Clinical Insights: July 27, 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

    Bylvay™ (odevixibat) Capsules – New Drug Approval – July 20, 2021 – Albireo Pharma, Inc., a rare liver disease company developing novel bile acid modulators, announced the U.S. Food & Drug Administration (FDA) approval of Bylvay™ (odevixibat), the first drug approved for the treatment of pruritus in all subtypes of progressive familial intrahepatic cholestasis (PFIC). Bylvay™ is a potent, non-systemic ileal bile acid transport inhibitor (IBATi), which does not require refrigeration and is easily administered as a once-daily capsule or opened and sprinkled onto soft foods. Albireo is launching Bylvay™ immediately to accelerate availability for the patients and families impacted by PFIC. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Dalvance® (dalbavancin) Injection – New Approved Indication – July 23, 2021 – AbbVie announced that the U.S. Food and Drug Administration (FDA) approved Dalvance® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. Dalvance® is the first single-dose option administered as a 30-minute intravenous (IV) infusion for the treatment of ABSSSI caused by designated susceptible Gram-positive bacteria in pediatric patients, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA). <Read More>  

    Keytruda™ (pembrolizumab) Injection – New Approved Indication – July 22, 2021 – Merck and Eisai Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the combination of Keytruda™, Merck’s anti-PD-1 therapy, plus Lenvima™, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. The approval for this population is based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which Keytruda™ plus Lenvima™ demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 32% (HR=0.68 [95% CI, 0.56-0.84]; p=0.0001), and progression-free survival (PFS), reducing the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.50-0.72]; p<0.0001), versus chemotherapy (investigator’s choice of doxorubicin or paclitaxel). <Read More>  

    Octagam® (immune globulin intravenous (human)) Injection – New Approved Indication – July 15, 2021 – The U.S. Food and Drug Administration (FDA) has granted approval to Octapharma USA for Octagam® 10% [Immune Globulin Intravenous (Human)], the first and only intravenous immunoglobulin (IVIg) to be indicated for the treatment of adult dermatomyositis, a rare immune-mediated inflammatory disease. The FDA approval is based on the results of ProDERM, a pivotal randomized clinical trial and the first study to evaluate the long term efficacy and safety of intravenous immunoglobulin (IVIg) for adults with dermatomyositis. The prospective, double-blind, placebo-controlled Phase III clinical trial enrolled 95 patients at 36 sites globally, including 17 sites in the U.S., and is the largest study to evaluate intravenous immunoglobulin as a treatment option for dermatomyositis. <Read More>  

    New/Updated Drug Shortage

    July 23, 2021

    July 22, 2021

    July 20, 2021

    July 19, 2021

    New Drug Recall and Safety Alerts

    Chantix® (Varenicline) Tablets by Pfizer – New Voluntary Recall – July 19, 2021 – Pfizer is voluntarily recalling two lots of Chantix® 0.5mg Tablets, two lots of Chantix® 1 mg Tablets, and eight lots of a Chantix® kit of 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level. <Read More>  

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Does IV Magnesium Treatment for Asthma Lead to Hospitalization? – July 26, 2021 – Guidelines currently recommend administering intravenous magnesium sulfate for refractory pediatric asthma in the emergency department, but hospitalization rates tied to asthma have been stable. An investigation in JAMA Network Open looked at whether receiving intravenous magnesium sulfate therapy was linked to subsequent hospitalization. Investigators performed a post hoc secondary analysis of a double-blind randomized clinical trial of children who had acute asthma and were treated from September 2011 to November 2019 in 7 Canadian tertiary care pediatric emergency departments. <Read More>

    How Tech-Driven Hubs in Specialty Pharmacy Can Improve the Patient Experience – July 26, 2021 – Specialty pharmacies now have to be ready to not only meet patient demand, but also provide patients the support they need to secure reimbursement, properly administer the drug, and ensure adherence and optimal outcomes. The use of specialty drugs in the U.S. has skyrocketed in recent years driven primarily by an increase in chronic condition diagnosis and the number of new medications on the market. In fact, it’s estimated specialty medications account for 75% of the approximately 7,000 prescription drugs currently in development, and by 2022, more than 60% of the 600 drugs expected to gain FDA approval will be specialty medications. <Read More>

    Mission Creep and the CDC Opioid Guideline – July 26, 2021 – It’s been over five years since the CDC released its opioid prescribing guideline for chronic pain. Now that the agency is looking at possible revisions, it’s worth taking a close look at what research is showing about the effects of the guideline. First, let’s revisit the goals of the 2016 guideline:  1) “This guideline provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care. 2) This guideline is intended to improve communication between clinicians and patients about the risks and benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy, including opioid use disorder, overdose, and death.” <Read More>

