Safety of care

Improving patient safety and reducing risks

New vaccines — What are your obligations

An article for physicians by physicians
Originally published September 2008 / Revised January 2009
IS0887-E

Abstract

Issues to consider when discussing vaccination with patients.

Of interest to all physicians

As new vaccines become available, physicians often wonder what their obligations might be. An article in the CMPA Information Letter in 2002 discussed the issues surrounding pneumococcal, meningococcal and varicella vaccines, including the fact that, although both the National Advisory Committee on Immunization and the Canadian Paediatric Society recommended routine immunization with these agents, not all provinces and territories included them in the list of vaccines covered by the health plans. Although more provinces and territories have subsequently agreed to pay for the administration of those vaccines, public funding is still not universal. In the meantime, other vaccines have become available and similar questions have arisen.

One example is the now available vaccine against human papilloma virus (HPV). Both the Society of Obstetricians and Gynaecologists of Canada and the National Advisory Committee on Immunization have recommended the use of this vaccine in girls and young women. These recommendations have generated some controversy both in medical journals and in the news media.

Is a physician obliged to recommend a vaccine?

Whether physicians should inform patients (or in appropriate cases, their legal guardian) about the use of a new vaccine depends on whether administration of the vaccine in the patient's circumstances is considered to be the standard of care by physicians in the community. A number of factors might be considered in making this determination. If the issue were to come before a Court, the Court might look to standards expressed in accepted medical publications, the common practice of other physicians, and recommendations made by professional bodies or health organizations such as those mentioned above. Specific circumstances, such as an outbreak of a particular infection, may also influence the standard of care.

When a physician discusses immunization, it is important that patients be made aware of relevant information. That information might include:

  • benefits of the vaccine,
  • risks1,
  • possible consequences of refusing the vaccine,
  • any official recommendations from authoritative groups, such as governments and medical specialty associations,
  • need for follow up, for example if immunization requires a series of injections, and
  • any cost of the vaccine if it is not covered by the provincial/territorial health plan.

When the patient or legal guardian chooses to have the vaccine administered, it is also important to provide information on signs or symptoms of complications, and actions to be taken if such symptoms occur.

Some physicians, because of unfamiliarity with vaccination, the lack of available equipment or personal convictions, may be uncomfortable with the administration of a vaccine. A physician in any of these circumstances might nevertheless explain the recommendation of the professional organizations or national committees regarding immunization, as well as the rationale for his/her position. Having been given the relevant information, the patients/legal guardians will be in a position to make an informed decision on the option to pursue the vaccination elsewhere. It would be reasonable for the physician to advise the patients where it could be obtained. All discussion with regard to these matters should be carefully documented by the physician.

1 Generally speaking, the more frequent the risk, the greater the obligation to discuss it beforehand. Further, even uncommon risks of great potential seriousness should be discussed.

When the patient/legal guardian refuses vaccination

If the vaccination is recommended but refused, a detailed note of both the consent discussion and the refusal should be made in the medical record. The physician might ask the patient/legal guardian to sign a standard form stating that he/she has been informed of the benefits and risks of the vaccine but has refused the vaccination despite being aware of the risks of doing so.

If a person refuses a vaccination solely for cost reasons, it raises troubling issues for physicians. However, physician concerns regarding cost issues should not preclude informing the patient/legal guardian about vaccination options.

Parents and/or legal guardians have sometimes refused consent for vaccination of children for philosophical or other reasons. In those circumstances in which the child is sufficiently mature to be considered competent to make this medical decision, she/he should be given the opportunity and the information on which to base her/his decision. In Québec however, the law generally permits minors aged 14 and over to consent to care.

In exceptional circumstances, where immunization has been refused but is medically appropriate and necessary to preserve the life or health of the child, it may be necessary to involve the services of child protection agencies.

The necessity for follow up

In situations where adequate immunization will require a series of injections, the importance of follow up should be made apparent to both patient and guardian before giving the first injection. It might be appropriate to have a system in place to follow up any patients who do not return for their subsequent injections, and to document the steps taken and the response.

The bottom line

  • Be prepared to provide information to your patients or their legal guardians about vaccinations.
  • Patients/legal guardians have the right to accept or refuse the advice given.
  • Carefully document the information given, and the response from your patients or their legal guardians (including their reasons for refusing the vaccination, if that is the case).
  • Arrange follow up for patients to complete the course of immunization, if required.

DISCLAIMER: The information contained in this learning material is for general educational purposes only and is not intended to provide specific professional medical or legal advice, nor to constitute a "standard of care" for Canadian healthcare professionals. The use of CMPA learning resources is subject to the foregoing as well as the CMPA's Terms of Use.