Clinical Insights: July 14, 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 

    UpneeqTM (oxymetazoline hydrochloride) Ophthalmic Solution – New Drug Approval – July 8, 2020 – Osmotica Pharmaceuticals plc, a fully integrated biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved UpneeqTM (oxymetazoline hydrochloride ophthalmic solution), 0.1%, formerly known as RVL-1201, its novel treatment for acquired blepharoptosis, or ptosis, a condition characterized by the abnormal drooping of the upper eyelid that can limit field of vision. UpneeqTM becomes the only FDA-approved medical treatment for ptosis. <Read More> 

    Inqovi® (decitabine and cedazuridine) Tablets – New Drug Approval – July 7, 2020 – The U.S. Food and Drug Administration approved Inqovi® (decitabine and cedazuridine) tablets for treatment of adult patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). This represents an important advance in treatment options for patients with MDS, a type of blood cancer, who previously needed to visit a health care facility to receive intravenous therapy. <Read More> 

    Qwo™ (collagenase clostridium histolyticum-aaes) Injection – New Drug Approval – July 6, 2020 – Endo International plc announced that it received U.S. Food and Drug Administration (FDA) approval of Qwo™ (collagenase clostridium histolyticum-aaes) for the treatment of moderate to severe cellulite in the buttocks of adult women. QWO™ is the first FDA-approved injectable treatment for cellulite. <Read More>

    New Formulation Approval

    No new update.

    New Indication Approval

    No new update.

    New Drug Shortage

    July 13, 2020

    July 10, 2020

    July 09, 2020

    July 08, 2020

    July 07, 2020

    New Drug Recall and Safety Alerts

    Metformin Extended-Release Products by Lupin Pharmaceuticals – New Drug Recall – July 8, 2020 – Lupin Pharmaceuticals Inc. is voluntarily recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg to the consumer level. As part of the ongoing assessment and continuation of the dialog with the FDA, additional analysis revealed that certain tested batches were above the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). Out of an abundance of caution, the company is recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg in the US. To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall. <Read More>

    Daptomycin Injection by Mylan – New Drug Recall – July 7, 2020 – Mylan N.V. announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in one single-dose vial manufactured by Mylan Laboratories Limited’s Specialty Formulation Facility. To date, Mylan has not received any reports of adverse events related to this recall. <Read More>

    New Generic/Biosimilar Approval and Launch

    Hulio® (adalimumab-fkjp) Injection – New Biosimilar Approval – July 9, 2020 – Mylan N.V. and Fujifilm Kyowa Kirin Biologics Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp), a biosimilar to AbbVie’s Humira® (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis (4 years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis, in both prefilled syringe and auto-injector presentations. <Read More>

    Clinical and Pharmacy News

    Unnecessary Use of Antibiotics and Laboratory Testing in Bronchiolitis: A Study in ED Practice Variations – July 13, 2020 – The desire to provide evidence-based high-quality cost-effective care is never more evident than in the diagnosis and management of bronchiolitis in the United States, based on the number of studies we and other journals have published on this topic. Trying to reduce the administration of antibiotics, avoid unnecessary radiographs, and not obtain bacterial cultures if not indicated are all methods of achieving value-based care. How does our use of antibiotics and lab testing for bronchiolitis compare to other countries? <Read More> 

    Treatment Of Nontuberculous Mycobacterial Pulmonary Disease: New Guideline – July 13, 2020 – American Thoracic Society along with a number of infectious diseases societies (ERS, ESCMID, IDSA) has released guidelines on Treatment of Nontuberculous Mycobacterial Pulmonary Disease…This guideline focuses on pulmonary disease in adults (without cystic fibrosis or human immunodeficiency virus infection) caused by the most common NTM pathogens such as Mycobacterium avium complex, Mycobacterium kansasii, and Mycobacterium xenopi among the slowly growing NTM and Mycobacterium abscessus among the rapidly growing NTM. <Read More>

    FDA Broadens Eligibility Criteria for Pediatric Clinical Trial Participants – July 13, 2020 – The FDA recently released guidelines expanding clinical trial eligibility for investigational cancer drugs for pediatric patients. “Unnecessarily restrictive eligibility criteria may slow patient accrual, limit patients’ access to clinical trials, and lead to trial results that do not fully represent treatment effects in the patient population that will ultimately use the drug,” the guidelines said. <Read More> 

