Skip to content

Clinical Insights: December 28, 2021

Posted on December 28, 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

Leqvio® (inclisiran) Injection – New Drug Approval – December 22, 2021 – Novartis announced the US Food and Drug Administration (FDA) approval of Leqvio® (inclisiran), the first and only small interfering RNA (siRNA) therapy to lower low-density lipoprotein cholesterol (also known as bad cholesterol or LDL-C) with two doses a year, after an initial dose and one at three months. “Leqvio® is a revolutionary approach to lower LDL-C, and creates new possibilities for how healthcare systems can impact cardiovascular disease, a defining public health challenge of our time,” said Vas Narasimhan, Novartis CEO. “We now have the opportunity, working together with partners, to provide this first-ever approved LDL-C–lowering siRNA-based therapy to tackle ASCVD at scale across the United States.” <Read More>

New Indication/Dosage/Formulation Approval

Otezla® (apremilast) Tablets – New Approved Indication – December 20, 2021 – Amgen announced that the U.S. Food and Drug Administration (FDA) has approved Otezla® (apremilast) for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. With this expanded indication, Otezla® is now the first and only oral treatment approved in adult patients with plaque psoriasis across all severities, including mild, moderate and severe…”With this expanded indication for Otezla®, patients across all levels of disease severity now have an oral, systemic option that has already been used by more than 650,000 people worldwide and has no lab monitoring requirement.” <Read More>

Caplyta® (lumateperone) – New Approved Indication – December 20, 2021 – Intra-Cellular Therapies, Inc., a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, announced that the U.S. Food and Drug Administration (FDA) approved Caplyta® for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate. <Read More>

Xarelto® (rivaroxaban) Tablets and Oral Suspension – New Approved Expanded Indication – December 20, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved two pediatric indications for Xarelto® (rivaroxaban): the treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral (injected or intravenous) anticoagulant treatment; and thromboprophylaxis (prevention of blood clots and blood-clot related events) in children aged two years and older with congenital heart disease who have undergone the Fontan procedure. Xarelto®  is the only direct oral anticoagulant (DOAC) FDA-approved for primary prevention of clots in pediatric patients following the Fontan procedure and the only DOAC in the U.S. to offer an oral suspension formulation for flexible, body weight-adjusted dosing options for pediatric patients. <Read More>   

New/Updated Drug Shortage

December 23, 2021

December 22, 2021

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Yusimry™ (adalimumab-aqvh) – New Biosimilar Approval – December 20, 2021 – Coherus BioSciences, Inc. announced that the United States Food and Drug Administration (“FDA”) approved Yusimry™ (adalimumab-aqvh), formerly CHS-1420, a Humira® (adalimumab) biosimilar product. Yusimry™ is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis…Approval was based on a comprehensive data package that demonstrated the biosimilarity of Yusimry™ to the reference product, Humira®. <Read More>

Clinical and Pharmacy News

Long Covid is Pitting Patients Against Doctors – December 24, 2021 – As of this month, nearly 250 million people around the world have recovered from Covid-19. But here, the word “recovered” refers only to the acute phase of the illness. Somewhere between 10 and 40 percent of Covid patients continue to experience symptoms several weeks to months after falling sick, a nebulous condition now referred to as post-Covid condition, or long Covid, we are witnessing the emergence of a legitimate new illness, officially recognized by the World Health Organization’s International Classification of Diseases. Because it is difficult to diagnose and treat, however, long Covid has also become a subject of contention between the people who suffer from it and the health care professionals charged with treating them. Long Covid patients have described feeling dismissed and “gaslit” by doctors who seem to question their illness — or who seem at a loss for what to do about it. <Read More>

Coronavirus FAQ: Remind me, How do you Define Mild, Moderate and Severe COVID? – December 24, 2021 – I hear a lot of talk in the news these days about the omicron variant and the kind of disease it might cause: mild, moderate, severe. Could you explain those terms? As the omicron variant spreads around the globe, everyone wants to know: Will it cause mainly mild disease? Moderate? Severe? Early studies suggest that many people could have asymptomatic or mild cases rather than severe, in part because many more people are now vaccinated or have had previous disease. There’s not yet enough data for a definitive answer. And then there’s the question of what exactly “mild,” “moderate” and “severe” mean vis-a-vis COVID. It turns out that question isn’t so easy to answer. That’s because doctors and patients have different concerns when assessing COVID. <Read More>

