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Abbott’s BinaxNOW Rapid Antigen Self Test will soon be available on shelves at Walgreens in an effort to expand access to testing, according to a press release from Walgreens.

The test received FDA emergency use authorization for OTC, non-prescription, asymptomatic use of the BinaxNOW Self Test for the detection of COVID-19 infection on March 31, 2021. The new indication allows patients with or without symptoms to access the test without a prescription, and Walgreens is one of the first mass retailers to make the test widely available, the company announced in a press release.

COVID-19 testing goes hand-in-hand with vaccination efforts, with on-site COVID-19 testing available at more than 5500 Walgreens pharmacies. By May, the press release said they plan to expand testing to 6000 drive-thru sites, with half of these offering the rapid Abbott ID NOW COVID-19 test.

“Even as vaccines become more widely available, COVID-19 testing remains a critical tool to keep our communities safe,” said John Standley, president of Walgreens, in the press release. “The addition of this over-the-counter test in-store will help ensure our customers have access to testing solutions when and how they need it—at home or at one of our conveniently located testing sites.”

The BinaxNOW Self Test allows users to self-administer the test using a short nasal swab rather than the deep nasopharyngeal swabs used in prescription tests, and results are available in 15 minutes. According to the press release, the BinaxNOW test is the most studied rapid antigen in the United States following its approval for professional use in August 2020. The test has the same format and technology as a professional test and will be available in a 2-count box to meet the FDA’s serial testing requirements for non-prescription, OTC purchase, according to the press release.

Patients should test themselves twice with at least 36 hours between tests, according to the manufacturer’s instructions for use. It can be used on children as young as 2 years old when samples are collected by an adult. Notably, individuals who test negative should still be cautious, including following social distancing and mask-wearing guidelines, and individuals who test positive should follow the latest CDC guidelines.

“The BinaxNOW Self Test opens the door for Americans to buy an accurate and affordable test on their own terms, when and where they need it,” said Andrea F. Wainer, executive vice president of rapid and molecular diagnostics at Abbott, in the press release. “Together with vaccines and like-minded partners such as Walgreens, we can help people get back to doing what they love—like spending time with friends and family.”

Walgreens Makes Abbott’s BinaxNOW COVID-19 Self Test Available Over-The-Counter at Stores Nationwide [news release]. Walgreens; April 19, 2021. 

https://news.walgreens.com/press-releases/walgreens-makes-abbotts-binaxnow-covid-19-self-test-available-over-counter-at-stores-nationwide.htm

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The test received FDA emergency use authorization for OTC, non-prescription, asymptomatic use for the detection of COVID-19 infection on March 31, 2021.

Walgreens To Begin Selling OTC COVID-19 Rapid Antigen Test

interviewed Donald Wood, PhD, the recently elected president and CEO of the Muscular Dystrophy Association, on muscular dystrophy research and care during the COVID-19 pandemic and beyond.

During the discussion, Wood addressed how care for patients with muscular dystrophy has evolved over time. Specifically, Wood noted that care for patients has not just changed, but has been revolutionized over the past several decades.

“When I first started my research, there was basically no treatments whatsoever for any of the 40 neuromuscular diseases. Today, I couldn’t even begin to tell you how many treatments there are,” Wood said. “We trained physicians who had never treated neuromuscular disease before.”

Wood explained that the ability to train physicians was made possible due to the development of treatments for neuromuscular disease, which, for many of these physicians during their time in medical school, was not something they were taught could be done.

“There was a time, not so long ago, maybe 40 to 50 years ago, when the medical community was taught in medical school that you weren’t going to be able to treat a patient with a genetic disease. Why? Because there were no treatments,” Wood said.

Researchers in the field were able to eventually identify drug treatments that would make life for patients with neuromuscular disease a bit easier. Overtime, as more and more medical professionals were trained, more treatments and diagnostic tests were identified in order to help patients get both diagnosed and treated as early as possible.

“The earlier you identify where problems are, the more opportunity you have to treat those problems and make life better for patients. And that has occurred over time,” Wood said. “Now we have patients who are living into adulthood, and that’s because of not just the science and research, but because we have trained medical professionals and attracted superior physicians into this field.”

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Contemporary Clinic ® interviewed Donald Wood, PhD, the recently elected president and CEO of the Muscular Dystrophy Association, on how care for patients with muscular dystrophy has evolved over the past several decades.

Care for Patients With Muscular Dystrophy Has “Been Revolutionized”

Although antihistamines are commonly used to manage hives, sneezing, and watery eyes during allergy season, many patients may be taking their medications incorrectly, according to Derek Chu, MD, PhD, a McMaster University allergy expert and clinical scholar.

