Publication: The Value of Pharmacovigilance in Building Resilient Health Systems Post-COVID: Overview Report
Loading...
Date
2023-08-15
ISSN
Published
2023-08-15
Editor(s)
Abstract
Although indispensable for improving health outcomes, medicines and vaccines or their administration and use can produce adverse effects, requiring continuous vigilance to ensure that the benefits outweigh the risks. Monitoring the safety of the use of marketed medicines and vaccines, also known as pharmacovigilance, should therefore become much more explicit in efforts to strengthen health systems and prepare for public health crises and normal times because the world is determined to build back better after the COVID-19 pandemic. The objective of this report is to examine the importance of pharmacovigilance in a health system both during a health crisis and in normal times, describe the function, structure, and processes of a functional pharmacovigilance system, and explain the value of drug safety monitoring in building resilience in health systems post-COVID-19 pandemic.
Link to Data Set
Citation
“Wang,Huihui; Marquez,Patricio V.; Figueras Sune,Albert-Jesus; Kseniya Bieliaieva. 2023. The Value of Pharmacovigilance in Building Resilient Health Systems Post-COVID: Overview Report. Pharmacovigilance and Essential Public Health Services Series. © World Bank. http://hdl.handle.net/10986/40205 License: CC BY-NC 3.0 IGO.”
Associated URLs
Associated content
Other publications in this report series
Journal
Journal Volume
Journal Issue
Collections
Related items
Showing items related by metadata.
Publication Pharmacovigilance in Brazil(World Bank, Washington, DC, 2023-08-15)The ability to oversee and monitor the use of all newly authorized drugs and vaccines, both brand name and generic, is critical to ensure that they work correctly and that their health benefits outweigh their known risks when used in daily clinical practice. This process, known as pharmacovigilance, plays a vital role in ensuring that patients receive appropriate vaccines and medicines that are safe and effective. While this may seem obvious, the process of building the necessary capacity and even recognition of the importance of this work has taken decades. Brazil is a particularly notable example because it ranks in the top five amongst the largest and the most populated countries—two characteristics that difficult the deployment and consolidation of a pharmacovigilance system.Publication Safety Monitoring of Medicines and Vaccines(World Bank, Washington, DC, 2023-08-15)Medicines, vaccines, medical devices, and blood are commonly used to treat disease. Medicines deserve a special focus because almost any medical visit ends with at least one prescription. So, monitoring the safety and effectiveness of therapeutic treatments and procedures is crucial at both the individual and community levels. In the case of medicines and vaccines, this surveillance activity is known as pharmacovigilance. Various methods are used to monitor the adverse and unwanted effects of medicinal products after they have received authorization for marketing, but reporting adverse reactions is the most widespread. The network of the Program for International Drug Monitoring (PIDM), which is supported by the World Health Organization (WHO), involves more than 170 countries. Its activities were initiated in 1968. The WHO-PIDM is the world’s most comprehensive network involving health professionals, patients, and manufacturers. This situation analysis describes relevant aspects of the PIDM, including achievements and weak points. The analysis is the product of a systematic revision of studies that focus on the WHO-PIDM activities and related findings published in different medical journals and listed in PubMed. Available information was selected and organized according to different topics and summarized and presented in the different sections of the report. As information for some countries and regions is lacking in the available literature, the report is not a comprehensive review of the pharmacovigilance across countries. The report, therefore, shows what is in place and highlight some of the difficulties faced by many countries, particularly low-and-middle income countries. It offers an overview of the (1) common points and failures; (2) the advantages of a national PV system; (3) the difficulties in scaling up and consolidating these systems; and (4) the advantages of regional collaboration. This report is part of a series of companion reports on pharmacovigilance, that provide a detailed overview and discussion on technical aspects and country and regional experiences.Publication Starting and Strengthening a National Pharmacovigilance System(World Bank, Washington, DC, 2023-08-15)The Spanish System of Pharmacovigilance (SSPV) started its activities almost 40 years ago, in 1985. Of particular interest to others considering various options for developing pharmacovigilance systems is the fact that this case study highlights an example that built from the ground up and actually started in academia: the SSPV began as a research project in a university institution in Catalonia that was later adopted by the Ministry of Health. From these origins, a regulatory framework gradually allowed this initiative to expand to the whole country. In 1990, after technical training for the professional staff involved, responsibility for coordinating the system was transferred to a specially created coordinating center for the SSPV located in the Spanish Medicines Agency. This report reviews the origins of the system and its key features, followed by two examples of the system in action and closing comments on aspects and lessons that may be of particular value to others developing pharmacovigilance systems elsewhere.Publication Overview of the Republic of Korea Pharmacovigilance System(World