Clinical Insights: September 15, 2020

    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

    GavretoTM (pralsetinib) Capsules – New Drug Approval – September 4, 2020 – Roche announced that the United States (US) Food and Drug Administration (FDA) has approved Gavreto™ (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. This indication was approved under the FDA’s Accelerated Approval programme, based on data from the phase I/II ARROW study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Trelegy ElliptaTM (fluticasone furoate, umeclidinium and vilanterol) Inhalation Powder – New Indication Approval – September 9, 2020 – GlaxoSmithKline plc and Innoviva, Inc. announced the US Food and Drug Administration (FDA) has approved a new indication for Trelegy ElliptaTM (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with chronic obstructive pulmonary disease (COPD). Trelegy ElliptaTM is not indicated for relief of acute bronchospasm. The FDA-approved strength for both COPD and asthma is fluticasone furoate / umeclidinium / vilanterol 100/62.5/25mcg. There is an additional strength for asthma alone which is fluticasone furoate / umeclidinium / vilanterol 200/62.5/25mcg. <Read More> 

    Trulicity® (dulaglutide) Injection – New Dosage Approval – September 3, 2020 – The U.S. Food and Drug Administration (FDA) approved two additional doses of Eli Lilly and Company’s Trulicity® (dulaglutide). The approval expands the label of once-weekly Trulicity®  to include 3.0 mg and 4.5 mg doses based on data from AWARD-11. The phase 3 trial showed the additional doses led to further benefits in A1C and body weight reduction when compared to Trulicity®  1.5 mg in people with type 2 diabetes. <Read More>

    New Drug Shortage

    September 11, 2020

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    A Way to Cut Back on Medication Alerts – September 14, 2020 – Everyone agrees: Medication alerts about patient safety are annoying. Most of the time (in ≥96% of cases, some research shows), providers simply override the warning, thereby defeating the whole purpose of the alerts. One hospital in the Netherlands has a possible answer to so-called “alert fatigue.” Within two years, St. Jansdal Hospital, in Harderwijk, reduced the number of pop-up alerts received by pharmacists by 70%. For prescribers, the number of alerts has fallen even more dramatically: For every 100 orders, prescribers receive only 3.2 pop-ups. <Read More> 

    As Oral Chemo Agents Surge, Pharmacists Help Care Teams Respond – September 14, 2020 – Cancer treatment programs are increasingly using oncology pharmacists to provide quality assurance and safety initiatives ranging from clinical verification of chemotherapy orders to patient adherence monitoring to drug interaction checks. But perhaps the most important role for pharmacists is in education. That’s because cancer patients leaving clinics with oral medication prescriptions “are basically on their own,” said Patrick Skeffington, PharmD, the co-team lead for oncology pharmacy at Southcoast Centers for Cancer Care (SCCC) in Fairhaven, Mass. “It’s not like a patient sitting in a chair in an infusion clinic where we can make sure they receive the right dose and it’s given on time.” <Read More>

    Telepharmacy: 5 Tips for Getting Started – September 14, 2020 – Every American health facility is scrambling to figure out the best way to fight the COVID-19 pandemic. Recently, the CDC suggested that providers use telemedicine whenever possible. But adopting the technology isn’t as simple as adding some video equipment and smiling for the camera. Here are some implementation tips for making a good start. <Read More>

    Switching Antirheumatic Therapies Has Low Risk of Clinical Worsening – September 13, 2020 – There is a very low risk of rheumatoid arthritis worsening as a result of changing treatments due to partial or inadequate response, a new study finds. In fact, more than half of such patients treated with adalimumab who had switched to sarilumab experienced clinically meaningful improvements. These findings were presented at the Clinical Congress of Rheumatology (CCR) East 2020 meeting. <Read More>

    Restocking in the COVID-19 Era – September 13, 2020 – Sanitizing crash cart trays and medical kits while restocking them was a routine procedure before COVID-19 arrived. Efforts have grown more formal and intensive in recent months to help prevent transmission of the highly infectious coronavirus, according to operations pharmacists at two hospitals. Physicians and nurses caring for COVID-19 patients under stressful conditions need assurance that sanitization took place, and if and when a patient codes, they can reach in quickly for what they need without extra anxiety. “Sharp objects are passed around, and they need to know things are clean,” said Alan Portnoy, PharmD, the operations manager at Reading Hospital, in Reading, Pa., which has averaged a daily census of 400 or more patients this year. <Read More>