    National Comprehensive Cancer Network® adds Zepzelca™ (lurbinectedin) to Clinical Practice Guidelines in Oncology – July 13, 2020 – Jazz Pharmaceuticals plc announced that Zepzelca™ (lurbinectedin) was added by the National Comprehensive Cancer Network (NCCN®) to the Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for small cell lung cancer (SCLC) on July 7, 2020. The U.S. Food and Drug Administration (FDA) approved ZepzelcaTM under accelerated approval on June 15, 2020 for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. <Read More> 

    CMS a Powerful Agent of Change for ABx Stewardship – July 13, 2020 – This year’s March 30 deadline to meet the Centers for Medicare & Medicaid Services (CMS) conditions of participation regarding antibiotic stewardship programs (ASPs) has come and gone. But the positive effects of the new rules remain, not the least of which is confirmation that policy revisions can be a powerful agent for change in facilities that are open to process improvement. <Read More> 

    Drug That Calms ‘Cytokine Storm’ Linked to Lower Risk of Death Among COVID-19 Patients on Ventilators – July 13, 2020 – Critically ill COVID-19 patients who received a single dose of a drug that calms an overreacting immune system were 45% less likely to die overall, compared with those who didn’t receive the drug, according to a new University of Michigan study. And they were more likely to be out of the hospital or off a ventilator one month after treatment, the research shows. The lower risk of death in patients who received intravenous tocilizumab happened despite the fact that they also had twice the risk of developing an additional infection, on top of the novel coronavirus. <Read More> 

    Expanding the Roles of Pharmacists: Specialty and Beyond – July 13, 2020 – Specialty pharmacy focuses on handling the complexities in interactions between drugs, cost, and FDA breakthroughs. Every year in the United States, the Centers for Medicaid and Medicare Services (CMS) determines the cost thresholds as a major complexity. The examination of prescription drug event data for the prior year reveals the percentage of monthly fills that exceed the stated limit. The lower threshold for the year 2020 stands at $670 per month. Numerous complex conditions are prioritized in the specialty pharmacy, such as cancer, infertility, HIV/AIDS, rheumatoid arthritis, multiple sclerosis, hemophilia, hepatitis C, Crohn disease, cystic fibrosis, growth hormone deficiency, pulmonary hypertension, and immune disorders. <Read More> 

    The Power—and Peril—of Protein in the ICU – July 10, 2020 – Delivering adequate protein to patients in the ICU is critical for optimizing outcomes. But just how much protein to deliver, to which patients—and when—remains unclear, according to a presentation at the ASPEN20 Virtual Conference. “Emerging data suggests that protein requirements in critical illness are probably more important than energy or kilocalorie requirements,” Todd Rice, MD, an associate professor of medicine in the Division of Allergy, Pulmonary and Critical Care Medicine at Vanderbilt University School of Medicine, in Nashville, Tenn., told the online audience. <Read More> 

    Panel Expert Details Changes to AUA BPH Guideline – July 10, 2020 – During the 2020 AUA Virtual Experience, Steven A. Kaplan, MD, explained the changes incorporated into the 2020 AUA Guideline on Benign Prostatic Hyperplasia (BPH): Surgical Management of BPH/Lower Urinary Tract Symptoms (LUTS). “This guideline [on LUTS secondary to BPH] should be used in conjunction with recent systematic literature reviews and an understanding of the patient’s treatment goals. In all cases, the patient’s preferences and personal goals should be considered when choosing therapy,” said Kaplan, a member of the AUA BPH Surgical Panel responsible for the guideline, and a professor of urology at the Icahn School of Medicine. <Read More> 

    Challenges of Channel Management for Specialty: Medical Benefit or Pharmacy Benefit – July 10, 2020 – When most people think of getting their medications filled, they take their prescription to their local community pharmacy or send their prescription to a mail service pharmacy. Usually, the vast majority of prescription medications are commonly covered under a pharmacy benefit on behalf of the person’s insurance. Although a retail or traditional mail channel makes sense for 97% to 99% of non-specialty prescriptions, the other 1% to 3% of prescriptions are specialty drugs that may need to be filled through another pharmacy channel (either a specialty pharmacy provider or an institutional setting). With specialty drugs, there is a fork in the claims processing and fulfillment road in which either the medical or pharmacy benefit may be the primary point for dispensing, administration, and reimbursement. <Read More> 

