Vaccine candidates for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the United States, the United Kingdom, and other countries are going through clinical trials at a faster rate than for any other disease in history. Some experts say a vaccine will be ready by the end of this year.

Moderna, for example, is in late-stage development of mRNA-1273, its vaccine candidate against coronavirus disease 2019 (COVID-19). Moderna finalized the phase 3 study protocol based on feedback from FDA, it said in a 

The randomized, 1:1 placebo-controlled trial is expected to start in July, and will include around 30,000 participants, Moderna said. Moderna remains on track to be able to deliver approximately 500 million doses— and possibly up to 1 billion doses—per year, starting in 2021. Moderna expects to begin the phase 3 study in July, according to the release.

Another promising vaccine candidate, ChAdOx1 nCoV-19, from the University of Oxford in the United Kingdom recently entered phase 2/3 trials.

"The clinical studies are progressing very well and we are now initiating studies to evaluate how well the vaccine induces immune responses in older adults, and to test whether it can provide protection in the wider population,” said Professor Andrew Pollard, head of the Oxford Vaccine Group, in a 

The phase 2 part of the study involves expanding the age range of individuals the vaccine is assessed in, to include a small number of older adults aged 56 to 69 years and aged over 70 and children aged between 5 to 12 years. In the phase 3 part of the study, investigators will assess how the vaccine works in a large number of individuals over the age of 18. Adult participants in both phase 2 and phase 3 groups will be randomized to receive 1 or 2 doses of either the ChAdOx1 nCoV-19 vaccine or a licensed vaccine (MenACWY) that will be used as a control.

 it reached an agreement with the Inclusive Vaccines Alliance of Europe to supply as many as 400 million doses of the vaccine, starting by the end of the year.

Estimates for the availability of a COVID-19 vaccine in the United States keep changing, ranging from later this year to early next year.

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Disease, said that, if everything goes right, a vaccine could be available in November or December.

Similarly, National Institutes of Health Director Francis S. Collins, MD, PhD, said that 4 or 5 vaccine candidates show promise of being ready for production quickly—possibly as early as this fall—during a live 

1. Moderna advances late-stage development of its vaccine (mRNA-1273) against COVID-19. Press release. Moderna; June 11, 2020. Accessed June 25, 2020. 

https://investors.modernatx.com/news-releases/news-release-details/moderna-advances-late-stage-development-its-vaccine-mrna-1273

2. Oxford COVID-19 vaccine to begin phase II/III human trials. Press release. Oxford University; May 22, 2020. Accessed June 25, 2020. 

http://www.ox.ac.uk/news/2020-05-22-oxford-covid-19-vaccine-begin-phase-iiiii-human-trials

3. AstraZeneca and Oxford University announce landmark agreement for COVID-19 vaccine. Press release. AstraZeneca; April 30, 2020. Accessed June 25, 2020. 

https://www.astrazeneca.com/media-centre/press-releases/2020/astrazeneca-and-oxford-university-announce-landmark-agreement-for-covid-19-vaccine.html

4. McCurdy, Christen. AstraZeneca to deliver 400M vaccine doses to Europe once approved. 

. June 13, 2020. Accessed June 25, 2020. https://www.upi.com/Top_News/World-News/2020/06/13/AstraZeneca-to-deliver-400M-vaccine-doses-to-Europe-once-approved/4421592086465/?ur3=1

5. Vogt, Adrienne. Fauci says he thinks a coronavirus vaccine is still on track for the end of 2020. 

https://www.cnn.com/us/live-news/us-coronavirus-update-05-27-20/h_973e424c39f953c9ac86483107c61b10

6. Coronavirus Q&A: Accelerating Therapies and Vaccines. 

Articles

Vaccine candidates for COVID-19 are going through clinical trials at a faster rate than for any other disease. 

COVID-19 Vaccine Trials Speed Up

Officials with the FDA approved fenfluramine (Fintepla, Zogenix) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older, according to a press release.

Dravet syndrome is a rare, childhood-onset epilepsy characterized by frequent and severe treatment-resistant seizures, associated hospitalizations and medical emergencies, significant development and motor impairments, and an increase risk of sudden unexpected death. However, despite existing therapies, there remains an unmet need in Dravet syndrome to reduce convulsive seizures.

The approval of fenfluramine oral solution in Dravet syndrome is based on data from 2 randomized, double-blinded, placebo-controlled phase 3 clinical studies, and safety data from an open-label extension trial.

According to the results, fenfluramine significantly reduced the monthly convulsive seizure frequency when added to existing treatment regimens compared with a placebo in study patients whose seizures were not adequately controlled on 1 or more antiepileptic drugs. Additionally, most patients in the study responded to treatment with fenfluramine within 3 to 4 weeks and these effects remained consistent over the treatment period.

Overall, the most common adverse reactions were decreased appetite, somnolence, sedation, lethargy, diarrhea, constipation, abnormal echocardiogram, fatigue, malaise, asthenia, ataxia, balance disorder, gait disturbance, increased blood pressure, drooling, salivary hypersecretion, pyrexia, upper respiratory tract infection, vomiting, decreased weight, fall, and status epilepticus. 

