Ms. Hester is Content Specialist with Contemporary OB/GYN and Contemporary Pediatrics.

 Cosentyx (secukinumab) from Novartis Pharmaceuticals Corporation for the treatment of moderate-to-severe plaque psoriasis in children aged 6 years and older who are candidates for phototherapy or systemic therapy. It’s the first pediatric approval for secukinumab in the United States. The approved pediatric doses are 75 mg or 150 mg, dependent on the child’s weight, and is administered via subcutaneous injection every 4 weeks following an initial loading dose. Following counseling and training in injection, secukinumab can be given to a child by an adult caregiver.

The approval was based on the results from 2 trials. The first trial was 52 weeks and was a randomized, double-blind, placebo- and active-controlled study of 16 randomized, double-blind, placebo- and active-controlled study of children aged 6 years of age who had severe plaque psoriasis. In the trial, secukinumab reduced psoriasis severity at Week 12 when compared to the placebo. The other Phase III study was a randomized open-label, 208-week trial of 84 children aged 6 years and older who had moderate-to-severe plaque psoriasis.

The most common side effects seen with secukinumab are upper respiratory infections, diarrhea, and cold symptoms.

In a release for the approval, Randy Beranek, President and CEO, National Psoriasis Foundation. "Having expanded treatment options for this patient population is a step in the right direction to help reduce the burden of plaque psoriasis."

This article was originally published by 

1. Novartis Pharmaceutical Corporation. Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis. Published June 1, 2021. Accessed June 2, 2021. https://www.prnewswire.com/news-releases/novartis-cosentyx-receives-fda-approval-for-treatment-of-children-and-adolescents-with-moderate-to-severe-plaque-psoriasis-301303365.html

Articles

The FDA approved Cosentyx (secukinumab) to treat moderate-to-severe plaque psoriasis in children aged 6 years and older.

FDA OKs Secukinumab for Children Aged 6 and Older

AmerisourceBergen Corporation (NYSE: ABC) today announced the completion of its acquisition of the majority of Walgreens Boots Alliance’s Alliance Healthcare businesses for $6.275 billion in cash, subject to a customary working capital and net debt adjustment, and 2 million shares of AmerisourceBergen common stock.

“We are excited to complete the acquisition and extend a warm welcome to the talented team at Alliance Healthcare,” said Steven H. Collis, Chairman, President and Chief Executive Officer of AmerisourceBergen. “The acquisition of Alliance Healthcare expands our reach and solutions in pharmaceutical distribution and adds to AmerisourceBergen’s breadth and depth of global manufacturer services. With Alliance Healthcare, we will advance our ability to provide innovative and global healthcare solutions and further our purpose of being united in our responsibility to create healthier futures.”

“This transaction provides great benefit for both companies and is a logical step following the continued success of our long-term strategic relationship,” said Ornella Barra, Chief Operating Officer, International, Walgreens Boots Alliance, Inc. “The Alliance Healthcare teams are joining a global pharmaceutical distribution leader and trusted partner in AmerisourceBergen, and we look forward to continuing to work together as strategic partners.”

AmerisourceBergen and Walgreens Boots Alliance will also execute on the expansion and extension of commercial agreements in order to drive incremental growth and synergies.

The Company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available or cannot be reasonably estimated.

Fiscal Year 2021 Expectations on an Adjusted (non-GAAP) Basis

AmerisourceBergen has updated its fiscal year 2021 financial guidance to reflect the expected contribution from the closing of the Alliance Healthcare acquisition and the weighted average share count impact of the 2 million shares of AmerisourceBergen common stock that the Company delivered at closing of the transaction. The Company now expects:

Revenue of at least $210 billion, up from revenue growth in the high-single digit percent range; and

Adjusted diluted earnings per share (EPS) to be in the range of $8.90 to $9.10, raised from the previous range of $8.45 to $8.60.

Weighted average shares of at least 208 million, raised from the previous expectation of between 207 million and 208 million for the fiscal year.

The Company continues to have strong performance across its businesses and expects to update the rest of its previously announced fiscal 2021 financial guidance when it reports results for the third quarter of fiscal 2021. Alliance Healthcare’s results will be reported in Other for the remainder of fiscal year 2021.

