Skip to content

Clinical Insights: September 20, 2023

Posted on September 20, 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

Ojjaara™(momelotinib) Tablets – New Drug Approval ­– September 15, 2023 – GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Ojjaara™(momelotinib) for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythaemia), in adults with anaemia. Ojjaara™is a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. To date, it is the only approved medicine for both newly diagnosed and previously treated myelofibrosis patients with anaemia that addresses the key manifestations of the disease, namely anaemia, constitutional symptoms, and splenomegaly (enlarged spleen). <Read More> 

New Indication/Dosage/Formulation Approval

Temodar® (temozolomide) – New Expanded Label – September 14, 2023 – The Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar®, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. This is the second drug to receive a labeling update under this pilot program. The first drug that received approval under Project Renewal was capecitabine (Xeloda®). <Read More>.

New Drug Shortage

September 18, 2023

September 14, 2023

Updated Drug Shortage

September 18, 2023

September 16, 2023

September 15, 2023

September 14, 2023

September 13, 2023

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Clinical Overview: Potentially Harmful Medications in Heart Failure – September 19, 2023 – Heart disease is the leading cause of death in the United States, with heart failure (HF) being one of the most common types of heart disease.1 The prevalence of HF is expected to increase from 6.5 million to >8 million Americans over the age of 20 by 2030. With this increased population, the total cost of care is expected to more than double, from $30.7 billion to $69.7 billion by 2030. An average patient with HF can take up to 6 medications for guideline-directed medical therapy; however, they may have other comorbidities that require pharmacologic management as well. <Read More>

It’s Time to Gear Up for Fall Vaccines – September 19, 2023 – Pharmacists play a vital role in providing education and administering influenza, COVID-19, and RSV Vaccines. Approximately 90% of individuals in the United States live within 5 miles of a community pharmacy, making pharmacists the most accessible health care professionals, particularly when it comes to administering vaccines. In fact, more adults were vaccinated at pharmacies than nonpharmacy medical settings between 2018 and 2022, according to a report by the IQVIA Institute for Human Data Science and the Global Healthy Living Foundation. Additionally, most children received their COVID-19 vaccines from pharmacies during the same period. <Read More>

Fifteen Pharmacists in Hospital C-Suite, Top Leadership Roles – September 18, 2023 – Besides filling the chief pharmacy officer and pharmacy director roles, pharmacists are filling other C-suite and senior leadership jobs in hospitals. Here are 15 hospital leaders who have a pharmacy background and currently serve in other top roles, including CEO, COO and president. 1) Robert Adamson, PharmD, executive vice president and CIO of RWJBarnabas Health (West Orange, N.J.), 2) Nannette Berensen, PharmD, chief operating officer of clinical shared services at Intermountain Health (Salt Lake City), 3) Josh Bright, PharmD, COO of North Arkansas Regional Medical Center (Harrison)…<Read More>

State Enacts Statute Prohibiting Pharmacists From Commenting on Efficacy of Therapy – September 18, 2023 – Pharmacist successfully mounts challenge to that limitation. The legislature of a Midwestern state enacted a statute with potentially negative implications for pharmacists and pharmacies. A pharmacist in the state went to federal court seeking an injunction prohibiting the board of pharmacy from enforcing that statute. Should the court rule in favor of the pharmacist or permit the board to proceed with enforcement action as authorized by the statute? The state legislature enacted a statute during the COVID-19 pandemic that became effective in August 2022. This legislation made an amendment to the state’s pharmacy practice act to prohibit the board of pharmacy from taking enforcement action against pharmacies that distributed ivermectin tablets or hydroxychloroquine sulfate tablets to manage the disease pursuant to an authorized practitioner’s request. <Read More>

Side Effects, Tolerability Are Top Considerations for Prescribing LAI Antipsychotics – September 18, 2023 – Side effects and tolerability ranked as the most important clinical concerns for psychiatric clinicians selecting a long-acting injectable antipsychotic (LAI) to prescribe for their patients with schizophrenia, and the dosing frequency preferred was once per month or less often, according to results from the Determining Clinician factors for Implementing LAIs and Defeating Barriers (DECIDE) survey, presented at Psych Congress, in Nashville, Tenn. In DECIDE, psychiatric clinicians were surveyed regarding their preferences when selecting and initiating LAIs for schizophrenia. DECIDE surveyed 380 practitioners across the United States, including 295 physicians and 85 nurse practitioners/physician assistants. Clinicians were analyzed by LAI use (high [≥31% of their patients using LAIs] versus low [≤14% using LAIs]) and attitude toward LAI archetypes (early LAI use, severity reserved, adherence reserved, LAI-hesitant). <Read More>

