Clinical Insights: October 12, 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

    Rethymic® (allogeneic processed thymus tissue-agdc) – New Drug Approval – October 8, 2021 – The U.S. Food and Drug Administration approved Rethymic® for the treatment of pediatric patients with congenital athymia, a rare immune disorder. Rethymic® is the first thymus tissue product approved in the U.S. “This action marks the first FDA approval of a therapy to treat this very rare and devastating disease in children,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “We remain committed to helping advance the development of safe and effective medical products for patients affected by rare diseases – an area of such critical need.” <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    No new update.


    New/Updated Drug Shortage

    October 08, 2021

    October 07, 2021

    October 06, 2021

    October 04, 2021

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    These are the Most Expensive Meds in the US – October 8, 2021 – The cost of specialty prescription drugs can be staggering. In 2020, the prices of 180 widely used specialty prescription drugs went up 4.8%, according to the results of a study by the AARP Policy Institute. Of note, this rise outpaced general inflation by 3.5 times in 2020… Recently, GoodRx published a list of the most expensive drugs in the United States. Let’s take a closer look at the top five. <Read More>   

    More Evidence That Rapid Opioid Tapering is Harmful – October 8, 2021 – The overdose crisis has motivated a sea change in prescribing practices. Opioid tapering is seen as a part of this change. But the risks and harms of tapering often outweigh its potential benefits, especially when tapering is rapid. The risks of rapid tapers are well known. The CDC warns providers to “avoid abrupt tapering or sudden discontinuation of opioids,” with a dose decrease of 10% per month a “reasonable starting point.” But more rapid tapers are very common. <Read More>

    NCQA Launches Specialty Pharm Accreditation – October 8, 2021 – With third-party payors and pharmaceutical manufacturers often requiring that specialty pharmacies obtain accreditation from multiple accrediting bodies, there’s a new player in the space: the National Committee for Quality Assurance (NCQA). “Specialty pharmacy is growing, both nominally and as a percentage of total pharmacy spend, and we felt that this is [an opportunity] for expansion,” said Brad Ryan, MD, NCQA’s chief product officer. “For some time, we’ve had feedback that NCQA could apply our best practices in this space.” <Read More>

    Common Medication Errors in LTC Communities: What Pharmacists can do to Help Prevent Them – October 8, 2021 – In the long-term care (LTC) setting, pharmacists are essential in the prevention of medication errors. We need to strive to minimize or even eliminate the most common medication errors to ensure we provide the highest-quality care for our patients. The most common medication errors seen in LTC facilities include dispensing errors, delay in delivery, and expired inventory. Dispensing errors entail incorrect dose, incorrect drug, incorrect patient, incorrect route, and incorrect time. Lookalike and soundalike drugs are among the biggest causes of medications errors seen in the pharmacy. <Read More>

    Pharmacist Workload Expected to Increase Again This Fall: How Technology can Help – October 8, 2021 – In the past 18 months, pharmacy-based COVID-19 testing and vaccination efforts have added to pharmacists’ workloads and made their crucial place on the care team abundantly evident nationwide. The demands on their time have been so steep that as of May 2021, 90% of community pharmacies reported having trouble staffing open positions. With their workload only expected to increase during the fall season with the possibility of COVID-19 boosters and the annual influenza vaccine roll-out, there is a real opportunity for technology to alleviate some of the administrative burdens pharmacists face so that they have more time to focus on patient care. <Read More>

    APhA Joins Pharmacy Associations to Offer Condolences to Families of Pharmacist and Two Others Killed in Maryland – October 8, 2021 – The American Pharmacists Association joined the leaders and members of 16 other pharmacy organizations to extend its deepest condolences to the families of Brian and Kelly Robinette, of  Ellicott City, Md., and Rebecca Reynolds of Cumberland, Md. Police say Mr. Robinette, a community pharmacist, was killed by a sibling who was upset that Mr. Robinette was administering COVID-19 vaccines. <Read More>   

    Medically Integrated Pharmacies, Oral Oncolytic Agents Grow in Importance During COVID-19 – October 7, 2021 – Despite efforts to diminish the effects of COVID-19 on care of patients with cancer, the pandemic still poses challenges to oncology care delivery. However, as practices have gained experience in this new environment, health care professionals have found innovative ways to work around many of the obstacles COVID-19 presents. Last year’s lockdowns and restrictions dramatically affected in-office care, initially halting screenings and new patient consults while changing the way care could be delivered to existing patients. Eventually, practices identified and adopted strategies that reduced immunocompromised patients’ potential exposure to the virus. Ultimately, changes were made that brought medically integrated dispensing (MID) pharmacies and oral oncolytic agents to the forefront of patient treatment, along with technologies facilitating continuity of care. <Read More>

