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Ambrose O. Isah - One of the best experts on this subject based on the ideXlab platform.
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Assessment of the state of Pharmacovigilance in the South-South zone of Nigeria using WHO Pharmacovigilance indicators
BMC pharmacology & toxicology, 2018Co-Authors: Abimbola O. Opadeyi, Annie Fourrier-réglat, Ambrose O. IsahAbstract:WHO Pharmacovigilance indicators have been recommended as a useful tool towards improving Pharmacovigilance activities. Nigeria with a myriad of medicines related issues is encouraging the growth of Pharmacovigilance at peripheral centres. This study evaluated the status of Pharmacovigilance in tertiary hospitals in the South-South zone of Nigeria with a view towards improving the Pharmacovigilance system in the zone. A cross-sectional descriptive survey was conducted in six randomly selected tertiary hospitals in the South-South zone of the country. The data was collected using the WHO core Pharmacovigilance indicators. The language of assessment was phrased and adapted in this study for use in a tertiary hospital setting. Data is presented quantitatively and qualitatively. A total of six hospitals were visited and all institutions had a Pharmacovigilance centre, only three could however be described as functional or partially functional. Only one centre had a financial provision for Pharmacovigilance activities. Of note was the absence of the national adverse drug reaction reporting form in one of the hospitals. The number of adverse drug reaction reports found in the databases of the centres ranged from none to 26 for the previous year and only one centre had fully committed their reports to the National Pharmacovigilance Centre. There were few documented medicines related admissions ranging from 0.0985/1000 to 1.67/1000 and poor documentation of Pharmacovigilance activities characterised all centres. This study has shown an urgent need to strengthen the Pharmacovigilance systems in the South-South zone of Nigeria. Improvement in medical record documentation as well as increased institutionalization of Pharmacovigilance may be the first steps to improve Pharmacovigilance activities in the tertiary hospitals.
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Assessment of the state of Pharmacovigilance in the South-South zone of Nigeria using WHO Pharmacovigilance indicators
BMC Pharmacology and Toxicology, 2018Co-Authors: Abimbola O. Opadeyi, Annie Fourrier-réglat, Ambrose O. IsahAbstract:BACKGROUND: WHO Pharmacovigilance indicators have been recommended as a useful tool towards improving Pharmacovigilance activities. Nigeria with a myriad of medicines related issues is encouraging the growth of Pharmacovigilance at peripheral centres. This study evaluated the status of Pharmacovigilance in tertiary hospitals in the South-South zone of Nigeria with a view towards improving the Pharmacovigilance system in the zone. METHODS: A cross-sectional descriptive survey was conducted in six randomly selected tertiary hospitals in the South-South zone of the country. The data was collected using the WHO core Pharmacovigilance indicators. The language of assessment was phrased and adapted in this study for use in a tertiary hospital setting. Data is presented quantitatively and qualitatively. RESULTS: A total of six hospitals were visited and all institutions had a Pharmacovigilance centre, only three could however be described as functional or partially functional. Only one centre had a financial provision for Pharmacovigilance activities. Of note was the absence of the national adverse drug reaction reporting form in one of the hospitals. The number of adverse drug reaction reports found in the databases of the centres ranged from none to 26 for the previous year and only one centre had fully committed their reports to the National Pharmacovigilance Centre. There were few documented medicines related admissions ranging from 0.0985/1000 to 1.67/1000 and poor documentation of Pharmacovigilance activities characterised all centres. CONCLUSION: This study has shown an urgent need to strengthen the Pharmacovigilance systems in the South-South zone of Nigeria. Improvement in medical record documentation as well as increased institutionalization of Pharmacovigilance may be the first steps to improve Pharmacovigilance activities in the tertiary hospitals.