AmerisourceBergen Corporation today announced the completion of its acquisition of the majority of Walgreens Boots Alliance’s Alliance Healthcare businesses.



AmerisourceBergen Completes Acquisition of Alliance Healthcare Businesses

The FDA has granted accelerated approval of sotorasib (Lumakras; Amgen Inc), the first treatment for non-small cell lung cancer (NSCLC) in patients whose tumors have genetic mutation KRAS G12C and who have received at least 1 prior systemic therapy.

KRAS mutations occur in a group of genes that aid in cell growth and division. These types of mutations account for an estimated 25% of all mutations found in NSCLC, 13% of which are GRAS 512C mutations.

Approval of sotorasib for this indication was based on a clinical trial that evaluated 124 patients with locally advanced or metastatic KRAS G12C-mutated NSCLC with disease progression after receiving an immune checkpoint inhibitor and/or platinum-based chemotherapy. The key outcomes of objective response rate – the proportion of patients whose tumor is destroyed or reduced – and duration of response of 6 months or more were 36% and 58%, respectively.

Based on available clinical data and pharmacokinetic and pharmacodynamic modeling, the FDA approved a 960-mg dose of sotorasib; however, the agency will also be requiring investigators to carry out a post-marketing trial in order to determine if a lower dose could be similarly beneficial.

The most common adverse effects of sotorasib include diarrhea, musculoskeletal pain, nausea, fatigue, liver damage, and cough. Health care professionals should be monitoring a patient’s liver function tests prior to starting treatment, according to the FDA.

“KRAS mutations have long been considered resistant to drug therapy, representing a true unmet need for patients with certain types of cancer,” said Richard Pazdur, MD, director, Oncology Center of Excellence, acting director, Office of Oncologic Diseases in the Center for Drug Evaluation and Research, FDA. “Today’s approval represents a significant step towards a future where more patients will have a personalized treatment approach.”

Sotorasib was approved using the FDA accelerated cpproval pathway, as well as fast track, priority review, and breakthrough therapy designations.

FDA Approves First Targeted Therapy for Lung Cancer Mutation Previously Considered Resistant to Drug Therapy. News Release. FDA; May 28, 2021. Accessed June 1, 2021. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-lung-cancer-mutation-previously-considered-resistant-drug

The FDA has approved sotorasib (Lumakras; Amgen Inc) for the treatment of non-small cell lung cancer in patients with KRAS G12C genetic mutations and who have received at least 1 prior therapy. 

FDA Approves Sotorasib for NSCLC With KRAS Genetic Mutations

Moderna announced it is seeking full FDA approval for its COVID-19 vaccine mRNA-1273.

In a statement released on Tuesday, the company said it has initiated the rolling submission process for the biologics license application (BLA) and will continue to submit data from its phase 3 study to support the application for use of the vaccine in individuals 18 years and older. Once the rolling BLA submission process is completed, the FDA will notify Moderna when it is formally accepted for review.

A Timeline of Key Regulatory and Clinical Updates

FDA authorized Moderna’s vaccine for emergency use

 based on a data analysis from the phase 3 COVE study and a primary efficacy analysis conducted on 196 cases which indicated a vaccine efficacy rate of 94.1%.

In February 2021, Moderna completes manufacturing of clinical trial material for its variant-specific vaccine candidate, mRNA-1273.351, against the SARS-CoV-2 variant known as B.1.351 and has shipped doses to the National Institutes of Health for the phase 1 clinical trial.

In an amendment to the ongoing phase 2 clinical study, the first participants were dosed with the company’s modified COVID-19 vaccines in March to evaluate booster vaccine candidates.

 demonstrated antibody persistence through 6 months following the second dose of the vaccine.

In May, Moderna reported initial data from its phase 2 study showing that a single 50 µg dose of mRNA-1273 or mRNA-1273.351 given as a booster increased neutralizing antibody titer responses against SARS-CoV-2 and variants B.1.351 and P.1.5

On May 25, Moderna released data from its 

, demonstrating the safety and efficacy of mRNA-1273 in adolescents aged 12 to <18 years. Moderna announced plans to seek authorization for this age group in June.

 of its COVID-19 vaccine, BNT162b2, for use in individuals aged 17 years and older.

