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Clinical Insights: December 14, 2021

Posted on December 14, 2021 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 Approval

Xaciato™ (clindamycin phosphate) Vaginal Gel – New Drug Approval – December 7, 2021 – Daré Bioscience, Inc., a leader in women’s health innovation, announced that the U.S. Food and Drug Administration (FDA) approved Xaciato™ [zah-she-AH-toe] (clindamycin phosphate vaginal gel, 2%) (formerly known as DARE-BV1) for the treatment of bacterial vaginosis in females 12 years of age and older. “The FDA approval of Xaciato™ marks a major milestone not only for Daré as a company but, importantly, for the 21 million women impacted by bacterial vaginosis,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. <Read More>

New Indication/Dosage/Formulation Approval

Zynrelef® (bupivacaine and meloxicam) Injection – New Expanded Indication – December 9, 2021 – Heron Therapeutics, Inc., a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Zynrelef® (bupivacaine and meloxicam) extended-release solution to significantly expand the indication. Zynrelef® is now indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. <Read More>

Rituxan®(rituximab) – New Expanded Indication – December 3, 2021 – The Food and Drug Administration approved rituximab (Rituxan®, Genentech, Inc.) in combination with chemotherapy for pediatric patients (≥6 months to <18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL). <Read More>

Darzalex Faspro™, Kyprolis®, and Dexamethasone – New Expanded Indication – December 1, 2021 – The Food and Drug Administration approved daratumumab + hyaluronidase-fihj (Darzalex Faspro™, Janssen Biotech, Inc.) and carfilzomib (Kyprolis®, Amgen, Inc.) plus dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. Efficacy was evaluated in a single-arm cohort of PLEIADES (NCT03412565), a multi-cohort, open-label trial. <Read More>

New/Updated Drug Shortage

December 10, 2021

December 09, 2021

December 08, 2021

December 06, 2021

New Drug Recall and Safety Alerts

Rompe Pecho™ Products by Efficient Laboratories, Inc. – New Expanded Voluntary Drug  – December 10, 2021 – Efficient Laboratories is expanding its voluntary nationwide recall to consumers to include an additional twelve lots of Rompe Pecho™ CF, Rompe Pecho™ EX, Rompe Pecho™ MAX, and Rompe Pecho™ DM due to microbial contamination concerns. These lots were distributed in 2019. To date, Efficient Laboratories has not received any reports of adverse events. <Read More>   

Lidocaine Topical Solution by Teligent Pharma – New Voluntary Drug Recall – December 7, 2021 – Teligent Pharma, Inc. is voluntarily recalling two lots of Lidocaine HCl Topical Solution USP 4%, 50ml in a screw cap glass bottle listed in the table below to the user level. The product is being recalled because the firm’s testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 9-month (Lot 16345) and 18-month (Lot 15594) stability timepoint. <Read More>   

Certain JAK Inhibitors by Pfizer, Abbvie, and Eli Lilly – New Required Warnings – December 7, 2021 – Based on a completed U.S. Food and Drug Administration (FDA) review of a large randomized safety clinical trial, we have concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz® and Xeljanz XR® (tofacitinib)…We are requiring new and updated warnings for two other arthritis medicines in the same drug class as Xeljanz®, called Janus kinase (JAK) inhibitors, Olumiant® (baricitinib) and Rinvoq® (upadacitinib). Olumiant® and Rinvoq® have not been studied in trials similar to the large safety clinical trial with Xeljanz®, so the risks have not been adequately evaluated. However, since they share mechanisms of action with Xeljanz®, FDA considers that these medicines may have similar risks as seen in the Xeljanz® safety trial. <Read More>

All Drug Products Compounded by Edge Pharma, LLC – New Voluntary Drug Recall – December 7, 2021 – Edge Pharma, LLC is voluntarily recalling all lots of all drugs compounded at Edge Pharma, LLC to the consumer level. All products are being recalled due to process issues that could lead to a lack of sterility assurance for products intended to be sterile and could impact the safety and quality of non-sterile products. Risk Statement: Administration of a drug product intended to be sterile, that is not sterile, could result in site specific infections as well as serious systemic infections which may be life- threatening. To date, Edge Pharma, LLC has not received and is not aware of any adverse events related to this recall. <Read More>

