Clinical Insights: June 9, 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

    No new update.

    New Formulation Approval

    No new update.

    New Indication Approval

    RecarbrioTM (imipenem-cilastatin and relebactam) Injection – New Drug Indication Approval – June 4, 2020 – The U.S. Food and Drug Administration approved RecarbrioTM (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age and older. RecarbrioTM was previously FDA-approved to treat patients with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety and efficacy data for Recarbrio TM. <Read More> 

    New Drug Shortage

    June 05, 2020

    June 04, 2020 

    June 02, 2020

    New Drug Recall and Safety Alerts

    Metformin Extended-Release Products by Apotex Corp – New Drug Recall – June 5, 2020 – Apotex is expanding the previously announced Retail Level recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg that was initiated on May 29, 2020 to Consumer Level. Apotex was notified by the U.S. Food and Drug Administration (US FDA) that one lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) and recommended recall of the one tested lot. Apotex Corp has agreed to recall this lot, and out of an abundance of caution, the company is extending the recall to all lots of Metformin Hydrochloride Extended-Release Tablets in the US. <Read More> 

    Metformin Extended-Release Products by Teva Pharmaceuticals USA Inc. – New Drug Recall – June 5, 2020 – Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI). <Read More> 

    Metformin Extended-Release Products by Marksans Pharma Limited – New Drug Recall – June 5, 2020 – Marksans Pharma Limited, India is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004, to the consumer level. FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of 96ng/day. <Read More> 

    Metformin Extended-Release Products by Amneal Pharmaceuticals LLC – New Drug Recall – June 1, 2020 – Amneal Pharmaceuticals LLC is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Consumer Level. Amneal was notified by the U.S. FDA that the Agency’s testing of seven lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, showed N-Nitrosodimethylamine (NDMA) amounts above acceptable FDA levels. FDA recommended the recall of the seven tested lots. <Read More> 

    New Generic Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Fate Of Pharma’s Reputation Lies In Gilead’s Hands On Pricing Of Covid-19 Drug Remdesivir – June 8, 2020 – Few remember the time when the pharmaceutical industry was the world’s most admired. The leader was Merck, which was deemed by Fortune magazine to be the “World’s Most Admired Company” for seven straight years starting in 1987…With Gilead’s remdesivir the first drug out of the gate, all will be watching to see how high – or low – the pricing bar will be set. Speculation has been all over the place. Most interesting has been the analysis done by the Institute for Clinical and Economic Review (ICER), the self-proclaimed nation’s watchdog on drug pricing. ICER believes that, assuming remdesivir can successfully treat Covid-19 and get people back to work at least four days earlier, a cost of $4,500 per patient is justified. That’s a stunning price, especially coming from the usually conservative non-profit ICER. <Read More>  

    Bad Math: The Impact of Medication Dosage Miscalculations – June 8, 2020 – Medication errors are a persistent and pervasive problem in the U.S. The latest estimates suggest that each year in the United States alone, 7,000 to 9,000 people die as a result of a medication error, costing more than $40 billion in associated health care costs. In their 2007 landmark report, the Institute of Medicine reported that at least 1.5 million preventable medication errors harm patients in the United States each year. Since then, technology has enhanced our ability to detect many types of medication errors, but human errors, especially those involving calculations, continue to be a problem. Medication dosage miscalculations are unfortunately common and often go unnoticed. Prescriptions can be filled incorrectly by simply missing one crucial piece of information, like weight, or applying a proportion calculation incorrectly. <Read More>  

    COVID-19 Infection Control Could Cut Community Pharmacy Capacity for Flu Vaccinations by Two-Thirds – June 8, 2020 – Pharmacies may only be able to administer one-third of the flu vaccines they have delivered in the previous flu seasons because of pandemic infection control measures, The Pharmaceutical Journal has been told. <Read More> 

    Compounding in the Time of COVID-19 – June 8, 2020 – FDA inspectors continue to keep a close eye on 503A compounding pharmacies, ensuring that every effort is taken to minimize the risk for drug contamination. However, the COVID-19 pandemic has added a few wrinkles, particularly as a result of shortages in personal protective equipment (PPE). <Read More> 

