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
Winlevi® (clascoterone) Cream – New Drug Approval – August 27, 2020 – Cassiopea SpA announced that the United States Food and Drug Administration (FDA) approved Winlevi® (clascoterone cream 1%) for the treatment of acne in patients 12 years and older. Notwithstanding acne being the most prevalent skin condition in the U.S. affecting up to 50 million Americans annually, the last FDA approval of an acne drug with a new mechanism of action (MOA) occurred nearly 40 years ago. <Read More>
New Formulation Approval
No new update.
New Indication Approval
Darzalex® (daratumumab) and Kyprolis® (carfilzomib) – New Expanded Indication – August 20, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) approval of Darzalex® (daratumumab) in combination with Amgen’s Kyprolis® (carfilzomib) and dexamethasone (DKd) for the treatment of adult patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy. Darzalex® has been approved in combination with two carfilzomib dosing regimens, 70 mg/m2 once weekly and 56 mg/m2 twice weekly, based on positive results from the Phase 3 CANDOR and Phase 1b EQUULEUS studies, representing the first-ever approval of an anti-CD38 with carfilzomib. <Read More>
New Drug Shortage
No new update.
New Drug Recall and Safety Alerts
Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP by Mylan – New Drug Recall – August 31, 2020 – Mylan N.V. announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the hospital/clinic level of four lots of Amiodarone HCl Injection, USP 450 mg/9 mL, packaged in cartons of 10 single-dose 9 mL vials and Tranexamic Acid Injection, USP 1000 mg/10 mL, packaged in cartons of 10 single-dose 10 mL vials. <Read More>
Nature-Throid® (thyroid) and WP Thyroid® (thyroid) by RLC Labs – New Drug Recall – August 25, 2020 – RLC Labs, Inc. is dedicated to the health and safety of our hypothyroid community. As our number one priority, we want to ensure that you are aware of our decision to issue a recall of all unexpired lots of Nature-Throid® (Thyroid USP Tablets) and WP Thyroid® (Thyroid USP Tablets) that are currently in commercial distribution. This recall has been initiated because testing found that certain lots of these products may be sub-potent (i.e. contain less than 90% of the labeled amount of liothyronine or levothyroxine). <Read More>
New Generic/Biosimilar Approval and Launch
No new update.
Clinical and Pharmacy News
Back-to-School Vaccinations Recommended in 2020 – August 31, 2020 – Approximately 2 to 3 million deaths worldwide are avoided each year because of vaccinations. This has led to a 100% decrease in smallpox infections; a greater than 97% decrease in measles, mumps, and rubella (MMR) infection; and a 99% decrease in Haemophilus influenzae virus infections since the 20th century. Although vaccine distribution and availability have increased internationally, about 14% of children worldwide are not fully vaccinated for polio, diphtheria, tetanus, pertussis, and measles diseases. Approximately 1.5 million individuals die from vaccine preventable diseases each year, and, as frontline providers, pharmacists are well positioned to improve vaccination rates and educate individuals about the risks and benefits of immunizations. <Read More>
Study: Evolocumab Significantly Reduces LDL Cholesterol in Pediatric Patients With Heterozygous Familial Hypercholesterolemia – August 31, 2020 – According to positive results from the recent HAUSER-RCT phase 3b study, evolocumab (Repatha®, Amgen) used in combination with statins and other lipid-lowering therapies was able to significantly reduce low-density lipoprotein cholesterol (LDL-C) in pediatric patients between 10 and 17 years of age with heterozygous familial hypercholesterolemia (HeFH). HeFH is an inherited, genetic condition that affects 1 in 250 people globally. Pediatric patients with high levels of LDL-C can be normal weight, follow a healthy diet, exercise regularly, and still have high LDL-C. <Read More>
Differentiate Allergy and COVID-19 Symptoms – August 31, 2020 – With allergy season in full swing during the coronavirus disease 2019 (COVID-19) pandemic, many individuals fear that their allergy symptoms may be a complication of COVID-19. Although some similarities exist, a few key differences can help differentiate the symptoms. COVID-19 symptoms appear 2 to 14 days after exposure to the virus, according to the CDC. These may include chills, cough, difficulty breathing or shortness of breath, and fever. The CDC recommends that patients immediately seek emergency medical care if they show any signs of bluish face or lips, an inability to stay awake or wake up, new confusion, or persistent pain or pressure in the chest. On the other hand, seasonal allergies range from mild to severe, with the most common symptoms including ear congestion; itchy ear canals, sinuses, or throat; itchy or watery eyes; postnasal drainage; a runny or stuffy nose; and sneezing. <Read More>
