Clinical Insights: May 19, 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

    QinlockTM (ripretinib) Tablets – New Drug Approval – May 15, 2020 – The U.S. Food and Drug Administration approved QinlockTM (ripretinib) tablets as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST), a type of tumor that originates in the gastrointestinal tract. QinlockTM is indicated for adult patients who have received prior treatment with three or more kinase inhibitor therapies, including imatinib. <Read More>

    New Formulation Approval

    No new update.

    New Indication Approval

    No new update.

    New Drug Shortage

    May 19, 2020 

    May 15, 2020

    May 12, 2020

    May 11, 2020 

    New Drug Recall and Safety Alerts

    Finasteride Plus 1.25mg Capsules by MasterPharm, LLC. – New Drug Recall – May 11, 2020 – MasterPharm, LLC. is voluntarily recalling 1 lot of Finasteride Plus 1.25mg, capsules to the consumer level. The Finasteride Plus capsules have been found to contain undeclared minoxidil, an antihypertensive drug, at levels greater than those found in FDA approved products. The undeclared minoxidil was found when tested with an independent testing laboratory. <Read More>

    New Generic Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Multiple Treatment Guideline Updates Released for Lung Cancer – May 19, 2020 – The National Comprehensive Cancer Network (NCCN) and the International Association for the Study of Lung Cancer (IASLC) released an updated treatment guideline for non-small cell lung cancer (NSCLC) and treatment guidance for lung cancer patients during the COVID-19 pandemic, respectively. <Read More>

    NICE Releases Updated Guidelines for Management of VTE – May 19, 2020 – National Institute for Health and Care Excellence (NICE) has released an updated version of its guideline on the diagnosis and management of VTE (original version 2012, minor update 2015). Venous thromboembolism in adults: diagnosis, management and thrombophilia testing guidelines by NICE will be relevant to primary care and secondary generalist physicians. <Read More>

    Motivational Interviewing: Effective Communication is Important for Technicians – May 19, 2020 – Pharmacy technicians are frequently the first point of contact when patients and customers arrive to pick up their prescriptions and/or purchase any OTC medications. Pharmacy technicians also interact with personnel from prescribers’ offices, health plans, informal caregivers, and other stakeholders in the medication use process. Thus, effective communication is among the most important skills for technicians, yet one that is often overlooked. <Read More>

    80% of ED Clinicians Feel Unready to Initiate Buprenorphine for Opioid Use Disorder – May 18, 2020 – Few ED clinicians expressed readiness to initiate buprenorphine for the treatment of opioid use disorder, according to study results published in JAMA Network Open. “This is a baseline evaluation for a larger implementation study, Project ED Health, that aims to use implementation facilitation to support development of programs to initiate treatment for opioid use disorder among four urban, academic EDs,” Kathryn F. Hawk, MD, of the department of emergency medicine at Yale School of Medicine, told Healio Psychiatry. <Read More>

    NACDS Urges Government to Consider Pharmacies’ Critical Role in COVID-19 Prevention – May 18, 2020 – To support the successful reopening of the country in a manner that prevents further coronavirus disease 2019 (COVID-19) outbreaks, the National Association of Chain Drug Stores (NACDS) has issued a report in which it urges government action on 3 key objectives related to testing, contact tracing, and vaccines or treatments. <Read More>

    11 Trends Influencing Biosimilars in 2020 – May 18, 2020 – Biosimilars are made to reduce healthcare costs, but a number of factors have kept them from taking off and grabbing the kind of market share that would put a serious dent in the price of biologics and overall healthcare bills. They range from patients and physicians being wary about how similar biosimilars really are to patent tactics by originator manufacturers to an assortment of misaligned incentives that keep less expensive products off the market. Elizabeth Oyekan, Pharm.D., FCSHP, CPHQ, vice president, access experience team with Precision for Value, notes over the past year, the U.S. is beginning to see long-awaited change to increased prescribing of biosimilars. <Read More>

