Clinical Insights: March 30, 2021

    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

    Abecma™ (idecabtagene vicleucel) Suspension for Intravenous Infusion – New Drug Approval – March 26, 2021 – Bristol Myers Squibb and bluebird bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Abecma™ (idecabtagene vicleucel; ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Abecmaä is a personalized immune cell therapy approved as a one-time infusion with a recommended dose range of 300 to 460 x 106 CAR-positive T cells. <Read More> 

    Zegalogue® (dasiglucagon) Injection – New Drug Approval – March 22, 2021 – Zealand Pharma A/S, a biotechnology company aspiring to deliver innovation with novel peptide therapeutics, announced that the U.S. Food and Drug Administration (FDA) has approved Zegalogue® (dasiglucagon) injection for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above. “This approval will help enable appropriate children and adults with diabetes to be able to address sudden and severe hypoglycemia, which can quickly progress from a mild event to an emergency,” said Dr. Jeremy Pettus, MD, Assistant Professor of Medicine at the University of California San Diego. “The magnitude and consistency of effect seen in the Phase 3 pivotal studies is clinically meaningful as minutes matter in severe hypoglycemia. Zegalogue® provided resolution of severe hypoglycemia following administration, with a median time to blood glucose recovery of 10 minutes across these clinical studies.” <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Keytruda® (pembrolizumab) – New Expanded indication – March 23, 2021 – Merck announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda®, Merck’s anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy. <Read More>

    New/Updated Drug Shortage

    March 29, 2021

    March 26, 2021

    March 25, 2021

    March 24, 2021

    March 23, 2021

    March 22, 2021

    New Drug Recall and Safety Alerts

    Acyclovir Sodium Injection, 50 mg/mL by Zydus Pharmaceuticals (USA) Inc. – New Voluntary Recall – March 25, 2021 – Zydus Pharmaceuticals (USA) Inc. is voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, to the Hospital/User level after receiving several complaints of crystallization in vials. Administration of crystalized Acyclovir Sodium Injection, 50 mg/mL has a potential of life-threatening adverse consequences including injection site inflammation of a vein and local reactions, damage and/or obstruction of blood vessels, which could induce clots, particularly in the lungs, the passage of the particulate matter into the bloodstream may lead to clots resulting in stroke, heart attack, decreased liver or kidney function or death of tissues or cells. <Read More>

    Telmisartan Tablets, USP, 20 mg  by Alembic Pharmaceuticals Limited – New Voluntary Recall – March 24, 2021 – Alembic Pharmaceuticals, Inc is voluntarily recalling one lot of Telmisartan Tablets, USP, 20 mg, packaged in 30-count bottles, Lot No. 1905005661 to the consumer level. The product is being recalled due to a market complaint received which stated that one bottle labelled as 30-count Telmisartan Tablets, USP, 20 mg incorrectly contained 30 tablets of Telmisartan Tablets, USP, 40mg. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Drug Coupons and Vouchers Cover Only a Sliver of Prescription Drugs – March 29, 2021 – Use of vouchers and coupons offered by pharmaceutical companies to defray patients’ out-of-pocket drug costs is concentrated among a small number of drugs. While these offsets significantly reduce patient costs, they are not targeted to patients who most need the price reduction, according to a study from researchers at the Johns Hopkins Bloomberg School of Public Health. The researchers, in what is thought to be the largest study of its kind to date, analyzed tens of millions of pharmacy transactions by more than 600,000 people in the U.S. during 2017-19, in order to get a better sense of how vouchers and other point-of-sale copayment “offsets” are used. <Read More>

    How Long Is Long Enough? The Ongoing Saga of Antibiotic Therapy – March 29, 2021 – Largely driven by inappropriate use of antibiotics, antimicrobial resistance continues to rise despite multiple efforts to reverse this process. Inappropriate use not only encompasses the wrong drug for the wrong bug, but also applies to giving too much antibiotic—toxic doses based on pharmacologically high concentrations or giving the antibiotic for too long. The duration of treatment (DOT) has been the subject of recent discussion in which we are reminded that a week is 7 days, as defined by Constantine the Great almost 2,000 years ago, and this is one of the most frequently prescribed periods of antibiotic use. However, evidence to support this duration is scant. <Read More>

