Reporting Process

By Drug Safety Hub

Imagine you’re hiking in a forest and you come across a fallen tree blocking the path. You want to report it to the park authorities so they can remove it. But how do you do it? This is similar to the reporting process for Suspected Unexpected Serious Adverse Reactions (SUSARs) in the world of medicine.

Reporting a SUSAR is like reporting the fallen tree. It’s a crucial step in ensuring the safety of all patients. But how is it done?

Step 1: Identification

The first step in the reporting process is identification. This is like recognizing that the tree has fallen and is blocking the path. In the context of SUSARs, this involves recognizing that an unexpected serious adverse reaction has occurred.

Step 2: Documentation

The next step is documentation. This is like taking a picture of the fallen tree or writing down its location. For SUSARs, this involves documenting all the relevant details about the adverse reaction, such as the symptoms, the timing, and any other relevant factors.

Step 3: Reporting

The final step is reporting. This is like calling the park authorities and telling them about the fallen tree. For SUSARs, this involves submitting a detailed report to the national regulatory authority.

The report typically includes information about the patient, the drug, the adverse reaction, and any other relevant details. It’s important to provide as much detail as possible to help the authorities understand the situation and take appropriate action.