Vaccines provide us with the best possible defense against serious illnesses. COVID-19 vaccination clinics have emerged in hospitals, large community centres, pharmacies, and pop-up locations, etc., to support the high immunization demand. These clinics will offer patients any of the Health-Canada approved COVID-19 vaccines (https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines.html), where applicable. Due to the rapidly evolving evidence regarding these vaccines and the increasing demand for dosages, patient safety considerations are necessary at all stages of the vaccination process.
Some patient groups are at greater risk of experiencing possible adverse effects to the COVID-19 vaccines. To identify potential vaccine contraindications and precautions, an organization/institution-specific or ministry-based screening tool should be used before vaccine administration. For example, administration of the COVID-19 vaccine should be delayed if the patient has received any other vaccine in the past 14 days. For special populations (e.g., immunocompromised, pregnant, or breastfeeding), a careful risk-versus-benefit assessment must be done prior to vaccine administration due to the lack of available evidence.
The stability of the novel COVID-19 vaccines relies heavily on specific storage conditions. Temperature excursions, whereby vaccines are stored outside the appropriate temperature for an extended duration, may result in product wastage. Vaccination clinics should be prepared to respond to events that could lead to temperature fluctuations (e.g., refrigerator or freezer failure). Routine process checks should be in place to ensure storage requirements are met and documented.
Planning and Preparation
COVID-19 vaccine recommendations are rapidly renewed and updated based on emerging real-world data and post-market surveillance. It is critical that vaccine clinic staff members are aware of the most up-to-date information and practice based on the latest evidence. Daily morning (or beginning-of-shift) huddles are an excellent way to ensure that the team stays informed.
Vaccination clinics should also ensure that there is adequate staffing and workspace to accommodate maximum capacity of patients at any given time. Clinics should have standard operating procedures to deal with events involving technology failure, including contact information for IT support. It is important to test technologies before patients arrive to resolve technical issues, and ensure that all staff members are adequately trained to minimize errors and inefficiencies during busy clinic days.
At the point of dose preparation, clinics may find it useful to provide a quick-reference guide to vaccine providers (or immunizers). Also, any prefilled syringes should be labelled to facilitate an extra check before dose administration.
An administration checklist (Table 1) may be useful to ensure a standard process is followed by each vaccine provider (or immunizer). During administration, proper landmarking technique should be completed to prevent shoulder injury related to vaccine administration. Once the vaccine has been given, providers (or immunizers) should document details of the vaccination in their computer system or medication administration records, and patients should be provided with a copy of this documentation.
Table 1: Vaccine Provider (or Immunizer) Administration Checklist
(This is based on the Government of Canada Vaccine Administration Practices: Canadian Immunization Guide, available at https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-1-key-immunization-information/page-8-vaccine-administration-practices.html#t2)
|Check (✓)||Vaccine Administration Checklist|
|1. Hands are sanitized, either by washing or using an alcohol-based hand sanitizer.|
|2. The patient’s immunization history and the vaccine schedule have been checked to ensure the appropriate vaccine is being administered at the appropriate time.|
|3. The correct vaccine has been selected and the expiry date has been checked.|
|4. The vaccine has been appropriately reconstituted or mixed, if necessary.|
|5. The appropriate needle length has been selected.|
|6. The dose and route of administration are correct.|
|7. The administered vaccine has been properly documented.|
Following vaccination, patients should be advised to wait inside the clinic for at least 15 minutes so that providers (or immunizers) or clinic staff can monitor them for signs and symptoms of serious reactions (e.g., anaphylaxis). An extended observation time of 30 minutes may be implemented for those with allergies to other vaccines or injectable therapies, and those with specific concerns regarding potential vaccine reaction. During the monitoring period, proper public health measures, social distancing, and best sanitation practices should be enforced.
In addition to everyone’s adherence to public health measures, the effort to contain the spread of COVID-19 relies heavily on the work of vaccination clinics. As clinics strive towards improved workflow efficiency, addressing safety concerns remains equally important. Strategies for optimizing safety include using a comprehensive patient screening tool, having proper vaccine storage, adequate clinic staffing and training, adopting a vaccine administration checklist, and ensuring post-vaccination monitoring. Preventable errors that occur at these clinics should be reported to the Canadian Medication Incident Reporting and Prevention System (CMIRPS) (https://www.cmirps-scdpim.ca/?p=14&lang=en), such as the Institute for Safe Medication Practices Canada (ISMP Canada) Individual Practitioner Reporting (https://www.ismp-canada.org/err_ipr.htm) program. Through incident reporting, we can learn from our mistakes, promote shared learning, and prevent the recurrence of COVID-19 vaccine incidents as the mass vaccination campaign progresses.
Rajiv Rampersaud, Jia Hui (Jay) Zhao, and Kunal Bhatt are PharmD graduates at the Leslie Dan Faculty of Pharmacy (LDFP), University of Toronto; and Certina Ho is an Assistant Professor at the Department of Psychiatry and the LDFP, University of Toronto.
To learn more about how to optimize safety at COVID-19 vaccination clinics, the following ISMP Canada Safety Bulletins may be of interest to you:
- Injecting Standardization into Vaccine Clinics (Volume 18: Issue 7; September 24, 2018), available at https://www.ismp-canada.org/download/safetyBulletins/2018/ISMPCSB2018-i7-VaccineClinics.pdf; and
- Preventing Errors with COVID-19 Vaccines: Learning from Vaccine Incidents (Volume 21: Issue 2; February 25, 2021), available at https://www.ismp-canada.org/download/safetyBulletins/2021/ISMPCSB2021-i2-COVID19-Vaccine-Error-Prevention.pdf