Abstract
Background
REGEN-COV is a non-Food and Drug Adminstration approved monoclonal antibody combination of casirivimab/imdevimab. Casirivimab/imdevimab was previously used for the treatment of SARS-CoV-2 infection (COVID-19), under an emergency use authorization, and has demonstrated a reduction in hospitalizations and death. With the ability to administer this monoclonal antibody combination subcutaneously in an outpatient setting, limited community pharmacies became a treatment location for patients.
Objectives
The objective of this study was to describe an innovative service and evaluate the safety of administering REGEN-COV, a monoclonal antibody combination of casirivimab and imdevimab, in a community pharmacy setting as treatment for COVID-19.
Practice Description
This study was conducted in a community pharmacy during traditional business hours.
Practice Innovation
A novel service of monoclonal antibody administration for the treatment of COVID-19 was implemented in a community pharmacy in response to community needs during the pandemic.
Evaluation Methods
A retrospective, observational study was conducted from September 1, 2021 to December 31, 2021. Patients were required to have a positive SARS-CoV-2 test and meet all inclusion and exclusion criteria. Patients were assessed for adverse drug reactions at the time of monoclonal antibody administration and 60-minutes after administration. Patients were contacted by phone to complete a survey to assess patient reported adverse drug reactions post administration, number of patients hospitalized, and number of patients able to return to normal daily activities.
Results
Of the 93 patients included in this study, adverse effects were reported in 4.3% of patients at administration and 9.7% at follow-up. Included patients receiving this service generated $32,688.68 in revenue for the community pharmacy.
Conclusion
Community pharmacists can administer casirivimab/imdevimab safely and effectively in an outpatient setting with low adverse events. This innovative monoclonal antibody administration service should be used as an example for a Call to Action of expansion of pharmacist scope of practice.
Key Points.
Background
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During the COVID-19 pandemic, inpatient intravenous casirivimab/imdevimab treatment options were limited to patients due to hospitals and infusion centers being at maximum capacity.
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REGEN-COV, casirivimab/imdevimab, has demonstrated a reduction in hospitalizations and death.
Findings
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This study demonstrates the adverse effect profile of positive SARS-CoV-2 patients after receiving subcutaneous casirivimab/imdevimab in a community pharmacy setting.
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This study describes the successful implementation of a monoclonal antibody administration service during the COVID-19 pandemic.
Background
SARS-CoV-2, the novel pandemic associated severe acute respiratory virus, was first discovered in humans in December of 2019. SARS-CoV-2 gathered attention across laboratories due to the unique spike protein, RNA dependent RNA polymerase, and cysteine amino-terminals. In March 2020, the World Health Organization declared SARS-CoV-2 a pandemic.1 , 2 As of July 2022, the World Health Organization has confirmed over 548 million SARS-CoV-2 (COVID-19) cases and a death toll of over 6.3 million worldwide.3
During the pandemic, pharmacies across the United States initially assisted in the testing of SARS-CoV-2. As vaccinations became available to the public, pharmacy vaccination services were rapidly utilized. These services were originally covered in the Third Amendment to the Department of Health and Human Services’ Public Readiness and Emergency Preparedness (PREP) Act which allowed for pharmacists, pharmacy technicians, and pharmacy interns to administer vaccines that are recommended through the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices—including COVID-19 vaccinations.4 In addition to vaccinations, multiple therapeutics were developed to treat COVID-19, including remdesivir (Veklury), casirivimab/imdevimab (REGEN-COV), tocilizumab (Actemra) sotrovimab (Xevudy), bamlanivimab and etesevimab, molnupiravir (Lagevrio), and nirmatrelvir and ritonavir (Paxlovid).