Moderna Announces Initiation of Rolling Submission of Biologics License Application (BLA) with U.S. FDA for the Moderna COVID-19 Vaccine. News Release. Moderna; June 1, 2021. Accessed June 1, 2021. 

https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-initiation-rolling-submission-biologics

Moderna Announces it has Shipped Variant-Specific Vaccine Candidate, mRNA-1273.351, to NIH for Clinical Study. News Release. Moderna; February 24, 2021. Accessed June 1, 2021. 

https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-it-has-shipped-variant-specific-vaccine

Moderna Announces First Participants Dosed in Study Evaluating COVID-19 Booster Vaccine Candidates. News Release. Moderna; March 10, 2021. Accessed June 1, 2021. 

https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-first-participants-dosed-study-evaluating

Doria-Rose N, Suthar MS, Makowski M, et al. Antibody persistence through 6 months after the second dose of mRNA-1273 vaccine for COVID-19. 

 April 6, 2021. Doi: 10.1056/NEJMc2103916

Moderna Announces Positive Initial Booster Data Against SARS-CoV-2 Variants of Concern. News Release. Moderna; May 5, 2021. Accessed June 1, 2021. 

https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-initial-booster-data-against-sars-cov

Moderna has initiated the rolling submission process for the biologics license application for its COVID-19 vaccine mRNA-1273. 

Moderna Begins Submission Process for FDA Approval for COVID-19 Vaccine 

As there are several shared risk and factors and mechanisms between migraines and abdominal aortic aneurysm (AAA), investigators from Taiwan set out to examine whether patients with migraine could have an increased risk of AAA.

Hypertension, hyperlipidemia and smoking are risk factors for both AAA and migraine, wrote Lin Jou-Yu, with Cheng Hsin General Hospital in Tapei, Taiwan and colleagues in a recent 

International Journal of Environmental Research and Public Health

“Activated matrix metalloproteinases (MMPs), endothelial dysfunction and vascular inflammation also overlap in the disease pathogenesis of AAA and migraine. However, there has been limited research regarding the association between migraine and AAA,” the investigators wrote.

Utilizing the National Health Insurance Research Database (NHIRD), the investigators selected patient and control cohorts by 1:4 matching according to age, sex, and comorbidities, including hypertension, diabetes, hyperlipidemia, acute ischemic stroke, intracerebral hemorrhage, coronary artery disease, atrial fibrillation, heart failure, chronic obstructive pulmonary disease (COPD), chronic kidney disease, and cancer.

They also recorded patients’ long-term medications associated with the treatment of migraine or AAA. These treatments included:

diuretics and angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers,

and anti-migraine agents such as ergot alkaloids, topiramate, valproate, tricyclic antidepressants, selective serotonin reuptake inhibitors, and flunarizine.

The investigators also tracked nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesic drugs other than NSAIDs, including aspirin, acetaminophen and cyclooxygenase-2 inhibitors.

The results demonstrated that patients with migraine had a significantly higher cumulative risk of developing AAA 5 years after the index date compared with the patients without migraine. At the end of the 15-year follow-up period, a significantly higher incidence of AAA (0.98% vs 0.24%) and several comorbidities, including hypertension, hyperlipidemia, COPD, and malignancies, were observed in the patients with migraine compared with those without migraine. In addition, males with migraine had a nearly 6-fold increased risk of AAA compared with females without migraine.

“We therefore propose that male patients with migraine should undergo additional screening examinations for AAA,” the investigators wrote.

Patients with migraine with aura were also more likely to develop AAA than patients who had migraine without aura. However, there were no differences regarding the use of cardiovascular medications, antimigraine medications, NSAIDs, or flunarizine at the end of the study.

Read more of the latest news in migraine 

1. Lin JY, Tung CS, et al. The association between migraine and abdominal aortic aneurysms: A nationwide population-based cohort study. 

. April 20, 2021. doi:10.3390/ijerph18084389.

A recent study examined whether individuals with migraine are at increased risk of abdominal aortic aneurysm. 

Study Identifies Link Between Migraines and Specific Aneurysm

Social distancing practices aimed at minimizing COVID-19 spread amid the pandemic appeared to reduce sleep quality and physical activity in many individuals, leading to worse migraines, according to new research.

