Clinical Insights: June 2, 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

    OriahnnTM (elagolix/estradiol/norethindrone acetate and elagolix) Capsules – New Drug Approval – May 29, 2020 – The U.S. Food and Drug Administration granted approval to OriahnnTM (an estrogen and progestin combination product consisting of elagolix, estradiol and norethindrone acetate) capsules, co-packaged for oral use, for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. <Read More> 

    ZilxiTM (minocycline) Topical Foam – New Drug Approval – May 29, 2020 – Menlo Therapeutics Inc., a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, announced that the U.S. Food and Drug Administration (FDA) has approved Zilxi™ (minocycline) topical foam, 1.5%, for the treatment of inflammatory lesions of rosacea in adults. Zilxi™, developed as FMX103 by Menlo’s wholly-owned subsidiary Foamix Pharmaceuticals Ltd. (“Foamix”), is the first minocycline product of any kind to be approved by the FDA for use in rosacea. <Read More> 

    TauvidTM (flortaucipir F 18) Injection – New Drug Approval – May 28, 2020 – The U.S. Food and Drug Administration approved TauvidTM (flortaucipir F18) for intravenous injection, the first drug used to help image a distinctive characteristic of Alzheimer’s disease in the brain called tau pathology. TauvidTM is a radioactive diagnostic agent for adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease. TauvidTM is indicated for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs), a primary marker of Alzheimer’s disease. <Read More> 

    Artesunate for Injection – New Expanded Approval – May 26, 2020 – The U.S. Food and Drug Administration approved artesunate for injection to treat severe malaria in adult and pediatric patients. Treatment of severe malaria with intravenous (IV) artesunate should always be followed by a complete treatment course of an appropriate oral antimalarial regimen. Prior to this approval, IV artesunate was only available to patients through the FDA’s Expanded Access program, which allowed the U.S. Centers for Disease Control and Prevention (CDC) to provide IV artesunate to U.S. patients with severe malaria and to patients with uncomplicated malaria who are unable to take oral medications under an investigational new drug (IND) protocol. There has been no FDA-approved drug for treatment of severe malaria in the United States since the marketing of quinine was discontinued by the manufacturer in March 2019. <Read More>

    New Formulation Approval

    No new update.

    New Indication Approval

    No new update.

    New Drug Shortage

    June 01, 2020 

    May 29, 2020

    May 28, 2020

    New Drug Recall and Safety Alerts

    Metformin Extended-Release Products by various manufacturers – New Drug Recall – May 28, 2020 – The U.S. Food and Drug Administration is announcing that agency laboratory testing has revealed levels of the nitrosamine impurity N-Nitrosodimethylamine (NDMA) above the agency’s acceptable intake limit in several lots of the extended-release (ER) formulation of metformin, a prescription drug used to control high blood sugar in patients with type 2 diabetes. The agency is in contact with five firms to recommend they voluntarily recall their products. Company recall notices will be posted on FDA’s website. There are additional manufacturers of the metformin ER formulation that supply a significant portion of the U.S. market, and their products are not being recalled. The FDA is continuing to work closely with manufacturers to ensure appropriate testing. <Read More>

    New Generic Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Trying Telepharmacy? Here’s What You Need to Know – June 1, 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, said Timothy P. Stratton, PhD, RPh, a professor of pharmacy practice at the University of Minnesota College of Pharmacy in Duluth. “For patients, telepharmacy can be provided through a number of different formats.” <Read More> 

    Prescriptions for Hydroxychloroquine Surge, But Drop for Hydrocodone – June 1, 2020 – Prescriptions for the antimalarial drugs hydroxychloroquine and chloroquine surged dramatically over the last few months, likely due to their off-label use for treating COVID-19, according to a new analysis published in JAMA. The study also found a significant decline in prescriptions for the opioid painkiller Vicodin and other hydrocodone/acetaminophen combinations. <Read More> 

    Revised Guidelines for the Management of Burns – June 1, 2020 – A panel of dermatology experts revised existing guidelines for the management of burns. The first iteration of these guidelines was published in 2016 and revised for 2020 by the Wound, Pressure Ulcer, and Burn Guidelines Drafting Committee of the Japanese Dermatological Association. Published in the Journal of Dermatology, the updated guidelines are intended to facilitate the diagnosis, treatment, and management of burn injury. <Read More>