REGEN-COV, a non-Food and Drug Administration approved monoclonal antibody combination of casirivimab and imdevimab, proved to be effective at reducing hospitalizations and death in patients with mild to moderate COVID-19 in a randomized controlled trial.5 , 6 This monoclonal antibody was granted Emergency Use Authorization (EUA) by the U.S. FDA for postexposure prophylaxis and treatment of COVID-19 on November 21, 2020.5 On September 14, 2021, the Department of Health and Human Services published the Ninth Amendment to the PREP Act which allowed pharmacists to order and administer COVID-19 therapeutics, including casirivimab/imdevimab.7 The use of casirivimab/imdevimab was first authorized as intravenous infusion.8 However, labeling updates allowed casirivimab/imdevimab to be administered by intravenous infusion or subcutaneous injection with subcutaneous injection allowing for the expansion of outpatient treatment.5 , 6
On August 17, 2021, the Tennessee Department of Health released a statement regarding the administration of monoclonal antibodies. This statement encouraged health care providers to implement effective monoclonal antibodies services for their patients in the community in an effort to reduce the overall health care burden that would traditionally be imposed on hospitals.9 Casirivimab/imdevimab was authorized in the EUA for use in patients as both postexposure prophylaxis and treatment of COVID-19, however, The Tennessee Department of Health limited the use of product for treatment only.10
During the fall months of 2021, the United States experienced a COVID-19 surge and delays in treatment were common as hospitals and infusion centers across the nation were at maximum capacity. The United States Department of Health and Human Services had estimated 96,000 intensive care unit hospital beds were in use in September of 2021.11 With 89% of patients living within 5 miles of a pharmacy, pharmacy-based programs are more accessible than hospital-based infusion centers and could reduce delays in life-saving treatments.12, 13, 14, 15 Literature on casirivimab/imdevimab outcomes and administration in a community pharmacy setting has not been previously reported. However, several states, including Tennessee, have news outlets reporting pharmacists administering casirivimab/imdevimab in a community pharmacy setting.16, 17, 18
Objective
The objective of this study was to describe an innovative service and evaluate the safety of administering REGEN-COV, a monoclonal antibody combination of casirivimab and imdevimab, in a community pharmacy setting as treatment for SARS-CoV-2 positive patients.
Practice description
The practice setting was in a single-center, rural, independent community pharmacy. The pharmacy has an area of approximately 5500 square feet, with 1 clinical exam room, and an attached large, multi-use garage space. Pharmacy services include medication counseling and dispensing of approximately 300 prescriptions daily. Clinical services offered by the pharmacy include: vaccinations, point-of-care testing, medication packaging, free delivery, and non-sterile compounding. Normal operations include 2 pharmacists and 5 certified technicians, along with a school of pharmacy faculty member with specialization in community-based pharmacy.
Practice innovation
In August of 2021, the pharmacy developed an order and patient documentation form utilizing the FDA EUA for REGEN-COV. A “Dear Provider” letter was created to engage providers in understanding the service, along with copies of the ordering and documentation forms. From September 1, 2021 to September 14, 2021, the pharmacy served patients with a prescription order for administration of the monoclonal antibody. During this time, a press release was written and published in multiple news outlets to make the community aware of the service.
On September 14, 2021, the Ninth Amendment to the PREP Act was enacted. As part of the PREP Act’s declaration, pharmacists were able to order COVID-19 therapeutics that were either authorized, approved, licensed, or cleared by the FDA and given via subcutaneous, intramuscular, or oral administration. Thus, pharmacists could now be the ordering provider for REGEN-COV for patients who tested positive for SARS-CoV-2. To comply with the Act’s qualified person statements, all medication administrators were certified in immunization delivery, upheld a current basic life support certification, and held active Tennessee Board of Pharmacy license in respective areas of pharmacist, pharmacy intern, or pharmacy technician as applicable.10
The ordering and documentation forms were carefully constructed to follow the requirements of the FDA EUA for casirivimab/imdevimab. The ordering form included patient demographic and prescriber information, along with necessary eligibility criteria for proper receipt of the product, specifically, age greater than 12 year old with a high risk of COVID-19 hospitalization or death.19 Included in the ordering form was an optional pretreatment protocol that consisted of acetaminophen 650 mg and diphenhydramine 25 mg by mouth 30 minutes prior to antibody administration to limit the possibility of hypersensitivity reaction.
