COVID-19 Immunization Guide for B.C. Pharmacies

COVID-19 Immunization Guide for B.C. Pharmacies

Updated: April 21, 2021 7:36 p.m. PDT

This guidance is co-developed with the British Columbia Ministry of Health

Please check this web page frequently, as information is constantly evolving and changing.

Table of Contents

• Training and Education
• AstraZeneca COVID-19/COVISHIELD vaccine product information
  • U.S.-labelled AstraZeneca COVID-19 Vaccine
• Dose 2
• Vaccine Expiry Date
  • Expiration dates for U.S. labelled batches/lots
• Distribution of Vaccine and Supplies
• Vaccine Storage
• Reporting Cold Chain Incidents
• Scheduling of Appointments
• Vaccine Eligibility Screening and Verification of Eligibility
• Informed consent
• Post-immunization monitoring and aftercare
• PharmaNet Data Entry and PINs
• Inventory Management
• Reporting Adverse Events Following Immunization (AEFI)
• Registering for CareConnect and Provincial Immunization Registry (PIR)
• Reporting of Vaccine Sub-numbered-dose Withdrawal Concerns
• More Resources

• To provide COVID-19 vaccines, B.C. pharmacists must be certified as per the College of Pharmacists of BC’s drug administration requirements.
• Pharmacists are encouraged to complete BCCDC COVID-19 immunization webinars, which provides a foundation of knowledge for the delivery of safe and effective COVID-19 vaccines. 
• The BCCDC has developed further resources for health professionals on COVID-19 vaccines.

Community Pharmacy Standards of Practice

• Pharmacists providing immunizations must follow the College’s Standards, Limits and Condition for Drug Administration by Injection and Intranasal Route.
• Pharmacists must follow the Community Pharmacy Standards of Practice.
  • Patient counselling
    • If a drug-related problem is identified during pharmacist/patient consultation, the pharmacist must take appropriate action to resolve the problem.
    • At a minimum, the pharmacist must confirm that the right patient is getting the right drug /strength and must also provide a direct opportunity for the patient to ask questions.
  • Reviewing PharmaNet*
    • A pharmacist must review the patient’s personal health information stored on the PharmaNet database before dispensing a drug and take appropriate action if necessary with respect to, but not limited to, appropriateness of drug therapy, drug interactions, allergies, adverse drug reactions, and therapeutic duplication.
  • Performing a final check
    • A pharmacist must review the prescription label to ensure it is consistent with the prescription and/or hardcopy.
    • Always check the expiry date of the product before providing the vaccine. Rotate vaccines according to expiry date (place those with the longest expiry date at the back)

* If COVID-19 vaccine dose is not on PharmaNet, check CareConnect

• COVID-19 vaccine: AstraZeneca COVID-19 Vaccine/ COVISHIELD (ChAdOx1-S [recombinant])  
• Storage temperature: Kept in refrigerated (2-8°C) until ready to be used. Do NOT freeze.

For COVID-19 vaccine product details, refer to BC Immunization Manual Part-4 Biological Products, which includes information on doses and schedule, administration procedures, storage and handling, dilution requirements, contra-indications, precautions, special considerations, and adverse events.

U.S.-labelled AstraZeneca COVID-19 Vaccine

See Health Canada notice regarding U.S.-labelled vaccine supplies of AstraZeneca COVID-19 Vaccines.

As per BCCDC product details, the two ChAdOx1-S vaccines (AstraZeneca COVID-19 Vaccine / COVISHIELD) are interchangeable within the vaccine series. However, they are NOT interchangeable with other COVID-19 vaccines (e.g., mRNA vaccines).  Therefore, if a patient has had a Pfizer or Moderna (COVID-19 mRNA) vaccine for Dose 1, do NOT give the AstraZeneca COVID-19 vaccine/COVISHIELD for Dose 2. 

