Sotrovimab Training Module for Healthcare Professionals
The Sotrovimab training module is designed for nursing and advanced care paramedic staff working in certain healthcare settings. It covers the uses, indications, administration procedure, eligibility criteria, and follow-up care for Sotrovimab, an antiviral monoclonal antibody developed for mild to moderate COVID-19 cases. The training is mandatory for Indigenous Services Canada health care professionals, contract nurses, and advanced care paramedics before administering Sotrovimab.
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Sotrovimab Training module for nursing and advanced care paramedic staff working in LRRCN
Training Objectives 1. Outline the uses and indications for Sotrovimab 2. Identify who this training applies to 3. Review who is eligible to receive Sotrovimab 4. Determine where Sotrovimab therapy will take place 5. Recognize the route of administration, supply, dosage and storage requirements for Sotrovimab 6. Outline the procedure for administering Sotrovimab 7. Identify the requirements for follow-up care following the administration of sotrovimab 8. Documentation for the administration of Sotrovimab 9. Review required assessment of learning to be completed prior to administering Sotrovimab
What is Sotrovimab? An antiviral/monoclonal antibody developed by GlaxoSmithKline Inc. Developed specifically for treating COVID-19 patients with mild to moderate symptoms Most effective when administered before the virus has progressed beyond a mild to moderate infection Individuals with COVID-like symptoms are advised to get tested once symptoms develop to allow time to determine eligibility for Sotrovimab treatment Effective for individuals who are at high risk for progressing to hospitalization and/or death Source: Education Module for the Administration of Sotrovimab Infusion in FNIHB Nursing Stations, 2021 3
Applicability Indigenous Services Canada (ISC) health care professionals (HCP), contract nurses and advanced care paramedics are required to complete the training prior to administering Sotrovimab. 4
Determining Eligibility Patients shall be assessed for eligibility through the Nurse in Charge (NIC) and HCP in consultation with the identified NP designated to the prescribing of Sotrovimab 1. The HCP will notify the NIC and will identify the patient that may be eligible for Sotrovimab therapy. 2. The NP and the NIC will confirm the eligibility of the patient for Sotrovimab therapy. 3. The NP will contact the patient and re-confirm that the patient is eligible and is agreeable to Sotrovimab therapy. Source: ISC LRRCN Community Process for Sotrovimab Therapy, 2021 5
Eligibility Criteria Patients shall be assessed for eligibility through the Nurse in Charge (NIC) and HCP in consultation with the identified NP designated to the prescribing of Sotrovimab The HCP will notify the NIC and will identify the patient that may be eligible for Sotrovimab therapy. The NP and the NIC will confirm the eligibility of the patient for Sotrovimab therapy. The NP will contact the patient and re-confirm that the patient is eligible and is agreeable to Sotrovimab therapy. Source: Education Module for the Administration of Sotrovimab Infusion in FNIHB Nursing Stations, 2021 6
NON VACCINATED VACCINATED 55+ regardless of health condition Immunocompromised including transplant patients (solid 18 yr or older with any of the listed preexisting health organ or stem cell) conditions: Oncology patients that have received a dose of any IV or oral chemotherapy or other immunosuppressive treatment since Diabetes (taking medication) Obesity BMI >30 Chronic Kidney Disease (GFR less than 60 mL per minutes) CHF (New York II, III, IV) COPD Moderate/severe asthma Pregnancy (consult OB/RAAPID and refer to High Level for infusion) Immunocompromised (See list in vaccinated column) December 2020 Patients with inflammatory conditions (e.g. rheumatoid arthritis, lupus, inflammatory bowel disease) who have received a dose of any systemic immunosuppressive treatment (such as rituximab or ocrelizumab or any other biologic treatment) since December 2020. High dose steroids ( 2 mg/kg/day or 20 mg/day if weight > 10 kg, for 14 days) 12 to 17 yr old (with consult to MOH and Pediatric ID as per Other biologics: Abatacept, Belimumab (as per ACR national guidance document) recommendations) 50-54 yr old (per national guidance document but will not be JAKs inhibitors: Tofacitinib, Upadacitinib, Baricitinib included as part of the AHS administration) It is important to note that eligibility criteria for 12-17 and 50-54 is NOT part of the AHS eligibility criteria. Individuals living in First Nations Communities between the ages of 12-17 and 50-54 are eligible per the Medical Officer of Health and National Guidelines. Any individual who is in this age group will not be able to receive Sotrovimab in High Level through the provincial program. 7
