Pharmacy Playbook for COVID-19 Vaccine Administration

Last Updated: July  8, 2021*

Section 1: Introduction
Section 2: Operational Considerations
Section 3: Workflow Considerations
  • Pre-Scheduling
  • Scheduling/Appointment Booking
  • Registration/Check-in
  • Eligibility Screening/Medical Screening/Vaccine Administration
  • Post-vaccine Observation/Check-out/Second Dose Booking
  • Administrative Tasks

Introduction

Background

The COVID-19 vaccination program is one of the largest and fastest immunization programs in history. As the most frequent touchpoint that many Ontarians have with the health care system, community pharmacies play a critical role in the success of the vaccination program.

To support the COVID-19 vaccine rollout, the Ontario Pharmacists Association (OPA), in collaboration with the Neighbourhood Pharmacy Association of Canada (Neighbourhood Pharmacies), has worked closely with the Ministry of Health to plan for the implementation of COVID-19 administration in community pharmacies. On March 2, 2021, as part of the preparatory work, OPA participated in a table-top exercise with representatives from the Ministry of Health, the Ministers’ COVID-19 Vaccine Distribution Task Force and various public health units during which we presented our Pharmacy Playbook for COVID-19 Vaccine Administration Version 1.0.

Goal

This playbook aims to address operational considerations required to support the successful implementation of COVID-19 vaccine administration in pharmacies including local planning, communications and engagement; vaccine supply and inventory management; operating model; technology and reporting; and clinical guidance, emergency management and security. Additionally, workflow considerations including pre-scheduling; scheduling; registration, eligibility screening, medical screening; vaccine administration; post-vaccine observation; and second dose scheduling are presented to help illustrate the process.

Details on how community pharmacies may participate, program patient eligibility, vaccines and reimbursement are determined by the Ministry of Health and are not included in this playbook. Additionally, distribution and allocation details are also not addressed as this will be facilitated through pharmacy wholesale channels.

Assumptions

The following assumptions were made at the time of developing this playbook and have been updated with subsequent versions.  Members are encouraged to take these assumptions into consideration when they plan for the vaccine workflow.

This playbook was developed based on the assumption that pharmacies will be able to administer both mRNA and viral vector vaccines (i.e., Pfizer-BioNTech (‘Pfizer’), Moderna and AstraZeneca/COVISHIELD). Participating pharmacies are expected to meet all cold chain management criteria pertaining to the storage and handling of these vaccines. For the purposes of this guidebook, the assumption was made that Pfizer and Moderna COVID-19 vaccines would be packaged and delivered to the pharmacy location in one of two states:

  • Frozen state between -25°C to -15°C OR
  • Refrigerated state using an insulated cooler (e.g., Playmate), that has been preconditioned to a refrigerated temperature of +2°C to +8°C. In this state, the vaccine would be transported for no more than 12 hours of cumulative time.

Once the vaccines arrive at the pharmacy, they will be immediately placed in the designated refrigerator and if frozen, allowed to thaw as per the product monographs, prior to use.

It was also assumed that while vaccine demand will exceed supply, participating pharmacies will have access to a stable and predictable supply of vaccine to appropriately schedule first and second dose appointments.

Lastly, it was understood that pharmacies will have access to and utilize COVaxON to track the inventory and document administration of COVID-19 vaccine, and the workflow described was based on the current version of COVaxON that was available at the time of development of the playbook.

Operational Considerations

Local Planning, Communications and Engagement

Communications and Community Engagement
  • As the most accessible health care provider, pharmacy professionals can support local public health units with communication and education to the public about the safety, efficacy, and availability of vaccines.
  • Clear communications that include defined processes that are aligned with Ministry and local public health efforts on community engagement should be provided to all participating pharmacies.
        • Leverage the existing communication channels in place for pharmacies participating in COVID-19 testing of asymptomatic persons to communicate with pharmacies participating in COVID-19 vaccinations (Executive Officer Notices, ONEMail communications, Association support).
        • Ensure pharmacies have access to a single repository of resources to address public education on the safety, efficacy, and availability of vaccines that are consistent and maintained centrally (Ministry approved resources).
  • Clearly defined roles and expectations with respect to community engagement should be established for pharmacies participating in vaccination efforts including:
        • The need to actively engage target priority groups in the community.
        • The expectation to engage existing patients of the pharmacy belonging to target priority groups.
Partnership and Engagement
  • Partnership and engagement with community pharmacies will increase adoption of public health measures including uptake of vaccines in target populations through improved access to the vaccines.
  • Pharmacists are one of the most trusted health care providers and first and most frequent touch point that many Ontarians have with the health care system.
  • With convenient access and, in many cases, extended hours beyond other primary care providers, community pharmacies serve Ontarians in urban, suburban, rural, remote and isolated communities and therefore supports equitable access to the vaccine.
  • Planning for delivery of vaccinations at participating community pharmacies should occur in collaboration with the Ministry and local public health units (PHUs) but should follow a consistent process for onboarding and training across the province for all pharmacies interested in participating.
  • A process should be defined for escalation of incidents or public concerns that may be of interest to local media to Ministry and local PHUs.
        • Pharmacy associations can help to facilitate this process by ensuring regular touchpoints with participating pharmacies and leveraging existing communication channels.