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Pharmacovigilance in Nigeria: An Overview
Pharmaceutical Medicine, 2016Co-Authors: Abimbola Olowofela, Annie Fourrier-réglat, Ambrose O. IsahAbstract:Nigeria was admitted into the WHO International Drug Monitoring Programme in 2004. That marked a new era of Pharmacovigilance in Nigeria. Nigeria is a large country in sub-Saharan Africa with essentially a homogenous black population of over 170 million people, a significant disease burden (communicable and non-communicable) and consequent medication use. Inevitably, the need for medicine safety is becoming increasingly appreciated by the government, health-care workers and patients. Pharmacovigilance activities in Nigeria are coordinated by the National Pharmacovigilance Centre (NPC) situated in the National Agency for Food and Drug Administration and Control (NAFDAC—the drug regulatory agency in Nigeria). NPC serves as a repository for reported adverse drug reactions from health workers and also liaises with other international groups such as the WHO, US Food and Drug Administration and the European Medicines Agency in improving drug safety in Nigeria. Increasing participation of the public in drug safety is also a major thrust of the NPC and the contributions of public-health programmes in this resource-poor setting to Pharmacovigilance cannot be overemphasised. The provisions of a unique policy to define the responsibilities of the stakeholders in Pharmacovigilance, as well as training of the health-care workers, are a few of the achievements of the agency in charge of Pharmacovigilance in Nigeria.
Sten Olsson - One of the best experts on this subject based on the ideXlab platform.
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Evaluation of Pharmacovigilance System in Iran.
International journal of health policy and management, 2020Co-Authors: Malahat Khalili, Sten Olsson, Hamid Sharifi, Bita Mesgarpour, Mehrnaz Kheirandish, Naghmeh Javidnikou, Ali Akbar HaghdoostAbstract: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.
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Comparative Assessment of the National Pharmacovigilance Systems in East Africa: Ethiopia, Kenya, Rwanda and Tanzania
Drug Safety, 2020Co-Authors: Abbie Barry, Sten Olsson, Omary Minzi, Emile Bienvenu, Eyasu Makonnen, Appolinary Kamuhabwa, Margaret Oluka, Anastasia Guantai, Ulf Bergman, Eugène PuijenbroekAbstract:Introduction The increased access to medicinal products in Africa is not well-matched with the Pharmacovigilance capacity to monitor drug safety. The objective of this study was to assess the functionality and identify the strengths and limitations of the national Pharmacovigilance systems in Ethiopia, Kenya, Rwanda, and Tanzania, and compare these systems. Methods Legal and statutory documents governing the Pharmacovigilance systems of each participating country were examined by assessors prior to on-site review. The staff of the Pharmacovigilance unit of the National Medicines Regulatory Authorities (NMRAs) were interviewed using the East African Community Harmonized Pharmacovigilance Indicators tool, supplemented with indicators from the World Health Organization (WHO) Global Benchmarking Tool. Responses were recorded, and data were analyzed. Results The Pharmacovigilance systems were supported by law and regulations in line with international standards. Standard operating procedures for receiving, processing, and communicating suspected adverse event reports were in place, but reporting of suspected medicine-related harm from stakeholders was inadequate in all countries. The number of Individual Case Safety Reports (ICSRs) received by NMRAs in Kenya, Ethiopia, and Tanzania (mainland) were 35.0, 6.7, and 4.1 per million inhabitants, respectively, in the last calendar year. At the time of assessment, Rwanda did not have an operational system. Overall, ≤ 1% of the total number of health facilities per country submitted ICSRs. Only Kenya and Tanzania had a designated budget for Pharmacovigilance activities and an electronic ICSR reporting system. The national Pharmacovigilance systems in all four countries did not have access to data on drug utilization. Conclusions The national Pharmacovigilance systems in the four East African countries have policy and legal frameworks defined by law and regulation to conduct Pharmacovigilance activities. However, the four national Pharmacovigilance systems are at different levels of capacity and performance with respect to conducting Pharmacovigilance activities. Targeted interventions are needed to strengthen the Pharmacovigilance systems to enable evidence-based decision making for patient safety.
