Clinical Insights: November 16, 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

    Besremi® (ropeginterferon alfa-2b-njft) Injection – New Drug Approval – November 12, 2021 – The U.S. Food and Drug Administration approved Besremi® (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. The excess cells thicken the blood, slowing blood flow and increasing the chance of blood clots…Besremi® is the first FDA-approved medication for polycythemia vera that patients can take regardless of their treatment history, and the first interferon therapy specifically approved for polycythemia vera. <Read More>

    Eprontia™ (topiramate) Oral Solution – New Drug Approval – November 8, 2021 – Azurity Pharmaceuticals, Inc. a private specialty pharmaceutical company focused on developing innovative products to meet the unique needs of patients with underserved conditions, announced the U.S. Food and Drug Administration (FDA) approval of EPRONTIA™ (topiramate) oral solution, 25 mg/mL…“Eprontia™’s ready-to-use liquid formulation provides HCPs a therapy that addresses an unmet medical need.” <Read More>

    Purified Cortrophin™ (Repository Corticotropin Injection USP) Gel – New Drug Approval – November 1, 2021 – ANI Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) for Purified Cortrophin™ Gel (Repository Corticotropin Injection USP) (Cortrophin™ Gel) for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), in addition to excess urinary protein due to nephrotic syndrome. Cortrophin™ Gel is an adrenocorticotropic hormone (ACTH), also known as purified corticotropin. <Read More>

    New Indication/Dosage/Formulation Approval

    No new update.

    New/Updated Drug Shortage

    November 12, 2021

    November 10, 2021

    November 08, 2021

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    How Rural Communities are Losing Their Pharmacies – November 15, 2021 – Batson’s Drug Store seems like a throwback to a simpler time. The independently owned pharmacy in Howard, Kansas, still runs an old-fashioned soda counter and hand-dips ice cream. But the drugstore, the only one in the entire county, teeters on the edge between nostalgia and extinction…But with the pandemic exacerbating the competitive pressures from large retail chains, which can operate at lower prices, and from pharmaceutical intermediaries, which can impose high fees retroactively, [the owner] wonders how long her business can remain viable. <Read More>

    Diabetes Management Expertise is in Demand – November 12, 2021 – The Public Readiness and Emergency Preparedness (PREP) Act has expanded opportunities for pharmacy technicians to administer COVID-19 vaccines and therapies and routine immunizations. This has also paved the way for technicians to play an integral role in diabetes management and it serves as an opportunity to enhance workflow. Technicians can get involved in supporting the National Diabetes Prevention Program (National DPP) to prevent type 2 diabetes by administering testing, performing screening assessments, raising awareness of prediabetes, and recommending patient referral. Technician roles in diabetes management are expanding, and motivational interviewing is an important component. <Read More>

    Specialty Pharmacies Call for Congress to Act on Pharmacy DIR Fee Reform in Budget Reconciliation Bill – November 12, 2021 – As Congress continues to develop and advance budget reconciliation legislation, specialty pharmacies are alarmed that the House has not included pharmacy direct and indirect (DIR) remuneration fee reform.  These rising DIR fees under Medicare Part D are harming specialty pharmacies and their patients who are living with life-altering and life-threatening medical conditions. National Association of Specialty Pharmacy President and CEO Sheila Arquette, RPh stated, “Congress has a real opportunity right now to reduce senior drug costs through pharmacy DIR reform, ending a decades long effort that has manipulated drug costs under Medicare Part D while directly hurting the specialty pharmacies that serve patients with conditions like multiple sclerosis, hemophilia, or cancer.” <Read More>

    WHO to set Guidelines on COVID-19 Antiviral Pills Soon – November 12, 2021 – World Health Organization (WHO) officials said on Friday they were hoping to convene a meeting soon to set guidelines on the use of COVID-19 antiviral pills, saying they offered “very attractive” new prospects for clinical care. Britain became the first country to approve one of the potentially game-changing pills earlier this month. Janet Diaz, the WHO’s top official for clinical care responses, said that a meeting of its guidelines development group would consider the question of COVID pills in a forthcoming meeting in three weeks. <Read More>

