University of Khartoum

Assessment of Pharmacovigilance System (Post-Market Surveillance of Adverse Drug Reaction) In Khartoum State, 2014

Assessment of Pharmacovigilance System (Post-Market Surveillance of Adverse Drug Reaction) In Khartoum State, 2014

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Title: Assessment of Pharmacovigilance System (Post-Market Surveillance of Adverse Drug Reaction) In Khartoum State, 2014
Author: Yassin, Salma Mohamed Elhassan
Abstract: Background: Adverse drug reactions (ADRs), contribute significantly to morbidity and mortality. The pharmacovigilance (PV) system safeguards the public through efficient and timely identification, collection, assessment, and dissemination of medicine-related adverse events. Assessment of PV systems over time is necessary to identify areas that need strengthening. The current study was conducted with an objective to assess PV in Khartoum state by using the Strengthening Pharmaceutical Systems (SPS) Program updated guidelines for the developing countries. Materials and Methods: This was a cross-sectional, observational, descriptive study. Data were collected from three different levels: National PV center, State PV unites and Drug Information Centers (DIC) assigned body for PV activity in hospitals. Sample size ensured total coverage of 17 sentinel site at hospitals. Data were collected by structured questionnaire and analyzed using Statistic Package for Societal Science (SPSS) version 21 and Microsoft excel. Results: The existence of all indicators at national, state levels and hospitals was found to be 56%, 60% and 4% respectively. Core indicators were shown to be at national, state levels and hospitals existed in the following sequence 69%, 61% and 6% respectively. While supplementary indicators were found to exist at national, state levels and hospitals as follow 35%, 50% and 0% respectively. According to the structural, process, and outcome classification ,the existence of structural indicators was found to be 80%, 88% and13% at the national , state levels and hospitals respectively , while process indicators existence was 44% ,46% and 0% respectively and outcome indicator`s existence was 40% ,44% and 0% respectively. The PV system was also evaluated according to five components the results of which were as follow: First component, (The Policy, Law, and Regulation) with 25% existence of indicator at national level only. The existence of indicators for the second component, (System, Structure, and Stakeholder Coordination) was found to be 93% , 90% at national and State levels respectively ,while 10% of indicators were present in 70% of hospitals. The existence of indicators for the third component, (Signal Generation and Data Management) was found to be 50% , 50% at national and State levels respectively, while 25% of indicators were present in only 20% of hospitals. The existence of indicators for the forth component, (Risk Assessment and Evaluation) was found to be 25% , 29% at national and state levels respectively, while 25% of indicators were present in only 7% of hospitals . The existence of indicators for the fifth component, ( Risk Management and Communication) was found to be 40% , 44% at national , state levels respectively ,while 75% of indicators were present in about(13-20%) hospitals respectively . Conclusion: The study concluded the existence of PV system at national and state centers and they demonstrate that PV activities were already taking place. Greater efforts are needed in hospitals to build this system and filling the gap and also to link existing activities to create a comprehensive PV system. Finally, the study recommends Country should development of strategic plans to incorporate both passive and active surveillance approaches, coordinate and work with all stakeholders, strengthen risk management and communication, and enhance the impact of PV and medicine safety systems.
Description: 153 Pages
URI: http://khartoumspace.uofk.edu/123456789/25888


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