Clinical Insights: August 31, 2021

    Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace. Contact us to learn more.

    New Drug Approval

    Tibsovo® (ivosidenib) – New Drug Approval – August 25, 2021 – The Food and Drug Administration approved ivosidenib (Tibsovo®, Servier Pharmaceuticals LLC) for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. The FDA also approved the Oncomine™ Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to aid in selecting patients with cholangiocarcinoma for treatment with ivosidenib. Ivosidenib was investigated in a randomized (2:1), multicenter, double-blind, placebo-controlled clinical trial (Study AG120-C-005, NCT02989857) of 185 adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation. The patient’s  disease must have progressed following at least one, but not more than two prior regimens, including at least one gemcitabine- or 5-flurouracil-containing regimen. Patients were randomized to receive either ivosidenib 500 mg orally once daily or matched placebo until disease progression or unacceptable toxicity. <Read More>

    Skytrofa® (lonapegsomatropin-tcgd) for Injection – New Drug Approval – August 25, 2021 – Ascendis Pharma A/S, a biopharmaceutical company that utilizes its innovative TransCon™ technologies to potentially create new treatments that make a meaningful difference in patients’ lives, announced that the U.S. Food and Drug Administration (FDA) has approved Skytrofa® (lonapegsomatropin-tcgd) for the treatment of pediatric patients one year and older who weigh at least 11.5 kg (25.4 lb) and have growth failure due to inadequate secretion of endogenous growth hormone (GH). As a once-weekly injection, Skytrofa® is the first FDA approved product that delivers somatropin (growth hormone) by sustained release over one week. <Read More>

    New Formulation Approval

    Gvoke® (glucagon) Ready-to-Use Injection – New Dosage Form Approval – August 23, 2021 – Xeris Pharmaceuticals, Inc., a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, announced that its supplemental new drug application (sNDA) of Gvoke® Kit was approved by the Food and Drug Administration (FDA) for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. Gvoke® Kit will be available as a 1 mg/0.2 mL single dose vial and syringe kit. Gvoke® Kit contains one (1) single-dose sterile syringe with markings for 0.1 mL (0.5 mg pediatric dose) and 0.2 mL (1 mg adult dose), and one single-dose vial containing 0.2 mL of solution. With this FDA approval, Xeris will begin manufacturing scale up immediately, and therefore anticipates Gvoke® Kit availability early in the first quarter of 2022. “Offering three different administration options – Gvoke HypoPen®, Gvoke® PFS, and Gvoke® Kit, allows for greater patient choice in a ready-to-use rescue product for the approximately 6.8 million people in the U.S. who rely on insulin and are at-risk of a severe hypoglycemic event. <Read More>

    New Indication/Dosage Approval

    Xarelto® (rivaroxaban) – New Approved Expanded indication – August 24, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved an expanded peripheral artery disease (PAD) indication for the Xarelto® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization (LER) due to symptomatic PAD. The approval is based on data from the Phase 3 VOYAGER PAD study. With this approval, Xarelto® is the first and only therapy indicated to help reduce the risks of major cardiovascular (CV) events in patients with coronary artery disease (CAD) and major thrombotic vascular events, such as myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology, in patients with PAD, including patients who have recently undergone LER due to symptomatic PAD. <Read More>  

    New/Updated Drug Shortage

    August 26, 2021

    August 25, 2021

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    ‘It’s Creative and We Certainly Need the Help’: CVS, Walmart, Walgreens Grow Consumer Presence With Counseling Services – August 30, 2021 – CVS Health, Walmart and Walgreens are expanding their healthcare presence to include cost-friendly, easily accessible mental health resources for consumers, The Wall Street Journal reported Aug. 29. “It’s creative and we certainly need the help,” Ken Duckworth, MD, medical director of the National Alliance on Mental Illness, told the Journal. “It’s an interesting idea to post a mental-health resource at a place where people already are at.” Eight things to know: <Read More>

    Seventh Circuit Endorses Objective Reasonableness as a Defense under the FCA – August 30, 2021 – In a much-awaited Seventh Circuit decision, the court joined four other circuits in endorsing the “objective reasonableness” defense under the federal False Claims Act (FCA)… In Schutte v. SuperValu, No. 11-cv-3290, 2021 WL 3560894 (7th Cir. Aug. 12, 2021), the defendant SuperValu pharmacies had offered price-matching discounts to compete with low-cost competitors like Walmart. The discounts were only applied, however, if a patient asked for them, and then only to the lowest price of a local competitor. SuperValu was alleged to have instructed its pharmacists to process these discounted transactions as cash transactions so the claims would not go directly to insurers. <Read More>   

    Pharmacy Professor Develops Novel Virus-Like Particle Platform for Vaccine Delivery – August 30, 2021 – A URI College of Pharmacy professor has developed a novel virus-like particle platform to safely and more effectively deliver vaccines to the body, a next step in the potential development of a universal flu vaccine and a new coronavirus vaccine. Dr. Xinyuan Chen recently received a $200,000 grant from the National Institutes of Health to continue research into his novel vaccine platform and develop new vaccines using the safer method of delivery. The platform includes the use of flagellin, a natural protein that is used as a carrier for vaccines, and which also is an agonist that stimulates an immune response. <Read More>  