    FDA Draft Study on Biosimilar Disclosures Draws Fire – September 11, 2020 – In a quest to ensure that product labeling disclosures about biosimilars are not unduly influencing the opinions of health care providers (HCPs) and consumers toward biosimilars, the FDA aims to conduct a study that will examine HCP and consumer responses to different types of label wording. In public comments submitted about the draft outlines for the study, various pharmaceutical companies and groups have offered their suggestions for improving the value of these studies and upgrading standard biosimilar disclosures so that unwarranted perceptions do not form in the minds of HCPs and consumers. <Read More>

    CDC Awards $7 Million For Pilot Project to Reduce Chronic Disease by Advancing Health Equity – September 11, 2020 – The Centers for Disease Control and Prevention (CDC) has awarded $7 million over two years to the Association of State and Territorial Health Officials (ASTHO) and the National Association of County and City Health Officials (NACCHO) to fund a pilot project that will identify up to 50 high-burden communities working to advance health equity by addressing social determinants of health. <Read More>

    Opioid Overdoses Are Rising: Is Your Pharmacy Equipped? – September 10, 2020 – As the coronavirus disease 2019 (COVID-19) pandemic sweeps across the nation, we are also seeing spikes in opioid overdoses. The pandemic is exacerbating many of the conditions that contribute to relapse or people using substances just to cope, including unemployment, stress, fear, anxiety, and isolation. Although public health officials know that social distancing slows the spread of COVID-19, it can also have an adverse effect on those who struggle with substance use. With the rising number of fatalities, it is imperative that all pharmacists demand that their pharmacies are stocked with naloxone (i.e. Narcan or Evzio), a medication that is easy to administer and is designed to rapidly reverse opioid overdoses, overall helping to save lives. By stocking naloxone in all pharmacies, it is easier for families and caregivers to help their loved ones by having it on hand in case it is needed. <Read More> 

    Intensive Multicomponent Fibromyalgia Treatment: A Translational Study to Evaluate Effectiveness in Routine Care Delivery – September 10, 2020 – The current study was designed to evaluate the translation of clinical trial outcomes and clinical guidelines for the treatment of fibromyalgia (FM) into an intensive multicomponent clinical program embedded in routine care delivery. The study aimed to assess the adaptation of these recommended strategies into routine clinical care while evaluating their effectiveness and durability in improving functional status and level of distress in a large clinical sample of FM patients. <Read More>

    New Treatment Guidelines for Antibiotic Resistant Infections | IDSA Update – September 10, 2020 – The Infectious Diseases Society of America (IDSA) has released timely recommendations on treating some of the most common pathogens in global health. New guidance from the IDSA comes as, amid the COVID-19 pandemic, some are rushing to “just in case” antibiotic prescribing. Antibiotics are an important tool, but pathogens can evolve to resist a drug’s intended effect. Inappropriate prescribing of antibiotics has led to what is called antimicrobial resistance (AMR), and experts claim the COVID-19 pandemic could make it much worse. <Read More> 

    FDA Warns Website Operators Illegally Selling Opioids to Consumers – September 10, 2020 – The U.S. Food and Drug Administration has issued warning letters to 17 website operators for illegally selling unapproved and misbranded opioids online in violation of the Federal Food, Drug, and Cosmetic Act. Misbranded opioids include those offered for sale without a prescription, as well as opioids that lack adequate directions for use. The opioids offered for sale include products such as tramadol and oxycodone. These are prescription drugs that have significant risks of addiction, abuse and misuse, which can lead to overdose and death, and should only be used under the supervision of a licensed health care provider. These warning letters are a continuation of the FDA’s commitment to take action against the illegal sale of opioids over the internet. <Read More> 