Consent to Receive Sotrovimab In all cases, patients must complete the Consent to Treatment Plan or Procedure consent form (completed by the referring physician or NP and the patient). Informed consent must be provided prior to treatment 8
Where Will Treatment Take Place? The NP will discuss the most appropriate facility for the patient to receive the Sotrovimab Therapy. At present there are two options (see next slide) 9
1. Admission of the patient to the Nursing Station 2. Referral to the Northwest Health Centre Sotrovimab Interim Clinic NP on call will obtain consent from the If unable to administer Sotrovimab therapy in patient over the phone while the patient nursing station, HCP is to call 811 (with the is in clinic and provide a written patient present) on behalf of the patient for prescription for Sotrovimab next steps (as per AHS recommendation) Both patient and NP will sign consent Do not send patient to the emergency form. Form to be placed in patients chart department (Sotrovimab is not being administered in the emergency department) NP will fax prescription to the nursing station. All prenatal clients should be referred to NWHC for Sotrovimab therapy Source: Education Module for the Administration of Sotrovimab Infusion in FNIHB Nursing Stations, 2021 10
Administration of Sotrovimab in the Nursing Station The following conditions are to be met in order to safely administer Sotrovimab: 1. Drug must be available in the nursing station 2. Availability of an isolation room with dedicated emergency equipment (including airway management and anaphylaxis kit) 3. Adequate staffing levels with the availability of a dedicated HCP for the sole purpose of administering the Sotrovimab infusion according to the approved process. 11
Storage of Sotrovimab Sotrovimab will be kept in the Nursing Station immunization fridge (in all three LRRCN facilities) and be reconstituted according to the parenteral monograph. Please ensure an email is sent to the FNIHB Pharmacist (jacqueline.ming@sac- isc.gc.ca) if a vial of Sotrovimab is administered in the nursing station. 12
Recommended Equipment in Isolation Rooms Kit to include: 100 mL infusion bag containing 0.9% sodium chloride 10ml syringe Blunt (unfiltered needle) Polyvinyl chloride (PVC) or polyolefin (PO) infusion set A 0.2 micron polyethersulfone (PES) filter is recommended The following documents: consent form, parenteral monograph, patient teaching sheet, Sotrovimab client care notes and a pen. Laminated door sign to alert staff that Sotrovimab administration is in process Other necessary equipment: Anaphylaxis Kit IV pump Vital Signs Machine This is a living document and updates may occur throughout the roll out of Sotrovimab. If you have any suggestions of equipment to add to the kit, please do not hesitate to get in touch with a member of the education team. 13
Instructions for Diluting and Administering Sotrovimab 1. Perform hand-hygiene (where required as per the four hand hygiene moments). Wear a mask and gloves when preparing the infusion to minimize exposure. 2. Remove one vial of sotrovimab from refrigerated storage and allow to equilibrate to room temperature, protected from light, for at least 15 minutes. It is recommended that the name and the batch number of the administered product is clearly recorded in order to improve traceability. 3. Visually inspect the vial to ensure it is free from particulate matter and that there is no visible damage to the vial. Should either be observed, the solution must be discarded, and fresh solution prepared. *Sotrovimab is a clear, colorless or yellow to brown solution do not confuse this discoloration with an unsafe solution. Gently swirl the vial several times before use without creating air bubbles. Do not shake or vigorously agitate the vial. 14
