Clinical Insights: July 28, 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

    TecartusTM (brexucabtagene autoleucel) – New Drug Approval – July 24, 2020 – Kite, a Gilead Company announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). <Read More>

    Breztri AerosphereTM (budesonide/glycopyrrolate/formoterol fumarate) Metered Dose Inhalation – New Drug Approval – July 23, 2020 – AstraZeneca’s Breztri AerosphereTM (budesonide/glycopyrrolate/formoterol fumarate) has been approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The approval by the US Food and Drug Administration (FDA) was based on positive results from the Phase III ETHOS trial in which Breztri AerosphereTM, a triple-combination therapy, showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere® (glycopyrrolate/formoterol fumarate) and PT009 (budesonide/formoterol fumarate). The approval was also supported by efficacy and safety data from the Phase III KRONOS trial. <Read More>

    XywavTM (calcium, magnesium, potassium, and sodium oxybates) Oral Solution – New Drug Approval – July 22, 2020 – Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) approved Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution on July 21, 2020 for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. XywavTM is an oxybate product with a unique composition of cations resulting in 92 percent less sodium – or approximately 1,000 to 1,500 mg/night – than sodium oxybate at the recommended dosage range of 6 to 9 grams. <Read More>

     Wynzora® (calcipotriene and betamethasone dipropionate) Cream – New Drug Approval – July 22, 2020 – MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard of topical therapies for chronic inflammatory conditions, announced that the U.S. Food and Drug Administration (FDA) has approved Wynzora® Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older. <Read More>

    New Formulation Approval

    No new update.

    New Indication Approval

    Tremfya® (guselkumab) – New Expanded Indication – July 14, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya® (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation. Tremfya® is the first treatment approved for active PsA that selectively inhibits interleukin (IL)-23, a naturally occurring cytokine that is involved in normal inflammatory and immune responses associated with the symptoms of PsA. <Read More>

    New Drug Shortage

    July 24, 2020 

    July 23, 2020

    New Drug Recall and Safety Alerts

    Dexmedetomidine Hydrochloride Injection by Fresenius Kabi – New Drug Recall – July 22, 2020 – Fresenius Kabi USA is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to the possibility of a trace amount of lidocaine present in these two lots and our investigation indicates that this issue is limited to these two product lots. This recall is being performed to the user level. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Ensuring Patient Access to Oncology Care During the COVID-19 Pandemic – July 27, 2020 – Experts Ali McBride, PharmD, MS, BCOP, FASHP, FAzPA, clinical coordinator at the University of Arizona Cancer Center, and Bhavesh Shah, RPh, BCOP, senior director of specialty, hematology, and oncology pharmacy at Boston Medical Center Health System (BMCHS), sat down in a Pharmacy Times webinar to discuss ongoing challenges for oncology patients and providers during the coronavirus disease 2019 (COVID-19) pandemic. <Read More>

    Outcomes Better for PAH Patients Treated at Specialty Centers, Study Finds – July 27, 2020 – People with pulmonary arterial hypertension (PAH) who are treated at specialty care centers have better survival chances and a lower likelihood of hospitalization, a study reports. These findings support referring PAH patients to specialty care centers for treatment, where factors like more careful disease monitoring might be decisive. The study, “Outcomes of Pulmonary Arterial Hypertension Are Improved in a Specialty Care Center,” was published in the journal Chest. <Read More> 

    Study Calls for Reassessment of Childhood Cancer Care Delivery In Light of COVID-19 Pandemic – July 27, 2020 – A study of the impact of the coronavirus disease 2019 (COVID-19) on childhood cancer, published in Cancer, found that the methods by which childhood cancer treatment delivery are approached during crises need to be reassessed, as treatment interruptions and delays are anticipated to affect patient outcomes in those otherwise largely curable disease settings. Moving forward, the researchers indicated that continued collaborative efforts are needed to better understand the direct and indirect impact of COVID-19. <Read More> 

    A Popular Heartburn Medicine Doesn’t Work as a COVID-19 Antiviral – July 27, 2020 – An over-the-counter heartburn remedy probably won’t directly stop coronavirus infections, a new study suggests. Anecdotal reports from China suggested people hospitalized with COVID-19 who were taking famotidine (sold under the brand name Pepcid) had better outcomes than people who took a different type of antacid called a proton pump inhibitor. But famotidine has no direct antiviral activity against SARS-CoV-2, the virus that causes COVID-19, according to preliminary results reported July 15 at…“We’re not challenging that famotidine might help,” he says. “We’re saying that the mechanism of action is not antiviral.” <Read More> 

