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 interviewed Caroline Carney, MD, MSc, FAPM, CPHQ, chief medical officer of Magellan Health, a board-certified internist, and a board-certified psychiatrist, to discuss the correlation between heart health and mental health.

 Mother’s Day is coming up, so joining me is Caroline Carney, the chief medical officer of Magellan Health, a board-certified internist, and a board-certified psychiatrist.

She’s joining me to discuss the correlation between heart health and mental health, especially in light of heart disease being the leading cause of death in the US and the number one killer of women aged 65 years and older, with approximately 1 woman dying every minute of this disease.

Why might pharmacists and other health care professionals in particular be struggling with a negative mental health outlook especially during the difficulties and trials of the COVID-19 pandemic?

 Yeah, those individuals who are on the front lines of health care absolutely have been exposed to fewer hours of sleep, higher levels of stress, and particularly post-traumatic stress.

The kinds of scenes that my colleagues have been living through over and over and over are those that are heartbreaking, and that kind of mental stress can contribute, again, to a poor health outcome overall for that individual, in addition to doing more of those kinds of behaviors that don't support our overall health as a way to mitigate stress or to try to treat that stress.

So, the medical community has really in the front line, whether these are first responders as EMTs, whether they're pharmacists knowing and understanding that individuals who were getting their medications filled for instance no longer are because they've stopped coming in for care, whether these were doctors and nurses and techs on the front lines in the hospitals or in clinics—they all have really been affected by what they have been doing to help save and treat the rest of us.

 Yeah, absolutely. How would you recommend health care professionals approach an awareness of their own negative mental health outlook?

 I think it's so critically important. The first thing that I have advised colleagues and others to do is to really step back and take a look at themselves to say, ‘Am I functioning the same way that I functioned before? Have my feelings become more hardened? Have I become more distant from that person I used to be able to have a connection with, whether that was a patient or whether it was someone in my family group or my friend group?’ and to look at the kinds of things that may have changed for them just overall in their well-being.

Secondly, if they look at how they're eating, how they're sleeping, how they're engaging in activities that they used to enjoy before and say they no longer get any pleasure from—so, if I used to love to come home and watch a certain television show, for instance, and now I come home from work and I just don't care, that is a huge predictor that something emotionally has changed for that individual.

Finally, taking a look at the kinds of behaviors: Am I drinking more, am I eating more, am I more reckless when I drive. What has changed about how I'm acting?

I think one of the hardest things is to hear from a loved one or a friend, ‘I'm worried about you.’ But if someone says, ‘I'm worried about you,’ you have to listen to them because that outside observation is often the most insightful and most important for us to hear. As hard as it may be, those around us, those who love us are often the best mirrors of how we're doing.

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Caroline Carney, MD, MSc, FAPM, CPHQ, chief medical officer of Magellan Health, a board-certified internist, and a board-certified psychiatrist, discusses the impact of trauma and stress on overall health during the COVID-19 pandemic.

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Expert: Trauma, Stress from the COVID-19 Pandemic Can Cause ‘Poor Health Outcomes Overall’ 

The FDA has approved pembrolizumab (Keytruda, Merck), an anti-programmec cell death protein 1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This indication has received accelerated approval based on tumor response rate and durability of response, though the results of confirmatory trials may change the approval status.

According to a press release from Merck, the approval for this indication is based on data from the ongoing phase 3 KEYNOTE-811 trial, in which pembrolizumab was combined with trastuzumab and either 5-fluorouracil plus cisplatin or capecitabine plus oxaliplatin. KEYNOTE-811 is a multicenter, randomized, double-blind, placebo-controlled trial that was designed to enroll 692 patients with HER2-positive advanced gastric or GEJ adenocarcinoma who had not previously received systemic therapy for metastatic disease. Patients were randomized into treatment arms containing either pembrolizumab or placebo alongside trastuzumab and investigator’s choice of chemotherapy regimen.

The pembrolizumab combinations demonstrated a statistically significant objective response rate of 74% for patients who received the regimen with pembrolizumab versus 52% for those who received trastuzumab and chemotherapy alone (

<.0001). For patients on the regimen containing pembrolizumab, the complete response rate was 11% and the partial response rate was 63%, whereas the patients receiving trastuzumab and chemotherapy alone had a complete response rate of 3.1% and a partial response rate of 49%.

“Today’s approval marks an important milestone, as this is the first time an anti-PD-1 therapy has been approved in combination with anti-HER2 therapy and chemotherapy as a first-line treatment for these patients,” said Roy Baynes, MD, PhD, senior vice president and head of global clinical development at Merck, in the release.

According to the trial, pembrolizumab and placebo were discontinued due to adverse effects (AEs) in 6% of patients in each arm, with pneumonitis being the most common AE leading to discontinuation in the pembrolizumab arm. AEs led to temporary interruption of pembrolizumab in 58% of patients, with the most common AEs being neutropenia, thrombocytopenia, diarrhea, anemia, hypokalemia, fatigue/asthenia, decreased appetite, increased aspartate aminotransferase, increased blood bilirubin, pneumonia, increased alanine aminotransferase, and vomiting. There were no clinically meaningful differences in the incidence of grade 3-4 toxicity between the 2 arms.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Combined With Trastuzumab and Chemotherapy as First-line Treatment in Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma [news release]. Merck; May 5, 2021. Accessed May 5, 2021. 

https://www.merck.com/news/fda-approves-mercks-keytruda-pembrolizumab-combined-with-trastuzumab-and-chemotherapy-as-first-line-treatment-in-locally-advanced-unresectable-or-metastatic-her2-positive-gastric-or-g/

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This indication has received accelerated approval based on tumor response rate and durability of response, though the results of confirmatory trials may change the approval status.