Prescriber orders were also accepted by fax, telephone, or e-scribe. Upon receipt of an order, patients were contacted by telephone and scheduled for treatment on the same or following day. Patients were instructed to arrive at the pharmacy at their scheduled time and to park in a designated parking space. Consent to treatment, demographic information, and billing information were collected from patients while also providing the Patient EUA sheet. Patients were then counseled on what to expect and pretreatment medications were administered to prevent hypersensitivity. Patients were then escorted to a multi-use garage space for monitoring and administration of the product. The administration and monitoring area provided space for patient privacy while also providing air flow and limiting exposure to staff.
The following were assessed prior to antibody administration, and approximately every 15 minutes afterwards for a total of 4 readings: temperature, blood pressure, heart rate, and pulse oximetry. The monoclonal antibody was administered via the subcutaneous route using 27-gauge needles as 4 different 2.5 mL injections at the abdomen, upper arm, buttock, or upper outer thigh. Patients were monitored for hypersensitivity and anaphylaxis reactions including fever, chills, headaches, nausea, hypotension, angioedema, throat irritation, rash, myalgia, and dizziness. Documentation of antibody administration was forwarded to the patient’s primary care provider. Patients were instructed to follow-up with their primary care provider and look for signs and symptoms of progressing disease that would necessitate medical intervention.
According to the Centers for Medicare and Medicaid Services, patients were not to be charged for the cost of the medication. The pharmacy billed for the service of administering the antibody and monitoring the patient post-administration using International Classification of Diseases Code M0243, with a national payment allowance of $450.00.20 The pharmacy used a third-party software billing platform and clearinghouse to process medical claims for commercial insurance and Medicaid plans. Medicare Part B was billed via the regional Medicare Administrative Contractor using an online portal as a Mass Roster Immunizer.
Evaluation methods
Study design
This study was a retrospective, institutional review board-approved, observational study that included patients who received casirivimab/imdevimab at a community pharmacy from September 1, 2021, to December 31, 2021. This study was completed in a single independent community pharmacy setting and evaluated SARS-CoV-2 positive patients' postadministration of casirivimab/imdevimab. Patients were evaluated at the time of administration for adverse drug reactions, and then reevaluated in 60 days via phone call using a patient survey. Other measures assessed were the number of patients hospitalized, number of patients able to return to normal daily activities, and if payment was successfully completed.
Inclusion and exclusion criteria
To assure proper following of the FDA EUA for casirivimab/imdevimab, the inclusion and exclusion criteria were formulated in accordance. The inclusion criteria for the retrospective study required for all patients to be age 18 years or older and to have a positive SARS-CoV-2 antigen or polymerase chain reaction test prior to receiving treatment. Though casirivimab/imdevimab is authorized for use in individuals age 12 or older, individuals 12-17 were excluded from the study. Patients were not eligible for antibody administration if they presented more than 10 days post-symptom onset, or positive test date. Patients were excluded from this study if unwilling to consent to a follow-up phone call 60 days post administration, or if the patient was unreachable at the 60 day follow up mark.
Data collection
Data collected included patient demographics: age, sex, body mass index (BMI), height, and weight. Also collected were SARS-CoV-2 test result, including days since symptom onset and days since positive test result, COVID-19 vaccination status, including vaccine manufacturer name (Pfizer, Moderna, or Johnson & Johnson) and number of doses received (if applicable), and insurance status.
To determine if patients were at a high-risk of severe or worsening disease, patients were assessed if they fell into any of these categories: age 65 years or older, BMI > 25kg/m2, or if they have a past medical history of chronic kidney disease, diabetes mellitus, immunosuppressive disease, history of taking immunosuppressive therapies, cardiovascular diseases such as hypertension, lung disease, sickle cell disease, pregnancy status, or if medical technology dependent. All patient background information was collected via a preadministration survey.
