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Clinical Insights: November 29, 2023

Posted on November 29, 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

Ogsiveo™ (nirogacestat) Tablets – New Drug Approval – November 27, 2023 – The U.S. Food and Drug Administration approved Ogsiveo™ (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo™ is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas. Desmoid tumors are non-cancerous but can be locally aggressive. The tumors may invade into surrounding structures and organs, resulting in pain, issues with being able to move, and decreased quality of life. <Read More>

New Indication/Dosage/Formulation Approval

No new update.

New Drug Shortage

November 27, 2023

November 21, 2023

Updated Drug Shortage

November 27, 2023

New Drug Recall and Safety Alerts

Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL by Novartis – New Voluntary Recall – November 27, 2023 – Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. The issue was identified during an investigation of crystallization in a different lot of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL. No other Sandimmune® formulations are impacted. <Read More>

Ting® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder by Insight Pharmaceuticals – New Voluntary Recall – November 24, 2023 – Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling two lots of Ting® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder to the consumer level. A recent review by our manufacturer and their third- party lab found that samples from two lots of the product contained elevated levels of benzene. While benzene is not an ingredient in any Ting® Antifungal Spray products, the review showed that unexpected levels of benzene came from the propellant that sprays the product out of the can. <Read More>

Neptune’s Fix or any Tianeptine Product – New FDA Warning – November 21, 2023 – FDA is warning consumers to not purchase or use any Neptune’s Fix products, or any other product with tianeptine — a potentially dangerous substance that is not FDA-approved for any medical use but is illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions. FDA has received severe adverse event reports after use of Neptune‘s Fix products, including seizures and loss of consciousness leading to hospitalization. Consumers who experience a bad reaction to any tianeptine product should seek immediate medical help. <Read More>

Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL by Bayer – New Voluntary Recall – November 17, 2023 – Bayer is voluntarily recalling one lot of Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles to the consumer/user level. The product is being recalled due to microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

United States Specialty Injectable Generics (Drugs, Biologics) Market Report 2023-: A $36.16 Million Market by 2030 – Growing Demand for Specialty Injectable Generics – November 28, 2023 – The U.S. specialty injectable generics market is expected to reach USD 36.16 million by 2030, expanding at a CAGR of 8.33% from 2023 to 2030. High presence of key pharmaceutical players in the U.S. and the rising prevalence of chronic diseases are among the key drivers for the growth. Furthermore, the growing number of FDA approvals for specialty injectable generics, emerging research & development activities, and well-established healthcare infrastructure contribute to U.S. space growth. <Read More>

Barriers to PrEP Access Continue to Grow Among Those Most at Risk of HIV – November 27, 2023 – Social determinants of health (SDOH) and commercial determinants of health have been known to affect access to health care. HIV preexposure prophylaxis (PrEP) is no exception, as the lack of PrEP access remains the largest for those at the most risk of HIV, according to authors of an article published by JAMA Network Open. The authors stated that there are “stark racial and ethnic inequities” for PrEP usage, with only 30% of eligible individuals in the United States likely to benefit from the use of prescribed PrEP in 2021. There was an approximate 18% increase in HIV diagnoses from 2020 to 2021, according to the CDC. The agency said that the increase could be due to the COVID-19 pandemic since there had been decreases from 2017 to 2020. <Read More>

The U.S. Pharmacy Industry is Crumbling. Here’s How to Fix it – November 27, 2023 – Canby Drug & Gifts, a pharmacy in rural Minnesota, is a paradox. It does good business, yet it is always on the verge of shutting down. “I’m one bad contract from closing,” says owner Mark Whittier. His drugstore, one of a few in his county of more than 9,000 people, exemplifies the struggle many independent pharmacies face. The store is a lifeline for customers, most of whom are on either Medicaid or the state’s health-insurance program. Yet profitability is now near-impossible because of the preposterous way the United States distributes pharmaceutical drugs. Without serious reforms, businesses such as Whittier’s could disappear. <Read More>

Patients Urge DEA to Stop Cutting Supply of Opioid Pain Medication –November 24, 2023 – Thousands of people in pain are urging the Drug Enforcement Administration to scrap plans to further reduce the supply of opioid medication in 2024. The DEA recently announced it would cut production quotas for oxycodone, hydrocodone, codeine and other opioids for the 8th straight year, despite complaints from pain patients and healthcare providers that the medications are already in short supply and difficult to get at pharmacies. The DEA invited people to comment on its plans in the Federal Register. Over 2,400 have so far – many with heart breaking stories to share about not being able to get the pain medication they need. <Read More>