    Rural Pharmacies Would Benefit from Disaster Preparedness Training, Regular Policy Guidance – March 29, 2021 – Rural pharmacies would highly benefit from disaster preparedness training, updated disaster preparedness plans that address infectious disease, and regular policy and informational guidance from professional bodies as well as state and national health organizations, according to a poster presented at the virtual American Pharmacists Association annual meeting. Conducted by UNC Eshelman School of Pharmacy, the objective of the study was to add to the limited research on rural community pharmacy disaster preparedness by documenting their preparedness for, and responses to, the COVID-19 pandemic. <Read More>

    American Pharmacists Association Collaborates with CDC to Build the Public’s Confidence in COVID-19 Vaccines – March 29, 2021 – The American Pharmacists Association (APhA) announced that it has entered into a collaborative agreement with the Centers for Disease Control and Prevention (CDC) to support the CDC’s efforts to build the American public’s confidence in the COVID-19 vaccines. The APhA initiative is aligned with the CDC’s three-part strategy of building trust, empowering health care personnel, and engaging communities and individuals. APhA’s work will include a comprehensive program to educate pharmacists and pharmacy personnel about COVID-19 vaccines. <Read More>

    The Unintended Consequences of the CDC Opioid Guideline – March 27, 2021 – …Who Should Write Clinical Guidelines? Many insurers and regulators have adopted rigid policies that cite the CDC’s voluntary guideline as if it was the standard of care. The CDC has admitted its guideline is being misapplied and is working on an update, but so far the agency has done little to correct the problem. In fact, the CDC has gone even further than the guideline, producing a fact sheet for physicians, “Nonopioid Treatments for Chronic Pain,” in which it recommends alternative medications for common chronic pain conditions including migraine, low back pain, osteoarthritis, fibromyalgia, and neuropathic pain. <Read More>

    PBM Reform Legislation Progresses in Michigan – March 26, 2021 – A new legislation recently passed by the Michigan’s House of Representatives would require reforms to many pharmacy benefit manager (PBM) reimbursement practices in the state. The bill passed the state’s House in a vote of 97-10. The bill had previously passed the Health Policy Committee, chaired by Rep. Bronna Kahle, in a vote of 18-1, and now heads to the Senate for consideration. The Michigan Pharmacists Association and National Community Pharmacists Association (NCPA) lauded the House Bill (HB) 4348 in a joint statement. NCPA previously issued a letter in support of the bill. In the letter, Matthew Magner, JD, director of state government affairs, wrote that the legislation would offer “greater protections for patients regarding their prescription drug benefits programs and establish greater oversight of the [PBMs] that administer those benefits.” <Read More>

    Pharmacists, Pharmacy Technicians Take Center Stage in Fight Against COVID-19 – March 26, 2021 – As the pandemic has continued, it has helped shine a light on how important pharmacists, pharmacy interns, and pharmacy technicians can help impact their communities. Over the past year, we have seen how COVID-19 has affected our lives and communities around the globe. This virus has required us to adapt to better protect ourselves and others around us. It has shown how important it is to come together as a community and work safely together to help reach the goals we aim to attain. As the pandemic has continued, it has helped shine a light on how important pharmacists, pharmacy interns, and pharmacy technicians can help impact their communities. <Read More>

    New Study Shows Teriparatide may be Better at Preventing Fractures than Bisphosphonates – March 25, 2021 – Fractures, especially subsequent ones, positively correlate with an increased mortality risk. Caucasian, postmenopausal women make up the highest percentage of patients who experience osteoporosis-related vertebral (74.4%) and nonvertebral (72.8%) fractures. Fractures, especially subsequent ones, positively correlate with an increased mortality risk. Although many studies have shown bone mineral density increases more with teriparatide compared to bisphosphonates, only 1 study, the VERO trial (NCT01709110), directly compares fracture incidence. A recent article, published in the journal Medicine, compares the efficacy of teriparatide and bisphosphonates in fracture prevention in postmenopausal women with osteoporosis. <Read More>