“People need to rethink what they stock in their home cabinets as allergy medicines, what hospitals keep on formulary, and what policymakers recommend,” Chu said in a press release. “The message needs to get out. This publication is on time for the spring allergy season and as COVID vaccines roll out, for which rashes are common and antihistamines can be helpful.”

Co-author Gordon Sussman, MD, FRCP, FACP, DIP.ABIM, FAAAAI, said in the press release that there are new second generation antihistamines that prescribers should know about. Their new study, published in the 

, lists 5 things to know about proper antihistamine use.

Antihistamines are among the most commonly and incorrectly used medications worldwide, according to the press release. Their best use is for the management of hay fever and outbreaks of hives, and not for management of asthma, eczema, coughs, or insomnia.

Notably, first-generation antihistamines are associated with substantial and sometimes fatal adverse effects (AEs). These antihistamines are ones with diphenhydramine, chlorpheniramine, or hydroxyzine, which can cause drowsiness and affect cognitive functions, such as school performance. Overdosing with these types of antihistamines can cause death and are potentially dangerous for both young and older people.

Second-generation antihistamines are safer and just as affordable and as effective as first-generation antihistamines, according to the study authors. Later-generation antihistamines are proven to be more effective and last longer with less severe AEs, such as drowsiness, according to the study authors.

In their fourth point, the authors said antihistamines should not be used instead of epinephrine to treat anaphylaxis. Oral drugs can be used in combination with epinephrine injections to treat anaphylactic reactions, but they are not a proper substitute.

Finally, they said most antihistamines are safe to use during pregnancy and breastfeeding. Researchers have shown that antihistamines at standard doses do not harm fetuses during pregnancy and may be used during breastfeeding. Similarly, the researchers said they are safe for children to use.

“These are new modern second-generation antihistamines that are potent, specific, fast acting, and of proven safety which everyone should be using to treat allergic rhinitis and hives,” Sussman said in the press release.

Are you using antihistamines properly? [news release]. EurekAlert; April 6, 2021. 

https://www.eurekalert.org/pub_releases/2021-04/mu-ayu040121.php

Second-generation antihistamines are safer and just as affordable and as effective as first-generation antihistamines, according to the study authors.

Note Proper Use of Antihistamines During Spring Allergy Season

Contemporary Clinic spoke with pediatric nurse practitioner Tina Rickenback, APRN, from NAPNAP about the latest updates on the COVID-19 vaccines and education around this topic.

Rickenback also discussed any myths or rumors surrounding the uncertainty of the vaccine and different ways that health care professionals can spread awareness and properly counsel patients on this topic. 

Latest Updates on the COVID-19 Vaccine and Education On Immunizations

Hiccups are that strange occurrence that comes out of nowhere, causes irritation, and then (usually) disappears.

Everyone has hiccups at some point, sometimes even at inconvenient times. What is going on in that body that causes hiccups, and what are ways to get rid of them? Let’s look at the biology of hiccups, the causes, and how to treat this generally harmless but annoying condition.

Hiccups are brief, involuntary, and irregular bursts of air that are really 2 different events causing 1 hiccup. First, there is an involuntary contraction of the diaphragm, the muscle at the base of the lungs. The second event is the closing of the glottis. It is here that the vocal cords are located, causing the "hic" sound.

 Most hiccups cease within hours and are harmless and self-limiting. They can last in cycles of 4 to 60 hiccups per minute and are classified by their duration into 3 categories

: acute: <48 hours; persistent: >2 days; and intractable: >1 month.

The results of a retrospective analysis of 54 charts at a community hospital between 1995 and 2000 shows that intractable hiccups are more common in men (82%) than in women, and 36 of those men were between 51 and 80 years of age.

 The results of a 2012 systemic review found that 1% to 9% of patients with advanced cancer experienced intractable or persistent hiccups.

 Because hiccups are a common occurrence with no geographical or racial variation, little is documented or known about the incidence and prevalence.

 The effects of hiccups can include inconveniences in communicating, drinking, eating, and sleeping.

Below are a few examples of risk factors that cause hiccups

. Additionally, a thorough assessment and physical examination can help determine the cause.

Central nervous system (CNS) disorders: brain injuries or seizures

Diet: alcohol consumption, eating too quickly, and overeating

Gastrointestinal disorders: esophagitis and gastroesophageal reflux disease

Medication induced: benzodiazepines and dexamethasone

Miscellaneous: cancer, imbalances, and surgery

We have all heard of or even tried home remedies, some reportedly successful. Some fun examples you might have heard of include eating a spoonful of sugar, receiving a sudden or fright, or singing a song.

 Some physical maneuvers that reportedly get rid of hiccups include drinking water, holding one’s breath, and pulling the knees to the chest.