    NICE Publishes New COVID-19 Rapid Guideline on Arranging Planned Care in Hospitals and Diagnostic Services – July 27, 2020 – The latest in its series of COVID-19 rapid guidelines, the guideline makes recommendations about how these services should be organised in order to balance the risks associated with COVID-19 with the potential harms that can arise from delays in elective treatment and diagnostic procedures. It promotes a flexible approach based on individual circumstances and the type of procedure and aims to support the prompt recovery of elective care, while advocating shared decision-making, balancing the risks and benefits. <Read More> 

    AACE Releases Updated Guideline On Osteoporosis Treatment – July 27, 2020 – The American Association of Clinical Endocrinologists (AACE) has released updated practice guidelines for the diagnosis and management of postmenopausal osteoporosis. They are meant to reduce the risk of osteoporosis-related fractures and thereby maintaining the quality of life for people with osteoporosis. The intent is to provide evidence-based information about the diagnosis, evaluation, and treatment of postmenopausal osteoporosis for endocrinologists, physicians in general, regulatory bodies, health-related organizations, and interested laypersons. <Read More> 

    Systemic Therapy Options for Treating HR+/HER2– Metastatic Breast Cancer – July 27, 2020 – An estimated 276,480 women in the United States will be diagnosed with invasive breast cancer in 2020. Approximately 42,170 women are expected to die from breast cancer in 2020. The average 5-year survival rate for patients with breast cancer is 90%, regardless of stage. However, the 5-year survival rate for patients with metastatic breast cancer is only 28%. The median age at the time of initial breast cancer diagnosis is 62 years. Following initial breast cancer diagnosis by mammography, MRI, or ultrasound, treatment is largely based upon the histologic subtype and staging of the tumor(s). <Read More>

    Updated Guideline for Vascular Access in Dialysis Patients – July 27, 2020 – The National Kidney Foundation has released an update to its Kidney Disease Outcomes Quality Initiative (KDOQI) clinical practice guidelines for vascular access in patients with chronic kidney disease (CKD) and end-stage kidney disease (ESKD). Published in the American Journal of Kidney Diseases and available for free online at, the guidelines provide a completely revamped set of 26 individual recommendations that focus on dialysis access choices and management. They are tailored to individual patient’s goals and access needs, with the objective of enhancing clinical outcomes. <Read More> 

    FDA Warns: Some Hand Sanitizers Contain Toxic Methanol – July 27, 2020 – The FDA has seen a sharp increase in hand sanitizer products that are labeled as containing ethanol but that have tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested. Methanol is not an acceptable active ingredient for hand sanitizers and must not be used due to its toxic effects, the agency said. <Read More> 

    Opinion: The Future of Pharmacy Care Services, Post-Pandemic – July 27, 2020 – Pharmacy care has always played a critical role in supporting patients’ access to needed services and overall health. At the onset of the COVID-19 pandemic, pharmacies’ ability to proactively engage and monitor patients became even more important as we saw a significant drop in the number of prescriptions filled, an increase in provider and pharmacy access challenges, and a greater need to monitor and protect high-demand medications. As restrictions are lifted across the country, I anticipate many pharmacy care services that evolved to meet market needs brought on by COVID-19 will continue. Digital platforms, home care services, prescription home deliveries and behavioral health support tools have helped pharmacies provide more affordable, higher quality, more efficient care. <Read More> 

    Tocilizumab Increases Risk Of GI Perforation In Rheumatoid Arthritis: BMJ – July 26, 2020 – Tocilizumab treatment versus TNF inhibitors in patients with rheumatoid arthritis (RA) doubles the risk of gastrointestinal perforations, suggests a recent study published in the BMJ journal RMD Open. Compared to patients who do not have RA, RA patients are known to be at increased risk of gastrointestinal (GI) complications. Of these, GI perforations are rare but potentially lethal. It is however not clear whether these perforations are caused by inflammation or other RA processes, or rather by RA treatments. <Read More>

    Study Introduces New Guidelines for Diagnosing Acute Aortic Syndrome – July 26, 2020 – A new study has recently outlined new guidelines aimed at helping clinicians identify the difficult-to-diagnose acute aortic syndrome. The study has been recently published in the Canadian Medical Association Journal (CMAJ). Acute aortic syndrome (AAS) is a life-threatening condition that underlies one in 2,000 visits to the emergency department for severe chest or back pain. The rate of misdiagnosis is estimated to be as high as 38 per cent and the risk of death can increase 2 per cent for every hour of delay in diagnosis. <Read More>

