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Clinical Insights: June 8, 2021

Posted on June 8, 2021 By RxStrategies, Inc. -

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

Tembexa™ (brincidofovir) – New Drug Approval – June 4, 2021 – The U.S. Food and Drug Administration approved Tembexa™ (brincidofovir) to treat smallpox. Although the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that the virus that causes smallpox, the variola virus, could be used as a bioweapon. Before its eradication in 1980, the variola virus mainly spread by direct contact among people. Symptoms typically began 10 to 14 days after infection and included fever, exhaustion, headache, and backache. A rash consisting of small, pink bumps progressed to pus-filled sores before it crusted over and scarred. Complications of smallpox included encephalitis (inflammation of the brain), corneal ulcerations (an open sore on the clear, front surface of the eye), and blindness. <Read More>

Ryplazim™ (plasminogen, human-tmvh) – New Drug Approval – June 4, 2021 – The U.S. Food and Drug Administration approved Ryplazim™ (plasminogen, human-tmvh) for the treatment of patients with plasminogen deficiency type 1, also referred to as hypoplasminogenemia, a disorder that can impair normal tissue and organ function and may lead to blindness. “Until now, there were no FDA-approved treatment options for patients with plasminogen deficiency type 1,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “This approval helps address an unmet medical need for individuals affected by this rare genetic disease.” <Read More>

Wegovy™ (semaglutide) Injection – New Drug Approval – June 4, 2021 – The U.S. Food and Drug Administration approved Wegovy™ (semaglutide) injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced calorie diet and increased physical activity. This under-the-skin injection is the first approved drug for chronic weight management in adults with general obesity or overweight since 2014. The drug is indicated for chronic weight management in patients with a body mass index (BMI) of 27 kg/m2 or greater who have at least one weight-related ailment or in patients with a BMI of 30 kg/m2 or greater. <Read More>

Brexafemme® (ibrexafungerp) Tablets – New Drug Approval – June 2, 2021 – Scynexis, Inc., a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, announced that the U.S. Food and Drug Administration (FDA) has approved Brexafemme® (ibrexafungerp tablets), for oral use in patients with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. Brexafemme®, which represents the first approved drug in a novel antifungal class in more than 20 years, was approved based on positive results from two Phase 3 studies in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC. Scynexis has partnered with Amplity Health, a leading global contract commercialization organization, to support U.S. commercialization of Brexafemme®, with commercial launch scheduled in the second half of this year. <Read More>

Lybalvi™ (olanzapine/samidorphan) – New Drug Approval – June 1, 2021 – Alkermes plc announced that the U.S. Food and Drug Administration (FDA) has approved Lybalvi™ (olanzapine and samidorphan) for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate. Lybalvi™ is a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity. <Read More>

Truseltiq™ (infigratinib) – New Drug Approval – May 28, 2021 – BridgeBio Pharma, Inc., through its affiliate QED Therapeutics, Inc., and Helsinn Group announced that the US Food and Drug Administration (FDA) has approved Truseltiq™ (infigratinib) under the accelerated approval program for the treatment of patients with previously-treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement. Truseltiq™  is an orally administered, ATP-competitive, tyrosine kinase inhibitor of FGFR. In the pivotal trial of patients with advanced, unresectable CCA, an aggressive malignancy with poor prognosis, Truseltiq™  led to cases of tumor shrinkage. CCA is known to affect approximately 20,000 people in the United States and European Union each year and has a median five-year survival rate of only 9%. <Read More>

New Formulation Approval

No new update.

New Indication/Dosage Approval

Cosentyx® (secukinumab) – New Expanded Indication – June 1, 2021 – Novartis, a leader in immuno-dermatology and rheumatology, announced that the U.S. Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients six years and older who are candidates for systemic therapy or phototherapy1. This is the first approval for Cosentyx® in a pediatric population in the US. The Cosentyx® clinical profile is supported by five years of adult data showing long-lasting efficacy and a consistent safety profile across moderate to severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis. <Read More>

