Clinical Insights: May 27, 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

    PhexxiTM (lactic acid, citric acid and potassium bitartrate) Vaginal Gel – New Drug Approval – May 22, 2020 – Evofem Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Phexxi™ (lactic acid, citric acid and potassium bitartrate) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. PhexxiTM is the first non-hormonal, on-demand, vaginal pH regulator contraceptive designed to maintain vaginal pH within the normal range of 3.5 to 4.5 – an acidic environment that is inhospitable to sperm. <Read More>

    KynmobiTM (apomorphine hydrochloride) Sublingual Film – New Drug Approval – May 21, 2020 – Sunovion Pharmaceuticals Inc. (Sunovion) announced that the U.S. Food and Drug Administration (FDA) has approved Kynmobi™ (apomorphine HCI) sublingual film (APL-130277) for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD). OFF episodes are the re-emergence or worsening of PD symptoms otherwise controlled with oral levodopa/carbidopa. <Read More>

    New Formulation Approval

    No new update.

    New Indication Approval

    Pomalyst® (pomalidomide) – New Orphan Indication Approval – May 15, 2020 – Bristol Myers Squibb announced that Pomalyst® (pomalidomide) was approved by the U.S. Food and Drug Administration (FDA) for patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy (HAART), or in patients with Kaposi sarcoma who are HIV-negative. <Read More>

    Rubraca® (rucaparib) – New Indication Approval – May 15, 2020 – The Food and Drug Administration granted accelerated approval to rucaparib (Rubraca®, Clovis Oncology, Inc.) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. <Read More>

    New Drug Shortage

    May 26, 2020 

     May 21, 2020

     May 20, 2020

     May 19, 2020

    New Drug Recall and Safety Alerts

    NP Thyroid® (Thyroid Tablets, USP)  by Acella Pharmaceuticals, LLC – New Drug Recall – May 22, 2020 – Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115.0% of the labeled amount of Liothyronine (T3). <Read More> 

    Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables by Biota Biosciences – New Drug Recall – May 20, 2020 – Biota Biosciences is voluntarily recalling Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables to the customer level. These injectable products are being recalled because they were marketed without FDA approval. The products claims on our website make these products unapproved new drugs. Further, the products are misbranded because the labeling fails to bear adequate directions for use. <Read More>

    Kore OrganicTM Watermelon CBD Oil by Summitt Labs – New Drug Recall – May 15, 2020 – Summitt Labs is voluntarily recalling Batch#730 Lot#K018 of Kore OrganicTM Watermelon CBD Oil Tincture, 30 ml bottle, 15mg 450x to the consumer level. The Florida Department of Agriculture and Consumer Services tested a random sample and found the product to contain lead levels at 4.7 ppm. When informed of this, Summitt Labs issued an immediate voluntary recall and started an internal investigation. <Read More>

    New Generic Approval and Launch

    No new update.

    Clinical and Pharmacy News

    A Pediatric CDS Guide to Peanut Allergy – May 26, 2020 –  Data indicate that peanut allergy is a growing epidemic, with a current prevalence of 2.2%, up from 0.8% in the early 2000s. Evidence suggests that parent and pediatric clinician concerns have grown in step with prevalence, as about one in 13 US children are now affected by food allergy. Of these, peanut allergy is the most common. The groundbreaking Learning Early About Peanut (LEAP) study answered the question of why there has been a large increase in peanut allergy cases and whether it can be prevented from developing, while also providing evidence supporting the introduction of peanut in infants prior to their first birthday. <Read More>

    Guideline Highlights Risk Stratification in Treating Postmenopausal Osteoporosis – May 26, 2020 – A baseline fracture risk should guide the selection of initial osteoporosis therapy for postmenopausal women, and treatment should be continued for as long as the expected benefits outweigh the potential risks, according to an updated guideline from the American Association of Clinical Endocrinologists and the American College of Endocrinology. <Read More>

    Trying Telepharmacy? Here’s What You Need to Know – May 26, 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>

    Fears of Coronavirus Second Wave Prompt Flu Push at U.S. Pharmacies, Drugmakers – May 26, 2020 – U.S. pharmacy chains are preparing a big push for flu vaccinations when the season kicks off in October, hoping to curb tens of thousands of serious cases that could coincide with a second wave of coronavirus infections. <Read More>