Vaccine Supply and Inventory Management [1]

Record of Shipment
  • Pharmacies will receive the vaccines in the appropriate storage and transport conditions from their assigned pharmacy wholesale distributor.
  • For ground transport of Pfizer and Moderna at -25°C to -15°C:
    • Transport containers should be packed as per the recommendations/specifications for the container (e.g., credo cubes, stirling coolers).
  • For ground transport of Pfizer and Moderna at +2°C to +8°C:
    • It is recommended that the vaccine is packaged for delivery in a frozen state to be transported to the pharmacy location using an insulated cooler (e.g., Playmate), that has been preconditioned to a refrigerated temperature of +2°C to +8°C.
  • In this state, the vaccine should be in transport for no more than 12 hours of cumulative time. The time in the insulated cooler needs to be documented and provided to the pharmacy.
  • Upon receipt of vaccine at the pharmacy, pharmacy staff should:
    • Immediately open all the transport containers and assess the digital temperature monitoring device(s) to ensure product has been maintained at the appropriate temperature (between -25°C to -15°C in the frozen state or between +2°C to +8°C in the refrigerated state), if not, quarantine the product. Please note, only Pfizer-BioNTech and Moderna COVID-19 vaccines can be shipped in either frozen or refrigerated states; AstraZeneca/ COVISHIELD COVID-19 vaccines should only be shipped in the refrigerated state.
      • For vaccines shipped in the frozen state: Instructions on how to unpack the Credo container used for shipping Pfizer-BioNTech and Moderna vaccines can be found in the TempTale Credo Instructions document included with the onboarding package and also provided with each shipment.
      • For McKesson Canada orders only: Vaccines are shipped in the refrigerated state. Pharmacy staff will only receive the shipping envelope containing the vaccines as each McKesson Canada pack-out contains multiple pharmacy orders and the pack-out stays with the McKesson Canada driver. The temperature logger is embedded in the McKesson Canada pack-out at all times and cannot be tampered with or manipulated as doing so may create an excursion and jeopardize the other shipments in the pack-out. Pharmacies do not need to ask the driver to see the temperature logger as McKesson is taking responsibility for this part of the distribution and are ensuring that the temperature is maintained during transport via cold chain pack-outs. Once pharmacies receive the shipping envelope, it should be kept upright (even while opening).
    • Examine the shipment for evidence of damage and quarantine the product immediately if damaged.
    • Document their name, the date and time of receipt of the vaccines and sign the manifest to acknowledge the receipt of the vaccines.
    • Unpack the shipment. Unpunctured AstraZeneca /COVISHIELD vaccine vials stored between +2°C to +8°C can be used up until the expiration date on the vial label. Label the Pfizer and Moderna products with the new expiry dates for pharmacy use only:
      • If received in the frozen state: Pfizer-BioNTech = 31 days; Moderna = 30 days
      • If received in the refrigerated state: Pfizer-BioNTech = 31 days minus any time the vaccine was in the container; Moderna = 30 days minus any time the vaccine was in the container
    • Place the vaccines immediately in the designated refrigerator.
    • Review the order against the packing slip(s) to confirm that the order is correct. If an issue is identified, immediately notify the pharmacy wholesaler/distributor.
    • For Pfizer or Moderna deliveries shipped in the frozen state, return the Credo container and data logger back to the driver for future deliveries.
    • Enter inventory into COVaxON by creating a parent record of shipment that includes the specific lots and expiries of the vaccines received. Note: if a shipment includes multiple lots of vaccine, each lot must be entered in separately. The expiry date entered into COVaxON is the one provided by the manufacturer on the vial and not the pharmacy-use only expiry noted above based on storage conditions. (For pharmacies receiving vaccine supply from their local PHU directly rather than from pharmaceutical distributors, these deliveries are considered as transfers rather than new shipments; please refer to the COVaxON Inventory Management Job Aid for more information about how to accept a transfer.)
Storage & Handling
Steps for vaccine storage unit malfunction/electricity disruption during storage
  • Document the time and the maximum, minimum and current temperature of the vaccine storage unit in the Temperature Logbook and reset the maximum-minimum thermometer (if applicable)
  • Do not allow the vaccine to remain in a non-functioning unit for an extended period of time. (Factors including the amount of vaccine being stored in the unit, the external temperatures (e.g., summer vs. winter) and the type, model and age of the vaccine storage unit will affect the duration of time vaccines within the unit will be kept within the vaccine manufacturers specified temperature range.)
  • During a scheduled or a time-limited electricity disruption where the power is expected to be restored before the vaccine storage unit temperature rises above the recommended range, the facility should follow these steps:
        • Keep the storage unit door closed until the power is restored to maintain an acceptable temperature range for as long as possible; and
        • Record maximum, minimum and current temperatures:
              • Continue to monitor the temperatures inside the vaccine storage unit at 30-minute intervals if the digital temperature monitoring device allows digital temperature monitoring without opening the storage unit doors
              • If this is not possible, keep the door closed and immediately implement plans for transfer of the vaccine into a functioning unit (i.e., vaccine refrigerator unit)
  • If it is unknown whether the problem can be corrected in time to maintain an appropriate temperature, the facility should initiate its contingency plan by:
        • Transferring vaccines to an alternative storage facility (that is connected to a generator) by:
              • Contacting the local public health unit to notify them of the need to transport vaccine to a different location. The public health unit will notify the Ministry Emergency Operations Centre (MEOC). This alternative storage facility should be identified as part of local contingency plans prior to receipt of vaccine.
              • Conducting an inventory of vaccines while packing all vaccines, using portable unit and/or insulated containers with appropriate packing materials and digital temperature monitoring devices. Place in an insulated container for +2oC to +8oC temperature range, the vaccines should go back into a refrigerator.
        • Recording the time and insulated container temperature before transporting the vaccines to and upon arrival at the alternative storage facility
        • Continuing to read and record the maximum, minimum and current temperatures twice daily.
        • If an alternative storage facility cannot be identified within a reasonable timeframe, place the vaccine in insulated containers with appropriate packaging material and digital temperature monitoring devices and record the temperature at the facility by:
              • Labelling the insulated containers; and
              • Continuing to monitor the temperatures inside the insulated container at 30-minute intervals using a temperature monitoring device that allows temperature viewing without opening the insulated container (e.g., in/out thermometer).
Steps for when the vaccine storage unit malfunction has been corrected or the electricity supply has been restored
  • Document the following:
        • Maximum, minimum and current temperatures inside the vaccine storage units;
        • Length of time the power has been off; and
        • Time when the electricity supply is restored.
  • Maintain the vaccines in the storage unit or remove the vaccines from the insulated container. If removed, place them into the purpose-built vaccine storage unit and resume regular vaccine storage and handling practices, as long as the vaccine storage unit and insulated container maintain the required temperature range as specified by the vaccine manufacturer(s).
  • If the purpose-built vaccine storage unit is unable to maintain the required storage temperature range, maintain the vaccines in the assigned container and continue to monitor temperatures inside the container. Place the vaccine back into the purpose-built unit once it is able to maintain the temperature range as specified by the vaccine manufacturer(s) in the product monograph.
  • If the vaccine was not maintained in the correct range, temperature excursion has occurred; see the process below.
Steps for cold chain excursions
  • When using two or more temperature monitoring devices/systems, determine which will be designated as the primary device/system.
      • Record the maximum, minimum and current temperature and download any data from the storage unit or data logger and save as a PDF file.
      • Download the PDF file to a computer from the data logger.
      • Save this file using standardized file format naming, including the vaccine product, location and date.
  • In the event that two or more temperature monitoring devices/systems are used, do not average or round the temperature data points. When submitting temperature data, ensure that data from the primary device/system is identified.
  • Contact your local public health unit to report the excursion through your normal process. Public health units should have an established process in place to deal with temperature excursions after hours and on weekends to ensure that vaccine is not held in quarantine for an extended period of time.
      • Email or fax the public health unit the following:
            • The date, time, temperatures (maximum, minimum and current temperature) and the details on the excursion (e.g., length of time).
            • Attach the PDF file.
  • The public health unit will contact the vaccine manufacturer and initiate the Adverse Storage Conditions form with the facility.
  • The public health unit will notify the MEOC once the vaccine manufacturer has been contacted to alert the ministry of the cold chain incident.
  • Once recommendations from the manufacturer have been received, the public health unit will follow-up with the facility to provide recommendations, education and necessary remediation.
      • The public health unit will report the outcome via email to the MEOC using the following reporting format:
            • Subject: FPT Delivery Temp Excursion Report
            • Date of Incident
            • Vaccine Delivery Site (VDS) Location
            • Number of doses impacted
            • Manufacturer recommendations
            • Wastage (number of doses or indicate no wastage)
            • Impact on local vaccination efforts
  • The MEOC will notify the NOC to advise of the incident, resolution and any impact on provincial vaccination efforts.
  • The pharmacy storing the vaccine will mark vaccines involved in a temperature excursion incident that have been determined to be usable, in accordance with manufacturers’ recommendations and direction from the NOC/MEOC, in order to identify them in case of a future exposure(s).
  • Dispose of any unusable/wasted vaccines, as directed by the public health unit. Public health units are to ensure that any wastage is documented in the ministry specified information system.
  • Update COVaxON through the ‘Inventory’ tab to reflect doses wasted due to excursion and ensure accurate on-hand pharmacy inventory.

