Sector/Thematic Studies

6,688 items available

Permanent URI for this collection

http://hdl.handle.net/10986/2110

Economic and Sectoral Work are original analytic reports authored by the World Bank and intended to influence programs and policy in client countries. They convey Bank-endorsed recommendations and represent the formal opinion of a World Bank unit on the topic. This set includes the sectoral and thematic studies which are not Core Diagnostic Studies. Other analytic and advisory activities (AAA), including technical assistance studies, are included in these sectoral/thematic collections.

Sub-collections of this Collection

Items in this collection

Now showing 1 - 10 of 48

The Value of Pharmacovigilance in Building Resilient Health Systems Post-COVID: Overview Report

(World Bank, Washington, DC, 2023-08-15) Wang,Huihui ; Marquez,Patricio V. ; Figueras Sune,Albert-Jesus ; Kseniya Bieliaieva

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.
Learning from the Republic of Korea: Building Health System Resilience

(World Bank, Washington, DC, 2023-08-15) Wang, Huihui ; Hwang, Inuk ; Marquez, Patricio V.

The response of the government of the Republic of Korea to COVID-19 has been heralded as among the most successful. In the first two years of the pandemic, the government was able to keep the size of the outbreak relatively small and the death toll relatively low. Although the number of COVID-19 cases jumped significantly subsequently in 2022 and 2023 due to the spread of the more transmissible Omicron variant and a revamped testing regime that cast a broader net to detect infections, Korea had a much lower rate of total confirmed COVID-19 deaths per million population than other high income countries (676 in Korea, as compared to 3,379 in the United Kingdom, 3,331 in the United States, and 2,599 in France). The government achieved this relatively positive result without resorting to the highly restrictive measures that were adopted by most high-income countries, such as strictly controlling borders, shuttering businesses, or issuing severe lockdown or stay-at-home orders. Indeed, since the start of the outbreak in January 2020, the distinguishing features of the response in Korea include the government’s ability to mobilize swiftly, even in the early stages of the pandemic, to flatten the epidemic curve. This report dissects the COVID-19 countermeasures successfully adopted in Korea. The analysis draws out insights and lessons that may be relevant to other countries as they mount responses to ongoing crises and prepare for future public health emergencies.
Starting and Strengthening a National Pharmacovigilance System: The Case of Catalan Regional Activities that Propelled the Spanish Pharmacovigilance System

(World Bank, Washington, DC, 2023-08-15) Wang, Huihui ; Marquez, Patricio V. ; Figueras, Albert ; Bieliaieva, Kseniya

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.
Safety Monitoring of Medicines and Vaccines: A Situation Analysis

(World Bank, Washington, DC, 2023-08-15) Wang, Huihui ; Figueras, Albert ; Marquez, Patricio V. ; Bieliaieva, Kseniya

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.
Overview of the Republic of Korea Pharmacovigilance System: Learning from Best Practices

(World Bank, Washington, DC, 2023-08-15) Wang, Huihui ; Marquez, Patricio V. ; Figueras, Albert ; Bieliaieva, Kseniya

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.
Pharmacovigilance in Brazil: Creating an Effective System in a Diverse Country

(World Bank, Washington, DC, 2023-08-15) Wang, Huihui ; Figueras, Albert ; Marquez, Patricio V. ; Bieliaieva, Kseniya

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.
The Caribbean Regulatory System: A Subregional Approach for Efficient Medicine Registration and Vigilance

(World Bank, Washington, DC, 2023-08-15) Wang, Huihui ; Figueras, Albert ; Extavour, Rian Marie ; Marquez, Patricio V. ; Bieliaieva, Kseniya

This report focuses on the Caribbean Public Health Agency (CARPHA), one of the three multi-national public health agencies in the world, that commenced operations on Jan 1, 2013, with the aim of delivering the functions of five previous regional health institutions through one platform for greater synergy and cost-effectiveness and as the principal institutional expression of Caribbean Cooperation in Health. The activities of CARPHA include the provision of a subregional mechanism that supports regulatory action to ensure access to safe medicines, such as the subregional system for reporting adverse drug reactions (ADRs) and substandard and falsified products (VigiCarib), and the regional post marketing drug quality testing program under the CARPHA Medicines Quality Control and Surveillance Department. Another relevant CARPHA activity is reviewing new medicines which want to enter the Caribbean market. This was especially important during the COVID-19 pandemic, with the plethora of new vaccines. VigiCarib is a good example of a subregional approach to facilitate well-functioning post marketing monitoring activities, including PV. Although this is a relatively new program, it is well established, integrates lessons from more experienced regulatory authorities, and supports small economies without specific PV programs, thus helping ensure the safety, quality, and effectiveness of medicines and vaccines. VigiCarib can serve as a model in other parts of the world where a regional approach to strengthening regulatory systems is under consideration. However, a key lesson of the experience of CARICOM, is that regional initiatives are complex and require clear objectives, harmonization, respect for the individual countries and territories, and mutual trust.
Gender-Based Violence Country Profile: Honduras

(Washington, DC, 2023-06-01) World Bank

Honduras has a small and informal economy that is predominantly agricultural, but its strategic location, solid industrial base, ample resources, and young population indicate potential for inclusive and resilient economic growth. Despite the growth, Honduras remains one of the poorest and most unequal countries in the region. Honduras has one of the highest rates of violent deaths of women in the world, by 2021, there were reported 318 violent deaths of women. Honduras is both a source and transit country for human trafficking, with women being the most affected by it. The COVID-19 pandemic has exacerbated the situation, resulting in an increase in reported cases of domestic and intrafamily violence.
Gender-Based Violence Country Profile: Brazil

(Washington, DC, 2023-06-01) World Bank

In Brazil, violence against women and girls (VAWG), which is a manifestation of gender-based violence (GBV), is a major concern. Intimate partner violence is the most common form of violence. The COVID-19 outbreak in early 2020 added new layers of complexity to the already unsettling GBV situation in the country. Services that are part of the national network to end violence against women, including health, social assistance, public security, and justice services, were stalled during critical transmission peaks, and faced budget cuts, as resources were redirected to fund emergency response actions related to the pandemic.
Gender-Based Violence Country Profile: El Salvador

(Washington, DC, 2023-06-01) World Bank

El Salvador has a long history of political and social challenges, including a 12-year civil war that ended in 1992. The country has struggled with high levels of crime, poverty, and inequality, which have hindered its economic and social development. The service sector is an important component in El Salvador’s economy. El Salvador has made progress in recent years in addressing some of its social and economic challenges. For instance, the country has implemented a number of social programs aimed at reducing poverty and inequality, such as the conditional cash transfer programs. Early pregnancy and child marriage are significant factors that can contribute to school dropouts as young girls are expected to take on domestic responsibilities and resources, social tolerance, and the capacity of state institutions and civil society organizations.