The observational study in Italy included 261 migraine sufferers with or without aura who practiced social distancing as a result of stay-at-home orders from March through May 2020. The results 

The participants’ physical activity (PA) levels and intake frequency of main Italian foods were tracked, and the investigators used the Insomnia Severity Index (ISI) questionnaire to measure participants’ sleep quality. 

Twenty-eight percent of participants reported that their migraines worsened during social distancing, whereas 33% said their headaches improved and 39% said their headache frequency was “stable.”

Overall, patients’ physical activity significantly decreased during social distancing, driven by the reported decrease in median walking minutes per week (METs). Simultaneously, time spent at the computer significantly increased in patients reporting headache worsening and in those reporting stable headache frequency. However, computer screen time did not significantly increase among patients reporting an improvement in their headaches.

Social distancing was associated with poor sleep quality as well, according to the findings. The investigators reported an increase in ISI scores in those reporting headaches worsening and stable headache, whereas patients indicating an improvement in their headache only reported slightly increased scores of initial and intermediate insomnia.

Notably, the reduction of physical activity was associated with poor sleep quality. “This correlation was already reported in the general population, imputed to multiple physiological and psychological factors,” the investigators wrote.

The study participants also reported a major increase in the consumption of carbohydrate-rich foods such as bread, pasta, potatoes, and cereal, as well as an increase in consumptions of sweets, across all subgroups. 

Overall, the investigators recommended exercise training and treatment for sleep disorders, “particularly in low pain threshold and frequent mood disordered migraines.”

1. Di Stefano V, Ornello R, et al. Social distancing in chronic migraine during the COVID-19 outbreak: Results from a multicenter observational study. 

Migraine sufferers reported worsened symptoms during social distancing, which may be attributed to reduced sleep quality and physical activity. 

How Social Distancing Amid COVID-19 Pandemic Affected Migraine Patients

The CDC estimates that more than 62% of US adults have received at least 1 dose of a COVID-19 vaccine as of this article’s press time. Keeping up with pandemic news is more important than ever, so check back to 

 to stay informed on the latest coronavirus-related news and research.

NCPA Urges for Transparency, Consistency in Medicare Part D Reporting Requirements

The National Community Pharmacists Association (NCPA) is urging the Centers for Medicare & Medicaid Services (CMS) to require full transparency and consistency in Medicare Part D Reporting Requirements for community pharmacies.

 will soon be available on DrugTopics.com. In this issue,you’ll find great insights into the latest pharmacy trends in independent community practice, technology, autoimmune diseases, and more.

In our newest podcast episode, Megan Numrich, director, support services, Macro Helix, will be talking about HRSA audits and how what pharmacists need to know to effectively prepare for an audit.

On Demand: Helping Retail and Specialty Pharmacies Use the Right Analytics to Unlock Value Beyond Prescription Reimbursements

Pharmacies are a trusted healthcare destination in their communities. But shrinking reimbursements continue to hinder growth and stretch resources. This on demand 

 can use the power of data to drive sustainable growth.

In Case You Missed It: FDA Issues EUA to GSK for COVID-19 Treatment Sotrovimab

Sotrovimab is authorized to treat COVID-19 patients 12 years of age and older with mild-to-moderate infection and who are at high risk for severe disease progression.

Here’s a preview of the featured content to watch for this week on Drug Topics®.

This Week on Drug Topics: May 31 to June 4

Patrick Yoder, PharmD, developed a passion for innovation re-engineering bicycles to better suit the needs of childhood. He started his career in medical research, then as a Clinical Pharmacist and an Informatician. As the vice president of Informatics and Clinical Development at Wolters Kluwer Health, he spearheaded the creation of a solution that established the company as the recognized market leader within four years. He also led the informatics team at Hennepin County Medical Center before co-founding LogicStream Health.

More than 90% of hospital executives and providers surveyed by BD Institute for Medication Management Excellence feel the diversion detection tools their hospitals are currently using are very or somewhat effective. If only.