U.S. labelled AstraZeneca COVID-19 Vaccine: As per Health Canada notice (March 31, 2021), AstraZeneca is providing US-labelled vaccine supplies with English-only vial and carton labels in order to expedite the distribution of AstraZeneca COVID-19 Vaccine in Canada. Two key points:

1. The expiration date is not printed on the US vial and carton labels. Pharmacists must verify the expiration date prior to vaccination. The expiration date for the corresponding batch/lots can be found in the “Product affected” section of this document, by going to www.AZCOVID-19.com, or by scanning the QR code on the US English-only carton label

Expiration dates for U.S. labelled batches/lots

2. There is no DIN on the packaging, it is the U.S. NDC Code.

• PharmaCare has activated the AstraZeneca COVID-19 Vaccine PIN (66127320) which applies to both 8-dose and 10-dose vials. Please see publicly funded vaccines and COVID-19 vaccine PINs for submission to PharmaNet below

Expiry Date Interpretation

As per BCCDC, the expiry date on vaccines should be interpreted as follows:

• When specified as month/year, product expires on the last day of the month and may continue to be administered until the end of the month (e.g., expiry of January 2021 means January 31, 2021, and may be used until 11:59 pm in the local time zone)
• When specified as a day/month/year, product expires at the end of the day of expiry i.e., may be administered up until the last minute of the labelled expiry day, within the time zone of use (e.g., product expiring on April 2, 2021, may be used until 11:59 pm on April 2, in the time zone).

What to do with Expired Product

• Remove expired vaccines from the refrigerator. 
• Ensure expired stock is clearly labelled/marked not to be used.
• Quarantine the clearly labelled/marked expired stock.
• Do NOT discard unusable expired vaccine doses in your pharmacy. More information to follow from BCCDC on the process for returning vaccines.

COVID-19 vaccines (AstraZeneca and COVISHIELD) are shipped to the major wholesaler distribution centres in B.C., which will directly ship a pre-determined allocation of doses to each selected pharmacy site. Vaccine supplies and personal protective equipment (PPE) will also be provided along with the vaccines and are available at no cost through the Provincial Health Services Authority (PHSA) supply chain.

The following vaccine and supplies will be delivered directly to your pharmacy:

*Supplies list may change depending on vaccine.

• Pharmacies are to adhere to the College of Pharmacists of BC’s Professional Practice Policy – 68: Cold Chain Management of Biologicals.
• Cold chain management principles and procedures are outlined in BC Immunization Manual Appendix E—Management of Biologicals.
• BCCDC guidelines outlines how to deal with refrigerator temperature excursions, equipment malfunctions and power failures.

1. If a temperature excursion occurs when vaccine has been received at your pharmacy, notify IBCOC_Operations@phsa.ca as soon as possible. Call 1-250-686-6061, if after hours.
2. Pharmacy sites must notify Public Health, which implements regular provincial reporting process as per section 5.3 Algorithm 1 in BCCDC Communicable Disease Control Manual Chapter 2: Immunization Appendix E – Management of Biologicals.
   • If the manufacturer must be consulted, call. If the incident is after hours (04:30-14:30 PST, M-F), email the manufacturer instead of calling and copy in the National Operations Centre (NOC): PHAC.vaccine.NOC-CNO.vaccin.ASPC@canada.ca; Robert.walsworth@canada.ca
3. Within 24 hours, the incident must be resolved, and a report submitted to IBCOC_Operations@phsa.ca with the following information:
   • Date of incident,
   • Location of incident,
   • Situation surrounding incident,
     1. Excursion temperature(s) and duration(s)
     2. Lot number, expiry
     3. Detail description of event
     4. Number of affected doses
     5. Impact on vaccination program.
4. The Immunize BC Operations Centre will be responsible to report the incident to the National Operations Centre (NOC).

• Pharmacies are responsible for booking immunization appointments (online and telephone). Consider options for walk-ins.
• Pharmacies will be informed of the number of doses they will receive. This will help with scheduling appointments according to available supply.
• If your pharmacy does not have an online booking system, but is interested in one, the BCPhA offers an online booking platform. More information can be found here. 

