COVER STORY: The COVID-19 Pandemic

covid -19 & phar macists on thefront lines

Bret Lentz, Caitilin Carriel, and Spencer Endecott of Drake University College of Pharmacy & Health Sciences

Undoubtedly, the most newsworthy topic of the last three months has been the Coronavirus, or COVID-19. Rightfully so, the entire world has changed dramatically in a way that we have not seen at any point in history. Everything from businesses, cities and even entire countries have been placed on lockdown causing society to invent a term for staying home and avoiding unnecessary interactions - social distancing. Healthcare however, has dutifully stayed the course, although not without some major changes and challenges. Pharmacists are once again at the forefront of these changes, especially in the community as pharmacies are some of the only establishments still open and fully operational. Naturally, pharmacists are being asked a variety of questions regarding the pandemic. This article is by no means a one-stop-shop for all answers COVID-19, but it does provide some helpful background, current events, and perhaps a glimpse at what the future may hold. For the most upto-date information on COVID-19 visit IPA’s website with resources and weekly webinars at iarx.com/covid19.

Background Let’s start with what the novel coronavirus is and how it is different from previous pandemics. There are a variety of coronaviruses that inhabit all kinds of mammals: humans, cows, bats, etc. This particular sequence is a betacoronavirus and like its two predecessors, MERS-CoV and SARS-CoV, it has been traced back to bats. This is why COVID-19 is occasionally referred to as SARS-CoV-2. The viral sequence in the United States, although slightly different, is similar to the one first found in Wuhan, China where the first outbreak of COVID-19 was reported. You may be wondering how this strain differs from its counterparts. For starters, this is the only coronavirus that has been classified as a pandemic. Before March 11, 2020, the World Health Organization had never classified a coronavirus outbreak as a pandemic. There have been four pandemics within the last century, all of which have been caused by a novel influenza virus. This suggests that this sequence of the coronavirus is far more contagious than its MERS and SARS relatives.

Signs/Symptoms Hallmark Symptoms 1. Fever 2. Cough 3. Shortness of Breath

Severe/Emergency Symptoms 1. Troubled Breathing 2. Persistent Chest Pain or Pressure 3. Cyanotic in Lips or Face 4. New Onset Confusion or Inability to Arouse

So how does it spread? It has been reported by the CDC that COVID-19 spreads primarily personto-person via respiratory droplets. Generally, this involves close contact with an infected person (within 6 feet) where a cough or a sneeze can spread the infection. 3 Most reports from the CDC have suggested that people are most contagious when they are the most symptomatic. There have been rare incidents where someone is spreading the disease while asymptomatic. 3 This is all the more reason to educate our patients of these hallmark symptoms, encouraging them to stay home when feeling ill or to seek emergency medical care when symptoms are severe. Symptoms can appear anywhere between 2 and 14 days after first exposure to the virus, so it is important to stay home to limit the spread throughout the community. However if the patient reports severe symptoms, they should be taken to the nearest emergency department for immediate testing and care. 4 Now more than ever, it is important for pharmacists to be able to recognize these tell-tale signs and symptoms in order to protect our communities, flatten the curve, and relieve some pressure on a healthcare system that is seeing an exponential growth in reported cases.

Global/National Infection Rates As of March 31st, COVID-19 has had 750,890 confirmed cases across the globe.The global death

toll due to COVID-19 has reached 36,405. Currently, the U.S. has the most confirmed cases in the world with 186,101. According to a projection done from the Institute for Health Metrics and Evaluation (IHME) out of the University of Washington in Seattle, COVID-19 cases will peak in the second week of April and will last for approximately 4 more months. On March 31st, the Trump Administration predicted a best-case scenario of 100,000 to 240,000 fatalities in the United States. Trump and his coronavirus task force have claimed the community mitigation over the last 15 days have helped, and the continuous use of these techniques is essential. They have also stated that without these community mitigation techniques, the death toll could have reached 1.5 million to 2.2 million Americans because of COVID-19.

U.S. Government/Public Health Reaction On March 16th, President Trump issued coronavirus guidelines for the U.S. The guidelines were to be in place for 30 days in an attempt to slow the spread of the virus. One of the largest bills passed because of COVID-19 is the $2 trillion coronavirus bill signed on March 27th. As stated in this bill, more than 150 million households will receive checks under the legislation, resulting in payments of $1,200 sent to many individual Americans plus $500 for children. Individuals with incomes above $99,000 are not eligible, and the total benefit is phased out for individuals earning between $75,000 and $99,000. This legislation also provides $100 billion to hospitals; $350 billion to small businesses; $500 billion to corporations, including airline companies and cruise lines; and about $150 billion for state and local stimulus funds.