The Community Pharmacist Role in Antiemetic Therapy for Outpatient Chemotherapy Treatment – August 31, 2020 – Despite improvements in the understanding and treatment of chemotherapy-induced nausea and vomiting (CINV), nausea and emesis continue to be a distressing adverse event for patients. CINV is associated with increased health care utilization and decreased health care-related quality of life, impacting both direct and indirect health care costs…Clinical oncology pharmacists have a fundamental role in many cancer treatment centers because they ensure the completion of appropriate antiemetic prescribing and patient counseling. However, cancer information overload at clinic visits can leave patients feeling overwhelmed and failing to remember specific details concerning their treatments. Community pharmacists are in an essential position to support patients and emphasize the importance of adherence to antiemetic medications when patients are dropping off or picking up prescriptions at their local pharmacy. <Read More>
New Recommendations Steer Doctors Away from Opioids to Treat Pain in Adolescent Athletes – August 31, 2020 – Athletes at all levels and ages commonly experience pain during practice and in competition. Identifying and appropriately managing acute and chronic pain is fundamental for short- and long-term health. This is especially true for adolescent athletes in whom inadequate or inappropriate pain management can lead to a lifetime of consequences including an increased risk of opioid misuse. A team physician consensus statement just released by the American College of Sports Medicine (ACSM) and five other professional sports medicine organizations shares guidelines to identify and manage pain in athletes ages 10 to 18. It urges team physicians and pediatricians to use nonpharmacologic treatments before prescribing opioids. <Read More>
DAPA-CKD: Dapagliflozin Drops Risk of Renal Decline or Kidney Failure Death 39%, Even Without Diabetes – August 30, 2020 – Dapagliflozin, the sodium glucose co-transporter 2 (SGLT2) inhibitor sold as Farxiga® (AstraZeneca), brought a stunning 39% decline in the risk of declining kidney function, the onset of end-stage kidney disease, or kidney failure death, according to results of the DAPA-CKD trial presented. The findings confirm the powerful properties of a drug class that has been a star of the European Society of Cardiology 2020 Congress, which is taking place virtually. <Read More>
Early Rhythm Control Therapy Improves Outcomes in Patients With Atrial Fibrillation – August 29, 2020 – Patients with newly diagnosed atrial fibrillation benefit from early rhythm control therapy, according to results of the EAST-AFNET 4 trial presented in a Hot Line session at ESC Congress 2020. Rhythm control therapy is typically delayed unless patients have persistent symptoms on otherwise effective rate control. The EAST-AFNET 4 trial investigated whether rhythm control therapy – with antiarrhythmic drugs or ablation – delivered soon after diagnosis improves outcomes. “The risk of severe cardiovascular complications and death in patients with atrial fibrillation is highest in the first year after diagnosis, suggesting that early therapy could be most beneficial.” <Read More>
Help Minimize Oral Pain – August 29, 2020 – In the United States, it is estimated that 34 million school hours and $45 billion are lost each year to unplanned dental care. According to a cross-sectional Saudi Arabian study, 29% of community pharmacists provided 30 or more oral health related consultation services per day during the study period. Pharmacists can provide appropriate recommendation of OTC products and/or referrals for optimal oral care. One common cause of oral pain is dental caries. Untreated dental caries often progresses to bacterial infection, which may result in inflammation and/or necrosis of the pulp tissue called apical abscess. If apical abscess is left untreated, cellulitis may develop in surrounding tissues. <Read More>
Hep Vaccines Lacking Among Liver Patients – August 28, 2020 – While guidelines call for patients with chronic liver disease to receive vaccinations against hepatitis A and B viruses, many candidates for liver transplants are not receiving the inoculations, a new study has found. In light of the results, researchers from the University of Cincinnati, who conducted the study, urged clinicians to obtain comprehensive vaccine histories for all patients scheduled for liver transplantation, and to ensure that their vaccine series are completed before the procedure. <Read More>
