Clinical Insights: April 30, 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

    Ongentys® (opicapone) Capsules – New Drug Approval – April 27, 2020 – Neurocrine Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Ongentys® (opicapone) 25 mg and 50 mg capsules as an add on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes. <Read More>

    MenQuadfiTM (meningococcal (groups A, C, Y, W) conjugate vaccine) Injection – New Vaccine Approval – April 24, 2020 – The U.S. Food and Drug Administration (FDA) has approved a Biologics License Application for MenQuadfiTM Meningococcal (Groups A, C, Y, W) Conjugate Vaccine for the prevention of invasive meningococcal disease in persons 2 years of age and older. <Read More> 

    TrodelvyTM (sacituzumab govitecan-hziy) – New Drug Approval –  April 22, 2020 –  The U.S. Food and Drug Administration granted accelerated approval to TrodelvyTM (sacituzumab govitecan-hziy) for the treatment of adult patients with triple-negative breast cancer that has spread to other parts of the body. Patients must have received at least two prior therapies before taking TrodelvyTM. <Read More>

    New Formulation Approval

    No new update

    New Indication Approval

    No new update

    New Drug Shortage

    April 29, 2020 


    April 28, 2020


    April 27, 2020 


    April 24, 2020

    April 22, 2020


    April 21, 2020

    New Drug Recall and Safety Alerts

    R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) by QuVa Pharma, Inc – New Drug Recall –  April 23, 2020 –  QuVa Pharma, Inc. confirms that is working with the U.S. Food and Drug Administration, and voluntarily recalling all lots of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe that were prepared using sterile Ketorolac being recalled by Fresenius Kabi. Fresenius Kabi recalled multiple lots of Ketorolac on April 20, 2020 due to the presence of particulate matter found in the reserve sample vials. <Read More>

    New Generic Approval and Launch

    No new update

    COVID-19 News

    Amid COVID-19, Bipartisan Letter Calls for Pharmacy DIR Reform as Part of Relief – April 27, 2020 – A bipartisan letter has urged Congress to consider including provisions permanently prohibiting pharmacy direct and indirect remuneration (DIR) clawbacks by pharmacy benefits managers (PBMs) in future coronavirus relief packages. <Read More>

    Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems – April 24, 2020 – The U.S. Food and Drug Administration issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems, that have been reported with their use for the treatment or prevention of COVID-19, for which they are not approved by the FDA. These risks, which are in the drug labels for their approved uses, may be mitigated when health care professionals closely screen and supervise these patients such as in a hospital setting or a clinical trial, as indicated in the Emergency Use Authorization (EUA) for these drugs to treat COVID-19. <Read More> 

    NICE Publishes New COVID-19 Guidelines – April 24, 2020 – The National Institute of Health and Care Excellence (NICE) has published new rapid COVID-19 guidelines covering the management of disorders of the digestive system treated with drugs that affect the immune response, and the care of people in hospital who develop heart problems as a consequence of COVID-19 infection. The guideline on gastrointestinal and liver conditions provides clinicians with advice on how to adjust care to reduce patients’ exposure to COVID-19 and how to balance the risks and benefits of taking drugs that affect the immune response during the pandemic. <Read More> 

    Managing Newborns of Mothers With COVID-19: Clinical Practice Guidelines (AAP, 2020) –  April 24, 2020 – The American Academy of Pediatrics (AAP) released initial clinical practice guidelines on the management of infants born to mothers with confirmed or suspected coronavirus disease 2019 (COVID-19). Owing to the increased likelihood of maternal virus aerosols and the potential need to administer newborn resuscitation to infants with COVID-19 infection, use airborne, droplet, and contact precautions when attending deliveries from women with COVID-19. <Read More> 