Bank, Washington, DC, 2023-08-15)Building capacity in countries to conduct thorough surveillance of the use of all newly authorized drugs and vaccines, both brand name and generic, is a critical “public good” investment to ensure that drugs work correctly and that their health benefits outweigh their known risks. Korea’s pharmacovigilance system (PVS) is an international best practice. It is the result of a continuous and sustained government effort over the past three decades—from small pilot projects to a nationwide monitoring network—and offers valuable lessons to other countries on the vital role that such a system can play in ensuring the safety of drugs post-marketing. This report provides an overview of the Korean pharmacovigilance system, describing its main structural and operational elements, to monitor the safety and effectiveness of medicines. It draws from a review of available literature in journal articles, as well as from the websites and reports of Korean institutions.Publication Realizing a Regional Approach to Pharmacovigilance(Washington, DC: World Bank, 2023-08-11)This report reviews the pharmacovigilance system of the European Union (EU) mapping out its structure and processes with any eye to features that may be of particular interest to decision makers in other regions as they weigh options related to creating a regional pharmacovigilance architecture for themselves. It begins with a review of the European Medicines Agency (EMA), which plays a central role in the EU system, followed by an overview of the EU PV assessment and monitoring process and an example of the system in action regarding COVID-19 vaccines. It concludes with a summary several key insights of particular relevance for decision makers.
Users also downloaded
Showing related downloaded files
Publication Ten Steps to a Results-Based Monitoring and Evaluation System : A Handbook for Development Practitioners(Washington, DC: World Bank, 2004)An effective state is essential to achieving socio-economic and sustainable development. With the advent of globalization, there are growing pressures on governments and organizations around the world to be more responsive to the demands of internal and external stakeholders for good governance, accountability and transparency, greater development effectiveness, and delivery of tangible results. Governments, parliaments, citizens, the private sector, Non-governmental Organizations (NGOs), civil society, international organizations, and donors are among the stakeholders interested in better performance. As demands for greater accountability and real results have increased, there is an attendant need for enhanced results-based monitoring and evaluation of policies, programs, and projects. This handbook provides a comprehensive ten-step model that will help guide development practitioners through the process of designing and building a results-based monitoring and evaluation system. These steps begin with a 'readiness assessment' and take the practitioner through the design, management, and importantly, the sustainability of such systems. The handbook describes each step in detail, the tasks needed to complete each one, and the tools available to help along the way.Publication Fiscal Incidence Analysis for Kenya(World Bank, Washington, DC, 2018-06-29)Kenya has made satisfactory progress in reducing poverty and inequality in recent years. Economic growth in Kenya between 2005-06 and 2015-16 averaged around 5.3 percent, exceeding the average growth of 4.9 percent observed for Sub-Saharan Africa. This robust economic growth resulted in a reduction in poverty, whether measured by the national or international poverty line. The proportion of the population living beneath the national poverty line fell from 46.8 percent in 2005-06 to 36.1 percent in 2015-16, showing a modest improvement in the living standards of the Kenyan population. Similarly, poverty under the international poverty line of US$ 1.90 a day declined from 43.6 percent in 2005-06 to 35.6 percent in 2015-16. At this level, poverty in Kenya is below the average in sub-Saharan Africa and is amongst the lowest in the East African Community (World Bank, 2018b). However, the proportion of the population living in poverty remains comparatively high in Kenya and the rate at which growth translated into poverty reduction was lower than elsewhere. At twice the average, Kenya’s poverty rate is still high for a lower-middle income country, a group that Kenya joined only in 2015. In addition, the Kenya’s growth elasticity of poverty reduction, the percentage reduction in the poverty rate associated with a one-percent increase in mean per capita income is only 0.57, lower than in Tanzania, Ghana, or Uganda (World Bank, 2018b). This leads to the obvious question of what can be done to make economic growth more pro-poor in Kenya. This study assesses the distributional consequences of Kenya’s system of taxes and transfers, covering 60 percent of revenue and between 25 and 30 percent of government spending. The analysis of fiscal incidence and distributional consequences of Kenya’s tax and transfer system is an important input for designing pro-poor policies and potentially for influencing the rate at which economic growth translates into poverty reduction. In this study, direct taxes and transfers, indirect taxes (VAT and excise duties), as well as public health and education spending are assessed in terms of their distributional impacts. Overall, these taxes and transfers account for about 60 percent of revenue and between 25 and 30 percent of government spending.Publication Making Devolution Work for Service Delivery in Kenya(Washington, DC: World Bank, 2022-02)Kenya adopted a new constitution and began the process of devolution in 2010, ceding many formerly national responsibilities to new county governments. As an institutional