    Doctors, Nurses and Medical Groups Call for Mandatory Coronavirus Vaccinations for Health Workers – July 26, 2021 – Medical groups representing millions of doctors, nurses, pharmacists and other health workers on Monday called for mandatory vaccinations of all U.S. health personnel against the coronavirus, framing the move as a moral imperative as new infections mount sharply. “We call for all health care and long-term care employers to require their employees to be vaccinated against covid-19,” the American Medical Association, the American Nurses Association and 55 other groups wrote in a joint statement shared with The Washington Post. “The health and safety of U.S. workers, families, communities, and the nation depends on it.” <Read More>

    Scratch Beneath the Surface: ABSSSI – July 23, 2021 – The terms skin and skin structure infection and skin and soft tissue infection encompass a broad spectrum of diseases affecting skin and underlying subcutaneous tissue, fascia, or muscle that can range in severity from mild to life threatening. Clinical trials using this terminology leave some ambiguity in interpretation because of the use of heterogeneous, broad inclusion criteria attributed to a lack of standardized nomenclature and monitoring parameters. To provide consistency in the identification of infections for which a treatment effect can be reliably estimated, in October 2013 the FDA released a guidance document that introduced the term acute bacterial skin and skin structure infections (ABSSSI) and defined quantifiable efficacy end points. <Read More>

    CDC Updates Guidelines on Treatment of Sexually Transmitted Infections – July 23, 2021 – The Centers for Disease Control and Prevention (CDC) has updated its guidelines for the treatment of people who have or are at risk for sexually transmitted infection (STIs). Key changes were made to treatment recommendations for Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis and pelvic inflammatory disease (PID). Along with the AAP Red Book, the guidelines are a source of clinical guidance for the diagnosis, management and treatment of STIs based on current evidence. <Read More>

    Pharmacy Fact: Clinical Research into Psychedelic Medicine Flourished for Decades Before Criminalization – July 23, 2021 – Despite the current illegality of most psychedelic drugs at the federal level in the United States, the US government has not always been averse to the exploration and funding of research into the benefits of psychedelic medicine. Until 1968 when psychedelics such as psilocybin, or mushrooms, and lysergic acid diethylamide (LSD) were made illegal and classified as Schedule I drugs, the government had funded a vast quantity of the research into the potential benefit of these drugs for human health, and specifically, mental health. <Read More>

    Virtual Verification Elevates Technicians – July 23, 2021 – Now that the COVID-19 vaccines have been rolled out, keeping immunizations on track is more critical than ever, and pharmacists have been called on to administer them at warp speed. For pharmacies to stay on track with immunizations, it is important to elevate the role of pharmacy technicians, modify existing workflows, and reallocate staff time to maximize efficiency. Balancing the routine prescription volume with patient consultations and increased immunization demand requires adjustments on the part of pharmacies, but there is 1 adjustment that will have a trickle-down effect on efficiency in general. Implementing virtual verification streamlines prescription verification by taking the process “to the cloud” and removing much of the manual work typically involved with processing prescriptions. <Read More>

    Factors Important to Underrepresented Minorities When Selecting a Pharmacy School – July 23, 2021 – Factors such as diversity in students and faculty, in addition to educational programming, are crucial to underrepresented minority (URM) populations, according to a session at the American Association of Colleges of Pharmacy Virtual Pharmacy Education 2021 conference. Hope Campbell, PharmD, BCPS, associate professor of pharmacy practice at Belmont University, discussed her research on minorities and their selection of a school of pharmacy. As the pool is highly competitive, she encourages students to truly look at the main factors of the school they want to attend. Location, class size, student-to-faculty ratio, and a strong alumni network are some of the recommendations that Campbell highlighted as main points to look for in a program. <Read More>

    Stewardship Programs Can Improve ABx Use in Cancer Patients – July 22, 2021 – Because of the complexity of their cases, immunocompromised patients such as individuals with cancer often have been excluded from antimicrobial stewardship programs (ASPs) and studies. But the limited amount of research available suggests that such programs can effectively reduce antibiotic consumption and improve outcomes (Ann Pharmacother 2020;54[6]:594-610). <Read More>