    Remdesivir Under Review by National COVID-19 Taskforce – June 1, 2020 – Remdesivir is among the drugs being touted as a possible treatment in the fight against COVID-19. But in its latest update, the National COVID-19 Clinical Evidence Taskforce (the taskforce) remains cautious and preliminary studies into the drug’s effectiveness remain mixed. <Read More> 

    APhA Coronavirus Watch: CDC Releases Updated Guidance for Pharmacies – June 1, 2020 – CDC released updates to its guidance for pharmacies as the COVID-19 pandemic continues and pharmacists are recognized as an essential part of the health care system.  Important updates include the delivery of adult immunizations and other non-COVID clinical care; the use of face coverings by patients and pharmacists and pharmacy technicians; screening patients for fever and COVID-19 symptoms; guidance on PPE; and more. <Read More>

    APhA Swears in Scott J. Knoer as its 13th Chief Executive Officer – June 1, 2020 – Scott J. Knoer, MS, PharmD, FASHP, was sworn in as the 13th Chief Executive Officer and Executive Vice President of the American Pharmacists Association, during a virtual ceremony witnessed by APhA members and staff. “Being sworn in as the leader of this storied organization is the greatest honor of my life. Guiding our profession through a global pandemic is also the biggest challenge of my life,” he said. “This is a challenge that I wholeheartedly accept and in fact embrace.” Dr. Knoer succeeds Thomas E. Menighan, who has served as CEO/EVP of APhA for the past 11 years, and last year announced his plans to retire in 2020. <Read More> 

    Fundamental Questions About Pharmacy Technicians: The Answers Suggest a Need to Move Forward – June 1, 2020 – Research on pharmacy technicians’ roles and work environments has increased exponentially in recent years. Foundational questions are being raised. For one, “If pharmacists are to take on new responsibilities in alternative models of care, then who is going to pick up some of the responsibilities previously borne by pharmacists, primarily in dispensing and administrative functions?” Given the answer to that question is the pharmacy technician, other fundamental questions have to be answered. <Read More> 

    Can Patients Be Part of the Drug Shortages Solution? – June 1, 2020 – Because patients lack the resources that hospitals have to search for clinical, cost-effective alternatives when prescribed drugs are out of stock or too costly, Scripta Insights has made its drug substitution search tool free for anyone to use during the COVID-19 pandemic. At first glance, it may seem unusual to enlist patients when navigating drug shortages. But that’s exactly what the website (drugfinder.scriptasaurus.com) is set up to do—albeit with the initial help of pharmacists. <Read More> 

    CVS Closes at Least 60 Stores Across 21 States. Call Ahead, If You’re Planning On Visiting One. – May 31, 2020 – Approximately 60 CVS stores across 21 states are closed, as of Monday. The chain drug store announced the closures in the wake of protests that began last week following the killing of George Floyd at the hands of Minnesota police. Amid the unrest, businesses in many cities have been broken into and looted. CVS told USA TODAY it does not have a complete list of the closed stores, due to the developing nature of the situation, but most store closures are in cities with large protests – Philadelphia, Washington, D.C., San Francisco and Los Angeles. <Read More> 

    CMS Lowers Medicare Insulin Copays – May 29, 2020 – The Centers for Medicare & Medicaid Services (CMS) is reducing insulin copays for seniors who are eligible for Medicare via an executive order from President Donald Trump. Participating enhanced Medicare Part D plans in 2021 will provide a broad set of insulins at a maximum $35 copay for a month’s supply of each type of insulin, the White House said in a fact sheet on the new initiative. <Read More> 

    HHS Clarifies Position on Copay Accumulators? Or Does It? – May 29, 2020 – The Department of Health and Human Services (HHS) attempted to clarify its position on the use of so-called “copay accumulators” with respect to private exchange-based health plans in a final rule published in the Federal Register on May 14, 2020 (the Final Rule). The revisions mandated under the Final Rule go into effect on July 13, 2020. <Read More> 

