The CDC estimates that 65.4% of US adults have received at least 1 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.

Labor Shortage Affecting Local Pharmacies

The national labor shortage is affecting independent pharmacies that are struggling with hiring employees, according to the results of a new survey released by the National Community Pharmacists Association.

 is now available on DrugTopics.com. In this issue, you’ll find great insights into the latest pharmacy trends in independent community practice, diabetes, respiratory and autoimmune diseases, and more.

Medical World News: Part 3 - Leverage Technology to Maximize COVID-19 Vaccinations, Boost Clinical Services and Transform Pharmacy Practice

 Jason Ausili, PharmD, chief clinical officer at FDS, discusses how independent community pharmacies can leverage technology to save time and reinvest in clinical services now and beyond the pandemic.

On Demand: What You Don't Know Can Cost You: Simple Ways to Make Data-Driven Decisions in Your Pharmacy

In this podcast episode with Jeff Harrell, PharmD, learn simple tools and tips to optimize profitability and streamline operations using objective data straight from your pharmacy.

Community Pharmacy, Health System Partnership Improves Hypertension Care

® article examines a partnership between the University of Michigan Medical Group and Meijer Pharmacies focused on improving care for patients with hypertension. Check back to drugtopics.com this week to read the article.

In Case You Missed It: Pharmacists’ Public Health Role Grows as Birth Control Prescribing Authority Expands

An increasing number of pharmacists are now prescribing birth control, further expanding their role as public health service providers.

Articles

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

This Week on Drug Topics: June 21 to June 25

Although COVID-19 remains a real threat, it seems we are now progressing toward a return to normalcy thanks to the widespread availability of vaccines and tireless efforts of our health care workers.

As the country continues to reopen, vaccinated Americans are gearing up to resume normal summertime activities, such as vacations and outdoor gatherings. Because June signals the beginning of summer—bringing warmer weather—Jennifer Gershman, PharmD, CPh, discusses in this issue 

how pharmacists can counsel patients with certain autoimmune conditions during summer months

 on ways to reduce symptom flares associated with rising temperatures.

June is also LGBTQ Pride Month, so we are examining the stark health disparities affecting LGBTQ+ individuals and how pharmacists can provide more inclusive care and services. In addition to being the medication experts, pharmacists are often the most frequent touchpoints a patient has with the health care system. Our 

t focuses on how pharmacists can best support LGBTQ+ patients and create a more inclusive environment in the pharmacy.

In this issue, we also recognize National Headache and Migraine Awareness Month by highlighting how pharmacists can assist patients in prevention, treatment, and medication management. This month, you’ll find an 

 of the various pharmacologic and nonpharmacologic therapies available for migraine

Health Insurance Portability and Accountability Act compliance

Although COVID-19 remains a real threat, it seems we are now progressing toward a return to normalcy thanks to the widespread availability of vaccines and tireless efforts of our health care workers. 

Pharmacists Can Help Patients as Signs of Normalcy Return

Jason Ausili Interview, Part 2

Jason Ausili Interview, Part 1

 What are some of those biggest barriers? Have they been able to keep up with demand without issues with supply?

 There was this period where, okay, we don't have vaccine yet. Let's try to prepare for the vaccine. And then boom! All of a sudden, it's like, “Okay, we've got vaccine. Now, what do we do?”

And some of the most popular barriers that pharmacies have encountered are, do I have a medical billing solution that can help me get paid for these vaccines? Because, especially the Medicare population, a lot of the Medicaid populations and the managed care organizations (MCOs), and even the uninsured require medical billing to get paid.

So, in order to do this in a way that's scalable and meaningful, pharmacists need to get the admin fee for administering the shots. So having a medical billing solution that really seamlessly integrates with their pharmacy management workflow was a key part of the overall goal.

Unfortunately, a lot of folks weren't prepared. The medical billing world is new to a lot of people and to pharmacy. They're so familiar with the prescription billing process and have sometimes gotten isolated in that world. When it came time to get used to a medical billing platform, it was a new to a lot of folks, and people had to go shopping for the right solution that could ensure that they're getting paid through all of their payer channels: Medicaid, Medicare commercial. And that's one of the angles that we've been able to help folks out. But there's a few other angles.

Dedicating resources in time was a huge struggle for many people, because their staff - the pharmacist and their staff are typically dedicated to the normal pharmacy workflow. And this massive vaccination effort created them to pivot and shift almost on a dime to free up pharmacist time to dedicate to the vaccination effort. In fact, not just pharmacists time, but the entire team needs to get involved in the process. So that was a big eye opener for many pharmacies.

Next was, you got to have a scheduling app, because you can't have a mad rush of patients in your pharmacy all at once to get the vaccine. It has to be coordinated. As pharmacies were working through the various phases, they had to wait to qualify patients for the phase and then schedule them appropriately.

And on top of that, state registry reporting is a big requirement with COVID-19 vaccination. Many pharmacies have been, exposed to them in the past with flu and other reportable vaccines, but they've done it largely in a manual way. And with the large volume of COVID-19 vaccines, it really became inefficient to try to do it manually and report those vaccines in the state in a way that wasn't automated.

