Tezepelumab’s biologic license application (BLA) was granted priority review by the FDA for the treatment of severe, uncontrolled asthma, according to AstraZeneca. 

Tezepelumab is the first biologic to show a reduction in asthma symptoms, according to phase 3 study results. Tezepelumab is a potential first-in-class human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades. TSLP is critical in the initiation and persistence of the types of airway inflammation associated with severe asthma.

Tezepelumab was granted priority review by the FDA due to its advantages over current options in the areas of safety improvement, preventing serious conditions, and enhancing patient compliance.1 The agency has set a regulatory decision date during the first quarter of 2022.

The BLA was based on the results of the PATHFINDER clinical trial program, including the phase 3 NAVIGATOR. In clinical trials, tezepelumab demonstrated superiority across every primary and key secondary end point when compared with placebo in a broad population of patients with uncontrolled asthma. Participants received tezepelumab in addition to standard-of-care treatment with medium- or high-dose inhaled corticosteroids (ICS) plus at least 1 additional controller medicine with or without oral corticosteroids (ICS).

The NAVIGATOR study included adults 18 to 80 years old and adolescents aged 12 to 17-years with severe, uncontrolled asthma who were receiving standard of care. The trial population included approximately equal proportions of patients with high and low blood eosinophil counts.

The study was conducted over 52 weeks and patients were grouped by baseline blood eosinophil count, fractional exhaled nitric oxide level, and serum specific immunoglobin E status (perennial allergen sensitivity positive or negative). The testing involved analyzing a patient’s blood and exhaled air.

The trial comprised a 5- to 6-week screening period, a 52-week treatment period, and a 12-week post-treatment follow-up period. All patients received their prescribed controller medicines without change throughout the trial. Key secondary end points included the effect of tezepelumab on lung function, asthma control, and health-related quality of life.

There were no differences in safety results between placebo and tezepelumab in trials. The most frequently reported adverse events with tezepelumab were nasopharyngitis, upper respiratory tract infection, and headache.

Severe asthma has been rising, however, some patients are warned against the use of biopharmaceuticals or biologics.1 Patients with severe asthma are severely affected by their condition. “Tezepelumab has demonstrated reductions in exacerbations irrespective of blood eosinophil counts, allergy status and fractional exhaled nitric oxide, and has the potential to transform treatment for a broad population of severe asthma patients,” said Mene Pangalos, executive vice president of BioPharmaceuticals R&D.

Approximately 10% of patients with asthma have severe asthma. Despite the use of inhaled asthma controller medicine, currently available biologic therapies and OCS, many severe asthma patients remain uncontrolled. Due to the complexity of severe asthma, many patients have unclear or multiple drivers of inflammation and may not qualify for or respond well to current biologic medicine.

Severe, uncontrolled asthma is debilitating with patients experiencing frequent exacerbations, significant limitations on lung function, and reduced quality of life. Patients with severe asthma are at an increased risk of mortality and compared to patients with persistent asthma have twice the risk of asthma-related hospitalizations. There is also a significant socioeconomic burden, with these patients accounting for 50% of asthma-related costs.

 for patients with severe asthma without an eosinophilic phenotype in September 2018.

1. Tezepelumab regulatory submission accepted and granted FDA Priority Review in the US for the treatment of patients with asthma. News release. AstraZeneca; July 8, 2021. Accessed July 12, 2021. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/tezepelumab-granted-fda-priority-review-for-asthma.html.

Articles

Tezepelumab is the first biologic medication to show a reduction in severe asthma symptoms.





FDA Grants Priority Review to Tezepelumab for Severe Asthma

The Janssen COVID-19 vaccine is linked to rare cases of Guillain-Barré syndrome, according to a recent news release from Johnson & Johnson. Only an estimated 100 cases among more than 12 million doses have been reported.

The FDA updated its emergency use authorization (EUA) for the Janssen COVID-19 vaccine and provided a warning of the increased risk of Guillain-Barré syndrome for up to 42 days after vaccination.

In April, the FDA and CDC placed a brief pause on administering the Janssen vaccine following reports of a rare but potentially lethal blood clotting condition called thrombosis with thrombocytopenia syndrome (TTS) in vaccinated individuals. On April 26, the agencies recommended resuming the vaccine after reviewing the known and potential risks and benefits. The FDA has also identified the risk of anaphylaxis and capillary leak, which are reflected in the EUA.

Still, the benefits of the vaccine outweigh the risks.

“Evidence has demonstrated that Johnson & Johnson’s single-shot COVID-19 vaccine offers protection against COVID-19 disease and prevents hospitalization and death, including in countries where viral variants are highly prevalent,” the news release stated.

 “A single-shot vaccine that provides this level of protection represents an important tool in the global fight against COVID-19, as we strive to help end this deadly pandemic.”

