Evaluation of Pharmacovigilance System in Iran

Abstract

Background: Evaluating 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. Methods: This study was conducted in 2 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 3-month prospective study was carried out to investigate 2 outcome indicators, ie, length of stay and costs of medicine-related hospitalization in all patients of 2 main referral hospitals in the southeast and north of Iran. Results: Iran has a PVC with national policy, trained staff, and a statutory budget. In 2017, the number of ADR reports was 15.0 per 100 000 population, and 262 signals were detected during the preceding 5 years. The average length of stay and costs of medicine-related hospitalization were 5 days and US$817.2 in Afzalipour hospital and 6.6 days and US$306.7 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. Conclusion: A 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.

Incidence of Adverse Drug Reactions in Two Tertiary Hospitals: A Prospective Observational Study

“…A detailed description of study methodology has been previously reported [23,28]. The following provides a summary with relevant additional detail as needed.…”

Heuristic Evaluation of adverse drug reaction reporting System

“…Most of the researches done regarding evaluationknowledge, attitude and performance of pharmacovigilance system. Meanwhile, the existence of a drug monitoring system has led to the improvement of the quality and quantity of drug side effect reports and provides more accurate decision-making in this eld [11].Around the world voluntary reporting systems have been working in the eld of pharmacovigilance for over forty years. Along with the activities carried out in many countries, also in Iran, the National Center for Registration and Investigation of Adverse Drug reactions is responsible for organizing the activities of adverse drug reactions and also to collect and review the reports at the national level.…”

“…In 1997, the rst cases of drug side effects were sent to the newly established ADR center of the country, and in 1998, Iran joined the WHO international program [12]. The Center for Registration and Investigation of Adverse Drugs, as the only national center in the country, collects and registers reports of drug side effects observed by the medical community in order to collect adverse drug reactions reports, according to international standards, yellow forms (Yellow card) has been prepared by this center [11].…”

Adverse Events Following Immunizations in Infants Under 1 Year of Age in Lorestan Province, Western Iran

“…An AEFI can be any unfavorable or unintended sign, abnormal laboratory finding, symptom or disease. Pharmacovigilance has a low priority in developing countries [ 16 ] such as Iran, where the status of pharmacovigilance is unclear [ 17 ]. Therefore, more studies on recognizing and reporting AEFIs are needed in these countries to guide legislators and patients in addressing their concerns about the safety of vaccines.…”