    ASHP Survey: Mechanical Ventilation Rx Shortages Remain a Challenge – April 24, 2020 – Five medications used to sedate or immobilize intubated COVID-19 patients on mechanical ventilation were cited most often by U.S. hospital pharmacy leaders as being in critically short supply, according to ASHP’s latest survey on the status of hospital and health-system pharmacy resources during the pandemic. The five IV drugs—cisatracurium, fentanyl, ketamine, vecuronium and midazolam—were part of a list of ICU medications that respondents were asked to rate by current inventory status and availability from suppliers. <Read More> 

    FDA MedWatch: Hydroxychloroquine or Chloroquine for COVID-19: Drug Safety Communication – April 24, 2020 – FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus disease (COVID-19) or to prevent that disease.  We authorized their temporary use only in hospitalized patients with COVID-19 when clinical trials are not available, or participation is not feasible, through an Emergency Use Authorization (EUA). <Read More> 

    BILLING FOR COVID-19 CARE; One Goal: Getting Your 20% Medicare Add-on Payment for COVID-19 – April 23, 2020 – In unprecedented crisis of COVID-19, the first instinct is to triage our activities, often weeding out the ones that seem to be the least important. Some of those will never surface again and just become part of the detritus left behind. However, documentation mustn’t be one of them. From a clinical standpoint, documentation is critical to caring for patients with COVID-19; it’s essential to tell the patient’s story accurately and completely. When this is done in a codable manner, it’s the key to bringing in desperately needed income and decreasing financial toxicity for the patient who’s often eligible for expanded resources. Such efforts also will help avoid medical billing and payment issues in the months and years following this pandemic. <Read More>

    CDC Guidance for Community Pharmacies During COVID-19 – April 23, 2020 – All pharmacy staff—along with everyone entering the pharmacy—should wear face masks, according to new guidance from the CDC. The CDC’s “Guidance for Pharmacists” also says that pharmacies should postpone and reschedule some routine preventive services, such as adult immunizations, since they require face-to-face interaction. “This guidance applies to all pharmacy staff to minimize their risk of exposure to the virus and reduce the risk for customers during the COVID-19 pandemic. <Read More> 

    Trying Telepharmacy? Here’s What You Need to Know – April 23, 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. For pharmacists accustomed to treating patients in a traditional brick-and-mortar setting, a rapid transition to telepharmacy may seem daunting. Indeed, there are many barriers that prevent pharmacists from quickly providing all services to patients in a remote fashion, but even simple phone calls enable pharmacists to remotely check in on patients and answer their questions. <Read More>

    Exploring the Importance of Pharmacies to Public Health – April 22, 2020 – Pharmacies have been one of the few types of businesses allowed to stay open despite states’ closures of nonessential businesses to help contain COVID-19 — a fact that reflects the key role they play in supporting public health, explains Dima M. Qato, an associate professor at the University of Illinois’ College of Pharmacy and the current National Academy of Medicine Fellow in Pharmacy. “The COVID-19 pandemic has reinforced that pharmacies are an ‘essential’ component of the health care system,” says Qato. <Read More> 

    Pharma Groups Seek Four Policy Changes to Aid their Coronavirus Response – April 22, 2020 – A dozen pharmacy groups, led by the American Pharmacists Association, issued a joint statement outlining four policy changes they say will allow pharmacists to “fully and effectively” support the U.S. COVID-19 response. The changes sought:

    1. Allow pharmacists to order, collect specimens, conduct and interpret tests, and when appropriate, initiate treatment for infectious diseases, including COVID-19, flu and strep, and interpret and discuss those treatments with patients.
    2. Allow pharmacists and pharmacy technicians with valid licenses to operate across state lines, including telehealth.
    3. Authorize pharmacists providing direct patient care to individual patients to conduct therapeutic interchange and substitution with appropriate physician notification when product shortages arise.
    4. Provide direct reimbursement for services delivered by pharmacists if within the scope of practice and covered for other healthcare providers.

