia gathered last week to flex their political muscles at the organization’s first virtual congressional conference. Over the course of the 3-day conference, participants got a crash course on crucial pharmacy practice legislation, worked with colleagues on advocacy strategy, and met with Members of Congress and their staff. During a total of 145 meetings, the APhA members urged their lawmakers to support 2 pieces of legislation that would expand access to pharmacists’ care, save money for patients and the health care system, and improve health outcomes. <Read More>

    Women Pharmacists Day: The Evolution of Women’s Role in US Pharmacy Practice – October 12, 2021 – As of 2020, approximately 62%-75% of pharmacists in the United States are female. That is a dramatic rise from the approximately 14% proportion that existed in the mid 1960s, and would have been an almost unimaginable amount just a century ago. Although October has long been celebrated as National Pharmacy Month, it is only in recent years that female pharmacists have been celebrated for their contributions to the profession and patient care. Starting in 2018, October 12 is now annual observed as National Women Pharmacist Day after its creation by Pharmacist Moms Group leader Suzanne Soliman, PharmD, BCMAS. <Read More>

    Drug Pricing in the USA – Will Things Change Under Biden? – October 10, 2021 – Since Donald Trump’s 2018 “American Patients First” plan, and long before, drug pricing in the USA has been both a lightning rod for strong opinions and stubbornly resistant to reform. In a new political cycle, with several years of political squabbling behind us, it may now seem a lifetime since Mr. Trump promised that drug prices would “come rocketing down”… Nine months into the job, new American president Joe Biden has taken up the mantle of pricing hawk, with more tough talk on the subject and the appointment of a like-minded Health and Human Services (HHS) Secretary, Xavier Becerra. <Read More>

    340B in the News

    United States: Pharmaceutical Antitrust – October 12, 2021 – The past year has continued to see an increase in US case law and other developments in the area of pharmaceutical antitrust. In this article we look at, among other things, antitrust claims under the rule of reason test announced by the US Supreme Court in Federal Trade Commission v Actavis for innovator and generic settlements of pharmaceutical patent litigation involving alleged reverse payments or ‘pay-for-delay’, product-hopping antitrust claims against innovator pharmaceutical companies that introduce new versions of brand-name drugs facing generic competition, and pharmaceutical pricing developments involving legislation, regulations and legal challenges in court. <Read More>

    340B Drug Pricing Program and Hospital Provision of Uncompensated Care – October 11, 2021 – Participation in the 340B Drug Pricing Program by general acute care hospitals and critical access hospitals has not been associated with increased provision of uncompensated care. Objectives: To evaluate whether hospital entry into the 340B Drug Pricing Program, which entitles eligible hospitals to discounts on drug purchases and intends for hospitals to use associated savings to devote more resources to the care of low-income populations, is associated with changes in hospital provision of uncompensated care. Study Design: We analyzed secondary data on 340B participation and uncompensated care provision among general acute care hospitals and critical access hospitals from 2003 to 2015. We constructed an annual, hospital-level data set on hospital 340B participation from the Office of Pharmacy Information Systems and on uncompensated care provision from the Hospital Cost Reporting Information System. <Read More>

    HHS Rescinds Rule to Provide Insulin and Injectable Epinephrine at 340B Prices – October 11, 2021 – The United States Department of Health and Human Services (“HHS”) rescinded the final rule entitled “Implementation of Executive Order on Access to Affordable Life-Saving Medications.” The rule required FQHCs and other recipients of grant funding under Section 330(e) of the Public Health Services Act (collectively “health centers”) a) to make insulin and injectable epinephrine available to eligible patients at or below the price paid by a health center through the 340B Drug Pricing Program and b) to establish practices for assessing patient eligibility. All future 330(e) grant funding was conditioned on compliance. Although the rule intended to help Americans afford vital medications, HHS determined that the rule ultimately would have harmed health centers and, consequently, the patients they serve. <Read More>