    New Technologies Boost Pharmacist’s Role – March 25, 2021 – Treatment modalities are expanding beyond medications to include digital therapeutics, which are software-based therapies that help manage, prevent, and treat disease. The first prescription digital therapeutic (DTx) was cleared by the FDA in 2017 to treat substance use disorder (SUD), and the first virtual reality (VR) therapeutic received FDA breakthrough device designation in 2020 to help treat chronic pain. Sensor-enabled medications that record and transmit data on medication use have entered the market, supporting patients in taking care of their health and providing pharmacists with actionable insights to guide medication optimization. <Read More>

    Expert: Pharmacy Profession Must Remain United on Retention of COVID-19 Regulatory Changes Post-Pandemic – March 25, 2021 – The COVID-19 pandemic significantly impacted pharmacy practice due to its role in supporting overwhelmed physicians, nurses, and other health care professionals who faced some of the immediate challenges of the crisis, according to Hoai-An Truong, PharmD, MPH, FAPhA, FNAP, professor of pharmacy practice and administration at the University of Maryland Eastern Shore, during a session at the American Pharmacists Association 2021 Annual Meeting and Exposition. For example, many states allowed pharmacies to conduct COVID-19 testing and other additional services in order to decrease the ongoing burden on physicians during the pandemic, Truong explained. <Read More>

    Error Found in Autism Screening Guidelines – March 24, 2021 – If a person thinks they might have autism, they will usually see their general practitioner as the first port of call. The general practitioner will use a screening test to help them decide if the person should be referred to a specialist for a formal diagnosis. However, we recently discovered, by chance, an error in the clinical guidelines clinicians use when making their initial autism assessment. That guideline is published by the U.K. National Institute for Health and Care Excellence (NICE), and it also informs clinical guidelines internationally. <Read More>

    Living Guidelines for Stroke Management can Guide Clinical Practice, Improve Patient Outcomes – March 24, 2021 – It is the first time there has been specific recommendation about progressive resistance training and how to apply it. It works by using a small number of repetitions of an activity with loads that are progressively increased, enhancing strength and movement. Weakness is the most common impairment after stroke, so this recommendation will benefit many stroke survivors. Its inclusion in the Clinical Guidelines for Stroke Management gives clinicians and patients confidence they are giving and receiving the best treatment.” <Read More>

    One Year Later: Key Issues Impacting Health System Pharmacies During the COVID-19 Vaccine Rollout – March 24, 2021 – Nearly 1 year after the start of the global pandemic, the number of COVID-19 cases and deaths in the United States continues to be problematic, but another key statistic is emerging: the number of Americans who are vaccinated. According to the Washington Post (at the time of writing), more than 44.1 million people in the United States have received at least 1 of the 2 required doses, and more than 19.4 million people are fully vaccinated. This vaccine rollout has become even more crucial for the US health care system, as new mutations of the coronavirus continue to emerge. Although the vaccines that have been granted Emergency Use Authorization by the FDA appear to be somewhat effective1 at containing the threat of these variants, the vaccination rate needs to pick up in order prevent further mutations and achieve much needed herd immunity. <Read More>

    Fully Vaccinated People Can Visit Unvaccinated Family and Friends: CDC – March 23, 2021 – Fully vaccinated people can visit unvaccinated family and friends without restrictions, but should restrict visits to one unvaccinated household at a time, the U.S. Centers for Disease Control and Prevention said Monday. “In the setting that the unvaccinated people are from a single household, and all the unvaccinated people are at low risk of severe COVID-19 illness, no prevention measures are needed, so these visits could happen indoors with no mask or physical distancing,” Tami Skoff, a CDC epidemiologist on the Clinical Guidelines Team of the Vaccine Task Force, said in a web briefing, CNN reported. “And the example we like to give here is fully vaccinated grandparents can visit with their unvaccinated daughter and her unvaccinated children, assuming none of them are at high risk of severe disease. These visits can be done indoors with no masks or physical distancing.” <Read More>