Liver Fibrosis in Routine Care for Diabetes Could Uncover Advanced Liver Disease Patients – August 28, 2020 – A pilot study from the UK has suggested that diagnosis of advanced liver disease in people living with diabetes could be increased 5-fold if the assessment of liver fibrosis is included in routine care…Routinely assessing liver fibrosis in people with type 2 diabetes mellitus (T2DM) has the potential to identify large numbers of previously undiscovered cases of advanced liver disease, according to a pilot study conducted in two primary care practices in North East England. <Read More>
CDC: Nursing Home Workers, Residents Likely Prioritized for Future COVID Vaccinations – August 28, 2020 – The Centers for Disease Control and Prevention has proposed guidelines for prioritizing who receives future COVID-19 vaccinations, highlighting nursing home employees in particular. In a Wednesday presentation, the agency’s Advisory Committee on Immunization Practices laid out scenarios for vaccine delivery targeting groups at high risk from severe disease. These include 17 million to 20 million U.S. healthcare personnel along with essential workers, people with high-risk medical conditions, and the estimated 53 million U.S. adults aged 65 years and older — about three million of whom live in long-term care facilities, the group reported. <Read More>
New Algorithm Can Help Spot Illicit Online Pharmacies – August 28, 2020 – Consumers are expected to spend more than $100 billion at online pharmacies in the next few years, but not all of these businesses are legitimate. Without proper quality control, these illicit online pharmacies are more than just a commercial threat, they can create serious health threats. In a study, a team of Penn State researchers report that an algorithm they developed may be able to spot illicit online pharmacies that could be providing customers with substandard medications without their knowledge, among other potential problems. <Read More>
President Trump Orders HHS to Rescind Discount Safe Harbor for PBMs, but Questions Remain – August 28, 2020 – Prescription drug prices are one of the biggest drivers of rising health care costs. To address this issue, the Trump administration issued its Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen (the “Order”) on July 24, 2020. The Order is in fact the latest chapter in a saga over drug prices that has been going on for several years and which had culminated in February 2019 with a proposed rule by the United States Department of Health and Human Services (“HHS”) which aimed to rewrite the existing Anti-Kickback Statute (“AKS”) safe harbor for discounts (“Discount Safe Harbor”). Specifically, the rule proposes to eliminate the protection of rebates provided by pharmaceutical manufacturers to Medicare Part D prescription drug plan (“PDP”) sponsors and their pharmacy benefit managers (“PBMs”) and shift those discounts to consumers at the point of sale. <Read More>
Few of Those Most at Risk Receive Powerful Cholesterol Drugs, and Most Can’t Meet Targets, Study Finds – August 28, 2020 – A new study finds that less than a fifth of very high-risk cardiovascular patients across 18 European countries are meeting their cholesterol goals based on current guidelines, and there’s a simple reason—only a fraction of them take the right medication to meet the targets. The study, called DA VINCI, reviewed how lipid-lowering therapies were used in both primary and specialty care, and whether patients were able to achieve cholesterol-reduction goals based on European guidelines: those of the European Atherosclerosis Society (EAS) and the European Society of Cardiology (ESC). <Read More>
ASHP Issues COVID-19 Vaccine Principles – August 28, 2020 – The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine rollout must focus on pandemic preparedness, supply chain management, distribution and clinical practice, according to new guidelines released by the American Society of Health-System Pharmacists (ASHP)…A COVID-19 vaccination is crucial in order to protect communities from worsening and future outbreaks, according to the organization. In preparation, ASHP has released 10 principles for vaccine development, distribution, allocation, mass vaccination, monitoring, and surveillance. <Read More>