In reality, nearly half (44%) of hospital pharmacists experienced a diversion event within the past 12 months, which is up from 37% in 2019. The COVID-19 pandemic has exacerbated this “hidden epidemic,” a multi-faceted challenge which poses serious risks to patients, clinicians and healthcare systems. In fact, 25% of hospital pharmacists reported that COVID-19 has increased the likelihood that they’ll implement additional drug diversion prevention approaches.

The good news is that health care systems increasingly recognize the need to switch gears to a more proactive approach. According to Kit Check’s 2020 State of Hospital Pharmacy Operations Report, 37% of hospital pharmacy leaders are investing more resources toward diversion prevention within the next 12 months, and more than half plan to bring in outside resources to help manage their prevention program.

In addition, governing bodies such as the Joint Commission and the American Society of Health-System Pharmacists (ASHP) are developing new guidelines and standards to drive improved best practices for diversion management.

Here are 5 questions frequently asked by health systems seeking to accelerate and improve their efforts to detect and mitigate drug diversion incidents.

What are the biggest challenges in identifying drug diversion?

Limited staff time and other priorities competing for staff attention pose the most common roadblocks, according to pharmacy leaders polled during a recent 

 sponsored by LogicStream Health and hosted by 

 Adding drug diversion identification and management on top of pharmacists’ regular responsibilities has always been challenging, but the COVID-19 pandemic has multiplied the burden.

Many pharmacists have been serving on the vaccination front lines, further limiting the time they can devote to ongoing diversion evaluation and monitoring. At the same time, they have also had to order larger-than-usual quantities of controlled substances and other lifesaving drugs to treat the continuing waves of critically ill COVID patients, increasing the opportunity and temptation for drug diversion within their hospitals.

How have responsibilities for addressing and resolving drug diversion issues evolved?

Drug diversion management has typically been handled by pharmacists. However, drug diversion investigation teams are increasingly expanding to include other departments such as nursing, risk management and human resources. In addition, with the implementation of electronic health records (EHRs), automated dispensing systems (ADS) and other technologies, much of the responsibility for targeting discrepancies has shifted to nurse managers and charge nurses. However, there is still a critical shortage of staff members with the time and skills needed to extract insights from the voluminous data generated. Across operating rooms, nursing floors, and stocking, most hospital pharmacy teams are spending up to 10 hours per week on discrepancies related to controlled substances.

What offers the biggest opportunity to improve diversion identification?

Nearly half (48%) of the Becker’s roundtable attendees said they saw technology – such as automation, machine learning, radio frequency identification and artificial intelligence (AI) – as the biggest opportunity to zero in on drug diversion activity more quickly and accurately. Many health systems still rely heavily on inefficient, time-consuming manual processes, such as periodically spot-checking approximately 10-20% of their total transactions monthly, using 30-day old data.

Health systems that have already deployed a fully automated system and begun reviewing 100% of their transactions are often stunned to see the discrepancies compared with their previously manual processes.

When selecting automated systems and software, which capabilities are most critical?

First and foremost, drug diversion software should integrate data in near-real-time from multiple technology platforms within a hospital system, including EHRs, ADS, and time and attendance systems. By highlighting potential risk, problem areas and documentation anomalies across the clinical continuum, the technology tools accelerate efficiency, accuracy and response time. If investigation is warranted, all-in-one diversion monitoring tools can galvanize collaboration and communication across distributed health system teams.

How do you justify the cost of technology in a difficult economic environment?

Implementing technology to drive improved drug diversion management delivers numerous benefits. Using software to automatically generate weekly reports, identify standard deviation differences and provide visibility into the entire drug lifecycle can eliminate the need to hire extra staff to track diversion. By streamlining investigation and follow-up, technology enables prompt and thorough reporting to the Drug Enforcement Agency (DEA) and licensing boards, which can help avoid negative economic impact as well as prevent continued diversion.

The ability to more quickly and accurately flag potential signs of diversion down to the individual level also allows health systems to get timely treatment for clinicians, pharmacists and other staff in need of help. Supporting caregivers not only prevents them from compromising their own health – it protects the patients for whom they provide care – which is what matters most.