Pharmacotherapy may be considered for intractable and persistent hiccups. The drug choice will be based on the underlying cause, and because this can vary among patient, the medication chosen will also vary. A 2015 systematic review for the pharmacological treatment of hiccups and a 2016 review of the management of hiccups in palliative care patients list the following medication recommendations:

: Considered first line for suspected CNS cause

: Considered first line for non-CNS cause

Proton pump inhibitors, omeprazole 20 mg twice daily

: Considered first line when suspecting reflux

Chlorpromazine* 10 to 50mg 3 times daily by mouth or intravenously

: Considered third line, because of adverse effects

Hiccups are generally harmless but can cause distress and inconvenience. Obtaining knowledge on the science behind and causes of hiccups provide insight on how to treat this peculiar occurrence.

 Updated February 17, 2021. Accessed March 24, 2021. 

2. Lembo A. Hiccups. In: UpToDate. Wolters Kluwer; 2021. Updated October 27, 2020. Accessed March 24, 2021. 

https://www-uptodate-com.mwu.idm.oclc.org/contents/hiccups?search=hiccups&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1

3. Nausheen F, Mohsin H, Lakhan SE. Neurotransmitters in hiccups. 

. 2016;5(1):1357. doi:10.1186/s40064-016-3034-3

4. Cymet TC. Retrospective analysis of hiccups in patients at a community hospital from 1995-2000. 

5. Calsina-Berna A, Garcia-Gomez G, Gonzalez-Barboteo J, Porta-Sales J. Treatment of Chronic Hiccups in Cancer Patients: A Systematic Review. 

2012;15(10):1142-1150. doi:10.1089/jpm.2012.0087

6. Cole JA, Plewa MC. Singultus. In: StatPearls. StatPearls Publishing; 2021.

7. Cabrera D. Hiccups: old remedies for an old malady. 

 October 27, 2014. Accessed March 26, 2021. 

https://emblog.mayo.edu/2014/10/27/hiccups-old-remedies-for-an-old-malady/

8. Vatomsky S. 7 cures for hiccups from world folklore. 

https://www.mentalfloss.com/article/500937/7-cures-hiccups-world-folklore

9. Jeon YS, Kearney AM, Baker PG. Management of hiccups in palliative care patients. 

. 2018;8(1):1-6. doi:10.1136/bmjspcare-2016-001264

10. Steger M, Schneemann M, Fox M. Systemic review: the pathogenesis and pharmacological treatment of hiccups. 

Let’s look at the biology of hiccups, the causes, and how to treat this generally harmless but annoying condition.

Hiccups: What Are They, and How Can We Stop Them?

Contemporary Clinic spoke with Laura Kelly, PhD, about Columbia Nursing's newest program and first-ever certificate in Professional Achievement in Transgender/Gender Non-Binary Health Care for Nurse Practitioners beginning this September.

Kelly also discussed why programs like this are important in today's health care world and what NPs can do to continue closing the gaps in treating transgender/gender non-binary patients. 

Professional Achievement in Transgender/Gender Non-Binary Health Care Certificate for Nurse Practitioners 

There are widespread mental health concerns among children and teens currently, with 1 in 4 to 5 having a mental health problem, said Bernadette Melnyk, PhD, RN, CPNP, PMHNP, FAAN, during a session at the National Association of Pediatric Nurse Practitioners Virtual Conference 2021. The most commonly occurring mental health disorders in this population are anxiety, depression, and ADHD.

However, it is estimated that less than 50% of children and teens with a mental health disorder receive any treatment. This is of particular concern considering suicide remains the second leading cause of death in people aged 10 to 34 years in the United States.

“If every clinician, advanced practice provider, and physician could get great at providing evidence-based screening and intervention for just anxiety and depression in children, teens, and young adults, we could really put a dent in these mental health problems,” Melnyk said during the session.

Furthermore, during the struggles many have endured during the COVID-19 pandemic, there is an additional mental health epidemic that has emerged within the pandemic, Melnyk explained. The CDC and the Morbidity and Mortality Weekly Report released data showing 25% of Americans aged 18 to 25 years have thought about suicide since the start of the pandemic, highlighting the critical need for mental health promotion and development of resiliency skills so that a paradigm shift can occur around this issue.

“Because so many people are suffering from depression and anxiety related to the COVID-19 pandemic, we are seeing a rise in substance use, unhealthy eating, and a decline in physical activity. If we do not address these mental health problems urgently now, we are also going to see downstream affects in chronic disease in 3 to 5 years from now,” Melnyk said during the session.

There are a variety of risk factors for mental health disorders in children and teens. Poor self-esteem is a significant predictor, although it is often not screened for by providers. For this reason, every contact with a patient should be seen as a potential opportunity to screen for mental health disorders, especially during the pandemic, according to Melnyk. Asking a single screening question during a session such as, “On a scale from 0 to 10, how good do you feel about who you are?” can be an effective tool for assessing patient risk.