IDSA Guidelines on Serologic Testing for the Diagnosis of COVID-19 – August 28, 2020 – Infectious Diseases Society of America has released Guidelines on Serologic Testing for the Diagnosis of COVID-19. IDSA’s goal was to develop evidence-based recommendations that assist clinicians, clinical laboratories, patients and policymakers in decisions related to the optimal use of SARS-CoV-2 serologic tests in a variety of settings. The guidelines also highlight important unmet research needs pertaining to the use of anti-SARS-CoV-2 antibody tests for diagnosis, public health surveillance, vaccine development and the selection of convalescent plasma donors. <Read More>
New Vaccines in the Pipeline 2020 – August 28, 2020 – Vaccines are the cornerstone in our defense against microbial pathogens that are widely recognized as causing substantial economic burden on society.1 It can often take more than 10 years and between $200 million and $500 million to produce a vaccine; however, vaccines have become the most cost-effective health intervention with the greatest success rates…To facilitate the creation and dissemination of new vaccines, the WHO maintains a list of all vaccines in the “pipeline” for clinical trials. Currently, a total of 2612 vaccines are being investigated for a number of infectious diseases, including respiratory syncytial virus, dengue fever, and malaria; however, this article will focus on reviewing the vaccine pipeline for the following viruses: Zika, Ebola, Lassa, Nipah, Middle East respiratory syndrome coronavirus (MERS-CoV), HIV, and coronavirus disease 2019 (COVID-19). <Read More>
Significant Update on Asthma Management – August 28, 2020 – The updated guidelines recommend as-needed low-dose budesonide-formoterol be used as an alternative to a daily maintenance low-dose inhaled corticosteroid preventer for the relief of symptoms in adults and adolescents aged over 12 with mild asthma. The update is supported by four randomised controlled trials of close to 10,000 adults and adolescents. Results showed as-needed low-dose budesonide-formoterol provided immediate symptom relief and reduced the risk of severe flare-ups by two-thirds compared to using short-acting relievers alone. <Read More>
AAP, 44 Chapters Call on HHS to Rescind Action on Pharmacy Vaccination – August 28, 2020 – The AAP and 44 of its chapters are asking federal officials to rescind their decision allowing licensed pharmacists to administer vaccines to children regardless of state laws. “This announcement threatens the medical home, depriving children and families of much needed medical care and clinical guidance, and further exacerbates inequities in the delivery of childhood immunizations,” the groups said in a letter to Health and Human Services (HHS) Secretary Alex M. Azar II, J.D., on Friday. <Read More>
Endovascular Stroke Therapy Less Beneficial After Transfer – August 27, 2020 – Acute ischemic stroke patients who undergo endovascular therapy have worse outcomes—specifically, higher in-hospital mortality and poorer function—if are transferred to another center before receiving the treatment, observational data from the United States show. “The documented magnitude of benefit was substantial (~35 lives saved per 1,000 procedures, number needed to treat 28.6),” Mohamad Alkhouli, MD (Mayo Clinic, Rochester, MN), and colleagues point out. <Read More>
Earlier Start to HIV Treatment May Reduce Long-Term Risk of Some Cancers – August 27, 2020 – For people newly infected with HIV, there are many health benefits to being diagnosed and placed on antiretroviral therapy (ART) as quickly as possible. New research that followed a large number of people living with HIV over 15 years finds reduced risk of certain cancers is among the benefits of early treatment. The study pulled together data from nearly 15,000 people diagnosed with HIV between 1996 and 2014 at more than 200 clinical sites in the United States and Canada, including Kaiser Permanente Northern California. <Read More>
Acute Cellulitis: Meta-Analysis Does Not Reveal Optimal Antibiotic Regimen – August 27, 2020 – Studies that might have informed appropriate antibiotic regimens for acute cellulitis were likely to be flawed by biased comparisons, inadequate follow-up periods, and/or lack of adverse event documentation, according to the conclusions from a recently published meta-analysis. Frequent disparities between practice and guideline recommendations for antibiotic treatment of acute cellulitis that result in excessive antibiotic use and questionable choice of intravenous (IV) route of administration prompted the investigators to review the literature and conduct a meta-analysis of pertinent studies to determine an optimal route and duration of antibiotic treatment. <Read More>