Premedication status was assessed and collected for data as no premedication, acetaminophen only, diphenhydramine only, or both. Adverse effects were evaluated at time of administration and within 60 days postadministration of casirivimab/imdevimab, via phone survey. This study defined adverse effects as hypersensitivity reaction, anaphylaxis, infection other than COVID-19, injection site reaction, death, new diagnosis or decompensation of previous cardiac or lung disorder, gastrointestinal distress, syncope, and/or headache. At follow-up, patients were asked if they were hospitalized due to the monoclonal antibody treatment or worsening disease, or if they were able to return to normal daily activities.
Payment type was collected as either commercial insurance, Medicare, Medicaid, or uninsured. The payment status was collected over the following months as reimbursement was obtained.
Outcomes
The primary outcome measured was reported adverse effects at 60 days. This was assessed by successful completion of a phone call conducted questionnaire that asked if patients experienced adverse drug effects and what those effects were as applicable.
The secondary outcomes measured were also conducted at the 60-day follow-up call. These secondary outcomes included the number of patients hospitalized due to the monoclonal antibody treatment, the number of patients hospitalized due to worsening disease, and/or the number of patients that were able to return to normal daily activities after treatment.
Statistical analysis
Descriptive statistics were used to characterize baseline characteristics and primary and secondary outcomes. No statistical testing was completed on the data because no comparator group was available.
Results
Two-hundred and nine patients received casirivimab/imdevimab from September 1, 2021 to December 31, 2021 at the community pharmacy and 116 patients were excluded from analysis. One hundred and fourteen patients could not be contacted for routine follow up with a phone call, and 1 patient did not consent to be interviewed during phone call. Ultimately, 93 patients were included in the final analysis.
Baseline characteristics are represented in Table 1 . All patients in the study received casirivimab/imdevimab for a confirmed SARS-CoV-2 infection. At the time of study medication administration, the average time from symptom onset and test positivity was 5.7 days and 3.4 days, respectively. Many patients had more than 1 high-risk factor at presentation. The most common risk factors were a BMI > 25kg/m2, diagnosed hypertension or cardiovascular disease, and age ≥65 years. No patients reported sickle cell disease, pregnancy, or dependence on medical technology devices. Very few patients reported immunosuppressive disease or treatment. COVID-19 vaccine status was reported in all but 5 patients and 46.2% of patients were unvaccinated. Information on third doses of COVID-19 vaccination was not collected. Most patients were premedicated with acetaminophen and none were administered diphenhydramine. The average time to phone follow-up and postinjection survey was 36.1 days, with a range of 2-121 days.
Table 1.
Demographic and clinical characteristics of patient population
| Characteristic | Patient data (n = 93) |
|---|---|
| Male sex, n (%) | 41 (44) |
| BMI, mean kg/m2 (SD) | 32.8 (7.8) |
| Age, mean y (SD) | 53.2 (14.6) |
| Premedication administered, n (%) | 85 (91.4) |
| Acetaminophen, n (%) | 85 (91.4) |
| Diphenhydramine, n (%) | 0 (0) |
| High risk factors for severe or worsening disease | |
| Age ≥ 65, n (%) | 21 (22.6) |
| BMI > 25, n (%) | 83 (89.2) |
| CKD, n (%) | 3 (3.2) |
| DM, n (%) | 14 (15.1) |
| Immunosuppressive treatment, n (%) | 2 (2.2) |
| Immunosuppressive disease, n (%) | 3 (3.2) |
| CV or HTN, n (%) | 36 (38.7) |
| Lung disease, n (%) | 15 (16.1) |
| Time since COVID-19 symptom onset, mean d (SD) | 5.7 (2.8) |
| Time since COVID-19 positive test, mean d (SD) | 3.4 (2.9) |
| Patient reported COVID-19 vaccine status | |
| Unvaccinated, n (%) | 43 (46.2) |
| Not reported, n (%) | 5 (5.4) |
| Pfizer, n (%) | 24 (25.8) |
| Moderna, n (%) | 12 (12.9) |
| Johnson and Johnson, n (%) | 6 (6.5) |
| Vaccinated but type unreported, n (%) | 3 (3.2) |
| Average time to phone call follow-up, d (SD) | 36.1 (25.9) |
Abbreviations used: BMI, body mass index; CKD, chronic kidney disease; DM, diabetes mellitus, CV, cardiovascular; HTN, hypertension.