And then finally, just overcoming other workflow barriers. COVID life is different for pharmacies. I remember in the beginning, people were really concerned about physical barriers and directing traffic in a way that if you did have a sick person in your store, they weren't infecting other people. So, it really has flipped pharmacy upside down in a way in parallel to highlighting the real value that we bring the communities.

So, where we're focused, Gabrielle, is really showing how technology can really overcome many of those barriers. And I'd love to be able to talk to you about that as well.

Starting at the top medical billing. Having a medical billing solution that really seamlessly integrates with the pharmacy management workflow is critically important. There's solutions that you really don't have to deviate from your normal prescription filling process. By coordinating with the medical plan, medical billers can grab that claim from the switch and convert it to a medical claim that's in a completely different format than the pharmacy claim.

But that's a really good thing, because as pharmacists, we need to ensure we're getting paid as providers and not dispensers of services. So, this is a really big move for pharmacies, and we need to double down on getting more volume and more traffic to the medical billing realm and getting more awareness from the medical payers. Otherwise, we have a steeper hill to climb in trying to get recognized as providers.

It is a new world for a lot of people. With filling prescriptions, you're so used to billing one way, and that’s billing for products, and it flows through the PBM and there's all sorts of considerations regarding reimbursement to that pathway. But in order to really get traction on the medical side, and be viewed as providers of services, we need to get more awareness and more volume on the medical billing side, so the medical payers recognize pharmacy as a provider of services.

COVID has definitely provided an expedited pathway there. And it's been a little rocky for some people as they're trying to get used to this new world, I just want to mention that, hey, this is this is scary, change can be scary. But there's folks out there to help you along the way and make sure that you're leveraging the tools that are in your tool belt, and that technology can really be used to grease the wheels for you, and help you get this done at the end of the day.

Because this is the beginning, I think of something that we see as only growing. COVID might have been a spark to the medical billing opportunities, but it's not the end. There's much more opportunities for pharmacies to show that they can drive improvement in their communities through public health, but also get paid as providers for those services through the medical billing channel.

Click here for more expert interviews from

Expert Interviews

In part 2 of our interview, Jason Ausili, PharmD, speaks to the challenges of COVID-19 vaccination processes and dives into technology solutions for these workflow barriers. 

Part 2: Leverage Technology to Maximize COVID-19 Vaccinations, Boost Clinical Services, and Transform Pharmacy Practice

Jennifer Barrett is the senior editor for 

Officials with the FDA have approved OTC azelastine HCl .15% (Astepro Allergy; Bayer) for the temporary relief of nasal congestion, runny nose, sneezing, and itchy nose due to hay fever or other upper respiratory allergies for adults and children 6 years and older.

The OTC formulation will be available in full prescription strength and includes flexible once or twice daily dosing that provides up to 24-hour symptom relief.

Prior to this approval, azelastine HCl .15% was only available with a prescription in the United States. With its OTC switch, azelastine HCl .15% is the only steroid-free, antihistamine nasal spray for allergies available over the counter.

“At Bayer, we help make self-care a reality for billions through everyday healthcare. This new differentiated product is 1 step in that direction, with the potential to help millions of people in the US that suffer from seasonal allergic rhinitis,” Catherine Vennat, VP/GM Bayer Consumer Health US, said in a statement. “With Astepro Allergy, allergy sufferers can get relief of allergy nasal symptoms in an over-the-counter treatment option without steroids or decongestants that will last up to 24-hours. It will bring crucial differentiated allergy product to the Bayer allergy portfolio to address unmet consumer needs with allergic rhinitis.”

OTC azelastine HCl .15% will be available at national mass retail locations in Q1 2022, according to Bayer.

FDA Approves Astepro Allergy Nasal Spray for Over-the-Counter Use in the United States. News Release. Bayer; June 17, 2021. 

https://www.businesswire.com/news/home/20210617005872/en/FDA-Approves-Astepro%C2%AE-Allergy-Nasal-Spray-for-Over-the-Counter-Use-in-the-United-States

The FDA has approved OTC azelastine HCl .15% (Astepro Allergy; Bayer).

FDA OKs OTC Use of Steroid-Free Antihistamine Allergy Nasal Spray

There was a marked decline in child and adolescent routine vaccine administration during the COVID-19 pandemic between March and September 2020; these vaccination rates have continued to lag behind.

Study results published by the CDC on June 11, 2021, emphasized that pediatric vaccine administration rates continue to lag behind prepandemic levels. The study was conducted from March through June 2020 over a 6-month period, which was subdivided into 2 time periods. The first was March through May 2020 and the second was June through September 2020.

Investigators analyzed immunization information data taken from 10 jurisdictions in the United States, including New York City, Michigan, Wisconsin, and Iowa. The findings revealed there were fewer administered doses of routine childhood and adolescence vaccines in all 10 jurisdictions from March through September 2020, during the COVID-19 pandemic compared with those recorded during the same period in 2018 and 2019.