    Novel Agent for HF Shows Mixed Results in Large Trial – July 22, 2021 – The novel selective cardiac myosin activator omecamtiv mecarbil reduced a composite of a heart failure (HF) event or death from cardiovascular (CV) causes among patients with HF and a reduced ejection fraction (HFrEF) in the placebo-controlled phase 3 GALACTIC-HF trial. However, there was no significant difference in the secondary outcome of death from CV causes, which led Amgen and Servier to terminate their collaboration with Cytokinetics to develop the drug. Cytokinetics still plans in the “next year or so” to file for FDA approval for the drug, which was granted fast track designation in May 2020. <Read More>

    Regulations Guiding Sterile Compounding Are Complex – July 22, 2021 – In 2013, the Drug Quality and Security Act (DQSA) was enacted in response to several cases of infections liked to contaminated steroid injections produced by New England Compounding Center in Framingham, Massachusetts, which led to at least 64 deaths and more than 700 injuries. The DQSA created requirements to increase tracking of pharmaceuticals through the supply chain process (Drug Supply Chain Security Act) and improve the quality of compounding processes through the Compounding Quality Act (CQA). The CQA gave the FDA more oversight authority over compounding pharmacies, specifically creating the 503B category of the federal Food, Drug, and Cosmetics Act (FDCA) for pharmacies to operate under established high-quality standards of current good manufacturing practices (cGMP) as outsourcing facilities. The act also reinstated section 503A of the FDCA, allowing a sterile compounding facility to operate under United States Pharmacopeia (USP) standards rather than the more rigorous cGMP under certain conditions. <Read More>

    SITC Releases Clinical Practice Guideline to Aid in the Management of Immune-Related Adverse Events from ICI Therapy – July 22, 2021 – The management of immune-related adverse events (irAEs) resulting from treatment with immune checkpoint inhibitor (ICI) monotherapy or in combination regimens was probed by an expert panel brought together by the Society for Immunotherapy of Cancer (SITC). Based on the review, SITC has published a clinical practice guideline, which provides key recommendations for managing irAEs. <Read More>    

    Investigational Antipsychotic Treatment Offers Sustained Benefits for People With Dementia-Related Psychosis – July 22, 2021 – Evidence of the sustained benefits of an investigational antipsychotic treatment for people with dementia-related psychosis has been published. Up to half of the 45 million people worldwide who are living with Alzheimer’s disease will experience psychotic episodes, a figure that is even higher in some other forms of dementia. Psychosis is linked to a faster deterioration in dementia. Despite this, there is no approved safe and effective treatment for these particularly distressing symptoms. In people with dementia, widely-used antipsychotics lead to sedation, falls and increased risk of deaths. Pimavanserin works by blocking serotonin 5HT2A receptors, and doesn’t interact with the dopamine receptors. It is licensed in the US to treat hallucinations and delusions in people with Parkinson’s disease psychosis. <Read More>  

    Reduced Medical Spending Associated With Integrated Pharmacy Benefits – July 22, 2021 – Members covered by an integrated pharmacy benefit (as opposed to a pharmacy carve-out) experienced slower growth in medical spending. Although pharmacy benefit carve-outs are promoted as a cost-containment tool, their impact on medical spending is not well understood. We compare the health care spending of Blue Cross and Blue Shield of Louisiana (BCBSLA) members covered by an integrated (“carved-in”) pharmacy benefit with that of members covered under a pharmacy benefit carve-out. <Read More>  

    Walmart Offers Unique Counseling Opportunities – July 22, 2021 – Walmart pharmacists are becoming leaders in COVID-19 vaccine administration across the country, further demonstrating their important role in medication therapy management (MTM) services through immunizations. As part of the CDC’s Federal Retail Pharmacy Program for COVID-19 Vaccination, Walmart is 1 of 21 national pharmacy partners across the United States. The company began administering COVID-19 vaccines on February 12, 2021, and now offers them at more than 1400 pharmacies in 35 states, Puerto Rico, and Washington DC. <Read More>

    A Major Ivermectin Study has Been Withdrawn, So What Now for the Controversial Drug? – July 22, 2021 – Ivermectin, an existing drug against parasites including head lice, has had a chequered history when it comes to treating COVID-19. The bulk of studies so far show there’s not enough evidence ivermectin is useful in treating or preventing COVID-19, either alone or with antibiotics or supplements. Yet interest in the drug remains, on social media, in some countries, with some doctors and with one politician in particular, Liberal MP Craig Kelly, touting its benefits. Now a large clinical trial that seemed to show positive results for ivermectin has been withdrawn. So you’d think that would be end of the ivermectin saga. But research into ivermectin is ongoing. Here’s what the evidence says so far and what we can expect next. <Read More>  

