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Monitoring the safety of medicines and vaccines: An essential public health service

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Person getting vaccinated Monitoring adverse drug reactions is an essential public health service that is fundament to create and sustain trust in the health sector. Copyright: World Bank

Vaccines and medicines are indispensable for preventing infections, treating diseases, or reliving pain. But there are risks of unwanted or unexpected events that can happen from harmful interactions between a medicine and food, beverage, or another medicine, or that the medicine may not work as expected and can cause additional problems.  Continuous monitoring is therefore required for managing the benefits and risks of medicines.   

A series of World Bank case studies illustrate the importance of this often overlooked but essential public health service that is fundament to create and sustain trust in the health sector and in its institutions.

Adverse drug reactions (ADRs) pose a significant challenge to health systems worldwide

The CDC estimated that more than 1 million individuals are seen in emergency departments for ADRs each year in the United States; more than one-quarter require hospitalization for further treatment. Similarly, a European Commission report documented that 3-10 percent of hospital admissions between 2012 and 2014 were estimated to have been associated with ADRs, totaling about 2.5–8.4 million annually. In Australia, serious ADRs were associated with considerably longer hospital stays, risk of readmission, or in-hospital death.

ADRs are also an important cause of morbidity in low-and-middle income countries (LMICs). For example, a systematic review in nine African countries, found that 8.4 percent of patients reported at hospital admission to have experienced ADRs, while a study in Brazil suggested a significant association between the use of off-label drugs (medications that are used in a way that has not be approved) and the occurrence of ADRs in patients admitted in an adult intensive care unit. 

Likewise, a study in South Korea showed that ADR-related emergency department visits and hospitalizations increase national health insurance costs and out-of-pocket expenditures by patients.

Building blocks of pharmacovigilance (PV)

The World Health Organization (WHO) defines PV as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.”  

WHO assessments suggest that majority of LMICs have limited institutional capacity to adequately monitor the safety of medicines when compared with the mature pharmacovigilance infrastructure in high-income countries. The experience of countries such as Korea, Brazil, and Ghana, and of regional organizations such as the European Medicines Agency and the Caribbean Public Health Agency, indicates that functioning and effective PV programs rest on five key pillars: 

  1. A strong legal and institutional foundation, including a strong human resource base;
  2. A nation-wide safety monitoring system;
  3. A computerized system to facilitate reporting of ADRs by different sources (i.e., health professionals, healthcare facilities, patients, and pharmaceutical companies);
  4. The use of PV evidence for policy making, regulatory action, risk communication, and education activities; and
  5. A sustainable funding arrangement.

How can drug safety monitoring contribute to building resilient health systems?

PV supports the performance of key functions in a health system: 

Looking ahead

PV should be seen as a ‘global public good’ whose benefits affect us all. As such, technical and financial assistance of international agencies is needed to complement country efforts to develop this capacity as part of initiatives to build resilient health systems.  In particular, support is required to assist countries leverage new technologies, such as artificial intelligence tools, that have the potential to transform safety monitoring by systematic mining and assessing large amounts of health data in real world settings. This is doable, as the results of a recent systematic review show that machine learning is already being used for this purpose.


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Juan Pablo Uribe

Global Director, Health, Nutrition & Population and the Global Financing Facility, World Bank

Patricio V. Marquez

Former World Bank Group (WBG) Lead Public Health Specialist

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