There was a substantial decline from March through May 2020, when many jurisdictions enacted stay-at-home orders. Some of the vaccines that were tracked included diphtheria, tetanus, pertussis, measles, mumps, and rubella, and human papillomavirus vaccines. Vaccine doses administered declined during the COVID-19 pandemic from between 15.7% to 71.3%. The older age group experienced a steeper decline in vaccines administered when compared with the younger-aged children.

From June through September 2020, after most stay-at-home orders had been lifted, the number of weekly routine pediatric vaccine doses administered increased from the previous 3 months. However, the increase was not sustained, and the number of vaccine doses still declined compared with 2018 and 2019 but at a lesser rate than the 3 months prior. Despite the vaccine administration rebound that occurred, the investigators indicated that the increase was not enough to address the number of catch-up vaccinations needed.

According to the investigators, the first limitation of the study was that vaccination data from only 10 US jurisdictions were analyzed. Therefore, findings might not be as ideal a representation of the United States as possible. The second limitation was that only 1 type of data system was used to analyze the data and there are multiple other data vaccination systems available. Thirdly, the study never scientifically analyzed the specifics regarding the reason for the decrease in the vaccination administration during the COVID-19 pandemic.

The investigators noted several factors may have caused this significant decrease in the amount of routine pediatric vaccines administered. For example, fear of contracting COVID-19 in health care facilities and the community during the pandemic may have prevented some from seeking routine pediatric care for their children. “While families followed public health warnings about going out, an unfortunate result was many missed routine vaccinations.”[1][2]

Vaccine-preventable disease outbreaks can lead not only to morbidity and mortality but also can lead to a loss of in-person learning for the children. When the COVID-19 vaccine becomes available to the pediatric population, the CDC recommends that health care providers should administer the COVID-19 vaccines with other routinely recommended vaccines for pediatric patients who are behind on their routine recommended vaccines. Through a group effort, health care providers should assess the status of all pediatric patients including adolescents, and contact those who are behind in their vaccination schedule to ensure they are caught up with their current vaccinations.

In August 2020, Alex Azar, MD, former secretary of the US Department of Health and Human Services [JB1]

 during the COVID-19 pandemic to authorize licensed pharmacists in the United States to administer routine vaccinations to children. This move was to prevent future outbreaks of measles and other preventable diseases and to help prevent the falling vaccination rates. “Enabling pharmacists to expand their offering of vaccination is welcome news for families and young patients, for whom neighborhood pharmacists are often the most accessible health care providers,” National Community Pharmacists Association CEO B. Douglas Hoey, MBA, RPh, said of the action.2

1. Murthy BP, Zell E, Kirtland K, Jones-Jack N, et al. Impact of the COVID-19 pandemic on administration of selected routine childhood and adolescence vaccinations—10 US jurisdictions, March-September 2020. 

2. Blank C. All Pharmacists Now Authorized to Administer Childhood Vaccines. 

. Published August 21, 2020. Accessed June 18, 2021. https://www.drugtopics.com/view/all-pharmacists-now-authorized-to-administer-childhood-vaccines.

Routine Pediatric Vaccinations Continue to Lag Amid COVID-19 Pandemic

Don’t waste time digging through articles to find the most up-to-date and important news. Drug Topics® 

has you covered with our weekly news roundup of the latest pharmacy-related news you should know before the weekend begins.

Here’s a roundup of the latest news coverage from

Keep Up With Policy Changes Affecting Independent Pharmacy

This special Over the Counter episode, brought to you by Total Pharmacy® and Omega Pharmacy Group, dives into how to navigate the business of independent pharmacy and get ahead of key policy changes.

Pharmacists’ Public Health Role Grows as Birth Control Prescribing Authority Expands

From our June 2021 issue: An increasing number of pharmacists are now prescribing birth control, further expanding their role as public health service providers.

FDA Approves Pneumococcal 20-Valent Conjugate Vaccine for Adults

The vaccine is indicated to prevent invasive disease and pneumonia caused by 20 Streptococcus pneumoniae serotypes.

Moderna Files for EUA for Use of COVID-19 Vaccine in Adolescents

Moderna has filed for FDA emergency use authorization for use of its COVID-19 vaccine in adolescents aged 12 through 17.

Novavax COVID-19 Vaccine Demonstrates 90% Overall Efficacy

Novavax’s recombinant nanoparticle protein-based COVID-19 vaccine showed an overall efficacy of 90.4% and 100% efficacy against moderate and severe disease.

FDA Approves Oral Pellet Formulation of Epclusa®

The US Food and Drug Administration (FDA) approved expanded pediatric indication for Epclusa® (sofosbuvir/velpatasvir) to treat chronic hepatitis C virus.

Plant-Based and Pescatarian Diets Lower Odds of COVID-19 Infection

A plant-based or pescatarian diet—which includes fish and seafood—significantly reduces the odds of developing moderate-to-severe COVID-19, according to new research in BMJ Nutrition Prevention & Health.

The nation's highest court has upheld the ACA three times.

Here’s a roundup of the latest news coverage from Drug Topics®. 

