Reporting of Adverse Events

Adverse Event Reporting

 

The Animal & Veterinary Service (AVS) monitors suspected adverse drug reactions resulting from the use of medicines and vaccines in animals (also known as adverse events) under our Pharmacovigilance Programme.

To ensure that veterinary medicines and vaccines used in Singapore are safe for our animals, veterinarians and the pharmaceutical industry should report information pertaining to adverse events to AVS.

 

 

What is an adverse event?

An adverse event is defined as any unwanted or harmful event that occurs after the administration of a medicine or vaccine to an animal, which may be according to the label or off-label.

When should an adverse event be reported?

An adverse event should be reported as soon as possible after it has occurred, even if it is not certain that the particular medicine or vaccine in question is the cause of the adverse event. All suspected adverse events, regardless of severity, should be reported.

Why report adverse events?

The reporting of adverse events resulting from the use of medicines and vaccines in animals contributes to the safeguarding of animal health through the identification of previously unrecognised rare or serious adverse drug reactions. The submitted reports will be reviewed and assessed by us to determine if they are related to the veterinary medicine or vaccine administered.

Who should report an adverse event?

AVS-licensed veterinarians, or professionals who are employed in a pharmaceutical company (e.g. manufacturer, importer, wholesaler) dealing with medicines or vaccines used in animals.

For pet owners, please speak to a veterinarian instead if you suspect that an adverse event has occurred to your pet.

How to report an adverse event?

To report, please click here.

Please complete all fields in the form to the best of your knowledge as all information will be useful for our assessment. It should not take more than 15 minutes.

For serious adverse events (i.e those which result in death; are life-threatening; result in persistence of significant disability/incapacity or result in congenital anomaly or birth defect), please report them to AVS no later than 15 days after the event.