    The Hidden U.S. COVID-19 Pandemic: Orphaned Children – More than 140,000 U.S. Children Lost a Primary or Secondary Caregiver Due to the COVID-19 Pandemic – October 7, 2021 – One U.S. child loses a parent or caregiver for every four COVID-19-associated deaths, a new modeling study published in Pediatrics reveals.  The findings illustrate orphanhood as a hidden and ongoing secondary tragedy caused by the COVID-19 pandemic and emphasizes that identifying and caring for these children throughout their development is a necessary and urgent part of the pandemic response – both for as long as the pandemic continues, as well as in the post-pandemic era. <Read More>

    Leveraging the EHR Among Tools for Boosting Biosimilars – October 6, 2021 – Despite the promise of huge savings with biosimilars—an estimated $140 billion in discounted spending over the next five years—adoption of these agents has been low, accounting for only one-fifth of accessible molecule volume across all markets in 2020. Fortunately, pharmacists can play an important role in increasing biosimilar uptake. Here’s how three hospitals achieved high levels of biosimilar use with the help of their pharmacists, including one large system that racked up $200 million in savings after achieving a 100% conversion rate. <Read More>

    Oklahoma Pharmacist Creates Unique Hashtag to Spotlight Poor Working Conditions – October 6, 2021 – An Oklahoma pharmacist is sounding the alarm about working conditions within retail pharmacies. Doctor of pharmacy Bled Tanoe told KOCO 5 this is a matter of life and death. So, she created a unique hashtag, #PizzaIsNotWorking, to get her point across. Tanoe said free pizza parties are not fixing the problem, which according to her, has only gotten worse because of the COVID-19 pandemic. “How the conditions have been affected, not just the pharmacists and technicians but also the patient,” Tanoe said. Tanoe has made it her mission to spotlight the working conditions for retail pharmacists and technicians. <Read More>

    Using Data to Show Specialty Pharmacy Expertise – October 6, 2021 – Compared with other types of specialty pharmacies, those based in health systems have superior access to patients and providers, as well as information in medical records, speakers said during a session at the virtual 2021 ASHP Specialty Pharmacy Conference. These factors can be leveraged to demonstrate value to various stakeholders. “Metrics commonly used to measure specialty pharmacy services today focus mostly on operational requirements,” said Amber Skrtic, PharmD, CSP, AAHIVP, a clinical pharmacist with Trellis Rx at Parkview Health, in Fort Wayne, Ind. “While we perform better on these metrics, they don’t show the full impact of our integrated services. Proving our value lies in showing how our higher level of integration allows us to provide differentiated services [and improve] clinical and qualitative outcomes.” <Read More>

    Startup Aims to be a ‘No-Compromises’ PBM, but the Market May Need Convincing – October 6, 2021 – Pharmacy benefit managers (PBMs) have long been controversial in U.S. healthcare…PBMs profit off of rebates and discounts, failing to pass on an estimated $120 billion back to consumers, according to research from Dr. Robert Goldberg of the Center of Medicine in the Public Interest. A better model, the National Community Pharmacists Association (NCPA) suggests, is a flat-fee pricing model, where PBMs are paid only for services rendered. Some states have already proposed this. And one startup is trying it out: Prescryptive Health, a blockchain-powered prescription data platform. <Read More>

    Pharmacy Organizations Launch Confidential Portal for Pharmacy Personnel to Report Their Experiences in the Workplace – October 6, 2021 – The American Pharmacists Association (APhA) and the National Alliance of State Pharmacy Associations (NASPA) announced the launch of the first confidential reporting mechanism of its kind to collect anonymous reports from pharmacists, pharmacy technicians, and student pharmacists about their positive and negative experiences in the pharmacy workplace. The Pharmacy Workplace and Well-being Reporting (PWWR) portal was developed in response to the desire by pharmacy personnel across many practice settings for a venue to address workplace concerns and suggest improvements, without fear of retribution. <Read More>

    CDC, ACIP at Odds Over COVID-19 Boosters – October 6, 2021 – The CDC Director Rochelle P. Walensky, MD, MPH, endorsed the CDC’s Advisory Committee on Immunization Practices’ recommendation for a booster shot of the Pfizer-BioNTech COVID-19 vaccine for certain populations. But she also recommended a booster dose for those in high-risk occupational and institutional settings. The CDC’s endorsement aligns with the FDA’s amended emergency use authorization (EUA) but rejects one of the ACIP recommendations; the ACIP did not recommend the booster for those with an occupational risk for COVID-19. <Read More>

    Is Rx Utilization Worth It at $100 Billion/Year? – October 6, 2021 – Drug utilization management programs cost physicians, patients, drug manufacturers and payors who impose these programs a collective $93.3 billion annually, according to a new report published in Health Affairs. The authors, led by Scott Howell, the chief strategy officer of U.S. pharmaceuticals at Novartis, reviewed the literature and found that patients spend approximately $35.8 billion annually in drug cost sharing; physicians devote approximately $26.7 billion in administrative time; manufacturers spend about $24.8 billion supporting patient access; and even the payors, who are trying to reduce costs, spend approximately $6 billion each year on administering utilization management programs. <Read More>