• Vaccines distributed to pharmacies in April 2021 are to be administered to individuals 40 years of age and older. DOSE 1 only.

  • As per BC Immunization Manual Part 4 – Biological Products, AstraZeneca/ COVISHIELD vaccine is indicated for individuals 40 years and older.

  • Although the vaccines are authorized for those 18 years of age and older, due to a safety signal identified in Europe following use of the AstraZeneca vaccine, the Provincial Health Officer has recommended that neither of the vaccines be used in people under 40 years of age.
  • Health Canada has updated the product monographs for both products to include information about observed events of thromboembolic/ thrombocytopenia, as these vaccines are comparable.
  • The minimum age for vaccine receipt is based on year of birth (i.e., the vaccine may be offered to individuals who will be turning 40 years of age within the current calendar year), per BC Government recommendations.
• See BCCDC Monitoring vaccine uptake, safety and effectiveness.
• Review/provide FAQ to patients with questions and concerns about the AstraZeneca/COVISHELD vaccines.
• Pharmacies must review patient identification (ID) and ensure ID matches the patient profile in PharmaNet.
  • See CPBC’s professional practice policy – 54 when identifying patients, and verify age through government issued ID (e.g., driver’s license, passport, BC Services card etc.).
  • As per Community Pharmacy Standards, Limits and Conditions for Drug Administration, pharmacists must assess the appropriateness of the vaccine for the patient, including reviewing the patient’s PharmaNet profile and resolve any issues identified, if required, in advance of providing the vaccination. 
• Review BCCDC’s COVID-19 Vaccine Screening Checklist.
  • Note that the only contraindication to receipt of a COVID-19 vaccine is a history of anaphylaxis to a previous dose or to a component of the vaccine.
  • See BCCDC FAQ for health care professionals regarding information on vaccinating special populations and contraindications. 
• (NEW!) Non-residents of B.C/ Non-Canadians are able to be vaccinated at a community pharmacy:
  • Anyone living, working or studying in B.C. during the pandemic can receive the COVID-19 vaccine, even if they are not a Canadian citizen or permanent resident (with ID showing they meet the age/current eligibility requirement).
  • Pharmacies will be reimbursed for this service. As with any other patient, a PHN is to be generated for the patient if they do not currently have one. No one that is eligible (as per current criteria) is to be turned away for an appointment they have booked. Name and date of birth of patient is required. 
• Confirm that patients are receiving their first dose. Note: PharmaNet does not show doses given at public health clinics
  • Check PharmaNet to ensure first dose was not already given by another pharmacy
  • If the pharmacy has access to CareConnect, check Provincial Immunization Registry to determine if patient has received a first dose at a public health clinic
  • Verbal confirmations should only be used as a secondary source of verification, as patient interviews are not 100% reliable

• Before administering any vaccine, pharmacists must obtain informed consent as per CPBC’s Standards, Limits and Conditions for Drug Administration.
• See BCPhA example COVID-19 Consent for Immunization, which incorporates BCCDC’s screening checklist.
• The BC Immunization Manual Appendix A – Informed Consent provides guidance on how to document informed consent.
• A link or copy of the HealthLink BC File for COVID-19 vaccines should be provided to each patient as part of the consent process.

• Patients are to remain in a designated area for 15-minute observation period following COVID-19 vaccine receipt.
• Provide the patient a record of immunization, as per PharmaCare policy manual section 8.10. At a minimum the record should include the patient name, dose number, date of administration, product given, lot number and pharmacy information.
• Encourage patients to sign up to Health GateWay to access their digital immunization record. PharmaNet data is fed into the Provincial Immunization Registry which is subsequently uploaded to Health Gateway where patients can access the health records themselves.
• Provide patients the COVID-19 Vaccine After care sheet, which includes information about rare cases of blood clots and/or bleeding following the AstraZeneca COVID-19 Vaccine/COVISHIELD and a list of symptoms for when to seek immediate medical attention.
• Following administration of COVID-19 vaccines pharmacists must provide the patient a record of immunization. This is a requirement in the PharmaCare policy manual section 8.10. At a minimum the record should include the patient name, dose number, date of administration, product given, lot number and pharmacy information.