Addressing Burnout: When the Body Says ‘Enough’ – November 24, 2023 – In part 2 of this series, trauma-informed pharmacist Helen Sairany, PharmD, MBA, discusses the physical manifestations of burnout. Whenever I give talks, I often ask the audience to raise their hands if they have had to seek medical attention. Naturally, many hands go up. I then ask attendees to keep their hands raised if their provider asks about early childhood adversities, workplace conditions, their relationship with supervisors, any recent challenges at work, overall job satisfaction, degree of loneliness, quality of life, time spent in nature, experiences, joy, anger, current stressors, etc. In a room packed with hundreds of people, the number of hands remaining elevated dropped significantly. Despite this, those unasked questions are the same reasons many people seek medical expertise. <Read More>

Guide Gives Pharmacists Road Map for Using Opioid Settlement Funds to Benefit Communities – November 24, 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 (Cencora, Cardinal and McKesson) 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. The funds will provide Wisconsinites with support for prevention, treatment and recovery from opioid use disorder (OUD). <Read More>

ASHP Launches Pharmacy Technician Society – November 22, 2023 – The Pharmacy Technician Society, a national membership organization exclusively dedicated to elevating pharmacy technician roles in patient care, has launched its operations. Created by the American Society of Health-System Pharmacists, TPTS is a new organization led by and comprised of pharmacy technicians to provide critical advocacy and advancement opportunities for the pharmacy technician workforce in all patient care settings. The new organization offers a range of services, including comprehensive continuing education, career development, networking, publications and resources and standards for the professional practice of pharmacy technicians. <Read More>

A Review of Newly Available Humira® Biosimilars for Pharmacists – November 22, 2023 – Adalimumab (Humira®, AbbVie) has become one of the world’s best-selling drugs for treating various inflammatory conditions spanning dermatology, gastroenterology, and rheumatology since its December 2002 US approval. In 2023—over 20 years after Humira®’s launch—9 biosimilars were introduced, creating a disruption in the adalimumab market. The arrival of these biosimilars is both an exciting and challenging event that requires focused planning by healthcare teams, and which pharmacists are uniquely equipped to navigate. The United States enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2010, paving the way for biosimilars to come to market and increase price competition and options for patients requiring biologic therapies. <Read More>

Pharmacy Technician Roles Are Growing and Expanding – November 22, 2023 – Pharmacy technicians’ roles continue to change. Previously, technicians were engaged in basic supportive tasks to the pharmacist. Although this is still the case, technicians are contributing to patient care in a much more expansive role. In recent years, largely because of excessive workflow burdens and technological advances, technicians have increasingly taken on a more essential role within the pharmacy and its daily activities. With workplace personnel shortages continuing, technicians are taking on more duties in support of patient care. Seasonal ebbs and flows in pharmacy demands can often catch pharmacies shorthanded, with not enough staff to attend to the various tasks required to maintain and run a pharmacy smoothly. With the onset of cold and influenza season, relief never seems to be in sight for pharmacists and pharmacy staff. In addition to already busy schedules, pharmacies have now been tasked with the burden of being a major source of COVID-19 vaccines. This autumn will be no different, and pharmacists will be dealing with a new vaccine and the start of insurance coverage for COVID-19 shots. <Read More>

Q&A: Dose of Relief Needed to Fix Pharmacy Fees Before the New Year –November 22, 2023 – How do DIR fees drive up costs for prescription drugs? Sticker shock at the pharmacy counter continues to hammer patients when they pick up their prescription medicines. Coupled with historic inflation that pushed up prices for groceries, rent and gas, U.S. households are stretched thin to afford their medications. Iowans may not realize the sticker shock at the pharmacy counter goes both ways. Community pharmacies are being pinched by excessive fees and surprise bills that are forcing some of them to close their doors. These fees and bills come from middlemen called pharmacy benefit managers (or PBMS) who are often vertically integrated with a large chain store pharmacy. So-called direct and indirect renumeration (DIR) fees took root from a loophole in Medicare regulations intended to reward quality care not harm it. It fostered an opaque payment scheme that forces pharmacies to make retroactive “clawback” payments for filling Medicare prescriptions, sometimes long after the patient received the medication. <Read More>

340B in the News

How Many Medicare Part D Claims Are Subject to 340B Discounts? – November 27, 2023 – The share of Medicare Part D claims eligible for discounts in the 340B drug pricing program increased from 1.7 percent to 9.6 percent between 2013 and 2020, a study published in JAMA Health Forum indicated. The 340B program allows certain healthcare entities to acquire outpatient prescription drugs at a discounted price. These entities often include disproportionate share hospitals, children’s hospitals, free-standing cancer hospitals, critical access hospitals, and federally qualified health centers. Prescriptions must be written by a 340B-affiliated clinician and dispensed from an in-house or contract pharmacy to be eligible for 340B discounts. <Read More>