News Roundup: FDA OKs New Pneumococcal Vaccine, Novavax COVID-19 Vaccine 90% Effective

AJ Rivosecchi, PharmD, is a product manager at Kit Check. He completed his undergraduate studies and Pharmacy school at the University of Pittsburgh, graduating Summa Cum Laude with a Doctor of Pharmacy (PharmD) degree. He has over 10 years of hospital pharmacy experience, most recently serving as the Manager of Pharmacy Operations for UPMC St. Margaret Hospital in Pittsburgh where he championed many process improvement projects including implementing a controlled substance diversion monitoring program in conjunction with nursing leadership. AJ was active in health-system pharmacy operations planning and initiatives including policy review and development, chairing the UPMC Pharmacy Operations Finance committee and serving on the Health System Pharmacy Operations Construction and Diversion committees. AJ has extensive experience in all aspects of health system pharmacy operations, controlled substance management, coordinating diversion investigations, peri-operative pharmacy services, and pharmacy automation.

Hospital pharmacies are one of the busiest hubs in any health care system. In addition to dispensing and keeping track of medications, pharmacies are faced with administrative tasks that consume valuable time that could be spent focusing on crucial initiatives like patient care. One of the biggest and most time-consuming challenges they must address on a regular basis is cost control and budget management. This has always been an obstacle for health care organizations, as many facets of cost management are uncontrollable, like rising drug prices, new biologics that provide better patient outcomes, and shifting patient needs.

Nothing has shed more light on the challenges of balancing hospital spending than the COVID-19 pandemic, which drove up hospitals’ costs while significantly reducing the income they usually generate through outpatient visits and elective procedures.

 With so many changing factors that hospitals can’t control, organizations must focus on managing what they can, especially considering some only have 12 to 45 days of cash on hand.

 Exacerbating this challenge is the fact that 60% of hospital pharmacists have been given a cost savings goal due to budget tightening as a result of COVID-19. And for 

, their savings goal is as large as $300,000.

 The hospital pharmacy must play its part by leveraging technology to control the costs of doing business and supporting the enterprise in addition to focusing on patient care.

Streamlining Budget Management With Technology

Manual budget management is extremely time-consuming for hospital pharmacy staff, who often lack the resources to compare prices and ensure they’re optimizing the negotiated contracts and prices available to them. Additionally, staff are more likely to make mistakes if they’re using manual processes, which can lead to suboptimal cost management. That’s why technological solutions can be so helpful for hospital pharmacies. In addition to streamlining the task and reducing the amount of work needed by staff, the real-time data they provide enables hospitals and health care systems to see exactly when prices and inventories change so that they can adjust and pivot as needed. This is crucial because of fluctuating costs. For example, GoodRx data from January 2021 showed that 832 drugs in total increased in price by an average of 4.5%.

Hospitals may also experience significant shifts in the types and quantities of drugs they need. When the COVID-19 pandemic hit, demand for the drugs necessary for sedation and intubation skyrocketed, and hospitals treating influxes of critically ill patients needed more of these medications than ever before. This major change impacted hospitals down the line, as they had to monitor their spending more carefully on medications that they keep permanently stocked as well as things like personal protective equipment. Not to mention, this is all on top of rising overall costs. According to the most recent report from the American Society of Health-Systems Pharmacists (ASHP) Research and Education Foundation,

 the average total drug spending per hospital admission increased by 18.5% in 2017 compared with 2015. As a result, 1 in 4 hospitals had to cut staff and more than 90% had to identify alternative therapies to cope with drug shortages or sharp price increases. Once again, price monitoring technology is poised to help. By tracking purchasing options from different wholesalers and monitoring an organization’s historical spending, these solutions can make suggestions as to the most cost-effective options that will still provide the best patient outcomes—every hospital’s top priority.

Budget management is more important now than ever, and with changing legislation around drug pricing,

 costs are likely to keep fluctuating. Now is the time for organizations to consider implementing tools that can help them stay organized and on track, as the health care system must remain poised to react to unpredictable events like the COVID-19 crisis. Access to real-time data and cost information can assist with preparation by enhancing price transparency, providing hospital pharmacists with updates on price fluctuations, and more. This can lead to improved evidence-based purchasing and, potentially, significant savings for hospitals.

AJ Rivosecchi is a Product Manager at Kit Check. He completed his undergraduate studies and Pharmacy school at the University of Pittsburgh, graduating Summa Cum Laude with a Doctor of Pharmacy (PharmD) degree. He has over 10 years of hospital pharmacy experience, most recently serving as the Manager of Pharmacy Operations for UPMC St. Margaret Hospital in Pittsburgh where he championed many process improvement projects including implementing a controlled substance diversion monitoring program in conjunction with nursing leadership. AJ was active in Health System Pharmacy Operations planning and initiatives including policy review and development, chairing the UPMC Pharmacy Operations Finance committee and serving on the Health System Pharmacy Operations Construction and Diversion committees. AJ has extensive experience in all aspects of health system pharmacy operations, controlled substance management, coordinating diversion investigations, peri-operative pharmacy services, and pharmacy automation.