There are other valuable screening tools providers can use as well, such as the Pediatric Symptom Checklist, which has been found to be a valid and reliable first screen, as it is a short form with 17 items that takes approximately 5 minutes to complete.

For assessing risk for depression and anxiety disorders, the PHQ-9, GAD-7 and SCARED screening tools are also valuable. Additionally, the CRAFFT screen is used for assessing substance use risk, while the ACE screen helps to assess adverse childhood experiences.

If the results of the screening tool demonstrate further investigation is needed, a clinical interview should then be conducted with further evaluation completed by a health care provider.

“But we have to remember that screening is not diagnosis alone. Screening just raises a red flag that requires a good comprehensive interview and evaluation by the health care provider,” Melnyk said during the session.

Melnyk highlighted a strong outline that is available for the integration of behavioral health into primary care using the Screening, Brief Intervention and Referral to Treatment (SBIRT) model. SBIRT details that the starting point should be a screening for a mental health disorder in the primary care setting, which is then followed by a brief intervention that can be provided in the primary care location.

If necessary, a referral to a mental health provider or a consultation service can proceed this, with subsequent treatment offered by the primary care provider, integrated psychologist, mental health provider, or specialty care based on the needs of the patient.

“I like to add another letter to SBIRT, and that is H for Hope. I never let a child, teen, or young adult leave me without instilling hope that there are fabulous, evidence-based treatments to help them,” Melnyk said.

In the primary care setting, the 2 most common mental health disorders that providers observe are anxiety disorders and depressive disorders. However, there are now a rising number of trauma, stress-related, and obsessive compulsive disorders emerging.

“But again, if we could just get really good at delivering cognitive-behavioral-health based interventions for children and teens with depression and anxiety, we would avoid long wait times to mental health providers,” Melnyk said during the session. “Unfortunately, a lot of people feel that if you’re not born with resilience, you can’t develop it, and that couldn’t be further from the truth. All throughout life, you can build resiliency skills and cognitive behavioral skills that are wonderfully protective factors against mental health disorders.”

Melnyk B, Lusk P. Evidence-based Screening and Mental Health Interventions for Primary Care. Presented at: National Association of Pediatric Nurse Practitioners Virtual Conference 2021; March 27, 2021; virtual. 

https://napnap21.org/community/#/session-stream/42207

There are widespread mental health concerns among children and teens currently, with 1 in 4 to 5 having a mental health problem.

Evidence-based Screening for Mental Health Disorders in Children, Teens is Critical During Pandemic

In addition to the usual considerations of treating pediatric patients, clinicians should consider how pharmacokinetics may differ for children with obesity, according to a session at the 2021 virtual National Association of Pediatric Nurse Practitioners meeting.

The CDC defines obesity in children as weight at the ninety-fifth percentile or above, according to presenter Heather Herrera, RN, MSN, CPNP-AC/PC. For children between 2 and 19 years of age, this amounts to 18.5% or approximately 13.7 million obese children and adolescents. Furthermore, Herrera said is it estimated that approximately 20% of admissions to children’s hospitals involve children with obesity.

Obesity in pediatric populations has both long- and short-term implications and affects every single body system, Herrera said. Psychosocial impacts can include low self-esteem, depression, and eating disorders. Cardiovascular impacts can include dyslipidemia, hypertension, chronic inflammation, and endothelial dysfunction, while endocrine impacts include type 2 diabetes and precocious puberty.

Obesity in children also causes changes in physiology, such as changes in tissue composition, larger amounts of both fat body mass and lean body mass, and impaired liver and kidney function. Herrera noted that obese adults have shown increased blood volume, cardiac output, and renal blood flow.

When considering pharmacokinetics, Herrera said understanding volume of distribution (Vd) and clearance is essential. Vd is a theoretical parameter correlated to the total amount of drug distributed in the body and the resulting plasma level, which then determines the loading dose. It is the outcome measure most affected by obesity and it is determined mostly by the physiochemical properties of the drug and is specific to each individual, although it may vary in physiological and pathological conditions.

There are several body measurements to be considered, and each has its own uses and situations in which it is the most helpful. Ideal body weight (IBW) is a weight believed to be maximally healthful, based chiefly on height but modified by factors such as gender, age, and build. Total body weight (TBW) is a measure of mass in kilograms or pounds, whereas lean body weight (LBW) is the amount of weight that isn’t fat. Finally, adjusted body weight reflects lean body mass plus excess fat mass determined by a cofactor, and is a measurement mostly used in adults.

Notably, despite these options, Herrera said there is no gold standard for how to calculate IBW in children. For children taller than 5 feet, Herrera recommended the calculation (2.27 x [height in inches -60]) plus 42 for girls and plus 39 for boys. For children shorter than 5 feet, the formula is ([height in inches]2 x 1.65/1000).

