01.Consumer reporting of adverse drug reactions
An adverse drug reaction occurs when you have a negative response to any type of drug. This can occur with both prescription, complementary and over the counter drugs and can be potentially serious. In the past, such reactions have only been reported by doctors. We believe that consumers should be able to report these events themselves and not only have to rely on their GP.
The benefits include the following:
- Earlier receipt of reports about potential adverse reactions.
- Increase in the frequency of reports of over the counter and complementary medicines.
It also compliments reports by health professionals and may address underreporting of adverse drug reactions by health professionals.
The Australian Council on the Quality and Safety in Healthcare funded the Adverse Medicine Events (AME) Line in October 2003. As of July 2005 the AME Line received 3,023 calls from consumers. Serious adverse drug reaction reports are sent to the Adverse Drug Reactions Committee which advises the Therapeutic Drugs Authority (TGA) about drug safety.
Reporting of adverse events by consumers has resulted in some important changes, including improvements in product labeling and the correction of an error in a commonly used medical reference book.
After facing uncertainty for some time, the National Prescribing Service has recently agreed to manage the AME Line with funding from the Department of Health and Aging. However, this is only guaranteed until the end of 2006-07. If funding is not continued, consumers will once again have to count on their GPs, even though the AME line showed that consumers are a valuable source of drug safety data.
The 28th Annual Meeting of the WHO (World Health Organisation) Program on Consumers Reporting Problems by Phone was held in Geneva in October 2005. Seventy eight countries participated in the program and the Australian AME line was used as a case study. Since 1968, 3.5 million reports have been generated in the WHO database as a result of consumer reporting of adverse events.
What we want
We want consumers to be able to report adverse medicine events. Consumers in other countries including Canada, the US, Netherlands and Sweden among others have such a mechanism and so should Australian consumers.
We think the National Prescribing Service is the best place for the AME line. The NPS runs a Medicines Line which advises consumers about medicines. The AME line compliments Medicines Line and means consumers can seek advice and report adverse events to one organisation. It is also important that there is a mechanism for the NPS to provide the information to the TGA quickly to enable a prompt response to issues with the safety of medicines.
What we’re doing
We are meeting with the stakeholders to stress the importance of consumer reporting of adverse events. Australian consumers should have access to a telephone medicines events line, as consumers in other countries do.