    Pharmacists’ Role in Tackling Social Determinants of Health – May 18, 2020 – Social determinants of health (SDOH) have become a prominent buzz word in the health care industry over the past few years. This is because conditions in which people live, learn, work, and play can affect their health risks and outcomes, making SDOH an important component in understanding patient health outcomes, according to a session at the Pharmacy Quality Alliance (PQA) 2020 Annual Meeting. At the first educational session of the meeting on May 13, the speakers discussed pharmacists’ roles in influencing outcomes associated with SDOH in the US population through the use of screenings and interventions that target medication adherence and reduce medical spending. <Read More>

    NACDS COVID-19 Report: Top Reopening Priorities and How Pharmacies Can Help – May 18, 2020 – Rapid coronavirus disease 2 (COVID-19) testing, contract tracing, and preparing for vaccines and treatments are the 3 key priorities as the United States reopens, NACDS said in a new report. In the report, Pharmacies: A Vital Partner in Reopening America, NACDS outlined 3 key operational considerations for President Donald J. Trump’s Administration, Congress, and governors as they develop reopening and recovery plans. The organization also urged that additional steps should be taken to ensure that pharmacists and pharmacies are fully utilized to support this national effort. <Read More>

    Structuring COVID-19 Protocols for Pharmacies – May 18, 2020 – The purpose of this article is to provide guidance to pharmacies on structuring an appropriate written protocol that implements necessary controls, including what reliable governmental sources a pharmacy can turn to for COVID-19 guidance, recommended controls for pharmacy employees, and recommended controls for pharmacy patients. <Read More>

    OSHA’s Alert to Protect Retail Pharmacy Workers from COVID-19 – May 18, 2020 – OSHA has issued an alert and safety tips for employers and workers in the retail pharmacy industry. Pharmacies are a critical part of society, and the public’s need to prescriptions and medications does not stop during a pandemic. <Read More>

    12 Reasons for the Lag in Pharm Tech Adoption – May 18, 2020 – As part of the Information Age, technology has become indispensable. Standardization and interoperability of systems are no longer optional. Yet pharmacy continues to lag in adopting and implementing new technologies. The explanation for this discrepancy is unclear. Here we explore some of the barriers that pharmacies face as they attempt to enter the technology revolution, as well as some strategies for breaking through them. <Read More>

    CMS Allows Pharmacies and Other Suppliers to Bill Medicare for COVID-19 Testing – May 15, 2020 – In an effort to address the need to increase the availability of COVID-19 testing, the Centers for Medicare & Medicaid Services (CMS) has issued guidance notifying pharmacies and other Medicare-enrolled suppliers that they may temporarily enroll as independent clinical diagnostic laboratories during the COVID-19 public health emergency (PHE) so that they may bill Medicare for COVID-19 testing. <Read More>

    The Pharmacist’s Role in Heart Health – May 15, 2020 – Heart disease is so common among Americans that it claims 1 life every 37 seconds. That number accounts for approximately 647,000 deaths annually, according to the CDC. As health care providers often serving on the front lines, pharmacists have potentially underused opportunities to help keep patients’ tickers in tip-top shape. The underutilization of pharmacists in wellness and disease-state management may come from the lack of recognition they receive for the value they add to the patient care equation, according to Andrew M. Freeman, MD, FACC, FACP, a cardiologist, cochair of the Nutrition & Lifestyle Work Group of the American College of Cardiology, and director of cardiovascular prevention and wellness at National Jewish Health in Denver, Colorado. <Read More>

    Technology Innovations Transforming Pharmacy Practice – May 15, 2020 – Digital health technology is transforming every aspect of pharmacy practice, whether it deploys robotics to fill prescriptions, uses analytics to track medication data, or offers access to digital therapy. Pharmacists in both the hospital and retail settings are using recently developed technology to prevent adverse drug effects, monitor the use of antibiotics, modify unhealthy behavior, and promote medication adherence. <Read More>

    Study: Using Data, Pharmacy Quality Alliance Measures to Assess the Opioid Crisis – May 14, 2020 – A study presented at the 2020 Pharmacy Quality Alliance (PQA) Annual Meeting engaged an employer, whose employee was recently involved in a bus accident and was found with opioids, to assess the nature of the opioid crisis through PQA quality measures. <Read More> 