Inventory Management (returns and wastage)[2]

  • Ensure a process is in place to cycle vaccine inventory according to date of receipt and ensure that vaccine is used prior to the expiry date based on storage conditions and/or all doses from punctured vials are used within the appropriate timeframe.
    • Pfizer-BioNTech COVID-19 vaccine:
      • Unpunctured vials can be stored in the fridge between +2°C to +8°C for up to 31 days (minus any time the vaccine was in the container during delivery if shipped in the refrigerated state between +2°C to +8°C).
      • After dilution, vials can be stored between +2°C to +25°C and used within 6 hours from time of dilution. During storage, minimize exposure to room light and avoid exposure to direct sunlight and ultraviolet light.
    • Moderna COVID-19 vaccine:
      • Unpunctured vials can be stored in the fridge between +2°C to +8°C for up to 30 days (minus any time the vaccine was in the container during delivery if shipped in the refrigerated state between +2°C to +8°C).
      • Punctured vials can be stored between +2°C to +25°C and used within 24 hours from the time of first puncture. During storage, vials should be protected from light.
    • AstraZeneca/COVISHIELD COVID-19 vaccine:
      • Unpunctured vials can be stored in the fridge between +2°C to +8°C up until the expiration date on the vial label.
      • Punctured vials can be stored in the fridge between +2°C to +8°C for up to 48 hours or at room temperature (up to +30ºC) for up to 6 hours from time of first puncture. The vial can be re-refrigerated, but the cumulative storage time at room temperature must not exceed 6 hours, and the total cumulative storage time must not exceed 48 hours.
    • In the event pharmacies can draw an extra dose from a vial, inventory should be managed through COVaxON under the Inventory tab and entering the number of doses under the “Extra Doses from Vial” field to ensure accurate on-hand pharmacy inventory. Please refer to the COVaxON Inventory Management Job Aid included with the COVaxON training package for more information.
    • In the event a dose is wasted from a vial, inventory should be managed through COVaxON under the Inventory tab and selecting “Report Wastage” or enter the details under the “Wastage Events” section of the specific inventory’s page to reflect the wasted dose(s) and ensure accurate on-hand pharmacy inventory. Please refer to the COVaxON Inventory Management Job Aid included with the COVaxON training package for more information.
    • In the event of a cold chain excursion (‘Steps for Cold Chain Excursion’ above), inventory should be managed through COVaxON under the Inventory tab and entering the details under the “Excursion Events” section of the specific inventory’s page to ensure accurate on-hand pharmacy inventory. Please refer to the COVaxON Inventory Management Job Aid included with the COVaxON training package for more information.
    • Recalls for any vaccine lots will be communicated through Public Health Ontario, the Ministry of Health and/or public health units. Pharmacies must recall the vaccine within the COVaxON system to ensure accurate on-hand pharmacy inventory. Please refer to the COVaxON Inventory Management Job Aid included with the COVaxON training package for more information. Pharmacies will not be able to select recalled vaccine lots for administration on COVaxON. Upon receiving the recall notice, pharmacies should quarantine affected lots immediately and follow instructions for return. Pharmacies should also assess available on hand inventory and reconcile with appointment bookings to ensure more vaccine is ordered and/or appointments are rescheduled as necessary.
    • Pharmacies with concerns about on-hand vaccine that may not be administered before the expiry date should notify their corporate head office or OPA as soon as possible to discuss contingency options.

