Clinical Insights: February 2, 2021

    Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place. Contact us to learn more.

    New Drug Approval

    No new update.

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Plegridy® (peginterferon beta-1a) Injection – New Approved Route of Administration – January 29, 2021 – Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new intramuscular (IM) injection route of administration for Plegridy® (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis (MS). The new IM administration offers people living with relapsing MS the well-characterized efficacy and safety of Plegridy® with the potential for significantly reduced injection site reactions. This approval expands Biogen’s industry-leading portfolio of MS treatments, which also includes the subcutaneous (SC) administration of Plegridy®, and follows the European Commission’s marketing authorization for the IM administration in December 2020. <Read More>

    New/Updated Drug Shortage

    January 29, 2021

    January 28, 2021

    January 27, 2021

    January 26, 2021

    New Drug Recall and Safety Alerts

    Cisatracurium Besylate Injection, USP 10mg per 5mL by Meitheal Pharmaceuticals, Inc. – New Voluntary Drug Recall – January 27, 2021 – Meitheal Pharmaceuticals, Inc. (“Meitheal”), announced that it is voluntarily recalling one (1) lot of Cisatracurium Besylate Injection, USP 10mg per 5mL to the user level. The decision to recall the product was made after a product complaint revealed that a portion of Lot C11507A of cartons labeled as Cisatracurium Besylate Injection, USP 10mg per 5mL, containing 10-vials per carton, contained 10-vials mis-labeled as Phenylephrine Hydrochloride Injection, USP 100mg per 10mL.   To date, Meitheal has not received reports of any adverse events or identifiable safety concerns attributed to the lot. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Dashboard-Enabled Diabetes Stewardship Drives $840K Savings – February 1, 2021 – Diabetes stewardship pharmacists at the University of Nebraska Medical Center (UNMC), in Omaha, have developed a novel dashboard, constructed using the hospital’s electronic health record system (EPIC), that provides real-time surveillance of glycemic fluctuations among patients hospital-wide. With specially trained pharmacists, including a dedicated pharmacist to monitor glycemic control and fluctuations in blood sugar in hospitalized patients, UNMC experienced a roughly 65% reduction in hypoglycemia (–70 mg/dL) in critical care units and a nearly 50% reduction in such readings in non–critical care units from January 2015 through June 2020, reported Jon Knezevich, PharmD, the hospital’s diabetes stewardship pharmacist. <Read More>

    Pharmacists Play an Essential Role in Managing Hypertension – February 1, 2021 – About half of US adults have hypertension, and only about 1 in 4 (24%) individuals have it under control, according to the CDC. Evidence shows that individuals with hypertension might be at an increased risk for severe coronavirus disease 2019 (COVID-19). Therefore, it is extremely important to ensure that individuals with hypertension are well controlled and are educated about COVID-19 precautions, including frequent handwashing, mask-wearing, and social distancing as the pandemic persists.2 Pharmacists can play an essential role in hypertension management through medication therapy management (MTM) services. <Read More>

    Advantages and Disadvantages of Janssen’s COVID-19 Vaccine Candidate – January 29, 2021 – An interim analysis of the phase 3 ENSEMBLE trial showed that a single dose of the COVID-19 vaccine candidate being developed by Janssen Pharmaceutical Companies was 72% effective in the United States, but showed lower efficacy in other countries, especially those with higher rates of SARS-CoV-2 virus variants. The experimental COVID-19 vaccine developed by Janssen, a subsidiary of Johnson & Johnson, has advantages over the current messenger RNA (mRNA) vaccines by Pfizer/BioNTech and Moderna that received an emergency use authorization (EUA) from the FDA last December. Most notably, it only requires one dose instead of two; requires refrigeration, but not the extremely low freezer temperatures of mRNA vaccines; and can be distributed through normal vaccine distribution channels. The Janssen vaccine also remains viable when refrigerated for months. <Read More>

    Bipartisan Correspondence Urges HHS to Increase Focus on Community Pharmacies for COVID-19 Vaccine Distribution – January 29, 2021 – US Representatives Abigail Spanberger (D-VA) and David B. McKinley (R-WV) have sent a letter to the Department of Health and Human Services (HHS) urging President Biden’s administration to follow the lead of states that have used a community pharmacist-led approach in the national coronavirus disease 2019 (COVID-19) vaccine distribution strategy. The correspondence follows a joint letter sent earlier this week from the National Community Pharmacists Association (NCPA) and the American Society of Consultant Pharmacists, which urged governors to utilize independent pharmacies. <Read More>