Veklury® (Remdesivir) Injection by Gilead – New Voluntary Drug Recall – December 3, 2021 – Gilead Sciences Inc. announced it is voluntarily recalling two lots of Veklury® (remdesivir 100 mg for injection) to the user level. Gilead Sciences Inc. received a customer complaint, confirmed by the firm’s investigation, of the presence of glass particulates. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

ACC/AHA Issues New Coronary Artery Revascularization Guideline – December 13, 2021 – The American College of Cardiology and the American Heart Association have collaborated to issue a new guideline on coronary artery revascularization, and simultaneously published it in the Journal of the American College of Cardiology and Circulation. This latest iteration—”2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization”—has been updated to incorporate six previous guidelines on coronary artery revascularization, as well as recent clinical data from trials of coronary artery revascularization. Guideline writers conducted a comprehensive literature search from May 2019 to September 2019 of PubMed, EMBASE, the Cochrane Collaboration, CINHL Complete, and other databases for relevant studies. <Read More>

Gender-Affirming Hormone Therapy: The Pharmacist’s Role – December 10, 2021 – Gender-affirming hormone therapy (GAHT) is an emerging area of clinical pharmacy, and pharmacists have a significant opportunity to contribute to patient care, said Karen M. Gunning, PharmD, the associate dean of community engagement and a family medicine clinical pharmacist at the University of Utah College of Pharmacy, in Salt Lake City, at a session on caring for transgender people at the ASHP Midyear Clinical Meeting and Exhibition, held virtually. <Read More>   

Florida Pharmacy Owner Found Guilty of Running $174M Telehealth Fraud Scheme  – December 10, 2021 – A federal jury has convicted Tampa, Fla., pharmacy owner Peter Bolos, 44, for his role in running an $174 million telehealth fraud scheme. Court documents and evidence presented at trial state that Mr. Bolos and several co-conspirators deceived pharmacy benefit managers about at least 60,000 prescriptions between May 2015 and April 2018, tricking them into authorizing false claims worth more than $174 million that insurers paid to pharmacies controlled by the co-conspirators. To obtain prescriptions, a co-conspirator and telemarketer Scott Roix used his business as a telemedicine service, calling patients and persuading them to accept medication and give up details about their medical insurance. Physicians would then remotely prescribe medication based solely on the information provided by the telemarketer. <Read More>

TRICARE Copays to Increase – December 10, 2021 – Starting Jan. 1, TRICARE pharmacy copayments will change for all beneficiaries, except active-duty service members, dependent survivors, and medically retired service members and their family members. The increases are part of a larger Department of Defense effort to fund improvements in military readiness and modernize the TRICARE health benefit. Congress and DOD worked together on these changes, which were passed into law as part of the National Defense Authorization Act for fiscal year 2018. Active-duty service members will continue to pay nothing for their covered prescriptions. Copayments remain the same for survivors, medically retired service members and their family members in 2022. All other beneficiaries will see an increase in TRICARE pharmacy copayments. <Read More>

Copay Use Continues to Increase Amid Pandemic – December 10, 2021 – The use of manufacturer copay coupon programs continued to grow during 2020 and into 2021 amid the COVID-19 pandemic, with adoption rates as high as 80% for certain high-cost specialty medications, according to new data presented at Informa Connect’s 2021 annual Coupon & Copay Forum. “Last year, patients’ out-of-pocket exposure on prescription drugs totaled approximately $91 billion, with copay coupons offsetting $14 billion of that for a total net exposure of $77 billion,” said Chris Dowd, the executive vice president for market and product development with ConnectiveRx, citing data adapted from IQVIA’s “Use of Medicines in the United States” report issued in May 2021. <Read More>

The 10 Biggest Pharmacy Stories in 2021 – December 10, 2021 – Here are the 10 most widely-read pharmacy stories published by Becker’s Hospital Review in 2021, listed in order from most to least popular:

  1. Mark Cuban launches generic drug company
  2. Health officials investigating death of Miami physician shortly after getting Pfizer vaccine
  3. Physicians prescribing ivermectin for COVID-19 despite FDA warning…   <Read More>

