Iranian Pharmacovigilance Center reported on pharmacovigilance activities in Iran and managing medication errors. They found that 16.8% of 370 patients experienced adverse drug reactions, with 58.8% of reactions being preventable. Preventable adverse drug reactions were more severe and led to longer hospitalizations than nonpreventable reactions. The number of reported adverse drug reactions and reports from hospitals increased after interventions by manufacturers to monitor safety and submit periodic safety update reports to Iranian regulatory authorities.

1. Pharmacovigilance activities in Iran
Experience in managing medication
errors
reported by:
Iranian Pharmacovigilance Center
Edited :
Behrouz Mansouri
Mahmoud Nasseri
Muhammad Tanvir
Amirmasoud Nikahd

2. • 16.8% (n = 62) of the 370 patients had at least one ADR.
(102 ADRs).
• 58.8% of the ADRs (60 reactions) :preventable
reactions
• Preventable ADRs were more severe than those that
were nonpreventable.
• the incidence of preventable ADRs increased with the
patients' age and caused longer hospitalization than did
nonpreventable ones.

9. Number of ADRs and reports from hospitals
before and after interventions

11. • Every manufacturer is responsible for safety of its products
and must implement pharmacovigilance system.
• Every manufacturer must introduce a trained person in the
field of pharmacovigilance to Iranian ADR Monitoring
Center. This person should be able to evaluate ADEs and
conduct risk- benefit assessment for related pharmaceutical
products.
• Manufacturers must submit PSUR for their product
according to published guidelines of Iranian Food and Drug
Organization.

12. • 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