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FDA Approves Pembrolizumab, Trastuzumab and Chemotherapy as First-Line Treatment for Certain Adenocarcinomas

Vaccinations, one of the greatest public health achievements, prevent more than 2 million deaths worldwide each year.

Coronavirus disease 2019 (COVID-19) had a substantial impact on adult and childhood vaccination rates in 2020 by increasing interest in influenza vaccinations to avoid a dual pandemic. However, many barriers and concerns regarding vaccine administration persist, including limited accessibility and lack of safe care because of health care provider shortages.

Recognizing the need for patient education and increased opportunities to receive immunizations, the American Pharmacists Association Academy of Student Pharmacists (APhA-ASP) established the Operation Immunization program. Since 1997, more than 1.4 million individuals have been immunized by the over 17,880 certified pharmacy student immunizers from 121 schools. Methods codeveloped and implemented by pharmacy students at Idaho State University (ISU) in partnership with the Idaho Immunization Coalition were designed to effectively, safely vaccinate Idahoans against influenza, using a drive-through model of care.

PharmD students at the ISU College of Pharmacy, in partnership with health care providers across the state, led a charge to improve access to influenza vaccine, trialing administration strategies that support social distancing measures and reduce COVID-19 transmission. Planning of the 4 drive-through immunization clinics began in July 2020. The initial step involved development and approval of protocols by the ISU-COVID Workgroup. The ISU COVID-19 response team was responsible for ensuring that the proposed protocols, safety measures, and workflows mitigated risk to health care providers, patients, and students participating in the DRIVE-RX event.

Training videos, developed by the APhA-ASP Operation Immunization team, detailed step-by-step safety protocols and required workflows such as patient screening, personal protective equipment use, and emergency procedures in the case of COVID-19 exposure and/or protester involvement. Training videos and competency assessment questions were added to the online learning platform for students to complete prior to event participation. Each ISU student volunteer was also required to attend a live online meeting that outlined the organizational workflow of the clinic, responsibilities, and roles of each station and student, and addressed potential patient concerns and questions.

The website SignUpGenius was used to schedule volunteers to assist at the 4 strategically located vaccination events in Idaho: October 3, 2020, in Meridian; November 21, 2020, in Pocatello; December 6, 2020, in Caldwell; and December 12, 2020, In Nampa. Each site chosen was accessible, well known to the community, and supported directional traffic flow, allowing for coordinated entry and exit.

All organizations and students involved helped set up the event and participated in a mock drive-through prior to the start of the clinic. Upon entering a standard parking lot, drivers were stopped for COVID-19 screening and were asked to wear masks. Patients were then directed to the first parking spot, where they filled out consent forms and told student pharmacists which vaccine they would prefer. Once the forms were completed, cars would pull forward into the next parking spot for patients to receive the vaccine. All students were monitored by a preceptor according to state guidelines. If patients had not received the vaccine before, they were instructed to wait 15 minutes to monitor for any adverse effects, such as allergic reactions or fainting. Finally, drivers were directed toward the exit (see figure).

Idaho Governor Brad Little and First Lady Teresa Little were first in line for their influenza shots, highlighting the importance of getting immunized while encouraging community involvement. More than 650 immunizations were administered by the 98 students during the 9-hour Meridian event, 200 immunizations were administered by 20 student pharmacists during the 4-hour Pocatello event, 34 immunizations were administered by 9 students during the 4-hour Nampa event, and 140 immunizations were administered by 4 students during the 4-hour Caldwell event.

Although drive-through clinics have been done in the past, this idea is innovative because it combined the use of pharmacy students to efficiently administer influenza vaccine safely to multiple individuals. To administer vaccines more effectively and reduce the spread of COVID-19, as well as waiting times, community pharmacies have encouraged patients to make appointments online. This has led many pharmacies to implement drive-through vaccination clinics. Furthermore, rural states, such as Idaho, have limited access to health care services. Therefore, using student pharmacists can mitigate structural inequities through the provision of health care services.

The ISU clinics administered more than 1000 vaccines in 21 hours during 4 events throughout Idaho. These influenza clinics reached underserved populations and guaranteed everyone an influenza vaccine, regardless of insurance status or ability to pay. Pharmacy students are an untapped resource that can be successfully used not only in vaccination efforts but also in future COVID-19 pandemic efforts, especially in vaccination administration. These events demonstrate that this model can be applicable in both large- and small-scale events in an effective and safe manner that broadens the availability of vaccines to our communities.

Anecdotally, we found that 3 students working in each immunization bay, with 1 students working in the consent form area, is the most efficient setup for this drive-through clinic. This allowed for less overlap of responsibilities and clearly defined roles. The number of students assigned per bay was further tailored to best fit the city/town in which the event would take place.

