Report of Adverse Events in Colombia: A Successful Case.

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).