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Clinical Insights: December 6, 2023

Posted on December 6, 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

No new update.

New Indication/Dosage/Formulation Approval

No new update.

New Drug Shortage

December 05, 2023

December 01, 2023

November 30, 2023

Updated Drug Shortage

December 01, 2023

November 29, 2023

November 27, 2023

New Drug Recall and Safety Alerts

Levetiracetam (Keppra®, Keppra XR®, Elepsia XR®, Spritam®) and clobazam (Onfi®, Sympazan®) – New FDA Warning – November 28, 2023 – The U.S. Food and Drug Administration (FDA) is warning that the antiseizure medicines levetiracetam (Keppra®, Keppra XR®, Elepsia XR®, Spritam®) and clobazam (Onfi®, Sympazan®), can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). It may start as a rash but can quickly progress, resulting in injury to internal organs, the need for hospitalization, and even death. As a result, we are requiring warnings about this risk to be added to the prescribing information and patient Medication Guides for these medicines. This hypersensitivity reaction to these medicines is serious but rare. DRESS can include fever, rash, swollen lymph nodes, or injury to organs including the liver, kidneys, lungs, heart, or pancreas. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

The Free Version of ChatGPT May Provide False Answers to Questions About Drugs, New Study Finds – December 5, 2023 – ChatGPT has once again been proven to be an unreliable tool in some medical situations and ended up providing false or incomplete information about real drug-related queries, a new study found. The American Society of Health-System Pharmacists presented the study at its Midyear Clinical Meeting between December 3 and 7 in Anaheim, California, according to a press release published Tuesday. The study took place between 2022 and 2023 and posed questions to ChatGPT that had come through the Long Island University’s College of Pharmacy drug information service over a 16 month period. <Read More>

Elevance Health’s CarelonRx Rolling Out New Digital Pharmacy – December 5, 2023 – Elevance Health’s pharmacy benefit manager is launching a new digital pharmacy that aims to make it easier for members to track their prescriptions. CarelonRx Pharmacy will launch on Jan. 1, and members will be able to connect with pharmacists via text, chat or phone around the clock. The platform will also allow them to check the price of medications for comparison and track their prescriptions throughout the order process, similar to how a customer may follow a pizza order. <Read More>

Eli Lilly Obesity Drug Now Available in US Pharmacies – December 5, 2023 – Eli Lilly (LLY.N) said its recently approved obesity treatment Zepbound™ is now available in U.S. pharmacies and could cost $550 a month for customers whose health insurance does not cover the drug, or half the list price. Zepbound™ is the latest entrant to the fast-growing market for weight-loss drugs, which is forecast to grow to about $100 billion by the end of the decade. Wall Street analysts expect sales of Zepbound™ to reach about $2 billion in 2024, and for sales of Novo Nordisk’s (NOVOb.CO) rival obesity drug Wegovy® to hit around $7.5 billion. <Read More>

Novo Nordisk Finds Compounded Wegovy® up to 33% Impure, Sues Florida Pharmacies – December 1, 2023 – Novo Nordisk (NOVOb.CO) said on Thursday it sued one compounding pharmacy and refiled a lawsuit against another after finding their products claiming to contain the active ingredient for its in-demand weight-loss drug Wegovy® were impure, some by as much as 33%. The Danish drugmaker said it found impurities in all the drugs tested from Wells Pharmacy and Brooksville Pharmaceuticals, both based in Florida. Novo first sued Brooksville in July, and discovered a substance called BPC-157 in samples from Wells. <Read More>

Medication Errors: The Year in Review – December 1, 2023 – January Through December 2022. Preventing medication errors is an essential component of caring for patients and must be a core mission of every pharmacy. For medication error prevention efforts to be effective, they must be a priority. An error reduction program begins by establishing a multidisciplinary medication safety team to improve medication use. To be successful, the team must be given reasonable time and resources to assess medication safety and implement systemwide changes that make it difficult or impossible for practitioners to make mistakes that endanger patients. This multidisciplinary team should accept ownership of the medication-use process and enthusiastically embrace the opportunity to improve medication safety. Effective results depend on understanding the entire medication-use process through varied perspectives and disciplines. <Read More>

Casting Specialty Pearls at ASHP Summer Meetings 2023 – December 1, 2023 – Each year the ASHP Summer Meetings & Exhibition feature a look at “specialty pharmacy pearls”: brief presentations, five minutes maximum, delivered back-to-back in a fast-paced session. The goal is to provide nuggets of wisdom about how to improve some aspect of specialty pharmacy service, such as forming collaborative pharmacy practice agreements (CPPAs), responding to ongoing drug shortages or getting treatment to patients as soon as possible. According to one observer, this year’s pearls presentations achieved that goal. <Read More> 

