Blacktown Hospital Trials Improved System for Reporting Adverse Drug Reactions

An improved system to report adverse drug reactions to the Therapeutic Goods Administration (TGA), now being trialled at Blacktown Hospital, is set to increase both the quality and quantity of reports sent to the TGA.

Reporting of adverse drug reactions is consistently low in Australian hospitals, but by linking the electronic medical record (eMR) system to the Pharmacy Department, the project’s Principal Investigator, Dr Ron Castelino, and clinical pharmacist Kristen Bondesio at Blacktown Hospital, hope to improve both the quality and quantity of reports sent to the TGA from the hospital.

“Clinicians don’t often report side effects to the TGA, but we know they will add the reactions into the patients’ eMR,” said Dr Castelino. “Now, with the Pharmacy Department reviewing the side effects before sending to the TGA, the quality of information sent to the TGA will be very good.”

Thanks to funding from the Sydney Health Partners Implementation Science Pilot Grant Program, a custom-built report that pulls all necessary information can now be generated, enabling the Pharmacy Department to easily review and submit reports to the TGA on a monthly basis.

Dr Castelino, who is also a clinical pharmacist at Blacktown Hospital, says that while reporting of adverse drug reactions to the TGA is voluntary, it is a crucial step in the drug lifecycle.

“When medicines enter widespread use, sometimes side effects emerge that weren’t discovered during clinical testing,” he said. “Understanding and reporting these side effects to the TGA allows it to take action, and potentially remove medicines from the market that cause harm to patients.”

Despite this, reporting is rarely done, in part due to the time-intensive nature of reporting. This requires completing an online or paper form, then emailing or posting it to the TGA.

“Research shows that only 10% of adverse reactions are sent to the TGA, and when we looked at Blacktown Hospital, there’s only been one or two reports sent in the past year,” said Dr Castelino.

Now that the reporting has been added into the eMR, the next step for Dr Castelino and the project team is to ensure its implementation is successful.

Projects funded as part of the Implementation Science Grant Program are required to show engagement with implementation science methods, with a clear plan for how the innovation is to be implemented into clinical practice.

To address this, the team undertook a survey of clinicians at the Hospital – including nurses, doctors and pharmacists – in order to understand the barriers and facilitators to the implementation of the project, and to plan educational modules to address these.

“We were surprised to find that a lot of the clinicians weren’t aware of the extra reporting step,” said Dr Castelino.  “Many clinicians thought that by adding adverse drug reactions to the eMR they were already reporting to the TGA.”

“So, there’s a bit of education to do there to ensure that they add the correct information into the eMR. Even though the process is now easier for clinicians, we know this doesn’t guarantee there will be uptake.  We need to support them.”