When considering pharmacological challenges, it is important to identify correct dose of medication at the onset of therapy, particularly in critically ill children who need quick improvement. Notably, inadequate dosing can lead to treatment failure and adverse events.

In obese children, Herrera said volume of distribution and clearance are best represented by TBW and LBW, and these measurements are often used to determine dosage of a medication. The degree of lipophilicity and hydrophilicity should also be considered, as well as differences in loading versus maintenance dosing. Loading doses of hydrophilic medications in obese children should be based on IBW, whereas partially hydrophilic and lipophilic medications should be based on TBW.

Finally, Herrera reviewed common medication classes and various considerations in children with obesity. Obese children seem to require less heparin, enoxaparin, and warfarin per kilogram TBW than non-obese children, and may also require less vancomycin and aminoglycosides per kilogram.

By carefully considering pharmacokinetics and physiologic changes in children with obesity, clinicians can prescribe proper dosages and treatments for children, whether in mild conditions such as allergies or in more critical care cases.

Herrera H, and Joiner J. Bigger is not always better: Pediatric obesity and its implications for critical care with case study discussions. NAPNAP 2021; March 27, 2021. 

https://napnap21.org/community/#/session-stream/42198

In addition to the usual considerations of treating pediatric patients, clinicians should consider how pharmacokinetics may differ for children with obesity, according to a session at the 2021 virtual National Association of Pediatric Nurse Practitioners meeting. 

Clinicians Should Consider How Obesity Affects Pharmacokinetics in Children 

With 1 in 4 children in the United States living in an immigrant family, the health care needs of this pediatric population are a critical area of focus when addressing health disparities for children, said Albrey Love DNP, APRN, PNP-PC, during a session at the National Association of Pediatric Nurse Practitioners Virtual Conference 2021.

For the purposes of understanding exactly what qualifies as a child living in an immigrant family, Love explained that this population is defined as children who are foreign born or are born in the United States who live with at least 1 foreign-born parent.

Currently, a significant portion (64%) of children living in an immigrant family reside in 6 states: California, Texas, New York, Florida, Illinois, and New Jersey. However, from 1990 to 2019, the largest growth in this population occurred elsewhere, in states such as North Carolina, Nevada, Georgia, and Arkansas.

The reason children migrated to this country vary widely, but some reasons can be quite complex, Love explained.

“Children migrate to this country with or without their parents for a number of reasons,” Love said during the session. “Some of the most common that you might be the most familiar with are economic needs, possibly educational pursuits, but some may also be a victim of human trafficking or are escaping a country due to violence.”

The immigration status in this population can also be highly variable, with some children entering on a temporary visa, a tourist visa, or on a lawful permanent residence visa. Some also qualify for the Deferred Action for Childhood Arrivals (DACA) program, which defers deportation of certain people who came to the United States as children and meet several guidelines. DACA allows these individuals to request consideration of deferred action for a period of 2 years, with the ability to renew.

“DACA allows young adults who had arrived in the United States as children without legal status but grew up here to essentially apply for deportation relief and working visas,” Love said during the session.

Children living in an immigrant family are also approximately twice as likely as other children in the United States to not be covered by health insurance. Love explained that sometimes this lack of insurance is due to the services not being available, whereas other instances may be due to a lack of knowledge regarding the programs that exist that could provide them with health insurance coverage.

This pediatric population is also more likely to live below the poverty level, with access barriers to programs and benefits causing such problems to persist. Love noted that additionally, for these children, the threat of deportation or forced separations from their families are very real.

“The family immigration status represents an important and often neglected social determinant of health in this family,” Love said. “The immigration status affects their access to care and intertwines with other social determinants of health.”

Love explained that these social determinants of health can include poverty, food insecurity, health literacy, educational disparities, or discrimination, the latter of which they may experience based on their family’s immigration status.

In order to assess the mental, emotional, and behavioral health of immigrant children in light of the varying factors at play in their health and wellness, there are several screenings that can be used to help assess their wellbeing.

“Screening for trauma is very important in these children,” Love said during the session. “It’s really easy for us to kind of think of their journey as just hopping on a plane and crossing into the country. However, depending on their country of origin, it can be quite traumatic or it could be seamless. It really just depends on the country they’re coming from and the reason migration is happening.”

Upon arrival to the United States, immigrant children may actually also be healthier than native-born children, which is termed the “immigrant paradox” or “healthy immigrant effect” in the literature, according to Love. This is important to recognize as these children may require longer term care in order to develop a rapport with their provider, at which point signs of trauma may begin to appear.

“That’s why this ongoing screening is recommended,” Love said. “Trauma can occur before the migration journey, during the journey, on arrival, or post migration.”

There are also various types of trauma that could have occurred previously or are occurring, such as physical or sexual abuse, witnessing interpersonal violence, human trafficking, actual or threatened separation from parents, or exposure to armed conflicts.