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The Monitoring Medicines Project: A Multinational Pharmacovigilance and Public Health Project
Drug Safety, 2015Co-Authors: Shanthi N Pal, Sten Olsson, Elliot G. BrownAbstract:The Monitoring Medicines project (MM), funded by the FP-7 EU framework, was carried out between 2009 and 2013 by a consortium of 11 partners. The objectives were to support and strengthen consumer reporting of adverse drug reactions (ADRs); expand the role and scope of national Pharmacovigilance centres concerning medication errors; promote improved use of Pharmacovigilance data; and develop methods to complement spontaneous reporting. The work was organised into four themes: patient reporting; medication errors; drug dependence, counterfeit and substandard medicines and clinical risk estimation; and active and targeted spontaneous Pharmacovigilance. MM differed from some other major Pharmacovigilance initiatives by having participants from developing countries in Asia and Africa and in leaning towards public health and communicable diseases. MM brought together stakeholders including WHO, drug regulators, Pharmacovigilance centres, consumers, public health and disease specialists and patient safety networks. Resources and methodologies developed directly by, or with support from, MM include electronic systems/tools for consumer ADR reporting and cohort event monitoring; publication by WHO of handbooks on consumer reporting, medication errors and Pharmacovigilance for TB medicines; methodologies for detecting drug dependence and substandard or counterfeit medicines in ADR databases; and a database on HIV treatment risks with a risk assessment tool. MM enabled stakeholders to achieve more than if they had worked alone in pursuit of patient safety.
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The Monitoring Medicines Project: A Multinational Pharmacovigilance and Public Health Project
Drug Safety, 2015Co-Authors: Sten Olsson, Elliot G. BrownAbstract:The Monitoring Medicines project (MM), funded by the FP-7 EU framework, was carried out between 2009 and 2013 by a consortium of 11 partners. The objectives were to support and strengthen consumer reporting of adverse drug reactions (ADRs); expand the role and scope of national Pharmacovigilance centres concerning medication errors; promote improved use of Pharmacovigilance data; and develop methods to complement spontaneous reporting. The work was organised into four themes: patient reporting; medication errors; drug dependence, counterfeit and substandard medicines and clinical risk estimation; and active and targeted spontaneous Pharmacovigilance. MM differed from some other major Pharmacovigilance initiatives by having participants from developing countries in Asia and Africa and in leaning towards public health and communicable diseases. MM brought together stakeholders including WHO, drug regulators, Pharmacovigilance centres, consumers, public health and disease specialists and patient safety networks. Resources and methodologies developed directly by, or with support from, MM include electronic systems/tools for consumer ADR reporting and cohort event monitoring; publication by WHO of handbooks on consumer reporting, medication errors and Pharmacovigilance for TB medicines; methodologies for detecting drug dependence and substandard or counterfeit medicines in ADR databases; and a database on HIV treatment risks with a risk assessment tool. MM enabled stakeholders to achieve more than if they had worked alone in pursuit of patient safety.
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Pharmacovigilance activities in 55 low and middle income countries a questionnaire based analysis
Drug Safety, 2010Co-Authors: Sten Olsson, Shanthi N Pal, Andy Stergachis, Mary CouperAbstract:Background: The WHO Programme for International Drug Monitoring aims to develop a comprehensive global Pharmacovigilance strategy that responds to the healthcare needs of low- and middle-income countries. However, first there is a need to measure and understand existing conditions and Pharmacovigilance initiatives intended in these settings. Very few investigations have carried out such a systematic assessment of the Pharmacovigilance landscape in recent years in low- and middle-income countries. Objective: To assess current and planned Pharmacovigilance activities in low-and middle-income countries, identify gaps and the most urgent Pharmacovigilance priorities at national and international levels, and define the elements of a sustainable global Pharmacovigilance strategy. Methods: A standardized questionnaire was sent to 114 representatives of countries participating in the WHO Programme for International Drug Monitoring (but excluding Australia, Canada, New Zealand, Switzerland and the International Conference on Harmonization countries, i.e. countries in Europe, Japan and the US) and to a few other