Use of antibacterial fixed-dose combinations in the private sector in eight Latin American Countries between 1999 and 2009

To assesses the safety and rationale of antibacterial fixed-dose combinations in the private sector in Latin America and determine the extent of their use.

Analysis of FDCs was based on retail sales data for eight Latin American countries (Argentina, Brazil, Chile, Colombia, Mexico, Peru, Uruguay and Venezuela) between 1999 and 2009. FDCs were classified according to the pre-defined criteria. Use was expressed as daily defined doses per 1000 inhabitants per day (DDD/TID).

A total of 175 antibacterial FDCs contained a mean of 1.3 antibacterial substances and 3.2 other active substances. Thirty-seven (21%) FDCs were classified as unsafe, 124 (70%) as lacking sufficient evidence for efficacy and only 14 (9%) of all FDCs were considered rational, for example amoxicillin and clavulanic acid. Consumption of unsafe FDCs decreased by 0.011 DDD/TID (95% CI: -0.012 to -0.009) annually, from 0.173 DDD/TID in 1999 to 0.070 DDD/TID in 2009 (overall decrease, 59.7%). Consumption of FDCs lacking sufficient evidence decreased by 30.3% (-0.018 DDD/TID [95% CI: -0.028 to -0.008] annually), while use of rational FDCs increased by 17.1% (from 1.283 DDD/TID to 1.497 DDD/TID annually).

The majority of antibacterial FDCs in the private sector lack therapeutic benefit. Despite the decrease in the consumption of unsafe antibacterials and those lacking sufficient evidence, their use remains high and their marketing does not fit into strategies of prudent use of antibiotics to contain antibacterial resistance.