    FDA Looks to Overhaul Orange Book, Seeks Input on Patent Listings – May 29, 2020 – Nearly 40 years after its creation, the US Food and Drug Administration (FDA) is looking to modernize its Orange Book, which lists patent, exclusivity and therapeutic equivalence information for approved drugs, as part of its effort to increase drug competition. <Read More> 

    Pharmacists Highlighted in Surgeon General Smoking Cessation Report – May 29, 2020 – In January, the Surgeon General released the first report on smoking cessation in 30 years. The report updates the latest findings on smoking cessation in the United States and highlights the important role pharmacists play in cessation efforts. “One of the most striking aspects of the report, compared to prior reports, is the extent of emphasis on pharmacists,” said Karen Hudmon, BSPharm, DrPH, professor of pharmacy practice at Purdue University College of Pharmacy in West Lafayette, IN. “It’s been slow progress, but our profession has made major strides over the past 2 decades to advance our role in tobacco cessation.” <Read More>

    Value Based Contracts for Specialty Pharmacy – May 28, 2020 – Why would a health plan pay for something that doesn’t bring any value? Or said another way, why would you pay the same amount of money for a product to treat all your patients when that product is only effective in only a few specific subpopulations? In our current health care system, this happens frequently when it comes to paying for prescription drugs. But what if health plans could pay for what brings them the most value in terms of bringing the highest quality of care at the lowest net cost? And what if this could be done through collaboration and risk sharing, creating a win-win for everyone. Sounds great, right? <Read More> 

    NCCN Adds Rucaparib to Prostate Cancer Guidelines – May 28, 2020 – The National Comprehensive Cancer Network has updated its Clinical Practice Guidelines in Oncology for Prostate Cancer to include new recommendations for the PARP inhibitor rucaparib (Rubraca). <Read More> 

    Surgeons Study Guidelines for Treating Cancer Patients During Pandemic – May 27, 2020 – The novel coronavirus (COVID-19) pandemic not only affects patients who have the virus, but strikes the entire healthcare system including the care for patients with cancer. Aggressive cancers, such as pancreatic cancer, require the continuation of oncological care during the pandemic. However, pursuing care exposes both healthcare professionals and vulnerable patients to COVID-19. <Read More> 

    Big Pharmacy Chains Also Fed the Opioid Epidemic, Court Filing Says – May 27, 2020 – Through years of lawsuits and rising public anger over the opioid epidemic, the big American pharmacy retailers have largely eluded scrutiny. But a new court filing Wednesday morning asserts that pharmacies including CVS, Rite Aid, Walgreens and Giant Eagle as well as those operated by Walmart were as complicit in perpetuating the crisis as the manufacturers and distributors of the addictive drugs. <Read More>

    340B in the News

    Hospitals Fear Pandemic May Threaten Their Eligibility to Participate in the 340B Drug Program – May 29, 2020 – In a March 20, 2020 letter to HHS Secretary Azar, 340B Health, a membership organization consisting of more than 1,400 nonprofit hospitals in the 340B drug pricing program, advised the Secretary that its member hospitals fear the COVID-19 public health emergency could have a “material impact” on hospital admissions and payor mix, which, in turn, could threaten hospitals’ ability to participate in the 340B program. Senator Ben Sasse (R-Neb.) then introduced Senate Bill 3631 with provisions that would prevent hospitals from losing their 340B program eligibility during the COVID-19 pandemic provided they met 340B eligibility requirements for the cost reporting period prior to the date the COVID-19 public health emergency went into effect. <Read More>

    Partner With 340B Executive Stakeholders – May 26, 2020 – According to results of 340B Health’s 2018 annual survey, “82% of hospitals reported that it would hurt their ability to provide more patient care services” if their hospital lost or had their 340B savings limited. This and many other similar statistics support why every 340B program should involve executive stakeholders. In fact, executives should actively participate in a covered entity’s 340B oversight committee. At minimum, they should engage in the overall value of the 340B program, including its compliance risks, financial opportunities, key advocacy efforts, and program resources and structure. <Read More>