response to longstanding grievances, this radical restructuring of the Kenyan state had three continuing main objectives: decentralizing political power, public sector functions, and public finances; ensuring a more equitable distribution of resources among regions; and promoting more accountable, participatory, and responsive government at all levels. The first elections under the new constitution were held in 2013 and led to the establishment of 47 new county governments. Each county government is made up of a county executive, headed by an elected governor, and an elected County Assembly that legislates and provides oversight. Making Devolution Work for Service Delivery in Kenya takes stock of how devolution has affected the delivery of basic services to Kenyan citizens nine years after the “devolution train” left the station. Whereas devolution was driven by political reform, the ensuing institutions and systems were expected to deliver greater socioeconomic equity through devolved service delivery. Jointly coordinated by the government of Kenya and the World Bank, the Making Devolution Work for Service Delivery (MDWSD) study is the first major assessment of Kenya’s devolution reform. The study provides key messages about what is working, what is not working, and what could work better to enhance service delivery based on currently available data. It provides an independent assessment of service delivery performance in five sectors: agriculture, education, health, urban services, and water services. This assessment includes an in-depth review of the main pillars of devolved service delivery: accountability, human resource management, intergovernmental finance, politics, and public financial management. In addition to its findings for the present, the MDWSD study provides recommendations on how Kenya can improve its performance in each of these pivotal areas in the future.Publication Nigeria Development Update, June 2021(World Bank, Washington, DC, 2021-06)In 2020, Nigeria experienced its deepest recession in four decades, but growth resumed in the fourth quarter as pandemic restrictions were eased, oil prices recovered, and the authorities implemented policies to counter the economic shock. As a result, in 2020 the Nigerian economy experienced a smaller contraction (-1.8 percent) than had been projected when the pandemic began (-3.2 percent). As part of its response, the government carried out several long-delayed policy reforms, often against vocal opposition. Notably, the government (1) began to harmonize exchange rates; (2) began to eliminate gasoline subsidies; (3) started adjusting electricity tariffs to more cost-reflective levels; (4) cut nonessential spending and redirected resources to COVID-19 (coronavirus) responses at both the federal and the state levels; and (5) enhanced debt management and increased public-sector transparency, especially for oil and gas operations. By creating additional fiscal space and maximizing the impact of the government’s limited resources, these measures were critical in protecting the economy against a much deeper recession and in laying the foundation for earlier recovery. However, several critical reforms are as yet incomplete, which threatens Nigeria’s nascent recovery. In the baseline scenario, Nigeria’s economy is expected to grow by 1.8 percent in 2021. Despite the current favorable external environment, with oil prices recovering and growth in advanced economies, reform slippages would hinder the renewed economic expansion and undermine progress toward Nigeria’s development goals. In a risk scenario, in which the government fails to sustain recent macroeconomic and structural reforms, the pace of economic recovery would slow, and GDP growth couldbe just 1.1 percent in 2021.Publication Managing County Assets and Liabilities in Kenya(Washington, DC : World Bank, 2022)Public entities around the world possess an enormous volume of assets and wealth, which includes land, buildings, historic sites, parks, and infrastructure networks, among many others. Good management of such assets is a catalyst for accelerating development and expanding services; poor asset management generates enormous losses, including lost opportunities to build wealth. Private enterprises increasingly use computerized systems to manage assets such as fleets and buildings. Many city leaders in developing countries, however, are unaware of asset management or feel they lack the time or money to undertake it. Managing County Assets and Liabilities in Kenya: Postdevolution Challenges and Responses can help them begin or maintain their efforts to manage assets sustainably. This book helps readers understand the basic concept of asset management; explains systems, tools, and procedures; and provides models and guidance. Kenya has achieved much since its 2013 devolution of governance and management to new counties. However, counties, which are the local governments in Kenya, are still working toward establishing systems and procedures, creating asset and liability registers, verifying and valuing assets, using assets strategically, and resolving disputes surrounding inherited assets and liabilities. This book provides glimpses into the Kenyan devolution process and asset transfer challenges, draws lessons, and explores options relevant to both Kenya and other nations. Ample studies discuss various aspects of municipal asset management, such as managing infrastructure, fixed assets, water services, building properties, roads, or fleets. This book is unique among asset management studies in three ways: it discusses all sorts of assets and liabilities and their interlinkages, exemplifies the close connection between financial results and asset management of municipalities, and reveals the political economy challenges in transferring assets and liabilities across public entities.