“There remains a huge unmet need for many Dravet syndrome patients who continue to experience frequent severe seizures even while taking 1 or more of the currently available anti-seizure medications,” Joseph Sullivan, MD, director of the Pediatric Epilepsy Center of Excellence at the UCSF Benioff Children’s Hospital and the principal investigator, said in a statement. “Given the profound reductions in convulsive seizure frequency seen in the Fintepla clinical trials, combined with the ongoing, robust safety monitoring that will be part of its use, I feel Fintepla will offer an extremely important treatment option for Dravet syndrome patients.”

Fenfluramine for use in Dravet syndrome will be launched through a restricted distribution program, called the Fintepla Risk Evaluation and Mitigation Strategy (REMS) Program, and is expected to be available through Zogenix’s specialty pharmacy partner by the end of July.

FDA Approves FINTEPLA (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome. News Release. Zogenix; June 25, 2020. Accessed June 26, 2020. 

https://zogenixinc.gcs-web.com/news-releases/news-release-details/fda-approves-finteplar-fenfluramine-treatment-seizures

Officials with the FDA approved fenfluramine (Fintepla, Zogenix) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.

FDA OKs New Treatment for Seizures Associated with Dravet Syndrome

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), has infected an estimated 9,635,935 individuals worldwide, and approximately 2.4 million Americans. Latest developments include pharmacists fighting for racial equality, clinical trials for potential vaccines speeding up, and increasing demand for a generic steroid shown to possibly decrease COVID-19 mortality.

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

Pharmacists: Fight Racial Disparities in Health Care

Pharmacists are banding together to “eliminate racism, discrimination, injustice, and the marginalization of individuals within the profession.”

The COVID-19 pandemic, coupled with recent protests in the United States, have inspired pharmacy organizations to take a stand in support of and pledge to racial equality in health care.

Vaccine candidates for SARS-CoV-2 in the United States, the United Kingdom, and other countries are going through clinical trials at a faster rate than for any other disease in history. Some experts say a vaccine will be ready by the end of this year.

Demand for Generic Steroid Spikes After Preliminary COVID-19 Results

Demand for an affordable generic steroid soared after preliminary findings from a study showed it may be effective in reducing deaths from COVID-19.

Flu-Like Illness Surveillance Suggests Surge in Undetected US COVID-19 Cases

Existing surveillance networks can track influenza-like illness and lead to improved assessments on impact, prevalence, and severity of COVID-19.

A new study showing a large increase in flu-like infections in the United States during the month of March may unlock key supportive evidence that the number of COVID-19 cases is far larger than official estimates say.

Researchers Suggest MMR Vaccine Could Protect Against COVID-19 Symptoms

The measles, mumps, and rubella (MMR) vaccine may demonstrate some degree of protection against septic inflammation, a symptom of COVID-19, according to a team of experts.

A new perspective paper published in the American Society for Microbiology’s 

 suggests that the MMR vaccine can guard against certain symptoms attributed to COVID-19.

Infectious Diseases Pharmacist Perspective on Remdesivir Trials

Julie Ann Justo, infectious diseases clinical pharmacist and associate professor at the University of South Carolina College of Pharmacy, discusses the latest data from Gilead's trials for remdesivir, a potential COVID-19 treatment.

Poll Identifies Concerns About Rising Costs of Drugs, Health Care Amid Pandemic

A new poll by Gallup and West Health found that a majority of Americans have expressed numerous health care system-related concerns, including rising costs of drugs, insurance premiums, and health care in response to COVID-19.

A collaborative poll between Gallup and West Health discovered that nearly 9 in 10 US adults feared that the novel COVID-19 could result in negative developments in the world of health care, with 55% saying they were “very concerned” and 33% saying they were “somewhat concerned” about the potentially rising costs of drugs due to the pandemic.

Older Adults in Long Term Care Amid COVID-19

Amie Blaszczyk, PharmD, FASHP, CGP, BCPS, associate professor and division head of geriatrics at Texas Tech University Health Sciences Center, explains the factors acting on older adults in long term care, and the response from these facilities.

American Telemedicine Association Pressures Congress to Keep New Telehealth Measures Post-Pandemic

“Telehealth has kept the entire health care system afloat and has enabled patients to continue to receive care,” the American Telemedicine Association’s president said in a testimony.

In a testimony before the full Senate Committee on Health, Education, Labor and Pension (HELP), American Telemedicine Association (ATA) President Joseph Kvedar, MD, urged policymakers to “take specific actions before the end of the public health emergency to make access to telehealth services permanent.”

Walgreens Reinstates Routine Immunization Services With COVID-19 Safety Measures

Keeping ahead of flu season and preventing illness through immunizations is critical to reducing an already-strained health care system.

Walgreens has announced that it has reinstated its routine immunization services with pandemic-prompted safety measures after postponing all non-urgent, routine immunizations because of the COVID-19 pandemic.

Check out this week's most important coronavirus-related news.