Note: Body mass index is the weight in kilograms divided by the square of the height in meters.
Vitals were collected at time of injection and 60 minutes after injection in half of the patients (Table 2 ) and were similar for blood pressure, pulse, and oxygen saturation. The number of patients experiencing fever was numerically lower 60 minutes after study medication administration, however this could be due to high rates of acetaminophen premedication.
Table 2.
Recorded patient vital signs at casirivimab/imdevimab administration visit
| Vital sign | Prior to Medication Administration (n = 45) | 60 min after medication Administration (n = 35) |
|---|---|---|
| Temperature ≥ 100.4°F, n (%) | 6 (13.3) | 1 (1.1) |
| Average SBP, mmHg (SD) | 138.6 (18.2) | 134.7 (20.5) |
| Average DBP, mmHg (SD) | 83.2 (14.3) | 81.2 (15.6) |
| Average pulse, bpm (SD) | 94.6 (14.3) | 82.9 (14.1) |
| Average pulse oximetry, % (SD) | 95.9 (2.8) | 95.6 (2.8) |
Abbreviations used: SBP, systolic blood pressure; DBP, diastolic blood pressure; bpm, beats per minute.
Primary and secondary outcomes are reported in Table 3 . Adverse events reported at time of study medication were low with only 4.3% of patients experiencing syncope. Reported adverse events were higher at the follow-up phone call with 9.7% of patients experiencing at least 1 event. The most reported events were gastrointestinal distress (5.4%) and injection site reaction (4.3%). Patients reported good outcomes after community pharmacy administration of casirivimab/imdevimab with 82.8% returning to normal daily activities by the time of follow-up phone call. Some patients did need advanced care with 9.7% reporting needing to be hospitalized after administration of casirivimab/imdevimab.
Table 3.
Adverse Event and Billing Outcomes
| Endpoint | Outcome (n = 93) |
|---|---|
| Adverse events reported at time of injection, n (%) | 4 (4.3) |
| Hypersensitivity or anaphylaxis, n (%) | 0 (0) |
| Infection other than COVID-19, n (%) | 0 (0) |
| Injection site reaction, n (%) | 0 (0) |
| Death, n (%) | 0 (0) |
| Gastrointestinal distress, n (%) | 0 (0) |
| New pulmonary disorder or cardiac disorder, n (%) | 0 (0) |
| Syncope, n (%) | 4 (4.3) |
| Headache, n (%) | 0 (0) |
| Adverse events reported at follow-up phone call, n (%) | 9 (9.7) |
| Hypersensitivity/anaphylaxis, n (%) | 1 (1.1) |
| Infection other than COVID-19, n (%) | 1 (1.1) |
| Injection site reaction, n (%) | 4 (4.3) |
| Death, n (%) | 0 (0) |
| Gastrointestinal distress, n (%) | 5 (5.4) |
| New pulmonary or cardiac disorder, n (%) | 1 (1.1) |
| Syncope, n (%) | 0 (0) |
| Headache, n (%) | 2 (2.2) |
| Patient reported hospitalization at follow-up phone call, n (%) | 9 (9.7) |
| Patient reported returning to normal daily activity at follow-up phone call, n (%) | 77 (82.8) |
| Billing for pharmacy services successful, n (%) | 77 (82.8) |
| Commercial insurance, n (%) | 56 (60.2) |
| Medicare, n (%) | 22 (23.7) |
| Medicaid, n (%) | 8 (8.6) |
| Cash, n (%) | 7 (7.5) |
Billing for medication administration and monitoring was successfully completed in 82.8% of patients, with the most common form of payment being from commercial insurance providers. Sixteen accounts were not successfully collected: commercial insurance—8, Medicare—1, Medicaid—1, and uninsured—6. For patients included in the study, $32,688.68 in revenue was generated with an average of $351.49 per patient.