Operating Model [3]

Pharmacy Set-up

Steps to consider when preparing the pharmacy premises to accommodate an influx of patients getting immunizations while maintaining physical distancing and other infection control procedures:

  • Determine limit on the number of people who may enter the pharmacy (or immunization space) at the same time, based on pharmacy size, physical distancing requirements and jurisdictional legislation.
  • Minimize patient movement and contact via:
    • One-way traffic flow
    • Separate entrance and exit, if possible, and limited access points
    • Indicators on the ground to denote which direction patients should move and how far they should stay apart
    • Tables or other distance barriers to add distance between patients
  • Determine required functional areas for service delivery (“stations”) and plan space allocations.
  • Separate stations 6 feet/2 metres apart where possible or separate stations/spaces by plastic sheeting barriers or plexiglass barriers. Note: separate rooms for different functions are ideal but likely not possible in many pharmacies. For all stations, consider:
    • Positioning hand sanitizers at key stations
    • Ensuring all surfaces that patients may come in contact with (e.g., chairs) can be easily cleaned
    • Ensuring adequate air flow or ventilation in all patient areas
    • Ensuring access to sufficient amounts of cleaning/disinfection products
  • Maximize ventilation by ensuring that heating, ventilation and air conditioning (HVAC) systems are in good working order. Drawing as much fresh air as possible from outside will decrease the concentration of aerosols that may be suspended in the air and reduce the chances of SARS-CoV-2 spread if those aerosols happen to contain the virus. If the weather and facilities permit, open a window.
Human Resources
  • Ensure there are enough staff to assist with workflow (refer to workflow considerations below) while still maintaining normal pharmacy services. This may require having more staff on shift.
  • Consider utilizing all pharmacy professionals (pharmacists, interns, students, technicians) with scope to administer vaccinations.
  • Where possible, designate staff to specific tasks for the duration of their shift. Consider dividing pharmacy staff into separate teams to prevent overlapping shifts.
  • When scheduling shifts and appointments/sessions, ensure the duration accounts for breaks for the team member. Consider having your designated immunizer work for no more than 4 hours before a break.
  • Ensure staff members are trained on your pharmacy’s immunization protocols, injection-related policies, appropriate PPE use, hand hygiene, and infection prevention and control procedures.
  • Before each shift, screen staff members for COVID-19 symptoms or potential exposure to COVID-19. Staff who screen positive should not be working in the pharmacy.
  • Continue to implement other pandemic sanitary measures as specified by public health and/or the provincial pharmacy college.
  • Instruct your staff on what to do if a patient screens positive at any time during the service. This may include:
    • Not performing the service
    • Collecting the patient’s name, phone number and date/time at the pharmacy (if the information has not already been obtained) in the event it is required for public health contact tracing
    • Instructing the patient to return home and call their local public health unit for more guidance
    • Wearing appropriate PPE and cleaning areas and surfaces touched by the patient
  • Consider strategies for managing patient situations that may create COVID-19 infection risks (e.g., a crying or thrashing child)
  • Pharmacy staff should be prepared to answer any patient questions about COVID-19 or direct them to the appropriate individual within the pharmacy team who can answer them.
  • All pharmacies should have a contingency plan in place to address potential staff shortages. Considerations include:
        • Maintain a list of available pharmacy personnel who can fill in for absences
        • Connect with nearby pharmacies to share staff resources if possible
        • Contact information for relief pharmacist groups or applications
Throughput
  • Estimated time per patient from when they come in the pharmacy door to leaving the pharmacy after check-out: approximately 30 minutes
  • Minimum average number of injections per day: 40 injections/pharmacy/day