Higher Buprenorphine Doses Associated With Improved Retention in Treatment for Opioid Use Disorder – September 18, 2023 – NIH-funded study suggests need to reevaluate opioid addiction treatment recommendations in the era of fentanyl. Individuals with opioid use disorder who were prescribed a lower buprenorphine dose were 20% more likely to discontinue treatment than those on a higher dose, according to a study of patients prescribed buprenorphine in Rhode Island from 2016 to 2020, as fentanyl became widely available. The study, published in JAMA Network Open, was supported by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, and conducted by researchers at Brown University, Providence, Rhode Island; NIDA and the Rhode Island Department of Health. <Read More>

AHA Comments on House Proposed “Lower Costs, More Transparency Act” – September 16, 2023 – On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, our clinician partners — including more than 270,000 affiliated physicians, 2 million nurses and other caregivers — and the 43,000 health care leaders who belong to our professional membership groups, the American Hospital Association (AHA) writes regarding H.R. 5378, Lower Costs, More Transparency Act, provisions. The AHA supports the suspension of the Medicaid disproportionate share hospital (DSH) reductions for two years and appreciates your work to include this provision, however hospitals and health systems strongly oppose efforts to include permanent site-neutral payment cuts. In addition, the AHA has serious concerns about the added regulatory burdens on hospitals and health systems from the provisions to codify the Hospital Price Transparency Rule and to establish unique identifiers for off-campus hospital outpatient departments (HOPDs). <Read More>

RFID Tags Reduce Restocking Errors of Anesthesia Medications – September 15, 2023 – Radiofrequency identification (RFID) tags can help decrease errors when restocking medications on anesthesia workstation carts, according to research conducted at the University of Utah. Implementing the tags led to better identification and replacement of expired medications and enabled one person to restock the carts instead of the two people needed for manual restocking (Am J Health Syst Pharm 2023;80[6]:384-389). “Using RFID in anesthesia workstations, to the best of our knowledge, has not been published about before,” said study author Carlie Wilke, PharmD, MS, BCPS, who is now a pharmacy manager for University of Wisconsin Health Pharmacy Services, in Madison. “It takes longer, but it’s a safer process.” <Read More>

HHS Warns Hospitals About Cyberattacks Via ‘Smishing’ – September 15, 2023 – The Department of Health and Human Services is warning of the dangers of so-called “smishing” attacks, one of the latest ways that cyber intruders are getting into the information technology (IT) networks of hospitals and health systems. Fortunately, experts said, there are proactive steps that health systems can take to prepare employees and patients for these threats. In a report released Aug. 10, HHS explained that smishing is a form of phishing (the by-now familiar practice of sending fraudulent emails in an attempt to steal personal information); in this case, the attacker “uses a compelling text message to trick targeted recipients into clicking a link, which sends the attacker private information or downloads malicious programs to a smartphone,” the report explained. (The term comes from combining SMS [Short Message Service], which refers generally to text messaging, with “phishing.”) <Read More>

Multistate Pharmacies: A Prescription for Navigating the Regulatory Maze – September 15, 2023 – In today’s pharmacy world, most pharmacies, whether large national chains or small regional businesses, are required to hold licenses and registrations in several states. Unfortunately, there is no universal pharmacy license on a federal level that would permit a pharmacy to operate in all 50 states. For pharmacies with multiple locations and/or operations that cross state lines, this complex patchwork of state requirements and licenses can be a regulatory maze. This also means that small errors can add up and lead to disciplinary actions from a state regulatory board. <Read More>

Delinking Deduction – September 15, 2023 – Pharmacy benefit managers (PBMs) are all the rage – often literally – on Capitol Hill these days, and they’ve been targeted with a variety of legislative proposals in the past several months. On Tuesday, Dr. Casey Mulligan, a PhD economist at the University of Chicago (full disclosure: Dr. Mulligan has written for the American Action Forum previously), released a working paper on the consequences of legislation that would “delink” PBM remuneration from the rebates they negotiate. Let’s explore that research and what it means for current and future PBM reform proposals. <Read More>

Local PBM market is Dwindling, AMA Finds – September 14, 2023 – Six pharmacy benefit managers account for 96 percent of the industry’s market share, and their lead is growing, according to an analysis from the American Medical Association. The nation’s largest PBMs — CVS Caremark, Express Scripts, OptumRx, Humana, Magellan Rx and MedImpact Healthcare Systems — already face little competition, but local PBMs are rapidly consolidating. Local PBMs are also becoming more concentrated, the report found. For example, at least 80 percent of state- and metropolitan-area level PBM markets were highly concentrated in 2021. <Read More>

