Roadmap for Implementing Oral COVID-19 Antiviral Therapy

March 2022 - Vol.19 No. 3 - Page #10
Category: Ambulatory Pharmacy Products

The COVID-19 pandemic has caused an unprecedented public health emergency with a variety of unforeseen obstacles that health systems must adapt to quickly and effectively. While the fight against COVID-19 continues, many lessons have been learned that will continue to guide patient care.

Early in the pandemic, treatment options for COVID-19 patients were limited. Millions of lives were impacted, and public health systems were overwhelmed as healthcare utilization and hospitalizations increased. Existing and novel therapies were investigated for treatment and prevention of COVID-19. Prior to development of an effective vaccine, treatment with remdesivir, an antiviral agent, showed a decrease in time to recovery in patients hospitalized with COVID-19.1 Shortly after, the COVID-19 monoclonal antibody bamlanivimab was granted FDA emergency use authorization (EUA) after favorable data from the BLAZE-1 trial showing significant reduction in COVID-19 related hospitalization when treating patients with mild to moderate symptoms as an outpatient.2 Since then casirivimab/imdevimab, bamlanivimab/etesevimab, sotrovimab, and bebtelovimab have been granted FDA EUA.

New Antiviral Options

Currently, two oral antiviral medications (nirmatrelvir/ritonavir (Paxlovid) and molnupiravir) have emerged as promising options for patients who are in the early stages of COVID-19 disease with mild to moderate symptoms.3,4 These medications were granted FDA EUA in December 2021 and are the first oral outpatient treatment options that can be self-administered. They are intended to be taken within the first 5 days of symptom onset and based on information at the time of this publication, they reduce risk of hospitalization and death by up to 88% (Paxlovid) and 30% (molnupiravir).3,4 COVID-19 monoclonal antibodies and oral antivirals have been shown to significantly reduce hospitalization risk and alleviate the strain on hospital resources.

As the pandemic has progressed, access to novel COVID-19 therapeutics comes with challenges that require a swift response. These therapies have been distributed by federal and state agencies based on COVID-19 case rates and therapy utilization. Local distribution strategies must focus on providing rapid access to these therapies and incorporate both patient safety and health equity as part of the equation.

The Department of Health and Human Services (DHHS) initially allocated 65,000 courses of Paxlovid and 300,0000 courses of molnupiravir,5,6 with individual states making allocations to pharmacies and health systems. Supply chain stressors, limited rollout guidance from federal entities, increasing demand, lack of reimbursement guidance, and concerns surrounding patient safety due to drug interactions, renal dose adjustments, and pregnancy risk further added to the challenges.

By sharing experiences, resources, and strategies in procurement, workflow, and management, we aim to provide practical education on the implementation of new oral antiviral COVID-19 therapies within an integrated health system.

Assembling an Interdisciplinary Team

The development of an interdisciplinary team with oversight for the implementation of new COVID-19 antiviral therapies is essential to preventing further hospitalizations and deaths from COVID-19. Stakeholders should include physicians, advanced practice providers (APPs), nursing representatives, and community pharmacists. There should also be collaboration with clinic staff that provide COVID-19 monoclonal antibodies for infusion. Leveraging relationships that exist across an integrated health system can be crucial for success.

Workflow Development

Clinical leaders are responsible for developing an ordering process, a patient scheduling and referral process, and educational components for patients, providers, and staff. Utilizing e-visits is an effective way to protect staff from potential exposure and minimize traffic into emergency departments.

Administration staff are responsible for determining the reimbursement of administration fees (product is provided by the US Government at no cost) as well as the delegation or execution of tasks such as direct ordering, reporting of adverse events, and utilization reporting. Within the health system, it is important that pharmacy leadership is involved in the design of the referring providers’ workflow to ensure medication safety is considered. Having a clear line of communication between the prescribers and the community pharmacy is also key to efficiently starting patients on therapy.

Clinical Program

Developing an evidence-based algorithm to ensure scarce therapies are reaching the most appropriate individuals is crucial. A clinical algorithm based on factors including patient population, risk for hospitalization, access to care, and availability of therapy is important to provide care in an equitable manner. The algorithm should address not only circumstances where oral therapy is given but also situations where monoclonal antibody infusions may be more appropriate. Current COVID-19 case rates and an assessment of community need will inform care choices through potential surges. Organizations must be sufficiently nimble in order to alter their algorithm to accommodate rapid changes that result from the nature of emergency use therapies. Significant changes could include the release of new clinical information, COVID-19 antiviral resistance data, adverse medication events, or changes in the supply of therapies (whether they become more or less abundant). Again, this underscores the importance of including pharmacy staff in the development of the clinical program for these therapies. As the last line of defense, the outpatient pharmacy must be knowledgeable of the treatment algorithm to ensure patients are receiving appropriate therapy.