For the most part, Iowa government officials have been following the guidance of the CDC and federal government. On March 7th, Governor Kim Reynolds announced partial activation of state emergency operation (No cases reported in Iowa at this time). On March 15th, Legislative leaders announced they intended to suspend session for 30 days. Gov. Kim Reynolds recommended all schools close for 4 weeks. Then on March 17th, Gov. Kim Reynolds declared a public health disaster in the state of Iowa, limiting gatherings of more than 10 people. The state Legislative body voted to suspend the session and give Gov. Reynolds expanded power to respond to the crisis. Updates are continuing to be released each day, and the state and federal governments are constantly responding with new guidelines.

Unforeseen Challenges As COVID-19 continues to spread, pharmacists in all settings will see changes to practice as they know it. One challenge that has rapidly emerged is the shortage of personal protective equipment (PPE) such as eye protection, gowns, facemasks, respirators, and ventilators. Patient care needs have exceeded the rate of production and delivery. In response, the CDC has issued recommendations on how to limit products that are in highest demand for both the general public and healthcare professionals. Currently, the CDC recommends that only those who have confirmed or suspected COVID-19 should use facemasks while being medically evaluated. To conserve supplies, the general public should not use facemasks otherwise. 5 N95 respirators should be reserved for healthcare providers directly caring for patients with confirmed or suspected COVID-19. To minimize consumption of other PPE, the CDC recommends considering extended use of these resources rather than single use. 6

COVID-19 test kits are also in low supply compared to the enormous demand. This relative shortage results from a number of factors, including a

shortage of chemicals used to run the tests, transit time from testing site to large outside laboratories, and a limited number of authorized manufacturers, all compounded by an everincreasing demand for testing. In response, the Food and Drug Administration (FDA) is in search of more manufacturers to license under special emergency rules designed to expedite the authorization process. In addition, Abbott and other companies are designing rapid point-of-care tests, such as those used to diagnose influenza or strep throat. 7 These developments will drastically shorten the time it takes the average American to get tested.

Another developing concern is the possible shortage of drugs in the United States. To date, only one drug shortage attributed to COVID-19 has been reported in the US; the drug has not been disclosed. However, this number may grow as the FDA has identified about 20 drugs that source their active ingredients or finished drug products exclusively from China, which is still recovering from COVID-19. The FDA continues to closely monitor this situation. 8

Perhaps one of the most emotionally challenging aspects of the current pandemic is the restriction on social contact. Many members of the public experience some confusion related to what distancing is expected of them in what situations. Below is a primer on some of the various types of distancing and of whom they are required.

Social distancing • Required of everyone • Stay at least six feet away from those who do not live in your household; avoid crowds and crowded spaces • Recommended duration: until instructed otherwise by federal officials

Self-quarantine • Required of those who have been exposed to COVID-19, are at higher risk of infection, or recently returned from an area with rapid spread of the virus • Practice standard hygiene including washing hands frequently and covering coughs and sneezes; do not share towels, utensils, etc; stay home; do not have visitors; stay at least 6 feet away from others in the household • Recommended duration: at least 14 days

Isolation • Required of those who test positive for COVID-19 • Practice standard hygiene including washing hands frequently and covering coughs and sneezes; wear a facemask while being medically evaluated; do not share towels, utensils, etc; stay home; do not have visitors; stay at least 6 feet away from others in the household • May take place at home or at a healthcare facility depending on severity of illness • Recommended duration: until directed otherwise by a healthcare provider 9

During this time, it may be beneficial to stay in touch with friends and family via phone calls, text messages, social media, and video calls.

Pharmacy and Healthcare Reactions Although healthcare professionals have been deemed essential, pharmacies, clinics, and hospitals have not been immune to change. The primary goal has been to prevent community spread of COVID-19 with a variety of preventative measures. The CDC has issued some general guidance, primarily aimed at keeping patients spread apart. They suggest using telemedicine whenever possible and cancelling or rescheduling non-essential appointments and elective procedures. When patients do have to leave their homes to receive care, they must be managed carefully once they arrive. All community pharmacy settings should limit points of entry and restrict visitors. Additionally, staff member numbers should be as low as possible to minimize the concentration of people present. Furthermore, all patients should be screened for respiratory symptoms at arrival. If possible, those with suspected or confirmed COVID-19 should be put in private rooms with the door closed to minimize spread. Lastly, pharmacies should use signage to encourage patients to maintain a 6-foot distance from others, use tissues to cover coughs, and to utilize good hand hygiene. These measures will greatly reduce the risk of infection for both patients and providers. 11

Statement/Information from Colleges Along with new business and educational strategies to prevent community spread, pharmacists have needed to be even more vigilant to ensure proper prescribing practices are taking place. There have

been multiple reports of prescribers inappropriately prescribing medications for themselves and their family members (typically chloroquine, hydroxychloroquine, and azithromycin) to prevent or treat COVID-19. Pharmacies and hospitals have also inappropriately been stockpiling these medications in expectation for future demand. The dilemma however, is that these medications do have a place in COVID therapy. On March 28, the FDA issued an Emergency Use Authorization (EUA) for the use of the oral cholorquines in hospitalized patients. 10 Pharmacists now more than ever need to use their professional judgement to determine the validity of prescriptions written for these select medications and to inquire if there are any suspicions.