Practice implications
Pharmacists are highly educated health care providers that have an opportunity for expanding their scope of practice. The COVID-19 pandemic and authorization of pharmacist services via the PREP Act allowed community pharmacists to provide patients with timely COVID-19 treatment in an outpatient setting. This study limited overall exposure to COVID-19 for health care providers at a time when traditional infusion treatment was given in crowded inpatient hospital settings. The total time required for patients to be screened based on the inclusion and exclusion criteria and receive treatment was 1 hour.
This study provides insight to the adverse effect profile of casirivimab/imdevimab when given in an outpatient community pharmacy setting. While the original casirivimab/imdevimab phase 3 trial was conducted as inpatient treatment using intravenous administration, a subset of the trial examined subcutaneous administration in prophylaxis. In this study most commonly reported adverse events were injection site reaction (4.2%), headache (1.8%), asymptomatic COVID-19 infection (4.1%), and symptomatic COVID-19 infection (1.1%).21 While these reported rates are higher than what was observed in this study, the lower number of patients included in this study and the retrospective, observational design could explain the difference.
This was a retrospective observational study with information only being collected as part of the service protocol. This resulted in patients with incomplete data sets. The most notable example of this was the collection of vital signs before and after casirivimab/imdevimab administration. Less than half of the patients had this data documented and this was because staffing did not allow for this to be completed systematically for all patients depending on patient volume for this service and overall pharmacy volume. Follow-up phone calls were also initially to be completed within 7 days of casirivimab/imdevimab administration, however due to limited time available, there was great variation in time between medication administration and phone follow-up. This could introduce recall bias in the information reported by the patients and may explain why reported adverse events were lower in our study when compared to previously published literature.
An additional limitation to this study included the absence of variant testing. SARS-CoV-2 variant testing is not commonly performed in practice when treating SARS-CoV-2 positive patients. Treatment is determined based on the percentage of circulating SARS-CoV-2 strain in the community, as reported by state and federal epidemiology data. Any test to determine variant strain confirmation would be a highly complex molecular test, which is not authorized for performance in a community pharmacy under a Clinical Laboratory Improvement Amendment waiver. At the time of this study, the Delta variant was the strain most commonly infecting patients in the United States, with casirivimab-imdevimab exhibiting activity against this strain. Due to decreased efficacy against the emerging Omicron variant, the FDA removed the EUA for casirivimab-imdevimab on January 24, 2022.
Unique to this service, the pharmacy was able to bill insurance benefits for administration of the antibody and post-administration monitoring. There was no cost to the pharmacy to order casirivimab/imdevimab and the cost of injection supplies was negligible. In this study, the number of pharmacist and pharmacy intern hours were not recorded. Overall, adding a monoclonal antibody administration service to this community pharmacy demonstrated revenue growth of $32,688.68 for 93 patients, an average of $351.49 per patient. Based on the average reimbursement, the total revenue potential for the service of 209 patients would be $73,461.41. A previous study demonstrated the cost and length of hospital stay for a patient receiving treatment for COVID-19 to be $11,267 and 6 days, respectively.19, 22 Although our study was not designed to determine cost savings and decreased risks of hospitalizations, a previous study has demonstrated the impact of treatment on reducing hospitalizations.23
Finally, this study helps provide further evidence for the need of a Call to Action for expansion of pharmacist-provided services. Many factors have contributed to the authorization of pharmacist involvement during the pandemic, including various amendments to the PREP Act along with product emergency use authorizations. However, without clear legislative action for permanent expansion, pharmacy services authorized during the pandemic will no longer be allowed once the pandemic is over. A recent article reported on pharmacist interventions during the COVID-19 pandemic including: more than 50% of COVID-19 vaccination programs led by pharmacists, over 100,000 monoclonal antibody treatments provided by pharmacists, over $450 billion in health care costs avoided, and more than 1 million deaths prevented.24 Federal legislation, like the Equitable Community Access to Pharmacist Services Act (H.R. 7213), would ensure patients continue to have access to these types of services, while also expanding access for testing and treatment related to influenza and Group A streptococcal infections.25 In addition, federal legislation would recognize pharmacists as providers in Medicare to receive payment for valuable services.
