Action 4.09

Any adverse event that may have been caused by a medicine is a suspected ADR. Suspected ADRs that patients experience during their episode of care that have not been previously experienced or documented are considered to be new. Report these new suspected ADRs to the TGA’s adverse event reporting system via the TGA website.

Assist communication and feedback about ADR reports by enrolling the health service organisation as a registered user when completing and submitting a report to the TGA’s adverse event reporting system.

Registered organisations have access to information about their own reports through the TGA website or by contacting the TGA directly. Reports sent by email will only be accessible if the organisation’s name and address are included in the report, and the reporter type is designated as ‘hospital’.

Review current information and training

Review current organisational policies, procedures and guidelines to ensure that all suspected ADRs that patients experience during their episode of care are reported to the TGA. Include or refer to specific TGA information about:

• What to report
• How to report suspected ADRs
• How to maintain a record of the suspected ADR in the patient’s healthcare record
• The process for a copy of the report to be sent to the organisation’s pharmacy department, drug committee or equivalent, or medication safety governance group.

The health service organisation can include the capability to report suspected ADRs online to the TGA as part of its strategy for electronic medication management.

Provide orientation, training and education to clinicians on reporting suspected ADRs to the TGA. This should include the importance of providing comprehensive information about the patient, the medicine that is suspected of causing the reaction, the patient’s concurrent medicines, the reaction they experienced and the organisation at which it was experienced.

Health service organisations can use online learning modules developed by the TGA for health professionals on reporting adverse events with medicines and vaccines.

Assess the quality, content and timeliness of ADR reports. Reports are most useful for detecting new safety issues if they are made soon after the reaction has occurred. Encourage clinicians to report ADRs by using awareness campaigns.

Access information on ADRs and medication safety issues by:

• Reading the Database of Adverse Event Notifications
• Visiting the Medicines safety page
• Subscribing to the Medicine Safety Update email list
• Subscribing to the TGA Safety Information email list.

Communicate about ADRs

Collate and review ADRs that have been experienced and reported, and circulate information to clinicians through medication safety bulletins, in-service orientation sessions, case reports or grand rounds.

Include ADR reports for the relevant governance committee to consider as part of the review of the safety of the medication management pathway.

Provide patients with information about ADRs, how to recognise symptoms and how to self-report to the TGA. Both the TGA and NPS MedicineWise have information on their websites that is suitable for consumers.

Any adverse event that may have been caused by a medicine is a suspected ADR. Suspected ADRs that patients experience during their episode of care that have not been previously experienced or documented are considered to be new. Report these new suspected ADRs to the TGA’s adverse event reporting system via the TGA website.

Assist communication and feedback about ADR reports by enrolling the health service organisation as a registered user when completing and submitting a report to the TGA’s adverse event reporting system.

Registered organisations have access to information about their own reports on the TGA website or by contacting the TGA directly. Reports sent by email will only be accessible if the organisation’s name and address are included in the report, and the reporter type is designated as ‘hospital’. This applies to day procedure services.

Review current information and training

Review current organisational policies, procedures and guidelines to ensure that all suspected ADRs that patients experience during their episode of care are reported to the TGA. Include or refer to specific TGA information about:

• What to report
• How to report suspected ADRs
• How to maintain a record of the suspected ADR in the patient’s healthcare record
• The process for a copy of the report to be sent to the organisation’s medication safety governance group.

The health service organisation can include the capability to report ADRs online to the TGA as part of its strategy for electronic medication management.

Provide orientation, training and education to clinicians on reporting suspected ADRs to the TGA. This should include the importance of providing comprehensive information about the patient, the medicine that is suspected of causing the reaction, the patient’s concurrent medicines, the reaction they experienced and the organisation at which it was experienced.

Health service organisations can access online learning modules developed by the TGA for health professionals on reporting adverse events with medicines and vaccines.

Assess the quality, content and timeliness of ADR reports. Reports are most useful for detecting new safety issues if they are made soon after the reaction has occurred. Encourage clinicians to report ADRs by using awareness campaigns.

Access information on ADRs and medicine safety issues by:

• Reading the Database of Adverse Event Notifications
• Reading the bimonthly Medicines Safety Update publication
• Subscribing to the Medicines Safety Update email list
• Subscribing to the TGA Safety Information email list.

Communicate about ADRs

Collate and review ADRs that have been experienced and reported, and circulate information to clinicians through medication safety bulletins, in-service orientation sessions or case reports.

Include ADR reports for the relevant governance committee to consider as part of the review of the safety of the medication management pathway.

Provide patients with information about ADRs, how to recognise symptoms and how to self-report to the TGA. Both the TGA and NPS MedicineWise have information on their websites that is suitable for consumers.

Examples of evidence

Select only examples currently in use:

• Policy documents on recording and reporting suspected ADRs to the TGA
• Record of suspected ADR reports submitted to the TGA
• Communication to the workforce explaining the process for reporting suspected ADRs to the TGA
• Reports from audits of workforce compliance in using the process for reporting ADRs to the TGA
• Communication with the workforce and the highest level of governance summarising TGAreports of suspected ADRs experienced within the health service organisation
• Consumer resources outlining how they can self-report ADRs to the TGA
• Orientation or training documents about identifying and reporting suspected ADRs to the TGA.

Any adverse event that may have been caused by a medicine is a suspected ADR. Suspected ADRs that patients experience during their episode of care that have not been previously experienced or documented are considered to be new.

MPSs or small hospitals that are part of a local health network or private hospital group should adopt or adapt and use the established process for recording and reporting new suspected ADRs.

Small hospitals that are not part of a local health network or private hospital group should:

• Report new suspected ADRs to the TGA through the Australian Adverse Drug Reaction Reporting System
• Enable communication and feedback about ADR reports by enrolling the health service organisation as a registered user when completing and submitting a report to the Australian Adverse Drug Reaction Reporting System.

MPSs or small hospitals may need to consider training for members of the workforce who are responsible for reporting ADRs online to the TGA.