As of Apr. 20, 2021, PharmaCare has started using Fan Outs to notify pharmacies on incorrect PharmaNet data entry for COVID-19 vaccines e.g., inventory not received, but administrations recorded; wrong (mismatch) DIN/PIN to LOT and incorrect SIG formats. The Fan Outs are targeted to specific pharmacies and are not broad fan outs. If your pharmacy receives a Fan Out message, please review carefully and follow instructions to correct the issue. Review the following PharmaNet data entry formats to ensure information in entered correctly.

PharmaNet Data Entry:

Recently, a connection was made between PharmaNet and the Provincial Immunization Registry (PIR) to ensure that all immunizations recorded in PharmaNet are reflected in a patient’s provincial immunization record. The PIR record is subsequently uploaded to the Health Gateway where patients can access their health records themselves.

Due to the strict reporting requirements of COVID-19 Immunizations, pharmacists must follow these rules:

1. Provide immunizations as per the immunization priority criteria. 
2. Record immunizations administered in PharmaNet by 11:59 p.m. on the day that they are given to the patient.
3. Follow all PharmaNet vaccine administration claim entry requirements for COVID-19 immunizations (see below)
4. Follow COVID-19 vaccine inventory receipt and daily wastage PharmaNet entry requirements (see below).
5. Verify patient identification and update demographics in PharmaNet if necessary. Note: address must be updated through the specific address update transaction feature

PharmaNet claim entry:

1. Use the product identification number (PIN) as assigned by PharmaCare.
2. The administering pharmacist should be the prescriber.
3. Follow the protocol for entry of the “Directions for Use” (Sig) field (see below).
4. Quantity is the amount administered to the patient, in millimetres (e.g., 0.5 mL for AstraZeneca/COVISHIELD) 
5. Days supply for first doses should be the anticipated interval to next dose (e.g., 112 days for AstraZeneca/COVISHIELD). 

Data to be entered in the Directions for Use field:
Some aspects of immunizations are not recorded in PharmaNet as separate data elements.  The Provincial Immunization Registry (PIR) requires these additional elements to ensure appropriate reporting and clinical follow-up.  To account for this, the pharmacy must follow new data entry requirements in the “Directions for Use”, or “Sig” field sent to PharmaNet.

 
Entry of this information in this format will allow PharmaNet to accurately extract these additional data elements and submit on behalf of providers to the PIR.  Only certain “allowable values” are permitted to be entered for each data element. PharmaNet will verify the information prior to sending to the PIR.  

This information should be recorded in the “Directions for Use” field in the above order separated by an underscore “_”.  DO NOT enter any other characters.

Example entries for “Directions for Use” for COVID-19 vaccines:
For COVISHIELD with lot number 4120Z003, example entries in the “Directions for Use” field are:
 

There is no need to add “LOT” or “Arm” or any other information like expiry or IM. 

Please do NOT enter the following example formats, otherwise it will not lead to a complete record in the Provincial Immunization Registry:
 

For vaccine PINS, see Publicly Funded Vaccines.

Ensure the PIN for the COVID-19 vaccine is entered correctly. If the wrong PIN has been submitted, the pharmacy MUST reverse the claim and BACKDATE under the correct PIN (if not, it will appear incorrectly as dose 2 in the Provincial Immunization Registry).

COVID-19 immunizations will be reimbursed via the usual process for vaccinations.  

At the time of submission, PharmaNet will indicate that the immunization is NOT a benefit. This is expected; reimbursement is done by a secondary process, which identifies the number of immunizations administered by a pharmacy, irrespective of adjudication results. You do not need to reverse and resubmit the claim.

