Pharmacovigilance in Iran

Pharmacovigilance activities in IranExperience in managing medication errors

reported by:Iranian Pharmacovigilance Center

Edited :

Behrouz MansouriMahmoud NasseriMuhammad Tanvir

Amirmasoud Nikahd

• 16.8% (n = 62) of the 370 patients had at least one ADR.(102 ADRs).• 58.8% of the ADRs (60 reactions) :preventablereactions• Preventable ADRs were more severe than those thatwere nonpreventable.• the incidence of preventable ADRs increased with thepatients' age and caused longer hospitalization than didnonpreventable ones.

Number of ADRs and reports from hospitalsbefore and after interventions

• Every manufacturer is responsible for safety of its productsand must implement pharmacovigilance system.• Every manufacturer must introduce a trained person in thefield of pharmacovigilance to Iranian ADR MonitoringCenter. This person should be able to evaluate ADEs andconduct risk- benefit assessment for related pharmaceuticalproducts.• Manufacturers must submit PSUR for their productaccording to published guidelines of Iranian Food and DrugOrganization.

• Immediate reporting• The following ADEs must report immediately:• Fatal ADEs• Life threatening ADEs• ADEs with permanent disability• ADEs leading to hospitalization• ADEs resulted in prolonged hospital stay• Birth defects suspected to an ADE