    Responding to Influenza Vaccine Misconceptions: Counseling Points for Pharmacists in 2020 – July 25, 2020 – Pharmacists will likely encounter increased demand for the influenza vaccine during the 2020-2021 influenza season because of the widely recognized value of this preventive health measure and the anticipated continued circulation of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).1 This will contribute to an increased awareness of, and desire for, individuals to become immunized for protection, and allow providers to advocate immunization for those without contraindications to the available influenza vaccines.1,2 It is probable that the current global pandemic will result in new misperceptions and resurrect age-old questions that pharmacists should prepare to address, some of which will be explored next. The enhancement of vaccination rates in the United States may help to reduce the trajectory of illness and complications associated with influenza. <Read More> 

    Comparison Finds Rifampin Superior in Cost, Safety to Isoniazid for Latent – July 24, 2020 – For both adults and children, a 4-month rifampin regimen is safer and less expensive than a 9-month isoniazid regimen for the treatment of latent tuberculosis infection, according to a study published in the Annals of Internal Medicine. <Read More>

    CDC Appoints New Opioid Workgroup for Guideline Update – July 24, 2020 – The Centers for Disease Control and Prevention has named a diverse group of physicians, pharmacists and academics to an “Opioid Workgroup” that will advise the agency as it works on an update and possible expansion of its controversial opioid prescribing guideline. Several advisors on the 20-member workgroup also advised the agency during the 2015-2016 guideline process. Notably lacking on the new panel are any members of Physicians for Responsible Opioid Prescribing (PROP), a small but influential group of radical anti-opioid activists who played an outsized role in drafting the original guideline. <Read More> 

    Adoption Slow for New Vanco Dosing Guidelines – July 24, 2020 – A new survey found a disconnect among hospital pharmacists between their belief that new vancomycin dosing guidelines will improve patient safety and their own plans to adopt the new guidelines. Although Michael J. Rybak, PharmD, MPH, PhD, the lead author of the 2020 guidelines, told Pharmacy Practice News that he didn’t think there was a disconnect, there is concern about the costs associated with implementation. <Read More> 

    Compliance with Treatment Guidelines for Ovarian Cancer Debulking Surgery – July 24, 2020 – Deviation from treatment guidelines for women undergoing interval debulking surgery for advanced epithelial ovarian cancer resulted in a significantly lower 5-year overall survival (OS) compared with results in those who remained treatment compliant, according to a study in the journal Cancer Reports. “One of the primary treatment strategies for advanced epithelial ovarian cancers includes neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS) and adjuvant chemotherapy,” wrote the authors from Tata Memorial Hospital in Mumbai, India. <Read More>

     Six Pharmacy Leaders Discuss How the Pandemic Has Affected Medication Adherence – July 24, 2020 – The pandemic has disrupted many of our daily processes and routines, which means many people’s adherence to their medication regimens may be thrown off. Here, six pharmacy leaders discuss how the pandemic has affected medication adherence and what their health systems are doing to make sure their patients can stay healthy. <Read More> 

    Interprofessional Communication Activities Enable Collaboration Between Pharmacy, Nurse Practitioner Students – July 24, 2020 – With interprofessional communication being a major goal of pharmacy school curriculum, implementing a communication activity between students in pharmacy programs and in doctorate nurse practitioner (DNP) programs can encourage student growth while preparing them for future interprofessional work…A well-designed activity fulfills elements from the 2016 standards from the Accreditation Council for Pharmacy Education (ACPE) as well as the Center for the Advancement of Pharmaceutical Education (CAPE) standards and meets requirements from the Core Entrustable Professional Activities (CEPA). <Read More>

    An Update on the WHO and ACIP 2020-2021 Influenza Vaccine Recommendations – July 24, 2020 – According to the CDC, between 39 million and 56 million cases of influenza occurred in the United States during the 2019-2020 influenza season, leading to 26 million medical visits, 740,000 hospitalizations, and 62,000 deaths.1 To combat this deadly disease, widespread vaccination efforts by health care providers must be combined with a targeted and effective annual influenza vaccine. The specific viruses used to create the annual vaccine are different each year and are selected from among those expected to be the most problematic during the upcoming influenza season. The World Health Organization (WHO) provides guidance on the development and production of influenza vaccines to national regulatory bodies and vaccine manufacturers in each country. <Read More> 

    Pharmacists Can Help Fight Obesity – July 24, 2020 – Obesity has been, and continues to be, on the rise in America. Adolescents, adults, and children have all shown substantial increases in weight gain since the 1960s. In 1960, the adult obesity rate in the United States was about 14%, and severe obesity was found in less than 5% of adults. The 1980s saw a large spike in the obesity rate, presumably because of the abundance of processed foods and more Americans eating outside the home. Rates have continued to increase. In 2018, the obesity rate was 42.4% and severe obesity was 9.2%…Pharmacists can make a significant impact in counseling patients about obesity. From making simple recommendations such as those mentioned to having patients come to the pharmacy and check in once a week, pharmacists can be very influential. <Read More> 

