Clinical Insights: June 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

    Fintepla® (fenfluramine) Oral Solution – New Drug Approval – June 26, 2020 – The U.S. Food and Drug Administration approved Fintepla® (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients age 2 and older. Dravet syndrome is a life-threatening, rare and chronic form of epilepsy. It is often characterized by severe and unrelenting seizures despite medical treatment. <Read More>

    Mycapssa® (octreotide) Oral Capsules – New Drug Approval – June 26, 2020 – Chiasma, Inc., a commercial stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved Mycapssa® (octreotide) capsules for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa® is the first and only oral somatostatin analog (SSA) approved by the FDA and the first product approved by the FDA utilizing Chiasma’s Transient Permeability Enhancer (TPE®) technology. <Read More>

    New Formulation Approval

    No new update.

    New Indication Approval

    Xpovio® (selinexor) Oral Tablets – New Expanded Indication – June 22, 2020 – Karyopharm Therapeutics Inc., an innovation-driven pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved oral Xpovio® (selinexor), the company’s first-in-class, Selective Inhibitor of Nuclear Export (SINE) compound, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. <Read More>

    New Drug Shortage

    June 26, 2020

    June 24, 2020

    June 17, 2020

    New Drug Recall and Safety Alerts

    No new update.

    New Generic Approval and Launch

    No new update.

    Clinical and Pharmacy News

    HHS Announces New Organ Transplant Guidance – June 29, 2020 – The U.S. Department of Health and Human Services and the U.S. Public Health Service (USPHS) published an updated solid organ transplant guideline to assess donors and monitor recipients for human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus infections. This guideline reflects advances in transplant technology and safety that can increase the number of organs available for transplants. <Read More> 

    Study Validates Combination Therapy for Aggressive Endometrial Cancer – June 29, 2020 – Yale Cancer Center (YCC) scientists have found that combining the targeted drug trastuzumab with chemotherapy significantly improves survival rates for women with a rare, aggressive form of endometrial cancer. These results may help to change the standard of care worldwide for the disease. The findings are published in the journal Clinical Cancer Research. <Read More> 

    Integrating Pharmacists Into General Practice Can Optimise Patient Treatment – June 29, 2020 – Research undertaken by RCSI University of Medicine and Health Sciences suggests that integrating pharmacists into general practice (GP) teams facilitates collaboration to optimise treatment plans for patients with long-term medical needs and alleviate pressures on GP practices. <Read More>

    High Rates of Inappropriate Antibiotic Prescribing for Acute Sinusitis in Primary Care – June 29, 2020 – Despite the existence of clear clinical criteria for the treatment of bacterial sinusitis, primary care clinicians were found to not follow Infectious Disease Society of America (IDSA) clinical practice guidelines with regard to prescribing and frequently overprescribed antibiotics, according to the results of a retrospective chart review published in Clinical Infectious Diseases. <Read More> 

    Expanding the Role of Pharmacists in Wake of COVID-19 – June 29, 2020 – With pharmacists being the most accessible health care providers, it is easy to see why considerations should be made regarding the expansion of their role during and after the coronavirus 2019 (COVID-19) pandemic. With lockdowns common worldwide, pharmacies are an example of a business that has remained open to serve the public during these trying times. Pharmacists answer questions for patients regarding their health on a daily basis, whether it be on the phone about medications or in person when someone is experiencing symptoms. <Read More> 

    Pharmacy Technician Certification Board Collaborates with American Pharmacists Association To Develop Immunization Credential Program for Pharmacy Technicians – June 29, 2020 – The Pharmacy Technician Certification Board (PTCB), the nation’s leading certifying organization for pharmacy technicians, is pleased to announce a collaboration with the American Pharmacists Association (APhA) to provide pharmacy technician credentialing in immunization delivery to those completing the APhA/Washington State University Pharmacy-Based Immunization Administration by Pharmacy Technicians program. The training program will serve as a stepping stone for PTCB Certified Pharmacy Technicians (CPhTs) to earn an Assessment-Based Certificate. Developed by APhA in partnership with Washington State University, the training program provides pharmacy technicians with the knowledge and skills they need to safely administer vaccinations to patients. <Read More>