Biosimilars Positioned for Continued Growth – December 9, 2021 – With 31 biosimilar products approved by the FDA in the United States to date, the agents are slowly gaining a foothold, according to a presentation at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually. But significant market penetration is still available. “Biosimilars offer high-quality treatment alternatives at a fraction of the cost,” said Jorge Garcia, PharmD, MHA, MBA, FACHE, the assistant vice president, system oncology pharmacy service line, at Baptist Health South Florida in Miami. “They provide a strong value proposition as it relates to that cost savings. Unfortunately, we see that many pre- and post-marketing implementation barriers still exist in the marketplace today. <Read More>

Adjuvanted Trivalent Flu Shot Reduces Influenza-Related Hospitalizations in Older Adults – December 9, 2021 – Data from an independent study in Italy over 18 influenza seasons demonstrated that an adjuvanted trivalent vaccine (aTIV; Fluad® Seqirus) was associated with a 12% lower risk for hospitalization and a 37% lower risk for respiratory-related hospitalizations compared with standard-dose, non-adjuvanted trivalent influenza vaccine (TIV) and standard-dose quadrivalent influenza vaccine (QIV). In addition, two studies demonstrated the cost-effectiveness of an adjuvanted quadrivalent influenza vaccine (aQIV; Fluad®Quadrivalent, Seqirus) in Spain and France, according to a presentation at the European Scientific Working Group on Influenza (ESWI) 2021 Virtual Conference. <Read More>

ISMP Adds New Medication Safety Best Practices – December 9, 2021 – The Institute for Safe Medication Practices (ISMP) is introducing three new 2022-2023 Targeted Medication Safety Best Practices for Hospitals, according to an ISMP specialist who presented during the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually. The three new standards should help hospitals prevent errors with oxytocin use and high-alert medications and reduce medication-use errors by expanding barcode administration to non-inpatient areas, noted Christina Michalek, RPh, a medication safety specialist with ISMP. <Read More>

Drug Testing Gap Spurs a Different COVID Crisis – December 9, 2021 – In addition to the millions of lives claimed by COVID-19, another group of victims has emerged: the users and abusers of prescription and illicit drugs alike, who—as a potential result of decreased drug testing during the pandemic—have seen their overdose rates skyrocket. In a presentation during the 2021 virtual annual meeting of the American Academy of Pain Medicine, Jeffrey Gudin, MD, a faculty member in the Department of Anesthesiology, Perioperative Medicine and Pain Management at the University of Miami Miller School of Medicine, discussed this worsening crisis within the pandemic, along with strategies for mitigating its effects. <Read More>

FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds – December 9, 2021 – The U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine. “Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” said Acting FDA Commissioner Janet Woodcock, M.D. “As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the delta and omicron variants continuing to spread, vaccination remains the best protection against COVID-19.” <Read More>

Facilitating Access to Oncology Medication – December 8, 2021 – A growing body of research supports the importance of timely access to cancer treatment because patients who obtain prompt care have been found to have better outcomes, including improved quality of life and increased survivability. Though the impact of timely access to care is well documented, time to treatment initiation (TTI) for patients with newly diagnosed cancer in the United States is increasing. A recent study found TTI for all cancers increased by 38% during a 9-year observation period. In order to understand the factors leading to this increase, it is important to assess the social determinants of health (SDOH) influencing access to oncology medications, how they affect TTI, and the role of oncology-focused specialty pharmacies in facilitating timely access to prescribed therapy. <Read More>

Hospital Pharmacists Optimize MRSA Screening – December 8, 2021 – Hospital pharmacists can improve methicillin-resistant Staphylococcus aureus (MRSA) screening and limit unnecessary use of vancomycin, researchers said at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually. Although it is recommended to withhold MRSA treatment in the presence of a negative swab (Clin Infect Dis 2016;63[5]:e61-e111), “data are lacking regarding pharmacist-led antimicrobial stewardship efforts using MRSA nasal screening,” said lead author Elizabeth Lee, PharmD, a pharmacy clinical specialist, Houston Methodist The Woodlands Hospital, in Tomball, Texas. <Read More>