    New Osteoporosis Recommendations From AACE Help Therapy Selection – July 23, 2020 – Recommendations on use of the new dual-action anabolic agent romosozumab (Evenity, Amgen) and how to safely transition between osteoporosis agents are two of the issues addressed in the latest clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis from the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE). <Read More> 

    ACR: Patients Can Restart Rheumatic Treatments 7-14 Days After COVID-19 Symptoms Resolve – July 23, 2020 – Patients with uncomplicated COVID-19 infections may consider restarting rheumatic disease treatments within 7 to 14 days of symptom resolution, according to updated guidelines from the American College of Rheumatology. On July 23, the ACR issued two additions to its previously released “COVID-19 Clinical Guidance for Adult Patients with Rheumatic Diseases.” The updates focus on treatment after COVID-19 infection. <Read More> 

    Updated Guidelines on Surgery for Crohn’s Disease – July 23, 2020 – Although rates of surgery for Crohn’s disease have decreased over the years, many patients still require surgical treatment – due to inadequate responses to medical therapy, severe attacks of acute colitis, and many other situations. Reflecting the latest research evidence and clinical practice, an updated set of recommendations for surgery in patients with Crohn’s disease have been published in Diseases of the Colon & Rectum (DC&R), the official journal of the American Society of Colon and Rectal Surgeons (ASCRS). The journal is published by Wolters Kluwer. <Read More> 

    The Pharmacist’s Role in COVID-19 Response Efforts – July 23, 2020 – As the COVID-19 pandemic continues, response efforts in the US continue to put pressure on health care organizations and resources. Direct patient care by pharmacists has been shown to potentially improve various patient outcomes during a public health emergency. In recognition of the role pharmacists can play during a pandemic, the administration recently issued guidance that permits pharmacists to order and administer COVID-19 tests, possibly preempting conflicting state laws. While the administration is also taking measures to expedite the manufacturing and distribution of a COVID-19 vaccine through Operation Warp Speed, pharmacy stakeholders are encouraging the administration to allow pharmacies to be included in the vaccine distribution plan. <Read More>

    More Pharmacy Covid Testing Backed by White House, Republicans – July 23, 2020 – Pharmacists pushing to get paid by Medicare for Covid-19 testing have gained key congressional allies but say they face opposition from the country’s top doctors lobby. Congressional leaders and the White House support altering Medicare rules to allow reimbursements for pharmacists who administer Covid-19 tests and a potential future vaccine, Rep. Buddy Carter (R-Ga.), the lead sponsor of the change, said Wednesday. Changing Medicare’s rules about who gets paid for delivering a Covid test would make it easier for people to get them, he said. “We all understand that to roll out our economy and get our people back into public and to work it’s going to include robust testing,” Carter, a pharmacist who started his own independent pharmacy in south Georgia, said. <Read More> 

    Best Practices for Monitoring Hazardous Drug Surface Contamination – July 23, 2020 – Occupational exposure to hazardous chemicals affects an estimated 13 million workers in the United States, with upwards of 8 million US health care personnel in clinical and nonclinical roles potentially exposed to hazardous drugs (HDs). The characteristics of HDs, along with adverse health effects from workplace exposure, are well described in the literature…This paper summarizes best practices related to monitoring workplace surface contamination, with a focus on surface wipe sampling for HDs. An upcoming 2020 consensus conference that plans to provide more detailed guidance for HD surface contamination monitoring also is introduced. A publication summarizing recommendations from this conference is planned for early 2021. <Read More> 

    Managing the Challenges of Long-Term Care Pharmacies for At-Home Patients – July 23, 2020 – Although the coronavirus disease 2019 (COVID-19) pandemic has caused a sharp increase in at-home care, long-term care (LTC) pharmacies caring for this population face a myriad of unique obstacles, especially the regulatory framework surrounding them. Although LTC pharmacies traditionally serve patients in assisted living, skilled nursing facilities, and group homes, the industry has seen a major shift to at-home care in recent years, pushed forward by the safety concerns of the COVID-19 pandemic. John W. Jones, JD, partner and chair of the health care transactions and regulatory practices of the health sciences department at Troutman Pepper, said that although he believes these inpatient facilities will always exist, he also thinks the trend of at-home care will continue. “I think the goal is ultimately to care for these patients in the home more and more, and less in an institutional setting,” he said in an interview with Pharmacy Times®. <Read More> 