Guillan-Barré syndrome is a nervous system disorder that causes the immune system to damage nerve cells, resulting in muscle weakness and may lead to paralysis in severe cases. Johnson & Johnson advised that those who received the single-dose vaccine seek medical attention if they have:

Weakness or tingling sensations, in the legs or arms in particular, that continues to worsen and spread

Difficulty speaking, chewing, swallowing, or moving their face

Difficulty with controlling bladder and bowel functions

To report adverse events of the Janssen vaccine to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS), call 1-800-822-7967 or visit 

The CDC Advisory Committee on Immunization Practices (ACIP) will be investigating the reports but has not yet included Guillain-Barré syndrome as a 

Johnson & Johnson Statement on COVID-19 Vaccine (7/12). News Release. Johnson & Johnson; July 12, 2021. Accessed July 14, 2021. 

https://www.jnj.com/johnson-johnson-july-12-statement-on-covid-19-vaccine

Pruitt-Young S. Johnson & Johnson Vaccine Is Linked To Neurological Disorder In Extremely Rare Cases. NPR. July 12, 2021. Accessed July 14, 2021. 

https://www.npr.org/sections/coronavirus-live-updates/2021/07/12/1015366005/johnson-johnson-vaccine-is-linked-to-neurological-disorder-in-extremely-rare-cas

Fact Sheet For Healthcare Providers Administering Vaccine (Vaccination Providers) Emergency Use Authorization (EUA) of the Janssen COVID-19 Vaccine To Prevent Coronavirus Disease 2019 (COVID-19). FDA. Revised July 8, 2021. Accessed July 14, 2021. 

https://www.fda.gov/media/146304/download

Johnson & Johnson released a statement providing more information on the risks and benefits of its single-shot COVID-19 vaccine. 

Rare Cases of Guillain-Barré Syndrome Reported in Janssen COVID-19 Vaccine

The FDA has approved finerenone (Kerendia; Bayer) tablets to reduce complications in adults with chronic kidney disease (CKD) associated with type 2 diabetes.

Finerenone is the first and only nonsteroidal mineralocorticoid receptor antagonist approved for adults with CKD associated with type 2 diabetes. It is indicated to slow CKD progression, reduce the risk of kidney failure, heart attack, heart failure hospitalization, and cardiovascular death. Many individuals with CKD associated with type 2 diabetes are at risk for disease progression and cardiovascular events and thus can be significantly helped by this new treatment option.

Diabetes is the leading cause of CKD and kidney failure in the United States. Patients with CKD and diabetes can experience complications related to fluid, electrolytes, and bodily waste buildup in the body as a result of faulty filtering. Further, this disease can sometimes progress to kidney failure and cause an elevated risk of heart disease.

 in preventing kidney and heart complications was studied in the randomized, multicenter, double-blind, placebo-controlled phase 3 FIDELIO-DKD trial. A total of 5674 adult patients with CKD associated with type 2 diabetes were included in the study. Patients were randomly assigned to receive either finerenone or a placebo. The investigators compared the 2 groups for the number of patients whose disease progressed to a combined end point: those with at least 40% reduction in kidney function, progression to kidney failure, or kidney death. The results of this study showed that 504 of the 2833 patients in the study experienced 1 of the events in the combined end point. This was compared with the 600 of the 2841 patients who received a placebo.

Flash Glucose Monitoring Vs Self-Monitoring in Diabetic Chronic Kidney Disease

Investigators looked at the 2 groups further to examine the number of patients who experienced cardiovascular death, a non-fatal heart attack, non-fatal stroke, or hospitalization for heart failure. The results showed that 367 of the 2833 patients receiving finerenone had at least 1 of the events in the combined end point compared with 420 of the 2841 patients who received a placebo.

The adverse effects of this drug include high levels of potassium, low blood pressure, and low levels of sodium. Patients with low hormone levels or adrenal insufficiency and those receiving simultaneous treatment with strong cytochrome P450 3A4 inhibitors should not take this medication, according to the FDA. 

Finerenone previously received priority review and fast track designations for this application. The FDA granted the approval of this medication to Bayer Healthcare.

Bayer's KERENDIA® (finerenone) Receives U.S. FDA Approval for Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes. News release. Bayer United States of America; July 9, 2021. Accessed July 13, 2021. https://bayer2019tf.q4web.com/news/news-details/2021/Bayers-KERENDIA-finerenone-Receives-U.S.-FDA-Approval-for-Treatment-of-Patients-with-Chronic-Kidney-Disease-Associated-with-Type-2-Diabetes/default.aspx.

FDA Approves Drug to Reduce Risk of Serious Kidney and Heart Complications in Adults with Chronic Kidney Disease Associated with Type 2 Diabetes. News release. U.S. Food and Drug Administration; July 9, 2021. Accessed July 13, 2021. https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-drug-reduce-risk-serious-kidney-and-heart-complications-adults-chronic-kidney-disease.

A new medication called finerenone (Kerendia; Bayer) has been approved for the treatment of kidney disease and type 2 diabetes.

FDA OKs Finerenone for Chronic Kidney Disease Associated With Type 2 Diabetes

Peter A. Kreckel practices pharmacy in Lemont Furnace, Pennsylvania.