    NICE Publishes Single Guideline for Managing COVID-19 – March 23, 2021 – In response to ongoing developments throughout the pandemic, NICE has produced numerous rapid COVID-19 guidelines to help healthcare workers respond to the ongoing pandemic. Feedback has indicated that users would now find it useful for all essential information about managing COVID-19 to be included in a single piece of guidance. The guideline was developed in the MAGICapp platform, a global system that promotes evidence sharing from different guideline creators, therefore increasing the speed at which guidance can be developed and the ease with which it can be updated. <Read More>

    Building an Outpatient Specialty Pharmacy Strategy: 3 Key Questions Hospital Leaders Should Consider – March 23, 2021 – A rise in the use and cost of lifesaving specialty medications is forcing hospital leaders to consider new strategies to better manage them. Hospital and health system leaders often believe that having an accredited specialty pharmacy is the best — or only — way to manage this growing area of their pharmaceutical spend, but there are other options hospital leaders should consider before taking on this demanding model, explained Michael Brown, RPh, vice president of Managed Services at Dublin, Ohio-based Cardinal Health. Here, Mr. Brown highlights three fundamental questions that hospital leaders should ask before developing their outpatient specialty pharmaceutical strategy to better prime their organizations for success. <Read More>

    340B in the News

    Eli Lilly Notches Win in 340B Lawsuit – March 28, 2021 – On Tuesday, March 16, 2021, the United States District Court for the Southern District of Indiana issued a ruling blocking the Biden Administration from implementing a controversial rule to handle 340B drug disputes. The final rule, published by the United States Department of Health and Human Services (HHS) on December 14, 2020, was published more than three years since the 2016 Notice of Proposed Rulemaking (NPRM) appeared in the Unified Agenda – with no new NPRM appearing in the Federal Register. In addition, in March 2020, the United States Health Resources and Services Administration (HRSA) released a statement indicating that it did “not plan to move forward on issuing a regulation due to the challenges with enforcement of guidance.” <Read More> 

    Hospitals Ask Supreme Court to Reverse Site-Neutral, 340B Payment Rulings – March 25, 2021 – How far can an agency go to allow agency-developed policy objectives to supersede concerns about faithful adherence to the law? Similarly, how much should health systems and others regulated by Medicare be concerned about continued lack of reimbursement system predictability? The Supreme Court will decide, likely before the end of its term in June, whether to take action in two key cases that could give everyone some answers. The American Hospital Association (AHA), other provider groups, and several hospitals filed petitions asking the Supreme Court to reverse two separate decisions of the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) upholding significant Medicare reimbursement changes from the Centers for Medicare and Medicaid Services (CMS). <Read More> 

    Federal Judge Blocks Implementation of 340B ADR Final Rule – March 24, 2021 – On March 16, 2021, a federal judge issued a preliminary injunction blocking HHS from implementing the 340B administrative dispute resolution final rule (the Final Rule) released in December 2020. The blocked Final Rule would have created a panel to settle disputes between hospitals and drug manufacturers on issues related to the 340B drug discount program. Judge Sarah Evans Barker of the U.S. District Court for the Southern District of Indiana held that because HHS issued the Final Rule without an additional notice and comment period, HHS failed to follow proper protocols and violated drug manufacturers’ rights. <Read More>

    340B Program Compliance Tools Vary in Ability, Accuracy – March 24, 2021 – Passed by the US Congress in 1992, the 340B drug pricing program allows eligible health care organizations, known as covered entities (CEs), to receive discounts on outpatient drugs. The program was designed to ease the financial burden on safety net institutions with disproportionate indigent, Medicaid, or Medicare populations. With drug prices and 340B compliance and regulation under scrutiny, CEs need experts who understand the program and advanced software solutions to remain compliant. However, many CEs use tools designed for other uses, such as electronic health records or pharmacy benefits, to manage their 340B programs. Making it more complicated, many companies that provide 340B software are not 340B specialists—some do not even focus on community health centers or health centers—and therefore miss the evolving, specific needs of CEs. As the drug pricing program has grown, confusion and misinformation have spread. <Read More>