    Community Pharmacist Group Urges White House to Drop Medicare ‘Secretive Rebate Game’ – July 23, 2020 – Douglas Hoey, CEO of the National Community Pharmacists Association, wrote a letter July 22 urging President Donald Trump’s administration to eliminate direct and indirect remuneration fees that affect the prescription drug costs of Medicare Part D plans. DIR fees refer to the money pharmacy benefit managers collect to offset Medicare Part D member costs. These fees increased by 45,000 percent between 2010-17, according to CMS Mr. Hoey’s letter argues that DIR fees increase prescription drug costs and force some community pharmacists to shut down their pharmacies, leaving many seniors without access to their medication. <Read More> 

    Pharmacist Management of Alpelisib-Associated Hyperglycemia – July 23, 2020 – Approximately 70% of invasive breast cancers diagnoses are for disease that is hormone receptor (HR)-positive and HER2-negative…Alpelisib is an oral agent that inhibits PI3Kɑ, providing its antitumor effects. When studied in vitro, alpelisib had significant activity against PI3Kɑ mutant cells…Pharmacists can also play a key role in toxicity management by providing recommendations for self-treatment or alternative therapies, or by referring patients to specialists. In the case of alpelisib-induced hyperglycemia, an ambulatory care pharmacist trained in diabetes management can help in the selection of antihyperglycemia treatment. Pharmacists who are certified diabetes care and education specialists can provide counseling on the pathophysiology of diabetes and its management, beyond the discussion of medications, to include advice on lifestyle modifications. <Read More> 

    Influenza Vaccine–Type Differentiation Updates for 2020 – July 23, 2020 – Seasonal influenza is usually active from October to May and is caused by A and B strains of the influenza virus. Although specific strains of the virus circulate each season, constant genetic mutations make cross-immunity between strains nearly nonexistent. As a result, vaccination against influenza is recommended each season. However, there are many different types of influenza vaccines and many different factors that can determine which vaccine to administer to patients. By understanding how these vaccines are made, the status of the virus particles inside the vaccine, and the characteristics of the patient needing the vaccine, pharmacists can be better equipped to help select the most appropriate influenza vaccine for their patients. <Read More>

    Rising Insulin Prices Catch Policy Makers’ Attention – July 23, 2020 – Starting in January 2020, the price of insulin for diabetic patients in Colorado was capped at $100 per month. In May 2019, Colorado Governor Jared S. Polis signed House Bill 19-1216, which was sponsored by Democratic Representative Dylan Roberts, into law. The bill not only caps the price of insulin but also authorizes the state attorney general’s office to investigate the pricing and issue a report to the legislature by 2020. The investigators are specifically instructed to look into the activities and decisions of manufacturers and pharmacy benefit managers, both of whom play a large role in setting drug prices. With more than 400,000 patients with diabetes in Colorado, accounting for almost 10% of the state’s total population, the bill will positively affect many patients’ monthly health care costs. <Read More> 

    National Kidney Foundation, NCQA Announce Measure to Boost Testing in Patients With Diabetes – July 23, 2020 – Kidney disease can be disabling and deadly to patients and costly to health systems, but life-threatening complications can be avoided if the disease is caught early. Too often, that does not happen, according to the National Kidney Foundation (NKF), which estimates that 90% of those affected are unaware. That’s why NKF and the National Committee for Qualify Assurance (NCQA) have spent the past 2 years developing a new measure to assess how well health systems are doing in testing patients with diabetes for kidney disease. <Read More> 

    New Long-Term Care Pharmacy Study Highlights Unrecognized Outcomes and Cost Related to Patient Rx Interventions – July 23, 2020 – (MHA), a leading health care services and software company focused on the alternate site health care provider marketplace, is excited to announce the release of new study titled “The Value of the Long-Term Care Pharmacist in the Delivery and Continuum of Care.” Authored with input from the MHA Long-Term Care Pharmacy Advisory Board, Membership, and Business Partners, this comprehensive study marks the first collaborative effort produced to help long-term care pharmacies overcome legacy barriers and achieve formal recognition of their role, value and cost to deliver care and value for the benefit of highly vulnerable patients with complex needs, as well as PBMs, Health Plans, pharmaceutical companies and other industry stakeholders. <Read More>

    ‘Enough is Enough’: APhA CEO Calls for Pharmacy Reimbursement Overhaul – July 22, 2020 – Pharmacy reimbursements need to be totally restructured so patient care in pharmacies becomes profitable, American Pharmacists Association CEO Scott Knoer, PharmD, wrote in a July 21 blog post titled “Chaos in pharmacy reimbursement leads to patient safety issues, and enough is enough.” In the post, Dr. Knoer wrote that misaligned incentives have turned pharmacies into factories and that pharmacy benefit managers often reimburse pharmacies so low that they lose money on prescriptions, leading to pharmacy deserts and patients losing access to care. If pharmacists were to get paid for patient care, pharmacy chains would change their business model to take advantage of that, he stated. <Read More> 