Accurate daily inventory accounting is critical. Both receipt of inventory and daily wastage of doses must be recorded for central reporting and management of inventory. To achieve this efficiently in PharmaNet, pharmacies must follow the procedures below. 

1. Receiving inventory

• Submit under the O-Med, a claim to PharmaNet under the PIN for the product received:
  • Quantity = total volume in mL received 
  • Directions for Use = Received_LOT
  • Note the underscore “_”
• This must be done on as soon as you receive/ on the same day you receive the vaccine.

2. Recording wastage

• Submit to PharmaNet using O-Med PHN, under the vaccine PIN for the product wasted:
  • Quantity = total volume in mL wasted
  • Directions for Use, depending on reason for wastage, please enter the following:
    • Wastage_CCI: Handling Error_Lot [for cold chain incidents]
    • Wastage_Damage to Product_Lot
    • Wastage_Expired Product_Lot

  • Note the underscore “_”

• This must be done on the same day the product is wasted.

• If you receive damaged or missing vials from the distributor, email IBCOC_Operations@phsa.ca the following information:

  • Damage to vials? If yes, describe how many and to what extent.

  • Missing vials? If yes, how many?

3. Transferring product between pharmacies *NEW*

• Transfer of vaccines can be done between selected B.C. pharmacies participating in the COVID-19 campaign.
• Pharmacists must adhere to the cold chain requirements as per College PPP-68 Cold chain management.
• Review BCCDC AZ/CS Redistribution Guidelines which provides information to support the redistribution of vaccine.
• Ensure appropriate insulated packaging when transporting vaccines as per BCCDC Immunization Manual Chapter 2: Immunization Appendix E – Management of Biologics.

PharmaNet data entry:

• Note: For transferring product between stores, use the 3-character PEC (e.g. A01) of the store you are transferring to, or the PEC of the store you are transferring from. See table for entry options.
   
• Pharmacy transferring out the product:
  • Submit to PharmaNet using O-Med PHN, under the vaccine PIN for product transferred:
    • Quantity = total volume in mL being transferred.

    • Directions for Use = Transfer_Lot_(to)PEC  

    • Example: PEC of pharmacy you are transferring to is ZBA. Sig field for transfer to: Transfer_4120Z003_ZBA

  • Must be done on the same day product is being transferred.
• Pharmacy receiving the transferred product:
  • Submit to PharmaNet using O-Med PHN, under the vaccine PIN for product transferred:
    • Quantity = total volume in mL being transferred.

    • Directions for Use = Received_Lot_(from)PEC

    • Example: PEC of pharmacy you are receiving product from is A01. Sig field for transfer from: Received_4120Z003_A01

  • This must be done on the same day product is received.

4. Returning product to BCCDC for redistribution

The following criteria must be met for vaccine(s) to be considered eligible for return to BCCDC vaccine distribution centre:

• The temperature was maintained between +2°C and +8°C for these products throughout their storage at site.
• Products were stored in a safe and secure location with no public access.
• The refrigerator temperature was logged at the start and end of each business day.
• Only full, unpunctured vials are being returned.

• Complete BCCDC COVID-19 Vaccine Redistribution form and fax to BCCDC at (604) 707-2581. 

• PharmaNet data entry: Submit to PharmaNet using O’Med PHN, under the vaccine PIN for product returned:
  • Quantity = total volume in mL being returned
  • Directions for use = Return_LOT_BCCDC
    • Note the underscore “_”
    • This must be done on the same day vaccine is returned to BCCDC.

Examples:

• Pharmacies will be reimbursed for vaccinations using the Product Identification Number (PIN) created for the vaccine. 