    Auditor McGuiness: Survey Shows Predatory PBM Practices Destroying Independent Pharmacies – August 30, 2021 – A survey of Delaware’s independent community pharmacists on the impact of pharmacy benefit managers (PBMs) reveals predatory practices are potentially devastating these small businesses, State Auditor Kathy McGuiness said as she released a new special report. “Your community pharmacists – who are your first line of defense when you are sick or hurting and need to talk – are struggling to keep their doors open,” said McGuiness, who is a licensed immunizing pharmacist and former small-business owner. “Our survey results show that these prescription drug middlemen, known as PBMs, are strangling these critically important community businesses.” McGuiness’ office surveyed independent community pharmacy owners across Delaware in June regarding how practices by PBMs are affecting their businesses. <Read More>

    Experts Recommend Diabetes Screenings for Overweight Adults Beginning at Age 35 – August 30, 2021 – Overweight adults should be screened for diabetes beginning at 35 years of age, according to an updated recommendation from the US Preventive Services Task Force. The new recommendation is 5 years earlier than previous recommendations. The new recommendation cited CDC data that approximately 13% of all US adults have diabetes and 34.5% meet criteria for prediabetes. Of those with diabetes, 21.4% were not aware of or did not report it, and only 15.3% of those with prediabetes reported being told by a health care professional that they meet the criteria. <Read More>

    Doctors, Pharmacists Split on Covid Herbal Medicines – August 28, 2021 – Doctors have blamed late presentation of Covid-19 patients to health facilities and high numbers of virus deaths in the country on herbal medicines being marketed as treatment for Covid-19. The doctors question the effectiveness of herbal medicines, which the government has permitted to be used in people with Covid-19 symptoms, saying the medicines must be subjected to clinical trials to prove whether they work. Pharmacists and experts in natural medicines, however, say herbal medicines deserve equal chance to be used in care for Covid-19 patients like synthetic drugs because there is still no proven cure for Covid-19, which has so far killed more than 2,832 people in the country and infected more than 93,000 since its outbreak last year. <Read More>

    New ESC/EACTS Guidelines for the Management of Valvular Heart Disease Published – August 28, 2021 – The European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS) Guidelines for the management of valvular heart disease are published online in European Heart Journal. It is estimated that 13% of people aged 75 and older in high-income countries have valvular heart disease (VHD). Prevalence increases markedly after age 65. Patients with mild or moderate VHD, and some patients with severe VHD, may have no symptoms and be unaware of their disease. Severe VHD leads to deterioration of the heart’s function, which can cause shortness of breath, chest pain, palpitations and fainting. This may require hospitalisation and intervention, and can lead to death. <Read More>  

    Opinion: How to Get FDA Clinical Efficacy Testing Waivers for Biosimilars – August 28, 2021 – Clinical efficacy studies are not always required for biosimilars, and it’s possible to resist if the FDA does ask for them. Sarfaraz K. Niazi, PhD, suggests a game plan. My analysis of all biosimilars licensed by the FDA and EMA shows a common trend: Except in a few instances, all products were tested for clinical efficacy and safety; none of the tests failed, and where results were borderline, the FDA allowed adjustment of acceptance criteria to make approval possible. No product was tested in more than 1 indication, despite the allowance of all indications by the FDA and European Medicines Agency (EMA). If you are one of the big pharma companies dabbling in biosimilars, you would prefer to conduct these studies because you are used to meeting with prescribers with published clinical studies in hand. Other companies, not as well grounded in the value of clinical studies, performed them because they kept thinking of biosimilars as new biologics and had great uncertainty in their abilities. <Read More>  

    CDC Director Defends School Guidelines Amid Delta Surge; US Deaths Still Increasing: COVID-19 Updates – August 27, 2021 – With the number of COVID-19 cases among children rising in recent weeks amid the delta variant’s surge and the start of a new school year, Centers for Disease Control and Prevention Director Dr. Rochelle Walensky defended the agency’s guidelines for school reopening. Walensky said Friday the agency was not considering revising the guidelines and most outbreaks in schools are occurring where the layered protection measures the agency recommends are not in place. <Read More>

    Biden Officials Step Up Pressure to Use Infection Control Measures in Schools – August 27, 2021 – Federal health officials stepped up calls for parents and officials to implement safety measures such as universal masking in schools as students return to in-person classes, citing outbreaks that forced many children back to temporary remote learning. “In our outbreak investigations, large scale quarantines or a large number of cases are generally occurring in schools because schools are not following our guidance, particularly our recommendations for teachers as well as students aged 12 and over to be vaccinated and for everyone right now to be masked,” Centers for Disease Control and Prevention Director Rochelle Walensky said Friday. <Read More>

    HHS Issues Additional Guidance Regarding CARES Act Provider Relief Fund Reporting – August 27, 2021 – HHS’s most recent guidance specifies the  deadlines within which health care providers must use and report on Provider Relief Fund payments and  provides much needed additional clarification concerning how and when health care providers can use such payments to offset permissible health care-related expenses and lost revenues attributable to coronavirus. <Read More>   

