HIV/STI Surveillance Research Center, and WHO Collaborating Center for HIV Surveillance, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.
National Institute for Medical Research Development, Tehran, Iran.
Int J Health Policy Manag. 2022 Jul 1;11(7):990-1000. doi: 10.34172/ijhpm.2020.243. Epub 2020 Dec 14.
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.
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.
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.
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.
评估药物警戒系统有助于发现其不足之处，并有助于采取措施补救和提高不良药物反应（ADR）报告的数量和质量，以及加强药物警戒系统的其他机会。本研究旨在使用世界卫生组织（WHO）药物警戒指标评估伊朗的药物警戒状况，以期发现差距和改进领域。
本研究分为两部分。第一部分包括使用基于世界卫生组织核心药物警戒指标的结构化数据收集表，对从伊朗国家药物警戒中心（PVC）获得的国家数据进行二次分析。第二部分是一项为期 3 个月的前瞻性研究，旨在调查伊朗东南部和北部 2 家主要转诊医院的所有患者的 2 个结果指标，即住院时间和与药物相关的住院费用。
伊朗拥有一个具有国家政策、培训人员和法定预算的 PVC。2017 年，ADR 报告数量为每 10 万人 15.0 份，在过去 5 年中发现了 262 个信号。Afzalipour 医院和 Razi 医院与药物相关的住院平均住院时间和费用分别为 5 天和 817.2 美元，6.6 天和 306.7 美元。伊朗公共卫生计划（PHPs）中的药物警戒状况未知，大多数指标无法评估。
一个强大的药物警戒系统是整个药品监管系统的关键部分。伊朗药物警戒系统具有相对适当的结构条件。尽管 ADR 报告，特别是与药物相关的死亡报告的漏报是一个重要问题，并且一些指标的状况尚不清楚。伊朗药物警戒计划需要更高的优先级，特别是在 PHPs 中，需要更多的资源分配和跨部门合作，以加强和实现药物警戒目标。