Guideline Updated for Nutrition in Chronic Kidney Disease – August 27, 2020 – The National Kidney Foundation and the Academy of Nutrition and Dietetics have updated the clinical practice guideline for nutrition in chronic kidney disease (CKD); the 2020 update was published as a supplement to the September issue of the American Journal of Kidney Diseases. T. Alp Ikizler, M.D., from the Vanderbilt University Medical Center in Nashville, Tennessee, and colleagues updated the Kidney Disease Outcomes Quality Initiative Clinical Practice Guideline for Nutrition in CKD. The guideline was expanded to include patients with stages 1 to 5 CKD not receiving dialysis and those with a functional kidney transplant. <Read More>
NACDS Urges Further State Action to Affirm Pharmacist-Administered Childhood Vaccinations – August 27, 2020 – Soon after the Department of Health and Human Services’ (HHS) decision last week authorizing pharmacists in all states to administer childhood vaccines, NACDS is urging states to do more to ensure that pharmacies are empowered to carry out these actions. In an email to the governors of all states, NACDS President and CEO Steven Anderson said they should issue an executive order that “explicitly allows pharmacists to initiate, order, and administer FDA-authorized vaccines to individuals age 3 and older without restrictions and to provide coverage for this professional service.” <Read More>
Caught in the Middle: Proposed CMS Changes Could Place Specialty Pharmacy Between Patient and Drug – August 27, 2020 – Every day thousands of critically ill patients receive specialty prescriptions. Many of these commercially insured patients rely on manufacturer-sponsored patient assistance programs (PAPs) for help in paying for their lifesaving drugs. These programs are often the difference between accessing the drug and increasing the abandonment rate. However, based on final rules and proposed changes from the Centers for Medicare & Medicaid Services (CMS), dramatic changes may be on the horizon that will affect the availability of these crucial safety net programs. Earlier this year, CMS permitted self-insured and many other types of health insurance plans to implement antiaccumulator programs. Established by pharmacy benefit managers (PBMs), these programs exclude the value of co-pay assistance from accruing toward patient deductibles and annual cost-sharing limits. CMS states that the PBMs take the position that “manufacturer-sponsored assistance programs steer consumers towards more expensive medications when there may be more cost saving options available to health plans,” and as a result, they force (“encourage”) health plans to apply manufacturer PAPs to the plan’s benefit instead of the patients’. <Read More>
Electronic Prior Authorization is Catching on – August 27, 2020 – Most providers absolutely dread prior authorization. It adds to administrative work and may seem to stand in the way of good patient care. But for payers, “prior auth” is among the sturdiest, sharpest tools in the managed care toolkit because it gives them a way to control costs and steer physicians toward cost-effective choices. Could electronic prior authorization (ePA) bring the two sides together? “Prior authorization has not changed much in the last five years, but we have seen a shift in the method in which prior authorization requests are submitted,” says Caitlin Graham, vice president of Core Network, a division of CoverMyMeds, a healthcare technology company in Columbus, Ohio, owned by McKesson Corporation. <Read More>
FDA Removes Boxed Warning for Amputation Risk From Canagliflozin – August 27, 2020 – Based on a review of latest data stemming from 3 clinical trials, the FDA has removed the boxed warning concerning amputation risk from the diabetes drug canagliflozin (Invokana®, Invokamet®, Invokamet XR®) prescribing information. Canagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. The drug was initially approved for use in conjunction with diet and exercise to lower blood sugar in adults with type 2 diabetes (T2D). The agency’s requirement of the boxed warning in 2017 was based on its assessment that the risk of amputations was substantial compared with the potential benefit of canagliflozin. <Read More>
Can Patients Be Part of the Drug Shortages Solution? – August 27, 2020 – Because patients lack the resources that hospitals have to search for clinical, cost-effective alternatives when prescribed drugs are out of stock or too costly, Scripta Insights has made its drug substitution search tool free for anyone to use during the COVID-19 pandemic. At first glance, it may seem strange to enlist patients in efforts to navigate drug shortages. But that’s exactly what the website (drugfinder.scriptasaurus.com) is set up to do—albeit with the initial help of pharmacists. <Read More>
