Informed consent for uninsured services: a primary care perspective on the new childhood vaccines

• Published in: Canadian Medical Association journal (CMAJ) 2004-10, Vol.171 (8), p.877-879
• Main Authors: Paterson, J Michael, Neimanis, Ieva M, Goebel, Cindy R, Kraftcheck, Daniel J
• Format: Article
• Language: English
• Subjects: Bioethics; Canada; Chicken pox; Child; Funding; Humans; Immunization; Information Services; Informed consent; Informed Consent - legislation & jurisprudence; Internet; Liability, Legal; Parents & parenting; Practice Patterns, Physicians; Primary care; Primary Health Care; Vaccination; Vaccination - legislation & jurisprudence; Vaccines
• ISSN: 0820-3946; 1488-2329
• DOI: 10.1503/cmaj.1031738

In February 2003 the federal government allocated $45 million over 5 years to "assist in the pursuit of a national immunization strategy,"14 and the latest federal budget promised a further $300 million over 3 years "to support the introduction of new and recommended childhood and adolescent vaccines (as proposed by the NACI)."15 These are important steps forward. But until such time as governments can agree on national standards for coverage, the potential for "patchwork policy" will continue to exist.16,17 In the interim, what are parents and practitioners to do? Should family doctors recommend "uninsured" vaccines? What should be said about them? And what, if anything, should be done if parents refuse vaccination? In this commentary we share results from a recent survey of Hamilton-area practice patterns, our response to the findings and some thoughts on how a national approach to informed consent for childhood vaccines could help jump-start the national immunization strategy. The Canadian Medical Protective Association (CMPA) recently clarified that "Whether physicians should notify parents of a new vaccine depends on whether administration of the vaccine is considered the 'standard of care' by other physicians in the community."18 Typically, legal judgements about what constitutes a standard of care are established by courts on a case-by-case basis through the testimony of expert witnesses, although published clinical practice guidelines and the recommendation of expert panels, such as the NACI, can be instructive.19-21 Accordingly, the CMPA concluded that "It seems likely that a court would hold that recommending the pneumococcal, meningococcal, and varicella vaccines has become part of the standard of care for [Canadian] physicians."18 It also advised that related discussions about informed consent should include 4 key elements: disclosing material risks, benefits and financial costs of vaccination, as well as the possible consequences of refusal; providing written material on these topics; answering parents' questions; and clearly documenting the outcome of the discussion. Finally, the CMPA suggested that physicians may wish to have parents who decline vaccines sign a "consent form," confirming that they have been fully informed of the risks and benefits of the vaccine and the consequences of refusal.18 Whether Canadian physicians are prepared to have parents sign forms when they decline vaccines is a separate issue. On this question, our colleague