Role of Specialty Pharmacists in Managing Patients Living With HIV – November 29, 2023 – In 2019, the Department of Health and Human Services announced a plan to end the HIV epidemic in the United States by the year 2030. The goal of the Ending the HIV Epidemic in the US initiative is to reduce new HIV infections in the United States by 75% by 2025 and 90% by 2030. Collaboration among federal, state, and local health departments and healthcare providers is needed to reach this target. Specialty pharmacists can assist this worthy challenge and ensure this goal is reached. This article will discuss HIV treatment and prevention guidelines and how specialty pharmacists can help physicians facilitate and optimize care for patients living with HIV. <Read More> 

Why Such ‘High Markups’? Senators Seek Drug Price Probe of Insurers who own PBMs. – November 28, 2023 – Two U.S. senators last week asked the Department of Health and Human Services’ Office of Inspector General to investigate high drug prices and any role played by health insurers’ shared ownership with the pharmacies that often fill the prescriptions. “In functioning markets, generic drugs cost 80-85% less than their name-brand equivalents, giving patients much-needed relief from high drug costs and saving taxpayer dollars,” Sens. Elizabeth Warren, D-Mass., and Mike Braun, R-Ind., wrote in a letter. “But patients — including patients in public health-care programs like Medicare and Medicaid — who either use or are compelled to use vertically integrated specialty pharmacies are not seeing this relief.” <Read More>

340B in the News

ASHP: What Pharmacy Leaders Should Know Heading Into 2024 – December 4, 2023 – More than three-fourths of hospital pharmacy leaders think health systems will cut service lines because of the rising cost and complexity of new drugs, according to a report released Dec. 4. The American Society of Health-System Pharmacists and its foundation published the 12th annual forecast to inform hospital pharmacy leaders on trends to watch in 2024. It focuses on six topics: ultra-high-cost drugs and innovations, workforce concerns, mental health and substance use disorders, healthcare equity, public health emergencies because of climate change, and artificial intelligence…2) “The 340B program will be reduced to the extent that hospitals no longer participate because the effort invested is not worth the services provided.” Sixty-eight percent said they’re unprepared, and 32% said they’re prepared… <Read More>

Mixed Results on how Hospitals use 340B Funds: 5 Things to Know – November 29, 2023 – New research of over 300 documents reveals a mixed bag of evidence surrounding the controversial 340B Drug Pricing Program’s impact on the U.S. healthcare system, a study published Nov. 22 in JAMA Health Forum found…Five things to know from the study:  1) Researchers found conflicts in how the revenue focuses on intended charity care and low-income populations. One study found that disproportionate share hospitals participating in 340B saw increases in charity care spending (29%), discounted care (4%), and income eligibility limit for discounted care (19%), but no association with offering low-profit medical service. However, one study found no evidence that uncompensated care increased after hospitals joined the 340B program, 2) Although low-income and underserved populations are the target for 340B, researchers found evidence suggesting some of the contracted pharmacies dispensing discounted drugs were stationed in higher-income, less diverse neighborhoods…<Read More> 

In Genesis Case, South Carolina District Court Scraps HRSA Interpretation of “Patient” Under 340B Statute – November 29, 2023 – On November 3, 2023, the United States District Court for the District of South Carolina issued its decision in the long-running dispute between Genesis Health Care Inc., a federally qualified health center and 340B-covered entity (“Genesis”), and the Health Resources and Services Administration (HRSA). In its widely anticipated decision, the court ruled that HRSA cannot enforce its restrictive interpretation of the term “patient” under the 340B statute as described in an audit enforcement letter issued to Genesis. The court’s holding is viewed as favorable to 340B-covered entities and continues the theme, reflected in recent 340B cases involving contract pharmacy restrictions, of raising questions about the limits of HRSA’s authority to enforce and administer the 340B program through its interpretations of the 340B statute. <Read More>

340B Drug Discount Program Under Scrutiny: Are Hospitals Using Funds for Other Purposes? – November 29, 2023 – The 340B drug discount program is generating revenue for hospitals, clinics and pharmacies by requiring drugmakers to provide discounts on medications. However, the jury is out on whether this revenue is being used to care for low-income patients as intended. “Covered entities used revenue from the 340B program to expand health-care services and programming, open specialty clinics, provide medications at reduced costs to patients and subsidize uncompensated care and staff salaries,” according to a study reported by JAMA Network. “Patients of covered entities received greater access to health-care services, but there was mixed evidence as to lower medication costs. “However, covered entities — notably disproportionate-share hospitals — also used 340B revenue for purposes seemingly unrelated to underserved patient care, including opening sites in higher-income neighborhoods and acquiring outpatient physician practices.” <Read More>

340B Drug Discount Program Yields Mixed Evidence on how Hospitals use Funds – November 27, 2023 – Amid ongoing controversy over 340B drug discounts, a sweeping review suggests the program is doing what it was intended to do: generate revenue for hospitals, clinics and pharmacies by requiring drugmakers to give them discounts on medications. Yet researchers — who reviewed almost 300 pieces of literature on 340B for the new analysis — found mixed evidence on whether hospitals and clinics are using 340B revenue as intended, to care for low-income patients. That’s been a major criticism of the drug discount program, as drugmakers and some legislators say hospitals are not being held to account for their use of 340B funds. <Read More>