Coronavirus News Roundup: Vaccine Trials Gaining Momentum, Pharmacists Fight Racism Amid COVID-19

Demand for an affordable generic steroid soared after preliminary findings from a study showed it may be effective in reducing deaths from the coronavirus disease 2019 (COVID-19).

, Former FDA Commissioner Scott Gottlieb, MD, 

 the steroid, dexamethasone (Decadron), could have an “immediate impact” on how providers treat the most severe cases of COVID-19.

 study published on medRxiv from several United Kingdom investigators. Preliminary results found that dexamethasone reduced deaths by one-third in patients receiving invasive mechanical ventilation (29% versus 40.7%). The steroid also reduced deaths by one-fifth in patients receiving oxygen without invasive mechanical ventilation, but did not reduce mortality in patients not receiving respiratory support.

“Dexamethasone is the first drug to be shown to improve survival in COVID-19,” Peter Horby, professor of emerging infectious diseases in the Nuffield Department of Medicine at the University of Oxford, and one of the chief investigators for the trial, said in a 

 “The survival benefit is clear and large in those patients who are sick enough to require oxygen treatment, so dexamethasone should now become standard of care in these patients.”

However, since the study results were published last week, demand for the drug has soared. Group purchasing organization Vizient Inc. said orders for dexamethasone soared from nearly 400,000 the week of June 8 to more 2.8 million for the week of June 15, 

 According to Vizient’s data, there was a 610% increase in demand by its member hospitals in the week since the initial trial results, with aggregated fill rates dropping from 97% to 54% over a 6-day period.

The study was part of the Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial, which was established as a randomized clinical trial to test a range of potential treatments for COVID-19.

Horby and his colleagues set out to study the effects of dexamethasone since corticosteroids “may modulate immune-mediated lung injury and reducing progression to respiratory failure and death,” they wrote in the preprint article.

In the study, 2104 patients randomly allocated to receive dexamethasone were compared with 4321 patients concurrently allocated to standard care. Dexamethasone 6 mg was given once daily for up to 10 days versus standard care alone. Overall, 21.6% of patients allocated dexamethasone and 24.6% patients allocated standard care care died within 28 days (age adjusted rate ratio 0.83; 95% CI 0.74 to 0.92; P<0.001), according to the study.

“In patients hospitalized with COVID-19, dexamethasone reduced 28-day mortality among those receiving invasive mechanical ventilation or oxygen at randomization, but not among patients not receiving respiratory support,” the investigators wrote.

1. Feuer, William. Potentially lifesaving coronavirus treatment dexamethasone could have ‘immediate impact,’ former FDA chief says. 

 June 16, 2020. https://www.cnbc.com/2020/06/16/potential-coronavirus-treatment-dexamethasone-could-have-immediate-impact-former-fda-chief-says.html 

2. Horby P, Shen Lim W, Emberson J, et al. Effect of dexamethasone in hospitalized patients with COVID-19: Preliminary report. Pre-print, 

, June 22, 2020. https://doi.org/10.1101/2020.06.22.20137273

3. Low-cost dexamethasone reduces death by up to one third in hospitalised patients with severe respiratory complications of COVID-19. Press release. University of Oxford; June 16, 2020. Accessed June 25, 2020. 

http://www.ox.ac.uk/news/2020-06-16-low-cost-dexamethasone-reduces-death-one-third-hospitalised-patients-severe

4. Hopkins, Jared S. Dexamethasone demand soars after positive COVID-19 study. 

https://www.wsj.com/articles/dexamethasone-demand-soars-after-positive-covid-19-study-11593079202

5. Vizient Data Show 610% Increase in Demand for Dexamethasone after Study Shows Effectiveness for Patients Severely Ill with COVID-19. News Release. Vizient; June 25, 2020. Accessed June 25, 2020. 

https://newsroom.vizientinc.com/vizient-data-show-610-increase-in-demand-for-dexamethasone-after-study-shows-effectiveness-for-patients-severely-ill-with-covid-19.htm

A new study showing a large increase in flu-like infections in the United States during the month of March may unlock key supportive evidence that the number of coronavirus disease 2019 (COVID-19) cases is far larger than official estimates say.

The study used surveillance networks for influenza-like cases, which had already been in place prior to the pandemic. Data reported a likely scenario, in which upwards of 8.6 million new SARS-CoV-2 infections occurred in March, and more than 80% of the cases have not been identified.

The investigators also mentioned the study’s relevance in supporting the use of surveillance networks for flu-like infections, as they could be implemented as a tool that more effectively and efficiently estimates the prevalence of COVID-19, a goal that has 

largely fallen short in the United States.

 Disjointed testing efforts using real time Polymerase Chain Reaction (RT-PCR) testing have resulted in high false negative rates, the investigators wrote. That, along with COVID-19’s hard to detect or asymptomatic responses, have led to grand underestimates in US COVID-19 confirmed cases numbers.

Low testing availability and challenges in detecting COVID-19 can be mitigated by an outpatient surveillance system for diseases that express symptoms similar to influenza – fever, cough, and sore throat. Existing surveillance networks can track influenza-like illness (ILI), and lead to improved assessments on the impact, prevalence, and severity of COVID-19.