    Pharmacists Fight HIV – June 8, 2020 – In the wake of the novel coronavirus 2019 (COVID-19) pandemic, pharmacists face an ongoing challenge with helping patients optimally manage chronic conditions. In HIV care, for example, pharmacists play a key role in monitoring treatments, counseling patients, and assisting with adherence challenges, all of which current social distancing measures can make more difficult. Furthermore, the potential effects of the COVID-19 virus on patients with HIV remain uncertain, even as reports indicate that other chronic conditions such as diabetes and hypertension may put affected individuals at higher risk. <Read More>  

    CMS Issues First of Two Final Rules Changing the Medicare Advantage and Medicare Prescription Drug Program – June 5, 2020 – In a final rule issued on May 22, 2020 (and published in the federal register on June 2, 2020), the Centers for Medicare & Medicaid Services (CMS) made several changes impacting Medicare Advantage (MA or Part C) and Medicare Prescription Drug Benefit (Part D) programs for contract year 2021. According to CMS, this first final rule will “increase access to telehealth for seniors in Medicare Advantage (MA) plans, expand the types of supplemental benefits available for beneficiaries with an MA plan who have chronic diseases, provide support for more MA options for beneficiaries in rural communities, and expand access to MA for patients with End Stage Renal Disease (ESRD).” <Read More>  

    A Quicker Way To Make Antibody–Drug Conjugates – June 5, 2020 – A USC School of Pharmacy-led team has engineered a new, faster way to make drugs that precisely target malignant cells — while leaving healthy tissue undamaged — that could lead the way to better treatments for numerous types of cancer. <Read More> 

    ISMP Warns of Medication Safety Issues with Critical Care Drug Products – June 5, 2020 – The Institute for Safe Medication Practices (ISMP) has issued an alert about potential safety issues with critical care drug products being introduced in the United States to help ease shortages due to the coronavirus disease 2019 (COVID-19) pandemic. The nonprofit organization urged practitioners to prepare for extra precautions with vials of neuromuscular blocking agents that do not have the “Warning: Paralyzing Agent” statement required on vial caps, and a propofol product that has double the concentration of what is available in the United States. <Read More>

    The Value of Biosimilars in the Pandemic Era – June 5, 2020 – COVID19 presents challenges for healthcare systems in the United States as the number of infections continues to rise. Recently, a study published in Health Affairs found that the potential direct medical cost of treating 80% of the population with COVID-19 requiring treatment in the US could be as high as $654 billion. As the US faces unprecedented challenges from both health and economic perspectives, it is time to think about fundamental ways to maintain the long-term sustainability of our healthcare system. With that in mind, we should all consider the broader adoption of biosimilars as one potential approach. <Read More>

    Flip The Pharmacy Program: Caring for Patients in a Pandemic – June 5, 2020 – Flip the Pharmacy is a unique initiative offered in partnership with the Community Pharmacy Foundation (CPF) and CPESN®USA. Throughout the 24-month program, independent pharmacies grow proficient in offering enhanced services to patients, with support from the Flip the Pharmacy (FtP) team. With monthly change packages, pharmacy teams learn how to coordinate care, offer clinical services, develop roles for pharmacy support staff, implement electronic care plans, and develop the business model. <Read More> 

    Remdesivir Error Points to Common Labeling Problem – June 4, 2020 – Confusion over remdesivir vial labels was a prime factor in a compounding error that resulted in overdosing multiple COVID-19 patients at one unidentified hospital, according to the Institute for Safe Medication Practices’ weekly Acute Care Medication Safety Alert!. “Like many investigational drug container labels,” the ISMP alert stated, the remdesivir vials were “not clearly labeled” and the information was “crowded and in a small font.” <Read More>  

    FDA Reevaluates User Fees for Biosimilar Reviews – June 4, 2020 – Coronavirus disease 2019 (COVID-19) put a crimp in just about everything, including the FDA’s new drug and biosimilars review activities. In so doing, the pandemic helped make the case for an FDA project to upgrade its system for assessing workplace capacity and setting user fees required from manufacturers that make drug application submissions. “Our staff is currently in a primarily telework environment,” the agency said in a recent statement that described the strain on its resources caused by COVID-19 and expressed uncertainty about the FDA’s ability to continue drug application reviews on schedule. <Read More>  

    As Doctors Prescribe Fewer Opioids for Injured Workers, What Do They Offer Instead? – June 4, 2020 – The good news is that doctors are less likely to prescribe opioids to injured workers than they were years ago. They have come to recognize that the pain medications have been overprescribed, causing addictions and deaths including suicides. The bad news is that the opioid crisis is not over by any means. <Read More>