CDC’s ACIP Votes in Favor of Universal Recommendation for 2023-2024 Monovalent COVID-19 Vaccines – September 13, 2023 – The CDC Advisory Committee on Immunization Practices (ACIP) voted in favor (13 to 1) of the universal recommendation for the use of the 2023-2024 monovalent, XBB containing COVID-19 vaccines authorized via Emergency Use Authorization (EUA) or approved by biologics license applications. After the vote, the CDC endorsed the ACIP decision. “Novavax is pleased that discussions at the ACIP meeting showed broad support for COVID vaccination this season via a universal recommendation and highlighted the urgent need for a protein-based option. Based on this discussion and upon authorization from the FDA, we anticipate that Novavax’s XBB COVID vaccine will be included in the ACIP’s recommendations in accordance with our label,” John C. Jacobs, president and CEO of Novavax, said in a statement. “Doses of Novavax’s vaccine are already in the [United States] and once authorized, will be the only protein-based non-mRNA vaccine option available for individuals aged 12 and older.” <Read More>

Fifty Drugs at Mark Cuban’s Pharmacy With Biggest Cost Reductions – September 13, 2023 – In 2023, Mark Cuban Cost Plus Drug Co. began selling two generic medications cheaper than their branded versions by more than $10,000. The two drugs are fingolimod hydrochloride, a multiple sclerosis medication, and penicillamine, which treats rheumatoid arthritis, metal toxicity and cystinuria. Fingolimod HCl is more than $13,000 and penicillamine is about $11,200 on average, according to Cost Plus Drugs’ website. Through Mark Cuban’s online pharmacy — which sells generics alongside a $5 pharmacy dispensing fee, $5 shipping fee and a 15 percent profit margin — these two medications are about 98 percent less expensive than the retail price. <Read More>

CVS Health Unconcerned About Changes to Blue Shield of California PBM Contract – September 13, 2023 – Reactions to Blue Shield of California’s decision to drop its contract with CVS Caremark to manage pharmacy benefits in favor of a partnership with five companies have been overblown, CVS Health CEO Karen Lynch said. On a Sept. 12 investor presentation, Ms. Lynch said Blue Shield’s plan is an unbundling, rather than a radical departure from typical PBM services. “I think people thought the Blue Shield contract was disruptive. What I would say is, it really is just an unbundling of PBM services. As a company, we continue to offer unbundled services as well,” Ms. Lynch said. <Read More>

California Found ‘Major Deficiencies’ at Hospital Pharmacy on Probation – September 13, 2023 – During a routine inspection in January 2019, an investigator noted “major deficiencies” related to compounding training among staff, according to documents on the probation agreement. The pharmacist in charge and her staff “had not conducted most of the training required prior to commencing compounding,” the investigator found. When asked to demonstrate knowledge of “aseptic hand washing, garbing, cleaning of a controlled environment and the ability to accurately document each documented drug compound,” inspectors found “major deficiencies” in employees’ knowledge of these regulations. <Read More>

 340B in the News

Letter: 340B Drug Pricing Program Needs Protection, Not Fundamental Reform – September 17, 2023 – While no government program should be immune from criticism, those who call for reforms should at least understand how the 340B program works. The recent column, “It’s Past Time for Congress to Reform 340B—Patients and Clinics Are at Risk,” relies on talking points straight from the drug companies’ playbook. Big Pharma hates the 340B program because it eats into drug company profits — profits that, unlike safety net provider 340B savings, have no accountability for their use at all. Here’s how the program actually works: <Read More>

Government Continues to Explore Role of 340B Contract Pharmacies – September 15, 2023 – The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal pharmacy to dispense drugs or otherwise choose not to dispense drugs, and they instead dispense drugs purchased under the Program (“340B drugs”) by contracting with an outside pharmacy (“contract pharmacy”). Amid concerns that the increasing prevalence of contract pharmacies has led to improper payments to covered entities and the diversion of 340B drugs, drug manufacturers continue to be wary of contract pharmacies. For example, on June 1, 2023, two additional drug manufacturers announced restrictions related to shipping 340B drugs to contract pharmacies.1 These announcements follow at least 21 other manufacturers that have placed limits on 340B drug deliveries to contract pharmacies. <Read More>

Healthcare Orgs Address Price Transparency, 340B Policies in OPPS – September 14, 2023 – Hospital and specialty groups are urging CMS to amend aspects of the CY 2024 Outpatient Prospective Payment System (OPPS) proposed rule, including 340B Drug Pricing Program policies and price transparency requirements. The American Hospital Association (AHA), Workgroup for Electronic Data Interchange (WEDI), America’s Essential Hospitals (AEH), and Community Oncology Alliance (COA) sent comments to CMS Administrator Chiquita Brooks-LaSure expressing their concerns. <Read More>