The study’s ILI data found that, starting in March 2020, states including Washington, New York, Oregon, Pennsylvania, Maryland, Colorado, New Jersey, and Louisiana saw surges in non-flu ILI cases that surpassed seasonal averages. During the last week of March, New York experienced 2 times higher non-influenza ILI cases, higher than any other season ILINet had recorded.

Investigators estimated the proportion and magnitude of the surge of US ILI attributable to COVID-19 infections in March 2020 through 3 assumptions:

That the patient population reported by sentinel providers is representative of their state each week

That changes in care-seeking behavior in patients with ILI is occurring at a similar rate as that of other patients with non-ILI

That the total number of patients in the United States who require medical care over the course of a year has not substantially changed since 2018

The study additionally incorporated surveys showing the average number of patients seen by providers, the number of providers in each state, and the total number of outpatient visits per year to estimate that, if outpatient clinics stayed open during the pandemic, there would have been about 2.8 million patient encounters with ILI due to COVID-19 between March 8 to March 28, 2020.

Limitations included that the observed ILI increase may include a second epidemic other than SARS-CoV-2, but investigators qualified the unlikeliness of this phenomenon. The study may also have incorrectly assumed similarity between mild ILI and non-ILI in health care seeking behavior, though assumptions were made based on NYC emergency department surveillance data.

“We found a clear, anomalous surge in ILI outpatients during the COVID-19 epidemic that correlated with the progression of the epidemic in multiple states across the US,” study investigators reported. “The surge of non-influenza ILI outpatients was much larger than the number of confirmed case in each state, providing evidence of large numbers of probable symptomatic COVID-19 cases that remained undetected.”

Influenza-like Illness surveillance reveals spike in undetected COVID-19 cases in March. News Release. EurekAlert; June 22, 2020. Accessed June 23, 2020. 

https://www.eurekalert.org/pub_releases/2020-06/aaft-iis062220.php

Silverman JD, Hupert N, and Washburne AD. Using influena surveillance networks to estimate state-specific prevalence of SARS-CoV-2 in the United States. 

 2020; eabc1126. doi: 10.1126/scitranslmed.abc1126.

 suggests that the measles, mumps, rubella (MMR) vaccine can guard against certain symptoms attributed to the novel coronavirus disease 2019 (COVID-19).

Co-authored by Paul Fidel, Jr, PhD, department chair, oral and craniofacial biology, and associate dean for research at Louisiana State University Health School of Dentistry in New Orleans, Louisiana and Mairi Noverr, PhD, professor of microbiology and immunology at Tulane University School of Medicine in New Orleans, Louisiana, the article indicates that the MMR vaccine in particular has the potential to lessen septic inflammation associated with COVID-19 infection.

In a press release, Fidel explained that the MMR vaccine, as a live attenuated vaccine, could provide relief for symptoms in patients who may not actually have the target pathogen. Noverr’s lab results corroborate this, as MMR was able to induce myeloid-derived suppressor cells (MDSCs) that could inhibit septic inflammation in non-COVID-19 cases. Researchers posit that the same vaccine could therefore reduce severe lung inflammation and sepsis, a key finding considering that COVID-19 deaths are often attributed to these symptoms.

Further evidence was found in the 955 sailors on the USS Roosevelt who tested positive for COVID-19, according to the article. The sailors exhibited milder symptoms, which may have been because all US Navy recruits must receive the MMR vaccine.

The researchers proposed a clinical trial to gather more data as to the full extent of the vaccine’s protection against the virus, and suggested that adults, especially those who risk contracting COVID-19, get a booster MMR vaccine.

“While we are conducting the clinical trials, I don’t think it’s going to hurt anybody to have an MMR vaccine that would protect against the measles, mumps, and rubella with this potential added benefit of helping against COVID-19,” Dr Fidel said.

The authors concluded that, if this hypothesis is correct, MMR vaccination in adults could represent a “low-risk, high-reward” preventive measure during the critical period of the COVID-19 pandemic.

Fidel PL, Noverr MC. Could an unrelated live attenuated vaccine serve as a preventive measure to dampen septic inflammation associated with COVID-19 infection. 

MMR Vaccine Could Protect Against the Worst Symptoms of COVID-19. News release. American Society for Microbiology. June 19, 2020. Accessed June 22, 2020. 

https://www.asm.org/Press-Releases/2020/MMR-Vaccine-Could-Protect-Against-the-Worst-Sympto

The MMR vaccine may demonstrate some degree of protection against septic inflammation, a symptom of COVID-19, according to a team of experts.

 This is Over the Counter, a podcast from 

. I'm Gabrielle Ientile. In this episode we'll be talking about professional burnout in the pharmacy, the many factors that lead to and intensify burnout, and what impact the COVID-19 pandemic might be having on rates of pharmacist burnout.

What is professional burnout? Experts generally define burnout from 3 aspects: 1, physical and emotional exhaustion; 2, depersonalization; and 3, one’s sense of autonomy and personal accomplishment.

