Medicines and vaccines: adverse events

Source: Michael B., Flickr

Who are the biggest reporters of adverse events and what does the TGA look for in a report?

This month the TGA published its annual report prepared by the Pharmacovigilance and Special Access Branch (PSAB), outlining adverse event reporting statistics for 2015.

In 2015 the TGA received approximately 17,000 reports of adverse events.


As seen in the figure above, the majority of reports were made by sponsors.

Of the 17,000 total adverse event reports last year, approximately 54% (9286) were from sponsors, an increase from the previous year.

Fifteen per cent (2516) were from State and Territory Health Departments – specifically reports of adverse events following immunisation.

Hospitals and hospital pharmacists were behind 14% (2381) of reports; 6% (1105) were from community pharmacists; 4% (675) from GPs; 4% (654) from consumers; and 3% (470) from other sources.

While health professionals are encouraged to report suspected adverse events to the TGA directly, they can also report to the sponsor or manufacturer.

The TGA’s reporting system for adverse events began in the late 1960s with a computerised database dating back to the early 1970s. By the end of 2015 there were approximately 312,000 reports of suspected adverse events in the database.

Reports are passed on to PSAB, which assesses them for causality of adverse event(s). Medical officers review serious reports and branch staff regularly analyse reporting data to identify potential safety signals.

The TGA encourages reporting of all suspected adverse events to medicines and vaccines in Australia, including prescription, OTC and complementary medicines. It particularly encourages reporting of:

  • Suspected adverse events involving new medicines and vaccines
  • Suspected medicine and vaccine interactions
  • Unexplained adverse events (that are not described in the PI)
  • Serious adverse events

However it says reporting of “seemingly insignificant or common adverse events” can help contribute to ongoing investigations of potential safety signals.

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1 Comment

  1. Alison Claxton

    Consumers can report suspected adverse events to the TGA via the NPS AME (Adverse Medicines Event) phone line on 1300 134 237 – Pharmacists collect the details and context the TGA desires and send it through. Consumers can also report directly to the TGA via the TGA website.
    Health Professionals please report directly to TGA or the manufacturer.

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