There remains an increasing need for health care workers who are able and willing to provide vaccinations, especially the new COVID-19 vaccine, to the public. Using student pharmacists in immunization efforts not only improves vaccine access for the public but also serves as a unique opportunity for students to gain clinical experience and use their skills as trained immunizers. The success of these student pharmacist-led drive-through clinics indicates that implementation of similar events may be beneficial for COVID-19 vaccinations.

This effective and safe model of care delivery showed potential for COVID-19 immunization efforts, exponentially increasing the workforce and expediting vaccination delivery. Since implementing the drive-through influenza vaccination clinics, pharmacy students in Idaho and Alaska—where ISU operates a pharmacy program in partnership with the University of Alaska Anchorage—have been assisting in COVID-19 vaccination efforts in hospitals, clinics, and other community sites.

is a PharmD candidate at Idaho State University (ISU) College of Pharmacy in Pocatello and the APhA-ASP Chapter Operation Immunization chair.

 is a PharmD candidate at ISU College of Pharmacy.

 is a PharmD candidate at ISU College of Pharmacy and the APhA-ASP Chapter president.

 is a PharmD candidate at ISU College of Pharmacy and the APhA-ASP Chapter finance vice president.

 is an associate professor of pharmacy at ISU College of Pharmacy.

 is assistant dean and director of experiential education at ISU College of Pharmacy.

Idaho State University partners with the Idaho Immunization Coalition to effectively and safely vaccinate patients against influenza.

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Pharmacy Students Lead Drive-Through Influenza Vaccination Event

Rates of in-hospital mortality among COVID-19 patients fell 38% between March 2020 and May 2020, but there was little further decline through November 2020, according to a study published in 

. The study is most comprehensive analysis to date of changes in hospital mortality throughout the pandemic, reviewing data on more than 20,000 patients admitted to hospitals for COVID-19 over 9 months, according to the Institute for Health Metrics and Evaluation at the University of Washington.

“Understanding why mortality rates changed is important for clinicians working to improve outcomes for patients hospitalized with COVID-19,” said Gregory Roth, MD, MPH, the study's lead author and an associate professor of medicine at the Institute for Health, in a press release. “Further analysis is needed to understand the drivers more precisely, but it speaks to a crucial need for information sharing and identifying hospital best practices that can prevent mortality rates from increasing again, particularly during possible future waves of COVID-19 infections.”

The investigators analyzed records from the American Heart Association's COVID-19 Cardiovascular Disease Registry, which include 107 hospitals in 31 states. They found mortality rates for patients in the registry were 19.1% in March and April, 11.9% in May and June, 11% in July and August, and 10.8% from September through November. Nearly one-third of patients were admitted to intensive care, and 1 in 5 were placed on mechanical ventilation.

The study was intended to uncover the most likely cause of the observed trend by controlling for patient age, sex, comorbidities, and severity of disease when the patient was admitted. However, they found that none of these factors fully explained the decline in mortality rates. They also found only small changes in patient characteristics during the observed period, including a small decrease in age, an increase in proportion of women, and an increase in BMI.

“Our findings suggest that the decline in mortality could be due to overloaded hospitals and changes in treatment,” Roth said in the release. “With more variants circulating, and many countries still struggling with overloaded hospitals and scarce resources, the more we know about this the better.”

Researchers publish most comprehensive study yet of COVID-19 hospital mortality [news release]. EurekAlert; May 3, 2021. Accessed May 4, 2021. 

https://eurekalert.org/pub_releases/2021-05/ifhm-rpm050321.php

The study is most comprehensive analysis to date of changes in hospital mortality throughout the pandemic, reviewing data on more than 20,000 patients admitted to hospitals for COVID-19 over 9 months, according to the Institute for Health Metrics and Evaluation at the University of Washington.

COVID-19 Hospital Mortality Rates in 2020 Remained Stable Over 6 Months After Initial Decline

Social media platforms such as Facebook, Twitter, and LinkedIn allow people to share personal and professional content as well as communicate and connect with each other online. These interactive tools have completely changed the landscape of information exchange with 72% of US adults in 2021 saying they use at least one social media site.

In light of the COVID-19 global pandemic, the internet and social media play an even more crucial role in our daily lives. Pharmacists have had to adapt to meeting more frequently online instead of in person, while embracing new ways of delivering care and disseminating health care information.

An emerging avenue is through social media influencing, in which influencers help promote brands, enhance their own or an organization’s popularity, and create effective communication strategies to engage the public.

 Many pharmacists have also entered this space, creating a new nontraditional role of pharmacist social media influencers (PSMIs).

In 2012, the American Society of Health-System Pharmacists published a statement encouraging pharmacists’ use of social media as tools to complement and enhance their relationships with the public, health care providers, and patients.

 Student pharmacists mostly use social media as a means to personally communicate with their friends.

A small percentage of pharmacists use social media predominantly or exclusively for professional purposes.

 For the pharmacists who have built an alternative career as PSMIs, their role is not well understood and has yet to be characterized.

As fourth-year University of California, San Francisco (UCSF) student pharmacist researchers, we surveyed 63 pharmacy students to understand their perceptions of PSMIs and compared this to what identified PSMIs described. The perception and attitude toward social media benefits and perceived outcomes predict social media usage and characterize the social media influence and career of PSMIs.

