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Report of Adverse Events in Colombia: A Successful Case
Ornella Moreno-Mattar1, Rosana Ramírez1, Andrés Alvarado1
1National Food and Drug Surveillance Institute (INVIMA), Carrera 10 # 64, 28 Bogota, Colombia.
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).
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