Nurtec® ODT (rimegepant) – New Expanded Indication – May 27, 2021 – Biohaven Pharmaceutical Holding Company Ltd., announced that the U.S. Food and Drug Administration (FDA) has approved Nurtec® ODT (rimegepant 75 mg) for the preventive treatment of migraine. Nurtec® ODT is indicated for adult patients with episodic migraine, e.g. those who experience less than 15 headache days per month. The approved product label was also expanded to include the use of Nurtec® 75 mg up to 18 doses/month, allowing for both acute and preventive therapy in the same patient.  This new approval makes Nurtec® the first oral CGRP antagonist approved for the preventive treatment of migraine, and the only migraine medication approved as a dual therapy for both the acute and preventive treatment. Nurtec® is approved for acute treatment in all eligible adult patients with migraine, regardless of the number of monthly migraine days. Since approximately 95% of all U.S. migraine patients experience less than 15 headache days per month, the new indication of preventive treatment significantly expands the market potential of Nurtec® and provides a new preventive treatment option for the vast majority of people living with migraine. <Read More>

Zeposia® (ozanimod) – New Expanded Indication – May 27, 2021 – Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Zeposia® (ozanimod) 0.92 mg for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD). Zeposia®, an oral medication taken once daily, is the first and only sphingosine 1-phosphate (S1P) receptor modulator approved for patients with moderately to severely active UC. The mechanism by which Zeposia® exerts therapeutic effects in UC is unknown but may involve the reduction of lymphocyte migration into the intestines. It is thought that by targeting S1P receptors on lymphocytes, a type of immune system cell, Zeposia® reduces the number of lymphocytes in peripheral blood. <Read More> 

New/Updated Drug Shortage

June 07, 2021

June 04, 2021

June 03, 2021

June 01, 2021

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Brovana® (arformoterol tartrate) Inhalation Solution – New Authorized Generic Approval – June 3, 2021 – Global pharma major, Lupin Limited (Lupin), announced the launch of the authorized generic version of Brovana® (arformoterol tartrate) Inhalation Solution 15 mcgꝉ/2 mL, unit-dose vials, of Sunovion Pharmaceuticals Inc. Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL, is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is for use by nebulization only. <Read More>

Clinical and Pharmacy News

Pharmacists Challenge the Need for Authorized Generic Drugs – June 6, 2021 – Have you ever heard of authorized generic (AG) drugs? Many regular readers of this newspaper column are up to speed on these products, but others have not encountered them. Even physicians, pharmacists or nurses may not know about this category of medications. How does an authorized generic drug differ from a standard generic medication? When a brand-name pharmaceutical loses its patent, other manufacturers can attempt to copy that medication. They have to reverse engineer it, though. That’s because the company that created the original product does not have to share any proprietary information with generic manufacturers. The Food and Drug Administration requires bioequivalence data that demonstrates a close approximation to the brand name. But the blood levels of the generic do not have to be identical to the original medicine. <Read More>

FDA Accepts Application for Pegfilgrastim Biosimilar – June 4, 2021 – The FDA has accepted the biologics license application (BLA) for a proposed biosimilar for pegfilgrastim (Neulasta), which had been developed by Lupin Limited. The application is supported by similarity data gleaned from analytical, pharmacokinetic, pharmacodynamic, and immunogenicity studies. “FDA’s acceptance of our BLA is a significant achievement and demonstrates our commitment to delivering products which increase access in areas of substantial medical need,” Vinita Gupta, chief executive officer of Luptin Limited, stated in a press release. “This BLA expands our oncology portfolio, an area of increasing focus for Lupin. We look forward to the opportunity to bring affordable biologic options to patients and increasing access to this important treatment.” <Read More>

The Path of Least Resistance: A Novel Tuberculosis Regimen Shortens Treatment Course for Patients – June 4, 2021 – Tuberculosis (TB) is a deadly infection that occurs in every part of the world. The standard treatment for TB, a six-month multidrug regimen, has not changed in more than 40 years. Patients can find it difficult to complete the lengthy regimen, making it more likely that treatment resistance will develop. A multi-institutional research team led by MUSC investigator Susan Dorman, M.D., reports in the May 6 issue of the New England Journal of Medicine that a four-month treatment regimen using rifapentine is effective for treating TB. Shortening the treatment duration is an important step toward increased patient adherence. Dorman is a professor in the College of Medicine at MUSC. <Read More>