    Discontinue Mammograms for Breast Cancer Survivors When Life Expectancy is Under 5 Years, New Guidelines Say – January 29, 2021 – When life expectancy reaches less than five years in older breast cancer survivors, clinicians can discontinue mammograms, according to new guidelines published in JAMA Oncology Jan. 28. The guidelines, applicable to breast cancer survivors ages 75 and older, also recommend to consider stopping mammograms when life expectancy is between 5 and 10 years, and to continue mammography when life expectancy is more than 10 years. An expert panel and clinician focus groups created the guidelines based on a literature review that analyzed the risk of ipsilateral and contralateral breast cancer events among survivors. <Read More>

    Anthem’s Pharmacy Revenues Ballooned in 2020 – January 29, 2021 – While Anthem’s fourth-quarter financial results may have disappointed investors, the insurer’s in-house pharmacy benefit manager — IngenioRx — saw significant growth in the final quarter of 2020, according to recent financial filings. In the fourth quarter of 2020, IngenioRx recorded revenues of $5.9 billion, up 81.4 percent year over year. Its operating gain for the fourth quarter of 2020 was $363 million, higher than Anthem’s combined operating gain for its commercial/specialty and government insurance businesses. For the year ended Dec. 31, 2020, IngenioRx brought in $21.9 billion in revenue, up 305.6 percent from $5.4 billion in 2019. <Read More>

    EntrestoTM Is Top HFrEF Treatment Recommendation in Updated ACC Guidelines – January 28, 2021 – Treatment optimization for heart failure with reduced ejection fraction (HFrEF) is the focus of the American College of Cardiology (ACC)’s 2021 update to its 2017 Expert Consensus Decision Pathway (ECDP) on managing patients with the condition, published in Journal of the American College of Cardiology. One focus of the 2021 Update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment: Answers to 10 Pivotal Issues About Heart Failure With Reduced Ejection Fraction is optimizing HFrEF treatment through expanded use of EntrestoTM (sacubitril/valsartan; Novartis). It is now recommended ahead of all other renin-angiotensin-aldosterone system (RAAS) inhibitors. <Read More>

    Pharmacists Among Medical Professionals, Scientists Facing Increased Online Harassment – January 28, 2021 – Experts are warning of increased online harassment of scientists and medical professionals, including pharmacists, in recent months. In response, online privacy and data removal services reported a sharp increase in sign-ups from health care groups in 2020…Pharmacists are also seeing new scrutiny as the first COVID-19 vaccines roll out. They face targeting by anti-vaxxers and others who are skeptical about the COVID-19 vaccines, as well as general stress and burnout that can come along with the pandemic. The report said that the targeting of pharmacists on the whole is concerning, and medical professionals should be aware of potential threats and how they can protect themselves. <Read More>

    ASCO Publishes Guideline Update for Initial Management of Noncastrate Advanced Prostate Cancer – January 28, 2021 – The American Society of Clinical Oncology (ASCO) has published an update to its guideline for initial hormonal management of noncastrate advanced, recurrent, or metastatic prostate cancer. The latest guideline, which was published online in the Journal of Clinical Oncology, was developed by a multidisciplinary expert panel. The recommendations were made based on a systemic review of 4 clinical practice guidelines, 1 endorsement of a clinical practice guideline, 19 systematic reviews, 47 phase 3 randomized controlled trials, 9 cohort studies, and 2 review papers. <Read More>

    Implementing Pharmacist Contraceptive Prescribing: A Playbook for States and Stakeholders – January 28, 2021 – More than 19 million individuals in the United States lack meaningful access to birth control within their communities. Low-income women, women of color and individuals from other historically marginalized communities have been shown to have greater difficulty in accessing reproductive healthcare generally and contraception in particular. Authorizing pharmacists to prescribe and dispense contraceptives is one strategy states can deploy to increase contraceptive choice and access and at the same time address health disparities. <Read More>

    ICS Withdrawal Not Found to Increase Risk of COPD-Related Exacerbations – January 27, 2021 – Physicians can withdraw inhaled corticosteroids (ICS) from triplet therapy without increasing patients’ risk of chronic obstructive pulmonary disease (COPD)-related exacerbations. Withdrawing inhaled corticosteroids (ICS) from a patient’s chronic obstructive pulmonary disease (COPD) treatment regimen will not increase their risk of exacerbations under certain conditions, according to a recent study published in Respiratory Research. The researchers said their results give more information on how ICS withdrawal affects patients with COPD generally excluded from randomized control trials such as those who are managed in primary care, who don’t have frequent exacerbations, or who have blood eosinophil concentrations below 300 cells/μL. <Read More>

