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Published: May 2009

Launch of an electronic adverse reaction reporting tool

Prescriber Update 30(2): 7
May 2009

An electronic adverse reaction reporting tool has been launched in New Zealand. This tool is designed to facilitate the reporting of adverse drug reactions to the Centre for Adverse Reactions Monitoring (CARM) and uses an online reporting form pre-populated with patient details from the GP practice software.

The World Health Organization rates New Zealand as having the highest number of reports submitted per capita compared to other countries in their programme. Reports from New Zealand are also rated as being of the highest quality. Despite this, international research indicates that at best, only 1 in 10 adverse reactions are being reported in New Zealand.

In addition, research conducted in New Zealand examined the data stored in the Patient Management Systems of 30 General Practices. Of the 725 entries in the medical warnings files that recorded an adverse reaction or allergy to at least one medicine, only 21 were reported to CARM.

Known barriers to reporting include the absence of a prompt to initiate reporting, considering that the reaction is already well known, and finally the time required to manually fill in adverse reaction forms. The adverse reaction reporting tool has been developed to help overcome these barriers.

When the tool is opened it automatically pre-populates the patient’s medical history, medicine history, and gives the reporter the option of including laboratory test results. If a vaccine is a suspected medicine, the tool pre-populates the batch number, the date of administration, and how the vaccine was given. Once a description of the reaction is entered, one click on the mouse sends an electronic report to CARM.

Reporters can be assured that the confidentiality of patient and reporter details is maintained in this reporting tool. Although the electronic form is routed through a third party server, the information in the report is only viewed by CARM.

We are hoping that electronic reporting will result in an increase in adverse reaction reports. In addition, providing laboratory and other investigation reports improves the ability of the clinicians reviewing the data to determine whether the medicine is causing the reaction. This will speed up the process of data analysis and improve the identification of safety signals. The tool is also expected to allow for easier reporting of reactions to over the counter medicines and complementary medicines, both of which are under-reported in New Zealand.

This new reporting system is one of the first in the world to deliver direct electronic reporting of adverse reactions to GPs. Use of this system will strengthen the close relationship that exists between prescribers and the medicines safety community.

Editors note: Medsafe has developed the adverse reaction reporting tool with BPACNZ. For further information on the reporting tool and how to gain access to it, please contact BPACNZ (www.bpac.org.nz)