    Engaging Colleges of Pharmacy to Assist Establishing Payer-Provider Relationships – July 22, 2021 – During a presentation at the 2021 annual meeting of the American Association of Colleges of Pharmacy, the presenters broke down how best to engage colleges of pharmacy to help in establishing payer-provider relationships. Todd Sorensen, PharmD, one of the session’s presenters, emphasized the importance of these relationships and what they can accomplish. “I like to think of partnerships as creating scenarios where 1 plus 1 equals 3,” Sorensen said during the presentation. “We can accomplish more in partnership than we can individually.” <Read More>

    Can Biologics Manufacturers Face Antitrust Risk For Pointing Out That Biosimilars Are Different? – July 22, 2021 – Biologics are revolutionizing the pharmaceutical industry, and in doing so, garnering an increasing share of antitrust attention. In recent years, the FTC, FDA, and antitrust plaintiffs’ bar have raised concerns about a perceived lack of biologics competition. In particular, these groups have observed that biosimilars have not taken substantial market share from their corresponding biologics or caused significant price erosion; thus, biosimilars have not replicated the impact of generic competition on small molecule brand drugs. This observation has prompted some to claim that biologics manufacturers are stifling competition by disparaging those biosimilar products, which may raise antitrust concerns. <Read More>  

    Pharmacists Can Help Patients Manage, Prevent Migraines – July 22, 2021 – Community pharmacists can play an important role in the prevention and management of migraines, whether by helping them identify differences between a migraine and a severe headache or by providing medication management, according to a panel of experts in a recent Pharmacy Times Peer Exchange. Identifying whether patients are experiencing a migraine or a severe headache is often the first step when patients come to a community pharmacist with questions, according to panelist Jennifer L. Mazan, PharmD, an associate professor at the Midwestern University College of Pharmacy in Downers Grove, Illinois. Unlike other headaches, migraines are complex and can present differently at different times, she said. <Read More>  

    Top Tech Predictions for the Future of Specialty Pharmacy – July 22, 2021 – It’s estimated specialty medications account for 75% of the approximately 7,000 prescription drugs currently in development. By 2022, more than 60% of the 600 drugs expected to gain FDA approval will be specialty medications. This seismic shift toward specialized therapies has put a spotlight on specialty pharmacies to help meet this demand by providing patients the support they need to ensure adherence and outcomes. Advanced technology will prove imperative in 2021 and beyond as specialty pharmacies take on the role of facilitating patient engagement, managing prior authorizations and patient adherence, and demonstrating outcomes. <Read More>

    Tip of the Week: Performance Appraisal and Feedback – July 21, 2021 – One of the most difficult responsibilities that managers face is appraising the performance of employees. Pharmacists could potentially be placed in a position of pharmacist-in-charge, supervisor, or manager very soon after graduating, and even if they are not formally designated as a manager, pharmacists will have technicians and clerical staff who report to them. Performance appraisals are difficult because we are providing feedback to people we probably know pretty well, and there could be much at stake in the review. There are a number of biases inherent to conducting a performance appraisal, such as the tendency to evaluate everyone similarly (central tendency), or too leniently (lenience), or around just 1 or 2 characteristics of the employee without considering the totality of their performance. <Read More>  

    Growing Your Hospital Pharmacy Analytics Program – July 21, 2021 – A robust hospital pharmacy analytics program can improve drug utilization and advance patient care delivery. In a webinar by Becton Dickinson held on June 16, expert pharmacy leaders discussed the critical elements of high-performing pharmacy analytics programs and how hospital pharmacy departments can grow them to drive operational, clinical, and financial decisions. Joe Lassiter, MS, PharmD, president of The Robertson Group (TRG), LLC, kicked off the presentation by underscoring the need for pharmacy analytics. <Read More>  

    Evidence of Sustained Benefits of Pimavanserin for Dementia-Related Psychosis – July 21, 2021 – Up to half of the 45 million people worldwide who are living with Alzheimer’s disease will experience psychotic episodes, a figure that is even higher in some other forms of dementia. Psychosis is linked to a faster deterioration in dementia. Despite this, there is no approved safe and effective treatment for these particularly distressing symptoms. In people with dementia, widely-used antipsychotics lead to sedation, falls and increased risk of deaths. <Read More>

