The outcome of accidental BCG overdosing during routine immunization of neonates

Date
2019-12
Journal Title
Journal ISSN
Volume Title
Publisher
Stellenbosch : Stellenbosch University
Abstract
ENGLISH ABSTRACT: In January 2015, 19 neonates were accidently given intradermal BCG culture SSI, a dose 62.5 times above the standard BCG dose for neonates at a Western Cape private hospital. After recognizing the error, all neonates who were given BCG culture instead of the BCG vaccine were identified and their parents informed. A panel of paediatric infectious disease specialists were consulted and the decision was made to start treatment with high dose isoniazid and rifampicin. Fourteen of the nineteen neonates were enrolled and followed-up in order to observe what proportion of neonates would develop adverse reactions. Complications that were observed for included severe local and regional adverse reactions and systemic BCG disease. In this case series, no regional or systemic BCG disease occurred in any of the healthy term neonates who received an accidental overdose of BCG culture, instead of BCG vaccine. The conclusions of this case series are however limited by inconsistent follow-up and failure by the treating paediatricians to systematically record the required data. Expected mild adverse reactions occurred in all the neonates (n=14, 100%) in our study, which was much higher than expected when compared to the usual occurrence of BCG adverse reactions to the Bacillus Calmette-Guerin (BCG) vaccine in neonates as demonstrated by the randomised control trial by Nissen et al. The more common occurrence of mild adverse reactions could be explained by the much higher dose of BCG administered. The majority of local adverse reactions were however of short duration with approximately one third resolving within 2 weeks and not a single one being present at 6 months.
AFRIKAANSE OPSOMMING: In Januarie 2015 het 19 neonate by ’n Wes-Kaapse privaat hospitaal per abuis intradermale BCG-kultuur-SSI ontvang, ’n dosis 62,5 keer hoër as die standaarddosis BCG vir neonate. Nadat die fout ontdek is, is die neonate identifiseer en hul ouers ingelig. ‘n Paneel pediatriese infeksiesiekte spesialiste is genader en het besluit om met behandeling van hoë dosis isoniasied en rifampisien te begin. Veertien van die neëntien neonate is by die studie ingesluit en oor die loop van twee jaar opgevolg om vas te stel watter proporsie van neonate, wat gedurende die eerste week van lewe blootgestel is aan ‘n immunisasie met ‘n oordosis BCG kultuur, komplikasies sal ontwikkel. Spesifieke komplikasies waarvoor daar ge-observeer is het erge lokale en plaaslike reaksies asook sistemiese siekte ingesluit. Geen plaaslike of sistemiese BCG siekte is in die gesonde term neonate wie blootgestel is aan ‘n oordosis BCG kultuur, in stede van BCG immunisasie, en ingesluit is by hierdie gevalle studie geobserveer nie. Die gevolgtrekkings van hierdie gevalle studie word egter beperk deur die sub optimale data versameling deur plaaslike pediaters asook die swak opvolg rekord van die neonate. Die voorkoms van verwagte matige lokale reaksies in al die neonate (n=14, 100%) ingesluit in die gevalle studie was aansienlik hoër as die insidensie van lokale reaksies wat voorheen beskryf is om in neonate wat met BCG ingeënt is voor te kom. Die bevinding kan moontlik toegeskryf word aan die hoë dosis BCG wat toegedien is. Die matige lokale reaksies was van korte duur en het in ‘n derde van die groep binne twee weke opgeklaar met geen reaksies teenwoordig op ses maande opvolg nie.
Description
Thesis (MMed)--Stellenbosch University, 2019.
Keywords
BCG immunotherapy, Medication errors, Immunization of infants, Neonates -- Drug overdose
Citation