    EAACI Guidelines for the Use of Biologic Therapies in Severe Asthma – July 9, 2020 – Targeted therapy with 1 of 5 available biologic medications may effectively manage severe asthma, according to treatment guidelines published by the European Academy of Allergy and Clinical Immunology (EAACI) in Allergy…EAACI recommendations are based on available evidence as well as clinical expertise and follow the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. These recommendations deal with treatment of severe asthma with 5 monoclonal antibody treatments: benralizumab, dupilumab, mepolizumab, omalizumab, and reslizumab. <Read More>

    Transmission of SARS-CoV-2: Implications for Infection Prevention Precautions – July 9, 2020 – This scientific brief provides an overview of the modes of transmission of SARS-CoV-2, what is known about when infected people transmit the virus, and the implications for infection prevention and control precautions within and outside health facilities. This scientific brief is not a systematic review. Rather, it reflects the consolidation of rapid reviews of publications in peer-reviewed journals and of non-peer-reviewed manuscripts on pre-print servers, undertaken by WHO and partners. <Read More>

    Pharmacists Help Study Sweet Wormwood for COVID-19 – July 9, 2020 – A hardy and prolific plant known as sweet wormwood, or Artemisia annua, contains a potent ingredient that could become a new medicinal weapon in the battle to stem the global COVID-19 pandemic. Or it could be just one more promising treatment that showed strong antiviral activity in the laboratory but failed in human trials against an implacable foe. That question is what investigators at the University of Kentucky (UKY) are determined to answer. They are about to launch two new clinical trial arms to test whether an extract from the dried leaves of Artemisia brewed in tea or coffee, or the tablet form of the antimalarial drug artesunate—also derived from sweet wormwood—are effective in newly diagnosed COVID-19 patients with cancer or other comorbid conditions that put them at high risk for severe disease. <Read More> 

    American Cancer Society Updates Guidelines for HPV Vaccination – July 9, 2020 – Following a review of 2 new 2019 Federal Advisory Committee on Immunization Practices (ACIP) recommendations, the American Cancer Society (ACS) has updated its guidelines for human papillomavirus (HPV) vaccination. Guidelines for use of the HPV vaccine were first issued in 2007; an update to those guidelines were published in 2016. The latest update addresses key concerns surrounding when routine vaccination should begin, the effectiveness of subsequent catch-up vaccinations, and whether to recommend shared clinical decision-making about vaccination. The ACS, in adapting these concerns, also provided several qualifying statements regarding their own interpretation of the new set of guidelines. <Read More> 

    Vitamin D Supplementation has Brain Health Benefits – July 9, 2020 – Most people recognize Vitamin D for its bone health benefits. Many are unaware of its pleiotropic effects including from neuroprotection, brain development, immune protection, and various other benefits. Vitamin D is a neurosteroid responsible for brain maturation and growth, and stimulation of the most important antioxidant in the brain, the neuroprotectant glutathione (GSH). It also regulates melatonin production and hormone regulation responsible for the development of normal sleep patterns and human circadian rhythm. <Read More> 

    Lowering Prolactin Levels in Patients With Psychosis – July 9, 2020 – Hyperprolactinemia is a common adverse effect of long-term antipsychotic treatment in patients with psychotic disorders due to dopamine D2 receptor antagonism in the tuberoinfundibular pathway, but is also seen in patients with first-episode psychosis. Potential acute effects of hyperprolactinemia are amenorrhea, galactorrhea, sexual dysfunction, decreased fertility, and gynecomastia, and common long-term effects include osteoporosis and hypogonadism. Current interventions for treatment of symptomatic and asymptomatic hyperprolactinemia include reducing dose or switching antipsychotic medications, or the use of adjunctive medications. <Read More> 

    National Association of Specialty Pharmacy Releases Agenda for Fifth Annual Specialty Pharmacy Law Conference – July 9, 2020 – The National Association of Specialty Pharmacy (NASP), a nonprofit organization representing specialty pharmacy industry stakeholders, announced the full agenda for the fifth Annual Specialty Pharmacy Law Conference. The conference will take place virtually Monday, September 14, in conjunction with the NASP Annual Meeting & Expo Virtual Experience… The Specialty Pharmacy Law Conference is a unique one-day event intended for general and in-house counsel for national and regional specialty pharmacies, manufacturers, practicing attorneys in health care law, compliance officers and executives. <Read More> 