    New Intralesional Therapy Combinations Are Poised to Expand Beyond the Oncology Setting – June 27, 2020 – Pairing intralesional therapies with immunotherapy agents has the potential to expand their use to nononcologists, especially if new formulations of the agents prove beneficial. Their expanded use could result in more patients gaining access. However, the skill set required by the nononcology professional would require significant revision and overhaul. <Read More> 

    Shorter Antibiotic Treatment Duration Effective for Acute Uncomplicated Cystitis – June 26, 2020 – Duration of treatment with third- and fourth-generation quinolones and pivmecillinam could be shorter than the currently recommended regimens and still serve to effectively manage acute uncomplicated cystitis, according to a review recently published in the Lancet Infectious Diseases. <Read More> 

    Therapeutic Differences Among Inhaled Corticosteroids Used to Treat Asthma – June 26, 2020 – In patients with asthma, fluticasone furoate (FF) may provide greater protection against airway hyperresponsiveness, with less systemic activity and a wider therapeutic index (TI, or systemic activity/airway potency ratio), compared with fluticasone propionate (FP) and budesonide (BUD), according to study results published in the British Journal of Clinical Pharmacology. <Read More> 

    NICE Rejects Novartis’ Mayzent® or Secondary Progressive MS – June 26, 2020 – NICE has turned down NHS funding in preliminary guidelines for use of Novatis’ Mayzent® (siponimod) as a treatment for secondary progressive multiple sclerosis (SPMS) with evidence of active disease. According to the Institute, clinical trial results show that the drug reduces the number of relapses and slows disability progression compared with placebo. However, it is uncertain how effective Mayzent® is compared with interferon beta-1b – the only disease-modifying treatment available for people with active SPMS – because there is no evidence directly comparing them. <Read More>

    Key U.S. Medical Group Adds Steroids to COVID-19 Treatment Guidelines – June 26, 2020 – The Infectious Diseases Society of America (IDSA) has updated its treatment guidelines to include generic steroid pills for patients hospitalized with severe COVID-19, the disease caused by the new coronavirus. The only other drug the medical group recommends for COVID-19 patients outside of a clinical trial is remdesivir, the intravenous antiviral medication made by Gilead Sciences Inc. <Read More> 

    A Path to Improve Colorectal Cancer Screening Outcomes: Faculty Roundtable Evaluation of Cost-Effectiveness and Utility – June 26, 2020 – The American Journal of Managed Care® and Exact Sciences Corporation hosted a roundtable meeting to discuss the impact of colorectal cancer (CRC) screening modalities on improving patient outcomes. The roundtable participants were a diverse panel of experts, including primary care, gastroenterology, and oncology providers; experts in health outcomes research and health policy; and managed care executives with commercial and public payer experience. Participants discussed CRC prevention and treatment strategies, screening modalities and adherence, molecular diagnostics, patient navigation, evaluation of large data sets, managed care, outcomes research, quality improvement, and reimbursement policies. <Read More> 

    COVID-19 is More Than a Pandemic – June 26, 2020 – The first confirmed case of the coronavirus disease 2019 (COVID-19) was reported in December 2019, and the contagion has since spread across international borders, leading to a widespread global pandemic that will likely define our modern times…Questions regarding the impact that COVID-19 will have on our economy, education system, mental and physical health, and overall well-being are fervently being explored worldwide. As health care providers, this pandemic provides an opportunity to rise and stand at the front line to care for patients while we adjust to a new sense of normalcy and rebuild our society. <Read More>

    Enter AI: How Technology is Changing the Pharmaceutical Industry for the Better – June 26, 2020 – It’s nearly impossible to discuss the future of any industry without mentioning artificial intelligence (AI). Whether it’s retail, manufacturing, or the health care industry at large, the discussion around the benefits continues…The pharmaceutical industry, in particular, is already seeing the immense benefit of AI and machine-learning technology. Pharma is currently facing challenges that affect providers, payers, and most importantly, patients. <Read More> 