Will Drive-Up Flu Vaccinations be Prevalent This Fall? – August 27, 2020 – As the coronavirus disease 2019 (COVID-19) pandemic unfolded, national pharmacy chains and some independents quickly stepped in and offered to be testing sites for the coronavirus. At many CVS and Walgreens stores, for example, individuals can drive up and receive a COVID-19 swab test. Now, drug stores are parlaying that same philosophy into making influenza vaccinations more convenient and safer during the pandemic. <Read More>
Pharmacists Issue Guidance for Mass COVID-19 Vaccination – August 26, 2020 – As society prepares for the rollout of COVID-19 vaccines, the American Society of Health-System Pharmacists (ASHP) has issued 10 guiding principles for development, distribution, allocation, and oversight of vaccines. The guidelines build on the organization’s research and best practices expertise in pandemic preparedness, supply chain management, distribution, and clinical practice. As the largest single vaccination effort the global community has ever undertaken, ASHP believes the following are vital to an effective vaccination rollout: <Read More>
Schizophrenia: Clinical Considerations in Men Versus Women – August 26, 2020 – The most consistently reported gender difference in schizophrenia is higher age of onset in women, though many domains may be affected. Symptomatology and the course of illness may also vary between gender, but the extant literature is inconsistent, with less consistent data on a possibly better clinical course and lower mortality in women. These differences raise the possibility for gender-specific guidelines for early diagnosis and treatment. Summer and colleagues aimed to describe the clinical course of schizophrenia in both genders. <Read More>
COVID-19 and the Impact on Oral Oncolytics: A Specialty Pharmacy Perspective – August 26, 2020 – The prevalence of individuals living with cancer continues to rise, largely because of an aging and growing population along with advances in oncology care. More than 16.9 million US individuals with a history of cancer were alive on January 1, 2019. On January 21, 2020, the United States reported its first case of coronavirus disease 2019 (COVID-19). Especially hard hit were patients with cancer who depended on regular visits to their cancer centers for infusions, follow-up care, procedures, radiation, and other forms of oncology care. The increasing prevalence of oral oncolytics use, further accelerated by COVID-19, heightens the need for strong patient-pharmacist treatment coordination, especially as drug pipelines and patient preferences move away from intravenous (IV) drugs. <Read More>
FDA Issues EUA for Convalescent Plasma as Potential COVID-19 Treatment – August 26, 2020 – The FDA issued an emergency use authorization (EUA) for the investigational use of convalescent plasma for treatment of COVID-19 in hospitalized patients. Despite encouraging early results, however, infectious disease specialists said more study in controlled trials is needed to ensure its effectiveness and to determine when this treatment should be given, which patients should receive it, the amount of antibodies the plasma should contain, and how long the immune response lasts. <Read More>
COVID-19 Underscores the Need for Digital Quality Measurement – August 26, 2020 – As science races to address COVID-19, among the weaknesses highlighted by the pandemic is our inability to rapidly develop clinical guidelines, related decision supports, and quality measures to assess their implementation. Building such a learning measurement system requires the ability to retrieve data from an array of electronic sources, including electronic health records (EHRs), health information exchanges (HIEs), and registries. The electronic ecosystem to do this also allows computable evidence synthesis to gather syndromic surveillance data in future pandemics and employ artificial intelligence and other tools to assess trends and treatment efficacy in near real time. <Read More>
NCCN Adds Tafasitamab-cxix in Combination with Lenalidomide to B-Cell Lymphoma Guidelines – August 26, 2020 – The National Comprehensive Cancer Network (NCCN) has added tafasitamab-cxix (MonjuviTM) to the Clinical Practice Guidelines in Oncology for B-cell Lymphomas, according to MorphoSys and Incyte, the co-developers of the agent. Specifically, the updated guidelines now include tafasitamab-cxix in combination with lenalidomide with a category 2A designation as an option for the treatment of previously-treated adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma who are ineligible for autologous stem cell transplant (ASCT). <Read More>