    SGLT2 Inhibitors Added to ESC Guidelines for Treatment of Chronic HFrEF – August 27, 2021 – The 5-year update could help solidify the role of sodium glucose co-transporter 2 (SGLT2) inhibitors in treating heart failure, years after the first evidence of their effectiveness emerged. Sodium glucose co-transporter 2 (SGLT2) inhibitors empagliflozin (Jardiance®) and dapagliflozin (Farxiga®) are now recommended for treatment of chronic heart failure with reduced ejection fraction (HFrEF), according to the latest 5-year update of the European Society of Cardiology (ESC) Guidelines in acute and chronic heart failure, which were released early Friday during the ESC Congress 2021. <Read More>  

    Basic Guidelines for Traveling During the Pandemic – August 27, 2021 – In 2020, the world went through a massive lockdown due to the Coronavirus pandemic. The entire course of life shifted, and there was chaos everywhere. The usual did not seem normal anymore, and people had to adapt to the new way of living. Isolation was considered the new way of living; people were locked within the premises of their own house for months, and traveling was restricted. The dangers associated with going out and mingling with people were too high to gamble with as no cure or treatment was available at the start. As time passed, several research experiments were processed, and eventually, scientists gathered enough information that enabled them to prepare treatment guides. At last, everything re-opened, and travel restrictions were lifted. <Read More>

    Five Pharmacy Execs Respond to Vaccinated Patients’ Worries They’re no Longer Protected Against COVID-19 – August 27, 2021 – The U.S. laid out its COVID-19 vaccine booster plan Aug. 18, saying it is ready to roll out third doses in late September. Some public health experts think the announcement may have been premature, claiming it could send the wrong message by leading fully vaccinated people to believe they’re no longer strongly protected against COVID-19. The following five hospital pharmacy executives share what they would tell a fully vaccinated patient who voiced that concern: <Read More>

    Cognitive Remediation Benefits Patients With Schizophrenia – August 27, 2021 – Cognitive remediation is effective for both cognitive and functional outcomes among patients with schizophrenia, according to a systematic review and meta-analysis published in the August issue of JAMA Psychiatry. Antonio Vita, M.D., Ph.D., from the University of Brescia in Italy, and colleagues conducted a systematic literature review to identify randomized clinical trials comparing cognitive remediation to any other control condition in patients diagnosed with schizophrenia spectrum disorders. <Read More>  

    FDA Approves First-of-Its-Kind Stroke Rehabilitation System – August 27, 2021 – The U.S. Food and Drug Administration approved the MicroTransponder Vivistim™ Paired VNS System (Vivistim™ System), a first-of-its-kind, drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke—a stroke caused by a blockage of blood flow to the brain with long-lasting symptoms—using vagus nerve stimulation (VNS). <Read More>    

    Pharmacy Fact: What is the Best City for Mental Health Care in the United States? – August 27, 2021 – Affordable and accessible mental health care is more important than ever, with conditions such as depression, anxiety, insomnia, and acute stress reactions being elevated by the pandemic. Pharmacists can play a key role in helping to manage patients’ mental health, with studies demonstrating that pharmacists focused on mental health medication management can assist with medication adherence, disease control, and avoidance of hospitalization. But where in the United States can patients best receive care easily and affordably? <Read More>   

    Building a Resilient Rx Drug Supply: A New HHS Office and Other Steps – August 27, 2021 – The COVID-19 pandemic has increased the public’s awareness of the need for high-quality, safe, and effective pharmaceutical products. Many have been surprised to learn of the US’s dependence on a highly globalized and largely opaque pharmaceutical supply chain. Yet, even before the COVID-19 pandemic, dozens, and sometimes hundreds, of prescription pharmaceutical products went into shortage every year. Drug shortages have caused disruptions in how patient care is provided and imposed significant costs on the operations of pharmacies, hospitals, and health care systems. Some have even led to adverse outcomes for patients. <Read More>

    FDA Approval of Pfizer Vaccine – Everything Prescribers, Pharmacies, & Vaccine Administrators Want to Know & Forgot to Ask ­– August 27, 2021 – The U.S. Food and Drug Administration’s (“FDA”) approval of the Pfizer vaccine under a new brand name, Comirnaty™, created a cascade of legal and regulatory issues for prescribers, pharmacies, and other vaccine administrators. This Q&A answers some of the most common and immediate questions raised by the approval. Why is off-label use not allowed for this FDA-approved product? It is critical that the vaccine is not administered in any manner that is inconsistent with the FDA-approved labeling. The rules and considerations related to off-label use and the authority of prescribers to issue prescriptions for off-label uses are not relevant to this product. Off-label use of the Comirnaty vaccine can result in False Claims Act (“FCA”) violations. <Read More>

    Emerging Trends in Sleep: Treating Central Disorders of Hypersomnolence, Breath Biomarkers in OSA, and More – August 27, 2021 – As reported by NeurologyLive®, the American Academy of Sleep Medicine issued new guidance for the treatment of central disorders of hypersomnolence, marking the first update since 2007 for these conditions. Published in the Journal of Clinical Sleep Medicine, the guidelines provide 20 recommendations for the use of medications in adults and 2 additional recommendations specific to pediatric patients with narcolepsy, in which recent FDA-approved medications in the treatment of narcolepsy, idiopathic hypersomnia, and Kleine-Levin syndrome are now included. <Read More>