1. John Commins. Pandemic Continues to Strain Hospital Volumes, Margins, Revenues in 2021. 

Updated February 22, 2021. Accessed June 14, 2021. 

https://www.healthleadersmedia.com/finance/pandemic-continues-strain-hospital-volumes-margins-revenues-2021

2. Findings Brief: NC Rural Health Research Program. The Cegil G. Sheps Center for Health Services Research, The University of North Carolina at Chapel Hill. May 2020. Accessed June 14, 2021. 

https://www.shepscenter.unc.edu/wp-content/uploads/dlm_uploads/2020/05/Most-Rural-Hospitals-Have-Little-Cash-Going-into-COVID.pdf

3. 2020 Hospital Pharmacy Operations Report. Kit Check. 2021. Accessed June 14, 2021. 

https://kitcheck.com/wp-content/uploads/2021/03/2020-HPOR-final.pd

4. Marsh T. Live Updates: January 2021 Drug Price Increases. GoodRx. Updated January 19, 2021. Accessed June 14, 2021. 

https://www.goodrx.com/blog/january-drug-price-hikes-2021/

5. Vermeulen LC, Eddington ND, Gourdine MA, Jorgenson J, et al. ASHP Foundation pharmacy forecast 2019: Strategic planning advice for pharmacy departments in hospitals and health systems. 

American Journal of Health-System Pharmacy

6. Van Antwerp G, Naaz B, Korba C. State drug pricing policies: Drug companies and PBMs should prepare for continued activity. Deloitte Insights. Updated July 16, 2020. Accessed June 14, 2021. 

https://www2.deloitte.com/us/en/insights/industry/life-sciences/state-drug-pricing-legislation.html

The hospital pharmacy must play its part by leveraging technology to control the costs of doing business and supporting the enterprise in addition to focusing on patient care.

Hospital Pharmacies and Budget Management: How Technology Can Help 

New data from the RECOVERY (Randomized Evaluation of COVid-19 thERapY) clinical trial indicated that the combination treatment with casirivimab and imdevimab (REGEN-COV; Regeneron Pharmaceuticals) significantly reduced the risk of death in patients who have been hospitalized with COVID-19.

Study investigators reported that casirivimab and imdevimab reduced the risk of death by 20% in hospitalized seronegative patients with COVID-19 – those who had not mounted a natural antibody response against SARS-CoV-2 – according to the 

The casirivimab-imdevimab combination has already been authorized by the FDA to treat nonhospitalized adult and pediatric patients with mild-to-moderate COVID-19 infection and who are at high risk for disease progression and death.

FDA Adjusts EUA for COVID-19 Antibody Treatment

This news closely follows recent dosing changes that are now reflected in the emergency use authorization (EUA) granted to Regeneron; casirivimab and imdevimab dosages were both reduced to half in light of data showing that a 1200-mg dose (600 mg casirivimab and 600 mg imdevimab) was just as effective as a 2400-mg dose.

From September 2020 to May 2021, 9785 patients across 176 hospitals in the United Kingdom who had been hospitalized with COVID-19 were randomized to receive usual care plus 8000 mg intravenous (IV) infusion of the antibody combination or usual care alone. Investigators of the independently run clinical trial found that the antibody treatment reduced hospital stays by 4 days (13 days in the treatment group versus 17 days with usual care only). Analysis of seronegative patients demonstrated that 8000 mg of casirivimab plus imdevimab reduced all-cause mortality by 20% compared with usual care alone (24% of patients in the REGEN-COV group died versus 30% in the usual care group by day 28; rate ratio [RR]: 0.80; 95% confidence interval [CI]: 0.70-0.91; 

Additionally, researchers reported that the proportion of patients discharged alive by day 28 was greater in the treatment group than the group receiving usual care (64% versus 58%; RR: 1.19; 95% CI: 1.08-1.30).

The UK-based clinical trial is the first to validate the potential for antibody treatments to improve survival rates in hospitalized COVID-19 patients. "Definitive phase 3 trials have now demonstrated that REGEN-COV can alter the course of COVID-19 infection, from prevention to very early infection, all the way through to when patients are on a ventilator in the hospital," said George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron.

Given the promising results, Regeneron intends to immediately update the FDA on the new findings and request that its EUA for the antibody treatment be expanded to include patients hospitalized with COVID-19. “We intend to rapidly discuss these results with regulatory authorities, including in the US where we will ask for our EUA to be expanded to include appropriate hospitalized patients,” Yancopoulos said.

REGEN-COV (Casirivimab and imdevimab) Phase 3 Recovery Trial Meets Primary Outcome, Improving Survival in Hospitalized COVID-19 Patients Lacking An Immune Response to SARS-CoV-2. News Release. Regeneron; June 16, 2021. Accessed June 16, 2021. 

https://investor.regeneron.com/news-releases/news-release-details/regen-covtm-casirivimab-and-imdevimab-phase-3-recovery-trial

The RECOVERY study demonstrated that an antibody combination therapy (REGEN-COV; Regeneron) improved survival in hospitalized patients, a first for COVID-19 antibody treatments. 