Technology and Reporting

Hardware
  • Pharmacies are already equipped with computers, internet connections, etc. and have standard operating procedures in place for what to do in case of a power outage/system downtime (e.g., who to contact for IT support).
  • Specifically, with respect to COVID-19 vaccine administration, contingency plans should include processes such as:
    • For pharmacies with electronic booking systems:
      • Regularly print a copy of the list of vaccine appointments the day before (this list should only be used in situations where the electronic booking system is down, otherwise the system should always be consulted for the most up to date appointment information).
      • Create a list of patients who need to be contacted when systems resume to schedule second vaccine dose appointments.
    • All patients complete the paper version of the COVID-19 Vaccine Screening and Consent Form (pharmacies may wish to adapt from the Ministry’s COVID-19 Vaccine Screening Form and the COVID-19 Vaccine Consent Form) and/or if applicable, the COVID-19 Vaccine Information for Individuals that received a first dose of the AstraZeneca COVID-19 vaccine/COVISHIELD vaccine and a youth-specific COVID-19 Vaccine Screening and Consent Form (pharmacies may wish to adapt from the Ministry’s COVID-19 Vaccine Screening Form and the Youth (Age 12-17) Consent Form). The pharmacist documents on these forms (as per workflow considerations) which contains all the information to be entered into COVaxON and the pharmacy system when system operations resume.
      • Document management of any AEFIs as well as medications used to be reported to local public health units when systems resume.
      • Reconcile vaccine inventory when system resumes (e.g., with deliveries, administered doses, wastage, etc.)
COVaxON
  • All pharmacy staff involved with COVID-19 vaccine administration (i.e., pharmacists, interns, pharmacy students, technicians, assistants) will need to be trained on, registered for, and use COVaxON.
  • All information required to be entered into COVaxON will be completed as per the pharmacy workflow described below.
  • Pharmacies will have a contingency plan in place in case of COVaxON system downtime which includes:
Scheduling
  • Scheduling of appointments will be completed either over the phone with the pharmacy directly or using the pharmacy’s booking platform (process is as described in the workflow below). Factors to consider when deciding on appointment times for COVID-19 vaccinations include, but are not limited to:
    • offering evenings and weekend appointment times
    • Expanded hours
    • Availability of staff to handle the extra workload
    • Capacity to administer a minimum average of 40 injections/day
  • Ensure appointments are booked to facilitate administering of all doses in a vial within a specified time frame based on manufacturer recommendations to prevent wastage (may need to recruit additional or reschedule existing appointments).
  • Pfizer-BioNTech COVID-19 vaccine:
    • Multiples of 6 within 6 hours of dilution.
    • All vials to be used within 31 days of receipt by the pharmacy (minus any time the vaccine was in the container during delivery if shipped in the refrigerated state between +2°C to +8°C).
  • Moderna COVID-19 vaccine:
    • Multiples of 10 within 24 hours from the time of first puncture
    • All vials to be used within 30 days of receipt by the pharmacy (minus any time the vaccine was in the container during delivery if shipped in the refrigerated state between +2°C to +8°C).
  • AstraZeneca/COVISHIELD COVID-19 vaccine:
    • Multiples of 10 within 48 hours (if stored between +2°C to +8°C) or within 6 hours (if stored at room temperature up to +30ºC) from the time of first puncture.
    • All vials must be used before the expiration date on the vial label.
    • In addition, when deciding appointment times, ensure that the total number of available time slots for each day are in multiples of the number of doses in a vaccine vial (e.g., for Pfizer, total appointments offered could be 42 (7 vials x 6 doses/vial) but not 40 appointments since the last 2 doses in the opened vial would then be wasted).
    • Review the appointment list a few days in advance. Contact patients to reschedule their appointments if possible, to ensure administration of all doses in a vial within the specified manufacturer’s recommended timeframe based on time of first puncture and/or storage conditions.
  • Cancelled appointments/no-shows – how to schedule someone in last minute:
    • Establish a wait list and/or standby list so that patients can be contacted in the event of cancellations/no-shows and an appointment becomes available.
    • When booking appointments, ask patients if they want to be contacted for an earlier appointment if available.
    • As a last resort, if a vial has leftover doses and there are no patients who fit the targeted eligibility criteria that these doses can be administered to before these doses are set to expire, pharmacies should try to administer to any individual, if medically appropriate, even if they are not the current targeted population to avoid vaccine wastage. In this situation consideration should also be given to other factors such as the:
    • Second dose appointments should be scheduled at the same time as booking for first doses or before the patient leaves the pharmacy after receipt of their first dose (refer to workflow considerations below). For more information about when to schedule patients for their second doses, please refer to OPA’s Supplementary Frequently Asked Questions on the Administration of Publicly Funded COVID-19 Vaccines in Ontario Pharmacies.
Client Support Services
  • Pharmacy staff can assist with making appointments over the phone and for those who have trouble/do not want to use the pharmacy’s online booking system if applicable.
  • Pharmacists, as well as interns/students under the direct supervision of a pharmacist, can provide counselling and information on COVID-19, the vaccine, address vaccine hesitancy, explain eligibility criteria for the vaccine, etc.
  • Follow-up calls and/or text and email reminders can be sent to patients to remind them of their appointments.

Clinical Guidance, Emergency Management, Security

IPAC Measures [4]
  • Perform routine environmental cleaning, especially in frequently visited areas (e.g., waiting area, registration area, door handles, washrooms) and on high-touch surfaces at least twice a day
  • Clean equipment shared with multiple people (e.g., pens, clipboards, chairs, tablet if digital information and consent performed) after each use
  • Station hand sanitizers at main areas of the pharmacy, including the entrance, exit, registration area, immunization area, waiting room and other areas of patient contact
  • Clean hands using alcohol-based hand sanitizer containing 60–90% alcohol; alternatively, wash with soap and water for at least 20 seconds
  • Clean and disinfect immunization area (e.g., chairs, table, door handles) after each patient immunization
  • Use sanitation verification logs to ensure areas are cleaned regularly
Personal Protective Equipment (PPE) Requirements [5]
  • PPE needs for all activities related to the delivery of immunizations in the pharmacy should be evaluated using a point-of-care risk assessment approach and based on public health guidance.
  • Remember to ensure a well-ventilated area in the immunization space and avoid overcrowding to minimize airborne transmission of COVID-19.
  • For immunization services provided to asymptomatic patients where staff will be within 6 feet/2 metres of the patient, without a barrier between them, the following PPE measures are suggested:
    • Consider sessional use for eye protection, masks and gowns (if worn). A session is defined as a period of time where a health care worker is undertaking duties in a specific setting or exposure environment, such as a 4-hour shift as designated vaccinator. A session ends when the worker leaves the environment
    • Wear eye protection (face shield or goggles) for duration of session; disinfect or dispose of after each session
    • Wear surgical/procedural mask for duration of session; replace sooner if it becomes damp, soiled or damaged
    • Gowns may not be required. Consider gowns in instances where vaccinator will be required to manage large numbers of patients; dispose or disinfect at the end of each session; in situations where gowns are not required, some pharmacists may choose to wear scrubs for the session
    • Gloves are usually not required for injectable vaccines except in certain cases such as skin not intact. Depending on their own specific point-of-care risk assessment, some pharmacists may also choose to wear gloves; if worn, they must be replaced after each immunization (sessional use or use of hand sanitizer or bleach solution on gloves for repeated use are not recommended) and proper hand hygiene is still required.
  • Follow all other donning, doffing and hand hygiene best practices.
Emergency Management
  • Although very rare, adverse reactions and anaphylaxis can occur following immunization and must be managed quickly and appropriately.
  • All injection-trained pharmacists/interns/students are required by the Ontario College of Pharmacists (OCP) to have successfully completed an injection training course approved by OCP and maintain valid certification in CPR and First Aid equivalent to St. John Ambulance or Red Cross Standard First Aid & CPR/AED Level C.
  • As part of this training, pharmacy professionals are equipped with the knowledge on how to manage adverse reactions and anaphylaxis.
  • The pharmacy should have a first aid kit and anaphylaxis management kit available and easily accessible.
  • Protocols must be in place for maintenance of kits including verifying that all the supplies are still present and none of the medications have expired (epinephrine auto-injectors can have short shelf lives). 
  • Each pharmacy should have a protocol on how to manage adverse reactions and anaphylaxis. Refer to the Anaphylaxis and other Acute Reactions following Vaccination: Canadian Immunization Guide for emergency protocols.
  • Pharmacists are required to document all adverse events following immunization (AEFIs) including any actions that were taken to manage the event and any medications administered. This information should be filed along with the patient’s vaccine administration record. In addition, all AEFIs are required to be reported to the local public health unit by completing the AEFI reporting form. For more information, consult the AEFI Reporting Fact Sheet.
Security
  • Pharmacies are encouraged to develop their own protocols addressing safety concerns, such as how to prevent robberies and what to do when a robbery occurs.
  • Many pharmacies already have policies and procedures in place for narcotics and controlled substances which can be used or adapted in this situation.
  • Vaccines are to be stored in refrigerators that are inaccessible to the public.
  • The OPA has developed additional information available on request to members to help supplement that information if required that address:
    • Prevention tips
    • Security measures
    • What to do in the event of a robbery

