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Clinical Insights: September 27, 2023

Posted on September 27, 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

Likmez™ (metronidazole) Oral Suspension – New Drug Approval – September 25, 2023 – Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”) ”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, announced that its manufacturing and commercialization partner, Saptalis Pharmaceuticals, LLC (“Saptalis”) received approval from the U.S. Food and Drug Administration (“FDA”) for Metronidazole Oral Suspension 500mg/5mL (ATI-1501). ATI-1501, Appili’s liquid oral reformulation of the antibiotic metronidazole, has been licensed to Saptalis for commercialization in the U.S., and other selected territories. The FDA also approved Likmez™ as the brand name for ATI-1501. <Read More>

New Indication/Dosage/Formulation Approval

Jardiance® (empagliflozin) Tablets – New Label Expansion – September 21, 2023 – The U.S. Food and Drug Administration (FDA) has approved Jardiance® (empagliflozin) 10 mg tablets to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease (CKD) at risk of progression, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced. <Read More>

New Drug Shortage

September 19, 2023

Updated Drug Shortage

September 25, 2023

September 22, 2023

September 20, 2023

September 19, 2023

New Drug Recall and Safety Alerts

Sucralfate Oral Suspension, 1g/10mL by VistaPharm LLC – New Voluntary Recall – September 22, 2023 – Largo, Florida, VistaPharm LLC is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL, to the consumer level, due to Bacillus cereus contamination in the product. In the population most at risk, the immunocompromised population, there is a reasonable probability that microbial contamination of the oral suspension can result in disseminated, life threatening infections such as endocarditis and necrotizing soft tissue infections. To date, VistaPharm LLC has not received any reports of adverse events related to this recall. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Finnish Study Finds Revised Dementia Guidelines Did Not Reduce Psychotropic Use – September 25, 2023 – A recent register-based study examined the impact of Finland’s revised clinical guidelines for the treatment of dementia, published in 2017, on the trend of users of psychotropics in older people with dementia in 2009-2020. Conducted at the University of Eastern Finland, the study found that the revised clinical guidelines did not reduce the use of psychotropics in the treatment of behavioral symptoms, despite a recommendation to avoid psychotropics. However, there was a slight reduction in the number of new users of psychotropics. <Read More>

The ‘DIR Apocalypse’ is Coming – September 25, 2023 – Are pharmacies prepared for the severe cash-flow hit that may occur as a result of doubled direct and indirect remuneration (DIR) fees beginning in January 2024? The payment policy has been called the “DIR apocalypse” or “DIR hangover” and it’s keeping pharmacy leaders up at night. “The first two quarters of 2024, in particular, will be a tough period” for many pharmacy providers, said Angie Amado, PharmD, the director of specialty pharmacy services for Visante. In fact, some facilities are so concerned that they are considering setting aside escrow accounts or even taking out loans to ensure patient care isn’t disrupted during the financial crunch. <Read More>

Education Gaps Exist for Veterinary Pharmacy – September 22, 2023 – Many pharmacists graduate pharmacy school knowing very little about veterinary pharmacy, which presents a challenge: if pharmacists aren’t exposed to veterinary pharmacy in the place they get their education, how are they going to learn about it to implement in their pharmacies? After all, when it comes to dogs and cats, approximately 25% of all prescriptions written by a veterinarian for a pet are human-use products, requiring customers to visit their human pharmacy in order to get the prescriptions filled. But if the pharmacist is not versed in veterinary medicine, the customer is going to go elsewhere. Gary Koesten, BPharm, president of Vet Pharm Consulting in Boynton Beach, Florida, and former director of pharmacy services at 1-800-PetMeds, understands the importance of education and training manuals for newly-hired pharmacists. <Read More>

Twelve Kansas City Area CVS Locations Close as Pharmacists Walk Out Over Working Conditions – September 22, 2023 – Twelve Kansas City area CVS locations unexpectedly closed Thursday and Friday because the pharmacists in charge there staged an organized walkout, calling in sick to protest recent corporate decisions. One pharmacist — who spoke to The Star on the condition of anonymity because, they said, speaking to the media without permission results in automatic termination at CVS — said the walkout was the result of steadily declining working conditions. Most of the affected locations locally are inside Target stores. <Read More>

Survey: 72% of Pharmacy Technicians’ Workflow Affected by Drug Shortages – September 22, 2023 – Approximately 96% of certified pharmacy technicians involved in a survey said that their pharmacy had drug shortages, according to an analysis conducted by the Pharmacy Technician Certification Board (PTCB). Respondents to the survey said chemotherapy drugs, medication for attention deficit/hyperactivity disorder (ADHD), glucagon-like peptide-1 agonists for weight loss and diabetes, and local anesthetics were among the drugs that had the biggest shortage. These drugs included tripeptide (Mounjaro®; Eli Lilly and Company), semaglutide (Wegovy® and Ozempic®; Novo Nordisk), and lidocaine. <Read More>

