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03/18/20 jm Antiviral Therapy for COVID-19 for ADULTS - Information for the Verifying Pharmacist
March 19, 2020

From: "Justin Muklewicz" <justin.muklewicz@hhsys.org>
To: "Pharmacists" <grp_allpharm@hhsys.org>
Cc: "Jonathan Edwards" <jonathan.edwards@hhsys.org>
Sent: Wednesday, March 18, 2020 4:33:19 PM
Subject: Antiviral Therapy for COVID-19 for ADULTS - Information for the Verifying Pharmacist

Staff,

Three antiviral therapies have been approved for the treatment of severe COVID-19 in ADULT patients by hospital administration. These include hydroxychloroquine (Plaquenil), lopinavir/ritonavir (Kaletra), and remdesivir (an investigational compassionate use medication). These antivirals appear to have the most in vitro evidence against SARS-CoV-19 currently, but with limited or no clinical data. There is very limited supply and no availability to order these medications currently. Remdesivir appears to have the best evidence but is only available through the manufacturer if patients meet criteria for compassionate use. Therefore, restriction and conservation measures for these antivirals have been enacted. The below information and COVID-19 Adult Treatment Pathway outline the recommended antiviral treatment for severe cases with confirmed positive SARS-CoV-19. This email outlines the order verification steps for pharmacists. The pathway is an evolving document and will be located on Pulse (operations 1 --> pharmacy --> clinical services --> antimicrobial stewardship --> COVID-19 Antiviral Treatment Pathway).

General guidance: 

• Antiviral therapy is limited to severe patients due to the limited supply and need for conservation to those that may benefit the most from antiviral therapy.
• Pharmacy will NOT be responsible for determining the severity of disease when verifying antiviral orders for patients with COVID-19. 
• Pharmacy will NOT be responsible for assisting with the remdesivir compassionate use application. This must be completed by the prescriber.
• Pharmacists MUST determine if restriction criteria are met (items in red) prior to order verification.
• Inpatients on maintenance therapy with these antivirals for other indications will be encouraged to utilize their home supply if available.

If I receive an order for one of these antivirals, what do I need to do as the verifying pharmacist?

For hydroxychloroquine or lopinavir/ritonavir orders: 

• Step 1: confirm that the prescriber is an infectious diseases or critical care provider.
• Step 2: confirm that the patient is positive for the SARS-CoV-2 virus, and if positive, move to step 3. If negative, discontinue the order and contact the prescriber to inform them that these antivirals are restricted to confirmed cases only. 
• Step 3: place the required number of doses on the order. This is an approved automatic stop date that does NOT require prescriber approval. Any treatment beyond the recommended duration must be approved by an infectious diseases provider. Contact a member of the AMT if it is unclear if approval has been granted at x50286.
• Hydroxychloroquine: 400 mg q12h x2 doses (1 day), followed by 200 mg q12h x8 doses (4 days).
• Lopinavir/ritonavir: 400/100 mg q12h x 28 doses (14 days). 
• Step 4: confirm that the correct route of administration and formulation are used.
• Hydroxychloroquine tablets have a film coating and cannot be crushed if administered via gastric tube because it will clog the tube.
• Hydroxychloroquine tablets can be halved, crushed and dispersed in water for oral (non-gastric tube routes of administration) if necessary.
• Hydroxychloroquine for gastric tube administration: extemporaneous compounding will be required. Contact central pharmacy and notate this on the order in Cerner.
•  Lopinavir/ritonavir cannot be crushed under any circumstances due to significant decreases in lopinavir AUC.

For Remdesivir orders: Prescribers will first need to complete the Gilead redemsivir compassionate use application. Once this has been complete, prescribers will then enter a "Hosp Consult To Pharmacy", reason for consult: "Other", comment: "Remdesivir Application has been submitted". Pharmacy will NOT have an active role in the application process or determining whether or not a patient meets exclusion or inclusion criteria.

• Step 1: confirm that the prescriber is an infectious diseases or critical care provider.
• Step 2: confirm that the patient is positive for the SARS-CoV-2 virus, and if positive, move to step 3. If negative, discontinue the order and contact the prescriber to inform them that this antiviral is restricted to confirmed cases only. 
• Step 3: verify the consult to pharmacy order and enter a pharmacy intervention for daily follow-up.
• Step 4: send an e-mail to jonathan.edwards@hhsys.org and justin.muklewicz@hhsys.org to notify us that an application has been submitted. AMT will complete daily follow-up on these patients until this process has been more well-defined. Once this process has been more well-defined, we may eliminate step 3 and 4. Staff will be notified if these steps are changed.
• Step 5: once the patient has been approved to receive this medication by the manufacturer, pharmacy will be notified by the manufacturer. Once approved, a pharmacist must enter a TNF order with the the following: 
• Medication name (remdesivir), route (IV), dosage (200 mg IV for 1 dose, then 100 mg IV q24h, and approved duration (2-10 days). The exact duration, diluent, infusion time, and carrier fluid will be provided by the manufacturer once the medication is delivered to us. The TNF order should be updated to include this.
• Step 6: once the medication has arrived on-site, pharmacy will coordinate the compounding, storage, and dispensing of the medication. The medication will be patient-specific and cannot be used for any other patients.
• Step 7: AMT will be monitoring patients that are receiving remdesivir to continuously monitor the appropriateness of therapy.

If the supply of these medications is depleted or if any changes to the above instructions are made, pharmacists will be promptly notified. If the prescriber has questions regarding the restriction criteria, inform them that any questions can be discussed with Dr. Hassoun or Dr. Chappell. 

For any questions, please don't hesitate to contact Jonathan or myself. x50286

Thank you for your patience.