Yet, immigrant families also bring strengths to the United States that may be less common in native-born families, which can be assessed using the Strengths and Difficulties Questionnaire. Love explained that a significant majority of immigrant families arrive intact, with multiple generations living in the same household. This can be a strength that can help build resilience in this pediatric population.

“Typically, what we see is that children in these families are not growing up in disjointed family units,” Love said during the session. “That’s an actual strength of these families and provides resilience for them, unlike children in the United States who are non-immigrants who are affected by divorce more commonly. These families are typically intact.”

Love A, Whited T. Nursing Beyond the Borders: Addressing Healthcare Needs and Health Disparities for Children in Immigrant Families. Presented at: National Association of Pediatric Nurse Practitioners Virtual Conference 2021; March 26, 2021; virtual. 

https://napnap21.org/community/#/session-stream/42189

With 1 in 4 children in the United States living in an immigrant family, the health care needs of this pediatric population are a critical area of focus when addressing health disparities for children.

The Importance of Screening for Both Trauma and the Strengths of Children Living in an Immigrant Family

With 3 FDA-approved COVID-19 vaccines and other potential candidates in the pipeline, addressing patients’ concerns and questions about the vaccines requires up-to-date information and careful review.

A session at the National Association of Pediatric Nurse Practitioners (NAPNAP) 2021 National Conference on Pediatric Health Care reviewed the latest information on COVID-19 vaccines. Presenter Dana DeShon, CNP, said that although the development process for COVID-19 vaccines has been accelerated, it is important to reassure patients that there were no shortcuts for safety and efficacy.

In addition to the Pfizer and BioNTech, Moderna, and Johnson & Johnson vaccines, which have received FDA approval, DeShon said there were 223 candidate vaccines as of December 2020, including 57 clinical phase vaccines and 166 pre-clinical phase vaccines. She explained that after vaccine candidates receive approval for testing in humans, they go through 4 phases. Phases 1 through 3 are conducted prior to FDA review, with increasing numbers of participants. Phase 4 is conducted after FDA review and involves 1000 or more participants.

Following this general review, DeShon explained the various approaches to vaccine development, such as DNA, non-replicating viral vectors, or purified protein.

The DNA approach to vaccine development involves getting DNA into the nucleus of the cell. A vaccine candidate by Inovio Pharmaceuticals uses this approach, with a phase 1 trial that began in April 2020 and a phase 2/3 trial that launched in November 2020. This vaccine requires 2 doses and is stable at room temperature for more than a year, with a 5-year projected shelf life at normal refrigeration temperatures. When counseling patients on DNA vaccines, DeShon said it is important to note that they enter the cell but do not change the recipient’s own DNA.

The Johnson & Johnson vaccine is an example of a non-replicating vital vector vaccine, which originates from a carrier virus, such as the adenovirus or pox virus. DeShon said a gene is inserted into a vector virus to code it, and it is important to note that the virus vector does not reproduce in the vaccine recipient.

The immune system then creates antibodies against proteins such as the COVID-19 spike protein, and antibodies directed against the spike protein will prevent COVID-19 from binding to the cell and thus prevent infection. In these vaccines, DeShon said the only concern could be if a patient had previous exposure to COVID-19, which could negatively impact the body’s response.

The vaccines from Pfizer/BioNTech and Moderna are both messenger ribonucleic acid (mRNA) vaccines. This approach is composed of a piece of the virus’s genetic code surrounded by lipids. Notably, it does not interact with DNA and patients cannot get COVID-19 from the vaccine.

The Pfizer and BioNTech vaccine demonstrated 95% efficacy against COVID-19 in a clinical trial of 43,448 participants, 21,720 of whom received the vaccine and 21,728 of whom received a placebo. Investigators observed 170 cases of COVID-19 with onset at least 7 days after the second dose, 162 of whom were in patients who received the placebo. They also found a response beginning 12 days after the first dose and 7 days after the second dose.

Notably, the Pfizer and BioNTech vaccine is the only one to be approved for individuals aged 16 years and older, as Moderna and Johnson & Johnson are approved for 18 years of age and older. The FDA approved the Pfizer/BioNTech vaccine in October to begin clinical trials in patients as young as 12 years of age.

Moderna’s vaccine is also an mRNA vaccine. In a clinical trial with 27,817 participants, 11 cases of COVID-19 were reported in the vaccinated group and 185 cases were reported in the placebo group as of November 21, 2020. Notably, there were no severe cases in the vaccinated group. Researchers found 80.2% protection 2 weeks after the first dose and 94.1% protection after the second dose.

DeShon said that safety monitoring for the mRNA vaccines did see some cases of anaphylaxis. Of patients who experienced this, 86% had onset within 30 minutes of vaccination and 81% had a history of allergies or allergic reactions. The most common adverse reactions include injection site pain, fatigue, headache, muscle pain, joint pain, and chills.

