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Clinical Insights: October 18, 2023

Posted on October 18, 2023 By RxStrategies, Inc. -

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/Vaccine Approval

Velsipity™ (etrasimod) Tablets – New Drug Approval – October 12, 2023 – Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved Velsipity™ (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC). The approved recommended dose for Velsipity™ is 2 mg.  <Read More>

New Indication/Dosage/Formulation Approval

Keytruda® (pembrolizumab) for Injection – New Label Expansion – October 16, 2023 – the Food and Drug Administration approved pembrolizumab (Keytruda®, Merck) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). Efficacy was evaluated in KEYNOTE-671 (NCT03425643), a multicenter, randomized, double-blind, placebo-controlled trial in 797 patients with previously untreated and resectable Stage II, IIIA, or IIIB (N2) NSCLC by AJCC 8th edition. <Read More>

Opdivo® (nivolumab) Injection – New Label Expansion – October 13, 2023 – Bristol Myers Squibb (NYSE: BMY) announced that Opdivo® (nivolumab) was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma, expanding upon the existing adjuvant indication for Opdivo® and further reinforcing the company’s legacy of providing treatment options for melanoma patients.1 The approval is based on the Phase 3 CheckMate -76K trial, which compared Opdivo® (n=526) to placebo (n=264). <Read More>

Braftovi® (encorafenib) Capsules – New Label Expansion – October 11, 2023 – the Food and Drug Administration approved encorafenib (Braftovi®, Array BioPharma Inc., a wholly owned subsidiary of Pfizer) with binimetinib (Mektovi®, Array BioPharma Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. FDA also approved the FoundationOne CDx (tissue) and FoundationOne Liquid CDx (plasma) as companion diagnostics for encorafenib with binimetinib. If no mutation is detected in a plasma specimen, the tumor tissue should be tested. <Read More>

New Drug Shortage

October 16, 2023

Updated Drug Shortage

October 16, 2023

October 13, 2023

October 12, 2023

October 11, 2023

October 10, 2023

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

The Value of a Pharmacy Technician – October 17, 2023 – Pharmacy Technician Day celebrates the myriad contributions of the unsung heroes of health care. On the third Tuesday of every October, we take a day to recognize pharmacy technicians, to celebrate the often-called “unsung heroes” of health care. But one day simply is not enough. At the Pharmacy Technician Certification Board (PTCB), we understand the immense value that pharmacy technicians bring to the health care system and the lives of patients. Because this important work is often behind the scenes, rather than words from us, we want to amplify the voices of a few of the many pharmacy technicians who are making a difference every day in their own lives and their communities: <Read More>

Ten Tips to Survive a Toxic Work Environment – October 16, 2023 – Pharmacy technicians are professionals who play an important role in today’s health care landscape, but dealing with a toxic work environment can significantly affect their motivation, productivity, and even their physical and mental health. Resignation from toxic job, workplace or relationship concept. There are many positions that can be deeply rewarding, but every so often, a workplace becomes a toxic work environment. It could be caused by a bad manager, a new coworker, or a new company that seems just not to care about its employees. A toxic work environment can drastically reduce productivity, affect employees’ mental health, and actually cause physical health issues. With deadlines, urgent orders, and patients to accommodate, pharmacy technicians need to handle a lot of stress and be mentally sharp at all times. Unfortunately, when working in a toxic environment, those challenges and the additional stresses are amplified. <Read More>

Kaiser Pharmacy Workers Continue 3-Week Strike, Approve to Double it – October 16, 2023 – As hundreds of pharmacy workers for Kaiser Permanente continue striking for up to three weeks in Oregon and Southwest Washington, their union approved another strike that could last almost four more weeks. The strike of pharmacy technicians, clerks and warehouse workers began Oct. 1 while UFCW Local 555 meets with representatives for the Oakland, Calif.-based system. The union said Kaiser offered “an insulting, out-of-touch proposal” to increase wages 3% every year. UFCW Local 555 is bargaining for a 43% wage increase over four years. <Read More>