AGA Issues Recommendations for Moderate-to-Severe Crohn Disease – June 4, 2021 –  In clinical practice guidelines from the American Gastroenterological Association (AGA) published in the June 1 issue of Gastroenterology, recommendations are presented for the management of moderate-to-severe luminal and fistulizing Crohn disease (CD) in adult outpatients. Joseph D. Feuerstein, M.D., from Beth Israel Deaconess Medical Center in Boston and colleagues presented recommendations from the AGA for the medical management of moderate-to-severe luminal and fistulizing CD in adult outpatients. The authors recommend use of anti-tumor necrosis factor α (TNFα) over no treatment for induction and maintenance of remission in adult outpatients with moderate-to-severe CD. In addition, vedolizumab is suggested over no treatment and ustekinumab is recommended over no treatment. <Read More>

Access Matters: The Future for Pharma – June 4, 2021 – Over the last two decades, the growth of payer power has made access increasingly challenging for pharmaceutical companies. In our previous article, we considered how health technology assessment (HTA) and increasingly aggressive pricing methods have put drug manufacturers under pressure. In this article, we will examine how the pricing of one product in particular has been a catalyst for changes shaping the access environment of today and tomorrow. One drug, in particular, has been the focus of criticism of pharmaceutical pricing in recent years. In 2014, Gilead’s Sovaldiä (sofosbuvir) transformed the treatment of hepatitis C. <Read More>

FDA Authorizes Lower Dose of Regen-Cov mAb Cocktail – June 4, 2021 – The FDA updated the emergency use authorization (EUA) for Regeneron’s Regen-Cov, lowering the dose to 1,200 mg (600 mg casirivimab and 600 mg imdevimab), which is half the dose originally authorized. As part of the updated EUA, casirivimab-imdevimab should be administered by IV infusion; subcutaneous injections are an alternative when IV infusion is not feasible and would lead to a delay in treatment. <Read More>

New Clinical Guidelines to Manage Insomnia With Intensive Behavioral Therapy – June 3, 2021 – If insomnia keeps you awake at night, Flinders University researchers recommend a trip to the doctor – not for a sleeping pill prescription but for a short course of intensive behavioral therapy. Researchers have developed new clinical guidelines for Australian doctors to give family GPs insights into the most effective treatment for insomnia – Cognitive Behavioral Therapy for insomnia (or ‘CBTi’). CBTi improves insomnia, mental health and quality of life, and can be more successful than sleeping pills, say Adelaide Institute for Sleep Health (AISH) sleep experts from Flinders University in a new paper in the Australian Journal of General Practice. <Read More>

Pharmacy Benefit Manager Formularies: Friend or Foe? – June 3, 2021 – Understanding how formularies work is essential in the world of pharmacy and knowledge on this topic can help pharmacists to better serve patients. The goal of a pharmacy benefit manager (PBM) is to help plan sponsors create a prescription drug benefit that meets the needs of plan members both clinically and financially. One of the tools that the PBM has is a drug formulary, which is a list of medications that are covered by a prescription drug plan or hospital. The list is supported by evidence-based medicine as well as the judgment of the pharmacy and therapeutics (P&T) committee. The P&T committee is an independent entity that is comprised of anywhere from 10 to 15 members. The committee is primarily made up of physicians and pharmacists, but can also include nurses, administrators, legal experts, and economists. <Read More>

Why Is It Difficult to Discontinue Use of Some Antidepressants? – June 3, 2021 – By looking at the molecular and cellular mechanisms that cause antidepressant withdrawal syndrome, researchers are a step closer to discovering why it is so difficult for people to stop some antidepressant medications. Current antidepressants can require approximately two months to take effect in patients, who then continue taking these drugs for years. Weaning patients off them can result in unpleasant symptoms that can range from flu-like feelings and persistent pain or itch to Parkinson’s-like conditions that can last for weeks. <Read More>

Enhancing Medication Adherence With Smart Packaging – June 3, 2021 – Demands on pharmacists are increasing, yet all the tasks historically part of a pharmacist’s day-to-day routine are still required. Aside from COVID-19 vaccinations and responding to overall increase in volume, medication adherence is a top concern for patients and pharmacists. Using technology solutions enables pharmacists to enhance patient safety both effectively and efficiently. According to Gerald Finken, RPh, CEO of RxE2 Inc and a 40-year veteran pharmacist, technology-driven medication packaging is a tangible reminder for patients to take their medication as prescribed. “Additionally, health plans, prescribers, and pharmacies are held accountable through adherence-driven quality metrics [such as proportion of days covered and medication possession ratio], and pharmacists can use packaging to improve these quality metrics,” Finken said. <Read More>