Observed differences between student pharmacist perception and reality may provide the necessary knowledge to boost the presence of PSMIs, encourage pharmacy students to potentially consider social media influencing as a career, and validate the importance of PSMIs. We believe this study to be the first, of hopefully many, detailing this emerging pharmacist role.

According to the American Influencer Council (AIC), social media influencers satisfy the following criteria: having an active and public social media presence, engaging in influencer marketing, representing or partnering with business-to-consumer or business-to-business brands, being publicly and industry-recognized as an influencer, and being known for personal branding, digital custom content, and follower integrity.

 However, our study showed that the only trait that PSMIs shared was having an active and public social media presence, while the presence of all other criteria varied among individual PSMIs.

Depending on the purpose of their social media use, PSMIs may not strictly meet all AIC criteria to achieve their goals. Consequently, defining a social media influencer is difficult and the potential negative connotation associated with “social media influencing” and varying definitions are likely reasons 27% of our surveyed PSMIs did not consider themselves as social media influencers but are considered by others as one. Lastly, out of more than 80 PSMIs that we identified and invited to complete the study, only 25 PSMIs participated.

Our study showed that most PSMIs (>50%) used LinkedIn, Instagram, Facebook, or a personal website for their social media work, whereas most students (>50%) used Facebook, Instagram, and YouTube for their leisure. Our data suggest that multiple archetypes of a PSMI exist. A majority of PSMI’s social media content involves education and advocacy, both of which are pharmacy- or health care-related. Additional content involves lifestyle, food and nutrition, fitness, finances, entertainment, travel, career, and technology.

Furthermore, a majority of PSMIs do not commit as much time toward their social media work as students perceive most PSMIs to commit. Most PSMIs spent 10 to 20 hours (38%) or 0 to 10 hours (27%) per week on social media for work as a PSMI, whereas most students believed that PSMIs commit 10 to 20 hours (41%) or 20 to 30 hours per week (35%) toward social media work. Interestingly, most students surveyed are heavy social media consumers who allocated 10 to 20 hours per week (45%) or 20 to 30 hours per week (35%) on social media.

We wanted to explore how satisfied PSMIs were with their job in social media and what their average yearly income was. In terms of job satisfaction, we conducted our surveys by asking Likert scale type questions related to various factors, such as career satisfaction, job fulfillment, appropriate workload, and value. For each Likert scale question, a numerical value of 1 through 4 was assigned with the ranges 1=strongly disagree, 2=somewhat disagree, 3=somewhat agree, and 4=strongly agree to determine how satisfied PSMIs were with their job.

Through our findings, we determined that PSMIs had a total composite mean score of 3.44. This was equivalent to the fact that on average, PSMIs had a positive outlook overall on the pharmacy profession as they somewhat agree that they are satisfied with their job.

In terms of income, PSMIs generated an average of approximately $31,250 from annual revenue earned from social media platforms. None of the PSMIs reported a net loss or did not make any money from their social media platforms. We also determined that most of the PSMIs’ main source of income came from sales of their own products and services (71%).

We also conducted in depth interviews with 6 PSMIs who provided additional insight into their social media careers. It is important to note that 83% of the interviewees did not consider themselves as PSMIs even though they were recognized as others to be a PSMI.

All the interviewees stated that they started using social media to share content based on their own experiences as a pharmacist and a third of the respondents created an online presence because they saw an educational gap and wanted to bring awareness to a certain niche of the profession. When asked if they ever found at any point that their social media presence has hurt their career, many of the interviewees mentioned that they were cautious about what they said on their social media platforms and maintained professionalism so as to not hurt their careers.

Half of the interviewees even stated that they set strict boundaries and never provided any medical advice via social media. Additionally, every interviewed PSMI defined success in their social media careers based not on number of followers but rather the value of the content. Finally, some advice PSMIs have for new pharmacists who want to establish an online social media presence include understanding your purpose and vision, identifying where and who your audience is, picking something you are passionate about, and finding something that makes you unique.

We hope that our study results are useful to both current and aspiring PSMIs. We observed a growing and supportive online community among PSMIs and their audience members and believe there is definitely a place in the social media realm for pharmacist social media influencers.

Grace Huynh, Tiffany Pham, Monica Vuong, and Curtis Yu are graduating student pharmacists from the University of California, San Francisco. Luke Tso PharmD, BCPS served as faculty advisor. For questions about our study, please contact Monica Vuong at monica.vuong@ucsf.edu.

Pew Research Center: Internet, Science & Tech. 2021. 

Demographics of Social Media Users and Adoption in the United States

. [online] Available at: <https://www.pewresearch.org/internet/fact-sheet/social-media/> [Accessed 30 April 2021].

Barry AR, Pearson GJ. Professional use of social media by pharmacists. Can J Hosp Pharm. 2015; 68(1):22-27. doi:10.4212/cjhp.v68i1.1421

ASHP Statement on Use of Social Media by Pharmacy Professionals: Developed through the ASHP Pharmacy Student Forum and the ASHP Section of Pharmacy Informatics and Technology and approved by the ASHP Board of Directors on April 13, 2012, and by the ASHP House of Delegates on June 10, 2012. American Journal of Health-System Pharmacy. 2012; 69(23):2095–2097. Accessed at https://doi.org/10.2146/sp120011

O’Hara B, Fox B, Donahue B. Social media in pharmacy: Heeding its call, leveraging its power. Journal of the American Pharmacists Association. 2013; 53(6):561,565,567-568. Accessed at https://doi.org/10.1331/JAPhA.2013.13536.