New Data Show Combination Antibody Treatment Reduces Risk of Death in Hospitalized COVID-19 Patients

Kathryn Wheeler, PharmD, BCPS, is assistant clinical professor of pharmacy practice, University of Connecticut School of Pharmacy, Storrs, Conn.

On April 2, 2021, the FDA approved viloxazine (Qelbree; Supernus Pharmaceuticals, Inc) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children aged 6 to 17 years. Viloxazine is a selective norepinephrine reuptake inhibitor and is the first new nonstimulant medication for treatment of ADHD in children in more than 10 years. 

The FDA evaluated the safety of viloxazine in 3 randomized, placebo-controlled trials. Studies 1 and 2 included participants aged 6 to 11 years and lasted either 6 or 8 weeks that included a titration period to achieve maintenance dosing of 100 mg, 200mg, or placebo daily (study 1) and 200mg, 400mg, or placebo daily (study 2). Participants aged 12 to 17 years were titrated to either 200 mg or 400 mg or placebo in study 3. The primary end point in each study is a change in total score on the ADHD Rating Scale (AHD-RS-5), comparing baseline to the end of the maintenance period assessments. The change in Clinical Global Impression-Improvement (CGI-I) score from baseline served as a secondary end point in each study. In all 3 studies, patients administered viloxazine demonstrated statistically significant improvements in ADHD rating scale scores and in CGI-I scores compared with participants administered placebo. 

In trials, 826 participants were exposed to a dose of viloxazine that ranged from 100 mg to 400 mg. In this group, the most common adverse effects (AEs) included nausea, vomiting, insomnia, irritability, decreased appetite, and somnolence. The most common AEs leading to discontinuation of the medication included somnolence, nausea, fatigue, decreased appetite, headache, tachycardia, and irritability. Viloxazine carries a boxed warning regarding higher rates of suicidal thoughts and behaviors among participants administered viloxazine in clinical trials compared with participants administered placebo. Patients treated with viloxazine should be monitored for suicidal ideation or behaviors, particularly when initiating or increasing therapy. Patients experiencing these symptoms may require a discontinuation of viloxazine therapy. Viloxazine may activate mania in patients at risk for bipolar disorder. Patients should be screened prior to initiating therapy for a history of suicide, depression, or bipolar disorder. 

Viloxazine may also cause an increase in blood pressure and heart rate. A patient’s blood pressure and heart rate should be assessed at baseline when initiating therapy and periodically throughout treatment. Somnolence and fatigue associated with viloxazine administration may affect a patient’s mental alertness. Until a patient knows how viloxazine will affect them, they should avoid operating machinery or driving. Concomitant administration of viloxazine with monoamine oxidase inhibitors is contraindicated due to an increased risk of hypertensive crisis. Viloxazine strongly inhibits cytochrome P450 1A2 (CYP1A2) and will increase exposure to concomitant CYP1A4 substrates and increase the risk of AEs to those medications. In addition, viloxazine weakly inhibits CYP2D6 and CYP3A4. Patients should be monitored for AEs associated with any additional medications they take that may be impacted by this interaction.

In patients aged 6 to 11 years, the recommended starting dosage of viloxazine is 100 mg once daily and may be titrated in 100-mg increments weekly to a maximum dosage of 400 mg once daily. The recommended starting dosage for patients aged 12 to 17 years is 200 mg once daily. In this age group, the dosage may be titrated up in 1 week to the maximum recommended dosage of 400 mg once daily. Capsules may be swallowed whole with or without food or may be opened and contents sprinkled on applesauce. The capsule or applesauce with sprinkled medication must not be chewed. Medication mixed with applesauce must be used within 2 hours of mixing and cannot be stored for later use.

Qelbree. Prescribing information. Supernus Pharmaceuticals Inc; 2021. Accessed May 11, 2021. 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211964s000lbl.pdf

Viloxazine is a selective norepinephrine reuptake inhibitor and is the first new nonstimulant medication for treatment of ADHD in children in more than 10 years.  

New Nonstimulant Medication Is Approved for ADHD in Children

However, my 4-year-old grandson Luke lives near a golf course, and one of our favorite activities is walking through the woods searching for golf balls. Luke describes these golf balls as the ones hit by “bad golfers.” We have collected more than 250 golf balls, and about 200 of them are white. Therefore, Luke feels it is safe to conclude that bad golfers buy white golf balls, since that is the predominant color we find. If you want to be a great golfer, don’t buy white golf balls.

As failed as this logic appears, we have individuals with vaccine hesitancy applying the same logic. Many nonexperts frequently take to social media to express their antivaccine views, with virtually no understanding of virology or immunology. It’s like getting golf advice from a 4 year old.

One simple statistic should convince everyone who is reluctant to get the COVID-19 vaccine. According to an analysis conducted by the Kaiser Family Foundation, “Since vaccinations began in mid-December 2020, the number of COVID-19 deaths in long-term care facilities across all states in this analysis has declined by 89% as of April 2021.”