Updated Society Guidelines Address Prevention of Second Stroke – June 3, 2021 – Health care providers should perform diagnostic tests to determine the cause of a first stroke within 48 hours of symptom onset, according to an updated American Heart Association and American Stroke Association Clinical Practice Guideline. The guideline also provides treatment recommendations based upon the cause of a first stroke or transient ischemic attack. Potential causes may include, but not limited to, blockages in large arteries in the neck or brain, damage to the small arteries in the brain from high blood pressure or diabetes, or irregular heart rhythms. <Read More>

ACCC Tool Offers Individualized Guidance for Geriatric Assessment in Cancer Care – June 3, 2021 – A comprehensive geriatric assessment can identify patient vulnerabilities and fitness levels, said Melissa (Kah Poh) Loh, BMedSci, MBBCh, BAO. Although geriatric assessment is not utilized routinely, the new Association of Community Cancer Centers (ACCC)’s how-to guide for practical application of geriatric assessment could provide a valuable tool to providers looking to standardize and build a geriatric assessment program at new institutions. “The first step [in developing a geriatric assessment protocol] is trying to figure out what kind of support and infrastructure [an institution] has locally and then build from there,” said Loh, an ACCC advisory committee member. “This resource from ACCC can serve as a first step to figure that out and [guide] the next steps to build.” <Read More>

American Cough Conference Preview: Diagnosing, Managing, and Treating Chronic Cough – June 3, 2021 – Treating cough can be difficult. There are no FDA-approved therapies on the market in the United States, and companies with drugs in clinical trials have to contend with a large placebo effect. Cough is a common issue for patients that can be divided into acute, subacute, and chronic cough depending on how long it lasts. Treating cough can be tricky, because there is a large placebo effect. Cough, according to Ron Eccles, PhD, DSc, BSc, emeritus professor at Cardiff University, can be voluntarily controlled or inhibited. During a session at the conference, Eccles will go into more detail on the placebo effect in cough and how to address it in clinical trials. He will speak during a session on general issues in cough clinical trials, such as the ideal trial design and developing a consumer technology–based automated cough counter. <Read More>

Six Steps to an ‘A’ Grade In Sterile Compounding – June 3, 2021 – Establishing a 503B sterile compounding facility isn’t for every hospital with a compounding pharmacy. The differences between the requirements for compounding under Section 503A of the Drug Quality and Security Act and Section 503B are fairly large. Most hospitals have 503A compounders, which are traditional, small-batch compounding pharmacies, making short-dated preparations for specific patients per prescription or in very limited quantities. They’re governed by state board of pharmacy regulations and USP General Chapters <795> and <797>. In contrast, because 503B facilities make more complex products that are designed for longer beyond-use dating (BUD), they must comply with much stricter federal standards, dictated by the Code of Federal Regulations Title 21, which governs the FDA—specifically Part 210 on Current Good Manufacturing Practice (CGMP) guidelines. <Read More>

‘Prescription’ to Sit Less, Move More Advised for Mildly High Blood Pressure and Cholesterol – June 2, 2021 – Physical activity is the optimal first treatment choice for adults with mild to moderately elevated blood pressure and blood cholesterol who otherwise have low heart disease risk. About 21% of adults in the US with mild to moderately raised blood pressure and 28-37% of those with mild to moderate elevated cholesterol levels may be best served by a prescription for lifestyle-only treatment, which includes increasing physical activity. <Read More>

IDSA Publishes Guidelines for SARS-Cov-2 Antigen Tests – June 2, 2021 – The Infectious Diseases Society of America published new guidelines for the use of SARS-CoV-2 antigen tests. “Antigen tests really have become increasingly available over the course of the pandemic and have helped us address a need for more universal and rapid access to diagnostic testing for SARS-CoV-2,” Kimberly E. Hanson, MD, MHS, associate professor of internal medicine and adjunct associate professor of pathology at the University of Utah School of Medicine, said during an IDSA press briefing. “These tests can be used in a variety of settings.” <Read More>