Conclusion
With the expansion in scope of pharmacy practice as a result from the COVID-19 pandemic, a monoclonal antibody administration and monitoring service was successfully implemented in a community pharmacy. This retrospective, observational study showed that community pharmacists can administer casirivimab/imdevimab safely and effectively in an outpatient setting with low adverse event rates comparable to prior studies.
Pharmacists should continue to evaluate potential clinical service offerings in pharmacies in order to increase patient health care access and demonstrate their value in the health care system. A Call to Action is needed for permanent expansion of federal and state pharmacy practice regulations in order to maintain the valuable public health services provided by pharmacists during the COVID-19 pandemic.
Acknowledgments
The authors thank Lacey George, PharmD, for her contributions to this manuscript.
The data described in this article is openly available to the Journal of the American Pharmacists Association.
Biographies
Tyler S. Dougherty, PharmD, BCACP, Associate Professor, Pharmacy Practice, South College School of Pharmacy, Knoxville, TN
Jimmy McBride, PharmD, Pharmacist and Owner, Clinton Drug Store, Clinton, TN
Carol L. Barnett, BS, PharmD Candidate, South College School of Pharmacy, Knoxville, TN
Wendy M. Gabriel, PharmD, BCPS, BCCP, Associate Professor, Pharmacy Practice, South College School of Pharmacy, Knoxville, TN
Footnotes
Disclosure: The authors declare no relevant conflicts of interest or financial relationships.
Funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
IRB approval statement: This study includes human participants and has been approved by South College School of Pharmacy’s Institutional Review Board.
References
- 1.Kirtipal N., Bharadwaj S., Kang S.G. From SARS to SARS-COV-2, insights on structure, pathogenicity and immunity aspects of pandemic human coronaviruses. Infect Genet Evol. 2020. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7425554/ Avaliable at: [DOI] [PMC free article] [PubMed]
- 2.Guo Y.-R., Cao Q.-D., Hong Z.-S., et al. The origin, transmission and clinical therapies on coronavirus disease 2019 (covid-19) outbreak - an update on the status. Mil Med Res. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7068984/ Avaliable at: [DOI] [PMC free article] [PubMed]
- 3.WHO coronavirus (COVID-19) dashboard. World Health Organization. https://covid19.who.int/ Avaliable at:
- 4.Third amendment to declaration under the public readiness and emergency Preparedness Act for medical Countermeasures against COVID-19. Federal Register. https://www.federalregister.gov/documents/2020/08/24/2020-18542/third-amendment-to-declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical Avaliable at:
- 5.Fact Sheet for health care providers emergency Use authorization (EUA) of REGEN-COV. https://www.fda.gov/media/145612/download Available at:
- 6.Erin K. McCreary PD. Routes of administration for monoclonal antibodies in adults with COVID-19. JAMA. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2790990?resultClick=3 Available at:
- 7.Expanding Access to Covid 19 Therapeutics. ASPR. https://www.phe.gov/Preparedness/legal/prepact/Pages/PREPact-NinethAmendment.aspx Available at:
- 8.Jorgensen S.C.J., Kebriaei R., Dresser L.D. Remdesivir: review of pharmacology, pre-clinical data, and emerging clinical experience for COVID-19. Pharmacotherapy. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7283864/ Available at: [DOI] [PMC free article] [PubMed]
- 9.Tennessee Department of Health. August 17, 2021. Monoclonal antibody statement. Available at: https://www.tn.gov/health/cedep/ncov.html. Accessed July 7, 2022.