The year 1981 was a special one for my wife, Denise, and me. We graduated from the University of Pittsburgh School of Pharmacy in April. We got married on the Fourth of July and took our first jobs as licensed pharmacists in August. Like all new graduates, we were ready to apply our new knowledge and patient counseling skills to help our patients. It didn’t take long to realize that the dream was becoming a nightmare.

After a couple months working with a major chain, I came home one night and told my new wife, “If this is retail pharmacy, I made a serious mistake choosing this profession.” When I begged for more tech help, my district manager said, “I’ve watched you work, Pete, and if you stop talking to those customers, you will have [a lot] of time to get my paperwork done.” As good fortune would have it, we later found 2 great jobs for an independent pharmacy chain. As I always tell my student pharmacists: “Your license hangs on the wall by a nail. If you are unhappy in your current position, find a new nail.” My license hung on that independent pharmacy chain’s nail for 26 years until I realized the chain was going to be sold to a major chain.

I found another great nail at a different independent pharmacy and had 12 great years of community practice there. I staffed the bench, and later on, I staffed a physician’s office 2 days per week. By most pharmacists’ standards, this was a dream job. However, I left that job to fill a position as director of clinical services at Nickman’s Drug store in Lemont Furnace, Pennsylvania. I chose this nail not only because of the owner’s interest in providing clinical services, but most importantly, the nail would be closer to my family. I had landed another dream job.

Did you notice that all 3 times I left a job, money had nothing to do with my career move? It was all about conditions outside the paycheck. The major chains have yet to learn this. Wave the big bucks in front of the newbies and get them signed up. After a short time, the joy of the big paycheck is overshadowed by lack of staffing, unattainable metrics, and long hours. As a result, these experienced pharmacists move on to lower-paying jobs with much more opportunity.

Brenda, a pharmacist who lives just up the lane from us, left her chain job for a pay decrease to be part of the West Virginia University community. She now gets to be a mom as well as a pharmacist. Mike, another neighbor of mine, left his job with a major chain shortly after he got married. He took a job with an insurance company doing medication therapy management for a few years and also became a member of the university community. He is now on the national circuit discussing opioid therapy and pain management. Like Brenda’s, Mike’s career moves involved a salary decrease for better conditions and opportunities.

I often compare the big chains to my beloved Pittsburgh Pirates. The Pirates develop players like Andrew McCutchen, Gerrit Cole, Josh Bell, and Josh Harrison, who move on to bigger and better opportunities. The New York Yankees, Washington Nationals, and Los Angeles Angels are grateful to the Pirates for developing the future stars of our profession. By providing better working conditions, staffing, and opportunities, the chains could keep these future stars for their own benefit.

As I celebrate my 40th year in this amazing profession, I’m sure that nail No. 4 will be my last. My extended family is always asking me, “When are you going to retire?” My answer is simple: “When [I’m] darn good and ready.” I love this profession and get great satisfaction going to work every day. My best advice to students and new pharmacists: “Keep looking for your nail.”

Money isn’t everything in this profession. 


What I Learned From 40 Years in Pharmacy

Objective structured clinical examinations (OSCEs) have been shown to be a reliable and valid form of assessment used in pharmacy education.

Journal of the American College of Clinical Pharmacy

, the results of a standardized questionnaire showed that most pharmacy students found OSCEs to be a valuable tool to assess clinical skills.

 Although the OSCEs were designed to evaluate health care professionals in a clinical setting, there has been limited data on its use in testing skills required in community pharmacies.

Bernadette Cornelison, PharmD, MS, BCPS, and Beth Zerr, PharmD, BCACP, assistant professors at the University of Arizona College of Pharmacy, sought to understand how to best assess clinical skills taught during a self-care pharmacotherapeutics course. The course teaches students about the appropriate use of medications for self-care in the community setting––an important skill considering the community pharmacists’ role in guiding the patient selection of OTC products. According to a recent survey from the American Pharmacists Association, pharmacists make an average of 29 OTC recommendations each week, and approximately 81% of consumers purchase an OTC product their pharmacists recommended.

According to Cornelison and Zerr, “OSCEs provide students with hands-on experiences prior to providing patient care to an actual patient. In the simulation setting, community pharmacists are able to spend the time needed to focus on evaluating student performance and provide feedback that will develop skills that are necessary to have in the community pharmacy setting.”

Cornelison and Zerr evaluated the use of a community pharmacy-based OSCE in assessing pharmacy students in their first year using a standardized questionnaire. The questionnaire asked 41 questions and focused on 4 areas including attributes of the OSCE, quality of the OSCE performance, OSCE scoring and objectivity, and comparison with other assessment methods. A total of 88 pharmacy students completed the questionnaire.

Students reported that the OSCE was fair (91%) and covered a wide range of skills (76%). The majority of the students (91%) agreed that the OSCE provided opportunities to learn and was a practical and useful experience (86%). Approximately 2-thirds (66%) of the students felt that the OSCE provided a true measure of essential clinical skills needed in self-care therapeutics. Fourteen facilitators participated in the OSCE and completed the questionnaire. Community pharmacists represented most of the facilitators (57%). Facilitators agreed that the OSCE tests the knowledge and skills needed to practice in community pharmacy (100%), according to the results.