Workflow Considerations

Actions at the PharmacyActions by Patient

Pre-Scheduling

  • Can be done by pharmacy dispensary staff
  1. Pharmacy is on-boarded for live roll-out and all relevant program information (including addressing all operational considerations) is provided.
  2. All participating staff are trained on all elements of the program, including use and registration for COVaxON.
  3. Pharmacy places orders for vaccine when available (done in parallel with scheduling step below to determine amounts to order).
  4. Vaccine delivery arrives at the pharmacy
  5. Receive vaccine (inspect, document date/time of receipt, acknowledge receipt, document time remaining based on storage conditions (if applicable), unpack and transfer to dedicated fridge for storage, review order against packing slip, enter inventory into COVaxON including lots and expiries). Refer to the TempTale Credo Instructions document for information about unpacking Pfizer-BioNTech and Moderna vaccines if delivered in the frozen state.
 

Scheduling/Appointment Booking

  • Can be done by pharmacy dispensary staff
  1. Recruit eligible patients (e.g., contacting patients who meet the eligibility criteria based on pharmacy records, offering vaccination to eligible patients visiting the pharmacy, posting signage with eligibility criteria, etc.), educate on the vaccine, address vaccine hesitancy, etc. and encourage patients to book appointment to get vaccine.
  2. Screen all patients for eligibility to receive vaccine (eligibility criteria as defined by the province and/or public health units, and if possible medical screening to evaluate appropriateness for patient to receive vaccine) before booking the appointment if applicable.
  3. Review the appointment list a few days in advance to ensure appointments are booked to facilitate administration of all doses in a vial within a specified time frame based on manufacturer recommendations to prevent wastage (see Scheduling considerations above) and reschedule as necessary.
  4. Contact patients a few days in advance to confirm the appointment. Ensure patient has not received a vaccine elsewhere or booked another appointment elsewhere.
  1. Eligibility determined by Ministry/PHUs and priority groups are notified by PHUs on how to book an appointment (option for mass vaccination clinic or participating pharmacy).
  2. Patient calls pharmacy to book an appointment or accesses pharmacy’s booking platform; if possible, pharmacies to include on the booking platform the applicable forms: COVID-19 Vaccine Information Sheet; the What you need to know about your COVID-19 vaccine appointment document including any instructions specific to the pharmacy; the COVID-19 Vaccine Screening and Consent Form (pharmacies may wish to adapt from the Ministry’s COVID-19 Vaccine Screening Form and the COVID-19 Vaccine Consent Form); the COVID-19 Vaccine Information for Individuals that received a first dose of the AstraZeneca COVID-19 vaccine/COVISHIELD vaccine; and for youths: COVID-19 Vaccine Information Sheet: For Youth (age 12-17), the What Youth Need to Know About their Appointment document including any instructions specific to the pharmacy, and COVID-19 Vaccine Screening and Consent Form (pharmacies may wish to adapt from the Ministry’s COVID-19 Vaccine Screening Form and the Youth (Age 12-17) Consent Form).

Registration/Check-in

  • Can be done by pharmacy dispensary staff; may wish to include ushers at the door (e.g., front store staff to direct traffic, manage capacity levels inside the store, retrieve patients for Vaccine Administration step)
  • Occurs at the dispensary counter; patient should be directed to a dedicated waiting area (in the pharmacy, outside of the pharmacy, patient’s car) as required
  1. Verify patient ID and check appointment list to confirm patient has an appointment.
  2. Conduct active screening of the patient for COVID-19.
    • If patient screens positive, inform them that they cannot receive a COVID-19 vaccination today. Advise them to return home and contact their local public health unit or Telehealth Ontario for further direction. Pharmacy professionals must also contact the local public health unit to report the probable case and follow IPAC procedures for the pharmacy.
    • If patient screens negative, proceed with the steps below.
  3. Check to see if the patient has a file in the Pharmacy software, if not, create the file and ensure completeness to allow for claim submission through HNS post-administration of vaccine.
  4. Find patient’s profile in COVaxON by searching with their OHIP number (for those with no OHIP number and/or no file in COVaxON, create a new profile). Update client record on COVaxON (e.g., patient’s contact information such as phone number or email) if needed.
  5. Optional: sociodemographic data can be captured as part of the registration process provided the patient consents to this.
  6. Complete Check-in for patient using COVaxON (obtain consent for data collection, consent to receive follow-up communications, consent to be contacted for research and enter in priority group – i.e., reason for immunization). Launch the ‘simplified flow’ process at this step if it is the same person to check a patient in, administer the vaccine, and check a patient out. Note that if the simplified flow is closed before finishing the check-out, the regular process must be used to complete the check-out and ensure vaccine administration is recorded properly in the system
  7. As part of the check-in process, the COVID-19 Vaccine Screening and Consent Form must be completed (i.e., prompt for ‘COVID-19 assessment’ within the Check-in tab):
    • Collect completed form from patient if applicable.
    • If completed using the pharmacy booking system, print out form and provide to immunizer.
    • If not completed yet, provide form to patient to complete while waiting for their turn.
  8. Direct patient to waiting area. Provide copies of the COVID-19 Vaccine Information Sheet and the What you need to know about your COVID-19 vaccine appointment (or for youth: COVID-19 Vaccine Information Sheet: For Youth (age 12-17) and the What Youth Need to Know About their Appointment) documents including any instructions specific to the pharmacy, if not already previously provided.
  9. Call patient for administration when the vaccinator is ready to proceed.
  1. Patient comes to the pharmacy at the appointment time – passive screening at the door.
  2. Notifies pharmacy staff of arrival.