 It's typically measured along those lines and individuals who are feeling a lot of exhaustion and a lot of disengagement tend to have higher burnout scores.

 That's Caroline Gaither, a professor in the department of pharmaceutical care and health systems at University of Minnesota College of Pharmacy. Dr. Gaither is coauthor of a national survey of pharmacist burnout and engagement, which was presented at the Midwest Pharmacists Workforce Consortium. Here's Dr. Gaither again to explain the results of that survey.

 They're telling you that the workloads have gotten higher and the staffing has decreased, and that has increased their feeling of job stress and also influence their satisfaction levels. So that has been another thing that we think has also contributed to some of these levels of exhaustion we've seen with the workforce study.

 Jon Schommer, a study coauthor and a professor in the department of pharmaceutical care and health systems at the University of Minnesota College of Pharmacy, explained that making sure pharmacists avoid burnout isn't enough. Pharmacists should be able to grow and thrive in their professional environment too.

 And then in addition to burnout, which is something that you would like to avoid, we also do research in the area of what's called well-being. That's being able to have constructive conditions at work and beyond even in your personal life that enable workers to thrive and achieve their full potential. So we're looking at: let's avoid burnout and some of the dimensions of that, but let's also look at our healthcare professionals able to thrive and achieve full potential.

 Matthew Witry, coauthor of the survey and an assistant professor in the department of pharmacy practice and science, division of health sciences research at the University of Iowa College of Pharmacy, said to keep in mind the complexity of these factors, individual and systemic.

 It's hard to disentangle these elements. If you're incredibly exhausted, because of a setting issue that's leading to exhaustion, that might prevent some of that personal accomplishment ability. A lot of these things are going to interact. Depersonalization, you might see more of that if you're already emotionally exhausted, so all these things are interacting with each other.

 Here's Dr. Gaither to shed some more light on these interconnected factors.

 National Academies of Science, Engineering and Medicine have been focusing on this issue of clinician burnout, and they've developed this model that I really do like. It talks about how you have frontline workers, and then you have these frontline workers, the health providers, who work for a particular health care organization who has different policies and procedures. Then there's also the external environment - so the things that are happening outside - and all of those things influence the provider who is providing care. They've talked about these work system factors which are things like job demands: so, what is your workload? How many hours are you working?

There's this idea of resources, and 1 of the things they talk about in terms of resources is how much control you have in your job. Those kinds of things are really influenced by the workplace and the system that you're working in. If there's a good balance there, then the health provider is able to really thrive but when the job demands become too high, then that's where you can get into some of the more negative consequences.

The other piece of that is, they say that these work system factors are also influenced by kind of the individual: so how much resilience that person has, and their ability to cope with adversity, and also how much their work and life are integrated. That can also influence burnout or the fulfillment that the health provider feels. I really I like the model because they've started to talk about the system factors that are beyond what the individual provider is able to contribute, and talk about the fact that burnout is not necessarily related to some kind of individual failure, but it's really related to kind of the way the work environment is structured.

 Dr. Gaither mentioned that corporate-owned chain pharmacy environments, where business decisions are out of pharmacists hands and workloads are increasing, those large companies are at risk for potentially burning out their pharmacists. But what about community pharmacies?

We’re seeing in community pharmacy practice that there's this great stress to conveniently and quickly and efficiently distribute medications, and that whole business model is changing.

 Improving pharmacy business models are vital for keeping pharmacists from burning out and staying in business. An estimated 2000 pharmacies have closed since 2018, many located in regions of the United States that are home to vulnerable populations, where their first point of care is often in their local pharmacy. Another non-negotiable way to minimize burnout and help pharmacists find fulfilment at their place of work is to address the system factors at play. 

As Dr. Gaither, Dr. Witry, and Dr. Schommer all mentioned, burnout is mainly a product of the health care system factors that get in the way of true fulfillment for medical professionals. Dr. Schommer explained that pharmacists are experiencing increasing pressure not just to be fast and efficient, but to be faster and more efficient in an increasingly competitive and instant-delivery world.

 In community pharmacy, practice, the distribution of pharmaceuticals is so vital and you have to have that pressure on you all day long to be as efficient as possible. At the same time, community pharmacies are being recognized by the public, by government agencies such as CDC, etc., as health care access points, that you can get vaccinations and immunizations and screening and point-of-care testing. There's a lot of patient care and public health services that are being provided. When you put those two goals together, work systems get very complicated, and it's very difficult to do both within the same space.

While pharmacists might be willing to take on these additional responsibilities to support their patients and provide the best care they can, these burnout factors - exhaustion, depersonalization and lack of a sense of autonomy and personal accomplishment - as well as the system constraints, can make it possible, especially during a pandemic.

They’re talking about this idea of moral injury, where the health providers want to be able to do certain things, but they're not able to because of other kind of constraints with within the organization, and that really affects how they can work to the best of their ability. Some of the things that I've heard about in pharmacy, is whether pharmacists get PPE and because they need them as well if they're going to be giving vaccinations and doing some of the services that the pharmacists typically do. What happens if your staff in the pharmacy gets ill with COVID-19?