New National Guidelines Are Step Toward ‘More Consistent and Comprehensive Approach’ to ALS Genetic Counseling and Testing – September 21, 2023 – With the Food and Drug Administration’s approval of the first gene-targeted therapy for ALS – and at least nine more in clinical development – genetic counseling and testing has become increasingly important. However, genetic counseling and testing is still not routinely offered to people with ALS in the United States. According to new evidence-based consensus guidelines published in the Annals of Clinical and Translational Neurology, everyone living with ALS should be offered genetic counseling and testing. “The offer of genetic testing to persons with ALS is not yet ‘standard of care,’ and many people who desire access to genetic testing are not offered it. <Read More>

Continuous Glucose Monitors Continue to Improve Diabetes Care – September 21, 2023 – For patients with diabetes, monitoring blood sugar can be a difficult and painful task. Most of these patients are asked to check their blood sugars multiple times a day and on a regular basis. These tests can take a toll on patients, as well as compliance with their therapy plan and on their physical health. Many of these patients may have sore fingers from testing their blood sugars too many times and for so long. This is why continuous glucose monitors (CGMs) can be life changing, with less finger pokes, improved compliance, and easier use methods. Because diabetic patients need to measure their blood sugars throughout the course of their lives, using CGM devices can make their lives easier on a daily basis. In interviews, many patients have said they appreciate the ease of CGM use and the lack of extra effort. <Read More>

Breaking Down SP Accreditation Into Small Steps – September 21, 2023 – Gaining one or more accreditations for your specialty pharmacy can seem daunting, but it helps to take a project management approach and break it down into smaller parts, an expert consultant said during an accreditation workshop at the NASP 2023 Annual Meeting & Expo, in Grapevine, Texas. When pursuing multiple new accreditations, assign a team or an individual to oversee and coordinate these efforts, said Jill Paslier, PharmD, CSP, FISMP, the chief operating officer and a senior clinical pharmacist consultant at Integral Healthcare Solutions, an accreditation consulting company. Also, consider applying for the most stringent accreditation first. Then the second one can be made a little easier “with just a few nuances,” she said. <Read More>

Save Billions or Stick With Humira? Drug Brokers Steer Americans to the Costly Choice – September 21, 2023 – Tennessee last year spent $48 million on a single drug, Humira—about $62,000 for each of the 775 patients who were covered by its employee health insurance program and receiving the treatment. So when nine Humira knockoffs, known as biosimilars, hit the market for as little as $995 a month, the opportunity for savings appeared ample and immediate. But it isn’t here yet. Makers of biosimilars must still work within a health care system in which basic economics rarely seems to hold sway. For real competition to take hold, the big pharmacy benefit managers, or PBMs, the companies that negotiate prices and set the prescription drug menu for 80% of insured patients in the United States, would have to position the new drugs favorably in health plans. <Read More>

Liposomal Tacrolimus Shows Promise for Hemorrhagic Cystitis – September 21, 2023 – Liposomal tacrolimus (LP-10) demonstrated promising efficacy and safety in patients with hemorrhagic cystitis (HC), according to results of a phase 2a study published in the Journal of Urology and Nephrology. The findings showed that LP-10 led to improvements in hematuria, bleeding sites on cystoscopy, microscopic urine analysis for red blood cells (RBCs), and urinary symptoms. LP-10 was also well tolerated; investigators did not report any treatment-related severe or serious adverse events (AEs). <Read More>

Kaiser Pharmacy Workers Authorize Strike – September 21, 2023 – Kaiser Permanente pharmacy workers in Oregon and Washington plan to strike for three weeks in October, adding to the growing tally of what could be the largest healthcare strike in U.S. history. The contracted pharmacy employees accuse Kaiser of engaging in unfair labor practices during months of negotiations aimed at bolstering staffing levels and increasing wages for first-year employees and those working nights and weekends. Local 555 of the United Food and Commercial Workers, a union that represents pharmacy technicians and other pharmacy staff at the Oakland, Calif.-based system, said Sept. 20 that 99.6 percent of its members voted to strike from Oct. 1 to Oct. 21. <Read More>

ChatGPT’s Limited Ability to Recommend Guideline-Based Cancer Treatments – September 20, 2023 – For many patients, the internet serves as a powerful tool for self-education on medical topics. With ChatGPT now at patients’ fingertips, researchers from Brigham and Women’s Hospital assessed how consistently the artificial intelligence chatbot provides recommendations for cancer treatment that align with National Comprehensive Cancer Network (NCCN) guidelines. Their findings, published in JAMA Oncology, show that in approximately one-third of cases, ChatGPT 3.5 provided an inappropriate (“non-concordant”) recommendation, highlighting the need for awareness of the technology’s limitations (2023; doi: 10.1001/jamaoncol.2023.2954). <Read More>