ATS Guideline Addresses Testing for Viral Pathogens in CAP – June 2, 2021 – In a clinical practice guideline issued by the American Thoracic Society and published in the May 1 issue of the American Journal of Respiratory and Critical Care Medicine, nucleic acid-based viral diagnostics are suggested for hospitalized patients with suspected community-acquired pneumonia (CAP) but only for patients who have severe disease or are immunocompromised. Scott E. Evans, M.D., from Yale University in New Haven, Connecticut, and colleagues examined the literature to develop recommendations regarding whether routine diagnostics should include nucleic acid-based testing of respiratory samples for viral pathogens other than influenza in adults with suspected CAP. <Read More>

Management of Chronic Obstructive Pulmonary Disease – June 2, 2021 – Chronic obstructive pulmonary disease (COPD) is a respiratory disease characterized by blockage of airflow from the lungs, which results in progressively worsening shortness of breath, coughing, wheezing, and production of excessive phlegm or mucus. For the more than 15 million Americans diagnosed with COPD, declining lung function, increasing hospitalizations, and comorbidities can make engaging in daily activities difficult, leading to diminished quality of life (QOL).1 Although there is no cure for COPD, medications coupled with lifestyle changes can help lessen respiratory symptoms and reduce exacerbations. <Read More>

Amid COVID-19 Pandemic, Many Americans are Foregoing Mental Health Care – June 2, 2021 – Findings showed a 34% decrease in the number of mental health services utilized by children under age 19 and a 22% decline in the number of mental health services utilized by adults aged 19 to 64. New data from the Centers for Medicare & Medicaid Services (CMS) show that many patients are foregoing mental health care during the COVID-19 pandemic, despite an increased need for many people caused by isolation and stress. Investigators analyzed data from Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries regarding the utilization of health services. They found that between March and October 2020, patients skipped millions of primary, preventive, and mental health care visits due to the pandemic compared to the same period in 2019. Although utilization rates for some health care sectors have rebounded to pre-pandemic levels, a press release noted that mental health services are having the slowest rebound. <Read More>

Diabetes Outcomes-Based Pilot Program Found Effective at Improving Patient Outcomes – June 2, 2021 – Launched in 2020, a diabetes pilot program developed by Pharmacy Quality Solutions (PQS) and Humana resulted in a significant improvement in patient outcomes for those enrolled. In light of these results, plans have been established to expand the program to additional pharmacies in 2021 to obtain more data and assess the efficacy of the program more broadly. “Our pilot saw a remarkable increase in patients meeting A1C goals and completing an A1C test. These results are a testament to the collaboration with pilot pharmacies and PQS. We look forward to engaging with more pharmacies and expanding their services in our diabetes outcomes program,” said Bethanie Stein, Humana pharmacy solutions president of PBM services, in a press release. <Read More>

Pharmacy Associations Praise Bill Seeking to Reform DIR Fees – June 2, 2021 – Several pharmacy associations have extended their praise for the introduction of a bill pursuing direct and indirect remuneration (DIR) fee reform and lowering drug costs for Medicare patients. The Pharmacy DIR Reform to Reduce Senior Drug Costs Act was introduced by a bipartisan group of lawmakers in the US House and Senate…“DIR fees are exerting unnecessary and devastating pressures on patients, on pharmacies, and on communities – particularly the most vulnerable and the underserved. We welcome the introduction of the Pharmacy DIR Reform to Reduce Senior Drug Costs Act, and we urge its passage this year,” the associations said in a group statement. <Read More>

High-Concentration Adalimumab Biosimilar Yields Positive 1-Year Data – June 2, 2021 – Celltrion Healthcare shared positive 1-year results from a phase 3 trial evaluating the safety and efficacy of its high-concentration adalimumab biosimilar (Yuflyma, CT-P17) compared with the reference product (Humira) in patients with moderate-to-severe active rheumatoid arthritis (RA)…“Demonstration of equivalent efficacy and comparable safety of CT-P17 to EU-sourced adalimumab in this study supports the ongoing clinical evaluation of CT-P17 as an adalimumab biosimilar,” said Jonathan Kay, MD, lead investigators and a professor at the University of Massachusetts Medical School, in a statement. <Read More>