For patients who have concerns about vaccine safety and adverse effects, DeShon said clinicians have several options to bolster trust. Telling personal stories about receiving the vaccine and using a direct, fact-based approach can both answer their questions and demonstrate safety.

DeShon, Dana. COVID-19 Vaccine. National Association of Pediatric Nurse Practitioners; March 26, 2021. Virtual; Accessed March 26, 2021.

Telling personal stories about receiving the vaccine and using a direct, fact-based approach can both answer patient’s questions and demonstrate safety when advising them on COVID-19 vaccines.

Practitioners Should Have Updated Information to Advise Patients on COVID-19 Vaccines

The importance of asthma-focused telehealth visits is crucial because children and families need regular visits to learn necessary skills to prevent asthma symptoms and attacks, according to a session at the virtual National Association of Pediatric Nurse Practitioners 2021 Annual Meeting.

Tammy Rood, DNP, CPNP-PC, AE-C, described how telehealth visits provide a unique opportunity to improve access to asthma care, yet many children are still not receiving asthma visits as often as needed.

“Through these regular asthma visits, children and families learn how to recognize early asthma symptoms that are coming on and then quickly act to prevent and minimize asthma symptoms and attacks,” Rood said.

Telehealth visits should be considered for all asthma patients, but especially for those who live in underserved areas, have fallen out of care, or are afraid of in-person visits due to COVID-19. As a health care professional (HCP) prepares for the visit, Rood mentions how taking 10 minutes before the visit to review the electronic medical record, including checking the asthma risk, checking medication adherence, reviewing any last clinic notes, and reviewing vital signs and key results.

Rood added that having the right technological equipment, environment, and communication are critical to establish to have a successful telehealth visit. Being in a telehealth setting gives the HCP the opportunity to observe the child and the family in the home setting while glancing at social determinants and supporting self-care. In the physical exam sense, it is more observational, as the HCP can observe the rate of breathing, assess for conversational dyspnea, and note the presence of cough.

There are many useful tools for HCPs to use when counseling their patients through telehealth to further improve assessment of asthma impairment and risk. Some of these resources can be available during the visit to help guide treatment decisions, such as the 2020 Focused Updates to Asthma Management Guidelines, according to Benjamin Francisco, PhD, PNP, AE-C.

“It’s important to know that not a lot of things changed, that’s the good news,” Francisco said. “The evidence did increase in 6 content areas to a degree that it was necessary to hire research teams to review systematically the literature and to come up with new recommendations.”

Francisco B, Rood T. Asthma-Focused Telehealth Visits- Maximizing the Experience. 2021 NAPNAP Virtual Conference.

Appropriately Maximizing Asthma-Focused Telehealth Visits

The National Rosacea Society (NRS) has designated April as Rosacea Awareness Month in an effort to educate the public on this potentially serious disorder that is estimated to affect over 16 million individuals in the United States. According to the NRS, even as rosacea treatment and care options become more abundant and sophisticated, many patients with rosacea remain untreated or using treatment plans not best suited for their individual cases.

Rosacea is a single inflammatory continuum despite having a number of different clinical features that can manifest at different times and in different combinations, according to the recently updated standard classification of the condition. The new standard management options include a comprehensive summary of treatment options for all of rosacea’s phenotypes.

“Today’s approach to rosacea treatment is different than in the past, when there were few options in our tool kit to address the variable signs and symptoms that may be present in an individual case,” said Linda Stein Gold, MD, director of dermatology clinical research at the Henry Ford Health System, in a prepared statement. “Now that there are effective therapies available to combat each sign and symptom, it is possible to tailor treatment to the needs of each patient.”

In a survey of 1714 patients with rosacea, 54% of those age 60 years and older reported that they are still using the first prescription therapy ever developed and approved for rosacea, compared to 41% of those under age 60 years. Further, 42% of respondents age 60 years and older had never changed their treatment regimen, compared to only 19% of those under age 60 years.

The treatment divide between older and younger patients with rosacea extends to other products as well. Respondents under age 60 years were more than twice as likely to be using topical ivermectin than those age 60 years and older (20.7% vs. 9.1%) and 5 times more likely to be using topical oxymetazoline (6.9% vs. 1.4%). Prescription azelaic acid foam was a frequent choice among both age ranges, with 15.1% of those under 60 years and 13% of those 60 years or older using the treatment.

“As dermatologists, we want patients to be healthy and happy in their skin,” Stein Gold said. “However, if a therapy is not doing its job, it may be time to try a different approach.”