    The Career Connection Between Pharmacy and Toxicology – November 12, 2021 – The pharmacy profession has a myriad of opportunities for advancement and a diverse array of career paths that anyone with a pharmaceutical education can pursue. Using the knowledge gathered through school and real-world experiences, pharmacists can easily transition from one role to another. One notable position that pharmacists can pursue is the role of a toxicologist. The extensive drug knowledge that pharmacists possess can increase their chances of success in the field of toxicology as well. <Read More>

    When Is It Safe to Stop ABx for Febrile Neutropenia? – November 11, 2021 – It may be safe to discontinue or deescalate antibiotics in some cancer patients who develop febrile neutropenia (FN) before the condition resolves, but guidelines and studies aren’t yet fully conclusive, a panel of speakers said during the Hematology/Oncology Pharmacy Association’s 2021 virtual annual conference. Marked by fever and absolute neutrophil count (ANC) of less than 500 cells/mm3, the incidence of FN varies between 10% and 50% in solid tumors and is reportedly greater than 80% in hematological malignancies. <Read More>

    Rightwing Anti-Vaxxers no Longer Big Fans of Pharmacists Refusing to Fill Prescriptions – November 11, 2021 – Dr. Simone Gold, of America’s Frontline Doctors Who Should Really Have Their Medical Licenses Revoked, is just outraged. For the first time in her whole entire life, she is hearing about pharmacists refusing to fill prescriptions! Not ever! Not even once! “NEVER before have Pharmacists violated the patient-doctor relationship or refused to fill legitimate prescriptions,” she tweeted. “It’s one of many scandals in this health crisis. Those who violate their oaths will soon be exposed”… As it turns out, there actually is an official Pharmacist’s Oath, and you will be shocked to discover that nowhere does it say that they are legally bound to fill every prescription no matter what. <Read More>

    Opioid Trial Jurors ask Witnesses Questions as Judiciary Reviews Practice – November 11, 2021 – In a trial over whether three pharmacy chains fueled the U.S. opioid epidemic, a Walgreens executive was asked how the company documented red flags of potential pain pill misuse and whether it offered the overdose antidote naloxone for free. It wasn’t an opposing lawyer who asked those questions. Nor the judge. Rather, it was jurors in the federal court in Cleveland, Ohio, who posed those questions in the first trial the pharmacies have faced over the opioid epidemic. <Read More>

    Virginia Pharmacy Gave Incorrect COVID-19 Vaccine Dose to Younger Kids – November 11, 2021 – More than 100 children in the 5-11-year-old age group mistakenly received a dose of the COVID-19 vaccine formulated for those 12 years and older at a pharmacy in Loudon County, Virginia. The Virginia Department of Health (VDH) believes that 112 children were affected on Nov. 3-4 at Ted Pharmacy in Aldie, receiving a lower dose than recommended. <Read More>

    The Value of Pharmacists in Treating Alzheimer Disease – November 10, 2021 – A pharmacist can offer up to date knowledge on the clinical evidence behind new drugs, serving as a source of guidance for patients amongst the controversy with aducanumab and other new medications for Alzheimer disease. The month of November is National Alzheimer’s Disease (AD) Awareness Month, a time dedicated to the life-altering disease that affects over 6 million Americans. AD is the most common cause of dementia. <Read More>

    As UTI Drug Resistance Increases, Treatment Choices Critical – November 10, 2021 – With recent data indicating that roughly 60% of antibiotics prescribed for urinary tract infections (UTIs) in the outpatient setting do not conform with clinical guidelines, and some UTI drug resistance rates markedly rising over the past several years, one expert urged pharmacists to carefully review the appropriateness of UTI prescriptions. “With a lot of UTI infections comes a lot of prescribing of antibiotics, and sometimes our providers don’t do the greatest job,” said Ryan Moenster, PharmD, a clinical pharmacy specialist in infectious diseases, VA St. Louis Health Care System, during a virtual session at the 2021 American College of Clinical Pharmacy Virtual Annual Meeting. <Read More>