Debunking the Myths: Pharmacy Technician Administration of Vaccines – October 16, 2023 – Engaging technicians in immunizations has been crucial to public health. In 2016, a seemingly shocking idea surfaced out of the state of Idaho: allowing pharmacy technicians to administer vaccinations. Gossip among the profession and on social media spread quickly, with many saying it would be unsafe and arguing that pharmacists should not give up this hard-won responsibility. What started as rumors, however, began to be taken seriously, and word spread at state and national pharmacy meetings. Over the next few years, boards of pharmacy continued to discuss the issue, and in 2019, the topic was presented in a poster at the National Association of Boards of Pharmacy Annual Meeting. <Read More>

Pharmacy Chain Rite Aid Files for Bankruptcy Amid Declining Sales and Opioid Lawsuits – October 16, 2023 – Major U.S. pharmacy chain Rite Aid said Sunday that it has filed for bankruptcy and obtained $3.45 billion in fresh financing as it carries out a restructuring plan while coping with falling sales and opioid-related lawsuits. In 2022, Rite Aid settled for up to $30 million to resolve lawsuits alleging pharmacies contributed to an oversupply of prescription opioids. It said it had reached an agreement with its creditors on a financial restructuring plan to cut its debt and position itself for future growth and that the bankruptcy filing was part of that process. <Read More>

Vaccine Update: What Pharmacists Need to Know About ACIP’s New Guidelines –  October 15, 2023 – The CDC’s Advisory Committee on Immunization Practices (ACIP) has been hard at work over the past year. Updated guidelines around certain vaccines and newly approved products have been on the committee’s agenda throughout 2023. These include respiratory syncytial virus (RSV) vaccines, updates regarding influenza vaccines, and potential vaccine candidates in the pipeline, among a few others. During a presentation at the National Community Pharmacists Association (NCPA) 2023 Annual Convention and Expo, Jean-Venable R. Goode, PharmD, director of the PGY1 Community Based Residency Program at Virginia Commonwealth University, discussed in detail the new guidelines from ACIP. <Read More>

Pharmacy Staff From Walgreens, Other Chains Could Stage Nationwide Walkout and Rallies in Coming Weeks – October 14, 2023 – Pharmacy staff from Walgreens are laying the groundwork for a nationwide walkout and multiple rallies at the end of October to protest unsatisfactory working conditions, and are in talks with employees from other retail pharmacies about joining them, CNBC has learned. Those potential plans, which some CVS employees are considering joining in, reflect years of growing discontent among retail pharmacy staff. One organizer sees nationwide walkouts across several retail pharmacy chains as the “next step” in the fight against current working conditions for pharmacists, pharmacy technicians and other support staff. <Read More>

Rethinking STI Testing Through Partnerships Between Community Pharmacy and Public Health – October 14, 2023 – Rates of sexually transmitted infections (STIs) in the United States are high—“far too high,” according to Melissa A. Habel, MPH, strategic partnerships and planning lead at the Division of STD Prevention at the CDC. In 2021, more than 2.5 million cases of chlamydia, gonorrhea, syphilis, and congenital syphilis were reported to the CDC. Although chlamydia rates have decreased, rates of gonorrhea, syphilis, and syphilis among newborns have increased since 2017. “This endemic of HIV, STI, viral hepatitis, substance use, and mental health…highlight the overlapping risk factors, as well as associations with the social determinants of health,” said Habel. <Read More>

Attract New Patients, Increase Sales With These Pharmacy Remodeling Tips – October 14, 2023 – It’s an undeniable fact of owning an independent pharmacy; your store needs a good face-lift every now and then. But what’s the best way to go about doing it? Gabe Trahan, former senior director of store operations and marketing at the National Community Pharmacists Association (NCPA), said during a presentation at NCPA’s Annual Convention and Expo that it’s about more than just a new paint job and getting rid of old carpets. Check out these top tips for retaining old customers, attracting news ones, and boosting sales. <Read More>

Guide Gives Pharmacists Road Map for Using Opioid Settlement Funds to Benefit Communities – October 12, 2023 – The Pharmacy Society of Wisconsin (PSW) released a tool kit to aid pharmacists and government officials in obtaining and allocating funds from a major settlement with the nation’s top three pharmaceutical distributors (Cardinal, McKesson and AmerisourceBergen) and the pharmaceutical manufacturer Johnson & Johnson relating to their culpability in the opioid crisis. The Wisconsin Department of Justice announced the settlement with opioid makers, which totaled more than $400 million, last February. Manufacturers of the drugs acknowledged culpability for deceptively downplaying the risk for addiction from their products while overstating their benefits, and encouraging doctors to treat patients showing signs of addiction by prescribing them more opioids. <Read More>