“Community pharmacists spend a large portion of their time interacting directly with patients,” coauthors Cornelison and Zerr continued. “Assessing students’ ability to interact with patients, including their ability to gather information from the patient, is difficult to do with traditional assessment methods.  The OSCE allows evaluation of a student’s entire interaction with a patient from start to finish, including gathering information, assessing their problem, creating a plan, and implementing the care plan for the patient.”

The study findings also demonstrated that the design of the simulation reflected the accurate amount of time a student intern would have to complete the Pharmacist’ Patient Care Process (PPCP). This finding further demonstrates that the PPCP can be applied to patients even when time may seem limited. The standardization of this process is an important step in advancing pharmacists as recognized patient care providers across the country.

“The high daily volume of face-to-face interactions with multiple patients sets community pharmacy practices apart from other health care providers,” Cornelison and Zerr said. “However, utilizing the PPCP is not unique to the community pharmacy setting and can be applied by any health care provider.  Incorporating the PPCP and utilizing an OSCE to assess the students’ ability to apply the PPCP to a patient, teaches the students the correct approach to evaluating a patient, regardless of setting.”

“OSCEs provide students with hands-on learning and the ability to learn from their mistakes without harming a patient. Traditional exams may encourage students to just do enough to pass the class. The pressure of an OSCE is similar to pressure students would have while completing their IPPE rotations, during their internships, or when a family member asks them a question about an OTC medication.  Numerous first-year students have shared experiences in which they applied what was learned in the class and the OSCE to their patients or family members,” Zerr and Cornelison explained.

In conclusion, a community-based pharmacy OSCE can provide a learning experience for pharmacy students and may be valuable.

1. Cornelison B, Zerr B. Experiences and perceptions of pharmacy students and pharmacists with a community pharmacy-based objective structured clinical examination. 

2. Assessment Tool Helps Future Pharmacists Prepare for Work in the Community. News release. University of Arizona Health Sciences; June 25, 2021.  Accessed July 8, 2021. https://healthsciences.arizona.edu/newsroom/news-releases/2021/assessment-tool-helps-future-pharmacists-prepare-work-community.

An assessment tool called the objective structured clinical examination has been shown to improve pharmacy education for students.


Assessment Tool for Pharmacy Students Helpful for Community Experience

The CDC estimates that 63.7% 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.

Getting Paid for Medication Management Services

The mechanics of getting paid for nondispensing services are shrouded in myths and lies. Conventional wisdom says pharmacists have always given away their clinicial, nondispensing services and payers won’t reimburse what they can get for free.

 is now available on DrugTopics.com. In this issue, you’ll find great insights into the 

 in independent community practice, diabetes, respiratory and autoimmune diseases, and more.

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This Week on Drug Topics: July 12 to July 16

At one point in our education, we all learned about Watson and Crick discovering the double helix structure of DNA in the 1950s. Although Watson and Crick did not know it at the time, this groundbreaking discovery would be the start of evaluating a patient’s specific DNA for more personalized pharmacological treatment.

After Watson and Crick’s discovery, there was a gold rush for DNA. Many new inventions and discoveries would follow years after. Half a century later, the Human Genome Project was launched in 1990 and completed in 2003.

 The goal of the Human Genome Project was to map and identify all of the human DNA base pairs and genes. Branching from the Human Genome Project is now the newer use of pharmacogenomics for medication therapy.

The first example of using DNA sequencing for disease treatment was the discovery of the human epidermal growth factor receptor 2 (HER2)-positive breast cancer mutation in the 1990s.

 Physicians were now able to screen for this HER2 mutation in patients with breast cancer. If the breast cancer expressed the protein HER2/neu, the patient would be receptive to trastuzumab (Herceptin), and therefore treatment would lead to a much better outcome. This proved to be a lifesaving discovery, and it inspired testing like this to continue.	

Since then, testing for genetic variations has become a standard of practice in several areas of health care, including cancer, cystic fibrosis, and HIV. The cost per human genome continues to decrease with technological advancements and more data. Therefore, conducting this testing has become more standardized and less expensive (see Figure).

Currently, pharmacogenomics testing is used for various pharmacokinetic and pharmacodynamic properties, mainly focused on the metabolism of different medicines. The pharmacogenomic results regarding metabolism express whether a patient will be predisposed to a lack of response due to a lower concentration of medicine, normal response, or toxicities from a higher concentration of medicine.

As developments in pharmacogenomics progressed over the years, several initiatives attempted to standardize pharmacogenomic medication information and guidelines. Because of this demand, the Pharmacogenomics Global Research Network and PharmGKB teamed up to develop a shared project termed the Clinical Pharmacogenetics Implementation Consortium (CPIC).