    Seeking Employment Outside Pharmacy: A Potential Path Forward in a Saturated Market – November 10, 2021 – As the number of pharmacy schools and pharmacy graduates continues to grow, it becomes increasingly difficult for those with pharmaceutical education to find jobs in their chosen field, and many may feel they need to look elsewhere to utilize the skills they learned as students. During a session at the American Association of Colleges of Pharmacy 2021 Annual Meeting titled “Will My Students Have a Job After Graduation? Providing ‘Outside the Box’ Workforce Solutions,” Sharon Park, PharmD, MEd, BCPS, associate professor of clinical and administrative sciences and assistant dean of academic affairs at the Notre Dame of Maryland University School of Pharmacy, explained there are alternative employment opportunities for pharmacists outside the pharmacy. <Read More>

    PBMs Enjoy the Benefit of Status Quo in Congress’ Swing-and-a-Miss on Reducing Prescription Drug Costs – November 9, 2021 – Following the public release of the Build Back Better Act by the U.S. House of Representatives, the American Pharmacists Association (APhA) is disappointed that Congress did not include provisions to rein in the excessive pricing gymnastics played by massive pharmacy benefit managers (PBMs) within Medicaid managed care and Medicare Part D programs. Simple reforms aimed at how PBMs distort and exploit our nation’s complex prescription drug supply chain were passed over in favor of other proposals that neglect the systemic problems that plague the core of our nation’s broken prescription drug pricing system. <Read More>

    Providing Patient Care in a Community Pharmacy Career – November 9, 2021 – The COVID-19 pandemic has changed the way the public seeks health care. For example, it has highlighted the value of community pharmacies as a location where health care professionals can provide vaccinations, testing, and medication-related care, in addition to triage or other health care services. Community pharmacy practice is experiencing a critical transformation that will modify the way pharmacy professionals and the public think of the community pharmacist’s role. Many factors are coinciding to set up community pharmacy for an exciting evolution that will continue to grow in the coming years. <Read More>

    340B in the News

    Insurers Paying Higher Prices for Drugs at Top-Performing Hospitals – November 12, 2021 – Reimbursement for clinician-administered drugs under Medicare Part B is set at the average sales price charged by manufacturers to wholesalers, plus a 6% markup. Although these prices had long been confidential, hospitals now are required to post payer-specific negotiated prices under a transparency rule that took effect early this year. In a report published in JAMA Internal Medicine, researchers analyzed a set of top-performing hospitals to quantify drug pricing variation across insurers…The gap between pharmaceutical acquisition costs and hospital charges is particularly wide for 340B entities, including many hospitals in the study sample. The 340B program was designed to help hospitals provide care to vulnerable patient populations and offset the costs of uncompensated care. <Read More>

    District Courts Issue Key Decisions in 340B Contract Pharmacy Cases – November 10, 2021 – Over the last two weeks we have seen a flurry of activity from U.S. District Courts across the country in the ongoing contract pharmacy disputes between pharmaceutical manufacturers and HRSA, the agency responsible for administering the 340B program…While the manufacturers’ policies differ in their scope, all are generally designed to limit 340B exposure from contract pharmacies in response to the precipitous rise in the total number of contract pharmacies in recent years, the undeniable growth in the overall 340B program, and claims from manufacturers about risks around the statutory prohibitions on drug diversion and duplicate discounts. <Read More>

    Drugmakers get Mixed Bag in Lawsuit Rulings Over 340B Contract Pharmacy Moves – November 8, 2021 – A federal judge found drug companies cannot unilaterally restrict sales of products discounted under the 340B program to contract pharmacies. But a separate ruling found that manufacturers don’t have to provide discounts. The opinions, released late Friday, are the latest in a legal fight between six drugmakers and the Biden administration over whether they must offer discounted products to contract pharmacies. Federal judges issued separate rulings in lawsuits filed by Novo Nordisk, Sanofi, Novartis and United Therapeutics. <Read More>