    Understanding the Beers Criteria Is Essential – September 9, 2020 – Even when prescribed in appropriate doses and for the right conditions, medications can increase the risk for death. As counterintuitive as this may seem, decades of data demonstrate that when patients take multiple medications for multiple conditions, also known as polypharmacy, their odds of adverse effects, hospitalizations, and even death are significantly greater. This is because when medications are studied for efficacy and safety, they are often studied in individuals taking few other medications and with few other chronic diseases. Unfortunately, this does not match the typical patient population, and as a result many patients are at risk of these adverse consequences of polypharmacy. In fact, more than two-thirds of Americans use 3 or more medications each month. Fortunately, pharmacists and pharmacy technicians can combat this hidden epidemic in their pharmacies. <Read More> 

    Handgrip Can Help Detect Type 2 Diabetes – September 9, 2020 – A handgrip screening test may be a simple, low-cost way to identify patients at-risk of type 2 diabetes (T2D), according to a new study published in Annals of Medicine. Diabetes in all forms is the ninth major cause of death in the world. Approximately 90% of all diabetes cases are T2D and in the United Kingdom, 1 in 10 adults over the age of 40 are living with T2D, according to the study…In a study of 776 people between the ages of 60 and 72 years with a history of diabetes over a 20-year period, researchers sought to determine whether there was a correlation between grip strength and diabetes. Participants squeezed the hands of a dynamometer with their dominant hand with maximum isometric effort and maintained this grip for 5 seconds. Until recently, the relationship between handgrip strength and T2D has been inconsistent. <Read More> 

    Specialty Pharmacies Improve Patient Outcomes, Minimize Costs to Health Care System – September 9, 2020 – As of January 2020, specialty drugs accounted for 39% of the total pharmacy benefit spend, which is expected to increase to almost 50% of total prescription spend by the end of the year. The specialty pharmacy industry is quickly expanding and its marketplace is expected to reach $400 billion in 2020. Currently, specialty medications are only used in approximately 1% to 2% of the population, but trends indicate that this utilization percentage will continue to rise. Seeing that high costs are associated with these medications and the magnitude of this increasing marketplace, it is important to examine what a specialty pharmacy is and the variety of important roles that it plays within this industry. <Read More> 

    APhA Hails HHS Announcement Authorizing Pharmacists to Administer COVID-19 Vaccines – September 9, 2020 – The U.S. Department of Health and Human Services (HHS) authorized pharmacists to order and administer (and interns to administer) COVID-19 vaccines that have been approved or licensed by the Food and Drug Administration (FDA) to all individuals age 3 or older. Pharmacist interns must do so while acting under the supervision of a qualified pharmacist. “This is tremendous news,” said Scott J. Knoer, MS, PharmD, FASHP, Executive Vice President and CEO of the American Pharmacists Association. “It properly recognizes that pharmacists serve a vital role in the nation’s response to this pandemic. It increases patients’ access to care during this emergency with providers whom they trust, at a time and place that is convenient to them.” <Read More> 

    Federal Government Adjusts COVID-19 Entry Strategy for International Air Passengers – September 9, 2020 – As the COVID-19 pandemic continues, the United States Government (USG) is innovating and taking a new approach to help keep international air passengers healthy. The new, more effective strategy focuses on the continuum of travel and the individual passenger, including pre-departure and post-arrival education, efforts to develop a potential testing framework with international partners, and illness response. This strategy is consistent with the current phase of the pandemic and more effectively protects the health of the American public. Beginning September 14, 2020, the USG will remove requirements for directing all flights carrying airline passengers arriving from, or recently had a presence in, certain countries to land at one of 15 designated airports and halt enhanced entry health screening for these passengers. Currently, enhanced entry health screening is conducted for those arriving from, or with recent presence in, China (excluding the Special Administrative Regions of Hong Kong and Macau), Iran, the Schengen region of Europe, the United Kingdom (excluding overseas territories outside of Europe), Ireland, and Brazil. <Read More> 

    National Survey Shows Encouraging Decline in Overall Youth E-Cigarette Use, Concerning Uptick in Use of Disposable Products – September 9, 2020 – The U.S. Food and Drug Administration, in partnership with the Centers for Disease Control and Prevention, released new data from the 2020 National Youth Tobacco Survey (NYTS), which show 1.8 million fewer U.S. youth are currently using e-cigarettes compared to 2019. After two years of disturbing increases in youth e-cigarette use, we are encouraged by the overall significant decline reported in 2020. This is good news; however, the FDA remains very concerned about the 3.6 million U.S. youth who currently use e-cigarettes and we acknowledge there is work that still needs to be done to curb youth use. Youth use of e-cigarettes remains a public health crisis that is affecting children, families, schools and communities, and we will do everything possible to stop it – including new actions we are taking today. <Read More> 