For more information on how to identify, manage and prevent drug diversion, please visit: 

2020 State of Hospital Pharmacy Operations Report. Kit Check. 2021. Accessed May 27, 2021. https://kitcheck.com/resource/hospital-pharmacy-operations-report-2020/

The COVID-19 pandemic has exacerbated the "hidden epidemic” of drug diversion. The good news is that health care systems are recognizing the need to switch to a more proactive approach.

5 Frequently Asked Questions about Drug Diversion Management

With all Americans 12 years and older able to get vaccinated for COVID-19 and the 

CDC releasing recent changes to guidelines

 for fully vaccinated individuals, it’s more important than ever to stay up-to-date on COVID-19 headlines.

Here’s a roundup of the latest coronavirus-related news.

Community Pharmacies with Health Mart, Health Mart Atlas Administer 1 Million COVID-19 Vaccine Doses

This week, 1370 community pharmacies affiliated with 

 have collectively administered 1 million COVID-19 vaccine doses.

Moderna COVID-19 Vaccine Appears Effective and Safe in Adolescents

The company has publicized data from the TeenCOVE study of the vaccine along with plans to seek authorization in the coming weeks.

ACOG Advisory Offers Guidance for COVID-19 Vaccination in Pregnant and Lactating Patients

The Practice Advisory, developed by the American College of Obstetricians and Gynecologists (ACOG), offers an overview of the latest guidance for COVID-19 vaccination in pregnant and lactating patients.

Want to Convince A Patient to Get the COVID-19 Vaccine? Talk To Them About Rubella

 recently talked to Dr Jeffrey Kahn, chief of Infectious Diseases at Children's Health and professor at UT Southwestern about the children's vaccine for COVID-19, the importance of pediatricians, and why the plan to get children vaccinated now should follow the rubella strategy.

Another COVID Inequity: Pandemic-related Decline in Mammography Not Evenly Distributed

 show that the pandemic-related decline in screening mammograms was steeper among Hispanic, American Indian-Alaska Native and Black women than among white women. The investigators reporting the results say the findings suggest yet another healthcare inequity in the COVID-19 pandemic.

Coronavirus News Roundup: Moderna Vaccine Appears Safe and Effective in Adolescents, Community Pharmacies With Health Mart Hit 1 Million Vaccine Doses

The FDA has issued an emergency use authorization (EUA) to GlaxoSmithKline (GSK) for sotrovimab for the treatment of mild-to-moderate COVID-19.

The authorization permits treatment with sotrovimab in both adult and pediatric patients 12 years older and weighing at least 88 pounds with positive SARS-CoV-2 test results who are at high risk for contracting severe COVID-19, including hospitalization or death.

Sotrovimab is a recombinant human immunoglobulin G1K monoclonal antibody that binds to the spike protein receptor of SARS-CoV-2 and blocks viral attachment and entry into human cells.

 The latest COVID-19 treatment will be administered intravenously as a 50- mg single dose. According to Denise M. Hinton, chief scientist at the FDA and author of the authorization letter to GSK, unopened vials of sotrovimab should be stored in refrigerated conditions (36°F to 46°F) and opened, diluted sotrovimab vials should be administered within 24 hours if kept at refrigerated temperatures and within 4 hours if kept at room temperature, including transportation and infusion time.

The FDA’s decision is based on review of the interim analysis of phase 1/2/3 data from the randomized, double-blind, placebo-controlled COMET-ICE clinical trial that evaluated the safety and efficacy of sotrovimab 500 mg in outpatients.

 The study incorporated 583 non-hospitalized adults with mild-to-moderate COVID-19 and a positive SARS-CoV-2 test. Participants were randomized to receive either sotrovimab (n=291) or placebo (n=292) within 5 days of symptom onset. Investigators demarcated a primary end point of COVID-19 progression, defined as hospitalization for more than 24 hours for acute management of any illness, or death from any cause, through day 29. Hospitalization or death occurred in 21 (7%) patients who received placebo and 3 (1%) patients who received sotrovimab, indicating an 85% reduction.

In addition, investigators reported that sotrovimab held up against SARS-CoV-2 variants from the United Kingdom, South Africa, Brazil, California, New York, and India.

