Abstract
BackgroundBetween 2014 and 2016, Brazil experienced a severe shortage in penicillin supply, resulting in a lack of treatment among some pregnant women and newborns with syphilis and the use of non-evidence-based regimens. This study evaluated all live births in Fortaleza reported with CS in 2015 in order to identify the different therapeutic regimens used in newborns during this period of penicillin shortage.MethodsA retrospective cross-sectional study design was conducted using manually extracted data from medical chart review of maternal and infant cases delivered in 2015 from all public maternity hospitals in the city of Fortaleza. Data collection occurred from June 2017 to July 2018.ResultsA total of 575 congenital syphilis cases were reported to the municipality of Fortaleza during 2015 and 469 (81.5%) were analyzed. Of these, only 210 (44.8%) were treated with a nationally-recommended treatment. As alternative therapeutic options, ceftriaxone was used in 65 (13.8%), Cefazolin in 15 (3.2%) and the combination of more than one drug in 179 (38.2%). Newborns with serum VDRL titers ≥1:16 (p = 0.021), who had some clinical manifestation at birth (p = 0.003), who were born premature (p < 0.001), with low birth weight (p = 0.010), with jaundice indicative of the need for phototherapy (p = 0.019) and with hepatomegaly (p = 0.045) were more likely to be treated with penicillin according to national treatment guidelines compared to newborns treated with other regimens.ConclusionDuring the period of shortage of penicillin in Fortaleza, less than half of the infants reported with CS were treated with a nationally-recommended regimen, the remaining received treatment with medications available in the hospital of birth including drugs that are not part of nationally or internationally-recommended treatment recommendations.
Highlights
Between 2014 and 2016, Brazil experienced a severe shortage in penicillin supply, resulting in a lack of treatment among some pregnant women and newborns with syphilis and the use of non-evidence-based regimens
In Brazil, congenital syphilis (CS) is a mandatory reporting event and recent epidemiological data indicate an incidence rate of 9.0 cases per thousand live births, with the Northeast Region presenting 9.6 cases per thousand live births [3]. These rates are much higher than the elimination threshold established by the World Health Organization (WHO), which is less than 0.5 cases for every thousand live births [4] showing that effective prevention measures in general and high-risk populations in Brazil need to be implemented for this goal to be achieved
This study evaluated all live births in Fortaleza reported with CS in 2015 in order to identify the different therapeutic regimens used in newborns reported with CS during the period of penicillin shortage
Summary
Between 2014 and 2016, Brazil experienced a severe shortage in penicillin supply, resulting in a lack of treatment among some pregnant women and newborns with syphilis and the use of non-evidence-based regimens. In 2015, more than 22,800 cases of CS were recorded in countries in Latin America and the Caribbean, corresponding to an incidence rate of 1.7 cases per thousand live births This rate is mainly related to the cases reported by Brazil, which corresponded to 85% of the records in this region [2]. Between 2014 and 2016, Brazil, along with 38 other countries, experienced a serious penicillin supply shortage due to manufacturing interruptions and quality assurance issues, resulting in lack of correct treatment among some pregnant women and infants with syphilis and use of non-evidence-based regimens [5]. These alternative treatments for infants were proposed without scientific evidence demonstrating their effectiveness [6]
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