    Insulin Costs and Coverage in Medicare Part D – June 4, 2020 – In May 2020, the Trump Administration announced the number of Medicare Part D plans that will be participating in 2021 in a Medicare Innovation Center model to address out-of-pocket costs for insulin products for Part D enrollees. Under the voluntary model, participating Part D plans can offer coverage of insulin for a flat monthly copayment of no more than $35, in contrast to varying cost-sharing amounts during different phases of the Part D benefit under the current design. The model comes in response to rising prices for insulin, which have attracted increasing scrutiny from policymakers, leading to congressional investigations and overall concerns about affordability and access for people with diabetes who need insulin to control blood glucose levels. <Read More> 

    Pharmacists Feel Overworked, Face More Discrimination – June 4, 2020 – Pharmacists, pharmacy technicians, and other pharmacy staff felt overtaxed even before the coronavirus disease 2019 (COVID-19) pandemic hit, according to findings from the 2019 National Pharmacist Workforce Study. The survey results showed that 69% of full-time pharmacists reported that their workload “increased” or “greatly increased” compared with the prior year. Although the profession is much more racially and gender diverse than in previous years, pharmacy staff reported age, race, and gender discrimination, according to the findings. The Midwest Pharmacy Workforce Research Consortium has conducted the annual study for the Pharmacy Workforce Center (PWC) since 2000. <Read More>  

    International Society of Hypertension Updates Global Treatment Guidelines – June 3, 2020 – Hypertension affects more than 1.4 billion people all over the world, leading to thousands of deaths each and every day. To help healthcare providers combat this fatal condition, the International Society of Hypertension (ISH) has released detailed guidelines for the treatment of hypertension. The full guidance, “ISH 2020 Global Hypertension Practice Guidelines,” was published in both the Journal of Hypertension and Hypertension. <Read More>

    Optimizing Care Model Bolsters Evidence for Technician Involvement in Delivery of Pharmacy Services – June 3, 2020 – Research continues to demonstrate the efficiency and efficacy of pharmacy technicians taking on expanded roles and new challenges. In the broadest sense, technician roles can be classified into direct patient care service support and medication distribution support. Recent evidence of technician involvement in direct patient care support is growing, and includes involvement in medication reconciliation, vaccine screening and administration, and various medication therapy management activities under the supervision of a pharmacist. <Read More> 

    As Beers List for Kids Debuts, New Research Replaces ‘Lore’ – June 2, 2020 – The publication of the Beers List in 1991 was a seminal event in the prevention of adverse drug events in older adults. Now, younger patients stand to benefit from a similarly ground-breaking effort in pediatrics. The KIDs (Key Potentially Inappropriate Drugs in Pediatrics) List, published this spring in the Journal of Pediatric Pharmacology and Therapeutics (2020;25[3]:175-191), contains 67 drugs and 10 excipients that are potentially inappropriate for prescribing in all or some pediatric patients. <Read More> 

    Surescripts Empowers Pharmacies with Benefits-Based Prescription Price Transparency Tool – June 2, 2020 – Surescripts Real-Time Prescription Benefit for Pharmacy service is now available, enabling pharmacists to access information on out-of-pocket prescription costs and therapeutic alternatives at the point of dispensing. This new tool empowers pharmacists to seamlessly collaborate with patients and prescribers on choosing an alternative medication that is both clinically appropriate and affordable. With pricing, coverage and prior authorization information shared directly from the patient’s benefit plan, pharmacies now have insight into different days’ supply and options on formulary that may be less expensive. <Read More>

    340B in the New

    HRSA Poised to Allow 340B Child Sites to Participate Before Appearing on Cost Report – June 8, 2020 – There are initial indications that the Health Resources and Services Administration (HRSA), which administers the federal 340B drug pricing program, may allow hospitals to begin using 340B drugs at offsite locations (“Child Sites”) as soon as those locations meet Medicare provider-based requirements, even if they do not yet appear on a filed Medicare cost report. <Read More>

    Could COVID-19 Reconfigure the Specialty Pharmacy Industry? – June 3, 2020 – Changes that are taking place during the COVID-19 pandemic could persist and significantly reshape the specialty pharmacy industry, experts believe…“More Medicaid fee-for-service dispensing will mean losses for the 25,000 340B contract pharmacy locations across the country that can earn substantial fees from 340B-covered entities,” because they acquire drugs at lower costs, Dr. Fein said. <Read More>