Vaccination, consent and multidose vials

Abstract

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.

Sepsis, parenteral vaccination and skin disinfection

“…Consequently it would be difficult to defend 106 a case of sepsis if skin preparation was omitted unless the risk of this very low prevalence event was adequately explained to the patient and documented prior to vaccine administration.…”

Multi-dose vials versus single-dose vials for vaccination: perspectives from lower-middle income countries

“…It has been argued that the use of multi-dose vials in immunization programs must be accompanied with disclosure to the beneficiaries of the additional but small risk of disease transmission associated with MDVs as part of the informed consent process. 29 However, from a biomedical perspective, it can be argued that incorporating client autonomy by disclosing the negligible higher risk of MDVs during immunization purposes can be counterproductive as it may have the potential to promote vaccine hesitancy in communities.…”