adverse events

Sep 24, 2009

What does informed consent mean when it comes to swine flu vaccination?

Further to the earlier post about Minister Roxon's spru

Melissa Sweet — Health journalist and <a href=Croakey co-ordinator" class="author__portrait">

Melissa Sweet

Health journalist and Croakey co-ordinator

Further to the earlier post about Minister Roxon's spruiking of swine flu vaccination (you can see various interviews here, here and here - what a busy day she's had), I've been pondering the issue of informed consent. Below is a document that the Medical Indemnity Protection Society has sent members, making it clear that they will be covered only if they obtain informed consent from patients. This means discussing the potential benefits and risks of vaccination versus no vaccination. It is interesting to contrast what the Government is telling the public with what doctors are expected to tell their patients. Quite a contrast. Now, don't get me wrong. I am not opposed to vaccination per se, and I am certainly not seeking to inflame anti-vaccination campaigns generally. What I do want, however, is for those in positions of authority to be upfront and honest with the public - in the way that the health professionals charged with delivering the vaccination program are expected to be. I've been thinking about what Minister Roxon could feasibly say when asked about the pros and cons of vaccination and issues such as the infection control concerns around multidose vials. Of course she doesn't want to say anything that will lead to alarmist tabloid headlines. But that doesn't mean she can't acknowledge that there are legitimate concerns, and to explain how these are being addressed. Apart from anything, this discussion might help members of the public play a more active role in their care. I was struck by a comment on the earlier Croakey post, where a reader asked: "Is there anything 'mug consumers' of swine flu vaccination can do to minimise their risk of contamination with multidose vials?" It's not such a silly question. Ensuring consumers are informed about potential risks is well acknowledged within the broader safety and quality field of being one way to minimise the risk of adverse events or to ensure they are effectively managed if they do arise. If the Government insists on treating the general public like mugs who are incapable of engaging with these issues in a sensible way, it is missing an opportunity. And so are the health professionals who would prefer all these debates stay firmly behind closed doors. Anyway, enough ranting from me. Here is the advice from the Medical Indemnity Protection Society to doctors: SWINE FLU VACCINATION – MEMBER INFORMATION The Australian Government plans to distribute the swine flu (H1N1) vaccine in the near future. This information from MIPS clarifies the indemnity issues surrounding this vaccination program for members and their employees. Indemnity for members MIPS will indemnify its members for administering the H1N1 vaccine however, members are required to: •    provide patients with adequate informed consent including a succinct summary of the current information needed to make an informed decision about H1N1 vaccination.  This should include information about the risks of the vaccine, the general risks of an injection and risks of electing not to have the vaccine; •    follow the current draft RACGP Guidelines for the use of multi-dose vials (MDV’s) available at; and •    meet MIPS general requirements of appropriate qualifications, training and experience. Informed consent Members need to appropriately advise patients of the risks of H1N1 and the risks of having or not having a H1N1 vaccination based on their individual circumstances so that patients can make an informed decision (and therefore provide informed consent to undergo vaccination). For example this should include: •    information regarding risks associated with H1N1 compared with seasonal flu; •    information comparing risks from catching H1N1 compared with risks associated with vaccination; •    advising that the vaccine is currently undergoing clinical trials; and •    that it is currently not clear whether one or two doses will be required to achieve immunity. Although presumed, it is not yet confirmed that the risks of H1N1 are in general much higher than normal seasonal flu and/or the extent that the risks of H1N1 are more serious and/or more likely than the risks associated with vaccination. According to the Australian Government there have been no concerns raised from early vaccination trial data, however it is possible concerns might be subsequently identified.  Members should also set patient expectations that a second vaccination dose may be required and ensure appropriate recall systems are in place to achieve that. Ultimately, it is the patient after having been appropriately informed, that must make a decision as to whether they wish to proceed with vaccination or not. Information material The Australian Government has advised it will provide health professionals and patients with Pandemic H1N1 Influenza Vaccine Information material and also a “consent” form. These should be used.  Refer  As for any health service the patient’s medical record must also reflect advice given and the patient decision. Multi-dose vials For adults the H1N1 vaccine will be presented in multi-dose vials. Practitioners and patients need to be aware of the steps taken to remove potential risks associated with use of multi-dose vials particularly in relation to vertical transmission of blood borne diseases. Strict adherence to the RACGP Draft “Guidelines for the use of multi-dose vials” is required by MIPS because it will remove that risk and thereby provide confidence to patients when making a decision about H1N1 vaccination. Other matters The normal issues associated with seasonal influenza vaccines for e.g. egg allergies/potential issues with preservative, risk of bruising, infection, sterile abscess, nerve damage etc. remain for consideration in respect of H1N1 vaccination. In addition, strict attention to maintaining the cold chain (especially in view of the huge volume of vaccine and potential vaccinations) provides a greater challenge than for other vaccination programmes. Indemnity for members, those under members direct supervision and practice staff For those members whose practices are considering arranging for employed staff such as practice nurses to administer the vaccine, in addition to compliance with the above requirements (e.g. for advice and use of multi-dose vials) it is important to remember under the individual MIPS Insurance medical indemnity policy a MIPS member is covered for vicarious liability claims that arise from the provision of healthcare by others under the member’s direction in accordance with clause 12.1.7 of the member’s medical indemnity policy. The relevance of the clause is the requirement for the member’s appropriate and adequate direct supervision and also for the supervised individual to act within practice protocols. The MIPS Insurance Policy can respond if the member’s practice staff seeks indemnity from the member on the basis that the claim against them is as a result of the member’s actions or inactions but only if all requirements are met. MIPS Members’ Practice staff and the practice entity are also indemnified in accordance with the terms and conditions of the MIPS Member Practice Entity Policy. (A practice entity is defined as a practice in which a member has a financial interest and the majority of shares are owned by medical practitioners working in the practice). In general terms this policy provides cover for health care errors made by practice nurses, receptionists and other administrative staff who act independently and which may financially implicate the practice and/or the member. It is important to remember that MIPS requirements (as listed above including consent and use of RACGP guidance for the use of multi-dose vials) will be a pre-requisite in relation to indemnity for any H1N1 vaccination matters that arise.

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3 thoughts on “What does informed consent mean when it comes to swine flu vaccination?

  1. al

    Is there anything ‘mug consumers’ of swine flu vaccination can do to minimise their risk of contamination with multidose vials?

    Yes, be the first patient of the day to get it (the shelf life of the vaccine is only 24 hours after opening), and insist that the dose is drawn up from a new vial in your presence.

    In particular, don’t accept a dose in a syringe that is pre-prepared if it isn’t labelled (meaning the syringe itself is labelled with the name of the vaccine and the time and date it was prepared, not just taken from a box with other syringes).

    Things to discuss with your doctor:
    1. What are the benefits for me in preventing flu and its complications?
    2. What are the common side effects?
    3. What are the rare but serious side effects, and how rare are they? (in particular, nerve damage and serious allergic reactions)
    4. What measures are taken at the practice to minimize the risks associated with multidose vials?
    5. If you are concerned about the mercury containing preservative in the vaccine, how does the mercury content compare to mercury found ‘naturally’ in foods?

  2. Why you should talk to your doctor about swine flu vaccination: consumer group – Croakey

    […] Skip to content « What does informed consent mean when it comes to swine flu vaccination? […]

  3. What does informed consent mean when it comes to swine flu … | H1N1VACCINATION.US

    […] more here: What does informed consent mean when it comes to swine flu … Posted in H1N1 Vaccination. Tags: a-succinct-summary, adequate-informed, consent-including, […]

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