Currently, our nation doesn’t have half of our citizens fully vaccinated. We community pharmacists are seeing vaccine hesitancy with the same zeal we saw for 

 the vaccine 6 months ago. I’ve even had discussions with pharmacists who have no interest in getting vaccinated. For the first 4 months of this year, there has been little movement of getting the “definitely nots” vaccinated. According to epidemiologists, we need to vaccinate 80% of the population to reach herd immunity. And to think we have 13% of Americans who are “definitely nots” that will never accept vaccination.

In my 40 years of health care, I’ve seen nothing like this. I remember that mysterious disease in the 1980s that devastated many communities in our nation. Three years after the first cases were reported, the etiology was discovered and named human immunodeficiency virus. Yes, it took a worldwide effort of 3 years to even name and elucidate the cause of HIV. It took another dozen years to have effective treatment protocols to include combinations of different HIV drugs to save lives. Today, treating HIV is easier than treating type 2 diabetes; patients simply need to be adherent to their medications

Here we are 15 months after the pandemic, and we have a vaccine that is 95% effective in preventing disease and nearly 100% effective in preventing death due to COVID-19. We pharmacists are struggling to find arms to get vaccines into from our overstocked refrigerators and freezers. Individuals read posts on social media, get advice from family members and friends and apply it to their decision whether to get the vaccine or not. Thanks to social media, everyone is an expert and has a forum to post their unsubstantiated opinions. 

I’m glad that in the middle of the HIV epidemic in the 1980s and 1990s, we had no such venue as social media. We listened to the experts and waited for the scientists to come up with treatment protocols and then treated our patients accordingly.

We are blessed to have a number of COVID-19 vaccination options, all efficacious, with the only substantial differences among them being storage requirements. We community pharmacists need to engage our patients and encourage them to get vaccinated; we don’t need them to turn to social media. 

If they believe everything on social media and they need to improve their golf game, I know a 4 year old who can give them advice from his scientific study. “Don’t buy white golf balls.”

Chidambaram P, Garfield R. COVID-19 long-term care deaths and cases are at an all-time low, though a rise in LTC cases in a few states may be a cause for concern. Kaiser Family Foundation. April 22, 2021. Accessed May 11, 2021. 

https://www.kff.org/coronavirus-covid-19/issue-brief/covid-19-long-term-care-deaths-and-cases-are-at-an-all-time-low-though-a-rise-in-ltc-cases-in-a-few-states-may-be-cause-for-concern/#:~:text=Since%20vaccinations%20began%20in%20mid,1%20and%20Appendix%20Table%201

Huetteman E. Covid vaccine hesitancy drops among all Americans, new survey shows. Kaiser Health News. March 30, 2021. Accessed May 11, 2021. 

https://khn.org/news/article/covid-vaccine-hesitancy-drops-among-americans-new-kff-survey-shows/

Many Americans still do not want to get vaccinated. Vaccine myths spread on the internet are a major part of the problem. 

Social Media Incites the COVID-19 Misinformation Epidemic 

Director, International Drug Information Center

Since the onset of the COVID-19 pandemic, emphasis has been placed on monitoring health status, screening for disease states, and ensuring that the general public is not exposed to the virus and/or exhibiting signs and symptoms of COVID-19. One of the methods used to detect illness and prevent the spread of the disease is monitoring for fever with the use of thermometers. According to IRI, a Chicago-based market research firm, the sale of personal thermometers increased by 297% during the 4-week period ending March 22, 2020, compared to the same time period 1 year earlier.

 Since COVID-19 remains a public concern, it is important for pharmacists to be familiar with the various types of thermometers available on the market and to provide proper guidance on their use.

The body maintains a state of homeostasis regulated by the hypothalamic thermoregulatory center. The center balances excess heat production from metabolic activity in the muscle and liver by allowing heat to be released from the skin and lungs to maintain a mean oral temperature of 36.8

 0.7o F). Fluctuations in body temperature occur throughout the day, with temperature being lower in the morning and higher in the evening.

 Furthermore, the temperature considered to be fever differs based on the measurement site (

Body Temperature per Site of Measurement

Considerations When Selecting a Thermometer

Various thermometers are available on the US market. When selecting a thermometer, identifying one that will provide an accurate reading is most important. Since the FDA regulates thermometers as medical devices, all approved thermometers are considered accurate and reliable, when used appropriately.

 To do so, considerations must be given to the ease of use, which may be a function of the site of temperature measurement. Thus, consideration should be given to the versatility afforded by certain thermometers, allowing for measurements to be obtained in more than one body site. The following is a discussion of various types of thermometers. 

Rectal thermometers have been generally accepted as the “gold standard” for measuring temperature in very young children; however, some caregivers refrain from using them due to their intrusive nature and associated risks. These risks may include the development of peritonitis, rectal or intestinal perforation, and retaining of the thermometer inside the rectum.

 Rectal temperature measurements should not be taken in patients with obstructive hemorrhoids or diarrhea, as well as in patients with neutropenia due to their increased susceptibility to infection. Other considerations when measuring rectal temperature are that it is cumbersome and time consuming and that rapid changes in body temperature may not be detected due to the large muscle mass and poor blood flow to the rectal area.