    Improved Type 2 Diabetes and Cardiovascular Disease Guidelines for GPs Released – July 22, 2020 – Bitesize information to help GPs “navigate the complexities” of treating people with type 2 diabetes and other health conditions have been released. The guidance has been put together by a global team of medical experts who were led by researchers from the NIHR Applied Research Collaboration (ARC) East Midlands. The document covers several chronic health conditions that people with type 2 diabetes are prone to developing, but there is a particular focus on cardiovascular disease, the collective name for problems related to the heart and blood vessels, including coronary heart disease. <Read More>

    FIP Advocates for Expanding Pharmacists’ Roles in Immunization Globally – July 22, 2020 – The International Pharmaceutical Federation (FIP) document, “Give it a shot: Expanding immunisation coverage through pharmacists”, offers practical guidance on implementing a vaccination service and sets out the roles and technical requirements for pharmacy-based vaccines-related services. The document, provided free to pharmacists and their teams around the world, “makes the case for pharmacy-based vaccinations and presents a compilation of evidence and best practice,” FIP said in a press release. “FIP strongly believes that pharmacists should be involved in vaccination strategies in a multitude of roles everywhere around the world and has given high priority to this area for a decade,” said FIP President Dominique Jordan. <Read More> 

    Understanding Health Disparities in Pharmacy – July 22, 2020 – Health disparities in racial, ethnic, and socioeconomic populations are well documented and have a negative impact on many communities. Pharmacists and pharmacy educators are in a position to help mitigate those differences. These messages were firmly established in a presentation by Dayna Bowen Matthew, JD, PhD, during the virtual 2020 meeting of the American Association of Colleges of Pharmacy, July 13-31…The main speaker in the AACP meeting’s opening session, Matthew addressed the issue of health equality by sharing data, historical references, and personal experiences. She explained that health equality means everyone has a fair and just opportunity to be as healthy as possible, and that they are free to pursue it by the removal of social determinants. <Read More> 

    Unnecessary Care: Levothyroxine Ineffective for Heart Attack Patients with Subclinical Hypothyroidism – July 22, 2020 – Treating subclinical hypothyroidism patients with levothyroxine after an acute myocardial infarction (MI) does not improve left ventricular ejection fraction (LVEF), according to new findings published in JAMA. Any guidelines currently recommending such treatment, the authors wrote, should be reconsidered. The Thyroxine in Acute Myocardial Infarction (ThyrAMI-2) trial tracked 95 subclinical hypothyroidism patients who had experienced an MI. The mean patient age was 63.5 years old, and they were treated at six different hospitals in the U.K. While 46 patients received levothyroxine treatment for one full year, the other 49 received a placebo for the same time period. MRI scans were used to assess cardiac volumes and function. <Read More> 

    Pharmacists Can Improve Diabetes Care – July 22, 2020 – In the United States, pharmacists account for the third-largest group of health care professionals. They are exceeded in number only by physicians and nurses. About 43% of American pharmacists practice in community settings. Public health policy makers are waking up to the fact that these highly skilled professionals are often underused. One disease on which pharmacists can make a considerable impact in terms of care is diabetes, which affects 10.5% of the US population.4 What would happen if they established better relationships with patients who have diabetes and used their skills to encourage better self-management? Investigators from the United Kingdom’s National Health Service (NHS), concerned about the burden of diabetes on their health care system, have explored ways in which pharmacy teams, including pharmacists, technicians, and assistants, can provide diabetes interventions. <Read More> 

    FDA Releases Initial Guidelines for Cannabis-Derived Drugs – July 21, 2020 – The Food and Drug Administration released a draft of rules that companies should follow to develop cannabis-derived drugs – a new category that has exploded with few federal laws to govern it. The guidelines cover drugs and treatments containing cannabis oil and other compounds found in the plant, the agency said on Tuesday. They include references for calculating weights for oral dosages and online resources related to clinical trials for cannabis-derived products. <Read More> 

    NACDS Invited to Join Federal COVID-19 Vaccine Consultation Panel – July 21, 2020 – Steven C. Anderson, FASAE, CAE, IOM, president and CEO of the National Association of Chain Drug Stores, has been invited to join the office of Health and Human Services’ (HHS) new coronavirus disease 2019 (COVID-19) Vaccine Consultation Panel (VCP). The panel aims to assist HHS in developing and implementing a vaccine for COVID-19. According to a press release, the panel is made up of external leaders in various communities, all of which must collaborate to launch the vaccine. “Producing a [COVID-19] vaccine is one piece of the task, but another critical component is ensuring public understanding, acceptance, and participation in any eventual vaccine campaign,” said the invitation from HHS Secretary Alex Azar, JD, to Anderson, according to a press release. “It is on this later challenge that I and our senior leaders in HHS could use your unique insight and expertise.” <Read More>