    Technology Can Help With Vancomycin Dosing – September 8, 2020 – Houston Methodist Hospital (HMH) is leading a shift this September toward area under the curve (AUC) antimicrobial dosing in all eight facilities of the Houston Methodist health system, said William L. Musick, PharmD, BCIDP, a clinical specialist in infectious diseases at HMH’s 1,200-bed flagship location. “We knew for almost two years this would be the direction of the new vancomycin guidelines, and the direction we had to move,” Dr. Musick said. <Read More> 

    ASHP Eyes Rx Trends Amid Pandemic – September 8, 2020 – The 13-member expert team working on the 2020 edition of ASHP’s 20th annual drug expenditures forecast was facing a formidable challenge. In the midst of researching and analyzing the myriad factors that go into producing a national drug spending model, a rare “black swan” event in the form of COVID-19 was threatening to throw projections into disarray. Erin Fox, PharmD, the senior director of Drug Information and Support Services at University of Utah Health, in Salt Lake City, described the uncertainty facing not only the ASHP team but also health systems and hospitals nationally that were trying to factor their own epidemiology and drug use data into reasonably accurate cost estimates. “You need to prepare for a surge in patients, but you don’t know how many are coming,” Dr. Fox told Pharmacy Practice News. “And it’s not knowing what you’re going to be treating. Will there be fewer transplants and cancer infusions? Will there be as many elective surgeries? Because of all of that uncertainty, it’s really difficult.” <Read More> 

    Pharmacists Should Have Priority Status in Vaccine Distribution, Pharmacy Groups Say – September 8, 2020 – A letter signed by APhA and 12 other pharmacy organizations urged the National Academies of Science, Engineering, and Medicine (NASEM) to prioritize the COVID-19 vaccination of pharmacists and pharmacy staff and to prominently include pharmacists in plans for the allocation and distribution for the COVID-19 vaccine. The letter was addressed to a NASEM special committee tasked with developing an overarching framework to assist domestic and global policymakers in planning for equitable allocation of vaccines against the virus. <Read More>

    340B in the News

    340B Action Heats Up: New Developments From the Courts, Administration and Drug Makers – September 14, 2020 – In the courts, in the Administration and in drug maker initiatives, action on the Section 340B prescription drug discount program has heated up this summer. The program, known by its section number of the federal Public Health Service Act, has been the subject of a D.C. District Court of Appeals decision upholding a reduction in Medicare reimbursement for certain 340B-purchased drugs, a regulatory proposal to reduce such reimbursement even further, steps by pharmaceutical manufacturers to address perceived compliance issues in the 340B contract pharmacy context, and an agency notice imposing additional 340B registration requirements for nonprofit hospitals. This article provides details on these issues, as well as on President Trump’s recent executive order regarding federally qualified health center prices for insulin and injectable epinephrine. <Read More> 

    AHA Analysis Touts Community Benefits Made by 340B Hospitals as Spat With Drugmakers Continues – September 11, 2020 – Safety net hospitals that participate in the 340B drug discount program generated $64.3 billion in total benefits to community programs and services tailored to help low-income patient populations, a new analysis finds. The analysis, published Thursday (PDF) from the American Hospital Association (AHA), comes as hospitals wage a war with drug companies that have begun restricting sales of discounted products to 340B contract pharmacies. AHA charges the 340B program enables safety net hospitals to help patients in vulnerable communities, but drug companies argue the program has gotten too large and hospitals are not helping patients with the savings. <Read More> 

    Hospitals Urge HHS to Step in on 340B Fight With Drug Manufacturers – September 11, 2020 – Another group of hospitals sent a letter to HHS Secretary Alex Azar on Thursday asking him to take action against the drugmakers limiting 340B drug distribution. “If the administration permits pharmaceutical companies to continue these practices, 340B hospitals will face increased difficulties serving high volumes of patients living with low incomes in our rural and urban communities,” More than 1,100 hospitals in the 340B Health group wrote. <Read More>