identified contacts from non-member countries. The questionnaire was sent out between March and July 2008 and was designed to collect information on the structure, resources, functions and achievements of Pharmacovigilance systems in low- and middle-income countries, with a focus on Pharmacovigilance activities supported by national health authorities including public health programmes. All questionnaires that were returned by the end of July 2008 were used in the analysis. Results: Fifty-five completed questionnaires were received by July 2008, representing a response rate of 55.5%. Forty-five percent of the Pharmacovigilance centres in the analysis were established during the 1990s and 49% were set up later; 69% were affiliated with their Drug Regulatory Agency, 20% with the Ministry of Health and 9% with a university or other scientific body. Few countries (23 of 55) have any budget allocated for Pharmacovigilance. Public health programmes (44%), the Global Fund to fight AIDS, Tuberculosis and Malaria (36%), universities (26%), poison centres (21%), Management Sciences for Health (18%) and Rational Use of Drugs networks (15%) sponsor some Pharmacovigilance activities. In addition to direct Pharmacovigilance activities, many centres are also involved in other activities such as drug information (63%), promoting patient safety (52%), rational use of drugs (46%) and poison information (15%). Some countries have sentinel sites to monitor HIV/AIDS patients (in seven countries) and other special groups. Information gathered through Pharmacovigilance activities is used to assist regulatory functions in most countries (n = 42), lack of training and funding were mentioned as being major challenges to Pharmacovigilance in many countries. Conclusions: This study has helped identify some of the special challenges and barriers to promoting Pharmacovigilance in low- and middle-income countries. A Pharmacovigilance strategy in these settings needs to help build health systems that can serve the purpose of multiple health conditions. It needs to identify and implement feasible systems, governance, infrastructures, human resource, training and capacity building, sustainable methodologies and innovations in Pharmacovigilance; a key component will be the dissemination of medicines safety information to policy makers and regulators and knowledge sharing with healthcare professionals through high quality informatics and learning tools, with rational use of medicines and patient safety as the ultimate goal of Pharmacovigilance.
Eugene Van Puijenbroek - One of the best experts on this subject based on the ideXlab platform.
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Pharmacovigilance skills knowledge and attitudes in our future doctors a nationwide study in the netherlands
Basic & Clinical Pharmacology & Toxicology, 2017Co-Authors: Tim Schutte, Jelle Tichelaar, Michael O Reumerman, Rike Van Eekeren, R Rissmann, C Kramers, Milan C Richir, Eugene Van PuijenbroekAbstract:Pharmacovigilance centres monitor the safety of drugs, based on adverse drug reactions (ADRs) reported by doctors, pharmacists and pharmaceutical companies. However, the underreporting of ADRs remains a major problem. Our aim was to investigate preparedness of future doctors for their role in Pharmacovigilance, by assessing their Pharmacovigilance awareness, skills and knowledge. The study was a nationwide e-survey among medical students (third to sixth year) of all eight medical schools in the Netherlands. The survey consisted of questions regarding Pharmacovigilance awareness, skills and knowledge. Overall, 874 students provided informed consent and participated (response 12%). Almost all students (96%) intended to report serious ADRs in their future practice. Almost half (44%) of the students did not know where to report an ADR, and 78% did not know which items were necessary for a good-quality ADR report. While more than 78% of the students agreed that Pharmacovigilance is an important topic in their medical education, only 26% found that their current curriculum covered Pharmacovigilance adequately. Although ADR reporting is considered relevant and important among future doctors, many do not know where and what to report. This is highly undesirable and should have consequences for pharmacotherapy teaching. This article is protected by copyright. All rights reserved.
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A global view of undergraduate education in Pharmacovigilance.
European journal of clinical pharmacology, 2017Co-Authors: Jenny Hartman, Linda Härmark, Eugene Van PuijenbroekAbstract:Purpose The aim of this study was to gain insight in current Pharmacovigilance educational activities and to gather information on which topics should be included in the undergraduate Pharmacovigilance core curriculum.
Abimbola O. Opadeyi - One of the best experts on this subject based on the ideXlab platform.