Treating a Man With Benign Prostatic Disease Requires Complex Decision-Making – June 2, 2021 – “Retreatment is the new buzz word and is very controversial, as parameters keep changing,” writes Gopal H. Badlani, MD. In the “good old days,” it was simple: An older man complaining of nocturia got his prostate resected. We have come a long way since then and are more aware of patient-centered outcomes, validated symptom scores, and objective parameters. The guidelines have evolved from benign prostatic hyperplasia (BPH) to male lower urinary tract symptoms (LUTS) due to BPH and not yet to the male LUTS due to benign prostatic obstruction (BPO). The interview in this issue with Alexis E. Te, MD, a recognized expert in the field, reflects the complex decision-making now required when a man presents with LUTS. <Read More>

National Clinical Guidelines Released for Endometriosis – June 2, 2021 – New national clinical practice guidelines to diagnose and treat endometriosis have been released, aiming to improve the lives of Australian women living with the debilitating condition. Endometriosis is an inflammatory condition that can be devastating for some sufferers but is often undiagnosed, although it affects one in nine women and girls. It involves cells similar to the endometrium (uterus) growing in other locations, usually in the pelvis but sometimes in other tissue and organs. <Read More>

Kentucky Sues CVS, Accuses Company of ‘Fueling’ Opioid Crisis by Turning Blind Eye – June 2, 2021 – Kentucky sued the drugstore chain CVS on Wednesday, accusing the company of “fueling” the opioid crisis that has ravaged the commonwealth. “As both distributor and pharmacy, CVS was in a unique position to monitor and stop the peddling of these highly-addictive drugs from their stores,” Kentucky Attorney General Daniel Cameron said in a statement. “Yet they ignored their own safeguard systems.” One CVS in Perry County (about 100 miles southeast of Lexington) purchased over 6.8 million dosage units of oxycodone and hydrocodone from 2006 to 2014, Cameron said. That was enough opioids to supply every man, woman and child in the county with over 26 pills every year during that time period. <Read More>

Gout Diagnosis and Management: Updated Treatment Guidelines – June 1, 2021 – Gout is a life-long, recurrent metabolic disorder considered to be type of arthritis, with both acute exacerbations and chronic joint damage and pain. Usually, the acute exacerbation of gout is associated with a rapid onset of severe pain and swelling in the joints. Most commonly affecting the big toe, inflammation and arthritic changes may also affect the heel, ankle, hand, wrist, or elbows, among other places in the body. Gout can affect the spine and can be a factor in low back pain. <Read More>

Reducing the Length of Outpatient Antibiotic Treatment – Is There an Easy Button for That? – June 1, 2021 – Antibiotic treatment guidelines have changed over the past decade. Whereas 10 days of antibiotics seemed to be the default, more recent research has demonstrated that for many infections, such as uncomplicated urinary tract infections or pneumonia, shorter durations are adequate. Additionally, shorter antibiotic treatment regimens are associated with fewer adverse events and less antibiotic resistance. Thus, antibiotic treatment duration is an important target of antibiotic stewardship programs. <Read More>

AUA Updates Guideline on Renal Masses and Localized Renal Cancer – June 1, 2021 – The American Urological Association (AUA) has officially amended its clinical guideline on Renal Masses and Localized Renal Cancer. “Renal cancer is one of the ten most common cancers in both men and women,” Steven C. Campbell, MD, PhD, chair of the AUA Renal Mass Guideline Panel, stated in a press release. “We believe this revised guideline will provide a useful, evidence-based clinical reference for the medical and surgical management of renal masses and localized renal cancer.” The guideline was initially published in 2013 and was last amended in 2017. <Read More>

Pharmacy Economist Describes Fork in the Road for Generics and Biosimilars – June 1, 2021 – Biosimilar manufacturers may encounter roadblocks in the months and years ahead, and generics manufacturers will find they’ve hit a ceiling, according to Adam Fein, PhD, CEO of the Drug Channels Institute. It is often said that legislators and patient advocates hope the biosimilars market will evolve as successfully as the generic market has, providing for robust competition and price declines that improve access. But a drug industry expert who spoke at the Association for Accessible Medicines’ Access! meeting said generic and specialty drug markets, which include biosimilars, are evolving in very different ways. <Read More>

Better Late Than Never: Clinical Guidelines are Too Late to Screen for Prostate Cancer – June 1, 2021 – Identifying the disease early remains key to treating patients successfully when addressing prostate cancer. As such, clinical guidelines for the age to start screening aim to ensure that patients are not harmed or the negatives effects are limited to a minimum when treating prostate cancer. However, due to the lack of sufficient data and relevance of data, the age at which early screening should begin remains unclear. This poses problems for diagnosis, later treatments, and the outcome of treatment, as patients may already be progressing into later stages of cancer development. <Read More>