Pharmacist and Two Pharmacies Agree to Pay $1 Million to Resolve Allegations of False Claims for Anti-Overdose Drug – December 8, 2021 – Riad “Ray” Zahr, a pharmacist in Dearborn, Michigan, along with two specialty pharmacies that Zahr formerly owned and operated, have agreed to pay the United States $1 million to resolve allegations that they submitted false claims for the drug Evzio™. Evzio™ was an injectable form of naloxone hydrochloride indicated for use to reverse opioid overdose. Evzio™ was the highest-priced version of naloxone on the market, and insurers frequently required the submission of prior authorization requests before they would approve coverage for Evzio™. <Read More>

Implementation of Pharmacy Technician Career Ladder Increases Job Satisfaction, Promotes Teamwork – December 8, 2021 – After implementing a pharmacy technician career ladder in a health system, researchers found improved technician job satisfaction, increased teamwork, more technician development, and defined leadership pathways. These results were presented at the American Society of Health-System Pharmacists 2021 Midyear Clinical Meeting. Pharmacy technicians are essential team members to ensure safe, effective, and efficient patient care, although recruitment and retention of technicians has been challenged by the COVID-19 pandemic. To implement the pharmacy technician career ladder, a workgroup was convened with pharmacy leadership from each of the 5 facilities in the health system. <Read More>

FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals – December 8, 2021 – The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld™ (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]). The product is only authorized for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2. <Read More>

Barcode-Enabled Liquid Dosage Dispense Preparation Process may Improve Safety, Quality of Pharmacy Services – December 8, 2021 – Implementing a barcode scanning product verification system for oral syringe dosage forms improves the safety and quality of pharmacy services, according to a case study presented at the American Society of Health-System Pharmacists’ Midyear 2021 conference. Although barcode scanning during product verification has greatly improved the safety of medication dispensing operations, many products aren’t easily incorporated into traditional dose preparation processes, including medications manually dispensed in oral syringes, according to the study. <Read More>   

Role of OTC Asthma Medications in the Community Pharmacy – December 8, 2021 – Of the approximately 25 million Americans with asthma, 20 million are adults aged 18 years and older. Asthma severity is classified into 4 groups: intermittent, persistent-mild, persistent-moderate, and persistent-severe. In the United States, nearly 65% of adults have persistent asthma and 35% have intermittent asthma. Intermittent asthma is defined as acute or subacute bouts of gradually intensifying cough, chest tightness, wheezing, and shortness of breath for 2 or fewer days per week and awakening from these symptoms 2 or fewer times per month as recalled by the patient or caregiver…As accessible health care professionals, pharmacists can recognize potential challenges and barriers to asthma care as well as provide counseling and access to OTC medications that are available for the management of mild symptoms of intermittent asthma. <Read More>

Study Finds Self-Administered Cognition Test Can Predict Early Signs of Dementia Sooner – December 8, 2021 – Although the test does not definitively diagnose problems such as Alzheimer disease, it helps physicians get a baseline of their patients’ cognitive functioning. A new study suggests that a self-administered test can identify the early signs of dementia sooner than the most used office-based standard cognitive test. The Self-Administered Gerocognitive Examination (SAGE) test, created by researchers at The Ohio State University Wexner Medical Center, College of Medicine, and College of Public Health, may be effective in treatment, especially when new therapeutics for dementia and Alzheimer are being developed, according to the study authors. <Read More>

Life-Size Modeling May Assist With Pharmacy Design – December 8, 2021 – Through the use of life-size modeling, pharmacy leadership at a growing pediatric intensive care unit was able to ensure an optimal critical care pharmacy design, according to a case study presented at the American Society of Health-System Pharmacist’s Midyear 2021 conference. The investigators found that modeling was a cost-effective method for determining the functionality of the proposed blueprint by transforming it into a physical space. Further, the study suggests that involving the pharmacy team early in development allowed for compromises in space and successful integration. <Read More>

WHO Issues Guidance Against Convalescent Plasma for COVID-19 – December 7, 2021 – The World Health Organization has updated its guidelines for COVID-19 treatments against the use of convalescent plasma for all cases of infection. In a statement, the WHO said that transfusing blood plasma from a person who has already recovered from the illness should only be applied in a clinical trial setting for COVID-19 patients in severe and critical conditions. However, it does not recommend this line of treatment for any COVID-19 case. <Read More>