McGowan BS, Wasko M, Vartabedian BS, Miller RS, Freiherr DD, Abdolrasulnia M. Understanding the factors that influence the adoption and meaningful use of social media by physicians to share medical information. 

. 2012;14(5):e117. Published 2012 Sep 24. doi:10.2196/jmir.2138

AIC Membership: Career Influencers. American Influencer Council - AIC. https://www.americaninfluencercouncil.com/aic-membership-for-career-social-media-influencers. Accessed August 1, 2020.

Pharmacists have had to adapt to meeting more frequently online instead of in person, while embracing new ways of delivering care and disseminating health care information. 

The Emerging Role of Pharmacists as Social Media Influencers

, Murray Aitken, executive director of the IQVIA Institute for Human Data Science, said the COVID-19 pandemic had an immediate impact on global medication spending and usage in the second quarter of 2020.

Shortly before the pandemic began but after the virus started spreading, Aitken said researchers saw a significant increase in medication usage, which he called the “stockpiling period.” In the first months of the pandemic, however, usage plummeted as patients relied on the medications they had stockpiled a few months earlier.

Aitken also reviewed some broader trends in medication spending and usage over the past decade, noting that global use of medicine has gradually slowed, although it has still increased at a 3% compound annual growth rate since 2014. This could have various causes, he said, including budgetary limitations in some countries.

 in IQVIA’s Global Medicine Spending and Usage Trends report.

IQVIA researchers saw a sharp uptick in medication usage shortly before the COVID-19 pandemic began, followed by a steep fall in the first few months of the pandemic. 

Global Medication Spending, Usage Impacted by COVID-19 Pandemic

The American Heart Association released a special report, “Diagnosis and Management of Cerebral Venous Sinus Thrombosis with Vaccine-Induced Immune Thrombatic Thrombocytopenia,” to provide important guidance about cerebral venous sinus thrombosis (CVST), thrombosis-thrombocytopenia syndrome (TTS), and vaccine-induced immune thrombotic thrombocytopenia (VITT) after receiving the COVID-19 vaccine.

“COVID-19 infection is a significant risk factor for CVST. A preliminary analysis of US data during the COVID-19 pandemic, available online, preprint on April 15, 2021, found that the risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” said Karen L. Furie, MD, MPH, lead author of the special report, in the press release. “The public can be reassured by the CDC’s and FDA’s investigation and these statistics—the likelihood of developing CVST after a COVID-19 vaccine is extremely low. We urge all adults to receive any of the approved COVID-19 vaccines.”

The analysis included data from 59 health care organizations and 81 million patients, more than 98% of whom were in the United States. Out of approximately 514,000 patients in the database who were diagnosed with COVID-19 infection from January 20, 2020, through March 25, 2021, 20 patients were diagnosed with CVST. These data were compared to the incidence of CVST in adults who received either the Pfizer or Moderna COVID-19 vaccine before March 25, 2021, excluding those who had been previously diagnosed with COVID-19.

“CVST blood clots are very rare adverse events. We recommend immediate screening of all patients who arrive in the ER with a suspected clot—did they receive a COVID-19 vaccine during the recent weeks prior to this event?” Furie said in the press release. “Patients who present with the symptoms of CVST or blood clots and who recently received the COVID-19 vaccine should be treated using non-heparin anticoagulants. No heparin products in any dose should be given for suspected CVST, TTS or VITT. With the right treatment, most patients can have a full recovery after CVST, TTS or VITT.”

Some of the highlights of the report include:

All patients with suspected CVST due to a COVID-19 vaccine should be treated with non-heparin anticoagulants, such as argatroban, bivalirudin, danaparoid, fondaparinux, or a direct oral anti-coagulant.

Blood tests should include a complete blood count.

Magnetic resonance imaging with a venogram or computed tomography with venogram is recommended to accurately detect and diagnose CVST.

“We are learning the various intricacies of COVID-19 live, in real-time with the patients we see in our hospitals every day. CVST is extremely rare, however, further research and investigation are necessary as the pandemic continues. We will need data and robust research on the people who did not develop blood clots after the vaccine, too, so that we can fully understand the molecular and cellular mechanisms underlying CVST related to COVID-19 infection or after vaccination,” Furie said in the press release.

https://newsroom.heart.org/news/guidance-on-treatment-for-rare-blood-clots-and-low-platelets-related-to-covid-19-vaccine

The AHA released a report to provide guidance about CVST, TTS, and VITT after receiving the COVID-19 vaccine.

Hematology

Guidance on Treatment for Rare Blood Clots, Low Platelets Related to COVID-19 Vaccine

When looking at the COVID-19 variants, it is increasingly necessary to assess them in terms of the mutations embedded in the variants themselves, explained Scott Gottlieb, MD, former commissioner of the FDA from 2017 to 2019, during a session at the NACDS 2021 Annual Meeting. Ultimately, it’s the mutations that create the risk depending on the type embedded in the variant.

Currently, there are certain mutations and variants that are being followed closely by investigators across the world. For example, the mutation E484K present in the South African variant B.1.351 seems to create a greater risk for reinfection and decrease some of the efficacy of COVID-19 vaccines. This same E484K mutation has also been found to be present in the Brazilian variant P.1 and the New York variant B.1.526.