Drug Distribution

The federal government manages supplies of COVID-19 oral therapies under a state coordinated distribution system. State public health officials determine which sites receive product and how much. State pharmacy organizations and local health departments can support your pharmacy as an access point for patients in the area. Chosen sites are required to report product utilization. Accurate and timely reporting to your state agencies is important to ensure your organization receives the maximal allocation based on the needs of your patient population. It is critical for EUA medications that pharmacies have a sound process in place to distribute these medications safely to eligible patients.

Effective Training for Therapy Distribution

As these medications are new and have significant contraindications, vigilance is paramount. Staff should be familiar with the unique packaging, dispensing requirements, dosing regimen/adjustments, and clinical parameters that will vary by patient. As new guidance develops and may potentially change the management of these medications, it is pharmacy’s responsibility to remain up-to-date on any developments and retrain staff as necessary. TABLE 1 highlights key data from the emergency use authorizations (EUA) for both of the oral antiviral COVID-19 therapies.

A primary benefit of utilizing health system community pharmacies is visibility into the electronic healthcare record (EHR), which allows pharmacists to evaluate medication lists, lab values, and document their education to patients in real time. Given the rapid entry to market of these new therapies, many typical safeguards including drug interaction checks, insurance drug utilization reviews, etc, are not as reliable. The community pharmacy must be vigilant in obtaining and assessing lab results and an accurate medication history.

It is imperative to utilize the advanced functionality within the EHR. The guidance for these new therapies has initiation considerations and dosing adjustments based on renal function. Pharmacy can ensure that the pertinent information is readily accessible through the EHR in order to determine appropriateness. Treatment algorithms should also take into account the risk of progression to severe COVID-19 disease, based on NIH guidelines and a social vulnerability index to ensure health equity. Having a dispensing pharmacy with visibility into these decisions is crucial.

Staff should be appropriately trained on best practices for transporting the medications to patients looking to acquire them on site. One approach is to instruct patients to stay in their car, use a drive through if available, ensure staff has and uses sufficient PPE, and provide the patient with a fact sheet prior to handing off medications. Many health systems can also utilize internally developed home delivery or courier options if delivery is feasible within the 5-day symptom window.

For health-systems with multiple community pharmacy locations, it is recommended to limit dispensing to a few select pharmacies to ensure staff are appropriately trained on the EUA requirements. As staff competency and medication allocations increase, considerations can be made to expand to additional health-system pharmacies. Staff training and competency should be balanced with ensuring maximum access of therapy to patients in the community.

Addressing Barriers

  • Supply Chain Barriers – It is important to understand that with the increase in cases of COVID-19 and the emergence of new variants, logistical and supply constraints are likely to arise. Providers should proactively use clinical judgement when prioritizing the use of these therapies in such a situation. Prioritization models should consider how to equitably distribute scarce resources to populations that may have less knowledge of and/or access to these therapies. Sites should report inventory and usage to their state public health officials weekly even when additional product is not needed, as this will assist in ensuring accurate federal allocations.
  • Patient Literacy & Safety – With the current COVID-19 pandemic, healthcare providers are tasked with a difficult challenge due to the heavy media coverage and national conversation occurring around the pandemic. In addition to determining the best clinical course of care for patients, it is imperative that healthcare providers also educate patients and address potential misinformation surrounding COVID-19, vaccine use, and new antiviral therapies. The first step is to base staff training material on the most up-to-date information. The ensuing patient education must be routinely emphasized, and the messages regularly reinforced. Patients should be encouraged to ask questions of your team and be provided with all necessary resources and take-home information. To improve outcomes and ensure information accuracy, patients must be informed of adverse events to look out for and be followed up with patient monitoring.
  • Reimbursement for Service Provision – There has largely been a lack of formal guidance from payors regarding reimbursement of dispensing fees. Oral COVID-19 therapies require a significant labor investment from pharmacists to ensure patients are appropriately screened and educated on these therapies. While EUA medications used to treat COVID-19 are currently provided at no cost, there is inconsistency surrounding payors’ acknowledgement of the financial support necessary to distribute these medications. While some payors assign a small dispensing fee to pharmacies, many others were slow to adopt mechanisms to reimburse pharmacies for the labor investment needed. This should continue to be monitored to ensure sustainable models for pharmacies to dispense these medications to patients.