Myasthenia Gravis Treatment Landscape Rapidly Evolving – September 20, 2023 – Approximately 70 to 300 million individuals worldwide are living with myasthenia gravis, an antibody-mediated autoimmune disorder that adversely affects neuromuscular junction function. Study authors are calling for frequent updating of clinical care treatment guidelines that consider costs vs benefits, risks, patient preferences, and comorbidities in light of the rapidly evolving treatment landscape for patients who have myasthenia gravis (MG), according to new research published in BMJ Medicine. <Read More>

Fentanyl Crisis Demands a Dose of Reality: More Buprenorphine? – September 20, 2023 – NIH-funded study suggests the need to reevaluate opioid addiction treatment recommendations in the era of fentanyl. People with opioid use disorder who were prescribed a lower buprenorphine dose were 20% more likely to discontinue treatment than those on a higher dose. This is according to a study of patients prescribed buprenorphine in Rhode Island from 2016 to 2020, as fentanyl became widely available. The study was published on September 18 in JAMA Network Open. It 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>

Transparent PBMs Form Coalition to Advance Industry Reforms – September 20, 2023 – As pharmacy benefit managers and drug manufacturers once again sparred on the Hill, a group of transparent PBMs revealed that they had come together to form a coalition that drives industry reform. The group, called Transparency-Rx, will push for changes to the PBM model that would likely ruffle feathers at the industry’s biggest companies. These include a ban on spread pricing as well as reforms to the rebate model that include the impact of group purchasing organizations. Other core tenets backed by the coalition include instituting a 100% pass-through model for discounts, “delinking” that requires PBMs to be paid by a disclosed flat fee and technology that backs data sharing with patients, insurers, pharmacists and other stakeholders. <Read More>

Doctors Need Better Guidance on Treating ADHD in Over 50s – September 20, 2023 – Doctors urgently need better international guidance on treating attention deficit hyperactivity disorder (ADHD) in the over 50s, conclude world-leading experts reviewing current research on this increasing issue globally. Published in the peer-reviewed journal Expert Review of Neurotherapeutics, the team’s findings highlight a ‘striking’ gap in knowledge about older people as existing guidelines focus on children and young adults. “Our analysis concludes that better approaches are urgently required to screen and diagnose people aged from around age 50 to 55,” says lead author Dr Maja Dobrosavljevic from the University of Orebro, in Sweden. <Read More>

Pharmacy Organizations Establish Pharmacy Workforce Suicide Awareness Day – September 20, 2023 – The American Society of Health-System Pharmacists (ASHP) and the American Pharmacists Association (APhA) have partnered together to establish Pharmacy Workforce Suicide Awareness Day, which will be observed annually on September 20, as part of Suicide Prevention Month. Suicide was the eleventh leading cause of death for Americans in 2021, according to data from the CDC, and suicides are estimated to be higher among health care professionals compared with the general population. While research has been conducted into suicide rates among nurses and physicians, little is known about pharmacist suicide, according to the authors of a study published in the Journal of the American Pharmacists Association. Those authors found that the suicide rate among pharmacists is 20 per 100,000 individuals—higher than the general population rate of 12 per 100,000 individuals. <Read More>

340B in the News

Big Pharma Attempt to Thwart Arkansas Drug Discount Rule Lands at 8th Circuit – September 20, 2023 – An Arkansas state law requiring drug manufacturers to discount drug prices for federal Medicare and Medicaid programs interferes with federal law, a pharmaceutical lobbying group argued Wednesday before an Eighth Circuit panel. A three-judge panel of the St. Louis-based Eighth Circuit took up the case revolving around whether the federal government’s 340B drug discount program is preempted by Arkansas’ Act 1103, which governs distribution of drugs discounted under the federal 340B program to pharmacies in the state. A lower court rejected a claim by the Pharmaceutical Research and Manufacturers of America, or PhRMA, which hinged on the theory that the Arkansas law is the state’s attempt to dictate how the federal program should operate. <Read More>

Amidst Ongoing Manufacturer Restrictions, 340B Covered Entities and Contract Pharmacies Get Creative – September 20, 2023 – Although 340B-participating covered entities likely don’t need the reminder, numerous manufacturers continue to significantly restrict 340B pricing available via traditional “bill to/ship to” contract pharmacy models, with some restrictions being in place for nearly three years. Many of these manufacturer policies have become more restrictive over time, further reducing the availability of a once-potentially significant 340B benefit for covered entities. Although these policies (and HRSA’s authority to regulate these policies) are the subject of fierce debate and ongoing litigation, the restrictions remain in place and will likely remain so for the foreseeable future. <Read More>