Gottlieb noted that the Los Angeles variant has a different mutation; however, a mutation present in this variant has been found to increase the fitness of the virus and its propensity to spread and, perhaps, reduce the efficacy of prior immunity.

Additionally, epistasis can occur among multiple variants, which is the combination of variant mutations into new strains that have much different characteristics from the original mutations.

“A mutation that has a certain characteristic and another mutation that has a certain characteristic, when you combine them together in 1 strain, suddenly you get a much different virus that has very unique characteristics that are very dissimilar to any of the characteristics of the individual mutations,” Gottlieb said during the session. “You can get a mutation that does X and a mutation that does Y, and when you put them together, it doesn’t do X and Y, it does Z.”

Epistasis may be what is occurring with the B.1.617 variant found in India, Gottlieb explained. In this variant, there are 2 mutations embedded within it that are of the greatest concern. One of these is similar to the E484K mutation but is called the E484Q mutation, whereas the other mutation is similar to the mutation of concern embedded in the Los Angeles variant. In the B.1.617 variant, both of these new mutations are present.

“That seems to be responsible for the out of control epidemic that is underway in India right now. The incidence of that B.1.617 mutation has gone from about 20% of cases 2 months ago to over 80% of cases at the beginning of this month, which means it must be higher right now because we only have data as of the beginning of April,” Gottlieb said during the session.

However, in order for the United States to be affected by the variants from India, South Africa, or Brazil, it is not necessary for the variants themselves to be transported into the country from abroad. Instead, convergent evolution is occurring, which is where the variants are growing up simultaneously in multiple parts of the world.

“They’re happening spontaneously. So, you don’t necessarily need them to be imported—they’re happening right here,” Gottlieb said during the session. “That’s why it’s important to get control of the virus.”

Some investigators in the field are considering that as the B.1.1.7 variant from the UK becomes the prevalent strain, it’s going to crowd out some of these other mutations. This may happen because the B.1.1.7 variant is similar enough to other mutations that people who were infected with B.1.1.7 will have some cross-immunity to the other strains.

Additionally, some investigators are considering that the virus may reach a fitness level whereby multiple mutations have evolved at once, leading the virus to not evolve at the same pace as it did initially. This may mean that the rate of change in the virus may start too slow.

“It has a certain repertoire, it has a certain range of things that it was going to do to try to evade our immunity, and if there are 20 things that it can do, it may have already done 15 of them,” Gottlieb said during the session.

In this way, COVID-19 may not be like the flu, in which the virus continuously adapts in order to stay ahead of our immunity to it, Gottlieb explained.

“It did a lot of evolution very quickly because of the intense pressure it was under and its wide spread,” Gottlieb said. “Now, it’s reached a new fitness level, and it’s rate of change is going to start too slow.”

Anderson SC, Paley L, Keyes R, Gottlieb S. Business Program I. National Association of Chain Drug Stores Annual Meeting 2021; April 26, 2021; virtual. Accessed April 28, 2021.

When looking at the COVID-19 variants, it is increasingly necessary to assess them in terms of the mutations embedded in the variants themselves.

Conference

Expert: Convergent Evolution Occurring Among COVID-19 Variants, With Mutations From Abroad Simultaneously Hitting the US

Processed diets may initially reduce the incidence of foodborne infectious diseases, such as 

, but might also increase the incidence of diseases characterized by low-grade chronic infection and inflammation, such as diabetes, according to researchers in the Institute for Biomedical Sciences at Georgia State University.

This study used mice to investigate how changing from a grain-based diet to a highly processed, high-fat Western-style diet impacts infection with the pathogen 

Gut microbiota provide a number of benefits, such as protecting a host from infection by bacterial pathogens, and can be influenced by a variety of factors, but specifically diet. The Western-style diet lacks fiber and contains high amounts of processed foods, red meat, high-fat dairy products, high-sugar foods, and pre-packaged foods. This lack of fiber is believed to have contributed to increased prevalence of chronic inflammatory diseases, such as inflammatory bowel disease, metabolic syndrome, and cancer, according to the study.

In the current study, the researchers found switching mice from a standard grain-based rodent chow to a high-fat, low-fiber Western-style diet resulted in a rapid reduction in the number of gut bacteria. Mice fed the Western-style diet were frequently unable to clear the pathogen 

 from the colon and were prone to developing chronic infection when re-challenged by this pathogen.

“We observed that feeding mice a Western-style diet, rather than standard rodent grain-based chow, altered the dynamics of 

 infection, reducing initial colonization and inflammation, which was surprising. However, mice consuming the Western-style diet frequently developed persistent infection that was associated with low-grade inflammation and insulin resistance,” said senior co-author of the study Andrew Gewirtz, MD, professor in the Institute for Biomedical Sciences in the press release. “These studies demonstrate potential of altering microbiota and their metabolites by diet to impact the course and consequence of infection following exposure to a gut pathogen.”

The researchers concluded the Western-style diet reduces the numbers of gut bacteria and promotes encroachment of microbiota into the intestine, potentially influencing immune system readiness and the body’s defense against pathogenic bacteria, according to the study.