    Why Ivermectin Should Not be Used to Prevent or Treat COVID-19 – August 27, 2021 – The Centers for Disease Control and Prevention (CDC) has issued a health advisory warning physicians and the public about the rise in prescriptions for the anti-parasitic drug ivermectin for use in the treatment or prevention of COVID-19. The CDC also cautioned about the risk of severe illness caused by ivermectin, which was seen in increased calls to poison centers. The Food and Drug Administration (FDA) echoed the CDC’s warning against the use of ivermectin for prevention or treatment of COVID-19. That is because ivermectin is not approved or authorized by the FDA for COVID-19. Additionally, the National Institutes of Health’s (NIH) COVID-19 Treatment Guidelines Panel determined that there is insufficient evidence and data to recommend ivermectin for treatment of COVID-19. <Read More>  

    NIH Launches Study of Extra COVID-19 Vaccine Dose in People With Autoimmune Disease – August 27, 2021 – The National Institutes of Health has begun a clinical trial to assess the antibody response to an extra dose of an authorized or approved COVID-19 vaccine in people with autoimmune disease who did not respond to an original COVID-19 vaccine regimen. The trial also will investigate whether pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine in this population. The Phase 2 trial is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, and is being conducted by the NIAID-funded Autoimmunity Centers of Excellence. <Read More>    

    Addressing Polypharmacy, PIMs in Geriatric Patients With Cancer – August 26, 2021 – In a narrative review published in The Journal of Geriatric Oncology, researchers outlined available studies assessing the effects of interventions aimed at reducing the burden of polypharmacy and potentially inappropriate medications (PIMs) among older adults with cancer. Based on their analyses, investigators concluded that implementing services to address polypharmacy and PIMS in both acute and ambulatory settings can help identify drug-related problems (DRPs) and mitigate adverse effects. In addition, applying more than 1 polypharmacy assessment tool increases the capability to identify more PIMs and increases the ability for interventions. <Read More>

    WHO Issues Rapid Communication on Updated Guidance for the Management of TB in Children and Adolescents – August 26, 2021 – A rapid communication released by the World Health Organization (WHO) Global Tuberculosis Programme has announced important updates to guidance on the management of tuberculosis (TB) in children and adolescents. This includes new recommendations on diagnostic options, treatment regimens, as well as treatment decision algorithms and optimal models of care for the delivery of child and adolescent TB services. “Tuberculosis in children and adolescents has been overlooked for many years,  reflected in large gaps in access to TB prevention and care. Therefore it is encouraging to see that options for the diagnosis, treatment, prevention and care for children and adolescents with TB or at risk of TB, are expanding, thanks to the generation of new evidence” said Dr Tereza Kasaeva, Director of WHO’s Global Tuberculosis Programme. <Read More>

    Patients on High Doses of Opioid Analgesics Risk Overdose When Tapering, Study Finds – August 26, 2021 – A new study published in JAMA Network reveals that patients who take substantial amounts of opioid analgesics over the long term are at a greater risk of experiencing a mental health crisis or an overdose when they taper their dose. The researchers examined a database of more than 113,000 patients prescribed higher doses of opioid analgesics between 2008 and 2019—an average of about 50 morphine milligram equivalents per day—for at least 1 year. They used this information to identify patients who tapered their dose, which researchers defined as reducing it by at least 15% over a 60-day period. Researchers found that the group of patients who tapered their dose experienced a 68% increase in overdoses and twice the number of mental health crises compared with patients who stayed on their typical dose of medication. <Read More>  

    FDA Warns of Pacemaker-iPhone Interference – August 26, 2021 – A study published this week in Heart Rhythm supported recommendations by the U.S. Food and Drug Administration that patients keep consumer electronic devices that may create magnetic interference, including cell phones and smart watches, at least six inches away from implanted medical devices. The study, which was coauthored by four investigators affiliated with the FDA’s Center for Devices and Radiological Health, built upon previous discoveries that the iPhone 12 Pro could trigger the “magnet mode” of a Medtronic implantable cardioverter-defibrillator. <Read More>

    Verily Teams up With Mayo Clinic to Develop Clinical Support Tool – August 26, 2021 – Alphabet’s life science subsidiary Verily is teaming up with the Mayo Clinic on a new effort to develop a digital point-of-care clinical decision support tool. The partnership will start by zeroing in on cardiometabolic conditions, and is directed at contextualizing information and giving care guidelines to clinicians. In the partnership, the Mayo Clinic will be responsible for the clinical content from its multidiscipline and multispecialty practices. Verily will take on the tech side, providing its clinical analytics to deliver the insights to healthcare professionals. <Read More>

    FDA Denies Marketing Applications for About 55,000 Flavored E-Cigarette Products for Failing to Provide Evidence They Appropriately Protect Public Health – August 26, 2021 – The U.S. Food and Drug Administration issued the first marketing denial orders (MDOs) for electronic nicotine delivery system (ENDS) products after determining the applications for about 55,000 flavored ENDS products from three applicants lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products. The products from JD Nova Group LLC, Great American Vapes, and Vapor Salon subject to this action are non-tobacco-flavored ENDS and they include flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal. <Read More>   

    Working With Health Plans to Improve Care – August 26, 2021 – Collaborations between health plan and health-system pharmacists can help organizations optimize medication use. At Blue Cross and Blue Shield of North Carolina (Blue Cross NC), for example, such partnerships have been integral to addressing the cost and quality of care, with each side bringing important assets to the table. “It really all comes down to the fact that all of us can work together to improve outcomes in our mutual patients,” said Brenden O’Hara, RPh, a clinical pharmacist, provider engagement initiatives at Blue Cross NC. <Read More>

