Three of the nation’s pediatric societies have reported that the government’s Essential Medicine Program (Promese/CAL) are protesting the winner of a tender that chose supplier of a pulmonary surfactant for use in newborn children. The pediatricians warn that there might be a problem with the company whose permit they say had been suspended in September 2007 by the Ministry of Public Health for “failure to provide test evidence of the product’s safety.”
A pulmonary surfactant is a vital substance that provides protection for developing lungs in newborn or premature babies. The medicine, which is introduced through the trachea, plays an important role in saving the lives of thousands of babies throughout the world.
This product is now for distribution by the nation’s “boticas” or government pharmacies.
The complaint, filed by the Dominican Neonatal Network (Redone), the Dominican Pediatric Society and the Dominican Society of Perinatal Medicine, alleges that these Dominican medical societies were not consulted regarding this contract.
In a press release sent to the Diario Libre, the medical societies pointed out that in spite of its approval by the ANMAT (the National Agency for the Administration of Medicines app foods and Medical Technology of Argentina) in March 2016, “there is no evidence of random studies or drug testing that support the safety of this pharmacological product nor is there any evidence of its experiences in use in other countries of the region.”
As reported in 7Dias, Promise said the supplier that won the tender presented a registration for the product that does not expire until 2021. Moreover, Promese/Cal states that the product has not yet been imported and they are open to hear the observations and suggestions from the medical societies.
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7 Dias
4 May 2017
