Publication: Safety Monitoring of Medicines and Vaccines: A Situation Analysis
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2023-08-15
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2023-08-15
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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.
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“Wang, Huihui; Marquez, Patricio V.; Bieliaieva, Kseniya. 2023. Safety Monitoring of Medicines and Vaccines: A Situation Analysis. Pharmacovigilance and Essential Public Health Services Series. © World Bank. http://hdl.handle.net/10986/40197 License: CC BY-NC 3.0 IGO.”
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