Vaccination, consent and multidose vials


Multidose vials (MDVs) for injectable therapeutic agents, including vaccines, pose a risk of infection to injected patients as a result of contamination of the vials. The Australian Government Department of Health and Ageing (DoHA) distributed the vaccine against pandemic (H1N1) 2009 influenza in MDVs. The distribution was accompanied by consent forms. The consent forms provided an inadequate basis for a discussion with patients about the risks associated with the use of MDVs. The High Court of Australia has previously held that medical practitioners who fail to explain the material risks of medical procedures to their patients might be held liable in negligence for any adverse sequelae of the procedures, even if the risks are very low. Medical practitioners, nurses, medical indemnity insurers and the DoHA should prepare now for the probable future use of MDVs by developing a consent form that would provide a solid foundation for a discussion of material risks with patients seeking vaccination.