“We speculate that reshaping gut microbiota by nutrients that promote beneficial bacteria that out-compete pathogens may be a means of broadly promoting health,” said senior co-author of the study Jun Zou, MD, assistant professor in the Institute for Biomedical Sciences at Georgia State, in the press release.

Processed Diets Might Promote Chronic Infections That Can Lead to Disorders Such as Diabetes, Researchers Find. Georgia State University. Published April 28, 2021. Accessed April 29, 2021. https://news.gsu.edu/2021/04/28/processed-diets-might-promote-chronic-infections-that-can-lead-to-disorders-such-as-diabetes-biomedical-sciences-researchers-find/

Processed diets may initially reduce the incidence of foodborne infectious diseases, such as E.coli, but might also increase the incidence of diseases characterized by low-grade chronic infection and inflammation.

Weight Management

Digestive Health

Study: Western-Style Diet Promotes Inflammation That Leads to Chronic Diseases

New research suggests that very few men between 18 and 21 years of age have received at least 1 dose of the human papillomavirus (HPV) vaccine at any time, compared to more than 40% of women in the same age range.

The CDC’s Advisory Committee on Immunization Practices recommends 2 doses of the vaccine administered at 11 or 12 years of age, although patients can still benefit from the vaccine if they receive it later, as long as 3 doses are administered by age 26. According to researchers at Michigan Medicine, however, just 16% of men and 42% of women aged 18 to 21 years have received a single dose at any time.

“Eighteen- to 21-year-olds are at this age where they’re making health care decisions on their own for the first time,” said first author Michelle M. Chen, MD, a clinical lecturer in the Department of Otolaryngology-Head and Neck Surgery, in a press release. “They’re in a period of a lot of transition, but young adult men especially, who are less likely to have a primary care doctor, are often not getting health education about things like cancer prevention vaccines.”

The HPV vaccine was designed to prevent reproductive warts and cancers caused by the virus, which the study authors said is the most common sexually transmitted infection in the United States. The vaccine was approved by the FDA for women in 2006 and for men in 2009.

At the time, preventing cervical cancer was a primary focus for investigators studying the virus, so girls and women were more likely to hear about the vaccine from their physicians or pharmacists. However, oropharyngeal cancer has now surpassed cervical cancer as the leading cancer caused by HPV, and 80% of those diagnosed with this cancer are men. In the press release, Chen said this has created a new need to vaccinate men.

“I don’t think that a lot of people, both providers and patients, are aware that this vaccine is actually a cancer-prevention vaccine for men as well as women,” Chen said in the press release. “But HPV-associated oropharyngeal cancer can impact anyone—and there’s no good screening for it, which makes vaccination even more important.

Chen added that she believes a dual-prong approach is necessary to increase HPV vaccination rates for men, including renewed pushes from health care providers to target children, as well as outreach to university health services and fraternity houses for young adult men who may have missed the vaccine when they were younger. In addition to physicians, urgent care providers, and emergency department providers, pharmacists can play a vital role in this outreach.

Few Young Adult Men Have Gotten the HPV Vaccine [news release]. Michigan Health Lab; April 27, 2021. 

https://labblog.uofmhealth.org/rounds/few-young-adult-men-have-gotten-hpv-vaccine

Although young women were the original targets of human papillomavirus vaccine outreach after its approval in 2006, the increasing rates oropharyngeal cancer has made vaccination for young men even more important.

Fewer Than 20% of Young Adult Men Have Received HPV Vaccine

In addition to overall concerns about COVID-19 vaccines patients may have stronger fears about the second vaccine dose since it is often accompanied with more adverse effects.

Address Patients’ Specific Concerns About Second COVID-19 Vaccine Dose

The symptom burdens experienced by breast cancer survivors after the end of treatment are widely variable, according to a study presented at the ESMO Breast Cancer 2021 Virtual Congress. This has revealed an unmet need for personalized follow-up care addressing the experiences of individual patients, according to the researchers.

“Follow-up programs are different in each country,” said Kelly de Ligt, PhD, in a press release. “In the Netherlands, for instance, breast cancer survivors have an annual visit with their treating physician for a follow-up period of 5 years, or 10 years if they are young. Previous studies had assessed side-effects experienced after the end of treatment as independent items, but in reality, survivors usually experience multiple symptoms that can add up and weigh heavily on their daily life. We wanted to measure the overall burden on their health-related quality of life and see if any patterns emerged that would better inform us on which individuals require active symptom management.”

The researchers selected 404 participants who had been surgically treated with or without adjuvant treatment for breast cancer stages I to III that were between 1- and 5-years post-diagnosis from the Netherlands Cancer Registry. These patients were questioned about their experienced burden for fatigue, nausea, pain, shortness of breath, insomnia, appetite, constipation, and diarrhea, as well as emotional and cognitive symptoms.

Analysis of these responses allowed the researchers to organize breast cancer survivors into 3 primary categories: low, intermediate, and high symptom burdens.

“In the low-burden group, to which almost a third of patients belonged, women were less affected compared to the average found among a representative sample of 1300 women of the general population in the Netherlands, who filled out the same questionnaire," de Ligt said in the release. “I was pleasantly surprised to find that so many survivors were doing as well or even better than the average Dutch woman.”

