Technician Corner

All About Remdesivir

From IPA’s June 2020 Tech Tidbits newsletter

There are currently no drugs approved by the U.S. Food and Drug Administration (FDA) as safe and effective for the treatment of COVID-19. New research from the National Institutes of Health suggests that certain patients with COVID-19 may benefit from receiving the antiviral drug remdesivir. Gilead Sciences, the drug’s manufacturer, released initial study results from an ongoing Phase 3 clinical trial on April 29, 2020 suggesting that some patients with severe cases of COVID-19 experienced shortened time to recovery when treated with remdesivir. Two days after the initial research was released, the FDA issued an emergency use authorization (EUA) for remdesivir, enabling appropriate patients to more readily access the investigational drug.

What does the initial research show? Gilead announced in a press release on April 29, 2020 that initial study results from an ongoing Phase 3 clinical trial, suggested that patients hospitalized with severe cases of COVID-19 who received remdesivir within 10 days of symptom onset were discharged from the hospital earlier than those treated beyond 10 days of symptoms. 1 These early results also demonstrate the potential for some patients to be treated with a 5-day regimen of remdesivir. The treatment was generally well-tolerated with the most common side effects being nausea, worsening shortness of breath, and elevated liver enzymes. 2 Gilead plans to share additional remdesivir data from the ongoing trial in the coming weeks.

Is remdesivir approved for treatment of COVID-19? Remdesivir is considered an investigational drug because it is still being studied. Despite promising initial study results, it is too early to draw conclusions regarding the use of remdesivir in the treatment of COVID-19. Remdesivir has also not yet been approved for the treatment of any other condition by any regulatory authority. Its use in the United States is currently limited to emergency COVID-19 treatment situations. Clinical trials are ongoing while scientists and medical professionals around the world patiently await the final results. What is an EUA? The FDA made remdesivir available under an EUA, or emergency use authorization, on May 1, 2020. This authorization allows the use of remdesivir, in emergency or life-threatening situations. Medical products made available under an EUA have not undergone the same extensive review process as an FDA-approved product. The FDA criteria to issue an EUA for a product are:

There are no adequate, approved, available alternatives. It is reasonable to believe that the product may be effective. The product meets standards for safety, performance, and labeling. The potential benefits outweigh the potential risks of the drug’s use. All of these criteria must be met to allow for a product to be used under an EUA. The EUA for remdesivir is set to remain in effect throughout the duration of the COVID-19 public health emergency unless new evidence suggests it should be terminated or revoked.

Who can be treated with remdesivir? The FDA’s emergency use authorization of remdesivir permits treatment of hospitalized adult and pediatric patients with severe cases of COVID-19. The drug product is only available by Intravenous (IV) infusion. ■

References: 1. Gilead Announces Results From Phase 3 Trial of Investigational

Antiviral Remdesivir in Patients With Severe COVID-19. Gilead.com. https://www.gilead.com/news-and-press/press-room/pressreleases/2020/4/gilead-announces-results-from-phase-3-trialof-investigational-antiviral-remdesivir-in-patients-with-severecovid-19. Published 2020. Accessed June 5, 2020. 2. Coronavirus (COVID-19) Update: FDA Issues Emergency Use

Authorization for Potential COVID-19 Treatment. U.S. Food and

Drug Administration. https://www.fda.gov/news-events/pressannouncements/coronavirus-COVID-19-update-fda-issuesemergency-use-authorization-potential-COVID-19-treatment.

Published 2020. Accessed June 5, 2020. 3. Remdesivir Clinical Trials. Gilead.com. https://www.gilead.com/ purpose/advancing-global-health/covid-19/remdesivir-clinicaltrials. Published 2020. Accessed June 5, 2020

COVID-19 Testing

From IPA’s July 2020 Tech Tidbits newsletter

With testing for COVID-19 rapidly expanding across the state of Iowa, pharmacy technicians will likely be asked questions from patients and family members about types of tests, who should get tested, and the different ways to take samples. It is important for technicians to know this information in order to provide quality care to patients, themselves, and loved ones as this pandemic continues to affect everyone across the state.

