Reporting of Suspected Unexpected Serious Adverse Reactions

By Drug Safety Hub

Imagine you’re driving on a highway and you see a car broken down on the side of the road. You immediately call for help, right? This is similar to the reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) in the world of medicine.

Reporting a SUSAR is like calling for help when you see a car broken down. It’s a crucial step in ensuring the safety of all patients. It helps healthcare professionals and regulatory authorities monitor the safety and effectiveness of medications, and take necessary actions if needed.

Why is Reporting Important?

Just like how your call for help can get the broken-down car the assistance it needs, reporting a SUSAR can help get the necessary attention to a potential drug safety issue. It can lead to further investigations, changes in the product information, or even withdrawal of the drug from the market, if necessary.

Reporting also contributes to the larger database of knowledge about the drug. It helps healthcare professionals and researchers understand the drug better, and make informed decisions about its use.

How is Reporting Done?

Reporting a SUSAR is usually done through a specific process set by the national regulatory authority. It involves the submission of a detailed report that includes information about the patient, the drug, the adverse reaction, and any other relevant details.

Healthcare professionals and patients can both report a SUSAR. In fact, patient reporting is encouraged as it provides first-hand information about the adverse reaction.

Role of Patients