Fifty-five percent of study participants were classed in the intermediate-burden subgroup, which had similar results to the general population, though their scores for fatigue, insomnia, and cognitive symptoms were slightly worse. The high-burden subgroup, according to the investigators, confirmed the necessity for personalized approaches to the follow-up of cancer patients, some of whom still required specialized treatment up to 5 years after diagnosis.

“This was the smallest group, only 15% of our population, but nonetheless, 1 in 6 women in our study had worse scores than the general population for all symptoms—and the differences, ranging between 15 and 20 percentage points, were large enough to be considered not just statistically significant, but clinically relevant as well,” de Ligt said in the release.

The study also found that patients with comorbidities such as heart disease and diabetes were more likely to experience a high symptom burden.

“This association was so strong in our analysis that we were not able to link the level of symptom burden patients reported with the type of therapy they had received.,” de Ligt said in the release. “However, because we measured symptom burden and comorbidities at the same time in the study, we cannot draw conclusions from these findings alone. Future research should attempt to measure patients' health-related quality of life through Patient Reported Outcome Measures (PROMs) before the start of treatment for breast cancer and afterwards to allow us to measure the effect of the therapy.”

Personalised follow-up care needed to address varying health burdens in breast cancer pts [news release]. EurekAlert; May 3, 2021. Accessed May 4, 2021. 

https://eurekalert.org/pub_releases/2021-05/esfm-pfc043021.php

Breast Cancer

Symptom Burdens for Breast Cancer Survivors Largely Variable, Indicating Need for Personalized Care

Medication therapy management (MTM) is a health care service provided by pharmacists to help patients manage their chronic diseases by managing their drug therapies, identify medication-related errors, and improve patients’ health outcomes. It has been estimated that approximately 1.5 million preventable adverse events occur each year, resulting in $177 billion in death and injury in the United States. Despite the benefits of these services, their practice is not yet commonplace. The top 6 barriers to their performance have been reported as: insufficient time, insufficiently trained staff, difficulty in billing, challenges in documentation, and organizational focus on high-volume dispensing.

Investigators recently examined MTM completion rates under the lens of the theory of planned behavior, which posits that a behavior—performance of MTM, for example—can be explained or perhaps predicted by intention to engage in that behavior, self-efficacy for doing so, subjective norms, and other variables. Study results published in the 

Journal of the American Pharmacists Association 

(JAPhA) showed among other things that pharmacy technician involvement can increase MTM completion rates and minimize pharmacists’ barriers in completing medication reviews for their patients. The results also suggest that pharmacy technicians are willing to help with MTM services if they receive proper training and are provided more time and support during work hours. Investigators also found that pharmacies with full-time pharmacists who had more positive attitudes towards MTM delivery significantly outperformed pharmacies with pharmacists who had negative attitudes and less involvement with MTM.

Pharmacy is making strides toward delivering upon its promise of a more patient-centric practice. The landscape, mechanisms of reimbursement, the general design of pharmacy practice, and inertia all have been countering forces in delivering on this promise. However, changes have been afoot, and pharmacy must seize impending opportunities. Moreover, even against prevailing winds that have slowed the evolution of consistent MTM practice, there has been variability, meaning that providing MTM services is more common among some pharmacies and some pharmacists than in others.

The study found that self-efficacy (somewhat akin to confidence) and attitudes about MTM make a considerable difference in MTM practice even in the face of those prevailing winds. Therefore, recognizing the need and value in MTM can facilitate its conduct.

 Managers, through direct 1-on-1 supervision, and through the support of additional continuing education and training of pharmacy personnel, can encourage the attitudes and skills necessary to deliver MTM services. Proper deployment of personnel and a consistent message to them that their doing so is of value to the pharmacy organization and will be rewarded all will go a long way into transforming practice.

Support from pharmacy management and increased job satisfaction for pharmacy technicians can improve MTM programs. This can come in the form of career laddering and slight bumps in salary, more for its intrinsic than its extrinsic benefit.

Pharmacy Management: Essentials for All Practice Settings, 5e

is a PharmD candidate at Touro University California College of Pharmacy in Vallejo.

, is a professor of social and behavioral pharmacy at Touro University California College of Pharmacy.

Medication therapy management (MTM) Services. Retrieved March 09, 2021, from 

https://www.pharmacist.com/medication-therapy-management-services

Adeoye OA, Lake LM, Lourens SG, Morris RE, Snyder ME. What predicts medication therapy management completion rates? The role of community pharmacy staff characteristics and beliefs about medication therapy management. 

Support from pharmacy management and increased job satisfaction for pharmacy technicians can improve medication therapy management programs. 

Tip of the Week: Predicting MTM Completion Rates With Planned Behavior Variables

Fatigue-inducing anemias caused by chronic diseases and inflammation may be treatable with a combination of inexpensive oral medications, according to a study published in 

. The second most common type of anemia, it can act as an added burden for organ-transplant recipients and people with autoimmune disorders, as well as patients battling conditions such as cancer or kidney disease.

Anemia of chronic disease and inflammation is triggered by restricted iron delivery to the bone marrow cells that make red blood cells and can result in severe fatigue, headaches, dizziness, rapid heartbeat, and sweating.

Fatigue-inducing anemias caused by chronic diseases and inflammation may be treatable with a combination of inexpensive oral medications, according to a study published in Nature Communications. 

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