Report of Adverse Events in Colombia: A Successful Case

Author(s): Ornella Moreno-Mattar*, Rosana Ramírez, Andrés Alvarado, Francisco Sierra, Javier Guzmán.

Journal Name: Current Drug Safety

Volume 14 , Issue 1 , 2019

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Graphical Abstract:


Background: The Colombian National Food and Drug Surveillance Institute (INVIMA) is responsible for monitoring the safety and efficacy of medicines circulating the Colombian market.

Discussion: This article summarizes the three key strategies the institution has implemented to strengthen the National Pharmacovigilance Program: improving the interaction and working relationship with regional health authorities, expanding the National Pharmacovigilance Network and implementing the electronic submission of adverse events.

Conclusion: The number of adverse events reported in Colombia increased from 5,447 in 2013 to 95,658 in 2017, reaching a population-based reporting ratio within international standards (563 in 2016).

Keywords: Adverse events, Colombia, electronic report, pharmacovigilance, INVIMA, regional, nodes.

World Health Organization. Reporting and learning system for medication errors: The role of pharmacovigilance centres. WHO Press [Internet] 2014; 96. Available from:
World Health Organization. Pharmacovigilance: Guarantee of safety in the use of medicines. Perspectives policies WHO on Medicam 2004; 1-6. Available from:
INVIMA. Resolution number 2004009455 of 2004. Colombia; 2004. Available from:
Ministry of Social Protection. Decree 2200 of 2005. Available from:
Tanti A, Micallef B, Serracino-Inglott A, Borg JJ. A review of the national pharmacovigilance system in malta - Implementing and operating a pharmacovigilance management system. Expert Opin Drug Saf 2017; 16(1): 65-76.

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Article Details

Year: 2019
Page: [53 - 56]
Pages: 4
DOI: 10.2174/1574886313666181109150648
Price: $65

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