Vaccines are valuable in preventing and controlling infectious diseases,1 and have saved countless lives.2 During the COVID-19 pandemic, the development and distribution of vaccines has been a major focus in the battle against the virus.
Physicians who provide vaccinations should be aware of their obligations, including giving patients, or their legal guardians, sufficient information about recommended vaccines so they can make informed decisions. The National Advisory Committee on Immunization is a helpful resource on recommended vaccines, including COVID-19 vaccines.3
While the value of vaccines is accepted by many people, some still debate their necessity, efficacy, and safety. This may present challenges for physicians who know a particular vaccine is indicated and appropriate, but the patient or the patient’s legal guardian is hesitant about or refuses the vaccine. Physicians should consider how to address vaccination hesitancy and refusal.
For more information specific to issues related to COVID-19 vaccines, see the CMPA COVID-19 Hub.
Discussing vaccines with patients and obtaining informed consent
When physicians determine a specific vaccine would benefit a patient and recommend it, the clinician must obtain the patient’s or legal guardian’s informed consent before administering the vaccination. In most cases, the informed consent discussion might include:
- benefits of the vaccine
- risks of the vaccine (including material risks and uncommon risks with serious consequences, such as paralysis or death)
- risks of the disease including complications
- possible consequences of refusing the vaccine
- relevant recommendations from authoritative groups, governments, provincial/territorial medical regulatory authorities (Colleges), and medical specialty associations and federations
- need for follow up, for example if immunization requires a series of doses
- any cost of the vaccine if it is not covered by the provincial or territorial health plan
If the patient (or the patient’s legal guardian) chooses to have the vaccine, physicians should inform them of common side effects and complications, and what to do if these occur. In the case of COVID-19 vaccines, for example, where the products were quickly deployed, there was an opportunity for disclosing that not all of the possible side effects of these products are known. (Regularly updated medico-legal information specific to COVID-19 vaccination may be found on the CMPA COVID-19 Hub..)
The need to document
Once the informed consent discussion has taken place, the details of the discussion and the patient’s (or legal guardian’s) consent to the vaccine should be documented in the patient’s medical record and/or a designated provincial/territorial record. The consent process is more than completing a specific form; it is a conversation, as described previously. Any consent form the physician relies on should also be kept in the medical record and/or a designated provincial/territorial record.
The Public Health Agency of Canada’s Canadian Immunization Guide recommends that healthcare providers record vaccinations in the following: the immunization record held by the vaccine recipient (or legal guardian); the patient’s personal health record maintained by the healthcare provider who administered the vaccine; and the local provincial or territorial immunization registry, if one has been established.4
To help patients (or their guardians) manage their vaccinations, including keeping a record of vaccinations they’ve received, physicians may want to make them aware of resources such as those on the websites of Health Canada, the Public Health Agency of Canada, and Immunize Canada.
The need to follow up
In some instances, adequate immunization requires a series of doses (such as certain COVID-19 vaccines). Before administering the first dose, physicians should talk with patients or legal guardians about the importance of obtaining all doses on the recommended immunization schedule. Physicians should be aware of the immunization schedules in their province or territory and discuss with patients any risks with delaying doses.5 It may be appropriate to have a system to follow up with patients who do not return for subsequent doses, and to document the steps taken and the response.
When patients or legal guardians are hesitant or refuse vaccinations
While routine immunizations are recommended to prevent certain infectious diseases3,6 and most people accept routine vaccination, some still refuse or delay it for themselves or their children.7,8,9 Public health officials and studies are concerned that vaccine hesitancy and refusal will increase the risk of epidemics of vaccine-preventable illnesses.10,11,12
If patients (or legal guardians) are reluctant about a vaccine, physicians should explore and address the reasons for their reluctance, answer any questions to the best of their ability, and consider referring patients or guardians to other relevant resources for information.5 For example, physicians could direct hesitant parents to the Canadian Paediatric Society’s website (caringforkids.cps.ca), or to #ScienceUpFirst, a hashtag used by an organization of independent scientists to present science-based information through social media posts.