    How the Crucible of COVID-19 Can Help Fix The Health Care System – July 21, 2021 – The COVID-19 pandemic has demonstrated the irreplaceable nature of physicians and other front-line health professionals. But it has also exposed many of the chronic frailties and shortcomings of the U.S. health system, and how those flaws are pushing the workforce to the brink. A discussion paper from the National Academy of Medicine (NAM), “Clinicians and Professional Societies COVID-19 Impact Assessment: Lessons Learned and Compelling Needs,” identifies the biggest challenges to doctors and other clinicians during the pandemic response and suggests priority actions for revitalizing the health care system to meet population-health needs, promote the well-being of health professionals, and head off future public health emergencies. <Read More>  

    Preventing New HIV Infections Through Vital Medication Guidelines – July 21, 2021 – Nearly 40 million people worldwide live with HIV (human immunodeficiency virus), and this number increases every year as more individuals acquire the incurable infection. There is no vaccine to prevent HIV infection and the virus, if left untreated, can lead to AIDS (acquired immunodeficiency syndrome). Although great advances have been made in both the prevention and treatment of HIV, new infections are declining too slowly and, despite global efforts, we did not reach the Joint United Nations Program on HIV/AIDS (UNAIDS) target of fewer than 500 000 new infections per year by 2020. As a result, research into preventing HIV infection continues to be a global priority. <Read More>  

    Drugmakers, Pharmacies Next Targets for U.S. Opioid Settlements – July 21, 2021 – With a $26 billion nationwide settlement in sight over claims that the three largest U.S. drug distributors and Johnson & Johnson (JNJ.N) helped fuel a nationwide opioid epidemic, state and local governments will soon turn their attention to pharmacies and a handful of drugmakers. U.S. state attorneys general are expected to unveil a settlement proposal this week with distributors McKesson Corp (MCK.N), Cardinal Health Inc (CAH.N) and AmerisourceBergen Corp (ABC.N) contributing a combined $21 billion, while Johnson & Johnson would pay $5 billion. <Read More>

    Congress Introduces Bill to Legalize Ingestible CBD – July 21, 2021 – The US Food and Drug Administration (FDA) maintains the position that it is illegal to “introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 USC § 355], or a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.” This prohibition is relevant to cannabidiol (CBD) companies because CBD is an active ingredient in at least 1 known “drug product that has been approved under section 505 of the FD&C Act,” but CBD does not fall into the recognized exceptions to that rule. <Read More>

    HIV Increases Risk for Severe and Critical COVID-19 – July 21, 2021 – Being infected with HIV is a significant independent risk factor for severe COVID-19 leading to hospitalization and death, according to a World Health Organization report given at the 2021 Annual IAS Conference on HIV Science. Overall, nearly one-fourth (23.1%) of all people living with HIV who were hospitalized with COVID-19 died, according to a poster presented by Silvia Bertagnolio, MD, a virologist with WHO. “Understanding that HIV infection is associated with severe and fatal COVID-19 is critical to guide public interventions and treatment of COVID-19,” Dr. Bertagnolio said at a press briefing during the conference. <Read More>  

    New Guidelines May Help Take Guesswork Out of Treating AAV – July 21, 2021 – The American College of Rheumatology and the Vasculitis Foundation have published new guidelines to improve the treatment and management of systemic vasculitis, a group of inflammatory disorders that includes ANCA-associated vasculitis (AAV). The rarity of these disorders can make them challenging to diagnose and treat. The new guidelines — the first created and endorsed by both organizations — are meant to help physicians better understand and treat vasculitis. “Many rheumatologists may have limited experience caring for patients with these diseases,” Sharon Chung, MD, director of the Vasculitis Clinic at the University of California, San Francisco, and the lead investigator of the guidelines, said in a press release. <Read More>  

    Leveling Up for Flu Season in the COVID-19 Era: How One Pharmacy is Rising to the Challenge – July 21, 2021 – Recently, an editor from Pharmacy Times sat down with Kevin Day, PharmD, president of Day’s Miami Heights Pharmacy in Cincinnati, Ohio, to discuss how his independent pharmacy is gearing up for influenza season while continuing to deliver COVID-19 vaccines safely. Pharmacy Times: How have pharmacy staff helped to streamline the immunization programs at your pharmacy? Day: In our pharmacy we have a clerk who works at the front register, right inside the door when someone walks in. That person is responsible for starting the process and identifying that a customer is there for a vaccine, whether they have an appointment or just walk in. There is a notification process for us in the pharmacy to know there’s a vaccine appointment or a vaccine walk-in ready for us. Then we generally use either a technician or a pharmacy intern to check in the person and complete any required paperwork or documentation, which varies by vaccine. With COVID-19 vaccines, the process is online; with most of the other vaccines, it’s still a paper process. <Read More>

