Updated May 27, 2020
TPA President Raewyn Snodderly, PharmD, penned an opinion editorial which was recently published in the Tennessean highlighting the important roles that pharmacists and pharmacy team members continue to play during this coronavirus pandemic.
From the article:
“Every day, health care professionals leave behind our families, our children and our lives to voluntarily run into a “burning building,” unsure of what we will find when we get there. Health care providers, including pharmacists and pharmacy team members, are fighting a massive battle against an invisible enemy. While our practices may not look the same as they did a few weeks ago, we’re still here for you. We might not greet you with hugs, handshakes, and laughter right now, but we are still here to celebrate life, to grieve and to heal with you. Our genuine care for you has not changed.”
CLICK HERE to read the full op-ed.
Health-system Directors of Pharmacy should be aware that this topic will be discussed in-depth during the Tennessee Health-System Directors of Pharmacy call on May 22, 2020, at 11:30 am Central (12:30 pm Eastern). All Directors of Pharmacy in Tennessee health-systems are highly encouraged to attend this call.
The information below was provided by the Tennessee Department of Health (TDH) and Tennessee Hospital Association (THA) on May 21:——As you know, in mid-May, the Tennessee Department of Health (TDH), acting on a recommendation from the Tennessee Hospital Association (THA), approved a distribution process for the federal allotment of remdesivir received by the state.
Treatment courses are distributed on a patient-specific, first come, first served basis using the approved criteria, with oversight by a panel of Vanderbilt University Medical Center (VUMC) physician experts. For greater efficiency and monitoring, VUMC is updating the request process for remdesivir using the online RedCap system instead of a paper request form, beginning immediately.
If a hospital has a patient for whom they think remdesivir may be appropriate, they should submit a request to RedCap or email COVIDRX@vumc.org, if they have difficulties with the RedCap link. Please note that any email requests sent to Mark Sullivan’s email address will be forwarded directly to COVIDRX@vumc.org.
Additional detail is provided in the Guidance Document on the clinical guidelines for both adult and pediatric patients and on logistics for requesting medication.
- There is limited clinical data on potential adverse effects for remdesivir at this time. As Tennessee health system pharmacists continue to use the drug per the FDA Emergency Use Authorization (EUA), we need to remain vigilant for potential serious adverse drug events (SAEs). MedWatch is in receipt of at least two reports to date from Tennessee; one acute kidney injury (AKI), and one thrombotic stroke. Pharmacists are urged to ensure that monitoring for both of these events is in place.
- Based on literature, the standard baseline and daily laboratory monitoring requirements include CMP, CBC, and INR. Pharmacists may see elevations in transaminases, which is mentioned in the FDA EUA Fact Sheet. It is unclear if this is related to COVID-19 or the drug. The FDA EUA requires daily chemistries, heme (CBC), transaminase, bilirubin, alkaline phosphatase, creatinine and creatinine clearance monitoring. These are the minimum mandatory tests for patients on remdesivir.
- Given the increased risk for thrombosis and other complications in this patient population, all COVID-19 confirmed patients should also receive baseline D-dimer quant, ferritin level, CRP, ESR, PT/INR, PTT, fibrinogen, LDH, and procalcitonin. If baseline D-dimer quant is elevated or other signs of DIC (low fibrinogen, abnormal PT/INR or PTT) are present, then daily D-dimer quant, PT/INR, PTT, fibrinogen, and CRP monitoring is recommended in addition to the testing required by EUA. For normal baseline D-dimer quant, repeating D-dimer quant, PT/INR, PTT, fibrinogen, and CRP is recommended every other day. In some cases, treatment for PE with enoxaparin has been started empirically in patients with a high index of suspicion for PE before diagnostic confirmation, given the very high rates and high mortality in this population.
To request reimbursement for the transport cost of Remdesivir, hospitals should follow these steps:
- Email an official hospital invoice to John Webb (John.Webb@tn.gov) and Valerie Oliver (Valerie.Oliver@tn.gov), and include the name of a hospital contact.
- Include a copy of the shipping invoice or a cost report of in-house courier services to serve as supporting documentation of the hospital invoice.
- State in the email that the invoice is for the transport of Remdesivir.
Payments will be made through TDH’s Edison system with a 15-day turnaround. For questions, contact John Webb, Deputy of Operations, at John.Webb@tn.gov.
|Executive Order #36 Extends Certain Pharmacy Provisions Contained in Previous COVID-19 Executive Orders
- Suspension of the Pharmacist-to-Technician Ratio – Extended to June 30.
