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

6.3 Improving the monitoring of
AEFI in Australia
Based on a consideration of the monitoring and
reporting procedures in place in Australia at
national and jurisdictional levels, the information
provided by jurisdictions, the interviews with
stakeholders and the information received about
international systems, the Review considers that
the monitoring of AEFI in Australia is in keeping
with international systems of passive adverse
events surveillance. The recent issues surrounding
the events that prompted this Review, however,
have demonstrated that improvements could be
made to make the system more robust and timely.
Areas considered for improvement have been
grouped under several headings:
• Governance arrangements
• Clarifying the objectives and processes for
AEFI monitoring
• Harmonising reporting and improving
information flows between TGA and the
jurisdictions
• Transparency and communication
• Improving the collection of vaccine
administration data
6.3.1 Governance arrangements
While the TGA has legislated responsibility
to monitor the safety of vaccines, many
organisations, committees and individuals have a
role to play in identifying, investigating and acting
upon safety signals related to vaccines in use in
Australia, particularly those used in the NIP. These
groups and their roles have been described in
the National Immunisation Program—Governance
section. The Review found, however, that there
was a lack of clarity about the relationships
between these groups and that their roles and
responsibilities in AEFI surveillance and vaccine
safety monitoring are not well understood
by jurisdictional health authorities, health
professionals and the public.
A particular issue is the differentiation between
when regulatory action for a product, which is
a legislated responsibility of the TGA, is required
and when non-regulatory action related to the
use of a vaccine in a national (or jurisdictional)
program may be indicated. The Review notes
that there are no Standard Operating Procedures
for responding to a vaccine safety issue that
does not require regulatory action but which has
possible implications for the use of a vaccine in a
vaccination program.
The Review notes that, with the increased
complexity of the NIP, governance arrangements
that were appropriate for a smaller program need
to be changed to meet the needs of the larger
program. Improved governance arrangements are
needed with the establishment of clear lines of
responsibility for managing a vaccine safety issue
and for reporting, decision making and action.
Options for achieving improved governance
identified by the Review include:
i. maintaining the current organisations and
structures but developing more robust and
clear governance and reporting through
clearly defining the roles and key areas
of responsibility of each of the existing
committees and organisations and their
relationships to each other.
or
ii. establishing and resourcing a Vaccine
Safety Committee (VSC), a new body with
responsibility for monitoring vaccine safety
in Australia. The new body could be a
subcommittee of the Therapeutic Goods
Administration (TGA) Advisory Committee
on the Safety of Medicines (ACSOM).
It should have a broad membership of
experts with knowledge of vaccines,
vaccine safety, pharmacoepidemiology and
vaccine program implementation.
or
30
Review of the management of adverse events associated with Panvax and Fluvax