Administration of Sotrovimab Administered as a single intravenous 500 mg infusion Administered over 60 minutes. Patient is then closely monitored for an additional 60 minutes post infusion Total administration time is about 2.5 hours, including set-up *Do not administer as an IV push or bolus *The prepared infusion solution must not be administered simultaneously with any other medication. Source: ISC LRRCN Community Process for Sotrovimab Therapy, 2021 15
Side Effects Source: Education Module for the Administration of Sotrovimab Infusion in FNIHB Nursing Stations, 2021 16
AHS Parenteral Monograph and Rx Vigilance Sotrovimab is administered according to the most current AHS parenteral monograph Link to Rx Vigilance (login details are located in all LRRCN Nursing Station pharmacies) https://webapps.vigilance.ca/ 17
Monitoring During Sotrovimab Administration Vital signs Prior to the start of infusion (temperature, pulse, respiration rate, blood pressure, Glasgow Coma Scale (GCS)) Then every 15 minutes throughout treatment And for 60 minutes post infusion Source: ISC LRRCN Community Process for Sotrovimab Therapy, 2021 18
Monitoring Post Sotrovimab Administration Patients will be monitored for 60 minutes post infusion of. Vital signs (temperature, pulse, respiration rate, blood pressure, GCS will be obtained every 15 minutes and charted on the Patient Care Notes Follow-up and discharge instructions shall be provided to the patient following the administration of the medication NP will call patient with follow-up questions. Ensure the contact number is current Ensure the administration of the medication is entered into Netcare Educate patient to delay COVID-19 vaccine by at least 90 days after the receipt of Sotrovimab Source: ISC LRRCN Community Process for Sotrovimab Therapy, 2021 19
Safe Practice Reminders Sotrovimab may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS) If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur during the infusion, immediately discontinue administration, and initiate appropriate medications and/or supportive care. Sotrovimab contains no preservative; and therefore, the diluted infusion solution should be administered immediately. COVID-19 vaccines should be delayed for at least 90 days after the receipt of SARS-CoV-monoclonal antibodies Source: Education Module for the Administration of Sotrovimab Infusion in FNIHB Nursing Stations, 2021 20
Adverse Events All Adverse Events (AE) must be documented and reported to the MOH on call (780-218-9929) The HCP will complete an incident report and report the adverse event to the NP and the Medical Officer of Health (MOH) on call 21
Required Training Complete and review ISC LRRCN Education Training Module for the administration of Sotrovimab On completion of the training module, the following quiz must be completed for a passing mark of 80% 22
Documentation Documentation will be recorded on the Sotrovimab client care notes (see document below) 23
Questions? 24
References Health Canada (July 30, 2021) Sotrovimab for injection (Solution for infusion, 500g/8mL (62.5 mg/mL) single use vial. Product Monograph Including Patient Medication Information. Interim Stocking of Sotrovimab for injection as a non-formulary medication at nursing stations on a temporary basis for the treatment of mild to moderate coronavirus disease 2019 (COVID-19). FNIHB, December 3, 2021. Monoclonal Antibody Module (Professional Development). Alberta Health Services (2021). Monoclonal Antibody Outpatient Treatment: Sotrovimab. Alberta Health Services (Powerpoint presentation) (December 15, 2021). National Advisory Committee on Immunization (2020). Recommendations on the use of COVID-19 Vaccine(s). Ottawa, ON: Public Health Agency of Canada. Outpatient Treatment for COVId-19. January 18, 2022. Retrieved from https://www.albertahealthservices.ca/topics/Page17753.aspx January 18, 2022. 25
Supporting Documents Appendix A AHS Parenteral Monograph.pdf Appendix B frm-09741 consent.pdf Appendix B Sotrovimab Consent ISC.pdf Appendix C Sotrovimab Screening V3.docx Appendix D Sotrovimab Evaluation Quiz.docx Appendix E FAQ for Health Care Providers.pdf Appendix F FAQ for Patients.pdf Appendix G Patient Teaching Sheet.pdf Appendix H ISC LLR Clinical Process Interim Sotrivimab Clinic V7.docx Sotrovimab Client Care Notes FINAL.pdf Appendix I Appendix J Health Canada Product Monograph.pdf Appendix K Sotrovimab NP FollowUp.docx Appendix L Sotrovimab Prescription ISC.docx Training Module V7.docx 26
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