Eligibility Screening/Medical Screening/Vaccine Administration

  • To be done by a dedicated pharmacist or pharmacy technicians/interns/pharmacy students under direct supervision of a pharmacist
  • Occurs in the counselling room or a private defined area of the pharmacy
  1. Beginning of shift – don PPE.
  2. Ensure Pfizer-BioNTech and Moderna COVID-19 vaccines are thawed prior to use.
  3. Let each vial stand at room temperature for the specified amount of time as per the product monograph if required before administering.
    • For Pfizer-BioNTech only: dilute each vial as required following the instructions outlined in the product monograph. (Note: vials must reach room temperature before dilution and must be diluted within 2 hours of exposure to room temperature.) Label vial with date and time of dilution. For tips about reconstituting the vaccine and withdrawing the 6th dose, please refer to the following information sheet.
 
  1. Pull up patient profile and verify patient identity
  2. Administration – click on the “Administer Dose” tab in COVaxON:
    • Select vaccine.
    • Ask patient the vaccine assessment questions or review these if pre-completed by the patient.
    • Provide information and answer patient questions about the vaccine.
    • Obtain informed consent which includes but is not limited to a discussion about the current vaccine options, information about possible adverse effects such as the very rare risk of myocarditis and/or pericarditis following immunization with an mRNA vaccine, confirmation that the patient understands which vaccine product they are receiving, the timing of future vaccine options and that the patient understands the risks of delaying the second dose if applicable.
    • Complete information requested (route, dose, site, date, time, reason for administration, location, immunizer) and review the summary screen.
    • Perform hand hygiene and prepare dose using aseptic technique. (Note: For new vials, label vial after first puncture with date and time. For used vials, check the date/time of first puncture on the vial to ensure the vaccine has not expired. Vials must be used within 6 hours from dilution for Pfizer; 24 hours from first puncture for Moderna; and 48 hours from first puncture for AstraZeneca/COVISHIELD vaccine if stored in a refrigerator or 6 hours if stored at room temperature).
    • Administer injection, perform hand hygiene and dispose sharps and waste.
  3. Direct patient to observation area
  4. Documentation
    • Document the immunization information (route, dose, site, date, time, reason for administration, location, reason for immunization, immunizer) on the COVID-19 Vaccine Screening and Consent Form to be scanned and uploaded into the patient file on the pharmacy software (see Step #29).
    • Confirm dose administered in COVaxON by clicking the “Next” button on the summary screen.
  5. Disinfect all patient-contact surfaces (e.g., chairs, door handles, tables) after each administration.
  6. Doff and/or change PPE.
    • If gloves are worn, change between immunizations and perform hand hygiene before putting on a new pair.
    • Other PPEs (such as mask, eye protection) can be changed after each session or when visibly soiled.
  1. Patient enters counselling room (or whichever designated room is being used for COVID-19 vaccination)

Post-Vaccine Observation/Check-out/2nd Dose Scheduling (if required)

  • Can be done by pharmacy dispensary staff, may require pharmacist/intern/pharmacy student if required to manage any AEFI
  1. Check out patient:
    • Ask if patient experienced any AEFIs and manage appropriately (document first aid administered as well as any medications used if applicable)
    • Record presence of any AEFIs in COVaxON. All AEFIs must be reported to the local public health unit by completing the AEFI Reporting Form. Consult the AEFI Reporting Fact Sheet for more information.
    • Provide a written and electronic (if applicable) record of the COVID-19 immunization to the patient, which includes the pharmacy’s contact information. (Note: a written receipt can be printed from COVaxON but it does not contain all the required information.)
    • For a patient receiving their first dose, book the second appointment using the pharmacy’s booking system (if not done so already) and provide the patient with the date/time (i.e., added to the bottom of the proof of immunization from COVaxON if providing a print-out; added to the separate written record of immunization provided to the patient along with the COVaxON proof of immunization).
    • Provide the patient with information on how they can reach the pharmacy should there be a need to reschedule as well as potential situations that may require the pharmacy to reschedule such as issues with vaccine supply.
  1. Self-directed check-out time
    • Wait in the post-immunization monitoring area (usually 15 minutes).
  2. Notify staff of end of monitoring period and report to the immunizer any AEFI.

Administrative Tasks

  • Can be done by pharmacy dispensary staff
  1. Submit claim for administration of vaccine through the HNS on the same day as the administration. Scan the COVID-19 Vaccine Screening and Consent Form and attach this file to the claim to support any audit requirements.
  2. End of the day:
    • Reconcile to make sure the number of HNS claims processed matches the number of patient administration information entry on COVaxON
    • Reconcile COVaxON inventory to on hand quantities (account for wastage, extra doses from vaccine vials, etc.).
    • Check PPE supply inventory and order supplies from the Ontario government stockpile to replenish, as necessary.
    • Check ancillary supply inventory and ensure 1:1 vaccine to supplies ratio (contact pharmacy distributor if there are any issues).
  3. Maintain temperature log for dedicated vaccine fridge to ensure appropriate cold chain management. Submit temperature logs to the local PHU as required.
  4. Follow-up with the patient prior to the second dose appointment to confirm booking. If the patient wants to change their appointment, check on COVaxON that the new appointment time is appropriate based on the interval required between the two doses, the appropriate vaccine product is available at the pharmacy and that the patient is eligible for a second dose as per provincial guidance before updating on the pharmacy booking system.
 