 CPIC addresses the need for guidelines to instruct clinicians on how to modify drug therapy based on genetic information. CPIC provides information on the proven genetic variations and the variations’ effects on medication therapy in 1 concise, clear guideline. CPIC information should be referred to and used by clinicians when applicable to select appropriate medications and doses for patients with genetic variations. As of this publication, there are over 40 medications with CPIC guidelines.

Through CPIC and other sources of pharmacogenomic data, prescribers can now use this information to optimize medication therapies for patients. Genetic variations can cause a patient to have altered responses to medications. The common area where these genetic variations are seen is in the metabolism of the particular medication. If a patient metabolizes a medication for elimination at a slower rate than expected, the patient can be predisposed to toxic concentrations when given standard doses of the medication. Additionally, if a patient metabolizes a medication for elimination at a faster rate than expected, the patient can be predisposed to a subtherapeutic concentration of the medicine. The opposite of these responses will happen when the medication in question is a prodrug, which is an inactive medication metabolized to an active pharmacologic agent in the body, ie, faster metabolism = toxic concentration; slower metabolism = subtherapeutic concentration.

Medication therapy can be optimized when a patient’s DNA sequence is evaluated for known genetic variations associated with certain medications. Personalizing medication choices and doses to the specific needs of a patient’s genetic results will lead to the correct therapeutic drug concentrations while avoiding toxicities or subtherapeutic concentrations.

Pharmacogenomics can not only optimize therapy through proper dose and drug selection but also lead to optimization in other areas of health care. If a patient experiences toxicities leading to adverse effects (AEs) from a medication, they often have to receive additional care either through emergency services or through additional  medication to control the AEs. If pharmacogenomics is considered at the time of prescribing, the therapy can be optimized from the start and additional treatment can be avoided. This saves time for the patient and saves health care dollars overall.		

The Role of the Pharmacist Across Care Settings

Today, pharmacists are the drug experts within the medical field, with extensive education in medication therapy including a heavy focus on pharmacokinetics and pharmacodynamics. Pharmacists have the knowledge and community presence to counsel patients about their genetic results, as well as educate other health care professionals. Through this education, pharmacists can help physicians make recommendations at the time of prescribing. These recommendations can include genetic testing to be done before new medication orders, as well as adjustments to be made on current medication orders.	

Additionally, pharmacists can help address pharmacogenomic components as the last point of intervention before dispensing the medication to the patient. If a new prescription arrives for a patient with an established AE profile, the pharmacist may be the last person to verify if genetic testing has been done. Detrimental AEs can be avoided through intervention at this point in the prescribing process.

Furthermore, pharmacists can serve as advocates for this area of health care. The only way to collect data on additional genetic variations and their associations with medications is through clinical trials. There is a lack of financial incentive for pharmacogenomic clinical trials to be conducted and many clinicians do not understand the importance of this area of research. Pharmacists can encourage health care professionals to begin trials to expand their knowledge of pharmacogenomics and its application in health care.

Though pharmacogenomics in health care has come a long way from where it started, there is still a great deal of growth in this field and there are many more barriers to be crossed. One barrier in pharmacogenomics is the issue of where to store a patient’s genetic information. With genetic results being protected by the Health Insurance Portability and Accountability Act, it is hard to deter- mine an easily accessible place where genetic information can be seen and used by all parties within the health care system. A potential suggestion some physicians have made is an electronic health record pop-up alert on a patient’s profile at the point of prescribing, but development is still needed in this area.

In addition, there is an ethical component when testing a patient’s genetics. Scientists could come across a mutation the genetic test was not indicated for. This is a gray area to decide whether the patient should be informed of the findings since they did not originally consent to search for that mutation. There is also the question of testing for 1 specific gene variation vs testing a multigene panel on a patient. Once again, this is an area that needs more discussion and development.	

As previously mentioned, clinical trials are imperative to the development and success of using pharmacogenomics in healthcare. There is no other way to get the information than to test a patient’s genes and evaluate them for their medication use. Pharmacists play a key role here in educating for clinical trial needs and advocating for more research. Overall, pharmacogenomics is an exciting and growing area of health care. Through additional research and a commitment to using pharmacogenomic findings, this information can eventually be brought to the bedside of every patient to optimize medication therapies for all.

1. The Human Genome Project. National Human Genome Research Institute. Updated December 22, 2020. Accessed June 3, 2021. 

2. Cornez N, Piccart MJ. Cancer du sein et Herceptin [breast cancer and herceptin]. 

3. DNA sequencing costs: data. National Human Genome Research Institute. Updated December 7, 2020. Accessed June 3, 2021. 

www.genome.gov/about-genomics/fact-sheets/DNA-Sequencing-Costs-Data

4. What is CPIC? Clinical Pharmacogenetics Implementation Consortium. Updated April 21, 2021. Accessed June 3, 2021. https://cpicpgx.org

Pharmacogenomics provides an opportunity for pharmacists to enhance their role in patient care. 


The Evolution of Pharmacogenomics

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

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

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

News Roundup: COVID-19 Vaccine Antibody Response in Fully Vaccinated Patients With Cancer, Empagliflozin Reduces Risk of CV Death, Hospitalization for Heart Failure

Pharmacists are an excellent resource for patients to ask questions about upper respiratory infections, especially with the ongoing COVID-19 pandemic. As trusted and accessible health care professionals, they can effectively counsel patients on appropriate OTC products and refer them to their physician when necessary.