    Biden Administration Should Continue Closing PBM Loopholes – January 27, 2021 – Now that the new administration has taken over, a lot of attention surrounds what President Biden plans for the future of health care in America. One especially important issue to consumers is that of prescription drug prices, and what the new President can do to bring them down. One way drug prices can be reduced involves the conduct of Pharmacy Benefit Managers (PBM’s). PBMs are large companies that manage prescription drug benefits on behalf of payers and insurance plan sponsors. PBMs are meant to make money from plan sponsors who hire them to run prescription insurance plans and manage costs, but they have found other ways to pocket additional profits. <Read More>

    Vaccines Are Here – January 27, 2021 – With more than 200 vaccines in development, the coronavirus disease 2019 (COVID-19) vaccine landscape is rapidly evolving. As of press time, there were 6 vaccines in development as part of Operation Warp Speed (OWS) that are considered front-runners (see Figure). The goal of OWS is to produce and deliver 300 million doses of effective and safe COVID-19 vaccines, with initial doses available by January 2021. The FDA’s guidance document for Emergency Use Authorization (EUA) for COVID-19 vaccines and the recent advisory committee meeting discuss the importance of efficacy and safety. Phase 3 placebo- controlled studies should demonstrate that the COVID-19 vaccine is at least 50% effective as 1 of the criteria for an EUA or FDA approval. Pharmacists will play an important role in COVID-19 vaccine education and administration, which makes it critical to stay up to date on the latest clinical information. <Read More>

    WHO Highlights Progress in Accelerating Access to Hepatitis C Diagnostics and Treatment in Low- and Middle-Income Countries – January 27, 2021 – Many low- and middle-income countries have reduced suffering from hepatitis C, thanks to increased access to testing and treatment. Some achieved a 20-fold increase in the number of people treated with safe and effective direct-acting retroviral drugs between 2015 and 2018, according to the Global progress report on accelerating access to hepatitis C diagnostics and treatment, released by WHO. Low- and middle-income countries can now aim to achieve a price as low as US$ 60 per patient for a 12-week course of treatment with WHO-prequalified generic sofosbuvir and daclatasvir. Prices offered by suppliers of WHO-prequalified HCV rapid diagnostic tests ranged between US$ 1 and US$ 8 per test. <Read More>

    Management of Diabetes and Hyperglycaemia in the Hospital – January 27, 2021 – Hyperglycaemia in people with and without diabetes admitted to the hospital is associated with a substantial increase in morbidity, mortality, and health-care costs. Professional societies have recommended insulin therapy as the cornerstone of inpatient pharmacological management. Intravenous insulin therapy is the treatment of choice in the critical care setting. In non-intensive care settings, several insulin protocols have been proposed to manage patients with hyperglycaemia; however, meta-analyses comparing different treatment regimens have not clearly endorsed the benefits of any particular strategy. Clinical guidelines recommend stopping oral antidiabetes drugs during hospitalisation; however, in some countries continuation of oral antidiabetes drugs is commonplace in some patients with type 2 diabetes admitted to hospital, and findings from clinical trials have suggested that non-insulin drugs, alone or in combination with basal insulin, can be used to achieve appropriate glycaemic control in selected populations. <Read More>

    The Moderna COVID-19 (Mrna-1273) Vaccine: What You Need to Know – January 26, 2021 – The WHO Strategic Advisory Group of Experts (SAGE) on Immunization has issued Interim recommendations for use of the Moderna mRNA-1273 vaccine against COVID-19 in people aged 18 years and older. Here is what you need to know. Who should be vaccinated first? As with all COVID-19 vaccines, health workers at high risk of exposure and older people should be prioritized for vaccination. As more vaccine becomes available, additional priority groups should be vaccinated, with attention to people disproportionately affected by COVID-19 or who face health inequities. <Read More>

    WHO Recommends Follow-Up Care, Low-Dose Anticoagulants for COVID-19 Patients – January 26, 2021 – WHO recommends that patients who have COVID-19 – both confirmed and suspected – should have access to follow-up care if they have persistent, new or changing symptoms. This is one of the recommendations made by WHO in revised clinical management guidelines. Evidence was gathered on the post COVID condition, so-called ‘long COVID’, where people who have recovered from COVID-19 continue to have longer-term issues like extreme fatigue, persistent cough and exercise intolerance. Understanding this condition is one of WHO’s priority areas of work. In February 2021, WHO will organize a series of consultations to reach consensus on a description of this condition and its subtypes, and case definitions. This scientific understanding will inform the name of the condition. The consultations will include a broad range of stakeholders, including patient groups. <Read More>