NCPA: Community Pharmacies Can Fill Gaps as National Chains Close Branches – October 12, 2023 – A new report from the National Community Pharmacists Association (NCPA) said community pharmacies are ready to step up and support patients as national chains cut pharmacy hours or close some branches outright. At the same time, those independent pharmacies said low reimbursements and other contracting issues could challenge those efforts. In a Sept. 28 announcement, the NCPA said the feedback came from its new survey of independent pharmacy owners and managers, and was in response to “news reports indicating that several major pharmacy chains are or will soon be cutting hours and shuttering stores as part of cost-saving strategies.” <Read More>

“We Should all Have an Equity Lens”: Insights From Hospital Equity Officers – October 12, 2023 – Interest in diversity, equity, and inclusion (DEI) in healthcare grew substantially in 2020 as a result of Black Lives Matter and other social justice movements. Hospitals recognized the need for an institutional focus on equity and many developed DEI offices to address this need. From 2019-2022, “Chief diversity and inclusion officer” was the fastest-growing c-suite position, Becker’s Healthcare reported. <Read More>

Why Pharmacists Still Fax – October 11, 2023 – The CDC is making a new push to encourage health facilities to share data with public health authorities using electronic case reports (eCR) rather than faxes. Electronic case reports automatically compile information from electronic health records (EHRs) about a patient’s demographics, clinical outcomes and risk factors. Before the COVID-19 pandemic, such case reports were barely in use in the United States, but now they are very widespread. CDC reports that 22,000 health facilities can file eCR today, compared with just 200 in early 2020. However, despite the seemingly clear advantage of avoiding faxes, their use also remains widespread throughout healthcare, including in pharmacy. This is not merely a case of inertia, a pharmacy leader told Pharmacy Technology Report. <Read More>

Twenty-two Healthcare Controversies in 1 Week – October 10, 2023 – Here are 22 healthcare industry-related controversies, investigations and other legal incidents reported by Becker’s since Oct. 3:  1) Brian Hyatt, MD, the former head of Arkansas’ state medical board, was arrested in connection with an alleged Medicaid fraud scheme. More than 40 patients have also accused Dr. Hyatt in civil lawsuits of imprisoning them against their will while running the behavioral health unit between February 2018 and May 2022, 2) A lawsuit was filed against Costco that alleges the warehouse club company shared customers’ protected health information with Facebook parent company Meta, 3) Two men with loaded handguns were arrested at Rochester (N.Y.) General Hospital. The men were taken into custody and each charged with two counts of criminal possession of a weapon… <Read More>

340B in the News

Surging Drug Sales Under Controversial Program Raises Concerns – October 13, 2023 – The Health Resources and Services Administration (HRSA) has reported a significant 22.3% surge in wholesale 340B prescription medication sales, reaching a staggering $53.7 billion from 2021 to 2022. This controversial program, in which about one-third of the nation’s hospitals participate, mandates manufacturer discounts on most outpatient pharmaceuticals to support safety-net providers. However, this surge in sales has not come without its fair share of controversy. Drugmakers have increasingly voiced concerns about providers potentially abusing the program, leading to a series of manufacturer-imposed restrictions, legal battles, and heightened lobbying efforts in recent months. <Read More>

A Year After Scathing New York Times Article, Bon Secours’ Prescription for East End Community Includes Jobs, Training, Upgraded Facilities – October 12, 2023 – Richmond Community Hospital continues to buzz with construction as its owner, Bon Secours, builds up operations at the East End health care center. The hospital system also is undertaking a major employee recruitment effort with the city’s Office of Community Wealth Building to fulfill its promise to diversify its work force and provide job opportunities for people living near the hospital. All of the projects are part of Bon Secours’ efforts to carry out a three-year plan to upgrade health offerings and services at the 104-bed hospital that it purchased in 1995 from a group of Black doctors. The projects also are intended to end criticism that Bon Secours used Richmond Community as a cash machine for the rest of its Richmond-area operations. <Read More>