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Action on reactions

22nd Aug 2011
Pamela Wilson   all articles by this author

Would reporting every adverse reaction to an immunisation improve vaccine safety? Pamela Wilson examines the new recommendations.


AT 8.30 AM one Saturday morning, two Sydney brothers, aged eight and five, had their first ever flu shot. At 3.30 pm – within five minutes of each other – both boys complained they felt sick. At 7.30 pm, they were in the emergency department of the Royal North Shore Hospital.

They had been vomiting constantly all afternoon. Neither could hold down even a sip of water.

“It seemed strange they both got very sick at exactly the same time, so we immediately thought it must have been from the immunisation,” explains the boys’ father, Anthony Johnston.

“We took them to hospital because we thought that if it was a reaction to the vaccine, we didn’t know what that meant or if the boys would get sicker.”

The boys were discharged late that night and by morning had fully recovered. “The doctor at the hospital couldn’t say if it was from the immunisation or not,” says Mr Johnston.

“We didn’t know how to report it so we just rang the GP on Monday, but I don’t know if she reported it or not.”

Both patients and immunisation providers can be confused about what constitutes an adverse reaction and how to deal with it: Is the event linked to an immunisation? If so, is it significant enough to report? Many consumers may not even draw the link and, if they do, like the Johnstons they may not know who to report it to.

Professor John Horvath investigated these responses in his recent report, the Review of the Management of Adverse Effects Associated with Panvax and Fluvax, which offers a host of recommendations to improve vaccine safety monitoring.

The review was commissioned by Parliamentary Secretary for Health and Ageing, Catherine King, after more than 100 cases of febrile convulsions were reported during last year’s seasonal influenza vaccine program.

Meanwhile, the MJA recently reported that 8% of adverse events following immunisation reported by passive surveillance in Australia in 2009 were judged to be serious (MJA 2011; 195(1):4-5).

The Department of Health and Ageing has accepted all  Prof Horvath’s recommendations, with initial work to begin on recommendation one and two (see box) and full implementation to occur over the next two years.

Nationally agreed protocols for action and communication (recommendation five) are expected to be in place prior to the start of the 2012 seasonal influenza immunisation program, a department spokeswoman says.

Professor Horvath found that while Australia’s vaccine monitoring system had many strengths, it could be more timely in its reporting.

“Factors that impact on this timeliness of reporting include: health professional and consumer knowledge of how to report; delays in information exchange between the jurisdictions and the TGA; reports being sent in batches; differing forms and protocols used in each jurisdiction, and a lack of agreed case definitions,” the report reads.

The findings and recommendations have been widely supported by industry members, but as RACGP National Immunisation Committee representative Dr Michael Crampton says, whether or not they are successful in achieving the aims depends on how they are implemented.

“Any of these processes that come from government that cook up plans and strategies and so on risk overloading the GP workflow,” he says.

“We have to be sure that whatever is put in place is effective from the profession’s point of view, is supported by the profession, and is able to be delivered by the profession.”

Dr Crampton adds that the college is still formulating its official response to the recommendations because it plans to put forward suggestions on how the implementation process should proceed.

AMA President Dr Steve Hambleton also has some ideas about how to improve the system, but is quick to point out that, in the absence of a safety signal, the high rate of febrile convulsions last year was picked up relatively swiftly.

“A couple of West Australian doctors on the front line twigged and started the reporting process… so it was fortuitous that the kids were concentrated in WA,” says Dr Hambleton, who was the AMA representative on the National Immunisation Committee between 2006-2010.

That’s why, he believes, there is a need for immunisation providers to report every subsequent event, perhaps through the vehicle of a whole-of-life immunisation register.

He says that for all health care providers there are barriers to timely reporting such as knowing what reports are important and having the time to fill in the forms.

“If there were adverse events in that (immunisation register) document, that would make it very easy to report,” says Dr Hambleton.

“There could be one extra box for adverse events and they could report everything… the reporter shouldn’t have to decide if it was related. They just write down everything subsequent.”

Brisbane GP and senior lecturer in general practice at the University of Queensland Dr Andrew Gunn believes vaccine side-effects would be grossly under-reported.

“People have things happen to them and you don’t necessarily link it to a vaccine,” he says.

“Even if something is clear cut, it is usually fairly minor… and usually you are so busy dealing with things that the reports don’t go off.”

Like Dr Hambleton, Dr Gunn feels that computer software that involves ‘ticking boxes’ would make it easier to report.

Consumers Health Forum executive director Carol Bennett sympathises with GPs, acknowledging that the process is burdensome in a profession already overloaded with paperwork.

“It is time-consuming for GPs when they are already very busy. You are asking them to print off a blue form, fill it in and send it off with no necessarily good feedback about what ends up happening with that information, so where’s the incentive?” says Ms Bennett.

But equally important, she says, is the need for a clear set of criteria in determining safety signals.

“If you don’t have a clear set of criteria around what constitutes a signal it’s very difficult to see how the system will be more responsive. It will simply be a data repository that doesn’t necessarily respond to emerging concerns,” she says.

But Dr Crampton says that reporting every subsequent event would actually add to the time GPs spent on reporting adverse events.

“If the direction was to report absolutely everything... you would have an enormous potential for an array of reports and an enormous potential impact on the clinician’s workflow,” he says.

National Centre for Immunisation Research and Surveillance Associate Professor Kristine Macartney says the reporting system needs to be easier for healthcare providers, but should focus on unusual, severe and unexpected reactions.

“The way GPs report adverse events currently varies significantly between the different states and territories and there are some improvements to be made to streamline and make it easier for GPs to report,” she says.

“GPs shouldn’t feel they need to make the link themselves, but by the same token any system that encourages reporting does so with an acknowledgement that many of the mild and expected reactions… can be managed by the immunisation provider, and parents can be given guidance about that.”

Also high on the agenda is getting right the recommendations of improved communication and better governance.

As Ms Bennett points out, real-time reporting would have overcome some of the delays in communication between the TGA and the West Australian Government during last year’s immunisation program.

“The fact that there were no clear governance arrangements in place was of particular concern,” she says.

“What we can do is strengthen the current system. We need some clarity around the roles and responsibilities and the criteria on which you base decisions, when to act and when not to and what information to give the community and when to hold information.”

The recommendations

1. Improved governance of the Vaccine Safety System, which may include the establishment of a Vaccine Safety Committee.

2. Improving management of adverse events from immunisations through the development of surveillance objectives, protocols and procedures.

3. Improvement of the national system for timely reporting of adverse events following immunisation.

4. Better education of jurisdictions, health professionals and consumers of vaccine safety monitoring processes.

5. Establishment of protocols around when to take action if a safety signal is detected.

6. Improved transparency of the TGA’s vaccine safety monitoring processes.

7. Development of e-health strategies around collection of vaccine usage and safety monitoring data.

Tags: , Child health

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