    Three Considerations for Selecting a Truly Transparent Pharmacy Benefits Partner – May 14, 2020 – Prior to the COVID-19 pandemic rattling the economy, data from the National Pharmaceutical Council showed that 63% of employers felt that pharmacy benefit managers (PBMs) are not transparent. With many companies looking to better manage expenses and ensure affordable access to prescriptions in today’s uncertain landscape, it’s more important than ever for benefits professionals to work with a transparent partner and find ways to reduce prescription drug costs for their employees. Although “transparency” is a widely used term across the PBM industry, varying definitions of this buzzword, as well as hidden costs and missing data, can skew PBM evaluations and cause employers to pay too much for their pharmacy benefits. <Read More>

    Pharmacy Schools Prepare Students for Specific Population Challenges – May 14, 2020 – A pharmacy desert is defined as an area where limited access to pharmacies is acute. A 2014 study in Health Affairs found that segregated black and Hispanic communities in Chicago, Illinois are more likely to be host to pharmacy deserts and that 1 million people in the city were living in these pharmacy deserts…That’s why lack of access to pharmacies can have a detrimental effect on patients, in particular those with chronic conditions, said Stephanie Kiser, PharmD, clinical assistant professor at The University of North Carolina Eshelman School of Pharmacy in Chapel Hill. <Read More>

    Benefits Alert: HHS Final Rule Addresses Application of Prescription Drug Copay Coupons to Group Health Plan Out-of-Pocket Limit – May 13, 2020 – On May 7, 2020, HHS announced a final rule in the HHS Notice of Benefit Parameters for 2021 (to be published in the Federal Register on May 14, 2020) (the 2021 Final Rule) that addresses the application of prescription drug manufacturer copay coupons to a group health plan out-of-pocket limit. Under the final rule, a group health plan may, but is not required to, exclude the value of prescription drug copay coupons from a participant’s out-of-pocket limit. <Read More> 

    Pharmacy School Speeds Up Graduation Amid COVID-19 – May 13, 2020 – To get pharmacists into the workforce faster amid the coronavirus disease 2019 (COVID-19) pandemic, Purdue University College of Pharmacy in West Lafayette, Indiana, helped its students graduate in record time this spring. Although there is not a shortage of pharmacists in most areas of the country, having an increasing number of pharmacists available is important for dealing with the ongoing pandemic, Eric Barker, PhD, BSPharm, dean of Purdue’s College of Pharmacy, told Drug Topics®. <Read More>

    NABP Announces Accreditation Program for Home Infusion Therapy Pharmacy – May 12, 2020 – The National Association of Boards of Pharmacy® (NABP®) is pleased to announce the addition of Home Infusion Therapy Pharmacy Accreditation. The addition of a Home Infusion Therapy Pharmacy Accreditation to the Association’s already robust offerings enables NABP to provide customers with the most comprehensive set of pharmacy accreditation options of any organization. <Read More> 

    ASH to Develop Clinical Practice Guidelines on the Use of Anticoagulation in Patients with COVID-19 – May 12, 2020 – Coagulopathy, or abnormal blood clotting, has been reported as a complication associated with increased risk of death in patients with COVID-19. Evidence is emerging about the potential role of anticoagulation to prevent and treat this complication, including blood thinning medications or mechanical interventions such as intermittent compression devices. To support clinicians treating this complication, the American Society of Hematology (ASH) today announced that it will develop clinical practice guidelines on the use of anticoagulation in patients with COVID-19. <Read More>

    Pharmacy Job Demand Could Grow Because of COVID-19 – May 12, 2020 – The growing recognition of the importance of pharmacists and pharmacy staff on the front lines of the novel coronavirus disease 2019 (COVID-19) pandemic could draw more students to the profession. Already, there is a heightened demand for retail pharmacists and pharmacy technicians. Soon after the pandemic hit the United States in mid-March, CVS said it would immediately fill 50,000 full- time, part-time, and temporary roles in its stores across the country. <Read More>

     

    340B in the News 

    No new update.