    FDA Says New System for Calculating Biosimilar Fees Is Reliable – June 26, 2020 – In an update on progress made on changing the methodology for calculating biosimilar drug review fees, the FDA said a new system would enable it to better plan for variation in workloads and have the resources available to do an effective job. Officials reported this week that overall revenue collections for biosimilars were short of revenue targets in fiscal year 2019 by 9%, and fee-paying applications from biosimilar developers were 22% lower than anticipated. <Read More> 

    Diabetes Prevention Signal Emerges For Farxiga® June 25, 2020 – An intriguing diabetes prevention signal was reported in a cut of Farxiga®’s heart failure study, Dapa-HF, at the Annual Diabetes Association annual meeting this month. Investigators found that over the course of the study Astrazeneca’s SGLT2 inhibitor reduced the risk of participants developing type 2 diabetes by almost a third. <Read More> 

    AUA, SMSNA Release New Disorders of Ejaculation Guideline – June 25, 2020 – The American Urological Association (AUA) and the Sexual Medicine Society of North America (SMSNA) will be releasing a new clinical practice guideline to aid in the diagnosis and treatment of ejaculatory disorders in men. <Read More> 

    Study: Misperceptions Between Health System, Health Plan Leaders May Inhibit Patient-centered Specialty Pharmacy Partnerships – June 25, 2020 – A recent qualitative study presented a potential explanation for why health system specialty pharmacies often find it difficult to partner with payers. The study showed that due to misperceptions regarding health system specialty pharmacies’ capabilities, outcomes, and pricing, health system specialty pharmacies can get pigeonholed by payers as being expensive providers of “commodity” services. <Read More> 

    CDC And Drugmakers Boost Influenza Vaccine Doses – June 25, 2020 – Public health officials and vaccine manufacturers are making millions of extra influenza vaccine doses in anticipation of a simultaneous assault of coronavirus and seasonal influenza this winter. Major influenza vaccine manufacturers report they plan to boost production by approximately 10%, to about 189 million doses, up from 170 million doses last year, to ensure enough doses exist for an anticipated surge in people seeking influenza shots. CDC has taken the rare step of purchasing 7 million doses directly from manufacturers to be distributed to states for adult vaccination, about 14 times the 500,000 doses the agency typically purchases for adults. <Read More>

    Consensus Guideline for Advanced Prostate Cancer Released by AUA, ASTRO, and SUO – June 25, 2020 – A new guideline for the diagnosis and treatment of patients with advanced prostate has been released through a combined effort of the American Urological Association (AUA), American Society for Radiation Oncology (ASTRO), and Society of Urologic Oncology (SUO). The guideline includes 38 clinical recommendations spanning the entire spectrum of advanced prostate cancer from PSA recurrence following use of all available local treatments to full metastatic disease. <Read More> 

    Building a Cleanroom Compliance Team – June 25, 2020 – In the wake of a series of four audits from different regulatory agencies between June 2016 and August 2017, each resulting in various levels of recommendations, including an FDA Form 483 observation report, Michigan Medicine decided that its network of 21 compounding pharmacy locations needed oversight by a skilled, dedicated, in-house team of compounding compliance experts. <Read More> 

    Proposed ‘Kitchen Sink’ Medicaid Rule Could Bring Changes for Pharmaceutical Manufacturers – June 24, 2020 – The Centers for Medicare & Medicaid Services (CMS) published a Proposed Rule on June 19, 2020 (the Proposed Rule) which, among other things, suggests updates to Medicaid policies and practices related to drug pricing and value-based purchasing (VBP), clarifies the treatment of manufacturer coupons or co-pay cards in the Average Manufacturer Price (AMP) calculation and Best Price determination, and proposes changes to Medicaid drug utilization reviews (DUR) related to opioids. Comments on the Proposed Rule are due to CMS by July 20, 2020. <Read More> 

