Ten Years Pharmacovigilance Activities in Iran

"nThe Adverse Drug Reaction Monitoring Center (ADRMC) in Iran started its activities as a full member of WHO Interna­tional Drug Monitoring Program in 1998. The Center has followed pharmacovigilance activities in the country with the main goal of increasing drug safety and preventing drug-related morbidity and mortality. To achieve its main goals, ADRMC has developed and implemented spontaneous ADR reporting system by health care professionals. In this article we have tried to elaborate on the achievement of the ADRMC in Iran. A total number of 17967 adverse drug events has been col­lected and evaluated by the Center. Evaluation of registered reports has led to 86 drug safety alerts to health care profes­sionals, recall of 23 pharmaceutical products and labeling changes of 30 others, suspension on distribution for 8 medicines and withdrawal from national drug list of 4 different products. &nbsp

Evaluation of anti-tuberculosis induced adverse reactions in hospitalized patients

Background: Tuberculosis has been one of the common diseases of human communities. Besides of disease-related complications, there are serious adverse reactions due to Anti-tuberculosis (Anti-TB) drug therapy. Objectives: To assess the rate of Adverse Drug Reactions (ADRs) induced by Anti-TB drugs in the infectious disease department for a period of one year. To detect serious and preventable recognized ADRs. Methods: All patients admitted to the infectious disease department at Imam tertiary teaching hospital in Iran who received Anti-TB drugs from July 2001 to July 2002 entered the study. These patients were monitored for ADRs during hospital stay. The ADRs were then classified based on patients and reactions factors. The causality and severity of the reactions were determined using Naranjo algorithm and Hartwig questionnaire, respectively. Results: During the study period, 83 patients received Anti-TB drugs; of them 44 developed at least one ADR. Total number of 81 ADRs was detected in this study. ADRs were recognized as the major cause of hospital admission in 11 (13.3%) patients. The most frequent system-organ class affected by ADRs was Liver and biliary system (37%). Hepatitis was observed in 21 (25.3%) patients leading to death in two patients. Conclusion: Anti-TB drugs could cause significant adverse effects both in quantity and severity leading to hospitalization, prolonged hospital stay and even death. More attention is needed to prevent these reactions

A Systematic Scoping Review of the State of Pharmacovigilance and Governance in the MENA Region: Challenges and Opportunities

Introduction Pharmacovigilance (PV) systems around the world vary in capacity and maturity. Many factors can influence PV. Objectives This systematic scoping review aims to explore the opportunities for effective PV in the Middle East and North Africa (MENA) region by (1) using the pharmacogovernance (PG) framework to evaluate the PV systems and (2) determining the factors influencing PV, including regulatory governance, PG, and international actors influence. Methods In accordance with Cochrane Collaboration guidelines, the STARLITE criteria were used to guide the systematic literature search and review process. The search included English and Arabic language databases, search engines, and grey literature and a supplementary search of the reference lists of included articles. Inclusion criteria were pertinent to the influence of PV, governance and health, PG framework domains, international actors, and MENA countries. Data synthesis followed the meta-aggregation process. Results From the 32 included records, the majority of PV-enhanced actions were from Saudi Arabia, Iran, and Morocco. The ‘policy, law, and regulations’ domain was the strongest in the MENA, whereas public ‘participation and representation’ was lacking. Further, the PG framework allowed the identification of shortcomings, including a lack of public inclusiveness and participation, resource scarcity, misalignment of resource allocation, issues with existing regulations, and deficiencies in ‘accountability and transparency’. Conclusion Most of the existing systems are still in their infancy, and disparities exist at national and regional levels. The operationalization of effective PV systems requires actions that assure (1) the development and enforcement of comprehensive regulations, (2) adequate and equitable aid for core PV processes, and (3) accountability and participation from all stakeholders.Funding This systematic scoping review was funded by Qatar University (Grant number: QUST-2-CPH-2017-7).Scopu