Issue 44 / 18 November 2013

A “POLICY gap” is affecting the way adverse drug reaction data are collected in Australia, says a medicine safety expert.

Dr Janette Randall, chair of the NPS MedicineWise board, said consensus was required on what should be reported and how that information should be used.

“There is no consensus about what we should be reporting and the purpose of that data”, she said.

Dr Randall was commenting on a survey of almost 5000 consumers, published this week in the MJA, which found that only about one in 10 respondents were aware of the processes to report adverse drug reactions (ADRs). (1)

The researchers said consumers could contribute to the understanding of medicine safety and called for promotion of reporting systems and education on how to use such systems.

However, Dr Randall said until consensus was reached on what events should be reported and how that information could be used, encouraging more consumers to report ADRs was “putting the cart before the horse”.

“There is really no understanding among consumers about what to report and why they would do that and I think the same is probably true for health professionals. So I think it is the responsibility of the National Medicines Policy stakeholders to do some work around the policy position of what should be reported and what we’re going to do with that data.”

Consumers Health Forum CEO Carol Bennett said increased investment was required to make consumer ADR reporting both practical and purposeful.

“To date, we have not seen the investment go into consumer reporting [that] we’ve always invested in industry reporting or health practitioner [reporting]”, she said.

Unless there was investment in ensuring that the correct information was provided by consumers and that the information was calibrated in a way that could be used effectively “then it’s not likely to be as robust a system as it should be”, she said.

Ms Bennett said consumer reporting had not been a high priority, and yet such reports could help to provide more rounded information about drug safety.

“Consumers can often report [events] that health professionals might not pick up on or might not be reported to drug companies, so we should be encouraging all parties to be reporting because they come at it from different perspectives”, she said.

“The problem with [the existing ADR reporting systems] is that they are not necessarily set up to interpret consumer adverse event reports and I think that’s partly why reporting is not overly encouraged.”

However, Ms Bennett said even without the ability to thoroughly interpret data, consumer ADR reporting could still provide powerful trend data.

Dr Randall said GPs remained the most likely conduit for the collection of consumer ADR information.

The MJA research found that of the 46.3% of respondents who had experienced a side effect from a medicine, 84.6% had reported the event to a health care professional. However, it also found that health professional reporting rates were low.

“Of the 14 400 reports received by the [Therapeutic Goods Administration] in 2011, only 7% were submitted by GPs, compared with 28% of the 10 981 reports received in 2003”, the researchers wrote.

Dr Randall said adverse event reporting was an added task for GPs. “GPs generally do things if they think there is some purpose or value in it and, at the moment, that is lacking”, she said.

Automation may have a future role in enabling ADR data collection, Dr Randall said, adding that NPS MedicineWise was developing a program that could be used to enable GPs to more easily record ADR data. The MedicineInsight program was expected to be available in 300 practices by the end of 2014, with a long-term goal of 500 practices. (2)


1. MJA 2013; 199: 684-686
2. NPS MedicineWise 2013; MedicineInSight


Would more explicit criteria encourage you to report adverse drug events?
  • Yes (70%, 32 Votes)
  • No - already reporting (20%, 9 Votes)
  • No -- other factors inhibit it (11%, 5 Votes)

Total Voters: 46

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