Mental Health Awareness is Vital Year-Round – June 1, 2021 – With May 31 marking the end of Mental Health Awareness Month, it is imperative to reflect on the state of mental health care in this country beyond just last month. Mental health in the United States is the midst of a crisis, and the recent pandemic has only exacerbated the situation. According to Czeisler et al,1 40.9% of Americans reported having a mental health or behavioral health condition as of June 2020, which went up from 20.6% in 20192 and 17.7% in 2008.2 In a comparison with 2019, Leeb et al3 reported that hospital emergency departments treated 14% more cases of drug overdose, 6% more patients after a suicidal attempt, 24% more children, and 31% more adolescents experiencing a mental health crisis in 2020. <Read More>

Employers Must Step Up to Control Health Care Prices – June 1, 2021 – During 2020, as the pandemic compelled us to shelter in place, Americans avoided doctor’s appointments and postponed elective surgeries. For the first time in decades, employers actually saw their spending on health care services decline…Prices remain the single biggest driver of health care cost growth, and economists agree that provider consolidation—mergers and acquisitions among hospitals and/or physician practices—is the fuel that keeps the fire raging. As demand dwindled for high-margin, elective procedures during the pandemic, some health care providers found themselves in financial dire straits, compelled to surrender to mega-sized health systems or shutter altogether. <Read More>

PBMs Still Need More Government Oversight – June 1, 2021 – In late March, Wisconsin passed legislation to rein in practices of pharmacy benefit managers (PBMs), joining a growing number of states looking to understand what drives the confusion behind prescription drug prices. As a small community pharmacy, we have been squeezed as a result of PBM practices for a long time, and it continues to threaten our business, and our ability to treat patients. When passing the legislation, Governor Tony Evers said it best, calling the PBM administration “a confusing and opaque system that often sends folks jumping through hoops just to access their life-saving medications.” This is true for patients and pharmacists. <Read More>

Pharmacy Students Say COVID-19 Pandemic Has Opened Their Eyes to the Value of Pharmacists – June 1, 2021 – Not only are pharmacists drug experts, but the pandemic demonstrated that they can also perform COVID-19 testing and vaccinations alongside physicians and other health care providers. Although the COVID-19 pandemic has had a massive impact on their experiences in pharmacy school, students at the Washington State University College of Pharmacy and Pharmaceutical Sciences said the pandemic has also opened their eyes to the important roles pharmacists play in health systems, communities, and throughout the country. <Read More>

Eleven Generic Versions of an HIV Drug Rush Onto the Market… And List Prices Go Up – May 31, 2021 – The health care system is supposed to incentivize the development of wonder drugs and then apply market forces to squeeze prices to a minimum. But a new report shows how at least for one drug, incentivizing is working a lot better than price-squeezing. For example, Blueberry Pharmacy in the Pittsburgh area opted out of the traditional insurance system. It can offer versions of a new generic for $25 a month, while programs connected with middlemen and insurance companies are offering it for $75 in the best instance and often for more than $1,000. <Read More>

340B in the News

HRSA, Drugmakers Square Off on 340B Restrictions – June 1, 2021 – The Health Resources and Services Administration (HRSA), which oversees the federal 340B Drug Pricing Program, has directed six drug manufacturers to immediately resume providing 340B discounted pricing to contract pharmacies without restrictions, and warned that they face Civil Monetary Penalties (CMPs) if they do not do so immediately… “This is exactly what we’ve been hoping HRSA would do,” said Barbara Straub Williams, JD, a principal at Powers Pyles Sutton & Verville, which represents the Ryan White Clinics for 340B Access. But she acknowledged the letters are unlikely to produce overnight change. <Read More>

From 340B to a Public Option: Four Healthcare Items you may Have Missed in Biden’s Budget – June 1, 2021 – President Joe Biden released his request for the federal fiscal 2022 budget that includes a major 23% boost to funding for the Department of Health and Human Services (HHS). But the budget request to Congress also includes several major changes to healthcare policies that could affect the 340B drug discount program, rural healthcare and the Affordable Care Act (ACA). Congress is not expected to fully take up Biden’s budget request, but it does highlight the administration’s priorities on where to allocate federal funding. <Read More>