    Protecting Cardiovascular Patients From Severe COVID-19 – July 21, 2020 – People with underlying cardiovascular disease (CVD) are particularly susceptible to cardiovascular complications and mortality due to COVID-19. Managing these challenges requires particular attention and expertise, according to a perspective provided during a recent webinar hosted by the National Foundation for Infectious Diseases. “We have learned that the COVID-19 infection has multiple implications for patients with cardiovascular disease,” said Thomas M. Maddox, MD, the chair of the American College of Cardiology (ACC) Science and Quality Committee. <Read More> 

    Easy Reading: Direct and Indirect Remuneration Fees – July 21, 2020 – Direct and indirect remuneration fees (DIR) refers to compensation received by Medicare Part D sponsors or their pharmacy benefit manager (PBM) after the point-of-sale. Although initially related only to Medicare Part D, they have crept their way into commercial plans as well. DIR fees were introduced by CMS when Medicare Part D was implemented. Plans/PBMs are required to report the DIR fees to CMS on an annual basis. CMS proposed the reports would capture rebates from pharmaceutical manufactures to PBMs that were being provided for formulary positioning and other remuneration. The fees were intended to provide an incentive to pharmacies by offering discounts, rebates, coupons, up-front payments, or any other price concessions. Lately though, they are being scrutinized for their ambiguity and year over year increases. <Read More> 

    Stepping-Down Asthma Medication May Reduce Costs Without Worsening Health Out – July 21, 2020 – International guidelines for asthma treatment recommend clinicians find the minimum effective dose that can control symptoms, yet asthma patients are increasingly prescribed high doses of medication. A study published in PLOS Medicine by Dr. Chloe Bloom at Imperial College London, United Kingdom and colleagues found that stepping-down medication doses did not increase asthma exacerbations and could significantly reduce medication costs. <Read More> 

    Developing a Framework for Delivery of Medication Therapy Management in a Specialty Pharmacy – July 21, 2020 – More than 1.5 million preventable medication adverse events happen each year in the United States, accounting for a cost of $177 million due to mortalities and morbidities. Delivery of safe, patient-centered, and efficient care requires collaboration between patients and diverse care providers. Pharmacists are central health care professionals in medication therapy management (MTM) and play a crucial role in improving life quality outcomes among patients by engaging in MTM and specialty pharmacy practices…MTM fits into the specialty pharmacy since pharmacists offer comprehensive information to patients after consultation with multiple care providers. Therefore, pharmacists become part of the overall care delivery program, focusing on assessing and evaluating the patient’s complete medication regimen instead of an individual medication product. <Read More> 

    NCCN Releases CAR-T Cell Guidelines for Patients with Cancer – July 21, 2020 – The National Comprehensive Cancer Network (NCCN) recently released new guidelines to try and aid patients with cancer in understanding CAR-T cell therapy and its accompanying side effects. The guidelines are intended to help patients answer any questions they may have about CAR-T cells, and also give patients an idea of what to anticipate if their physician recommends CAR-T cell therapy. <Read More>

     Full Dexamethasone Study Released, Shows Fewer Deaths For Ventilated COVID-19 Patients – July 21, 2020 – A full study testing dexamethasone — a cheap, widely available steroid — as a treatment for COVID-19 found that the drug reduced mortality rates among patients on ventilators or who were receiving oxygen, but not in patients receiving no respiratory support. The study was released by the RECOVERY group, in partnership with the University of Oxford in England. The groups put out a news release in June touting the results of the clinical trial, but full results of the trial weren’t published until July 17. Some scientists have called dexamethasone a major breakthrough in COVID-19 treatment, as it is the first drug that has been shown to improve survival rates. Gilead’s remdesivir shortened recovery time, but didn’t reduce mortality rates. <Read More> 

    Chaos in Pharmacy Reimbursement Leads to Patient Safety Issues, and Enough is Enough – July 21, 2020 – News broke last week that the Oklahoma State Board of Pharmacy (OSBP) had fined four CVS pharmacies in the state for poor staffing and medication errors. This is a positive development for both the well-being of pharmacists and technicians and the prioritization of patient safety. But it’s going to take much more than a fine to keep patients safe. The actual sum of the fine—$125,000—is a drop in the bucket for a massive conglomerate like CVS Health. What’s significant is that the OSBP sanction validates the outcry of pharmacists and technicians that understaffing, lack of breaks, and volume metrics make medication errors more likely to occur. Raised awareness, however, is far from the solution to the problem. We need a total restructuring of pharmacy payment mechanisms. <Read More>