    FDA Revises Hospital and Health System Compounding Guidance to Help Preserve Patient Access to Compounded Drugs – October 6, 2021 – Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug. The FDA is continuing our efforts to help preserve access to compounded drugs for patients who have a medical need for them. We understand that compounded drugs can serve an important role for patients in hospitals and other healthcare settings whose medical needs cannot be met by an FDA-approved product, and that hospital care raises unique considerations and needs. Recognizing this, in 2016 the agency proposed a policy in draft guidance, that described certain flexibilities for hospital and health system pharmacies that distribute compounded drugs within their health system before receiving patient-specific prescriptions. <Read More>

    How Pharmacists Play an Important Role in Population Health and Community Wellness – October 5, 2021 – Pharmacists working in the community setting are practicing public health pharmacy practice on a daily basis, but probably just didn’t have a name for it. Public health means “the health of the many versus the health of the one,” i.e., focusing on the health and wellness of the population rather than the individual patient. It’s distinguishable from clinic medicine because of its emphasis on communicable disease prevention rather than curing disease. <Read More>

    ADHD Awareness Month and the Pharmacist’s Role – October 5, 2021 – Every October, ADHD Awareness Month brings attention to a common, but still somewhat misunderstood condition that pharmacists encounter on a near daily basis. Attention-deficit/hyperactivity disorder (ADHD) is among the most diagnosed neurobehavioral disorders in school-aged children and older, affecting up to 9% of children and 4% of adults. However, on many occasions, the time leading to this diagnosis can be prolonged due to the perceived stigma that accompanies the diagnosis and the idea that the patient does not have a disorder, but simply does not behave or pay attention. <Read More>

    HHS Awards $2.21 Billion in Fiscal Year 2021 to Help Americans Access HIV Care, Support Services, and Medication – October 5, 2021 – The U.S. Department of Health and Human Services (HHS) announced approximately $2.21 billion in Ryan White HIV/AIDS Program funding for cities, counties, states, and local community-based organizations in fiscal year (FY) 2021. This funding, through the Health Resources and Services Administration (HRSA), supports a comprehensive system of HIV primary medical care, medication, and essential support services critical to improving the health outcomes of nearly 560,000 people with HIV in the United States. <Read More>

    FDA Authorizes Additional OTC Home Test to Increase Access to Rapid Testing for Consumers – October 4, 2021 – The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the ACON Laboratories Flowflexä COVID-19 Home Test, an over-the-counter (OTC) COVID-19 antigen test, which adds to the growing list of tests that can be used at home without a prescription. This action highlights our continued commitment to increasing the availability of appropriately accurate and reliable OTC tests to meet public health needs and increase access to testing for consumers. <Read More>   

    FDA Updates on Hand Sanitizers Consumers Should Not Use – October 4, 2021 – FDA has tested certain artnaturals scent free hand sanitizer labeled with “DIST. by artnaturals Gardena, CA 90248” and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. The agency urges consumers not to use this contaminated product and has added artnaturals hand sanitizer products to the list of hand sanitizers consumers should not use. To date, artnaturals has not responded to multiple FDA attempts to discuss the contaminated hand sanitizers, including identification of the manufacturer, possible recalls, and the scope of the contamination. Therefore, as of October 4, FDA is urging consumers not to use any artnaturals hand sanitizers. <Read More>

    340B in the News

    HRSA Orders Boehringer Ingelheim to Comply With 340B Drug Pricing – October 5, 2021 – The Health Resources and Services Administration has sent a letter to Boehringer Ingelheim ordering the pharmaceutical company to comply with federal requirements under the 340B drug pricing program. HRSA informed the company that its August 1 policy cutting off discounted pricing to hospitals on drugs dispensed at community-based pharmacies is unlawful. The agency directed Boehringer Ingelheim to produce a plan by October 18 for restoring the discounted pricing and said the company must issue credits or refunds to affected hospitals for all past overcharges. <Read More>

    How Drugmaker Restrictions on 340B Discounts Affect Hospital Pharmacies: 5 Systems Weigh In – October 4, 2021 – In July 2020, drugmakers began imposing restrictions on 340B discounts afforded to hospitals participating in the federal drug pricing program. Eight drugmakers have now put a restriction on 340B discounts, some requiring hospitals to submit claims data for patients filling prescriptions through a contract pharmacy and others putting limitations on how far a contract pharmacy can be located from a hospital…Becker’s Hospital Review spoke with five health systems on how restrictions to 340B discounts have affected their pharmacy operations. <Read More>