WHY SHOULD YOU REPORT?

The Reporting Form is at the heart of the Pharmacovigilance system and information collection is performed based on local reports received. Therefore, the importance of reporting is essential for the proper functioning of the pharmacovigilance system in Albania. You can download the form and submit it completed to AKBPM, or complete and submit it electronically. If there are several reports of the same case, then a signal is raised, which marks the start of the activity of the pharmacovigilance system. A high number of reports play a key role in Albania’s membership as a full member of the International Drug Monitoring Program (WHO-PIDM).

WHAT TO REPORT?

Report any side effects or health concerns that occur to you that you suspect have arisen from the drug you are taking. If you check for the side effect and it turns out that it is listed in the leaflet, you should still report it.

Find the following definition of side effect:

Undesirable effect is the unwanted or harmful response of the organism during the administration of a drug under normal conditions of use.

 Serious adverse effect, is any adverse effect that results in death, is life threatening, requires hospitalization of the patient or extension of the period of hospitalization, results in permanent or significant disability or disability, or is an anomaly inherited or birth defect.

Unexpected side effect is any unwanted effect, the nature, significance or outcome of which is inconsistent with the summary of product characteristics.

WHO CAN REPORT?

Doctors, Pharmacists, Dentists, Nurses, Other Health Professionals.

HOW TO REPORT?