Metabolic Syndrome Linked to Increased Risk of COVID-19 Mortality – August 26, 2020 – Patients with a combination of high blood pressure, obesity, and diabetes who are hospitalized with coronavirus disease 2019 (COVID-19) may be more likely to die from the disease, according to a new study. Results from the study, published in Diabetes Care, showed that metabolic syndrome was linked to worse outcomes from COVID-19. Individuals with metabolic syndrome were over 3 times more likely to die, according to the findings. <Read More>
FDA may Fine Drugmakers, Universities $10K for Failing to Report Clinical Trial Results – August 25, 2020 – The FDA has released final guidelines for penalizing companies and universities that fail to report clinical trial results. According to the guidance, clinical trial sponsors that don’t provide required information to ClinicalTrials.gov may face a $10,000 fine for each infraction. The move comes after transparency advocates have pushed the FDA to encourage greater transparency about clinical trials. Researchers have argued that without access to specific data, trial results can’t be easily replicated, which hinders the understanding of how medications might work and can lead to adverse treatment decisions and higher healthcare costs, STAT reported. <Read More>
Clinical Practice Guidelines for Bladder Cancer: A Systematic Review and Meta-Analysis Using the AGREE II Instrument – August 25, 2020 – Numerous health care organizations have established guidelines on diagnosis and treatment of bladder cancer. However, the lack of a standardized guideline development approach results in considerable differences of the guidelines’ methodological quality. To assess the methodological quality of all relevant clinical practice guidelines (CPGs) for urinary bladder cancer and provide a reference for clinicians in choosing guidelines of high methodological quality. A systematic literature search was conducted in Medline via PubMed, 4 CPG databases, and 7 databases of interdisciplinary organizations. <Read More>
ACIP Updates Vaccine Recommendations for 2020: What Pharmacists Need to Know – August 25, 2020 – The Advisory Committee on Immunization Practices (ACIP) is a branch of the CDC that comprises medical and public health experts who develop recommendations related to use of vaccines…ACIP meetings traditionally have been held at the CDC headquarters in Atlanta, Georgia, but the June 2020 meeting was the first to be held virtually…At the June 2020 meeting, the agenda included discussions of the meningococcal vaccine, influenza vaccine, and coronavirus disease 2019 (COVID- 19). The recommendations made during this meeting are discussed next. <Read More>
Pharmacy Groups Express Concern About Mail Delays, Which Could Impact Medication Supply for 1 in 4 Americans Over 50 – August 25, 2020 – As many patients have turned to mail-order pharmacies during the coronavirus disease 2019 (COVID-19) pandemic, several pharmacy organizations have released statements expressing concern about potential mail delays and how they could affect patients. Not only would a delay in medication deliveries limit the ability of patients to manage their health care needs, but a statement from Pharmacists for Healthier Lives said running out of lifesaving medications could threaten patients’ lives. “Specifically, a reduction of mail service can delay delivery of vital prescription drugs, and this may put patients’ lives at risk,” the group said in a press release. “According to the National Association of Letter Carriers, the [United States Postal Service] shipped 1.2 billion prescriptions in 2019. This accounted for 20% of all prescriptions filled in the US last year. And this was before a pandemic that required people with pre-existing conditions to avoid leaving their homes.” <Read More>
Cleveland Clinic Provides Blood Management Strategy Innovation during COVID-19 – August 25, 2020 – It goes without saying that the ongoing coronavirus 2019 (COVID-19) pandemic has taken a great toll on healthcare systems and services around the US. While social distancing measures have remained in place, a shortage of blood supply products has pushed healthcare providers to respond, innovate, and strategize so that they can meet the needs of patients while keeping safe both caregivers and patients. In a recent article published by Deborah Tolich, DNP, MSN, RN, and colleagues at the Cleveland Clinic, they describe strategies implemented in the face of blood supply chain disruptions and donations due to the pandemic. <Read More>
340B in the News