    <Read More>

    NIH Panel Issues Guidelines for COVID-19 Treatment – April 22, 2020 – In the face of the rapidly evolving COVID-19 pandemic and the absence of FDA-approved treatments, the National Institutes of Health (NIH) has issued “living” treatment guidelines. The recommendations will be updated online as new data from peer-reviewed publications and other authoritative information become available. A multidisciplinary panel of 30 scientific, clinical, and government experts started working on the guidelines in late March. <Read More>

    NPTA Survey: Pharmacy Technicians Feel Unprotected from COVID-19 – April 21, 2020 – The majority of pharmacy technicians working in chain/mass/grocery-based retail settings feel “unsafe, unprotected, uninformed, and ill-equipped” in the face of the COVID-19 pandemic, according to survey results released by the National Pharmacy Technician Association (NPTA). The survey compared the workplace conditions and opinions of pharmacy technicians in the United States working in various practice settings. Chain drugstores, mass-retail and grocery-store pharmacies showed particularly shocking disapproval numbers from pharmacy technicians. Overall, a mere 26.1% of pharmacy technicians working in chain/mass/grocery-based retail pharmacies felt safe at work, compared with  63.8% of independent pharmacy workers and 52.8% of hospital pharmacy workers. <Read More>

    Early Data on Remdesivir for COVID-19 Cause Guarded Optimism – April 21, 2020 – Two-thirds of patients with severe COVID-19 treated with remdesivir under a compassionate-use protocol showed clinical improvement, and early reports on phase 3 trials of the drug indicate promise, but researchers stress that definitive randomized, placebo-controlled trial data still are needed to confirm the drug’s safety and efficacy. Seven such trials are in the works to test remdesivir, a nucleoside analog antiviral agent being developed by Gilead. <Read More>

    Clinical and Pharmacy News

    Telehealth Offers Myriad Unique Opportunities for Pharmacists – April 29, 2020 – Telehealth involves the use of electronic information and telecommunications to promote or support long-distance clinical health care, education, and public health. This may include remote patient monitoring, store-and-forward imaging (collecting clinical information and sending to another site for evaluation), telephone communication, and video conferencing (figure). Pharmacists can establish medication therapy management (MTM) telepharmacy services by engaging caregivers, health care providers, and patients. The Centers for Medicare & Medicaid Services began reimbursing for telehealth services in 2019, and Medicare Advantage Plans are offering more benefits in 2020. <Read More>

    Groups File Amicus Briefs in PBM Supreme Court Case – April 28, 2020 – Health advocacy organizations, employers, and retailers were among the groups that filed amicus curiae briefs in the Rutledge v Pharmaceutical Care Management Association (PCMA) suit. The case, which will affect states’ ability to regulate certain PBM practices, is set to be heard by the U.S. Supreme Court. PCMA argues that Act 900, the Arkansas law that sought to regulate PBM practices in the state, is preempted by the Employee Retirement and Income Security Act (ERISA) of 1974. PCMA contends, therefore, that states cannot regulate PBMs. <Read More> 

    Literature Evaluation: More Than Just the Guidelines – April 28, 2020 – Building literature evaluation skills is an essential teaching component during all stages of pharmacy education. However, these skills are poorly understood among students, and often times they are not taken seriously during didactic education due to lack of context. It is difficult to understand how literature evaluation should be performed when there is no application context available. Lack of understanding the importance of primary literature evaluation is apparent in the case example given below. <Read More>

    High-Alert Medications Require Special Safeguards – April 28, 2020 – Medication errors have occurred because of confusion between Fiasp and NovoLog, which are both marketed formulations of insulin aspart 100 units/mL manufactured by Novo Nordisk. However, Fiasp and NovoLog have different onsets of action after subcutaneous injection and are not substitutable. Fiasp contains niacinamide, which increases the speed of absorption and allows for administration at the start of a meal or within 20 minutes of starting a meal. Patients should administer NovoLog within 5 to 10 minutes before a meal. <Read More> 