    Medicare Part D Audits: Top 11 Areas for Scrutiny – August 26, 2021 – Medicare Part D pharmacy audits are on the rise, and pharmacists would be wise to adapt their business practices and know how to respond, an audit expert said at the virtual MHA 2021 Business Summit. “Prior to COVID-19, we’ve seen a nearly 80% increase in audits that pharmacies experience,” said Trenton Thiede, PharmD, MBA, the president of PAAS National, a pharmacy audit assistance company. These have primarily been from pharmacy benefit managers (PBMs) but also by plan sponsors and the Centers for Medicare & Medicaid Services, Dr. Thiede noted. The increase has occurred partly as a result of escalating health care costs and the opioid epidemic, as well as instances of fraud, waste and abuse, he said. There’s been a shift from on-site to more quick turnaround desk audits that try to validate quick outliers, such as high-dollar items or incorrect days’ supply. Nearly one-fourth of desk audits seen by his company now are for these prescription validation requests, he said. <Read More>

    What Patients Want From a Functional HBV Cure – August 26, 2021 – Untreated HBV leaves people at higher risk of liver complications, including cancer. While antiviral treatment exists, based on current guidelines only about a quarter of people with hepatitis B are eligible to take it. Those who do take it need to stay on it for years, generally for the remainder of their lives. While scientists do not immediately foresee a sterilizing cure for HBV, which would entail a complete disappearance of the virus from the body, they’re working on developing a functional cure. This would facilitate the clearance of hepatitis B surface antigen from the body, as well as prolonged undetectable HBV DNA levels and a normalization of liver enzymes. <Read More>

    WHO Study Reveals Global Adult Hypertension Doubled Since 1990 – August 26, 2021 – High-income countries such as South Korea, Canada, Germany, the US, and some middle-income countries such as Iceland and Costa Rica have shown remarkable improvements in control and treatment of hypertension. The number of adults between the ages of 30 and 79 living with hypertension across the globe has doubled over the past 30 years to an estimated 1,278 million (652 million men and 626 million women) in 2019. The figure was an estimated 648 million (317 million men and 331 million women) in 1990. Most of this rise was found to be in low- and middle-income countries. In India, the prevalence has also gone up over 30 years to 38 per cent in men and 32 per cent in women from 29 per cent and 28 per cent respectively. <Read More>

    Time for Heads to Roll at the US National Center for Injury Prevention and Control – August 26, 2021 – A long-time critic of 2016 CDC guidelines for prescription of opioids calls for replacement of the CDC writers’ team now revising the guidelines. Draft recommendations reviewed July 16th, 2021, double down on errors of science and misdirections which characterized the original. The present team has fundamental professional conflicts of interest and lacks first-hand expert knowledge of pain management practice. <Read More>    

    The Pharmacist’s Role in Managing Allergies – August 26, 2021 – For many patients, allergy season can be a dreaded time of year. Seasonal allergies affect 10%-30% of Americans on a yearly basis and can cause a plethora of symptoms, ranging from sneezing, runny nose, and itchy, watering eyes to shortness of breath, wheezing, swelling, and rash. Luckily for these patients, there are many effective treatment options for mild to severe allergies available both OTC and by prescription. In fact, there are so many available treatment options that patients may often need guidance to choose the best products for their symptoms, which is the primary place the pharmacist comes in. There are many places in a patient’s allergy treatment journey where a pharmacist can plan an important role. <Read More>  

    Pharmacy Benefit Managers Are Feeling a Push From States to ‘Turn the Lights on’ to Their Business Practices – August 26, 2021 – More than 100 bills targeting pharmacy benefit managers have been introduced across the country this year, after the three biggest PBMs processed roughly 77% of all U.S. prescription claims in 2020. The Biden administration tabled a Part D drug rebate rule to help pay for the infrastructure package, while PBM-focused bills in the Senate have stalled or face tricky paths forward. The top PBM trade group is battling state-led regulatory efforts, saying that “the focus for state policymakers should be to examine brand drug manufacturers’ pricing strategies.” <Read More>

    Optimizing Patient Data in the Time of COVID-19 – August 26, 2021 – The COVID-19 pandemic has forced society to change rapidly and in incalculable ways, bringing stakeholders and health care organizations into the 21st century and enabling them to operate with more efficiency and greater flexibility. Nevertheless, pharmacists and providers must remain nimble to help patients continue receiving the medications they need, as technology now plays a central role in workflow and medication management. This enormous shift has also brought opportunities to leverage data and embrace technology to meet the needs of patients and providers. As more pharmacies and health systems tap into larger sets of data from disparate systems, they hope to access relevant information that is high quality, reliable and relevant. <Read More>

    Society Supports CDC Booster COVID-19 Vaccination for Immunocompromised Rheumatology Patients – August 26, 2021 – The CDC’s new recommendation for immunocompromised people to receive a third COVID-19 vaccination was championed by the American College of Rheumatology (ACR). The recommendation applies to all patients on immunosuppressive drugs such as high-dose corticosteroids, alkylating agents, antimetabolites, tumor necrosis factor blockers and other biologic agents, and only involves the Pfizer-BioNTech and Moderna mRNA vaccines (notably not the one-shot Johnson & Johnson vaccine). <Read More>  