    Opioid Use Common Among Patients With Migraine – June 24, 2020 – Although consensus statements and guidelines do not recommend the use of opioids for the management of acute migraine, more than one-third of patients report current opioid use or keep opioids on hand to manage their migraines, according to results from a study published in Neurology. <Read More> 

    Updated 2020 American College of Rheumatology Gout Management Guidelines – June 24, 2020 – The American College of Rheumatology (ACR) developed an updated set of guidelines in 2020 for the management of gout, which includes indications and use of urate-lowering therapy (ULT), treatment of gout flares, and lifestyle and medication recommendations. The full report was published in Arthritis Care & Research.  <Read More> 

    CDC Study Finds ‘No Significant Change’ in Use of Rx Opioids – June 24, 2020 – A new study by CDC researchers has a surprise finding, concluding that there has been “no significant change in the use of prescription opioids” over the past decade by U.S. adults. The study is based on the National Health and Nutrition Examination Survey, in which a nationally representative sample of nearly 20,000 adults is asked every two years about their healthcare and nutrition. Although the number of opioid prescriptions in the U.S. has dropped 43% since their peak in 2011, the survey found that the use of opioid medication hasn’t changed much at all. <Read More>

    Physicians Say Prior Authorization Leads to Care Complications, But Health Plans Say Process Rooted in Clinical Evidence – June 24, 2020 – Physicians say prior authorizations continue to interfere with patient care, causing treatment delays and adverse events, according to new survey data from the American Medical Association. While health plans agree the process is burdensome, they argue it adheres to clinical guidelines and is used in selective circumstances. <Read More>

    Vaccinating Adults Amid Crisis Poses Challenges – June 24, 2020 – Vaccinations are some of the most cost-effective preventive health care tools available and have significantly contributed to the steady rise in life expectancy. Despite this, adult vaccination rates in the United States remain below Healthy People 2020 goals, leaving individuals vulnerable to otherwise preventable diseases, as illustrated by recent outbreaks of hepatitis A, measles, and mumps. As a result, there is a continuing need to maintain high vaccination rates to prevent future outbreaks of vaccine-preventable diseases (VPDs). In light of the coronavirus disease 2019 (COVID-19) pandemic, pharmacists face the challenge of keeping patients and staff members safe from this new infectious disease while continuing to provide patient care. Pharmacists should consider several factors when deciding to vaccinate during this pandemic. <Read More> 

    First Guidelines for Providing Oncology Pharmacy Services in COVID-19 – June 24, 2020 – The first set of guidelines for providing oncology pharmacy services to cancer patients during the coronavirus disease 2019 (COVID-19) pandemic was recently published in JCO Oncology Practice. “These guidelines, specifically focused on the oncology pharmacy field, to the best of our knowledge, are the only ones available in Europe and even worldwide,” the guidelines authors wrote. <Read More> 

    Short- and Long-term Impact of COVID-19 on Specialty, Community Pharmacies – June 24, 2020 – Since the start of 2019, the world as we knew it has been upended with the eruption and unprecedented escalation of the coronavirus 2019 (COVID-19) pandemic. The tragic details of the impact of this outbreak on the entire world calls for innovative and adaptive strategies across many industries. Similarly, to industries such as food service, hotels, transportation, and higher education, the pharmaceutical industry has been gravely affected by COVID-19. Pharmacists, being the most accessible health care professionals, have an important role to play in the management of this pandemic. Community pharmacies and specialty pharmacies will continue to be the focal points of health care delivery in various communities across the globe. <Read More> 

    Academy of Breastfeeding Medicine Releases Updated Guidelines on Breast Cancer, Breastfeeding – June 23, 2020 – As the most common malignancy in women worldwide, breast cancer will affect many women who are also actively breastfeeding or hope to breastfeed in the future. With so many potential complications for both mother and infant, the Academy of Breastfeeding Medicine released new guidelines for clinicians and multi-disciplinary teams. “This protocol is a guide for mothers who are undergoing diagnosis and treatment for breast cancer,” said Arthur Eidelman, MD, editor-in-chief of Breastfeeding Medicine, in a statement. “It emphasizes that they do not have to categorically give up on their nurturing role as breastfeeding moms.” <Read More> 