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Assessment of the state of Pharmacovigilance in the South-South zone of Nigeria using WHO Pharmacovigilance indicators
BMC pharmacology & toxicology, 2018Co-Authors: Abimbola O. Opadeyi, Annie Fourrier-réglat, Ambrose O. IsahAbstract:WHO Pharmacovigilance indicators have been recommended as a useful tool towards improving Pharmacovigilance activities. Nigeria with a myriad of medicines related issues is encouraging the growth of Pharmacovigilance at peripheral centres. This study evaluated the status of Pharmacovigilance in tertiary hospitals in the South-South zone of Nigeria with a view towards improving the Pharmacovigilance system in the zone. A cross-sectional descriptive survey was conducted in six randomly selected tertiary hospitals in the South-South zone of the country. The data was collected using the WHO core Pharmacovigilance indicators. The language of assessment was phrased and adapted in this study for use in a tertiary hospital setting. Data is presented quantitatively and qualitatively. A total of six hospitals were visited and all institutions had a Pharmacovigilance centre, only three could however be described as functional or partially functional. Only one centre had a financial provision for Pharmacovigilance activities. Of note was the absence of the national adverse drug reaction reporting form in one of the hospitals. The number of adverse drug reaction reports found in the databases of the centres ranged from none to 26 for the previous year and only one centre had fully committed their reports to the National Pharmacovigilance Centre. There were few documented medicines related admissions ranging from 0.0985/1000 to 1.67/1000 and poor documentation of Pharmacovigilance activities characterised all centres. This study has shown an urgent need to strengthen the Pharmacovigilance systems in the South-South zone of Nigeria. Improvement in medical record documentation as well as increased institutionalization of Pharmacovigilance may be the first steps to improve Pharmacovigilance activities in the tertiary hospitals.
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Assessment of the state of Pharmacovigilance in the South-South zone of Nigeria using WHO Pharmacovigilance indicators
BMC Pharmacology and Toxicology, 2018Co-Authors: Abimbola O. Opadeyi, Annie Fourrier-réglat, Ambrose O. IsahAbstract:BACKGROUND: WHO Pharmacovigilance indicators have been recommended as a useful tool towards improving Pharmacovigilance activities. Nigeria with a myriad of medicines related issues is encouraging the growth of Pharmacovigilance at peripheral centres. This study evaluated the status of Pharmacovigilance in tertiary hospitals in the South-South zone of Nigeria with a view towards improving the Pharmacovigilance system in the zone. METHODS: A cross-sectional descriptive survey was conducted in six randomly selected tertiary hospitals in the South-South zone of the country. The data was collected using the WHO core Pharmacovigilance indicators. The language of assessment was phrased and adapted in this study for use in a tertiary hospital setting. Data is presented quantitatively and qualitatively. RESULTS: A total of six hospitals were visited and all institutions had a Pharmacovigilance centre, only three could however be described as functional or partially functional. Only one centre had a financial provision for Pharmacovigilance activities. Of note was the absence of the national adverse drug reaction reporting form in one of the hospitals. The number of adverse drug reaction reports found in the databases of the centres ranged from none to 26 for the previous year and only one centre had fully committed their reports to the National Pharmacovigilance Centre. There were few documented medicines related admissions ranging from 0.0985/1000 to 1.67/1000 and poor documentation of Pharmacovigilance activities characterised all centres. CONCLUSION: This study has shown an urgent need to strengthen the Pharmacovigilance systems in the South-South zone of Nigeria. Improvement in medical record documentation as well as increased institutionalization of Pharmacovigilance may be the first steps to improve Pharmacovigilance activities in the tertiary hospitals.
Annie Fourrier-réglat - One of the best experts on this subject based on the ideXlab platform.
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Assessment of the state of Pharmacovigilance in the South-South zone of Nigeria using WHO Pharmacovigilance indicators
BMC pharmacology & toxicology, 2018Co-Authors: Abimbola O. Opadeyi, Annie Fourrier-réglat, Ambrose O. IsahAbstract:WHO Pharmacovigilance indicators have been recommended as a useful tool towards improving Pharmacovigilance activities. Nigeria with a myriad of medicines related issues is encouraging the growth of Pharmacovigilance at peripheral centres. This study evaluated the status of Pharmacovigilance in tertiary hospitals in the South-South zone of Nigeria with a view towards improving the Pharmacovigilance system in the zone. A cross-sectional descriptive survey was conducted in six randomly selected tertiary hospitals in the South-South zone of the country. The data was collected using the WHO core Pharmacovigilance indicators. The language of assessment was phrased and adapted in this study for use in a tertiary hospital setting. Data is presented quantitatively and qualitatively. A total of six hospitals were visited and all institutions had a Pharmacovigilance centre, only three could however be described as functional or partially functional. Only one centre had a financial provision for Pharmacovigilance activities. Of note was the absence of the national adverse drug reaction reporting form in one of the hospitals. The number of adverse drug reaction reports found in the databases of the centres ranged from none to 26 for the previous year and only one centre had fully committed their reports to the National Pharmacovigilance Centre. There were few documented medicines related admissions ranging from 0.0985/1000 to 1.67/1000 and poor documentation of Pharmacovigilance activities characterised all centres. This study has shown an urgent need to strengthen the Pharmacovigilance systems in the South-South zone of Nigeria. Improvement in medical record documentation as well as increased institutionalization of Pharmacovigilance may be the first steps to improve Pharmacovigilance activities in the tertiary hospitals.