The other thing that I think a lot about is, you're also serving people who have chronic illnesses, and whether they can get their medications. Are they afraid to come to the pharmacy? Are they still being taken care of in this situation?

I think there's a lot of things that this pandemic is revealing about the holes or disparities in the system. The other thing is some of the pharmacy benefit managers cutting some of the reimbursements. This is not the time to cut reimbursements, or do things that can inhibit the abilities of the pharmacist to do different tasks. That is something to that I'm hoping; I hope that these reimbursements and the way that pharmacists and other health providers are reimbursed does not get short shrift.

 Dr. Witry gave us an example of just how complex burnout factors can be, especially during a pandemic. He explains that while pharmacists may be emotionally and physically exhausted from working longer and more frequent ships, and my experience depersonalization from having to provide care to patients from behind a mask, and a plexiglass guard, they might also feel elevated levels of personal accomplishment for being able to assist the patients when they need them most.

 If someone feels that their employer isn't providing a safe environment, or you're interacting with patients who aren't taking this seriously, I would imagine that that's going to be a significant source of anxiety. On the other hand, a lot of pharmacists are probably feeling really appreciated. They're making a difference. They’re getting that getting that care to people, being that access point, answering important questions, being a source of care when people aren't going to their primary care physician appointments. They can still call their pharmacist or they can still talk to the pharmacist across the Plexiglas. The pharmacists are still in that position, especially in the community setting.

 There are also other potential issues that the COVID-19 epidemic can bring to the surface too, like hoarding medications and administering vaccines.

 As we move forward in the future, there will be new things. There's some evidence that patients are becoming very acutely aware that there could be drug shortages due to the pandemic and the effect on manufacturing around the world and are starting to consider hoarding and stop taking medications so that if it runs out, they would have a supply There's a lot of anxiety for our patients that we that we help. Also, what kind of role from a public health standpoint would pharmacists play? When a vaccine is discovered and developed or there's treatments being provided, there's a whole new set of things that pharmacists will be looked to provide and that requires change and updating our work systems and our processes of care. That all creates the opportunity, or the possibility, that pharmacists will experience stress and burnout.

 Experts are hopeful that the COVID-19 pandemic will open up the opportunity for improving pharmacist care and addressing health care system shortfalls.

 It opens up new opportunities for pharmacists to do really what we're called to do, which is to take care of our patients.

 We've recognized how fragmented our care system is, so being able to better communicate across different health providers and across different health systems. You have the pharmacists in the community, you have the pharmacist in the health system, pharmacists in long term care, and the ability to better communicate, I think across the different pharmacists, but also with other health providers would be very, very important.

Also, do the pharmacists feel that the employers kind of have their backs? Do they feel supported? I would say that in some places, they may not feel as supported as they could. Our employers really stepping up to take care of their health providers, I think is something that also probably needs to change. And then this idea of, I'm not exactly sure how to say this, but the profit motive in health care. There’s a lot of things that we could do better with if we had more resources and more reimbursements and those kinds of things to really provide patient care.

 So with the task as big as the United States health care system, what are the next steps?

 We like to use a certain quote. We look at the financial pressures in health care system, all the burden of documentation that we that we do in healthcare, the pressure to meet production metrics are places of practice, and this constant specter of litigation that's over us, really distract us from patient centered care, and it can even lead to conflicts of interest. If it happens once in a while, that's 1 thing, but it's in incessant, intensely routine, drip, drip, drip that we experience and again, as we talked before, really improving the systems in which we work, and that can be everything from personnel staff, processes of care, computer systems and technology needing to be updated, so they interact and provide information that we need when we need it. That is really an important next step for us to improve and to develop good work environments that we can thrive in.

We always go back to those quotes. It's not just pharmacy that's saying this, but all healthcare professions are saying pretty much the same thing. Moving forward, I would echo what Caroline Gaither said, in really focusing on our systems of care and employees, knowing that their workplace is there to as she put it, “I've got your back. I am here to really help you thrive so we can do what we're called to do.”

 That's all for this episode of Over the Counter. Check back next week for another expert interview covering the latest news trends and innovations in pharmacy. And don't forget to subscribe and share with your pharmacy friends. Thanks for listening.

Podcasts

In the newest episode of Over the Counter, 3 experts on professional burnout discuss the factors at play, and the impact the COVID-19 pandemic may be having on rates of pharmacist burnout. 

Over the Counter Episode 2: A Pandemic's Effect on Pharmacist Burnout

. Today I'm going to be interviewing Dr. Julie Ann Justo, infectious disease clinical pharmacist and associate professor at the University of South Carolina College of Pharmacy.

And our last interview, Dr. Justo highlighted some of the preliminary results supporting remdesivir as a potential treatment for COVID-19. Since then, Gilead has announced their latest phase 3 SIMPLE trial results, and Dr. Justo joins again to provide expertise on this data.

 Dr. Justo, thank you so much for joining me again today to give us an update on the remdesivir trials.

 So last time, you described some of the more preliminary data surrounding remdesivir as a potential COVID-19 treatment. Can you give us a little review on that data that you told us before we get into the updated trial results?