    The WHO Living Guideline: Drugs to Prevent COVID-19 Currently, Check Out – August 26, 2021 – Both the waves of coronavirus were deadly and created havoc all over the world. In many countries, different variants, especially delta variants are creating problems. There are various types of guidelines being issued by WHO, the world health organization, for precautions as well as related to vaccination and drugs to prevent Covid-19. Here we look at those WHO living guidelines, regarding drugs to prevent Covid-19. The WHO Living rules: Drugs to forestall Covid-19. These are forward-thinking suggestions for the utilization of medications to forestall Covid-19. The current use of drugs to prevent Covid-19 is variable and clinical trials are also on. <Read More>

    NIH HEAL Initiative: Research Meets the Moment to Address the Opioid Public Health Crisis – August 26, 2021 – An article published in the Journal of the American Medical Association highlights the results of numerous strategies through which the National Institutes of Health’s Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, is finding scientific solutions to address the nation’s opioid crisis. The task is even more urgent since the COVID-19 pandemic fueled a nearly 30% increase in overdose deaths in 2020, the highest 12-month increase in decades. To date, the initiative has funded $1.5 billion to more than 500 research projects to address opioid misuse and pain management. <Read More>  

    Why the CDC Doesn’t Recommend Screening Straight Men for STDs – August 25, 2021 – Earlier this summer, the CDC announced the first update since 2015 to treatment guidelines for sexually transmitted infections (STIs). While the CDC added several new screening recommendations, including one-time screening for hepatitis C for all adults over 18, there remained little guidance for screening for STIs such as chlamydia and gonorrhea in heterosexual men. “It’s a pretty obvious discrepancy,” says Jodie Dionne-Odom, MD, who studies infectious disease in women at the University of Alabama at Birmingham Hospital. <Read More>  

    Outcomes4Me Incorporates NCCN Guidelines® Update into Mobile App for Breast Cancer Patients – August 25, 2021 –  Outcomes4Me Inc. announced it has updated its mobile app to include the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.6.2021 released last week. The app serves as a digital health partner that proactively delivers timely information of value to empower patients to take more control of their care. The update includes new treatment options for early-stage breast cancer, based on the recent FDA approval of the immunotherapy pembrolizumab (Keytruda®, Merck) and recently published results from the OlympiA trial with the PARP inhibitor olaparib (Lynparza®, AstraZeneca Pharmaceuticals LP). <Read More>  

    There is More to Medication Storage Than Meets the Eye – August 25, 2021 – Over the past 20 years, the expectations and roles of pharmacy staff members have changed drastically to meet the ever-changing demands of health care. Pharmacists have taken on a greater role providing direct patient care as clinicians, resulting in greater reliance on pharmacy technicians. Among the many areas traditionally overseen by pharmacists where technicians have assumed responsibility, medication storage may be one of the most important. Medication storage is a vital element in pharmacy operations that affects many areas, from clinical practice to regulatory compliance. Improper storage of medications can result in a decrease in drug efficacy and may also lead to medication errors. <Read More>  

    Pharmacy Benefit Managers: The Mystery Bureaucrats Managing Your Prescription Drugs – August 25, 2021 – About 40% of Americans struggle to afford their regular prescription medicines – with 1/3 saying they have skipped filling a prescription one or more times, because of the cost. COVID-19 has exacerbated the problem by causing job and health insurance loss and delaying routine care. Rhode Island policymakers know skyrocketing prescription drug prices must be better controlled. Unfortunately, they have ignored a key cost driver: Pharmacy Benefit Managers (PBMs). PBMs such as CVS Caremark, Express Scripts and OptumRx “manage” prescription drug benefits on behalf of insurers and siphon off enormous revenues in the complex non-transparent system that gets drugs from manufacturers to patients. Other states are doing a much better job monitoring and controlling PBMs and have saved consumers and tax payers hundreds of millions of dollars. <Read More>

    IPC Guidance Is Issued on Safety of Biosimilar Switching in Psoriasis – August 25, 2021 – Guidance from the International Psoriasis Council (IPC) on biosimilars emphasizes a cautious approach to switching patients from reference products (RPs) to biosimilars and retention of physician control when it comes to substitution. Further, the IPC guidance recommends that switching from RPs to biosimilars in psoriasis should be done only with patient knowledge and agreement. The IPC notes the FDA’s strong emphasis on pharmacokinetic (PK) and pharmacodynamic (PD) aspects of biosimilars and its tendency to place less value on clinical studies in the determination of biosimilarity, compared with the development of RPs. However, the IPC guidance indicates the group wants clinical evaluations to continue to play a significant role in verifying the safety and efficacy of biologics, including biosimilars. <Read More>  