    OSU Pilots Cancer Drug Repository Program – May 26, 2020 – In Ohio, cancer patients who have a supply of prescription drugs they can no longer use—for example, because their treatment plan or dosage has changed—can now donate their surplus medications to other patients in need via a new drug repository program at the Ohio State University Comprehensive Cancer Center (OSUCCC) Arthur G. James Cancer Hospital, the institution announced. <Read More> 

    Evidence Supports Prophylactic Treatment for Migraine – May 22, 2020 – Migraine is one of the most common neurologic disorders in children and adolescents with a prevalence of 7.7%. The prevalence is actually higher in boys compared with girls prior to puberty. However, after puberty, the incidence and prevalence of migraine increase more rapidly in girls than boys with girls ultimately having a higher prevalence after age 11 years. Given this prominence, the American Academy of Neurology and the American Headache Society have standard practice guidelines for the pharmacologic treatment for pediatric migraine prevention. These guidelines were most recently updated and published in 2019. <Read More> 

    APhA Coronavirus Watch: OSHA Takes Small But Notable Steps Toward Protecting Pharmacy Workers – May 21, 2020 – Heads up, pharmacy employers: the Occupational Safety and Health Administration (OSHA) has issued an alert listing safety tips to protect essential workers at pharmacies. Released May 14, 2020, it is OSHA’s first alert specifically recognizing pharmacy employees—but the recommendations are not binding. <Read More> 

    Plan Sponsor Alert: Truths About PBM and Manufacturer Rebates – May 20, 2020 – Plan sponsors are far too trusting of pharmacy benefit managers (PBMs) when it comes to understanding drug manufacturer rebate revenue. Rebate administration is one of the main services that PBMs offer to governmental entities, self-funded employers, insurers, and managed health care organizations (collectively, “plan sponsors”). PBMs receive two types of rebates: manufacturer rebates and pharmacy rebates. Manufacturer rebates are cash payments made by pharmaceutical manufacturers to PBMs that are theoretically designed to act as drug discounts. Pharmacy rebates are point-of-sale fees or post-sale chargeback (e.g., audit recoupment) that PBMs retain from their member pharmacies. Unfortunately, rebates became a lucrative revenue source for non-transparent PBMs at the expense of plan sponsors, manufacturers, patients, pharmacies and taxpayers. <Read More>

    Adherence to Disease-Modifying Drugs Lowers Chronic Opioid Use in Patients with Inflammatory Conditions – May 19, 2020 – Patients who are adherent to prescribed biologic disease-modifying anti-rheumatic drugs (bDMARDs) tend to have lower rates of chronic opioid use, according to a new study of more than 1,500 patients. <Read More>

    ISMP Issues Alert on Remdesivir Labeling, Propofol Dosing – May 19, 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’ latest edition of its weekly Acute Care Medication Safety Alert!. <Read More>

    340B in the News

    A Proposal Being Pushed By Ben Sasse Would Benefit Louisiana Hospitals – May 21, 2020 – One of the things that’s been really revealed in the COVID-19 crisis is the fact that bureaucratic red tape is the single biggest threat to our society in times of crisis…The 340B program itself allows poorer patients access to cheaper drugs, and keeps rural health care providers open and providing essential care. The problem is that workers are required to make federally-mandated “eligibility determinations” to see if a patient qualifies under the program. The pharmaceutical companies do not like the program because it eats into their profits. Nebraska Senator Ben Sasse, however, wants to take the program a step further, and to do that, he introduced the Relief for Rural Providers During Emergencies Act. The legislation pauses eligibility determinations for the 340B drug discount program for fiscal years 2020 and 2021. Essentially, he is aiming to shelve the federally-mandated paperwork while this emergency is ongoing. <Read More>

    Bowling Elected to 340B Health Board of Directors – May 20, 2020 – Karen Bowling, Vice President of Care Delivery and Transformation for the West Virginia University Health System and president and CEO of WVU Medicine’s Braxton County Memorial Hospital and Summersville Regional Medical Center, has been elected to a three-year term on the 340B Health Board of Directors. Headquartered in Washington, D.C., 340B Health is a membership organization of more than 1,400 public and private nonprofit hospitals and health systems in the federal 340B drug pricing program. <Read More>