    How PBMs Can Help Control the Cost of Specialty Medications – July 20, 2021 – PBMs can implement a clinically rigorous approach to specialty pharmacy management that ensures members have appropriate access while helping payers control their pharmacy spend. Specialty medications are making headlines for a reason: they’re a major and growing driver of health costs. As the nation’s largest pharmacy benefit manager (PBM), we see the impact that these treatments have on pharmacy spend first-hand. In 2020, 52% of pharmacy spend for our clients was driven by a tiny fraction—just 2.5%–of members who use specialty medications. So, it’s no surprise that they are a major area of concern for payers and employers looking to control plan costs while providing sustainable health benefits. <Read More>  

    Technical Literacy, Digital Etiquette Are Essential to Teaching Telehealth in Pharmacy Schools – July 20, 2021 – In addition to teaching students about the Health Insurance Portability and Accountability Act (HIPAA) and other policies surrounding the use of telehealth, pharmacy students must learn technical literacy skills and digital etiquette, according to a session at the American Association of Colleges of Pharmacy Virtual Pharmacy Education 2021 conference. Pharmacists are reimagining how they work within health care teams and how they can incorporate the rapidly changing field into pharmacy curriculums, according to session moderator Danielle Miller, PharmD, MEd, RPh, BCACP. Although telehealth was first suggested 140 years ago in an article published by The Lancet, its practice has drastically changed and is continuing to constantly evolve, according to the presenters. <Read More>  

    Pharmacists: Medicare Fee Program Costing Seniors – July 20, 2021 – It seemed like such a good idea at the time. U.S. pharmacies collecting millions of Medicare dollars would be offered incentives to do more than simply push pills. If they don’t meet the new standards, such as making sure their patients receive their medications and get flu and pneumonia shots, they’ll have to give up some of that Medicare funding. The concept featured Direct and Indirect Remuneration fees, or DIR fees. Such fees “were originally supposed to be a way to offer incentives instead of a way to ‘claw back’ money from pharmacies,” the Pharmacy Times noted. <Read More>

    Chronic High-Risk Prescription Opioid Use in Patients With HIV – July 20, 2021 – A study has found that opioid prescriptions, including receipt of prescriptions for long durations, appear to be common among people living with HIV who are in primary care. Efforts are needed to prevent chronic high-risk prescriptions in patients receiving HIV care with comorbid conditions. Healthcare providers continue to face many challenges in ensuring effective chronic pain management while simultaneously preventing and addressing opioid misuse, opioid use disorders (OUD), and opioid-related morbidity among persons with HIV (PWH). Despite the availability of guidelines promoting safe and effective chronic pain management, studies conducted over the past decade have shown that PWH have a high prevalence of chronic pain at all stages of HIV and often have undertreated pain. <Read More>  

    Calls Grow for Treatment Deintensification of HPV-Positive OPC – July 20, 2021 – Clinicians cite long-term complications and younger patients with better prognoses as reasons to pull back on oropharyngeal cancer therapy. Oropharyngeal cancer (OPC) is a type of head and neck cancer that affects structures in the back of the throat, including the base of the tongue, the posterior pharynx, the soft palate, and the tonsils.1 In the United States, rates of OPC are increasing each year, with an estimated 54,010 new cases in 2021.2 Well-established risk factors include alcohol abuse; exposure to tobacco, including chewing tobacco, cigarettes, and pipes; and infection with human papillomavirus (HPV). <Read More>  

    340B in the News

    340B Programs Help Hemophilia Treatment Centers Promote Care – July 21, 2021 – Hemophilia treatment centers (HTCs) represent the medical standard of care for individuals living with a bleeding disorder. Using a highly specialized, multidisciplinary team, HTCs provide focused medical care proven to reduce hospitalizations, mortality, and other complications. HTCs are federally funded and organized into 10 regions across the country. Federal funding for HTCs has declined over the years. Individual HTCs receive an average of just $35,000 in government funding annually. Many HTCs incorporate 340B pharmacy programs to reduce reliance on limited federal funding and expand their comprehensive model of care. Approximately 71% of federally funded HTCs participate in the Health Resources and Services Administration’s (HRSA) 340B program, according to the National Hemophilia Foundation. <Read More>