Pharmacist Prescribed Contraceptive Access Program Successful  – December 7, 2021 – Researchers sought to describe the patient experience in accessing contraceptive through pharmacist prescribing across a selection of chain and independent pharmacies in California. In particular, the researchers aimed to characterize the populations who used this service, evaluate patient satisfaction, and determine “patient intentions around utilization of preventive health services”…In total, 32 pharmacies reported participating in recruitment efforts for the study, including handing out cards, containing information about the study and survey instructions, to interested participants; a total of 232 cards were distributed and 159 surveys were recorded across 24 facilities for a response rate of 69%. <Read More>

Study: Increasing Naloxone Access Improves Opioid Outcomes – December 7, 2021 – Opioid-related deaths have been on the rise over the last 20 years in the United States. Data show that in 2018, approximately 47,000 deaths from opioid overdoses occurred. The CDC has since released guidelines for health care providers prescribing naloxone; however, study findings presented at the 2021 ASHP midyear Clinical Meeting & Exhibition revealed that naloxone is prescribed to only about 1% of patients. To study naloxone prescribing and the role that community pharmacists have on the opioid crisis, researchers at 5 retail pharmacies screened patients with an opioid prescription. Inclusion criteria included total daily morphine milligram equivalent (MME) of >50 MME or an opioid co-prescribed with a benzodiazepine, gabapentin, or pregabalin. <Read More>

‘Exciting Progress’ on Provider Status Cited During ASHP Town Hall – December 7, 2021 – Governments at the state, local and national levels are increasingly recognizing the roles that pharmacists can play and contribute to health care, a government relations expert said at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually. Gains in practice made during the COVID-19 pandemic can serve as a precedent to keep pushing the boundaries. “We’re still working away at full provider status and, ultimately, recognition in the Medicare program,” said Tom Kraus, JD, MHS, ASHP’s vice president of government relations, during a town hall meeting on pharmacist provider status. “But we’re making exciting progress, and we’ve seen an acceleration over the past two years.” <Read More>

Opioid Stewardship Programs Led by Pharmacists Proliferating – December 7, 2021 – More and more hospital pharmacies are developing opioid stewardship programs and reducing the risk for related overdoses, experts said during a press briefing at the ASHP 2021 Midyear Clinical Meeting and Exhibition. Anna Legreid Dopp, PharmD, the senior director of clinical guidelines and quality improvement at ASHP, said the group surveyed thousands of hospitals across the country and found the percentage of institutions with opioid stewardship programs rose from 40.9% in 2018 to about 47.3% in 2019, with programs with pharmacists in leadership positions growing from 54.8% to 64.8% over the same period. <Read More>

Workgroup Develops Comprehensive Review, Adoption Process for Biosimilar Therapies – December 6, 2021 – In a case study presented at the American Society of Health-System Pharmacists’ Midyear 2021 conference, pharmacists implemented a reliable process for evaluating the financial impact of biosimilar drug options. According to the investigators, this analysis assists with selecting the optimal system formulary biologic agents where biosimilar options exist. Further, the process allows for future reevaluation to ensure that the decisions made remain appropriate. In the case reviewed, the pharmacy department created an interdisciplinary Biosimilar Task Force responsible for making decisions relating to the adoption of biosimilar therapies, with a subgroup called the Pharmacy Biosimilar Workgroup. <Read More>

340B in the News

Comprehensive Regulatory Reform From the Bottom Up: The Case of 340B – December 12, 2021 – Using the ruse of “price negotiation”, the proponents of the Build Back Better legislation are pushing an ill-fated drug price control plan. Patients will bear exceptionally large costs should their idea of government-directed prices become law. These costs will include lower health outcomes due to reduced access to innovative drugs. They will also include increases in other types of healthcare spending as less drug access would, ironically, increase hospitalizations and use of other healthcare services and could more than offset any potential savings from drug price controls. <Read More>

Supreme Court Hears Arguments on 340B Outpatient Payment Cuts—and Discusses ‘Chevron Deference’ – December 10, 2021 – Over the summer, my colleague Tom Barker discussed how the Supreme Court was planning to hear several health care cases during the October 2021 term.  Last week, the Court heard oral arguments for two noted cases: during Monday’s (November 29) arguments for Becerra v. Empire Health Foundation, the Court was asked to decide if the Administrative Procedure Act (APA) gives HHS authority to interpret the Medicare statute and recalculate payments made to disproportionate share hospitals (DSH); and on Tuesday, November 30, the Court heard arguments for American Hospital Association v. Becerra, which focused on CMS’ 2018 change in Medicare reimbursement policy for drugs acquired by hospitals under the 340B program.  Since we often write about the 340B program because of the inextricable link between the discount-drug program and the Medicaid prescription drug program, today, we are going to talk about the AHA v. Becerra arguments. <Read More>