The treatment is not for use in patients who have been hospitalized due to COVID-19, nor is it authorized for individuals requiring oxygen therapy for a SARS-CoV-2 infection. Only health care settings with immediate access to medications for anaphylaxis and the ability to activate the emergency medical system can administer sotrovimab treatment. Potential adverse effects include anaphylaxis and infusion-related reactions, as well as rash and diarrhea.

“With the authorization of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research.

 “It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of COVID-19 in the United States.” 

Health care professionals who will be administering sotrovimab under the EUA are encouraged to review the 

Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19. News Release. FDA; May 26, 2021. Accessed May 27, 2021. 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-monoclonal-antibody-treatment-covid-19

Hinton DM. Emergency Use Authorization 100. FDA; May 26, 2021. Accessed May 27, 2021. 

https://www.fda.gov/media/149532/download

Sotrovimab is authorized to treat COVID-19 patients 12 years of age and older with mild-to-moderate infection and who are at high risk for severe disease progression. 

FDA Issues EUA to GSK for COVID-19 Treatment Sotrovimab

Herpes zoster, also commonly known as shingles, is a viral infection that occurs when the dormant varicella-zoster virus (VZV) reactivates in the body after causing an earlier case of chickenpox. Once a person recovers from chickenpox, VZV travels deep into nerve tissues and remains dormant for decades. When it reawakens, it travels back up the same nerve to the skin where it reemerges as shingles.

Any individual that has had chickenpox can develop shingles unless they have been vaccinated against it, which greatly decreases their risk. Approximately 60% of all shingles cases occur in people over the age of 60.

 is a painful and blistering raised rash that erupts most often along one side of the torso, waist, chest, neck, or back. Other sites include around an 

Shingles on the scalp is particularly tricky to treat because the skin there is very sensitive. Simple pressure from washing or brushing the hair can result in broken and bleeding blisters.

Besides pain, shingles on the scalp can cause headaches and weakness on one side of the face that makes it appear to droop. It can also cause hair loss from combing or scratching, or even permanent baldness from cicatricial alopecia, which destroys the hair follicles that generate hair growth and replaces them with scar tissue.

When diagnosing shingles on the scalp, one of the first steps a health care provider takes is to examine the appearance and feel of the rash. They also ask about other symptoms the patient is experiencing.

Symptoms associated with shingles include itching, burning, redness, or tingling in the area of the rash; mild to severe pain in the affected area; fever, chills, nausea, headache, sensitivity to light, and fatigue. A course of antivirals should be started as soon as possible to shorten the length of the infection and help prevent serious complications.

During the acute eruptive phase of shingles of the scalp, the blisters form and then break. A dry crust then forms on the skin. The focus should be on managing the 

 and itching while preventing permanent damage to the scalp.

Recommendations include applying cold compresses to the affected area to numb the pain and using calamine or menthol lotion to lessen itching. Use gentle, unscented shampoos and warm water to wash the hair, and avoid scrubbing the scalp. Don’t use hair spray and styling products for the duration of the rash, which could last 3 to 5 weeks.

, the only shingles vaccine available in the United States, is the one way to protect against shingles and postherpetic neuralgia (

), the most common complication from shingles. The vaccine is recommended for healthy adults age 50 and older. It is administered in 2 shots given 2 to 6 months apart.

“Two doses of Shingrix are more than 90% effective at preventing shingles and PHN. Protection stays above 85% for at least the first 4 years after you get vaccinated,” notes the CDC on its website.

Pay special attention to prevent permanent hair loss.

Managing Shingles on the Scalp	

Keith Loria is a contributing writer to Medical Economics.

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. 

Joann Seigel, RPh, vice president of pharmacy services for Masonic Villages in Elizabethtown, Pennsylvania, noted that with automated packing technology, pharmacists can confidently handle increased volume in the pharmacy without an increase in errors.

“It allows you to service a volume you could never manage manually,” she said. “Smart technologies streamline the med packing process.”

For the pharmacist, smart technology ensures that all a patient’s medications are synced up and billed at the same time, explained Donald Brindisi, RPh, pharmacy manager of Masonic Villages.

“It saves headaches around the concern that a patient is taking their medications as they are prescribed,” he said. “Without technology, supporting a patient that could have 10-plus medications in a single blister would be nearly impossible to do efficiently. We feel much more confident because of our automation.”