- 10.Tennessee Department of Health. September 23, 2021. Dear Providers of COVID monoclonal antibody therapy. Available at: https://www.tn.gov/content/dam/tn/health/documents/cedep/novel-coronavirus/mAb_Current_Providers.pdf. Accessed July 7, 2022.
- 11.HHS Protect public data Hub. https://public-data-hub-dhhs.hub.arcgis.com/pages/Hospital%20Utilization Available at:
- 12.NACDS supplemental comments. 2014. http://www.nacds.org/ceo/2014/0508/supplemental_comments.pdf Available at:
- 13.Staff NACDS Pharmacists rank second again among Gallup's most trusted professionals. NACDS. https://www.nacds.org/news/pharmacists-rank-second-again-among-gallups-most-trusted-professionals/ Available at:
- 14.Elbeddini A., Prabaharan T., Almasalkhi S., Tran C. Pharmacists and covid-19. Journal of pharmaceutical policy and practice. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7303584/ Available at: [DOI] [PMC free article] [PubMed]
- 15.Kelling S.E. Exploring Accessibility of Community Pharmacy Services. View of exploring accessibility of community pharmacy services. https://pubs.lib.umn.edu/index.php/innovations/article/view/392/386 Available at:
- 16.Nemarich K. Pharmacists hope new treatment will keep Covid patients out of the hospital. WJHL. https://www.wjhl.com/local-coronavirus-coverage/pharmacists-hope-treatment-willkeep-covid-patients-out-of-the-hospital/ Available at:
- 17.Oregon health plan (OHP) coverage of pharmacist-administered monoclonal antibody treatment effective September 1, 2021. https://www.oregon.gov/oha/HSD/OHP/Announcements/mAb-Pharmacists0921.pdf Available at:
- 18.Chronis K. Regeneron covid treatment at Milwaukee Infinity pharmacy, '70% effective'. FOX6 news Milwaukee | Wisconsin & local Milwaukee news WITI. https://www.fox6now.com/news/regeneron-covid-treatment-at-milwaukee-infinitypharmacy-70-effective Available at:
- 19.Scientific evidence for conditions associated with higher risk for severe COVID-19. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-cov/science/science-briefs/underlying-evidence-table.html Available at: [PubMed]
- 20.Covid-19 vaccines and monoclonal antibodies. CMS. https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/covid-19-vaccines-and-monoclonal-antibodies Available at:
- 21.O'Brien M.P., Forleo-Neto E., Musser B.J., et al. Subcutaneous regen-COV antibody combination to prevent covid-19. The New England Journal of Medicine. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8362593/ Available at: [DOI] [PMC free article] [PubMed]
- 22.Ohsfeldt R.L., Choong C.K.-C., Mc Collam P.L., Abedtash H., Kelton K.A., Burge R. Inpatient hospital costs for COVID-19 patients in the United States. Advances in Therapy. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8491188/ Available at: [DOI] [PMC free article] [PubMed]
- 23.Weinreich D.M., Sivapalasingam S., Norton T., et al. REGEN-COV Antibody combination and outcomes in outpatients with Covid-19. N Engl J Med. 2021;385(23):e81. doi: 10.1056/NEJMoa2108163. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 24.Grabenstein JD. Essential services: quantifying the contributions of America’s pharmacists in COVID-19 clinical interventions. J Am Pharm Assoc. Available at: https://www.japha.org/article/S1544-3191(22)00279-5/fulltext. Accessed December 2, 2022. [DOI] [PMC free article] [PubMed]
- 25.Equitable community access to pharmacist services Act, H. R. 7213, 117th Congress. Available at: https://www.congress.gov/117/bills/hr7213/BILLS-117hr7213ih.pdf. Accessed December 1, 2022.