 Notably, rectal temperatures tend to run higher than oral temperatures.

Oral thermometers are commonly used in medical offices and within households. However, to obtain accurate readings, certain factors must be kept in mind. For instance, oral temperature readings should be obtained at least 20 to 30 minutes after drinking and/or eating and should not be taken in patients who have a difficult time keeping the thermometer under their tongue and/or difficulty creating a tight seal around the thermometer.

 For younger patients who may struggle with these issues, pacifier thermometers are an alternative option to measure temperature. To obtain a proper reading with a pacifier thermometer, patients should wait 30 minutes after eating or drinking and should hold the pacifier in their mouth without moving it for 2 to 6 minutes.

 Lastly, oral temperatures should not be obtained in patients who are hyperventilating, uncooperative, lethargic, confused, and/or those who have had recent oral surgery.

Tympanic thermometers are usually used in pediatric offices to take the temperature via the ear. These provide a relatively quick and accurate measurement because the ear is close to the hypothalamus which allows for an accurate reading of core body temperature.

 However, proper positioning of the thermometer is extremely important to ensure an accurate reading. Other factors such as inflammation of the ear canal, age (children younger than 6 months do not have fully developed ear canals), and earwax buildup may also affect temperature readings.

 Additionally, cold or hot weather can affect temperature readings so it is recommended to wait at least 15 minutes after being exposed to extreme temperatures before using the thermometer.

Proper technique requires the user to pull the ear backward to help straighten the ear canal and to aim the tip of the probe towards the patient's eye on the opposite side of his or her head.

Temporal touch thermometers use an infrared scanner to scan the temporal artery in the forehead. This task is completed by placing the thermometer on 1 side of the forehead and then moving it across the forehead; the process usually takes a few seconds. This method of measuring temperature can be very sensitive in detecting fever but the scanner needs to be in contact with the skin at all times. Overall, this method provides an easy and accurate temperature reading in most patients.

 Yet, one must keep in mind that direct sunlight, cold temperature, sweaty forehead, and poor technique can impact the accuracy of the reading.

Noncontact temporal thermometers also use infrared technology but these do not require direct contact with the skin. Thermometers are generally held between 1.2 and 6 inches from the skin.

 Using a forehead noncontact infrared thermometer is quick, convenient, noninvasive, and carries a low risk of disease transmission. Studies suggest that taking temperature immediately after coming in from the cold underestimates body temperatures and as such, infrared temporal thermometers are not ideal for screening for diseases during cold weather.

 To ensure accuracy, measurements should be taken at least 10 minutes after coming in from the cold.

 These thermometers should also be used in environments free from secondary infrared sources, such as direct sunlight and incandescent lamps.

Axillary temperatures usually run lower than oral temperatures. Compared with the rectal and oral methods of measuring temperature, axillary thermometers are less reliable at detecting fevers.

 Although they may be favored because of their ease of use and noninvasive nature, their use should be discouraged because of concerns with accuracy.

 When used, temperatures should not be taken directly after vigorous activity or bathing since these can alter body temperature.

Basal thermometers are used to monitor basal body temperature for the purpose of tracking ovulation in women who are trying to conceive or prevent pregnancy.

 The digital basal thermometers have smaller gradations than regular thermometers (0.1 degree vs 0.2 degree), enabling them to detect small changes in body temperatures. This is important since the temperature increase that follows ovulation is small (approximately 0.4 to 1.0

Temperature can be taken orally, rectally, or vaginally; however, the same site must be used each day. Temperature must also be taken at approximately the same time each morning before rising, after at least 3 hours of sleep.

Color change thermometers usually involve placing a strip on the forehead, which changes color according to the heat radiating from the body. These thermometers are easy to use, provide a quick reading, and are sometimes reusable. However, they can be inaccurate as they do not reliably detect changes in the core temperature but only changes in skin temperature.

Glass Thermometers vs Digital Thermometers

Two types of glass thermometers are available, one with mercury and the other without it. Mercury-containing thermometers are no longer recommended due to toxic effects and may be banned in some states.

 Notably, though, individuals may still have access to these thermometers at home. Before taking measurements, it is important to ensure that the thermometer’s mercury is at the bottom of the measurement column. If this is not the case, the thermometer should be flicked to bring down the mercury in the column. Mercury-free glass thermometers use a gallium-indium-tin alloy, as a substitute for mercury.

 Glass thermometers differ in their tips. Those that utilize a long, thin tip are indicated for oral and axillary use whereas those with a short, round tip are for rectal use.

Digital thermometers are commonly used as an alternative to glass thermometers since they are faster, easier to read, and remove the environmental concern of mercury.

 Furthermore, there are no clinically significant differences between the accuracy of glass thermometers and digital thermometers.

 Digital thermometers are portable and can be used to measure oral, axillary, and rectal temperatures.

Several factors should be considered when selecting a thermometer. Thermometers vary in their mechanisms of measuring temperatures and in their intended uses. Pharmacists must be familiar with the different thermometers so they can ensure proper use by the consumer.

Pharmacists must be familiar with the different thermometers so they can ensure proper use by the consumer. 

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