Most upper respiratory infections are caused by a virus and include the common cold, sinusitis, pharyngitis, epiglottitis, and laryngotracheitis (see Table).

Sinusitis is an acute inflammation of the paranasal sinuses and can be caused by viruses or bacteria.

 Symptoms include pain, pressure, and tenderness around the sinus, as well as nasal discharge. Patients may feel tired and have a slight fever. Symptomatic treatment with analgesics and moist heat, as well as a decongestant, can be helpful. If an antibiotic is needed, amoxicillin/clavulanic acid is a first- line treatment.

Pharyngitis is an inflammation of the pharynx (throat), which can be caused by bacteria, virus, or fungus, or by smoking.

 Most cases are viral and occur with a common cold or flu. Symptoms include a red, sore, or “scratchy” throat. Fever, fatigue, muscle pain, or headache may occur, as well as swollen lymph nodes and difficulty swallowing. Treatment is symptomatic unless the virus is caused by herpes simplex, in which case acyclovir is used. If an antibiotic is needed, a penicillin or macrolide is often used.

The common cold is the most prevalent type of respiratory infection.2 Usually caused by a virus, its symptoms include a stuffy or runny nose, sneezing, sore throat, and cough. Fever rarely occurs, and complications are rare. Sometimes, sinusitis or an ear infection may develop. Treatment for a common cold is symptomatic. caused by bacteria, virus, or fungus, or by smoking.

Most cases are viral and occur with a common cold or flu. Symptoms include a red, sore, or “scratchy” throat. Fever, fatigue, muscle pain, or headache may occur, as well as swollen lymph nodes and difficulty swallowing. Treatment is symptomatic unless the virus is caused by herpes simplex, in which case acyclovir is used. If an antibiotic is needed, a penicillin or macrolide is often used.

Epiglottitis or laryngotracheitis (croup) is an inflammation of the upper airway. The diagnosis depends on location, symptoms, and pathogens.

type b, is less common in adults and can be associated with viral or bacterial infections. Laryngotracheitis is usually viral. Epiglottitis symptoms begin with sudden onset of fever, sore throat (“cherry-red” epiglottis), hoarseness, drooling, and difficulty swallowing. It can quickly progress to severe respiratory distress and can be fatal. Epiglottis is a medical emergency, especially in children, who need immediate emergency care including intubation and antibiotics (against 

Symptoms of laryngotracheitis (croup) include a runny nose, fever, sore throat, and mild cough, progressing to tachypnea, a barking cough, and stridor. Treatment includes observation, fluids, and humidified air. The 

type b conjugate vaccine (and immunization against diphtheria) is recommended in all children for prevention.

Lower respiratory infections include bronchitis, bronchiolitis, and pneumonia. They are often bacterial in nature, requiring antibiotics in such cases.

Otitis media, or middle ear infection, is another common infection, especially in children. It may be bacterial or viral and should be referred to the pediatrician or internist.

Morton Tavel, MD, is a clinical professor emeritus of medicine at Indiana University School of Medicine. Tavel reminds pharmacists that “despite the discomfort from the sneezing, sore throat, cough, and runny nose of a viral infection, happily, it gets better on its own without requiring any special treatment, usually within a week but sometimes a bit longer.”

Chris Schiller, PharmD, is the CEO of Economy Pharmacy, Inc, in Muskogee, Oklahoma. He recommends guaifenesin or guaifenesin-pseudoephedrine (Mucinex or Mucinex-D), depending on symptoms, as well as humidifiers and camphor eucalyptus oil-menthol (Vicks VapoRub).“My primary focus is on immune system health,” he said. He recommends supplements such as probiotics and immune support products, which combine vitamin D, vitamin C, zinc, and quercetin.

Tavel says pharmacists should dis- cuss other conditions the patient has that may not be compatible with a recommended OTC medication (for example, patients with hypertension should not use an oral decongestant).

According to the CDC, at least 47 million unnecessary antibiotic prescriptions are issued every year in the United States, which can lead to adverse effects and antibiotic resistance.

 When counseling patients, pharmacists should remind them that antibiotics do not treat viral infections. “[Seeing] they have no effect on the culprit viruses, contrary to the almost universal misconception, antibiotics should not be employed,” Tavel said. “Using them will neither shorten the cold’s duration nor prevent its spread to others. Moreover, the more we take antibiotics, the greater chance of producing resistant bacteria that could create mischief to others at a later time.”

Instead, Tavel recommends that patients consult their physician if their cold lasts for over a week or causes a moist cough, or if a fever lasts for more than 2 days. Antibiotics are needed for certain bacterial infections, such as pneumonia or sepsis. They are also necessary for high-risk patients, such as those with severe kidney disease or who are undergoing chemotherapy.

