This content is current only at the time of printing. This document was printed on 21 February 2017. A current copy is located at http://apvma.gov.au/node/12886
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Adverse reactions and how to report them
Report an adverse reaction directly to the APVMA
Anyone who observes an adverse reaction associated with administration of the Hendra virus vaccine to a horse can report it directly to the APVMA through the Adverse Experience Reporting Program.
Reports can be made in one of two ways:
- online, or
- downloading the form and send it to the APVMA (People without internet access can call 02 6210 4701 and request a form)
Successful submission of your online reports will be acknowledged on the final screen including a reference number and contact details. Reports submitted by other methods (email, fax, post) will receive a written acknowledgement of the receipt of the report.
Reports of adverse reactions can otherwise be made to your veterinarian or the product registration holder, Zoetis. Multiple reports can be made about the same event, for example, even though you may have made a report to your veterinarian or the product registrant, you can also make a report to the APVMA if you wish.
If you are making a report direct to the APVMA where a report has also been made through the veterinarian who administered the vaccine, please indicate this in your report and include as much detail as possible. Information about the horse’s unique microchip identification number, where available, is of particular assistance to the APVMA in reconciling the reports it receives.
All reports are welcome, although reports from individuals who are directly involved and present during an event are the most valuable.
Section 161 of the Agvet Code requires the product registration holder to provide any relevant information, which may include information about or knowledge gained from adverse experiences, to the APVMA as soon as the holder becomes aware of the information. Significant penalties may also apply under section 161 of the Agvet Code if a person contravenes that provision.
What happens after you make a report?
The APVMA evaluates and classifies every adverse experience report it receives. If we require more information from you we may contact you directly and we will let you know the result of the assessment of your report.
The report will be provided to the product registration holder for them to conduct their own investigations and to provide their opinion about the likely relationship between the product and the symptoms observed. The APVMA will then take this information into account when making an independent assessment of the likely relationship between the product and the reported adverse experience.
The experience reported will then be given a rating of unlikely, unknown, possible, or probable based on what we know about the product and the circumstances of administration.
A rating of 'probable' requires the following three criteria to be met:
- a reasonable association between exposure to or the use of a product and the onset and duration of the reported reaction
- the presenting signs are consistent—or at least plausible—with the known pharmacology and toxicology
- there are no other equally plausible explanations
When any of these criteria is not met because of insufficient or conflicting data, the relationship is not classified as ‘probable’.
A 'possible' rating is given when the administration of the Hendra virus vaccine is one of several possible and equally plausible explanations for—or contributing factors to— the adverse experience, such as a previously existing condition.
See a full explanation of the rating classifications.
Each report is also considered in the context of other reports we have received to identify trends and allow thematic analysis. All reports are considered relevant and are added to our database, even if the symptoms reported are classified as being unlikely to be related to the vaccine.
As new reports, information or trends emerge we may revisit our classifications of earlier reports. We use all this information to inform our regulatory activities.
It is not the role of the APVMA to do a detailed investigation into each report. We do not undertake independent testing—we work on the basis of the information we have and expert judgement about the likelihood the use of the product caused the reported symptom. We do not provide a definitive diagnosis for individual animals or cases.