Evaluation of Pharmacovigilance System in Iran

BackgroundEvaluating a pharmacovigilance system helps identify its deficiencies and could facilitate measures to remedy and improve the quantity and quality of adverse drug reaction (ADR) reports and other opportunities for pharmacovigilance systems strengthening. This study aimed to evaluate the status of pharmacovigilance in Iran using the World Health Organization (WHO) pharmacovigilance indicators with the prospect of identifying the gaps and areas for improvement. MethodsThis study was conducted in ۲ parts. The first part included a secondary analysis of the national data obtained from the Iranian National Pharmacovigilance Center (PVC) using a structured data collection form based on WHO core pharmacovigilance indicators. In the second part, a ۳-month prospective study was carried out to investigate ۲ outcome indicators, ie, length of stay and costs of medicine-related hospitalization in all patients of ۲ main referral hospitals in the southeast and north of Iran. ResultsIran has a PVC with national policy, trained staff, and a statutory budget. In ۲۰۱۷, the number of ADR reports was ۱۵.۰ per ۱۰۰ ۰۰۰ population, and ۲۶۲ signals were detected during the preceding ۵ years. The average length of stay and costs of medicine-related hospitalization were ۵ days and US۸۱۷.۲ in Afzalipour hospital and ۶.۶ days and US۳۰۶.۷ in Razi hospital, respectively. The status of pharmacovigilance in the Iranian public health programs (PHPs) is unknown, and most of the indicators could not be assessed. ConclusionA robust pharmacovigilance system is a pivotal part of the overall medicines regulatory system. The Iranian pharmacovigilance system has relatively the proper structural condition. Though the underreporting of ADRs, especially medicine-related deaths, is an important issue, and some indicators’ status was unclear. The Iranian pharmacovigilance program requires a higher prioritization, particularly in the PHPs, a greater allocation of resources, and cross-sectoral cooperation to bolster and achieve the pharmacovigilance objectives.

Keywords:

Pharmacovigilance , Adverse drug reaction , Pharmacoepidemiology , Iran