Conclusion

To facilitate safe and effective distribution of new oral COVID-19 therapies, a multidisciplinary approach is key to supporting the flexibility needed to adapt to a constantly changing landscape of therapeutics. Designing and implementing an effective oral COVID-19 therapy distribution program relies on clinical expertise, an investment in logistics, appropriate training for staff and education for patients, compliance with often changing regulations, and a focus on individual patient needs. Strategies used to develop safe processes for EUA medications will not only aid in managing the current pandemic, but will also help pharmacy leaders prepare for future events. Ultimately, pharmacy must remain nimble to provide appropriate care to our communities.


References

  1. Beigel JH, Tomashek KM, Dodd LE, et al. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020;383(19):1813-1826.
  2. Chen P, Nirula A, Heller B, et al. SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19. N Engl J Med. 2021;384(3):229-237.
  3. Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults. U.S. Food & Drug Administration. December 23, 2021. Accessed February 22, 2022. www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-oral-antiviral-treatment-covid-19-certain
  4. Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19. U.S. Food & Drug Administration. December 22, 2021. Accessed February 22, 2022. www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19
  5. Paxlovid (nirmatrelvir/PF-07321332 and ritonavir). Public Health Emergency. January 12, 2022. Accessed February 22, 2022. www.phe.gov/emergency/events/COVID19/investigation-MCM/Paxlovid/Pages/default.aspx
  6. Molnupiravir (MK-4482). Public Health Emergency. January 12, 2022. Accessed February 22, 2022. www.phe.gov/emergency/events/COVID19/investigation-MCM/molnupiravir/Pages/default.aspx

Thanh Pham, PharmD Candidate, is a PY4 at the University of North Carolina Eshelman School of Pharmacy. He received his bachelor’s degree in Health Sciences at the University of Central Florida. Thanh plans to be involved in the pharmaceutical industry with a focus on clinical development after graduation.

Nicholas P. Gazda, PharmD, MS, BCPS, CSP, is the assistant director of specialty pharmacy at Cone Health in Greensboro, North Carolina. Nick completed his BS and PharmD at the UNC Chapel Hill Eshelman School of Pharmacy. His professional interests include ambulatory care, specialty pharmacy, productivity, pharmacy operations, and financial management.

Yatin Patel, PharmD, BCPS is the clinical pharmacy coordinator for non-oncology infusion services at Cone Health. He completed his PharmD at the University of Kentucky College of Pharmacy in Lexington, Kentucky. Yatin’s professional interests include specialty pharmacy, ambulatory, and home infusion services.

Molly Schneider, PharmD, MHA, CSP, is the director of retail and specialty pharmacy services at Cone Health. She received her PharmD from the UNC Eshelman School of Pharmacy and an MHA from the UNC Gillings School of Public Health. Her professional interests include specialty and community pharmacy, ambulatory care, and pharmacy finance.


Cone Health, a five-hospital, regional community teaching health system with 1273 beds in Greensboro, North Carolina incorporated the new oral COVID-19 antiviral therapies into the algorithm previously used to allocate monoclonal antibody infusions for COVID-19 treatment. A group of Advanced Practice Providers (APPs) across multiple disciplines created a referral process for all health system and community providers. These APPs accepted referrals and utilized the algorithm developed by an interdisciplinary team of physicians, providers, and pharmacists to determine which therapies were most appropriate.

The state of North Carolina initially distributed the two oral COVID-19 therapies to select community pharmacies to dispense to patients. As was the case with North Carolina’s initial COVID-19 vaccine roll-out, health systems were prioritized for allocations due to their strong relationship with community providers and acute care facilities.

With seven community pharmacies, Cone Health received an initial allocation. The allocation was assigned to Cone’s internal specialty pharmacy and the home delivery pharmacy. This approach allowed for staff to receive training and develop competence with the nuances of these therapies while leveraging their existing experience with similar therapeutics. Paxlovid, in particular, has a significant drug interaction profile due to its pairing with the booster ritonavir, which is commonly used in HIV treatment. Leveraging our specialty pharmacy expertise allowed us to evaluate prescriptions for safety without inhibiting access to this crucial therapy.

A standardized dispensing process was developed:

  1. Enter prescription from the pharmacy dispensing system queue
  2. Review APP note in the EHR

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