    Diabetic Eye Conditions: When Tight Glucose Control Fails, Treatments Are Available – June 23, 2020 – Diabetic eye disease is a significant concern for specialty pharmacists. This disease is subdivided into diabetic macular edema (DME) and diabetic retinopathy (DR), with the latter affecting 1 in 3 of this country’s 30 million people with diabetes…The primary approach should be prevention with tight control of blood glucose levels, blood pressure, and cholesterol, but treatments are also available. <Read More> 

    Operational Changes Related to Pandemic Can Open Up Risks – June 23, 2020 – The coronavirus disease 2019 (COVID-19) pandemic presents significant patient care and safety challenges globally and in the United States. Necessary changes in the normal day-to-day operations of community pharmacies are designed to keep patients and pharmacy staff members safe while continuing to provide care. Two such changes include increased prescribing by telephone and moving prescription delivery away from the pharmacy counter. Although these changes can introduce the risk of medication errors, there are steps pharmacies can take to safeguard their practices. <Read More> 

    Investigational Drugs, Pipeline Vaccines Are Evolving – June 23, 2020 – Although there are no FDA-approved medications for treating coronavirus disease 2019 (COVID-19), more than 405 clinical studies are underway to evaluate potential treatments, according to a search of ClinicalTrials.gov. In April, the National Institutes of Health (NIH) published treatment guidelines for managing patients with COVID-19 based on disease severity, and recommendations will be updated as new evidence becomes available. Pharmacists practicing in community and hospital settings play a vital role as part of the frontline health care team in managing patients with COVID-19 by staying up-to-date with the latest drug information. <Read More> 

    Joint Statement of the American Medical Association, American Pharmacists Association, and American Society of Health-System Pharmacists on new FDA action to Remove Emergency Use Authorization of Medications to Treat COVID-19 – June 23, 2020 – The American Medical Association, American Pharmacists Association, and American Society of Health-System Pharmacists appreciates the Food and Drug Administration’s (FDA’s) continuing efforts to review and advise the nation on the safe and effective use of hydroxychloroquine, chloroquine, and other medications to prevent and treat coronavirus. We recognize the body of evidence for addressing the COVID-19 global pandemic is evolving rapidly, requiring vigilant yet timely decision making. <Read More> 

    Insufficient Sleep: A Likely Cause of Poor Performance Among Pharmacists, Pharmacy Students – June 23, 2020 – Sleep plays a significant role in the normal functioning of the human body. It is vital in health, cognition, and emotion and may affect learning and memory. Generally, sleep is considered to provide optimal benefits only in sufficient amounts, with either a lack or excess of sleep potentially posing risks…Insufficient sleep is prevalent among pharmacy students, and college students more generally, with studies showing that many pharmacy students in the didactic portion of the academic curriculum suffer from poor quality sleep. This is further exacerbated at specific periods during the semester as a majority obtain fewer than the recommended 7 hours of sleep, especially close to an examination. <Read More>

    340B in the News

    Wasteful Spending on 340B Keeps Growing and Growing – June 26, 2020 – One of the many programs whose problems seem to have gotten lost during the response to the COVID-19 pandemic is the 340B drug safety-net program.  Citizens Against Government Waste (CAGW) has expressed concerns about 340B since 2014, including a June 18, 2018 letter signed by 58 organizations to Health and Human Services Secretary Alex Azar, calling for reforming the program. <Read More> 

    New Risks, New Rewards, New Exposure – June 24, 2020 – On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major proposed rule (“Proposed Rule”) in a bid to update and expand key regulations governing the Medicaid Drug Rebate Program (“MDRP”). If finalized as written, these changes will impact manufacturers’ commercial strategies, government payor program liabilities, lifecycle management plans, patient assistance regimes, and other important considerations…If finalized, this could result in a substantial expansion of Medicaid rebate liability and 340B exposure for pharmaceutical manufacturers of innovator oral solid drugs. <Read More>