    Latent TB Infection: New Guidelines and Preferred Treatments – April 27, 2020 – The Centers for Disease Control and Prevention (CDC) estimates that up to 13 million people in the United States have latent tuberculosis (TB) infection. These patients do not feel sick, do not show symptoms of TB disease, and cannot spread the bacteria to others. They can, however, develop TB disease themselves. In fact, more than 80% of TB disease cases in the United States result from untreated latent TB infection. Treating latent TB infection is effective in preventing TB disease and is safer and less costly than treating TB disease. <Read More> 

    FDA Warns Manufacturers and Retailers to Remove Certain E-cigarette Products Targeted to Youth from the Market – April 27, 2020 – Today, the U.S. Food and Drug Administration issued ten warning letters to retailers and manufacturers who sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth. The warning letters were sent to establishments marketing unauthorized products, such as a backpack and sweatshirt designed with stealth pockets to hold and conceal an e-cigarette, ENDS products that resemble smartwatches, or devices appearing as children’s toys such as a portable video game system or fidget spinner. <Read More>

    PBMs and Community Oncology: “We Just Can’t Let Them Get Away With What They’re Doing” – April 25, 2020 – Despite the immediate distraction from coronavirus disease 2019 (COVID-19), panelists at the 2020 Virtual Community Oncology Conference said community oncologists must keep pressure on pharmacy benefit managers (PBMs) as the 2020 campaign heats up—lest they lose the momentum to rein PBM practices within the umbrella of drug pricing reform. The byzantine system of rebates and fees and the favored status that pharmacy benefit managers (PBMs) bestow on pharmacies they control continue to bedevil community oncologists, who must employ special staff to ensure patients receive appropriate treatments. <Read More> 

    Evolving Technology, Data Capture Needs in Specialty Pharmacy – April 23, 2020 – As specialty pharmacy continues to evolve, new technology is becoming more vital to ensure the successful management of increasingly sophisticated products, patients with growing needs, and a more difficult payer landscape. Particularly, patient management and comprehensive data capture needs are intensifying while many pharmacy management platforms try to keep up with the new requirements. Many specialty pharmacies have implemented new external systems, while others have developed their own in-house solutions to meet these evolving needs. <Read More> 

    Novel Agents Can Treat Asthma – April 23, 2020 – The CDC estimates that in 2017, 7.7% of adults and 8.4% of children in the United States had asthma and mortality because of asthma was 13.41% for adults and 2.51% for children. In addition, asthma costs the US economy more than $80 billion annually in deaths, loss of productivity, and medical expenses. In recent years, the use of physician-pharmacist collaborative management (PPCM) of asthma has increased in primary care settings. PPCM has been shown to provide clinical benefits to patients with asthma, such as a reduction in emergency department visits and hospitalization and an improvement in quality of life. <Read More> 

    The High Cost of Hepatitis C Infection – April 23, 2020 – Approximately 3.4 million people in the United States have chronic hepatitis C virus (HCV) infection and it is more prevalent than HIV infection. An estimated 50% of those infected with HCV are not even aware of it, 1 in 3 are aware of their infection but untreated, and only 1 in 6 are referred to specialist care for treatment. The infection becomes chronic in approximately 75% to 85% of cases and 10% to 20% of infected individuals will develop cirrhosis over a period of 20 to 30 years.¹ The death toll caused by HCV infection increases each year, compared with other infections but the good news is that HCV can be cured with treatment. <Read More>

    FDA Warns Companies Illegally Selling CBD Products to Treat Medical Conditions, Opioid Addiction – April 23, 2020 – The U.S. Food and Drug Administration has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act). This action is a continuation of the FDA’s efforts to pursue companies that illegally market CBD products with claims that they can treat medical conditions, including opioid addiction or as an alternative to opioids. <Read More> 