    Heartburn Medication Use Doubles COVID-19 Risk, ‘Stomach Acid Is There For A Reason’: Study – July 8, 2020 – Here comes yet another addition to the long list of risk factors for COVID-19. A recent observational study of over 53,000 Americans pointed out that drugs commonly used to relieve symptoms of acid reflux or gastroesophageal reflux disease (GERD) increase a person’s odds of reporting a positive COVID-19 test. Despite being warned of adverse effects like bone fractures and heart attacks, 15 million Americans still continue to take proton pump inhibitors (PPIs) on a regular basis. The researchers reported that PPI use, especially when taken twice every day, was linked to increased odds for testing COVID-19 positive, despite accounting for several lifestyles, sociodemographic and clinical variables. <Read More> 

    Management Of Microhematuria: AUA/SUFU Guidelines – July 8, 2020 – The American Urological Association (AUA), in partnership with the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), released a new clinical guideline for the diagnosis, evaluation, and follow-up of microhematuria. The purpose of this guideline is to provide a clinical framework for the diagnosis, evaluation, and follow-up of microhematuria (MH). <Read More>

    Newer Therapy Recommended for Treatment-Refractory MAC Pulmonary Infection – July 8, 2020 – A newer therapy that acts like a Trojan horse to attack bacteria should be reserved for patients with certain treatment-refractory lung infections, according to updated nontuberculous mycobacterial (NTM) pulmonary disease guidelines…The new guidelines align with the FDA approval that the treatment, amikacin liposome inhalation suspension (Arikayce, Insmed), should only be given to patients with Mycobacterium avium complex (MAC) who have not improved after six months or more of standard therapy. <Read More> 

    Pharmacy and Healthcare Professionals Nationwide Recognize Patient Safety Benefits of New Consensus Vancomycin Dosing Guidelines, But Fewer than One in Three Plan to Adopt Them – July 8, 2020 – For the first time since 2009, consensus guidelines for vancomycin dosing were published in March 2020 by four pharmacy and infectious disease professional societies. The milestone marks a broad-based effort to reduce the incidence of acute kidney injury (AKI)—potentially fatal kidney failure or kidney damage—that can result from improper dosing of the antibiotic, as evidenced by a recent retrospective study found that 33% of 320 patients who received vancomycin sustained an AKI. The new guidelines call for moving away from an older method called trough-based dosing and adopting an area-under-the-curve (AUC) approach to estimating vancomycin exposure, preferentially recommending the use of Bayesian software to estimate AUC. <Read More> 

    Short-Term and Long-Term Impact of COVID-19 on Community Pharmacy – July 8, 2020 – With the current coronavirus disease 2019 (COVID-19) pandemic, it is not surprising that the impact seen in the pharmacy industry is going to be long-lasting. The initial waves of change that were felt in the beginning of 2020 are sure to be accompanied by a ripple effect when things begin to normalize. This is strictly speaking for the United States of course, as other regions of the world not previously affected are now seeing substantial rises in cases. Whether it be delivery options, remote pharmacy, increasing roles for pharmacists and technicians, or the increase (and then sudden decrease) in the volume of patients, the impact of this virus can be felt in community pharmacies all across the United States. <Read More> 

    ASHP Annual Survey Reveals Key Trends in Health-System Pharmacy – July 7, 2020 – The American Society of Health-System Pharmacists (ASHP) announced the results of its annual survey of pharmacy directors from almost 5000 hospitals across the country, which delivered valuable insights on hospital and health system pharmacy practice. The 2019 ASHP National Survey, published in the American Journal of Health-System Pharmacy (AJHP), gauged prescribing and transcribing strategies used by hospital pharmacy and therapeutics (P&T) committees, with the most common tools including therapeutic interchange, evidence-based clinical practice guidelines, opioid stewardship, and comparing the efficacy of products when making formulary decisions. The survey also pointed to additional trends in areas of staffing and the use of mobile technology. <Read More>

    340B in the News

    No new update.