Representation in Oncology Drug Trials Impacts Patient Health – December 24, 2021 – The FDA looks to address a lack of diversity in cancer drug trials. In clinical trials evaluating the effects of cancer drugs on patient populations, there has been a long-standing, consistent lack of diversity that is representative of the US patient populations likely to receive the treatment. Additionally, landmark oncology trials frequently fail to report the racial diversity of their patient populations, with one study finding that only 33% of the trials reviewed over a 14-year period reported on ethnicity, and a second finding that trials leading to FDA oncology drug approvals reported race only 63% of the time between 2008 and 2018. <Read More>

COVID-19-Related Stress Associated With Poorer Cognitive Ability, Risk-Taking Behavior – December 24, 2021 – Study indicates those who experienced a greater amount of stress from the COVID-19 pandemic had reduced information processing speed. Stress from the COVID-19 pandemic may have had a negative impact on cognitive abilities and risk perception among the general public, according to a study published in PLoS ONE. “The impact of stress and of worry on cognitive function are well known, but are typically studied in the laboratory setting,” says Madeleine Sharp, MD, researcher and neurologist at The Neuro, in a press release. “Here, were able to extend these findings by studying the effects of a real-world stressor in a large sample. An important future direction will be to examine why some people are more sensitive than others to stress and to identify coping strategies that help to protect from the effects of stress.” <Read More>

Pharmacists Nationwide Have Said Pizza Is Not Working. Instead, They Want Better Labor Conditions – December 24, 2021 – Bonnie Woody became a pharmacist, sometimes known as the “most accessible” health care professional, largely for the patient interaction. She’s worked at the same store now for more than a decade — the Tom Thumb pharmacy at South Hulen Street and Bellaire Drive in Fort Worth. “That’s a lot of life lived with people, both good and bad,” she said… “When we talk about health care burnout, we hear about doctors and we hear about nurses and we hear about all of that from a hospital perspective,” he said. “But sometimes we overlook the ones who are literally keeping communities alive on a day-in, day-out basis, on a month-in, month-out basis. And that’s where the community pharmacists come in.” <Read More>

As HIV Rates Fail to Plunge Among Gay Black and Latinx Men, Providers Describe a Lack of Resources to Equalize PrEP Access – December 24, 2021 – Mary Elizabeth Marr sees trouble coming. She’s the CEO of Thrive Alabama in Huntsville, a federally qualified health center (FQHC) that serves about 8,000 patients—1,000 of them living with HIV and many more of them belonging to key HIV risk groups: gay men (especially Black gay men), transgender women, and Black cisgender women… But everything changes on Jan. 1, 2022, which is the source of Marr’s troubles. On that day, Gilead stops “reimbursing” centers like hers at those huge rates, meaning a massive cutback in revenues for promoting and prescribing PrEP. This is especially concerning because PrEP has been adopted more swiftly by gay white men than gay Black and Latinx men, who are more at risk for HIV. <Read More>

Wrongful Death Case is Tied to Additive Effects of Multiple Drugs – December 23, 2021 – A patient who allegedly had consumed a mixture of 3 prescription medications met his demise, and the judge dismissed the widow’s lawsuit against the chain pharmacy. Was that the correct decision, and what was the proper role of the widow’s expert witness pharmacist? A worker at a factory in a Midwestern state had completed his usual night shift and returned home at 7:30 am. He met his wife in the driveway and they spoke for about an hour. At that time, the wife noticed nothing unusual about his communication or conduct. She left for her place of employment, and her husband entered the house. He died at approximately 3 pm while sleeping. The cause of death was identified as alprazolam, fentanyl, and oxycodone intoxication. <Read More>

Overwhelmed, Overburdened Pharmacists Spend Less Time With Patients, Hurting Retail Pharmacy Business – December 23, 2021 – The health of a pharmacy business is under attack from many directions, but retail pharmacies can take steps to alleviate some of this pressure to improve the health of their business. There was a time, not too long ago, when an engaging consultation with your local pharmacist was a typical part of filling one’s prescription medication. As recently as 2013, pharmacists spent an average of 2 hours each day counseling patients. There’s a good chance they even knew their customers by name. Anyone who has picked up a prescription in recent years has probably had an entirely different experience. Most of the time, you’re lucky if the pharmacist lifts their head from behind the counter to make eye contact. Instructions about medication use are impersonal, delivered either via the cashier working the register or via an electronic keyboard with generic, pre-programmed questions. <Read More>

Hello, Teleph(armacy) Line: DEA Seeks Public Comment Concerning Telepharmacy Regulation – December 23, 2021 – With a nod to the Electric Light Orchestra’s 1976 song, “Telephone Line,” the Drug Enforcement Administration (“DEA”) issued an Advanced Notice of Proposed Rulemaking (“ANPR”) regarding the practice of telepharmacy.1 The Controlled Substances Act (CSA), enforced by the DEA, regulates telepharmacies if they dispense controlled substances.2 However, the DEA is seeking comments from specific groups involved with telepharmacy, as well as the general public, to better understand the actual practice of telepharmacy. <Read More>

FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults – December 23, 2021 – The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. Molnupiravir is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. <Read More>

Home Infusion Technology Use Adapted to the Needs of the COVID-19 Pandemic – December 22, 2021 – With home infusion providers experiencing increased demand since the start of the COVID-19 pandemic, pharmacists have had to utilize new technology to coordinate care, communicate with team members, and practice and deliver a higher quality of service. Modern technology is crucial to the provision of home infusions, according to Vincent Thompson, founder of Thompson Solutions, an Ohio-based consulting company serving home infusion pharmacies. After 32 years in the home infusion space, Thompson said, he has seen reliance on technology increase significantly. For pharmacies, this involves clinical documentation, reimbursement, billing, and tracking of dispensing, inventory, lot numbers, and more. <Read More>

Five Things Pharmacists Should Know About C. difficile Infection – December 22, 2021 – Pharmacists play an important role in educating patients and other health care practitioners on the signs and symptoms of C. difficile infection. According to the CDC, C. difficile infection (CDI) is a major and urgent threat that remains one of the most common health care-associated infections in US hospitals, affecting approximately half a million people annually. Caused by a contagious bacterium of the same name, CDI can become a serious health threat to not only patients with CDI, but also others in the home and the community. During the COVID-19 pandemic, there has been a call for renewed attention on CDI, particularly occurrences of CDI with recurrent infection. This increase in attention may be a result of the increase in antibiotics being prescribed to patients with COVID-19 to treat or prevent bacterial infections such as pneumonia—antibiotic use can be a risk factor for CDI. <Read More>

FDA’s Decision To Block Pharmacists From Ordering COVID-19 Oral Antivirals Will Hurt COVID Positive Patients, National Pharmacy Groups Warn – December 20, 2021 – The American Pharmacists Association (APhA), American Society of Consultant Pharmacists (ASCP), American Society of Health System Pharmacists (ASHP), National Alliance of State Pharmacy Associations (NASPA), and the National Community Pharmacists Association (NCPA) issued the following statement in response to the FDA’s decision to authorize the Pfizer COVID-19 oral antiviral but specifically prevent pharmacists from writing the prescriptions:  “The Food and Drug Administration’s decision to grant an emergency use authorization (EUA) for the first COVID-19 oral treatment is a welcome development in the fight against COVID-19. However, FDA created an unnecessary hurdle for access to this important new treatment option.” “Pharmacists have ordered and administered nearly 200 million doses of the COVID-19 vaccines and vast numbers of COVID-19 tests. They have immunized more Americans than any other category of health care provider, and they have been instrumental in the success of the COVID vaccine program. It makes absolutely no sense to restrict their ability to help patients rapidly mitigate the severity of COVID-19 symptoms just as the most aggressive strains of the virus to date are driving up hospitalizations and fatalities across the country.” <Read More>

Trust in Pharmacists is Key to Customer Loyalty – December 22, 2021 – Paying close attention to the pharmacy’s operational and financial success does not have to come at the expense of quality patient care. While pharmacy continues to evolve into more patient-centric practice, we should not lose sight of the fact that pharmacy is a business, as is the case with medicine and other health professions. If the pharmacy is forced to close due to poor management, then it will obviously never again offer patient-centric services. Paying close attention to the pharmacy’s operational and financial success does not have to come at the expense of quality patient care. In fact, the best pharmacists are those who understand how to meld business and clinical aspects of practice. Successful business hinges upon customer and patient loyalty. <Read More>

FDA Authorizes First Oral Antiviral for Treatment of COVID-19 – December 22, 2021 – The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid™ (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid™ is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. <Read More>

340B in the News

Lack of Transparency in 340B Program Leads to Lack of Access for Patients – December 27, 2021 – More transparent drug pricing could improve patient care. Pricing transparency has become an increasingly discussed issue in health care spending, with the United States spending 17.7% of its gross domestic product (GDP) on health care compared with similarly developed countries, which spend no more than 12%, according to a report from the Community Oncology Alliance (COA). Such transparency is especially important with regard to the 340B Drug Pricing Program, which is designed to ensure access to comprehensive services for eligible patients who might otherwise be unable to receive adequate care as a result of high drug prices. Created in 1992, the program requires manufacturers to provide eligible hospitals with discounts on outpatient drugs. According to the COA report, although estimates of the discounts vary, the minimum discount is 23.1% and the average is 34.7%. <Read More>