Patients should visit their internist if symptoms persist or are severe. The internist can perform an examination, order labs and cultures if warranted, and decide if an antibiotic is needed.

1.Upper respiratory tract. MedlinePlus. [KM1]Updated February 26, 2021. Accessed March 24, 2021.

https://medlineplus.gov/ency/imagepages/19378.htm

2.Dasaraju PV, Liu C. Infections of the Respiratory System. In: Baron S, ed. 

 University of Texas Medical Branch at Galveston; 1996. Accessed xxx xxxx.[KM2]

https://www.ncbi.nlm.nih.gov/books/NBK8142/#:~:text=Acute%20upper%20respiratory%20infections%20

3.Antibiotic prescribing and use. CDC. Updated November 13, 2020. Accessed March 24, 2021.

https://www.cdc.gov/antibiotic-use/index.html

4.Be antibiotics aware: smart use, best care. CDC. Updated November 17, 2020. Accessed March 24, 2021.

https://www.cdc.gov/patientsafety/features/be-antibiotics-aware.html

5.Antibiotic do’s & don’ts. CDC. Updated January 31, 2020. Accessed March 24, 2021.

https://www.cdc.gov/antibiotic-use/community/about/can-do.html

Pharmacists can offer OTC recommendations for symptom relief.







Self-care for Upper Respiratory Tract Infections

A recent clinical trial is the first to show that empagliflozin (Jardiance; Eli Lilly and Company) can significantly reduce the risk of the composite of cardiovascular (CV) death or hospitalization for heart failure (HF) in patients with a certain type of chronic HF, with or without diabetes.

HF is an increasingly prevalent disease in Western countries and is among the leading causes of hospitalizations globally. The Boehringer Ingelheim-sponsored clinical trial investigated patients with HF with preserved ejection fraction (HFpEF). This subset of HF is the result of a malfunctioning left ventricle, in which the volume of blood entering the heart is less than normal.

There are currently no FDA-approved therapies shown to improve outcomes for individuals with HFpEF, “leaving a significant unmet medical need in this already prevalent and increasingly common form of heart failure,” said Mohamed Eid, MD, MPH, MHA, vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals.

The EMPEROR-Preserved clinical trial is 1 of 2 EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) phase 3, randomized, double-blind trials researching the safety and efficacy of empagliflozin in adults with HF with either preserved or reduced ejection fraction, both with and without diabetes, who are receiving current standard of care. The Preserved study took place between March 2017 and April 2021 across 619 trial sites in the United States and 22 other countries and included 5988 adults with HFpEF randomized to receive once-daily empagliflozin 10 mg or placebo. Exclusion criteria included myocardial infarction, major cardiovascular surgery, stroke, or transient ischemic attack (TIA) in the past 90 days.

Investigators reported that the study met the primary end point of reducing the risk for the composite of CV death or hospitalization for HF in adults with HFpEF. Other outcome measures included the occurrence of adjudicated hospitalization for heart failure, estimated glomerular filtration rate (eGFR), and time to first occurrence of chronic dialysis or renal transplant sustained reduction of eGFR, among others. The full results of EMPEROR-Preserved will be presented at the European Society of Cardiology (ESC) Congress 2021 on August 27.

"We look forward to presenting the EMPEROR-Preserved results at ESC 2021, which should offer a significant breakthrough in cardiovascular medicine and a new hope for people with HFpEF, which is an increasingly prevalent public health issue,” said professor Stefan Anker, heart failure cardiologist at Charité Berlin, Germany, and EMPEROR-Preserved principal investigator.

"Building on previous results from the EMPA-REG OUTCOME trial, and the EMPEROR-Reduced trial in heart failure with reduced ejection fraction, the EMPEROR-Preserved findings demonstrate that empagliflozin reduces cardiovascular death or hospitalization for heart failure and has the potential to transform the care of people living with heart failure."

Breakthrough results for Jardiance® (empagliflozin) confirm EMPEROR-Preserved as first and only successful trial for heart failure with preserved ejection fraction. News Release. Lilly; July 6, 2021. Accessed July 7, 2021. 

https://investor.lilly.com/news-releases/news-release-details/breakthrough-results-jardiancer-empagliflozin-confirm-emperor

Kathleen Beitzel is the vice president of professional solutions and services at Omnicare.

With the worst of the COVID-19 pandemic behind us, hope, connection, and community has returned to many long-term care (LTC) facilities. As we all learn to navigate this “new normal,” the LTC industry is finding new ways to address staffing, financial, and public perception challenges, making it more important than ever for facilities to remain innovative and focused on patient care. Clinical consultant pharmacists have become even more invaluable and are a tremendous asset for facilities to assist with these challenges, lending support where needed.

 is the leading LTC pharmacy services provider, and services around 10,000 LTC facilities across 48 states. As the vice president of professional solutions and services at Omnicare, I work closely with our clinical consultant pharmacists in partnership with pharmacists in our Clinical Intervention Centers to seek out new ways to help our customers.