Although treatment options have been limited during the pandemic, hope is on the horizon. Two vaccinations against COVID-19 are currently under research and development. SARS-CoV-2 mRNA1273 is currently in phase 1 clinical trials, but the US Department of Health and Human Services and its manufacturer, Moderna, are already preparing for phases 2 and 3 so that they may begin as soon as possible. 12 It is being studied via an openlabel dose ranging clinical trial as two doses given intramuscularly in the upper arm about 28 days apart. 13 Its phase 1 trial expected completion date is June 1, 2021.1 4 Another vaccine, Ad26 SARSCoV-2, is also under development. Its phase 1 trial is set to begin no later than fall 2020 with a goal of emergency use in early 2021.

Conclusion All of this considered, there are still numerous unknowns in this new day and age with COVID-19. It is still extremely difficult to reasonably predict the next several weeks, not to mention the next several months due to the ever-changing landscape of COVID-19. Press releases from state and federal officials are always reactive. Policies for businesses, schools, and healthcare facilities continue to evolve based on new recommendations from the government and CDC. Now more than ever, it is important for pharmacists to be up-to-date on current events as patients will inevitably have more and more questions. Pharmacists need to also be flexible with the changing policies and recommendations. This is ultimately a waiting game as the world works to get a handle on the situation. In the meantime, social distance as much as possible, constantly use good hygiene, and continue to provide care for your communities as they need pharmacists now more than ever. ■

References: 1. COVID-19 Background Information. (2020, March). Retrieved from https://www.aapmr.org/news-publications/covid-19/covid-19- background-information 2. COVID-19 Situation Summary. (2020, March 26). Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/ summary.html 3. How Coronavirus Spreads. (2020, March 4). Retrieved from https:// www.cdc.gov/coronavirus/2019-ncov/about/index.html 4. Symptoms of Coronavirus Disease 2019 (COVID-19). (2020, February 29). Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/ about/symptoms.html 5. Healthcare Supply of Personal Protective Equipment. (2020, March 12). Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/hcp/ healthcare-supply-ppe-index.html 6. CDC 2019 Novel Coronavirus Response. (2020, February 11). Retrieved from https://www.cdc.gov/vaccines/videos/coronavirus/COVID-19- webinar.pdf 7. Why It Takes So Long to Get Most COVID-19 Test Results. (2020, March 28). Retrieved from https://www.npr.org/sections/healthshots/2020/03/28/822869504/why-it-takes-so-long-to-get-mostcovid-19-test-results 8. FDA Reports First Drug Shortage Due to Coronavirus. (2020, March 9). Retrieved from https://www.pharmacist.com/article/fda-reportsfirst-drug-shortage-due-coronavirus 9. Coronavirus, Social and Physical Distancing and Self-Quarantine. (2020, March 31). Retrieved from https://www.hopkinsmedicine.org/ health/conditions-and-diseases/coronavirus/coronavirus-socialdistancing-and-self-quarantine 10. Joint Statement of FSMB and NABP on Inappropriate Prescribing and Dispensing of Medications During the COVID-19 Pandemic. (2020, March 30). Retrieved from https://nabp.pharmacy/newsroom/news/ joint-statement-of-fsmb-and-nabp-on-inappropriate-prescribingand-dispensing-of-medications-during-the-covid-19-pandemic 11. Interim Infection Prevention and Control Recommendations. (2020, April 1). Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/ infection-control/control-recommendations.html 12. HHS Accelerates Clinical Trials, Prepares for Manufacturing of COVID-19 Vaccines. (2020, March 30). Retrieved from https://www. hhs.gov/about/news/2020/03/30/hhs-accelerates-clinical-trialsprepares-manufacturing-covid-19-vaccines.html 13. NIH Clinical Trial of Investigational Vaccine for COVID-19 Begins. (2020, March 16). Retrieved from https://www.nih.gov/news-events/newsreleases/nih-clinical-trial-investigational-vaccine-covid-19-begins 14. Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA1273) for Prophylaxis SARS CoV-2 Infection. (2020, March 3). Retrieved from https://clinicaltrials.gov/ct2/show/NCT04283461?term=vaccine& cond=Covid-19&cntry=US&draw=2&rank=1 15. Global/U.S. Infection projection rates. (2020, March 31) Retrieved from https://covid19.healthdata.org/projections 16. U.S. Government Public Health Reaction. (2020, March 31). Retrieved from https://governor.iowa.gov/sites/default/files/documents/ Public%20Health%20Proclamation%20-%202020.03.31.pdf 17. Iowa Public Health Reaction. (2020, March 26). Retrieved from https://governor.iowa.gov/sites/default/files/documents/Public%20 Health%20Proclamation%20-%202020.03.31.pdf 18. Coronavirus Bill. (2020, March 27). Retrieved from https://www. nbcnews.com/politics/congress/house-gives-final-passage-2- trillion-coronavirus-stimulus-bill-n1170281