Review of the management of adverse effects associated with ...

The AEFI reporting system requires national
harmonisation and improved information flows
to ensure that relevant information is available in
‘real time’ to both the TGA and to the jurisdictions.
A consolidated reporting pathway should be
developed that is consistent nationally and is
user friendly. An agreed template/reporting
form should be developed for reporting AEFI in
all jurisdictions. Both health care professionals
and consumers should be able to make reports
using the same template and any phone reports
should be recorded on it as well. Simultaneous
reporting should occur with jurisdictions and the
TGA receiving copies of reports as they are made,
rather than in batches. Reporting of AEFIs to the
TGA by the jurisdictions and vice versa should be
standardised.
6.3.4 Transparency and Communications
The Review found there is a considerable lack
of knowledge of the AEFI surveillance system
among health professionals and consumers.
For the jurisdictions, there could be better
clarity of the processes within the TGA and the
interrelationships between TGA, the broader
Department and other bodies with roles in the
NIP. The distinction between the role of TGA as
regulator of the product (ie the vaccine) and the
role of the broader Department and the CMO
in making program decisions, in consultation
with the jurisdictions, about the use of vaccines
in the NIP is also not clear to many stakeholders.
The importance of prompt reporting of AEFIs
with accurate clinical information and sufficient
detail to enable follow up if necessary is not
well understood by many health professionals.
However, health professionals and consumers
who want to make a report are often not aware
of how to do so.
The Review also found a lack of understanding
by the community of the significance of reports
of AEFIs, when they constitute a safety signal and
when they are of sufficient concern to warrant a
suspension or cancellation of the use of a vaccine.
Informing the community of how the safety
system operates and makes decisions would
improve confidence in the system when specific
events occur.
The Review considers that an appropriate
communication strategy should be developed to
improve knowledge and awareness of the system
among stakeholders and encourage prompt
reporting.
Some health professionals and consumers felt they
were not sufficiently informed of the unfolding
events surrounding the suspension of the program
and the subsequent investigation, particularly
in the early stages before the suspension was
announced. The Review notes there are significant
challenges in determining how to communicate
with health professionals and the community
during the early stages of an investigation, when
there is a level of doubt about the significance of
the events. Jurisdictions and health professional
and consumer organisations may have to deal
with enquiries, including from the media, based on
rumours of a problem, before there a clear signal of
a potential safety issue warranting investigation has
been identified. In these situations, it is important
that there is a statement from a recognised
authority, such as the TGA or the CMO, to avoid
confusion and ensure that safety information is
available to the public.
The Review considers that a protocol for taking
program action, including informing health
professionals, consumers and the media, in the
event a possible safety signal affecting a NIP
vaccine is detected should be developed and
agreed by the DoHA and the state and territory
health authorities.
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Review of the management of adverse events associated with Panvax and Fluvax