Thomas E. Hanzel, PharmD, MBA, national vice president of long-term care/nutraceutical at Parata Systems in Durham, North Carolina, said pharmacies are starting to be held accountable and, to some level, rewarded for improving adherence. 

“The right technology can provide customizable adherence packaging that is flexible enough to be adopted by all customer types and, therefore, improve medication management,” he said. “Pharmacists can verify compliance, as the customer receives notice in a cyclical calendar format where the medications are automatically refilled. This can be on a weekly, monthly, or whatever cycle is best for the customer—therefore, decreasing the chance of missing a dose.”

Sapna Patel, RPh, director of clinical services at Mosaic Pharmacy Service in Sterling, Virginia, explained that previously, pharmacists had to spend a lot of time manually counting, filling, and labeling medications. With the automation of these tasks, pharmacists have additional time for patient interaction, including counseling patients on harmful drug-drug interactions, educating patients on disease states, and reiterating the importance of staying adherent to their medication.

“Pharmacy automation has also decreased medication errors made by pharmacists,” Patel said. “Many automation systems have a pill verification system that increases patient safety while decreasing human error.”

Therefore, adherence packaging services can increase a patient’s confidence in medication management and improve their overall health by helping them take their medications as prescribed.

If a pharmacy isn’t currently offering an adherence program, it usually is due to a lack of efficient technology. To start an adherence program, it can be helpful to have show-and-tells or introductory meetings with provider offices, discharge planners, short-term rehabilitation centers, and insurance companies, Seigel said.

“Getting key players involved early on to demonstrate the value of engaging with your adherence program is a great way to begin those partnerships,” she said. “Compliance packaging typically comes first and is then supported by the introduction of automation into the pharmacy.”

It will also depend on one’s customer base. For example, although smart cards are great for retail and behavioral health settings, they are not as ideal for long-term care settings.

“Knowing which patient populations you’re looking to support will dramatically change the type of adherence program and the way it is implemented,” Seigel said.

More and more seniors are staying in their own homes rather than going to a nursing home. A recent article in the 

 reported a 15% drop in nursing home occupancy since 2019—mainly due to concerns around the COVID-19 pandemic.1 Seniors who live on their own may need additional support from their care providers when it comes to medication adherence.

“Adherence packaging has allowed pharmacists to help manage patients’ medications better by spending less time filling and more time managing their overall health,” Patel said.

For example, Patel cited a recent case study on a 70-year-old man on 25 medications. The patient has an extensive medical history, which includes diabetes, hypertension, overactive bladder, hyperlipidemia, gastroesophageal reflux disease, and neuropathy. He lives alone and has a hard time remembering to take some of his medications. He became nonadherent due to cost and medication overload.

“Mosaic Pharmacy Service leverages a comprehensive care model that includes filling medications in adherence packaging to help our medically complex patients stay adherent to multiple medications,” she explained. “I switched this patient to more cost-effective medications organized by date and time of dose in adherence packaging, which helped to simplify his routine and ultimately made it easier to stay adherent.”

COVID-19 has disrupted daily processes and routines for many patients, leading to medication adherence concerns. Pharmacists have had to implement strategies to help their patients stay adherent amid a variety of logistical challenges; this includes services like curbside pickup, home delivery, and—of course—adherence packaging.

“[COVID-19] has allowed pharmacists to see the importance of adherence packaging to help manage patient’s medication regimens,” Patel said. “Having all their medication synchronized to fill once a month allows for better adherence and more time for pharmacists to focus on helping patients manage their chronic conditions.”

Adherence packaging is good for any patient managing multiple chronic conditions that require them to take medications multiple times per day. It is also good for patients who have a caregiver helping them manage their medication because adherence packaging makes it easy to see if the medications have been taken at the scheduled time.

The patients most likely to benefit from adherence packaging are those whose caregivers may be far too busy to manage family members’ medications.

“Home health agencies really value compliance packaging for their facilities,” Seigel said. “Patients who may be very far away from their loved ones or a power of attorney can rest easier knowing their medications are being managed safely—which provides peace of mind for both the patient and those responsible for their care.”

The senior population is also at high risk of nonadherence, which is why Patel believes seniors who are on 5 or more medications would benefit most from adherence packaging.

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