The Hospital Industry is in a Financial Mess: We Have a Unique Opportunity to Fix it – August 27, 2020 – Since the declaration of COVID-19 as a pandemic in early March 2020, there has been a deluge of articles describing its horrible effects on hospital finances. In this post, I review the state of reporting about the pandemic’s effects on hospital finances, highlight shortcomings of the federal response thus far, and present a path to greater preparedness, equity, and competition in hospital markets…As part of this plan, lawmakers should consider expanding the scope of the Federal Trade Commission’s surveillance to include regional monopolies and acquisition of physician practices. The plan to create a more competitive hospital system should extend beyond antitrust issues to include changes in other federal policies that have contributed to hospital consolidation, such as laws permitting large nonprofit hospital corporations to shield billions of dollars from taxation and the 340B drug pricing program, which incentivizes hospital purchases of private physician practices. <Read More>
COA Statement on Ongoing Drug Price Negotiations Between White House and Pharmaceutical Manufacturers – August 27, 2020 – The Community Oncology Alliance (COA) is extremely concerned by news reports about ongoing drug price negotiations between the White House and pharmaceutical manufacturers proposing solutions that would upend the nation’s cancer care system in the middle of a global pandemic. Playing election politics with a fragile cancer care system as the COVID-19 (novel coronavirus) crisis is nowhere near over is simply dangerous and puts some of the most vulnerable Americans at risk…COA has been supportive of some of the drug price solutions put forth by the Administration and Congress, including efforts to fix the broken 340B Drug Pricing Program and the corrupted world of pharmacy benefit managers (PBMs) driving up drug costs with rebates. <Read More>
AHA Slams Big Pharma Over Efforts to Limit 340B Drug Discounts – August 27, 2020 – August 27, 2020 – The American Hospital Association (AHA) is demanding that five major pharmaceutical companies cease new efforts to curtail 340B drug discounts. In the past couple of weeks, Merck, Eli Lilly, Sanofi, Novartis, and AstraZeneca have all notified hospitals that they will no longer provide discounts to hospitals in the 340B program if they do not abide by new requirements set by each company. AstraZeneca, for example, announced earlier this month that, starting October 1, 2020, it would cease distribution of 340B drugs to contract pharmacies if hospitals already had their own in-house pharmacy. Hospitals without an in-house pharmacy would also see their 340B drug shipments decrease. <Read More>
Seven Hospital Groups Urge HHS to Enforce 340B Drug-Pricing Rules – August 27, 2020 – Seven national hospital and pharmacy groups sent a letter to HHS Secretary Alex Azar Aug. 26 urging him to ensure drugmakers follow the rules laid out under the 340B drug-pricing program. Created in 1992, the 340B program requires drugmakers to offer discounts on all outpatient drugs to hospitals and clinics that serve indigent populations. About 2,500 hospitals around the country participate in the program. Since Late June, Merck, Sanofi, Eli Lilly, Novartis and AstraZeneca have all told 340B hospitals that they may withhold 340B discounts for various reasons. AstraZeneca and Eli Lilly said they’d withhold the discounts for some or all of their drugs if they are dispensed by community-based pharmacies. Merck, Novartis and Sanofi have said they will withhold discounts if they don’t receive claims data for all commercially insured, Medicaid, and Medicare Part D patients filling prescriptions in a 340B contract pharmacy. <Read More>
Drugmakers Getting Bolder in Fight Over 340B Drug Discounts – August 26, 2020 – Drugmakers are getting bolder in their bid to restrict access to drugs discounted under the 340B program as legal experts say a lack of enforcement has created a regulatory void. Hospitals are imploring the Department of Health and Human Services (HHS) to clamp down on several moves by drug companies, including Novartis and AstraZeneca, to limit distribution of certain 340B drugs. But experts say an administration-wide change in what agencies can enforce is likely behind drugmakers’ aggressive moves. “It is an outrage that these actions are being taken at a time when hospitals are in the midst of their response to the COVID-19 public health emergency, which has further demonstrated the fractured, inadequate state of the prescription drug supply chain,” the American Hospital Association said in a release last week. <Read More>