Abstract

MESQUITA, Mirta et al. Prescription of Off-label and Unlicensed Drugs in Hospitalized Newborns: a Multicenter Study in Five Hospitals in Greater Asuncion, Paraguay. Pediatr. (Asunción) [online]. 2014, vol.41, n.3, pp.208-214. ISSN 1683-9803.

Introduction: The scarcity of clinical studies on the efficacy and safety of medications in newborns leads to the use of alternative treatment using unapproved drugs. Objectives: To determine the prevalence of the use of drugs not approved by the U.S. Food and Drug Administration in newborns hospitalized at care facilities of various levels in Asuncion and Greater Asuncion. Methodology: We conducted a cross-sectional observational and descriptive study with an analytic component. Included were newborns in intensive care, intermediate care, and minimal care wards of five hospitals. Variables were birth weight, gestational age, gender, route of delivery, postnatal age on inclusion in the study, ward in which hospitalized, mechanically assisted ventilation, and type and number of unapproved drugs (UD) administered to each patient at the time of completing the questionnaire. The data were entered and analyzed using SPSS 17 and expressed as proportions and means. The Chi squared test was used and an Alpha error deemed as 5%. Results: We analyzed 105 patients aged 12±8 days upon inclusion in the study and with 11±8 days of hospitalization. UD were administered to 41 newborns (39%), comprising 92 prescriptions, most commonly (49%) in intensive care wards (p=0.01) compared to other care-level wards. The number of UD administered per newborn was 2.29±1.7 (range: 1-8). The UD most commonly used were antibiotics (42%), omeprazol and ranitidine (11%), and corticosteroids (9%). Conclusions: The prevalence of use of unapproved medications was high and demonstrated association with mechanically assisted ventilation and diagnosis of infection.

Keywords : Newborn; neonate; unlicensed drugs; unapproved drugs; off-label use.

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