 Absolutely. I believe the last time that we spoke, we had preliminary findings in primarily press release form that announced the ACTT-1 trial results. That's a study that's sponsored by the NIH. And then we also had preliminary positive results from the Gilead phase 3 SIMPLE trial, which was based on severe patients. Since we last spoke, both of those trials have been published in full, and so we've had a chance to read them in detail and analyze all the different enrollment, what patients were in the trial, different subgroup analyses, and so on. We have a lot more information now than we did a few weeks ago.

 Can you give us a little update on the Gilead severe trial?

 Absolutely. So, again, we had a simple trial that looked at severe adult hospitalized patients that had oxygen saturations less than or equal to 94% or were requiring oxygen supplement form. That's the definition of severe COVID-19 as they described it in the trial.

What they did was they actually looked at patients that were randomized to receive remdesivir either 5 days versus 10 days in that severe trial. It was important to note there was no placebo controlled arm for that particular study, and the main question that Gilead was trying to answer designing this trial was figuring out if 5 days of therapy had the same efficacy as10 days and that's really important because if so, if five days is comparable to 10, and that could extend the limited resource of our industry supply that we currently have available. What the study found was that for their primary endpoint of clinical improvement at day 14, and that they had similar outcomes in the 5 days versus 10 days in terms of odds of reaching that clinical improvement threshold for their patients, which was very positive findings, and encouraging for a lot of us who are trying to make the limited supply of remdesivir stretch to as many patients as possible.

 With these updated trial results, what do you see in in upcoming weeks related to remdesivir supplies being allocated to hospitals?

 I think there was a lot of details. The first thing that we noted when the full trial results were published that we didn't have the last time that you and I spoke was that we noticed the randomization wasn't fully balanced between the 2 treatment arms. Randomization is intending to balance the 5 day arm versus the 10 day arm on all the different baseline characteristics and other potential confounders both measured and unmeasured, that might impact the chances of clinical outcomes for these patients.

What we found, which we didn't know before, was that the 10 day group, again, this is a study of nearly 400 patients, the 10 days group was more severely ill at baseline, and that's based on the score that they received on that ordinal scale when they were enrolled in the trial. And that's very important, because while the study investigators did try to adjust for this baseline difference, it's not 100% clear if they were effective in doing so. We think that the 5 days is just as good as the 10 days and I think we can glean that information from the trial, but we also have to take into account that we're not entirely sure what happened with the patients in the 10 day group because they started in a clinically worse position.

In addition, if we're looking at the study results when we look at the details, about 86% of patients in the 5 day run of remdesivir completed the full 5 days of remdesivir. Whereas at the point of analysis, only 44% of the patients in the 10 day group completed the full 10 days of remdesivir that was intended. Now that sounds like a big difference, which it is. The main drivers are understandable when you look at the way the trial was designed.

These investigators are pressed to get these analyses out as quickly as they can, because everyone is wondering the results of the trial. But what that results in is that in the 10 day arm, a lot of the patients at that point had either been discharged from the hospital or had died. For whatever reason, they didn't complete a full 10 days of remdesivir therapy. Some patients may have received 6 or 7 or 8 or 9 or 10 days.

In addition, there's another important piece of information that we found. We found that they did an analysis where they looked at where were folks at the point of day 5 remdesivir therapy, and then the group versus the 10 day group, you would notice that the 10 day group, if you were at day 5, were on invasive mechanical ventilation.

Okay, so let me take a step back. For the patients that were enrolled in this trial, mechanical ventilation at baseline was an exclusion. However, if they started off not on mechanical ventilation, but met the definition of severe, and then progressed to mechanical ventilation by day of remdesivir therapy, they were allowed to stay in the trial.

If we look at that interesting, small, but severely ill subgroup of patients, what we found is that patients on 5 days of remdesivir, about 40% of those patients that were on mechanical ventilation at day 5, and that ended up dying versus 17% of the patients in the 10 day group and then ended up dying so 40% death versus 7%. Those numbers are small, and it's just a numerical difference; however, that's enough information for a lot of clinicians at this point of time to suggest for patients that are mechanically ventilated on remdesivir they probably need to have consideration for extension from 5 days to 10 days of therapy. So that's an important thing that we learned from the full published trial results in the severe trial. So again, just to summarize, patients that are mechanically ventilated with severe COVID-19 10 days may be better for them than 5 days. That's a lot of where that information came out in the FDA emergency use authorization (EUA) that had that recommendation for 10 days duration of therapy specifically for patients on mechanical ventilation.

 Do you believe that they're going to continue to pursue this since it was a small population?

 It's very difficult to say if you look at the main drivers of clinical outcomes across all the studies that we have to date, so I'm talking about the 1 trial from the NIH, and the Gilead remdesivir trial, and now we have a new press release from Gilead that talks about preliminary results from the SIMPLE moderate trial, which is patients that have oxygen saturations above 94%.

If you're looking at all this data, in summary, what it's suggesting is that remdesivir does the best for patients that are early in their hospital admission, and not yet to the point where they're requiring life support care in the form of mechanical ventilation, or other things.