    The Challenges of Prostate Cancer Management – August 25, 2021 – “The major shift for many urologists over the past 10 years has undoubtedly been the understanding of how to treat advanced prostate cancer,” writes Raoul S. Concepcion, MD, FACS. Historically, the urology community has been the “gatekeeper” for the diagnosis and management of prostate disorders, malignant or benign. Prior to the advent of medical therapy and minimally invasive procedures to treat benign prostatic hyperplasia (BPH), if one were finishing their training and in search of a job opportunity, the litmus test to determine how busy a urologist was in practice was to ask how many transurethral resections of the prostate (TURPs) were being performed annually? If the number was more than 125 cases per year, that was considered a robust clinical practice. My recollection from my case log as a resident in the late 1980s was maybe 100 cases over a 4-year residency span, and I cannot fathom what that might look like today in the modern era! The transition from open prostatectomy, TURP, medical therapy, and now minimally invasive procedures has required, to some degree, subspecialization to optimize outcomes rather than being the staple procedure for all urologists in practice. <Read More>  

    Examining the True Cost of Carve-out Savings: Quality Clinical Care – August 25, 2021 – As the price tags for therapies coming to market have soared into the hundreds of thousands and even millions on occasion, paying for them has become an ever-greater cause of concern and focus area. Specialty conditions—and often the therapies used to treat them—are complex. Getting diagnosed alone can be a source of anxiety. For people living with these conditions, successfully managing their symptoms while also dealing with complicated medications regimens and adverse effects (AEs) can be challenging. The lifestyle changes often required for successful condition management can make the experience overwhelming. These medications are also usually very expensive, which is major area of concern for payers and patients alike. <Read More>

    LETTER: Allow Pharmacists to do Their Jobs – August 25, 2021 – For those living in rural areas, local, independent pharmacies are our first point of contact in the healthcare system. They are not only the closest to us, with larger hospitals located closer to cities and metro areas, they are a part of our community and provide trusted healthcare information, helping to improve health outcomes immensely. But to best serve the community and focus on patient care, independent pharmacies need help…PSAOs (pharmacy services administrative organizations) even help in negotiations with entities like pharmacy benefit managers (PBMs), who oversee reimbursements independent pharmacists are owed. <Read More>

    The Impact of Independent Community Pharmacists on NCPDP Standards – August 25, 2021 – In 2012, the Community Pharmacy Foundation (CPF) and the National Council for Prescription Drug Programs (NCPDP) began an organizational collaboration with the goal of increasing representation of independent community pharmacists within NCPDP membership and forums. The CPF is a non-profit organization dedicated to advancing community pharmacy practice and patient care delivery. NCPDP is a not-for-profit, ANSI-accredited Standards Development Organization (SDO) that relies on its collaborative, consensus-building process to develop national standards for real-time, electronic exchange of health care information, and creation of best practices for patient safety. <Read More>  

    Reybold Joins APCI Team to Fight PBM Abuses – August 25, 2021 – American Pharmacy Cooperative, Inc. (APCI) announces Greg Reybold as Director of Healthcare Policy and General Counsel effective September 1, 2021. In his new position, Mr. Reybold will work with the APCI legislative team to develop healthcare policy at both the state and federal levels as well as manage the co-op’s legal strategy. Mr. Reybold is a veteran healthcare attorney, government affairs professional, and litigator with an expertise in combating abusive pharmacy benefit manager (PBM) practices through legislative and regulatory processes. Prior to joining APCI, Mr. Reybold served as General Counsel and Vice President of Public Policy for the Georgia Pharmacy Association (GPhA). <Read More>

    It’s Prime Time For Ambulatory Infusion Centers – August 25, 2021 – The time is ripe for ambulatory infusion centers (AICs) to gain a stronger foothold in U.S. health care, a panel of experts said during the MHA 2021 Business Summit, held virtually. “There’s a lot of tailwinds in this industry,” said Reece Norris, JD, a co-founder and the CEO of WeInfuse, an infusion software and consulting company. Payors and health plans are looking for sites of care (SOC) for infusion therapies that are more cost-effective than hospitals without compromising care, Mr. Norris said. With many autoimmune biologic specialty drugs having a limited distribution, the logistics of getting this in the home can be so burdensome that “it makes sense” to administer them in AICs, he noted. <Read More>  

    Maximizing the Benefit of Venetoclax in AML – August 25, 2021 – The approval of venetoclax in combination with hypomethylating agents (HMAs) or low-dose cytarabine provides significant benefit for older adults with newly diagnosed acute myeloid leukemia (AML). But the therapy also comes with a specific set of challenges that clinicians are learning to tackle. Venetoclax (Venclextaâ, AbbVie/Genentech) has been a “huge medical breakthrough and a much-welcomed addition” to AML therapy, one of the most aggressive leukemias, said Sara Kim, PharmD, BCOP, a senior clinical oncology pharmacy specialist at Northwell Health, in New York. <Read More>  

    Could Aspirin Prevent Mechanical Ventilation in COVID-19 Patients? Maybe – August 25, 2021 – There appears to be a positive effect in patients hospitalized with COVID-19 who are taking aspirin, according to a recent study, but more research is needed before the approach is ready for prime time (Anesth Analg 2021;132[4]:930-941). Patients taking aspirin were half as likely to require mechanical ventilation as those with COVID-19 not taking the drug, according to the retrospective, observational cohort study of adult patients. Patients were admitted to multiple hospitals in the United States between March 2020 and July 2020. The investigators reviewed the charts of 412 patients, of whom 76.3% did not receive aspirin, and the remainder received aspirin within 24 hours after admission or for seven days or more prior to admission, primarily for cardiovascular disease. <Read More>