From 340B to Short-Term Health Plans: Here are the Top 4 Regulations to Watch for in 2022 – December 10, 2021 – The Biden administration released its 2022 unified agenda that details regulations it plans to release in the coming year. The agenda, released Friday by the Office of Management and Budget, is not binding but gives a look at which areas Department of Health and Human Services (HHS) officials are hoping to address in the year ahead… The Health Resources and Services Administration (HRSA) aims to publish a new proposed rule creating requirements for resolving disputes between 340B-covered entities and drugmakers. The rule would replace a final rule that was published in December 2020; a judge halted the rule back in March after objections from drugmakers. The proposed rule would be released in January, the unified agenda said. The new rule comes as HRSA is pushing to fine several drugmakers for restricting access of discounted products to contract pharmacies. <Read More>

340B Program, PAPs Help Ensure SP Rx Success – December 9, 2021 – Actively managing participation in the federal 340B Drug Pricing Program, coupled with efforts to boost financial assistance and medication access, can help maximize savings and ensure the overall success of specialty pharmacy services, a panel of experts said during the 2021 ASHP Conference for Pharmacy Leaders, held virtually. For example, when the FDA approved the pediatric cystic fibrosis medication elexacaftor-tezacaftor-ivacaftor (Trikafta®, Vertex) in June, the specialty pharmacy team at Atrium Health Wake Forest Baptist, in Winston-Salem, N.C., worked with eligible patients and their families to ensure they were completing necessary lab tests and education counseling during clinic visits leading up to the approval so patients would be ready, said Regina Schomberg, PharmD, BCPS, the system director of pharmacy, retail and specialty pharmacy services. <Read More>

Optimizing Purchasing Important to Maximize 340B Program Savings – December 8, 2021 – Ensuring accurate pricing for drugs purchased through the 340B Drug Pricing Program is critical in ensuring compliance and supporting program savings for hospitals, a panel of experts said during the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually. Pharmacy directors should leverage relationships with their wholesaler and manufacturer partners to ensure accurate pricing and maintain compliance for all stakeholders, they said. It pays to be proactive. Develop tools and reports to help identify savings opportunities, and alert your teams to potential pricing discrepancies. <Read More>

The Death of Chevron? Supreme Court Hears Oral Arguments on Medicare Cuts to 340B Reimbursement – December 7, 2021 – The U.S. Supreme Court recently heard oral arguments from a coalition of hospital plaintiffs who are challenging Medicare’s nearly 30% reduction in outpatient drug reimbursement rates for 340B Program-participating hospitals. However, in addition to myriad effects this case may have on hospitals’ participation in the 340B Program, the case also presents a significant administrative law question concerning whether the Court’s Chevron deference doctrine could be overturned by a now conservative-leaning court. <Read More>

New Study Suggests 3 Florida Hospitals Profiting Off Federal Drug Reimbursement Program – December 6, 2021 – A new study conducted by the non-partisan Pacific Research Institute (PRI) suggests that 3 Florida hospitals — Baptist Hospital of Miami, Orlando Health, and St. Joseph’s Hospital — accrued profits of hundreds of millions through a federal discount drug program. The 340B program was intended to provide discounted drugs to grant uninsured and financially disadvantaged individuals access to medicines. Participating manufacturers provide qualifying clinics and hospitals discounts up to 50 percent or more off the costs for outpatient drugs…The PRI study claims that the three Florida hospitals tend to provide less charity care, while maximizing profits, stating that oversight of the program is loose, and susceptible to clerical errors leads to commonly occurring excess reimbursement. “The 340B program is supposed to help vulnerable patients receive their medicines, but our study shows that 340B hospitals are more profitable than traditional hospitals while not providing more charitable care,” said Dr. Wayne Winegarden, author of the study. <Read More>