    US May Reverse HHS Guidelines Allowing for Easier Buprenorphine Prescription – January 26, 2021 – President Joe Biden’s administration is preparing to block the previous administration’s last-minute effort to allow physicians to prescribe buprenorphine more easily, anonymous sources familiar with the plan told the Washington Post. On Jan. 15, HHS said it would update its guidelines to exempt physicians from the X waiver, a requirement mandated by Congress in 2000 that necessitates physicians receive a day’s training before they can prescribe buprenorphine, a drug that treats opioid addiction and chronic pain. Before he was elected, President Biden’s plan to end the opioid crisis supported this measure. However, since President Biden took office, legal experts have warned the White House administration that HHS is not authorized to issue guidelines that allow physicians to eschew requirements Congress mandated, sources told the newspaper. <Read More>

    Telepharmacy Offers Opportunity Amid Pandemic – January 26, 2021 – In 2020, the worldwide spread of coronavirus disease 2019 (COVID-19) has created major disturbance in the daily life of billions of individuals. The spread of COVID-19 and the lockdown of major cities have forced people to rethink how to obtain goods and services, including health care…Without considering COVID-19 or any other pandemic, the need for pharmacists to contribute to health care teams as recognized telehealth providers is driven by the alarming predictions for provider shortages within the next decade. A deficit of 122,000 primary care providers is expected in the United States by 2032.3 At the same time, projections show increased life expectancy and an exponential increase in patient demand for telehealth services— putting pharmacists in a unique position to close the gap in their communities and be further recognized as major players in primary care. <Read More>

    Pharmacists Play a Vital Role in Asthma Management – January 26, 2021 – According to the CDC, 1 out of 13 people have asthma and more than 11.2 million people report having experienced 1 or more asthma attacks or episodes in 2018. Asthma is a condition that causes the airways to narrow and swell, making it hard to breathe…Pharmacists can play an important role in a patient’s asthma management by examining the patient’s refill history, adherence, and proper inhaler techniques. A systematic review and meta-analysis in 2018 showed that pharmacist-led interventions can significantly improve medication adherence. <Read More>

    What Lies Ahead For Pharmacists in 2021 – January 26, 2021 – Long gone are the days when pharmacists were sometimes referred to as pill-counters and considered just dispensers of medication. Pharmacists have become recognized as critical front-line workers in the fight against coronavirus disease 2019 (COVID-19) while remaining active members of the patient care team. Their role expanded considerably in 2020 as they administered childhood vaccines, conducted COVID-19 testing, virtually counseled patients and more. This year, pharmacists’ role will continue to evolve because of, or despite, the pandemic. Below are my predictions on what lies ahead for pharmacists in 2021.  <Read More>

    As Amazon Rolls Out Pharmacy Venture, Pharmacists Must be at Top of Their Game – January 26, 2021 – When online retail giant Amazon launched its new pharmacy venture in November 2020, chain community pharmacy stocks, including Walgreens, CVS, and Rite Aid, tumbled in response. The market reaction suggested that community pharmacy stood to take a major hit in the wake of Amazon’s newest enterprise. But, experts say that this newcomer to the pharmacy world gives community pharmacists the opportunity to demonstrate the unique value of the services they offer. “The key,” said Kurt Proctor, PhD, BSPharm, senior vice president of strategic initiatives for the National Community Pharmacists Association, “is that community pharmacists clearly communicate to their patients the value that they bring. You can’t rest on your laurels and assume that all your customers will be loyal. You need to be at the top of your game.” <Read More>

    340B in the News

    More than 40 Lawmakers Oppose Medicaid Prescription Drug Change – January 28, 2021 – Opposition in the state Legislature is growing to changes to how prescription drugs are paid for in the state’s Medicaid program, with more than 40 lawmakers backing a letter to reverse the policy. At issue is the state’s plan to “carve out” Medicaid prescription drugs that advocates and lawmakers worry will hurt safety net providers that participate in what’s known as the 340B program. The program allows providers to purchase prescription drugs at a discounted price and in turn provide services like food and housing assistance to lower-income New Yorkers. Many of the prescription drugs impacted included medication for HIV and hepatitis C treatment. <Read More>

    HHS Freezes Trump Administration Rule on Insulin, Epinephrine Drug Discounts – January 25, 2021 – HHS has frozen a rule implemented by former President Donald Trump that requires federally qualified health centers to pass discounts on insulin and epinephrine directly to patients…The rule requires all health centers receiving section 330(e) grant funds and participating in the 340B drug-pricing program to make insulin and epinephrine available to low-income patients at or below the cost the health center purchased them through the 340B drug-pricing program. <Read More>