Clinical consultant pharmacists are local, personal pharmacists and resources, offering an individualized approach to their community facility’s needs. Their role is to provide geriatric clinical expertise and education to the prescriber and nursing staff and to be a patient advocate when it comes to medication therapy. The pharmacists bring expertise and knowledge to ensure optimal prescribing, dosing, and administration of medications and act as a partner working with both the dispensing pharmacy and facility to promote efficient quality of care. They can also help create, implement, and monitor policies and procedures, provide oversight, and ensure the facility remains aligned with federal and state regulations.

All of these tasks are critically important to help a facility run smoothly and provide a high standard of care and based on the results of the most recent Omnicare customer satisfaction survey, it is evident that the work being done is beyond satisfactory. With more than 3000 survey responses, evaluating the quality of care for our network of more than 300 consultant pharmacists, satisfaction ratings are consistently over 90% satisfied, with many comments specifically directed at the positive impact the clinical consultants have on the facility.

Anecdotally, these statistics are further supported by stories we hear daily about consultant pharmacists going above and beyond their typical job description. For example, Jan Cigich volunteers her time around the holidays dressing up and visiting her local nursing homes to provide some entertainment. Pre-COVID, with facility approval, she would also bring her certified therapy dogs with her while consulting in assisted living facilities.

Similarly, Danielle Venturi had forged a great relationship as a member of the interdisciplinary team at a facility, and being present on the unit made it easy to recognize when something was not right with a resident who experienced repeated falls. She ultimately discovered that the resident was receiving a medication that could be contributing to frequent falls. Danielle contacted the practitioner and had the medication reviewed, thereby improving patient outcomes.

It’s not only the actions taken but the fact that our consultants become a part of the fabric of the facilities they service that makes them so valuable. When challenges are presented, they don’t take the easy road but work to find solutions, and never leave their customers or residents unsupported. Like many, their job responsibilities shifted suddenly during the COVID-19 pandemic, but our consultant pharmacists proved they are always willing and able to adapt, leading the efforts for infection control, personal protective equipment, testing, and vaccination.

As we finally begin to enter post-pandemic life, they continue to adapt to the evolving challenges facing the LTC industry. Finding this level of commitment is often difficult, yet incredibly important. Especially with the experiences each of our consultant pharmacists endured throughout this pandemic, I am confident they are adequately prepared for the post-pandemic challenges ahead.

Clinical consultant pharmacists offer an individualized approach to the needs of long-term care facilities. 

The Ever-Expanding Role of Consultant Pharmacists in Long-term Care

Johnson & Johnson Consumer Inc (JJCI) voluntarily recalled all lots of 5 NEUTROGENA® and AVEENO® aerosol sunscreen and after-care sunscreen product lines yesterday citing internal test results that identified traces of benzene, a human carcinogen, in some samples of these products. The company advised consumers to stop using the affected products immediately.

The recall includes only these products, noted the press release:

NEUTROGENA® Beach Defense® aerosol sunscreen,

NEUTROGENA® Cool Dry Sport aerosol sunscreen,

NEUTROGENA® Invisible Daily™ defense aerosol sunscreen,

NEUTROGENA® Ultra Sheer® aerosol sunscreen, and

AVEENO® Protect + Refresh aerosol sunscreen.

The move comes less than seven weeks after 

 that Valisure, a pharmacy dedicated to batch testing medications before they reach consumers, found detectable levels of benzene in 78 sunscreen and after-care sunscreen products. Valisure’s laboratory test examined 294 unique batches of sun care products from 69 companies. Results showed 27% of the samples tested contained detectable levels of benzene. However, other batches exceeded the FDA concentration limit of 2 parts per million by up to 3 times.

This is not the first time Valisure has identified harmful contaminants in consumer products. In March, it released a 

 asking the FDA to recall various brands of hand sanitizer after detecting benzene contamination in multiple batches.

Watch our interview with Valisure Founder and CEO David Light, here.

® report, according to the U. S. Center for Disease Control and Prevention (CDC), the World Health Organization (WHO), U.S. Department of Health and Human Services, and various other regulatory agencies, benzene is known to cause cancer in humans. The National Institute for Occupational Safety and Health (NIOSH) also defines benzene as a carcinogen and exposure can include “inhalation, skin absorption, ingestion, and skin and/or eye contact.”

Benzene has been associated with blood cancers such as leukemia. What makes these findings "particularly concerning", according to Valisure, is that these products are absorbed through the skin and multiple studies conducted by FDA researchers have shown chemicals in sunscreen products are found in the blood at high levels following skin application.

The consumer products giant voluntarily recalled 4 NEUTROGENA® and 1 AVEENO® spray sunscreen products July 14 after internal testing found low levels of benzene, a carcinogen, in some product samples.


The Ever-Expanding Role of Consultant Pharmacists in Long-term Care

Johnson & Johnson Recalls 5 Aerosol Sunscreen Brands with Benzene Traces

Stanford Study Shows Memory T Cells Are Active Defense Against Severe COVID-19

Part 3: Leverage Technology to Transform Pharmacy Practice

Novel Antifungal Treatment Approved for Vaginal Candidiasis