Physicians should be empathetic and respectful, and remind patients or guardians that their best interests (or those of their child) are the primary concern.5 Helpful articles13 and resources are available, such as the 2018 Practice Point from the Canadian Paediatric Society, "Working with vaccine-hesitant parents," which provides useful evidence-based approaches on how to communicate effectively.5
Physicians should make every effort to continue to care for patients in the existing doctor-patient relationship in accordance with current standards of care.14 For assistance with caring for patients who are reluctant about a vaccine, physicians should consult with their College and other organizations such as the Canadian Paediatric Society. For medico-legal questions, physicians should contact the CMPA.
Despite good explanations, parents and/or legal guardians may still refuse to consent to the vaccination of their children. Except in Québec, physicians should generally respect an informed decision by a child who they consider to be a mature minor and capable of understanding the risks of refusing the vaccination. In Québec, the law generally only permits children 14 years of age and older to consent to care.15 Physicians should document the wishes of the minor and the parent, if known, in the medical record along with the physician’s assessment of the child’s capacity to consent and understanding of the risks.15
If a vaccine is recommended, but refused, a detailed note of both the consent discussion and the refusal should be made in the medical record. The physician should also keep the lines of communication open for future discussions about immunization and consider directing the patient or legal guardian to a trusted source of reliable information.5
Physicians may be troubled if a patient refuses a vaccine solely for reasons of cost. The patient or legal guardian can be advised to contact their provincial/territorial health ministry on programs and assistance available for vaccinations.
In exceptional circumstances where a patient (or a patient’s legal guardian) has refused immunization, but the vaccine is medically appropriate and necessary to preserve the life or health of the child, it may be necessary to contact child protection agencies. For information on child protection agencies across Canada, physicians can refer to the Canadian Child Welfare Research Portal.16 Physicians may also wish to contact the CMPA for advice.
Questions on vaccine alternatives
Patients (or legal guardians) may have questions about alternatives to routine vaccines, such as unproven homeopathic therapies.17 To respond appropriately, primary care physicians and those practising in related areas should stay up to date on relevant or common vaccines, their effectiveness, significant risks, and the risks if the diseases are not prevented. Physicians should be prepared to communicate clearly and professionally with patients or legal guardians on the matter and keep in mind that a healthcare provider’s advice generally has significant influence on decision-making for vaccines.5
Treating unvaccinated patients
Physicians with unvaccinated patients should consider arranging their office to reduce any risks from these patients coming into contact with vulnerable patients, such as those with suppressed immune systems or those who have not yet received vaccinations. Scheduling appointments at different times of the day or week to treat each type of patient could be one approach. Physicians should encourage unvaccinated patients or their legal guardians to inform healthcare providers they come in contact with that they are not fully immunized. These steps are especially important in the context of the COVID-19 pandemic.
The bottom line
- Tell patients or their legal guardians about the benefits and significant risks of recommended vaccines, and the risks if the disease is not prevented.
- Have a robust informed consent discussion when recommending new vaccines, such as COVID-19/ vaccines.
- Be familiar with your province’s or territory’s immunization schedules and legislation, and your College’s policies on vaccination.
- Document the information you give patients and their responses in the medical record and/or designated provincial/territorial record (including their reasons for refusing the vaccine).
- Document in the medical record the vaccines discussed with, refused by, or administered to patients.
- Patients or legal guardians have the right to accept or refuse the vaccine. Be patient and empathetic to their needs and beliefs, and keep the lines of communication open.
- Follow up with patients to complete the course of immunization, if required, and document the steps taken.
