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

Become EABM
Become Reviewer

Graphical Abstract:


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.

[1]
World Health Organization. Reporting and learning system for medication errors: The role of pharmacovigilance centres. WHO Press [Internet] 2014; 96. Available from: http://apps.who.int/iris/bitstream/10665/137036/1/9789241507943_eng.pdf?ua=1%0Ahttp://apps.who.int/iris/bitstream/10665/137036/1/9789241507943_eng.pdf
[2]
World Health Organization. Pharmacovigilance: Guarantee of safety in the use of medicines. Perspectives policies WHO on Medicam 2004; 1-6. Available from: www.who.int/medicinedocs/pdf/s6166s/s6166s.pdf
[3]
INVIMA. Resolution number 2004009455 of 2004. Colombia; 2004. Available from: https://www.invima.gov.co/resoluciones-en-medicamentos/resolucion-2004009455-2004-pdf/detail.html
[4]
Ministry of Social Protection. Decree 2200 of 2005. Available from: http://doi.wiley.com/10.1111/j.0954-6820.1937.tb03385.x
[5]
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.


Rights & PermissionsPrintExport Cite as

Article Details

VOLUME: 14
ISSUE: 1
Year: 2019
Page: [53 - 56]
Pages: 4
DOI: 10.2174/1574886313666181109150648
Price: $65

Article Metrics

PDF: 33
HTML: 2
EPUB: 1
PRC: 1