• According to BCCDC, an adverse event following immunization (AEFI) is defined as an untoward event temporarily associated with immunization that may or may not have been caused by the vaccine or immunization process.
• For criteria on reporting AEFIs, and to help healthcare providers interpret AEFIs and their implications for subsequent immunization, see BC Immunization Manual Part 5 – Vaccine Associated Adverse Events.
• Other AEFI resources:
  • BCCDC Reporting AEFI Questions & Answers.
  • AEFI Reporting Procedure 
• Pharmacist are encouraged to record relevant Adverse Drug Reactions (ADEs) in PharmaNet in addition to the AEFI form.

Recently, BCCDC Pharmacy has been receiving reports from immunizers not being able to withdraw the minimum-number of labeled doses from COVID-19 vaccine vials despite taking the appropriate preparation and withdrawal diligence.

Effective immediately, if this occurs in your pharmacy, please complete the survey and send directly to Immunize BC Operations Centre (IBCOC), IBCOC_Operations@phsa.ca.  This will allow IBCOC to better assess the issues and trends for possible solutions.

• To access the Provincial Immunization Registry (PIR), pharmacists need access to CareConnect. It’s anticipated that all pharmacists will need to access the PIR to administer Dose 2.
• Getting CareConnect access:
  • Independent pharmacies, email Private.Careconnect@phsa.ca
  • Corporate and small groups: contact head office.

• Complete the following survey form through this link -   Enrol in CareConnect.  Once completed, the CareConnect team send the instructions for the next steps.
  • IMPORTANT NOTE: You may have received information on CareConnect enrolment through the College of Pharmacists of BC email in mid-March.  The above link is the same link shared by the College. 

For health professionals

• BCCDC FAQ Use of AstraZeneca/COVISHIELD Vaccine NEW!
• BCCDC Resources for Indigenous Communities NEW!
• Ministry of Health PharmaNet Cheat Sheet for COVID-19 Vaccines
• AztraZeneca Global site for access to resources, current product monograph and patient information

• BCCDC Infection, Prevention and Control Guidance for Community Immunization Clinics 
• BCCDC resources for Culturally safe care 
• BCCDC Immunization Communication Tool (vaccine hesitancy)
• BCCDC COVID-19 Resources for health professionals
• BCCDC Continuity, Prioritization and Safe Delivery of Immunization Services during COVID-19 Response. Updated October 27, 2020
• BCCDC COVID-19 Immunization Program QA document for health professionals
• National Advisory Committee on Immunization
• NACI Rapid Response: Recommended use of AstraZeneca COVID-19 vaccine in younger adults
• NACI Recommendations on the use of COVID-19 vaccines
• NACI: Guidance on the prioritization of key populations for COVID-19 immunization
• NACI Planning guidance for immunization clinics for COVID-19 vaccines
• Health Canada: Webinars on COVID-19 vaccines
• Health Canada COVID-19: Guidance documents for Health Professionals
• PHAC COVID-19 Vaccination Tool Kit for Health Care Providers

For Patients

• Health Gateway Health Gateway - NEW
• HealthLink BC COVID-19 Vaccines
• BCCDC COVID-19 Vaccines
• BCCDC COVID-19 Immunization Plan
• BCCDC Getting a Vaccine (Registering for the vaccine, what to expect, after getting the vaccine).
• BCCDC Vaccine Considerations (includes information for people with health conditions that make them clinically extremely vulnerable).
• First Nations Health Authority (FNHA) COVID-19 Vaccine Resources
• ImmunizeBC COVID-19 Vaccine
• ImmunizeBC COVID-19 Vaccine Frequently Asked Questions
• Health Canada COVID-19 How vaccines are developed (video)
• Health Canada: What you need to know about COVID-19 vaccines for Canada
• Health Canada: Vaccine development and approval in Canada
• World Health Organization’s (WHO) Science in 5 COVID-19 Series (video and audio series) – available weekly on WHO’s YouTube, Instagram, Facebook, Twitter and LinkedIn channels and on all major podcast platforms.

Resource Centre

• Online Booking Platform
• Health Topics
• COVID-19 (Coronavirus) Resources