Summary of updates:

Version 1.0: March 7, 2021

Description of Revisions: Document created

Version 2.0: March 30, 2021

Updated Sections: 

Section 2: Operational Considerations

  • Operating Model
  • Technology and Reporting

Section 3: Workflow Considerations:

  • Scheduling/Appointment Booking
  • Registration/Check-in
  • Eligibility Screening/Medical
  • Screening/Vaccine Administration
  • Post-vaccine Observation/Check-out/Second Dose Booking
  • Administrative Tasks

Description of Revisions:

Updated information on minimum average number of injections per day; new instructions to contact the Pharmacy IT department for COVaxON support; multiple sections updated with new links to resources including pharmacy signage, Pre-Screening Assessment Tool for Health Care Providers, COVID-19 Vaccine Consent Form, COVID-19 Vaccine Information Sheet, What you need to know about your COVID-19 vaccine appointment and After Your COVID-19 Vaccine fact sheet; updated instructions for the check-out and administrative tasks sections of the workflow

Version 3.0: April 20, 2021

Updated Sections: 

Section 1: Introduction

  • Assumptions

Section 2: Operational Considerations

  • Vaccine Supply and Inventory Management
  • Technology and Reporting

Section 3: Workflow Considerations:

  • Scheduling/Appointment Booking
  • Eligibility Screening/Medical Screening/Vaccine Administration
  • Post-vaccine Observation/Check-out/Second Dose Booking

Description of Revisions:

Updated throughout to include information on Pfizer-BioNTech and Moderna COVID-19 vaccines; updated information on how to manage inventory through COVaxON; additional workflow steps included to assist with scheduling/appointment booking; updated requirements with respect to booking of second dose appointments

Version 4.0: April 29, 2021

Updated Sections: 

Section 1: Introduction

  • Assumptions

Section 2: Operational Considerations

  • Vaccine Supply and Inventory Management

Section 3: Workflow Considerations

  • Pre-Scheduling
  • Eligibility Screening/Medical Screening/Vaccine Administration

Description of Revisions:

Updated throughout based on information that Pfizer-BioNTech and Moderna vaccines will be shipped to pharmacies in the frozen state

Version 5.0: May 3, 2021

Updated Sections: 

Section 1: Introduction

  • Assumptions

Section 2: Operational Considerations

  • Vaccine Supply and Inventory Management
  • Technology and Reporting

Section 3: Workflow Considerations

  • Pre-Scheduling

Description of Revisions:

Updated throughout to include information about Pfizer-BioNTech and Moderna vaccines if shipped to pharmacies in the refrigerated or frozen states

Version 6.0:  June 3, 2021

Updated Sections: 

Section 1: Introduction

  • Assumptions

Section 2: Operational Considerations

  • Vaccine Supply and Inventory Management
  • Technology and Reporting

Section 3: Workflow Considerations

  • Scheduling/Appointment Booking
  • Registration/Check-in
  • Eligibility Screening/Medical Screening/Vaccine Administration
  • Administrative Tasks

Description of Revisions:

Updated throughout to include the revised handling and storage information for Pfizer-BioNTech and Moderna vaccines; included information about receiving transfers of vaccine supplies from public health units; added new Ministry vaccination forms; updated information on considerations for the contingency plan for leftover doses; included additional considerations for second dose appointment bookings

Version 7.0:  June 10, 2021

Updated Sections: 

Section 1: Introduction

  • Assumptions

Section 2: Operational Considerations

  • Vaccine Supply and Inventory Management

Section 3: Workflow Considerations

  • Registration/Check-in

 

Description of Revisions:

Updated information referring to the Ministry’s COVID-19 Vaccine Storage and Handling Guidance which now aligns with the Pfizer-BioNTech product monograph; addition of shipping information for vaccine orders from McKesson Canada; inclusion of link to information about selecting the appropriate reason for immunization in COVaxON

Version 8.0:  June 23, 2021

Updated Sections: 

Section 1: Introduction

  • Assumptions

Section 2: Operational Considerations

  • Vaccine Supply and Inventory Management
  • Technology and Reporting

Section 3: Workflow Considerations

  • Scheduling/Appointment Booking
  • Registration/Check-in
  • Eligibility Screening/Medical Screening/Vaccine Administration

Description of Revisions:

Updated throughout to include the revised storage information for Moderna COVID-19 vaccine; included new references to provincial guidance on the acceleration of second doses; updated links to vaccine information sheets; provided examples of topics to discuss when obtaining informed consent

Version 9.0:  July 8, 2021

Updated Sections: 

Section 1: Introduction

  • Assumptions

Section 2: Operational Considerations

  • Technology and Reporting

Section 3: Workflow Considerations

  • Eligibility Screening/Medical Screening/Vaccine Administration 

 

Description of Revisions:

Removal of the assumption for storage and handling guidance for Moderna as all Ministry documents have been updated to reflect the information provided in the product monograph; edited references for contingency planning to reflect current provincial guidance; inclusion of the NACI recommendation that informed consent for people receiving an mRNA vaccine should include a discussion about the very rare risk of myocarditis and/or pericarditis following immunization

[1] Ministry of Health’s COVID-19 Vaccine Storage and Handling Guidance Version 6.1

[2] COVaxON Inventory Management Job Aid. Accessed on April 6, 2021.

[3] CPhA’s Suggested Best Practices for Community Pharmacy Providing Influenza Immunizations During the COVID-19 Pandemic

[4] CPhA’s Suggested Best Practices for Community Pharmacy Providing Influenza Immunizations During the COVID-19 Pandemic

[5] CPhA’s Suggested Best Practices for Community Pharmacy Providing Influenza Immunizations During the COVID-19 Pandemic