Influenza virus vaccine, Fluzone®. Photo: United States Centres for Disease Control and Prevention
The Australian Government has commenced its H1N1 influenza vaccination program and the Department of Health and Ageing (DoHA) has published the consent form that patients are being asked to sign. You can look at a copy of the consent form here
Vaccine delivery and consent
The Panvax® influenza vaccine (manufactured by CSL Ltd) is being supplied in multi-dose vials, the use of which is known to be associated with the risk of contamination of the vaccine and the risk of cross-infection of vaccinated patients. In August, the Australasian Society for Infectious Diseases raised their concerns about the use of multi-dose vials with the Commonwealth Chief Medical Officer, Dr Jim Bishop, and urged the Government to abandon its vaccination plan until single-dose vials became available. Nonetheless, despite those concerns, DoHA has pressed ahead with its vaccination plan.
In a couple of earlier postings I asked how the public would be informed about the risks associated with multi-dose vials so that each patient would be able to make an informed choice about whether to get vaccinated now or to wait until single-dose pre-filled syringes are available. If you look at the consent form you will see that that issue has now been settled. Patients will not be told anything!
The Bolam Principle
After seeing the consent form for the first time yesterday, I wrote to DoHA earlier today. I asked (1) why is there no mention on the consent form of the risks of using multi-dose vials? and (2) why DoHA has not heeded the very specific admonishments of the High Court in its 1992 judgement in the medical negligence case of Rogers v Whitaker? 
The reply that I received did not address either of those questions. In fact, it didn’t even try to answer them. Instead (and revealingly) the response simply quoted an unrelated and irrelevant earlier media release: “The vaccine will be distributed in multi-dose vials. This is consistent with countries around the world also delivering mass vaccination programs. Guidelines for the safe use of the vials have been developed by Australia’s specialist immunisation reference group, the Australian Technical Advisory Group on Immunisation in consultation with the Royal Australian College of General Practitioners and the Australian Nursing Federation.”
In other words, “doctor knows best”. Patients do not need to be told about the risks because DoHA is delivering the vaccine in a form that is consistent with medical opinion about the best method of delivery. On the humorous side, the reference to the “specialist immunisation reference group” reminded me of the famous line at the end of the film, Raiders of the Lost Ark, when Harrison Ford asks what has been done with the Ark. He is told, “I assure you, top men are working on it right now.” Harrison Ford then asks naively, “Who?” The answer: “Top men”.
More seriously, I remarked (above) that the response from DoHA was revealing. How so? Readers who are familiar with the law of medical negligence will recognize that the approach taken by DoHA is entirely consistent with a legal doctrine known as the “Bolam Principle”. To quote from the judgement in Rogers v Whitaker, “The Bolam principle may be formulated as a rule that a doctor is not negligent if he acts in accordance with a practice accepted at the time as proper by a responsible body of medical opinion even though other doctors adopt a different practice.” The problem with that approach for doctors, nurses and for DoHA is that the High Court refused to accept the Bolam principle as the basis on which to determine medical negligence cases! Instead, the High Court decided that the law, “should recognize that a doctor has a duty to warn a patient of a material risk inherent in the proposed treatment” and added that “a risk is material if, in the circumstances of the particular case, a reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to it …”
In other words, with regard to vaccinations, the issue is not about how likely it is that a risk of contamination or cross-infection will materialize; it is not about how dangerous such contamination is likely to be; it is not about whether the doctor is doing everything as well as they know how; it is not about whether having a vaccination is more likely to protect you from a serious H1N1 infection than it is to create a problem of its own. It is simply about patient autonomy—the right of each competent individual to decide for themselves whether or not to be vaccinated.
How do the risks with multi-dose vials arise?
A multi-dose vial is a bottle that has enough vaccine in it for about 12 people. The bottle is sealed with a permeable cap. The doctor or nurse attaches a needle to the end of a syringe, sticks the needle through the cap, and draws up enough of the vaccine for a single dose. The patient then gets injected with the vaccine. What could possibly go wrong?
Scenario 1: The person doing the vaccinations could accidentally reuse the syringe and needle for more than one patient. If the first patient to receive the vaccine has a disease that is transmissible by needle stick, then the second person to be vaccinated with the same needle might become infected with that disease. Sure, the guidelines say that a new needle and new syringe must be used; but, the nature of accidents is that they are accidental. If they were not, we would assume that some sort of deliberate malfeance was involved! The nature of a mistake is that something that should have been done is not done, or that something that should not have been done is done without the person doing it having done so deliberately. By refusing to acknowledge the risk of a mistake, the DoHA consent form tacitly implies that in the history of vaccination, no needle or syringe has ever been accidentally reused when the guidelines say that needles and syringes should not be reused. Furthermore, they suggest that such an accident could not ever happen.
If the form had spelled out those tacit implications would you believe them? Do you believe in Santa Claus? Interestingly, in contrast to the implications of the DoHA consent form, the United States Centers for Disease Control specifically acknowledges that things can happen contrary to safety guidelines.
Scenario 2: Person A has an infection and has a vaccination with a new syringe and new needle. The person giving the vaccinations accidently begins to reuse the equipment but realises their mistake, but only after they have put the used needle back through the cap of the bottle of vaccine and transferred infective material from the used needle to the vaccine. The remaining vaccine in the multi-dose vial might then infect up to 11 more people even if new needles and syringes are used for each of them.
Scenario 3: The vaccine becomes contaminated after the vial is opened and that the contamination occurs independently of any particular person being vaccinated.
As I remarked in an earlier post, none of the risks with the mutli-dose vials will necessarily lead a person to refuse the vaccine but that is a decision for the patient and not for the doctor.
How could DoHA go so wrong?
My guess—but that is all it is—is that DoHA sought medical advice about how to phrase the consent form but did not seek legal advice from someone familiar with the law of medical negligence. Traditions take a long time to change and the idea that the medical profession knows what is best is well entrenched. If you think that you know what is best for your patients and you are convinced that the risk associated with the use of multi-dose vials is small, then in your presumptive though unintended arrogance you might just neglect to mention those risks! For a discussion of similar problems that arise in psychological practice, you might like to have a look at a paper  that Angela O’Brien-Malone and I wrote for Australian Psychologist.
 Rogers v. Whitaker, F.C. 92/04 (High Court of Australia 1992).
 O’Brien-Malone, A., & Diamond, M. R. (2006). Tell your patients you might hurt them. Australian Psychologist, 41(3), 160-167(8). DOI: 10.1080/00050060600776366
Contributors: Mark R. Diamond, Angela O’Brien-Malone