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Assessment of the state of Pharmacovigilance in the South-South zone of Nigeria using WHO Pharmacovigilance indicators
BMC Pharmacology and Toxicology, 2018Co-Authors: Abimbola O. Opadeyi, Annie Fourrier-réglat, Ambrose O. IsahAbstract:BACKGROUND: WHO Pharmacovigilance indicators have been recommended as a useful tool towards improving Pharmacovigilance activities. Nigeria with a myriad of medicines related issues is encouraging the growth of Pharmacovigilance at peripheral centres. This study evaluated the status of Pharmacovigilance in tertiary hospitals in the South-South zone of Nigeria with a view towards improving the Pharmacovigilance system in the zone. METHODS: A cross-sectional descriptive survey was conducted in six randomly selected tertiary hospitals in the South-South zone of the country. The data was collected using the WHO core Pharmacovigilance indicators. The language of assessment was phrased and adapted in this study for use in a tertiary hospital setting. Data is presented quantitatively and qualitatively. RESULTS: A total of six hospitals were visited and all institutions had a Pharmacovigilance centre, only three could however be described as functional or partially functional. Only one centre had a financial provision for Pharmacovigilance activities. Of note was the absence of the national adverse drug reaction reporting form in one of the hospitals. The number of adverse drug reaction reports found in the databases of the centres ranged from none to 26 for the previous year and only one centre had fully committed their reports to the National Pharmacovigilance Centre. There were few documented medicines related admissions ranging from 0.0985/1000 to 1.67/1000 and poor documentation of Pharmacovigilance activities characterised all centres. CONCLUSION: This study has shown an urgent need to strengthen the Pharmacovigilance systems in the South-South zone of Nigeria. Improvement in medical record documentation as well as increased institutionalization of Pharmacovigilance may be the first steps to improve Pharmacovigilance activities in the tertiary hospitals.
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Pharmacovigilance in Nigeria: An Overview
Pharmaceutical Medicine, 2016Co-Authors: Abimbola Olowofela, Annie Fourrier-réglat, Ambrose O. IsahAbstract:Nigeria was admitted into the WHO International Drug Monitoring Programme in 2004. That marked a new era of Pharmacovigilance in Nigeria. Nigeria is a large country in sub-Saharan Africa with essentially a homogenous black population of over 170 million people, a significant disease burden (communicable and non-communicable) and consequent medication use. Inevitably, the need for medicine safety is becoming increasingly appreciated by the government, health-care workers and patients. Pharmacovigilance activities in Nigeria are coordinated by the National Pharmacovigilance Centre (NPC) situated in the National Agency for Food and Drug Administration and Control (NAFDAC—the drug regulatory agency in Nigeria). NPC serves as a repository for reported adverse drug reactions from health workers and also liaises with other international groups such as the WHO, US Food and Drug Administration and the European Medicines Agency in improving drug safety in Nigeria. Increasing participation of the public in drug safety is also a major thrust of the NPC and the contributions of public-health programmes in this resource-poor setting to Pharmacovigilance cannot be overemphasised. The provisions of a unique policy to define the responsibilities of the stakeholders in Pharmacovigilance, as well as training of the health-care workers, are a few of the achievements of the agency in charge of Pharmacovigilance in Nigeria.