    Helping Pharmacists Excel in the ‘New Normal’ – August 25, 2021 – Pharmacists’ roles are not what they used to be in pre-COVID times and likely won’t return to that way for quite some time, if ever. Pharmacists continue to combat COVID-19 with vaccination efforts and testing coupled with COVID-19 fallouts, such as the decline in routine childhood vaccinations and a potentially difficult upcoming flu season. And though pharmacists haven’t slowed down, the overwork is catching up with them. In one survey, 73% of pharmacists cited higher work volume because of COVID-19, whereas another survey found support staff is limited. A National Community Pharmacists Association (NCPA) survey found that nearly 4 in 5 pharmacies are struggling to recruit pharmacy technicians. These two factors are likely contributing to growing burnout, with one-third of respondents in a separate poll feeling “a lot” or “totally” exhausted emotionally and physically. <Read More>  

    Study: Physical Activity Associated With Better Cognition in Breast Cancer Patients – August 24, 2021 – There is a strong connection found between high levels of physical activity and the ability to maintain cognitive function among patients with breast cancer treated with chemotherapy, according to a new study from Washington University School of Medicine in St. Louis. This research lays the foundation for future clinical trials aimed at investigating whether moderate to vigorous exercise can minimize “chemo brain,” which is a decline in cognitive function many patients with breast cancer experience. <Read More>  

    Insight Into How Often COVID-19 Spreads Through Households – August 24, 2021 – A new study published in the Clinical Infectious Diseases journal demonstrates how quickly COVID-19 can spread through a household, and provides insight into how and why communities of color have suffered disproportionately from the pandemic. The observational study, conducted between April and October of 2020, followed 100 COVID-positive patients around the Raleigh, NC area and included a total of 208 additional household members. A household member was defined as someone who was staying in the same living space as the person who tested positive. <Read More>

    No Update to Budesonide Guidance as Study Confirms Covid Efficacy – August 24, 2021 – Results published in The Lancet have confirmed the benefit of inhaled budesonide in Covid recovery in higher risk patients in the community. But the Department of Health and Social Care (DHSC) said advice to only prescribe the treatment on a ‘case by case’ basis remains in place for now. It is understood that NICE are reviewing the evidence from the PRINCIPLE trial, which first published interim results in April. The Lancet paper confirms that use of budesonide in over 65s or over-50s with high risk conditions who had tested positive for SARS-CoV-2 recovered 2.94 days sooner than those who had usual care. <Read More>  

    North Carolina Lawmakers to Deliberate Over Pharmacy Benefit Managers Regulations – August 23, 2021 – The North Carolina General Assembly will negotiate the details of a bill that increases consumer protections in the health care industry. Senate Bill 257 increases state regulation of pharmacy benefit managers. Pharmacy benefit managers are subcontractors that often dictate how much a pharmacy can charge a customer for prescription medications. Health insurance companies and Medicaid pay pharmacy benefit managers to negotiate prices with drug manufacturers on their behalf and maintain medication lists. The Senate unanimously approved their version of the measure June 1. The House added provisions to the measure that senators said they needed to review. The House approved the measure, 101-0, on Wednesday. <Read More>  

    340B in the News

    Dem Proposal Looks to Dramatically Decrease Price of Prescriptions, Reduce Disparities – August 30, 2021 – Wisconsin Democratic lawmakers introduced a sweeping legislative package this month with the aim of lowering prescription drug costs for consumers statewide. Key elements of the initiative include efforts to invest in community-based healthcare and reigning in pharmaceutical industry practices which disproportionately harm low-income and underinsured Wisconsinites… The task force also voiced alarm regarding a perceived lack of oversight to protect 340B affiliated healthcare providers–a vital lifeline for underinsured communities–from predatory drug reimbursement practices. <Read More>  

    Pharmacy Benefit Managers: The Mystery Bureaucrats Managing Your Prescription Drugs – August 25, 2021 – About 40% of Americans struggle to afford their regular prescription medicines – with 1/3 saying they have skipped filling a prescription one or more times, because of the cost. COVID-19 has exacerbated the problem by causing job and health insurance loss and delaying routine care. Rhode Island policymakers know skyrocketing prescription drug prices must be better controlled. Unfortunately, they have ignored a key cost driver: Pharmacy Benefit Managers (PBMs)… 340B discounted drugs make up “more than 8% of the total United States. drug market and about 16% of the total rebates and discounts that manufacturers provide.”…but PBM problems generally involve their engaging in “discriminatory reimbursement,” e.g., offering 340B entities lower reimbursement rates than those offered to non-340B entities. Currently, the federal 340B statute allows PBMs to make significant revenues and not pass money to those Section 340B intended to help. <Read More>

    States Remain the Drivers of New Drug Pricing Legislation as Washington Weighs in – August 24, 2021 – State legislatures continue to push forward on drug pricing with legislation designed to reduce the cost of prescription drugs. Recent steps across a number of states include laying the groundwork for effective drug-importation programs and increasing drug-pricing transparency. Change at the federal level may be coming as well, as both the White House and Congress ramp up their attention to drug pricing… These new state laws establish novel drug-importation programs, require pricing transparency from pharmaceutical manufacturers, mandate disclosures from pharmaceutical benefit managers (PBMs) and insurers, cap consumer cost-sharing on certain drugs, and curb discriminatory contracting in the 340B program, among other changes. <Read More>