Taking that into account, I'm still interested in some further information about whether or not remdesivir will provide any help for patients with mechanical ventilation. As I suggested, there are some limitations to how they’ve designed the study. We also have only just been looking at remdesivir in monotherapy form right now. A lot of clinicians are very interested in seeing how remdesivir could help even more severely ill patients like mechanically ventilated folks, if it's used in combination with other agents such as convalescent plasma, or immunotherapies, such as tocilizumab, all agents that are currently being considered as experimental agents in actual bedside situations.

 Dr. Justo, thank you so much for joining me again and your continued work as well.

This interview transcription has been lightly edited for style and clarity.

Expert Interviews

Julie Ann Justo, infectious diseases clinical pharmacist and associate professor at the University of South Carolina College of Pharmacy, discusses the latest data from Gilead's trials for Remdesivir, a potential COVID-19 treatment.

 found a correlation between high mortality rates from coronavirus disease 2019 (COVID-19) and individuals who currently smoke and are diagnosed with chronic obstructive pulmonary disease (COPD).

The study, co-published by Jaber Alqahtani, PhD, determined this association by searching databases of scientific literature to find publications on conditions similar to those found in victims of COVID-19, as well as the prevalence of COPD in patients with COVID-19. Of 15 research papers with reports on 2473 patients with COVID-19 , 58 (2.3%) were diagnosed with COPD, and 221 (9%) as smokers.

One of the most common symptoms of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is dysfunction of the respiratory system. Individuals with COPD experience similar effects, and given this similarity, the team wanted to see if there was a clear correlation between the condition and the virus.

The study determined that patients with COPD who were critically ill with COVID-19 had a 63% risk of severe disease and a 60% risk of mortality; meanwhile, patients with COVID-19 without COPD had a 33.4% risk of severe disease and 55% risk of mortality. Current smokers showed a risk of 22% of contracting severe complications, as did 46% of ex-smokers. Current smokers also exhibited a 38.5% mortality rate, according to the study.

Despite these percentages, the study investigators were unable to determine an association between the frequency of COPD exacerbations, or severity of COPD, with COVID-19 complications, primarily because COPD was low in reports of COVID-19 cases. Other hinderances were the diversity of locations, settings, and designs of the 15 studies.

COPD and smoking associated with higher COVID-19 mortality. News Release. ScienceDaily; May 11, 2020. Accessed June 23, 2020. 

https://www.sciencedaily.com/releases/2020/05/200511142146.htm

Alqahtani JS, Oyelade T, Aldhahir AM, et al. Prevalence, severity and mortality associated with COPD and smoking in patients with COVID-19: A rapid systematic review and meta-analysis. 

https://doi.org/10.1371/journal.pone.0233147

Results of a PLOS ONE study determined a positive relationship between COPD and smoking and mortality rates from COVID-19.

COVID-19 Mortality Higher With COPD and Smoking, Study Finds

Researchers have discovered a new type of vaccination that could improve and sustain protection against HIV.

The vaccine—which has been tested on monkeys by a team of investigators from the Stanford School of Medicine and other institutions—is distinctive because it boosts cellular immunity rather than just stimulating serum immunity by increasing antibodies in the body.

“All licensed vaccines to date work by inducing antibodies that neutralize a virus. But inducing and maintaining a high enough level of neutralizing antibodies against HIV is a demanding task,” Bali Pulendran, PhD, professor of pathology and of microbiology and immunology at Stanford said 

 “We’ve shown that by stimulating the cellular arm of the immune system, you can get stronger protection against HIV even with much lower levels of neutralizing antibodies.”

In the new study, which was recently published in 

, the research team used a 2-prong approach to try to stimulate both serum and cellular immunity in the test group of rhesus macaques by dividing the subjects into distinct groups.

The first group received sequential inoculations of Env, a protein on the virus’s outer surface that is known to stimulate antibody production, according to the release. The group also received an adjuvant often used to strengthen the immune response.

The second group received a similar inoculation to the first group, but also received injections of 3 different infectious—but not dangerous—viruses that had an added viral protection gene known as Gag aimed at stimulating the cellular immunity in participants. The third group served as the control group of the study and researchers gave the subjects only the adjuvant.

The researchers found that when exposed to SHIV, a simian version of HIV, that both of treatment arms demonstrated significant initial protection from viral infection.

According to the results of the study, after 10 vaginal challenges with the autologous virus, protection was observed in the first group at 53.3%, whereas that rate was even higher—at 66.7%—for the second group that received the added viral protection gene Gag.

“Notably, though several Env-plus-Gag animals—but none of the Env animals—remained uninfected even though they lacked robust levels of neutralizing antibodies,” the release stated.

The group who received the Env-plus-Gag combination also demonstrated an increased duration of protection effect. After a 20-week break, researchers reported that 6 monkeys from the Env group and 6 from the Env-plus-Gag group were exposed once again to SHIV.

Researchers have discovered a new type of vaccination, which has been tested in monkeys, that could improve and sustain protection against HIV.