    VigiLanz and Tabula Rasa HealthCare Partner to Improve Antimicrobial Dosing – April 23, 2020 – VigiLanz, a provider of clinical surveillance technology, is partnering with Tabula Rasa HealthCare (TRHC), a health care technology company involved in medication safety, to optimize pharmacy workflow and improve patient safety around antimicrobial dosing and dispensing. The companies will integrate TRHC’s DoseMeRx with VigiLanz’s software platform. The integration of DoseMeRx within VigiLanz’s software platform will provide hospital customers with instant access to personalized dosing for vancomycin and other antimicrobials, optimizing pharmacy workflow and improving patient safety. <Read More> 

    Medication Adherence Programs: Strategies for Creating More Loyal Patients – April 22, 2020 – The expression goes, “always do what the doctor ordered.” Unfortunately, there are a few folks out there that do not adhere to this piece of sage yet cliché advice. Medication adherence is an important part of treatment for a patient’s well-being and from a cost-savings perspective. A high level of adherence to a patient’s medication regimens can have profound impacts on their quality and length of life, their health outcomes, and overall health care costs. But how do health care providers initiate and communicate this meaningful message to patients in an impactful, yet non-domineering fashion? The answer is medication adherence programs. <Read More> 

    UPMC Expert Discusses Price Variation for Biosimilars – April 22, 2020 – From the perspective of a practitioner, what determines biosimilar access is more complicated than price or the number of biosimilars on the market. Payment channels and institutional policies to a large degree determine the biosimilar armamentarium, according to Adam Brufsky, MD, PhD, FACP, of the University of Pittsburgh Medical Center (UPMC) in Pennsylvania…A manufacturer might introduce a biosimilar on market with the statement that it will be priced at 15% less than the reference product, but when this discount is filtered through all of the other factors that influence cost, it becomes very difficult to know on a broad scale what the medical system is really paying for biosimilars, Brufsky said. <Read More>

    Kit Check Hospital Pharmacy Operations Report Reveals Over a Third of Hospital Pharmacy Professionals Are Aware of at Least One Colleague Who Has Stolen Controlled Substances – April 21, 2020 – Kit Check, the leader in automated and intelligent medication management solutions for hospitals, announced the findings of its 4th annual Hospital Pharmacy Operations Report, which surveyed 237 top hospital pharmacy leadership professionals in the fourth quarter of 2019. The report aimed to capture sentiment, expectations and circumstances that collectively reflect the state of pharmacy operations in more than 1,000 U.S. hospitals and was conducted prior to the COVID-19 pandemic. <Read More>


    340B in the News

    CMS Cleared to Survey 340B hospitals on Their Drug Acquisition Costs – April 24, 2020 – CMS received final approval April 23 to conduct a survey to collect drug acquisition costs for hospitals in the 340B drug-pricing program, a survey hospitals in the program have strongly opposed.  CMS argues that the survey will make sure Medicare pays the same amount for drugs covered under the program as hospitals pay to acquire those drugs. But hospitals in the 340B program argue that the survey is designed as a way for CMS to slash Medicare Part B reimbursement rates to levels below what is required by federal law. After several months of public comment, CMS received final approval April 23 to conduct the survey. 340B Health, a group that represents hospitals participating in the program said it is “deeply disappointed” by the CMS decision. <Read More>

    Report: Deals Among Oncology Practices Increased 20% Since 2018 – April 24, 2020 – Over the past two years, there has been a 20% increase in community oncology practices being acquired by another practice or corporate entity, a new report says. The report released Friday by the Community Oncology Alliance, which represents such practices, said the jump is likely due to practices wanting to avoid acquisitions by hospitals and other financial incentives … The COA has been fighting for site-neutral payments that would cut payments to off-campus hospital clinics. “The shifting of cancer care to large health systems is the result of the runaway 340B program and disparate site-of-service payments that basically mint money for hospitals,” COA Executive Director Ted Okon said in a statement. <Read More>