Public Health Agency of Canada. PHAC;2020 Feb 14. Canadian Immunization Guide: Introduction [cited 2021 Feb 18] Available from: https://www.canada.ca/en/public-health/services/canadian-immunization-guide/introduction.html”
Chan M. World Health Organization;2017. Ten Years in Public Health 2007-2017: Report by Dr. Margaret Chan, Director-General, World Health Organization [cited 2021 Feb 18] Available from: https://apps.who.int/iris/bitstream/handle/10665/255355/9789241512442-eng.pdf;jsessionid=DBF83B5AE1E75D9B067D5427F4656301?sequence=1”
Public Health Agency of Canada. PHAC;2021 Feb 15. National Advisory Committee on Immunization (NACI): Statements and publications [modified on: 2021 Feb 15; cited 2021 Feb 18] Available from: https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci.html
Public Health Agency of Canada. PHAC;2016 Feb 2. Canadian Immunization Guide: Immunization records [modified 2016 Sep 1; cited 2021 Feb 18] Available from: http://www.phac-aspc.gc.ca/publicat/cig-gci/p01-11-eng.php
MacDonald NE, Desai S, Gerstein B. Canadian Pediatric Society. Working with vaccine-hesitant parents: An update. Paediatr Child Health. 2018 [cited 2021 Feb 18];23(8)562 DOI: https://doi.org/10.1093/pch/pxy144 Available from: https://www.cps.ca/documents/position/working-with-vaccine-hesitant-parents
Canadian Paediatric Society. CPS;2016 Apr 26. Are we doing enough? A status report on Canadian public policy and child and youth health [cited 2021 Feb 18] Available from: https://www.cps.ca/uploads/advocacy/SR16_ENG.pdf
Dubé E, Gagnon D, Quakki M, et al. Measuring vaccine acceptance among Canadian parents: A survey of the Canadian Immunization Research Network. Vaccine. 2018 Jan 25 [cited 2021 Feb 18];36(4);545-552. DOI: 10.1016/j.vaccine.2017.12.005
Public Health Agency of Canada. PHAC;2021 Jan. Vaccine coverage in Canadian children: Results from the 2017 Childhood National Immunization Coverage Survey (cNICS) [modified 2021 Jan 29; cited 2021 Feb 18] Available from: https://www.canada.ca/en/public-health/services/publications/healthy-living/2017-vaccine-uptake-canadian-children-survey.html
Angus Reid Institute. ARI;2021 Dec 14. More Canadians willing to roll up their sleeves right away as national COVID-19 vaccine rollout begins [cited 2021 Feb 18] Available from: http://angusreid.org/canada-covid-vaccine-december/
World Health Organization. WHO;2019. Health Topics: Ten threats to global health in 2019 [cited 2021 Feb 18] Available from: https://www.who.int/news-room/spotlight/ten-threats-to-global-health-in-2019
Kempe A, Saville AW, Albertin C, et al. Parental hesitancy about routine childhood and influenza vaccinations: A national survey. Pediatrics. 2020 July [cited 2021 Feb 18];146(1): e20193852. DOI: https://doi.org/10.1542/peds.2019-3852
De Figueiredo A, Simas C, Karafillakis E., et al. Mapping global trends in vaccine confidence and investigating barriers to vaccine uptake: a large-scale retrospective temporal modelling study. Lancet. 2020 Sep 26 [cited 2021 Feb 18];396(10255):898-908 DOI: https://doi.org/10.1016/S0140-6736(20)31558-0 Available from: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31558-0/fulltext
Gagneur A. Motivational interviewing: A powerful tool to address vaccine hesitancy. Can Commun Dis Rep 2020 [cited 2021 Feb 18];46(4):93–7. DOI: https://doi.org/10.14745/ccdr.v46i04a06
Shen S, Dubey V. Addressing vaccine hesitancy. Clinical guidelines for primary care physicians working with parents. Can Fam Physician. 2019 Mar [cited 2021 Feb 18};65(3)175-181 Available from: http://www.cfp.ca/content/65/3/175?rss=1.full.pdf+html
Canadian Medical Protective Association. CMPA;2014 May. Can a child provide consent? [cited 2021 Feb 18] Available from: https://www.cmpa-acpm.ca/en/legal-and-regulatory-proceedings/-/asset_publisher/a9unChEc2NP9/content/can-a-child-provide-consent-
Canadian Child Welfare Research Portal. CWRP. Provincial and Territorial Assistance [cited 2021 Feb 18] Available from: http://cwrp.ca/help
Loeb M, Russell ML, Neupane B, et al. A randomized, blinded, placebo-controlled trial comparing antibody responses to homeopathic and conventional vaccines in university students. Vaccine. 2018 Nov 19 [cited 2021 Feb 18];36(48):7423-7429 DOI: 10.1016/j.vaccine.08.082 Available from: https://pubmed.ncbi.nlm.nih.gov/30352746/