There are two main categories of testing being performed in Iowa currently, including a diagnostic or polymerase chain reaction (PCI) test, and an antibody or serologic test. The diagnostic test essentially tests for an active infection, usually done through collecting a specimen through a swabbing of the nose or throat (nasopharyngeal swab), which is then sent to centralized labs for analysis. Research into collecting specimens through saliva is also being conducted, but this is not yet commercially available. Pharmacies across the state performing diagnostic tests are training pharmacists and technicians how to observe patients perform their own nasopharyngeal swab to ensure the accuracy of the test results. Therefore, it is important to know what a proper nasopharyngeal swab looks like. Various educational videos are available online (https://health.ucdavis. edu/coronavirus/coronavirus-testing.html) and pharmacies in Iowa performing diagnostic tests will provide these videos to technicians helping in the testing process. Labs such as the State Hygienic Lab are using a Real-Time RT-PCR Diagnostic Panel, and results are typically seen within 24-48 hours after the lab has received the specimen. There are also two types of rapid PCR tests run on specialized equipment widely distributed throughout the U.S. which can produce results in as little as 13 minutes, yet there are questions about accuracy and there are no pharmacies in Iowa currently using these tests. Serologic tests determine if a person has already been exposed to the virus. The body produces specific antibodies for the virus when exposed or infected, and this blood test measures the presence of these antibodies. Results are usually back within minutes, yet due to potential inaccuracies patients should not make decisions based off this test alone. The test has been known to provide false-positive results in which the test shows the person is positive for antibodies when in fact they are not, as well as false-negative results in which the opposite occurs. It is worth mentioning as well that even if you have antibodies for the virus, researchers are still unclear as to how much immunity or protection the presence of those antibodies brings. In terms of who should and should not be tested, refer to the CDC website (https:// www.cdc.gov/coronavirus/2019-ncov/symptomstesting/testing.html) or the TestIowa website (https:// www.testiowa.com/en) for further instructions and guidelines. By having a strong understanding of the types of COVID-19 tests, how they are performed, and who should be tested, pharmacy technicians across the state can do their part to help flatten the curve while keeping their own safety and the safety of loved ones in mind. ■

References: 1. Coronavirus Tests. Coronavirus Today. www.coronavirustoday.com/ coronavirus-tests. 2. Crush the Curve: Coronavirus (COVID-19) Testing in Iowa. Crush the

Curve: Coronavirus (COVID-19) Testing in Iowa, 2020, www.testiowa. com/en. 3. Coronavirus (COVID-19) Testing: What You Should Know. Updated

June 1, 2020. Coronavirus (COVID-19) Testing: What You Should

Know | UC Davis Health, 2020, health.ucdavis.edu/coronavirus/ coronavirustesting.html. 4. The University of Iowa. The State Hygienic Laboratory COVID-19

Testing, 2020, covidtesting.shl.uiowa.edu/.

Newly Phar

Certified Iowa macy Tec hnicians

Congratulations to the following pharmacy technicians on becoming PTCB-certified! April 1, 2020 – June 30, 2020

Alexander Albrecht Julie Awtry Desirae Bales Karen Bandy Casandra Batten Hailey Benedict David Black Caden Burkamper Esmeralda Contreras Victoria Daniels Christina Dettbarn Megan Douglas Samantha Drilling Dylan Erdelt Jennifer Frank Emily Gilbertson Zachary Glanz Dhanya Gopinathan Nair Lynsea Gordon Edina Grbic Alayna Hansen Lyndsay Hill Rene Hitchcock Ashley Hytrek Kyler Johnson Mersad Kajtazovic Anders Landis Abby Martin Jade Miller Courtney Mitchell Benjamin Nelson Grace Panneck William Robinson Sydney Ross Kodjo Tovor Makayla Van Beek Adrienne Waller Abigail Whitaker Bryana Whyte

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