Rosacea Awareness Month to highlight broad range of treatment options [news release]. Barrington, IL; National Rosacea Society: February 9, 2021. Accessed February 9, 2021. 

https://www.rosacea.org/press/2021/february/rosacea-awareness-month-to-highlight-broad-range-of-treatment-options

Survey shows most patients are satisfied with therapy, but more awareness of treatment options is needed. National Rosacea Society. Accessed February 9, 2021. 

https://www.rosacea.org/rosacea-review/2020/fall/survey-shows-most-rosacea-patients-are-satisfied-with-therapy

The National Rosacea Society (NRS) has designated April as Rosacea Awareness Month in an effort to educate the public on this potentially serious disorder that is estimated to affect over 16 million individuals in the United States. 

National Organization Brings Awareness to Rosacea Treatments

interviewed Lea Davis, PhD, an associate professor of medicine in the Department of Medicine at Vanderbilt University Medical Center and an investigator in the Vanderbilt Genetics Institute, on a recent study she co-authored that was published in 

 on the epidemiology of functional seizures among adults treated at a university hospital.

Are functional seizures experienced throughout patients’ lives, or is its occurrence associated with the exacerbation of these other comorbid symptoms, such as the psychiatric conditions?

 Actually, both. So, they are experienced throughout the lifetime for many people, and they can be exacerbated. So, for example, if somebody has [post-traumatic stress disorder (PTSD)] and experiences a PTSD flashback, that can also trigger a seizure event. But the range of seizure events is pretty broad for functional seizure patients. There can be some who maybe only occasionally experience seizures and others who experience dozens of seizures a day, and it is extremely impairing.

Lea Davis, PhD, of the Vanderbilt University Medical Center and Vanderbilt Genetics Institute, discussed the frequency with which patients may experience functional seizures.

Expert: Functional Seizures Can Be ‘Extremely Impairing’ for Patients

The CDC’s update to the immunization schedule highlights 2 separate schedules—child and adolescent (birth through 18 years of age) and adult (19 years of age and older)—and includes updates to the influenza vaccine, meningococcal vaccine, and the new COVID-19 vaccine, according to a session at the virtual National Association of Pediatric Nurse Practitioners 2021 Annual Meeting.

Mary Beth Koslap-Petraco, DNP, PPCNP-BC, CPNP, FAANP, lead the discussion on specific vaccine changes that are important to bring to health care professionals’ attention. For example, in terms of the diptheria-tetanus-acellular pertussis (DTaP) vaccine, the notes were revised to include a “special situations” section containing information about the recommendation for use of DTaP in wound management.

 B vaccine (HIB booster) was revised, which indicates that catch-up vaccination is not recommended for previously unvaccinated children who are 5 years of age and older. In this year’s HIB note, it is indicated that for catch-up vaccination, no further doses are recommended if a previous note was administered at 15 months of age and older.

Further, the “birth dose” section of the HepB note contains additional text clarifying the recommendation for infants with a birth weight of less than 2000 grams who have HBsAg-negative mothers, according to Koslap-Petraco.

In terms of the pneumococcal vaccine, Koslap-Petraco reiterated the importance of administering PCV13 before PPSV23.

“PPSV23 turns off PCV13,” Koslap-Petraco said. “If you give a dose of PPSV23 and you give PCV13 too soon, it will be like you didn’t even give them the PCV13 because the way these vaccines work, they compete with each other because of their mechanisms of action, so you always want to be careful to give PCV13 first with the appropriate interval.” 

A major addition to this year’s immunization schedule is the COVID-19 section, which addresses the issue of vaccine coadministration. These vaccines should be administered alone, with a minimum interval of 14 days before or after administration of any other vaccines. As for vaccinating children, Koslap-Petraco mentioned the current ongoing studies from Pfizer, Moderna, and AstraZeneca that are focused on the 16 years and younger population.

“We should be seeing these results by the end of summer,” Koslap-Petraco said.

Keeping up with routine vaccines is an essential preventive service for children, adolescents, and adults, including pregnant people, that should not be delayed because of the COVID-19 pandemic, according to Koslap-Petraco. She emphasized the importance of assessing the vaccination status of all children and adolescents at each patient visit, avoiding missed opportunities for vaccination, and ensure timely vaccine catch-up.

“We have dropped off on vaccines, and one of our biggest fears we have is that we are going to see a vaccine preventable disease outbreak because children are just not getting their vaccines on time,” Koslap-Petraco said.

Koslap-Petraco MB. Immunization Update 2021- Focus on the Schedule. 2021 NAPNAP Virtual Conference.

Murphy, Jill. CDC releases 2020 immunization update. Contemporary Clinic. Published June 11, 2020. Accessed March 26, 2021. https://www.contemporaryclinic.com/view/cdc-releases-2020-immunization-update

Mary Beth Koslap-Petraco, DNP, PPCNP-BC, CPNP, FAANP, lead the discussion on specific vaccine changes that are important to bring to health care professionals’ attention.

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