    340B in the News

    Trump Administration Releases Series of Executive Orders on Drug Pricing – July 25, 2020 – The Trump Administration issued a series of Executive Orders (“EOs” or “Orders”) Friday afternoon related to drug pricing.  Several of the EOs seek to restart stalled or withdrawn policy initiatives previously announced by the Administration…The Executive Order on Access to Affordable Life-saving Medications applies exclusively to FQHCs participating in the 340B drug discount program, and mandates that HHS condition future federal grants to FQHCs on the requirement that FQHCs provide insulin and injectable epinephrine to certain low-income individuals at the FQHCs’ 340B acquisition cost for the drug, plus a minimal administrative fee. While the ostensible purpose of the EO is to pass the FQHC’s 340B savings through to low-income patients, FQHCs are already required by statute and regulation to provide steeply discounted and free services to low-income individuals. <Read More>

    Trump’s Executive Orders On Drug Pricing Contain Caveats And Limitations – July 25, 2020 – On Friday, July 24th, President Trump issued four executive orders on prescription drug pricing. The executive orders are designed to, in the president’s words “completely restructure the prescription drug market”… A third executive order requires federally qualified community health centers – clinics that deliver care to low-income patients – to pass through 340B program discounts for insulin to diabetics and epinephrine auto-injectors for severe allergy sufferers. Though narrow in scope in terms of the numbers of products impacted this executive order does tangentially address a widespread concern about the 340B program. <Read More> 

    COA Statement on White House Executive Orders to Lower Drug Prices – July 24, 2020 – The Community Oncology Alliance (COA) supports aspects of the Trump Administration’s efforts announced to lower drug prices and the overall costs of health care for all Americans, while reserving judgement on other parts of the President’s plan…COA believes that the Executive Order passing discounts on insulin directly to patients is an important first step in fixing what is a completely broken 340B Drug Pricing Program. What was once a program intended to help patients in need receive drug cost assistance from a small number of safety net providers has grossly mutated into one where discounts and profits benefit large, corporate hospitals. Worse yet, PBMs have now gotten into the 340B game as contract pharmacies, realizing that 340B allows them to virtually print money off the backs of patients in need. <Read More>

    No discounts for Cialis? Drug sparks spat between 340B Coalition and Eli Lilly – July 24, 2020 – Major drug makers Eli Lilly and Merck are going to war with 340B contract pharmacies by installing new requirements and in some cases refusing to provide their products. The advocacy group 340B Coalition, a group of healthcare advocates and providers, wrote to the Department of Health and Human Services last week objecting to several moves made by manufacturers Eli Lilly and Merck. The group was furious Lilly declined to provide a discount for three formulations of the erectile dysfunction drug Cialis if the product is sent to a contract pharmacy, and that Merck wants pharmacies to provide claims data. <Read More> 

    HRSA Announces New Registration and Recertification Requirements for 340B Program – July 22, 2020 – The Office of Pharmacy Affairs (OPA) of the Health Resources and Services Administration (HRSA) recently issued a new Program Update that includes new covered entity registration and recertification requirements, as well as enhancements to the 340B Office of Pharmacy Affairs Information System (OPAIS). HRSA may be implementing these new registration requirements in order to identify and potentially take action against covered entities that HRSA believes do not qualify under a 340B covered entity category and to provide additional information to states and drug manufacturers necessary to identify and recoup duplicate discounts. <Read More>

    Bipartisan Group of Senators Introduces Legislation to Waive 340B Eligibility Requirements Due to COVID-19 – July 21, 2020 – On July 2, a bipartisan group of six senators introduced legislation to waive 340B eligibility requirements for hospitals participating in the program during the COVID-19 pandemic. S. 4160 permits hospitals that are 340B-eligible based on their disproportionate share (“DSH”) adjustment percentage to maintain eligibility even if their DSH adjustment percentage falls below the requisite threshold. <Read More>

    340B Update: HRSA Indicates It Lacks Authority to Enforce 340B Program Guidance – July 21, 2020 – The Health Resources and Services Administration (HRSA) recently indicated that it lacks authority to enforce 340B Drug Pricing Program (340B Program) guidance in response to Eli Lilly and Co.’s notice to 340B covered entities that contract pharmacies will no longer be eligible to receive formulations of its erectile dysfunction drug Cialis at 340B prices. Eli Lilly’s notice challenges HRSA’s longstanding interpretation of the 340B statute in its contract pharmacy guidance that has allowed contract pharmacies to access drugs at 340B prices, effectively inviting HRSA to defend its contract pharmacy guidance and statutory authority in litigation. <Read More>