Complaint

Pharmacovigilance Is the Science and activities concerned with detecting, analyzing and evaluating side effects of drugs and problems related to their use with the aim of reducing or preventing their occurrence (WHO 2002)

It Is The Patient’s unintended, unwanted or undesirable response to A drug, Including abnormal laboratory results that occur when the Patient takes approved doses of the drug.

What drug safety Information should be reported?

1. A side event
2. Side effect
3. Lack of drug efficacy
4. Overdose or misuse of the medicine outside the scope of the indications for use mentioned in the medicine leaflet
5. Use of medicine when pregnant or breastfeeding
6. Transmission of germs through medicines
7. A defect in the pharmaceutical manufacturing or fraudulent medicines
8. Mistakes in using the medecine
9. Drug interactions
10. Exposure to medication while working

1. Reporter identified: Name, phone, address
2. Patient identifier: The initials of the name, age or gender
3. Effect or side effects suspected of occurence
4. The name of a suspected drug: The trade name and the active ssubstance