- Refills of Maintenance Medications up to 90 Days – Extended to June 30.
- Remote Verification of Prescriptions – Extended to June 30.
- Authorization for Pharmacists to Provide Telehealth or Telemedicine Services – Extended to June 30.
- Suspension of Fees and Notary Requirements for Initial License Applicants – Extended to June 30. Now applies to initial application fees between March 12, 2020, and May 31. Deadline to pay fees extended to June 30.
- Granting of Licenses, Registrations, or Certificates for Retired or Out-of-Practice Healthcare Professionals – Extended to June 30.
- Suspension of Continuing Education Requirements – Extended to June 30. Note that this order does not waive the requirement for applicants to complete continuing education, but extends the deadline to earn continuing education credits.
- Expiration of Health Care Professionals and Facilities Licenses – Extended to June 30. Any renewal application received by the Tennessee Department of Health by August 31, 2020, shall be accepted as timely.
- Out-of-State Licensed Health Care Professionals – Extended to June 30.
- TennCare Changes – Extended to June 30.
- Tennessee Department of Commerce and Insurance – Extended to June 30.
- Certificate of Need Requirements – Extended to June 30.
- Suspension of Certain Required Board of Pharmacy Inspections – Extended to June 30.
- Suspension of Certain Required Health Care Facility Inspections – Extended to June 30.
- Alternate Testing Site Allowance – Extended to June 30.
- Setting Prices on Medical Supplies, Emergency Supplies, or Consumer Food Items – Extended to June 2.
|OSHA, CDC Release Pharmacy Guidelines
- Encourage workers who are sick to stay at home.
- Install clear plastic barriers between workers and customers at order/pickup counters.
- Use signage and floor markers to keep waiting customers at least six feet from the counter, other customers, and pharmacy staff.
- Encourage drive-through or curbside pickup and home delivery, where feasible.
- Encourage customers to submit prescriptions online or by phone. Allow customers to provide their insurance information verbally or virtually (e.g., through mobile apps or the pharmacy’s website).
- Specify hours dedicated to vulnerable populations (the elderly, people with underlying health conditions, etc.).
- Increase the use of self-serve checkout to minimize worker interaction with customers.
- Limit the number of customers allowed inside the facility at any point.
- Frequently clean and disinfect checkout and customer service counters.
- Provide a place to wash hands and alcohol-based hand rubs containing at least 60 percent alcohol.
- Allow workers to wear cloth face coverings or surgical masks over their nose and mouth to prevent them from spreading the virus.
- Provide gloves and eye and face protection, as necessary, for workers in the pharmacy.
- Pharmacists providing clinical services to patients, such as immunizations, might need additional protections. Consult OSHA’s healthcare worker and employer guidance.
- Encourage workers to report any safety and health concerns.
In addition, the Centers for Disease Control and Prevention (CDC) released its Guidance for Pharmacists and Pharmacy Technicians in Community Pharmacies during the COVID-19 Response.
TPA encourages all members working in community pharmacies to ensure compliance with these recommendations and use them to develop policies and processes to promote a safe and healthy workplace for both staff and patients.
|HHS Confirms Pharmacists’ Authority to Order and Administer COVID-19 Tests
On May 19, the Department of Health and Human Services (HHS) issued Advisory Opinion 20-02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration Under the Act.
In this advisory opinion, HHS states that “Any state or local law or legal requirement that prohibits or effectively prohibits licensed pharmacists from ordering and administering FDA-authorized COVID-19 tests are different from or in conflict with the declaration—and therefore, a legal requirement under the PREP Act. So during the effective period of the PREP Act declaration, a state or locality cannot establish, enforce, or continue any such legal requirements under the PREP Act’s preemption provision.”
The advisory opinion goes on to state, “It is important to note that the PREP Act does not preempt all state and local legal requirements. Not all legal requirements that regulate the pharmacy profession differ from or conflict with the PREP Act or any declaration issued under that Act with respect to COVID-19 tests.”
Pharmacies interested in providing COVID-19 testing services should review TPA’s previously released COVID-19 testing guidance and Medicare enrollment email to obtain a federal CLIA waiver, to file for state-based waived testing authorization, and to enroll with Medicare as an Independent Clinical Diagnostic Laboratory.